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News

Amryt Reports Q3 2022 Financial and Operational ResultsAmryt ReportsQ3 2022 Financial and Operational Results 8.2% YoY revenue growth in Q3 to $61.1M- 12.5% on a constant currency basis 11th consecutive quarter of positive EBITDA generation; $12.5M in Q3 2022 Operating cash flows of$14.3M for Q3 2022 Cash of $83.4M at September 3, 2022 Mycapssa® re...
Amryt ReportsQ3 2022 Financial and Operational Results 8.2% YoY revenue growth in Q3 to $61.1M- 12.5% on a constant currency basis 11th consecutive quarter of positive EBITDA generation; $12.5M in Q3 2022 Operating cash flows of$14.3M for Q3 2022 Cash of $83.4M at September 3, 2022 Mycapssa® revenues increased 26.9% QoQ to $5.7M and 292.8% YoY CHMP positive opinion for Mycapssa® for the treatment of acromegaly in the EU Pathway agreed with the FDA to initiate a Phase 3 study for NET - expected in Q1 2023 Filsuvez® European launch progressing well Significant metreleptin LATAM $8.3Mtender won - revenue expected to be recognized in Q4 Reaffirming FY 2022 revenue guidance to $260M - $270M, representing 17-21% YoY growth Conference call and webcast today at 0830 ET / 1230GMT DUBLIN, Ireland, and Boston MA, November 3, 2022, Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today provides a business update and announces unaudited financial results for the third quarter ended September3, 2022. Joe Wiley, CEO of Amryt Pharma, commented:“We arepleased to report today’s strong operational and financial results which reflect another excellentquarter for Amryt.These results demonstrate the robust growth we are experiencing and represent our eleventh consecutive quarter of positive EBITDA generation. Our commercial team delivered a record Mycapssa® quarter with revenue growth of 26.9%QoQ and 292.8% YoYwhich illustrates the success of the relaunch initiatives we highlighted previously.In Q3, we added an additional 31 new prescribers which brings the YTD total new prescribers to 89, the vast majority of whom are community-based physicians. During the quarter, we also successfully negotiated our first PBM contract with Express Scripts which will greatly simplify the patient access process for Mycapssa®. Regarding Filsuvez®, theMHRA approved the product for the treatment of partial thickness wounds associated withdystrophic and junctional EB in patients 6 months and older in Great Britain. This follows on from the approval earlier on in the summer of Filsuvez® in the EU.Filsuvez® has now been launched successfully in Europe and we are encouraged by early demand. Given the strong underlying performance of our business year to date and notwithstanding the significant impact of the strengthening US dollar on our Euro revenues, we are today reaffirming our full year 2022 revenue guidance of $260-$270 million which represents growth of 17%-21% over 2021.” Q3 2022 and Recent Business Highlights: Metreleptin Metreleptin delivered significant growth in the USwith revenues growing by 10.3% YoY in Q3 2022 with patients on therapy in the US now at an all time highRobust EMEA patient demand continued in Q3 and patients on therapy grew by 25.4%YoY, however revenues were impacted by a strong US dollar. Growth on a constant currency basis during Q3 would have been 13.8% YoY.EMEA growth drivers include reimbursement for partial lipodystrophy (PL) in Italy, general lipodystrophy (GL) in the Netherlands andastrong performance in Turkey andthe Middle EastReimbursement processes are also being progressed in six other EMEA marketsSignificantLATAM tender process won and order for $8.3Mexpected in Q4 revenues Lomitapide EMEA lomitapide revenues impacted by strong US dollar despite increasing patient numbers Robust EMEA patient demand continued in Q3 and patients on therapy grew by 20.6%YoY. Revenue growth on a constant currency basis during Q3 would have been 11.8% YoY.Performance in Q3 has been strong in all EU countries - driven by Germany, Greece and SpainRecent $6M annualized Saudi Arabiatender awarded with deliveries expectedin Q4 2022 Mycapssa® Mycapssa® relaunch progressing well - steady increase in prescriber base with an additional 31 new prescribers added in Q3, 97% of whom were community-based physicians - this brings the YTD total for new prescribers to 89Continued engagement with broad group of endocrinologists during the quarter through in person calls and presence at 11 regional conferences Additional 22 million covered lives for Mycapssa®️, as a result of successful removal from Express Scripts National Formulary Exclusion list effective early SeptemberPathway agreed with the FDA to initiate a Phase 3 study for NET - expected in Q1 2023CHMP positive opinion for the use of Mycapssa® in Acromegaly in the EU - European Commission (EC) recommendation is expected on Mycapssa® by end of Q4 2022COMP positive opinion on Orphan Disease Designation for Mycapssa® for the treatment of acromegalyPresented Mycapssa® data from MPOWERED Phase 3 trial at ENEA 2022 meetingMycapssa® new US patent announced, further strengthening IP portfolio with protection to 2040Received Orphan Drug Designation from the FDA for Mycapssa® for the treatment of carcinoid syndrome associated with neuroendocrine tumors (NET) Filsuvez®1 Filsuvez® launched in Germany in SeptemberGood demand since launch - exceeding forecasts in first monthStrong inbound interest from other EU countries Expect to begin deliveries to EB patients in other EU countries by end Q4Filsuvez® approved in Great Britain for the treatment ofpartial thickness wounds associated with dystrophic and junctional EB in patients 6 months and olderPresented new positive open-label 12-month data analyses from the EASE Phase 3 trial in EB at SPD 2022British Journal of Dermatology published results from EASE Phase 3 Trial in EB Corporate Stock repurchase program -294,182 ADSs purchased in Q3 2022 at a weighted average price of $7.43 for a total cost of approx. $2.19MDistribution agreements signed with Farmamondo for markets within the APAC region Legacy Aegerion Corporate Integrity Agreement(CIA) - term of enforcement ended in September 2022FY 2022 revenue guidance of $260M - $270M reaffirmed, representing 17-21% growth over 2021 Q3 2022 Commercial Product Performance: Q3 2022 (unaudited) US$’000 US EMEA Other Total Metreleptin 20,670 16,381 875 37,926 Lomitapide 7,967 6,149 3,069 17,185 Mycapssa® 5,708 - - 5,708 Filsuvez® - 27 192 219 Other - 88 - 88 Total revenue 34,345 22,645 4,136 61,126 Q32021 (unaudited) US$’000 US EMEA Other Total Metreleptin 18,748 15,618 1,926 36,292 Lomitapide 8,568 6,406 3,565 18,539 Mycapssa® 1,453 - - 1,453 Filsuvez® - - 69 69 Other - 166 - 166 Total revenue 28,769 22,190 5,560 56,519 8.2% YoY revenue growth in Q3 2022 to $61.1M (Q3 2021: $56.5M);12.5% YoY revenue growth on a constant currency basis4.5% increase in metreleptin revenues YoY to$37.9M in Q3 2022 (Q3 2021: $36.3M)US accounted for 54.5% of global metreleptin revenues and EMEA accounted for 43.2% in Q3 2022US metreleptin revenues grew by 10.3% YoY and EMEA metreleptin revenues grew by4.9% YoY in Q32022US accounted for 46.4% of global lomitapide revenues and EMEA accounted for 35.8% in Q3 2022292.8% increase in Mycapssa® revenues YoY to $5.7Min Q3 2022(Q3 2021: $1.5M) and 26.9% growth versus Q2 2022 Q3 2022 Financial Highlights: $10.5M operating loss before finance expense for Q3 2022 (Q3 2021: $21.4M operating loss). Excluding non-cash items andshare based compensation expenses, this resulted in EBITDA3of $12.5M.Filsuvez® EMA approval €10.M ($9.7M) milestone payment paid in Q3 2022Filsuvez® CVR on EMA approval of $5.7M paid in Q3 2022Cash of $83.4M at September 30, 2022 (June 30, 2022: $90.7M). Excluding the impact of the EMA milestone payment and CVR, cash would have increased to $98.8M at September 30, 2022.The strengthening US dollar impacts Euro denominated revenues but has a negligible effect on EBITDA given the natural hedge created by Euro denominated costs IFRS and non-GAAP adjusted Q3 2022results: US$M Q3 2021 (unaudited) Q3 2022 (unaudited) Q3 2022 Non-cash adjustments2 Q3 2022 Non-GAAP Adjusted Revenue 56.5 61.1 - 61.1 Gross profit 29.3 27.4 19.7 47.1 R&D expenses (11.0) (8.0) - (8.0) SG&A expenses (25.7) (27.0) 0.4 (26.6) Restructuring and acquisition costs (11.3) - - - Share based compensation expenses (2.7) (2.9) 2.9 - Operating (loss) / profit before finance expense (21.4) (10.5) 23.0 12.53 Operating (loss) / profit before finance expense and restructuring and acquisition costs (10.1) (10.5) 23.0 12.53 1 Filsuvez® (birch extract)gel (“Filsuvez®”) has been selected as the brand name for Oleogel-S10. Filsuvez® is approvedin the EU and Great Britain for the treatment of partial thickness wounds associated with junctional and dystrophic Epidermolysis Bullosa in patients 6 months and older. 2 Non-cash items include amortisation of the acquired metreleptin, lomitapide, Mycapssa® and Filsuvez® intangible assets ($16.6M), amortisation of the inventory fair value step-up related to the acquisition of Chiasma, Inc. ($3.1M), depreciation and amortisation ($0.4M) and share based compensation expenses ($2.9M). 3 EBITDA is earnings before interest, tax, depreciation, amortisation and share based compensation expenses. To supplement Amryt's financial results presented in accordance with IFRS generally accepted accounting principles, the Company uses EBITDA as a key measure of company performance as the Company believes that this measure is most reflective of the operational profitability or loss of the Company and provides management and investors with useful supplementary information which can enhance their ability to evaluate the operating performance of the business. EBITDA, as measured by the Company, is not meant to be considered in isolation or as a substitute to operating profit / loss attributable to Amryt and should be read in conjunction with the Company's condensed consolidated financial statements prepared in accordance with IFRS. Filsuvez®Regulatory Update: In June and September respectively, Amryt announced the European Commission (EC) and UK Medical Healthcare & Products Regulatory Agency (MHRA)approval of Filsuvez® in the European Union (EU) and Great Britain for the treatment of partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa (EB) in patients 6 months and older. EB is a rare and distressing genetic skin disorder affecting young children and adults for which, until now, there has been no approved treatment in any market. The EC and MHRA approvals of Filsuvez® are supported by Phase 3 data from the EASE trial which was the largest ever global trial conducted in patients with EB, performed across 58 sites in 28 countries. As previously announced, Amryt plans to proceed to the Formal Dispute Resolution pathway withthe FDA’s Center for Drug Evaluation and Research (CDER) by which NDA applicants can seek to resolve scientific and/or medical disputes that cannot be resolved at the division level. The Company expects to submit the formal dispute resolution in November 2022. Guidance & Outlook: Given the continued strong performance of the Company’s commercial productsand notwithstanding the impact of the strengthening US dollar on the Company’s Euro denominated revenues, the board is today reaffirming revenue guidance for FY 2022 in the range of $260M - $270M which represents growth of 17% to 21% on FY 2021. Conference Call & Webcast: Amryt will host a conference call and webcast for analysts and investors today at 0830 ET/1230 GMT. Webcast Player URL:https://edge.media-server.com/mmc/p/6nxxorrj Telephone Dial in details: Standard International Number + 39 (0) 02 802 0911 United States +1 718 705 8796 United Kingdom +44 (0) 1212 818004 Ireland +353 (1) 526 9444 A playback facility will be available from November 3, 2022 - November 10, 2022. Access details for the playback facility are as follows: Dial +39 02 802 0987 then press 700723# and 723#. About Amryt Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets. Amryt’s commercial business comprises four orphan disease products – metreleptin (Myalept®/ Myalepta®); oral octreotide (Mycapssa®); lomitapide (Juxtapid®/ Lojuxta®); and Oleogel-S10 (Filsuvez®). Myalept®/Myalepta® (metreleptin) is approved in the US (under the trade name Myalept®) as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in the EU (under the trade name Myalepta®) as an adjunct to diet for the treatment of leptin deficiency in patients with congenital or acquired GL in adults and children two years of age and above and familial or acquired partial lipodystrophy (PL) in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control. For additional information, please follow this link. Mycapssa® (octreotide capsules) is approved in the US for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. Mycapssa® is the first and only oral somatostatin analog approved by the FDA. Mycapssa® has also been submitted to the EMA and has received a positive opinion by the CHMP recommending the approval of Mycapssa® in the European Union (EU). For additional information, please follow this link. Juxtapid®/Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia ("HoFH") in the US, Canada, Colombia, Argentina and Japan (under the trade name Juxtapid®) and in the EU, Israel, Saudi Arabia and Brazil (under the trade name Lojuxta®). For additional information, please follow this link. Filsuvez®(Oleogel-S10) is approved in the EU and Great Britain for the treatment of partial thickness wounds associated with junctional and dystrophic Epidermolysis Bullosa in patients 6 months and older. Amryt’s pre-clinical gene therapy candidate, AP103, offers a potential treatment for patients with Dystrophic EB, and the polymer-based delivery platform has the potential to be developed for the treatment of other genetic disorders. For more information on Amryt, including products, please visit www.amrytpharma.com. Forward-Looking Statements This announcement may contain forward-looking statements and the words "expect", "anticipate", "intends", "plan", "estimate", "aim", "forecast", "project" and similar expressions (or their negative) identify certain of these forward-looking statements. The forward-looking statements in this announcement are based on numerous assumptions and Amryt's present and future business strategies and the environment in which Amryt expects to operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. These statements are not guarantees of future performance or the ability to identify and consummate investments. Many of these risks and uncertainties relate to factors that are beyond Amryt's ability to control or estimate precisely, such as future market conditions, the course of the COVID-19 pandemic, currency fluctuations, the behaviour of other market participants, the outcome of clinical trials, the actions of regulators and other factors such as Amryt's ability to obtain financing, changes in the political, social and regulatory framework in which Amryt operates or in economic, technological or consumer trends or conditions. Past performance should not be taken as an indication or guarantee of future results, and no representation or warranty, express or implied, is made regarding future performance. No person is under any obligation to update or keep current the information contained in this announcement or to provide the recipient of it with access to any additional relevant information that may arise in connection with it. Such forward-looking statements reflect the Company’s current beliefs and assumptions and are based on information currently available to management. Contacts Joe Wiley, CEO / Rory Nealon, CFO/COO, +353 (1) 518 0200, ir@amrytpharma.com Tim McCarthy, LifeSci Advisors, LLC, +1 (917) 679 9282, tim@lifesciadvisors.com Amryt Pharma plc Condensed Consolidated Statement of Comprehensive Loss Three Months Ended September 30, Nine Months Ended September 30, Note 2022 (unaudited) 2021 (unaudited) 2022 (unaudited) 2021 (unaudited) US$’000 US$’000 US$’000 US$’000 Revenue 3 61,126 56,519 188,791 167,713 Cost of product sales (14,036) (14,127) (45,502) (41,108) Amortization of acquired intangibles (16,593) (12,701) (45,490) (34,184) Inventory fair value step-up (3,074) (437) (6,850) (1,641) Total of cost of sales (33,703) (27,265) (97,842) (76,933) Gross profit 27,423 29,254 90,949 90,780 Research and development expenses (8,005) (11,000) (28,556) (28,454) Selling, general and administrative expenses (26,976) (25,706) (82,918) (62,438) Restructuring and acquisition costs 5 (9) (11,226) (676) (14,679) Share based payment expenses 4 (2,902) (2,689) (8,930) (5,905) Operating lossbefore finance expense (10,469) (21,367) (30,131) (20,696) Non-cash change in fair value of contingent consideration 5 (771) (3,030) 3,522 (8,897) Non-cash contingent value rights (loss)/gain 5 (504) (1,915) 781 (5,515) Net finance expense – other (6,356) (6,424) (24,243) (20,163) Loss on ordinary activities before taxation (18,100) (32,736) (50,071) (55,271) Tax (charge)/credit on loss on ordinary activities (2,695) 15,527 7,736 14,726 Loss for the period attributable to the equity holders of the Company (20,795) (17,209) (42,335) (40,545) Exchange translation differences which may be reclassified through profit or loss (14) 240 (383) 2,583 Total other comprehensive (loss)/income (14) 240 (383) 2,583 Total comprehensive loss for the period attributable to the equity holders of the Company (20,809) (16,969) (42,718) (37,962) Loss per share Loss per share - basic and diluted, attributable to ordinary equity holders of the parent (US$) 6 (0.06) (0.07) (0.13) (0.20) Amryt Pharma plc Condensed Consolidated Statement of Financial Position As at, Note September 30, 2022 (unaudited) December 31, 2021 (restated*) US$’000 US$’000 Assets Non-current assets Goodwill 7 54,124 54,124 Intangible assets 7 449,816 503,330 Property, plant and equipment 6,738 7,416 Other non-current assets 1,749 1,885 Total non-current assets 512,427 566,755 Current assets Trade and other receivables 8 50,810 53,908 Inventories 9 90,238 81,835 Cash and cash equivalents, including restricted cash 10 83,400 113,032 Total current assets 224,448 248,775 Total assets 736,875 815,530 Equity and liabilities Equity attributable to owners of the parent Share capital 11 25,561 25,500 Share premium 11 322,982 318,153 Other reserves 11 247,122 246,303 Accumulated deficit (271,388) (231,194) Total equity 324,277 358,762 Non-current liabilities Contingent consideration and contingent value rights 5 51,820 81,113 Deferred tax liability 5,809 15,144 Long term loan 12 98,945 93,395 Convertible notes 13 109,655 105,788 Provisions and other liabilities 14 3,225 4,049 Total non-current liabilities 269,454 299,489 Current liabilities Trade and other payables 134,947 149,734 Provisions and other liabilities 14 6,966 7,545 Contingent consideration 5 1,231 — Total current liabilities 143,144 157,279 Total liabilities 412,598 456,768 Total equity and liabilities 736,875 815,530 *see Note 16 Amryt Pharma plc Condensed Consolidated Statement of Cash Flows Nine months ended September 30, Note 2022 (unaudited) 2021 (unaudited) US$’000 US$’000 Cash flows from operating activities Loss on ordinary activities after taxation (42,335) (40,545) Net finance expense - other 24,243 20,163 Depreciation and amortization 46,672 35,238 Amortization of inventory fair value step-up 6,850 1,641 Share based payment expenses 4 8,930 5,905 Non-cash change in fair value of contingent consideration 5 (3,522) 8,897 Non-cash contingent value rights (loss)/gain 5 (781) 5,515 Deferred taxation credit (9,335) (15,677) Movements in working capital and other adjustments: Change in trade and other receivables 8 3,287 (2,609) Change in trade and other payables (17,205) (108,468) Change in provision and other liabilities 14 (848) (2,756) Change in inventories (15,253) 39 Change in non-current assets 136 763 Net cash flow from/(used in) operating activities 839 (91,894) Cash flow from investing activities Net cash received on acquisition of subsidiary — 107,942 Milestone payments for contingent consideration and contingent value rights (16,208) — Payments for property, plant and equipment (892) (92) Payments for intangible assets (109) (830) Deposit interest received 135 3 Net cash flow used in investing activities (17,074) 107,023 Cash flow from financing activities Net proceeds/(costs) from issue of equity instruments 1,311 (116) Payments for share repurchases under Share buyback program (2,197) — Proceeds from long term borrowings - net of debt issue costs 98,344 — Repayment of long term debt (98,761) — Interest paid (8,997) (7,597) Payment of leases (912) (789) Net cash flow used in financing activities (11,212) (8,502) Exchange and other movements (2,185) (2,248) Net change in cash and cash equivalents (29,632) 4,379 Cash and cash equivalents at beginning of the period 113,032 118,798 Restricted cash at end of the period 10 150 50 Cash at bank available on demand at end of the period 10 83,250 123,127 Total cash and cash equivalents at end of the period 10 83,400 123,177 Amryt Pharma plc Condensed Consolidated Statement of Changes in Equity For the period ended September 30, 2022 Note Share capital Share premium Treasury shares Share based payment reserve Merger reserve Reverse acquisition reserve Equity component of convertible notes Other distributable reserves Currency translation reserve Accumulated deficit Total US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 Balance at January 1, 2022as restated* 25,500 318,153 — 20,593 42,627 (73,914) 29,210 217,634 10,153 (231,194) 358,762 Loss for the period — — — — — — — — — (42,335) (42,335) Foreign exchange translation reserve — — — — — — — — (383) — (383) Total comprehensive loss — — — — — — — — (383) (42,335) (42,718) Transactions with owners Issue of shares for share options exercised and vesting of RSUs 11 120 6,535 — (5,155) — — — — — — 1,500 Shares repurchased from Share buyback 11 (59) (1,706) (432) — — — — — — — (2,197) Share based payment expense 4 — — — 8,930 — — — — — — 8,930 Share based payment expense – Lapsed — — — (2,141) — — — — — 2,141 — Total transactions with owners 61 4,829 (432) 1,634 — — — — — 2,141 8,233 Balance at September 30, 2022 (unaudited) 25,561 322,982 (432) 22,227 42,627 (73,914) 29,210 217,634 9,770 (271,388) 324,277 * see Note 16 For the period ended September 30, 2021 Note Share capital Share premium Warrant reserve Treasury shares Share based payment reserve Merger reserve Reverse acquisition reserve Equity component of convertible notes Other distributable reserves Currency translation reserve Accumulated deficit Total US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 Balance at January 1, 2021 (audited) 13,851 51,408 14,762 (7,421) 7,860 42,627 (73,914) 29,210 217,634 5,730 (235,605) 66,142 Loss for the period — — — — — — — — — — (40,545) (40,545) Foreign exchange translation reserve — — — — — — — — — 2,583 — 2,583 Total comprehensive loss — — — — — — — — — 2,583 (40,545) (37,962) Transactions with owners Issue of treasury shares in exchange for warrants 11 23 99 — 439 — — — — — — — 561 Issue of treasury shares for share options exercised 11 25 89 — 465 (191) — — — — — — 388 Issue of shares and treasury shares in exchange for warrants 11 749 7,496 (14,762) 6,517 — — — — — — — — Issue of shares in consideration of Chiasma acquisition 5 10,547 249,789 — — — — — — — — — 260,336 Share based payment reserve recognized on Chiasma acquisition 11 — — — — 10,157 — — — — — — 10,157 Issue of shares for share options exercised and vesting of RSUs 11 66 1,897 — — (1,467) — — — — — — 496 Share based payment expense 4 — — — — 5,905 — — — — — — 5,905 Share based payment expense - Lapsed — — — — (54) — — — — — 54 — Total transactions with owners 11,410 259,370 (14,762) 7,421 14,350 — — — — — 54 277,843 Balance at September 30, 2021 (unaudited) 25,261 310,778 — — 22,210 42,627 (73,914) 29,210 217,634 8,313 (276,096) 306,023 1. General information Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets. As used herein, references to ‘‘we,’’ ‘‘us,’’ ‘‘Amryt’’ or the ‘‘Group’’ in these condensed consolidated interim financial statements shall mean Amryt Pharma plc and its global subsidiaries, collectively. References to the ‘‘Company’’ in these condensed consolidated interim financial statements shall mean Amryt Pharma plc. Amryt Pharma plc is a company incorporated in England and Wales. The Company is listed on Nasdaq (ticker: AMYT). The Company was also listed on the AIM market of the London Stock Exchange (ticker: AMYT) up until January 11, 2022, on which date the Company completed the cancellation its admission to AIM. The cancellation was announced by the Company on November 22, 2021, and following the AIM delisting, the Company’s American Depositary Shares (“ADSs”) remain listed, and will only be tradeable, on Nasdaq. The Company’s last day of trading on AIM was January 10, 2022. Amryt acquired Chiasma, Inc. (“Chiasma”) in August 2021. The combined company will be a global leader in rare and orphan diseases with four on-market commercial products, a global commercial and operational footprint and a significant development pipeline of therapies with the financial flexibility to execute its growth plans. Amryt’s commercial business comprises four orphan disease products – metreleptin (Myalept®/ Myalepta®); oral octreotide (Mycapssa®); lomitapide (Juxtapid®/ Lojuxta®); and Oleogel-S10 (Filsuvez®). Filsuvez® (Oleogel-S10) is approved in the EU and Great Britain for the treatment of partial thickness wounds associated with junctional and dystrophic Epidermolysis Bullosa in patients 6 months and older. During Q2 2022, Amryt had a Type A meeting with the FDA to discuss the issues raised in the Complete Response Letter (CRL) received in February 2022 relating to Amryt’s New Drug Application (NDA) for Oleogel-S10. Following this meeting, Amryt is proceeding to the Formal Dispute Resolution pathway in the FDA’s Center for Drug Evaluation and Research (CDER) by which NDA applicants can seek to resolve scientific and/or medical disputes that cannot be resolved at the division level. The Company expects to submit the formal dispute resolution in November. 2. Accounting policies Basis of preparation The condensed consolidated interim financial statements of the Group have been prepared in accordance with IAS 34 Interim Financial Reporting. They do not include all the information required in annual financial statements in accordance with International Financial Reporting Standards (‘‘IFRS’’) and should be read in conjunction with the annual consolidated financial statements for the year ended December 31, 2021. Selected explanatory notes are included to explain events and transactions that are significant to an understanding of the Group’s financial position and performance since the last annual financial statements. The accounting policies used in the preparation of the interim financial information are the same as those used in the Group’s audited financial statements for the year ended December 31, 2021, and those which are expected to be used in the financial statements for the year ended December 31, 2022. Results for the nine-month period ended September 30, 2022, are not necessarily indicative of the results that may be expected for the financial year ending December 31, 2022. Basis of going concern Having considered the Group’s current financial position and cash flow projections, the Board of Directors believes that the Group will be able to continue in operational existence for at least the next 12 months from the date of approval of these condensed consolidated interim financial statements and that it is appropriate to continue to prepare the condensed consolidated interim financial statements on a going concern basis. As part of their inquiries, the Board of Directors reviewed budgets, projected cash flows, and other relevant information for a period not less than 12 months from the date of approval of the condensed consolidated interim financial statements for the period ended September 30, 2022. Basis of consolidation The condensed consolidated interim financial statements comprise the financial statements of the Group for the period ended September 30, 2022. Subsidiaries are entities controlled by the Company. Where the Company has control over an investee, it is classified as a subsidiary. The Company controls an investee if all three of the following elements are present: power over an investee, exposure or rights to variable returns from its involvement with the investee and the ability to use its power to affect those variable returns. Control is reassessed whenever facts and circumstances indicate that there may be a change in any of these elements of control. Subsidiaries are fully consolidated from the date that control commences until the date that control ceases. Accounting policies of subsidiaries have been changed where necessary to ensure consistency with the policies adopted by the Group. Intergroup balances and any unrealized gains or losses, income or expenses arising from intergroup transactions are eliminated in preparing the condensed consolidated interim financial statements. Presentation of balances The condensed consolidated interim financial statements are presented in U.S. dollars (‘‘US$’’), rounded to the nearest thousand, which is the functional currency of the Company and presentation currency of the Group. The following table discloses the major exchange rates of those currencies other than the functional currency of US$ that are utilized by the Group: Foreign currency units to 1 US$ € £ ILS NOK DKK Average three-month period to September 30, 2022 (unaudited) 0.9919 0.8496 3.3994 9.9752 7.3795 Average nine-month period to September 30, 2022 (unaudited) 0.9403 0.7966 3.3118 9.4089 6.9958 At September 30, 2022 (unaudited) 1.0275 0.9148 3.5461 10.7479 7.6414 Foreign currency units to 1 US$ € £ ILS NOK DKK Average period to December 31, 2021 (audited) 0.8454 0.7271 3.2322 8.5975 6.2875 At December 31, 2021 (audited) 0.8830 0.7413 3.1115 8.8074 6.5664 Foreign currency units to 1 US$ € £ ILS NOK DKK Average three-month period to September 30, 2021 (unaudited) 0.8479 0.7252 3.2342 8.7609 6.3057 Average nine-month period to September 30, 2021 (unaudited) 0.8358 0.7221 3.2573 8.5522 6.2158 At September 30, 2021 (unaudited) 0.8589 0.7417 3.2149 8.7140 6.3870 (€ = Euro; £ = Pounds Sterling, ILS = Israeli Shekel, NOK = Norwegian Kroner, DKK = Danish Kroner) Changes in accounting policies and disclosures There are no new standards and amendments to IFRS effective as of January 1, 2022, that are relevant to the Group. Critical accounting judgements and key sources of estimation uncertainty In preparing these condensed consolidated interim financial statements in conformity with IFRS management is required to make judgements, estimates and assumptions that affect the application of policies and amounts reported in the condensed consolidated interim financial statements and accompanying notes. The estimates and associated assumptions are based on historical experience and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis of making the judgements about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates. The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimate is revised if the revision affects only that period or in the period of the revision and future periods if the revision affects both current and future periods. The significant estimates, assumptions or judgements, applied in the condensed consolidated interim financial statements were the same as those applied in the Group’s audited financial statements for the year ended December 31, 2021. Principal accounting policies The condensed consolidated interim financial statements have been prepared in accordance with the accounting policies adopted in the Group’s audited financial statements for the year ended December 31, 2021. 3. Segment information The Group is a global, commercial-stage biopharmaceutical company dedicated to commercializing and developing novel therapeutics to treat patients suffering from serious and life-threatening rare diseases. The Group currently operates as one business segment, pharmaceuticals, and is focused on the development and commercialization of four commercial products and a number of development products. The Group derives its revenues primarily from one source, being the pharmaceutical sector with high unmet medical need. The Group’s Chief Executive Officer, Joseph Wiley, is currently the Company’s chief operating decision maker (‘‘CODM’’). The Group does not operate any separate lines of business or separate business entities with respect to its products. Accordingly, the Group does not accumulate discrete financial information with respect to separate service lines and does not have separate reportable segments. The following table summarizes total revenues from external customers by product and by geographic region, based on the location of the customer. Three months ended September 30, 2022 (unaudited) U.S. EMEA Other Total US$’000 US$’000 US$’000 US$’000 Metreleptin 20,670 16,381 875 37,926 Lomitapide 7,967 6,149 3,069 17,185 Mycapssa® 5,708 — — 5,708 Filsuvez® — 27 192 219 Other — 88 — 88 Total revenue 34,345 22,645 4,136 61,126 Three months ended September 30, 2021 (unaudited) U.S. EMEA Other Total US$’000 US$’000 US$’000 US$’000 Metreleptin 18,748 15,618 1,927 36,293 Lomitapide 8,568 6,406 3,564 18,538 Mycapssa® 1,453 — — 1,453 Filsuvez® — — 69 69 Other — 166 — 166 Total revenue 28,769 22,190 5,560 56,519 Nine months ended September 30, 2022 (unaudited) U.S. EMEA Other Total US$’000 US$’000 US$’000 US$’000 Metreleptin 61,225 56,495 4,251 121,971 Lomitapide 23,606 20,334 8,436 52,376 Mycapssa® 13,634 — — 13,634 Filsuvez® — 27 334 361 Other — 449 — 449 Total revenue 98,465 77,305 13,021 188,791 Nine months ended September 30, 2021 (unaudited) U.S. EMEA Other Total US$’000 US$’000 US$’000 US$’000 Metreleptin 52,726 39,594 16,992 109,312 Lomitapide 25,382 21,338 9,452 56,172 Mycapssa® 1,453 — — 1,453 Filsuvez® — — 194 194 Other — 582 — 582 Total revenue 79,561 61,514 26,638 167,713 Major Customers For the three and nine months ended September 30, 2022, one customer accounted for 47% and 45% of the Group’s net revenues (2021: 47% and 48%) and accounted for 4% of the Group’s September 30, 2022, accounts receivable balance (December 31, 2021: 36%). 4. Share based payments Share-based Compensation Plans Amryt’s Equity Incentive Plan Amryt’s Equity Incentive Plan was adopted by a special resolution on September 23, 2019. Prior to such date, we granted options under a prior employee share option plan, which had the same terms and conditions as the Equity Incentive Plan. On September 24, 2019, all options held under our prior share option plan were rolled over into options to subscribe for our ordinary shares with the key terms including strike price, vesting and the expiration date of such rolled over options remaining the same as they were on the issue date of the options under the prior share option plan. The Equity Incentive Plan was approved for amendment by the Board on May 18, 2020, August 3, 2021, and November 2, 2021. The purpose of the Plan is to provide for the granting of Equity Incentives to Directors and Employees of, and Consultants to, the Company or any Associated Company. Chiasma Equity Incentive Plan When Amryt acquired Chiasma in August 2021, the Chiasma Stock Option and Incentive Plan transferred across to Amryt. Each outstanding and unexercised Chiasma Stock Option or RSU, whether vested or not vested, ceased to represent a right to acquire shares of Chiasma common stock and were converted into an option to purchase Amryt ADSs on the same terms and conditions as were applicable under such Chiasma Stock Option and Incentive Plan immediately prior to the acquisition. No new stock option or RSUs will be granted under the Chiasma stock option and incentive plan. Terms and Conditions of New Share Option Grants The terms and conditions of new grants are as follows, whereby all options are settled by physical delivery of shares: Vesting conditions The employee share options vest following a period of service by the officer or employee. The required period of service is determined by the Remuneration Committee at the date of grant of the options. There are no market conditions associated with the share option vesting periods. Contractual life The term of an option is determined by the Remuneration Committee provided that the term may not exceed a period of seven to ten years from the date of grant. All options will terminate 90 days after termination of the option holder’s employment, service or consultancy with the Group except in certain circumstances or where a longer period is approved by the Board of Directors. Under certain circumstances involving a change in control of the Group, some options will automatically accelerate and become exercisable in full as of a date specified by the Board of Directors. All share option incentives granted are in the form of ordinary shares. Share option exercise prices below are the exercise price per ordinary share. The ADS equivalent exercise price will be the ordinary share exercise price multiplied by five and the number of ADSs will be the number of ordinary shares divided by five. The number and weighted average exercise price (in Sterling pence) of share options per ordinary share granted under Amryt’s Equity Incentive Plan and the Chiasma stock option and incentive plan is as follows: Amryt Equity Incentive Plan Chiasma Stock Option and Incentive Plan Units Weighted average exercise price (Sterling pence) Units Weighted average exercise price (Sterling pence) Balance at January 1, 2021 18,753,648 122.79p — — Granted 11,337,459 190.88p — — Transferred to Amryt on acquisition — — 18,139,060 189.07p Forfeited (1,288,165) 174.97p (4,098,425) 226.22p Exercised (300,000) 93.00p (3,320,515) 116.35p Outstanding share option per ordinary share at December 31, 2021 (audited) 28,502,942 147.83p 10,720,120 197.40p Outstanding share option per ADS at December 31, 2021 (audited) 5,700,588 739.15p 2,144,024 987.00p Exercisable share option per ordinary share at December 31, 2021 (audited) 9,347,338 118.87p 8,005,390 192.35p Exercisable share option per ADS at December 31, 2021 (audited) 1,869,468 594.35p 1,601,078 961.75p Balance at January 1, 2022 28,502,942 147.83p 10,720,120 197.40p Granted 17,571,590 104.71p — — Forfeited (2,594,275) 164.74p (3,315,340) 199.89p Exercised (492,905) 113.22p (536,075) 96.99p Outstanding share option per ordinary share at September 30, 2022 (unaudited) 42,987,352 129.58p 6,868,705 204.03p Outstanding share option per ADS at September 30, 2022 (unaudited) 8,597,470 647.90p 1,373,741 1,020.15p Exercisable share option per ordinary share at September 30, 2022 (unaudited) 13,280,645 133.62p 5,616,445 248.91p Exercisable share option per ADS at September 30, 2022 (unaudited) 2,656,129 668.10p 1,123,289 1,244.55p The fair value of the Amryt equity award is estimated at the date of grant using the Black-Scholes pricing model, taking into account the terms and conditions attached to the grant. The fair value of the Chiasma equity awards transferred to Amryt on acquisition were measured in accordance with IFRS 2. The portion of the value of the equity transferred to Amryt attributable to pre-combination service is included in the consideration at the date of acquisition. The portion of the equity awards transferred to Amryt attributable to post combination service is estimated at the date of transfer using Black Scholes pricing model, taking into account the terms and conditions attached to the grant. The following are the inputs to the model for the equity instruments granted during the period: September 30, 2022 OptionsInputs (unaudited) December 31, 2021 Options Inputs (unaudited) Days to Expiration 2,555 2,555 Volatility 39% - 41% 32% - 49% Risk free interest rate 1.96% - 2.96% 0.77% - 1.33% Share price at grant per ordinary share (in Sterling pence) 99.9 – 131.7p 146.87 - 201.2p Share price at grant per ADS (in Sterling pence) 499.5 – 658.5p 734.35 - 1006.0p In the nine months ended September 30, 2022, a total of 17,571,590 share options over ordinary shares exercisable at a weighted average price of US$1.23 (£1.05) were granted. The fair value of share options granted in the period ended September 30, 2022, was US$24,249,633/£18,399,362. The share options outstanding under the Amryt 2021 Equity Incentive Plan as at September 30, 2022, had a weighted remaining contractual life of 5.14 years with exercise prices ranging from £0.76 to £2.012 per ordinary share. In the year ended December 31, 2021, a total of 11,337,459 share options over ordinary shares exercisable at a weighted averageprice of £1.91 were granted. The fair value of share options granted in the year ended December 31, 2021, was£21,641,094/US$29,818,000. The share options outstanding under the Amryt 2021 Equity Incentive Plan as at December 31, 2021 have a weighted remainingcontractual life of 5.42 years with exercise prices ranging from £0.76 to £2.012 per ordinary share. The share options outstanding under the Chiasma Share Option and Incentive Plan transferred across to Amryt on acquisition. As at September 30, 2022, they have a weighted remaining contractual life of 4.76 years with exercise prices ranging from £0.54 to £7.41 per ordinary share. No new share options will be granted under the Chiasma Stock Option and Incentive Plan. Restricted Share Units Under the terms of Amryt’s Equity Incentive Plan, restricted share units (“RSUs”) to purchase 3,429,595 ordinary shares were outstanding at September 30, 2022. Under the terms of this plan, RSUs are granted to officers, consultants and employees of the Group at the discretion of the Remuneration Committee. For the nine month period ended September 30, 2022, a total of 2,588,215 RSUs were granted to employees of the Company. For the year ended December 31, 2021, a total of 625,205 RSUs were granted to employees of the Company. The fair value of the RSUs is based on the share price at the date of grant, with the expense spread over the vesting period. The fair value of RSUs granted in the nine month period ended September 30, 2022, was US$3,691,000. At September 30, 2022, the total RSUs granted to date have a weighted remaining contractual life of 2.1 years. Under the terms of Chiasma’s Stock Option and Incentive Plan transferred to Amryt on acquisition, restricted share units (“RSUs”) to purchase 48,795 ordinary shares were outstanding at September 30, 2022. At September 30, 2022, the total RSUs granted to date have a weighted remaining contractual life of 1.36 years. No new RSUs will be granted under the Chiasma Stock Option and Incentive Plan. The following table summarizes the RSU activity per ordinary share for the period: Amryt Equity Incentive Plan Chiasma Stock Option and Incentive Plan Units Weighted average fair value (US$) Units Weighted average fair value (US$) Balance at January 1, 2021 1,549,910 $2.34 — — Granted 625,205 $2.62 — — Transferred to Amryt on acquisition — — 202,145 $2.75 Lapsed (243,505) $2.35 (56,405) $2.75 Vested (362,855) $2.34 (39,180) $2.75 Outstanding RSU per ordinary share at December 31, 2021 (audited) 1,568,755 $2.44 106,560 $2.75 Outstanding RSU per ADS at December 31, 2021 (audited) 313,751 $12.20 21,312 $13.75 Balance at January 1, 2022 1,568,755 $2.44 106,560 $2.75 Granted 2,588,215 $1.43 — — Lapsed (289,065) $1.97 (8,465) $2.75 Vested (438,310) $2.45 (49,300) $2.75 Outstanding RSU per ordinary share at September 30, 2022 (unaudited) 3,429,595 $1.72 48,795 $2.75 Outstanding RSU per ADS at September 30, 2022 (unaudited) 685,919 $8.60 9,759 $13.75 Performance Stock Units Under the terms of Amryt’s Equity Incentive Plan, performance share units (“PSUs”) to purchase 1,961,102 ordinary shares were granted to officers and employees at the discretion of the Remuneration Committee in the nine month period to September 30, 2022. Performance conditions determine how many of these performance stock units will vest and, if performance targets are exceeded, additional performance stock units will be issued and vest in accordance with the terms of the relevant performance stock units award. The PSUs vest based on the Total Shareholder Return (“TSR”) of Amryt’s NASDAQ traded common stock relative to the TSRs of the constituents that comprise the NASDAQ Biotechnology Index (the Peer Group) as of January 1, 2022. TSR for Amryt and each peer company will be measured over the period from January 1, 2022, to December 31, 2024. The payout schedule can produce payout percentages ranging from 0% to 150%. The following table summarizes the PSU activity per ordinary share for the period: Amryt Equity Incentive Plan Units Weighted average fair value (US$) Balance at January 1, 2022 — — Granted 1,961,102 $1.42 Lapsed — — Vested — — Outstanding PSU per ordinary share at September 30, 2022 (unaudited) 1,961,102 $1.42 Outstanding PSU per ADS at September 30, 2022 (unaudited) 392,220 $7.10 Warrants There are no outstanding warrants at September 30, 2022 (December 31, 2021: nil). In August 2021, an Amryt institutional investor exercised subscription rights relating to 8,966,520 zero cost warrants. These warrants were issued in September 2019 as part of the Company’s acquisition of Aegerion. Certain institutional investors elected to receive warrants to subscribe for new ordinary shares of £0.06 each in Amryt (“Ordinary Shares”), in place of the same number of Ordinary Shares, as consideration for the Company’s acquisition of Aegerion and their equity investments in the Company in September 2019. Each warrant entitled the holder to subscribe for one Ordinary Share for no additional consideration. Separate warrants consisting of 345,542 as at December 31, 2020, which were issued in connection with the admission to the AIM in 2016, are no longer outstanding; 283,389 warrants were exercised in March 2021 and 62,153 warrants lapsed in April 2021. The number and weighted average exercise price (in Sterling pence) of warrants per ordinary share is as follows: Warrants Units Weighted average exercise price (Sterling pence) Balance at January 1, 2021 9,312,062 0.05p Granted — — Lapsed (62,153) 1.44p Exercised (9,249,909) 0.05p Outstanding at December 31, 2021 (audited) — 0.00p The value of share options and RSU’s charged to the Condensed Consolidated Statement of Comprehensive Loss during the period is as follows: Three months ended September 30, Nine months ended September 30, 2022 (unaudited) 2021 (unaudited) 2022 (unaudited) 2021 (unaudited) US$’000 US$’000 US$’000 US$’000 Share option expense 1,875 2,173 7,481 4,525 RSU expense 750 516 1,112 1,380 PSU expense 277 — 337 — Total share based payment expenses 2,902 2,689 8,930 5,905 5. Business combinations and asset acquisitions Acquisition of Chiasma On May 5, 2021, Amryt announced that it had signed a definitive agreement to acquire Chiasma, Inc. (Nasdaq: CHMA) in an all-stock combination. Under the terms of the transaction, each share of Chiasma common stock issued and outstanding prior to the consummation of the transaction was exchanged for 0.396 Amryt ADSs, each representing five Amryt ordinary shares. On August 5, 2021, Amryt completed the acquisition of Chiasma, Inc. and, in conjunction with the completion, Amryt allotted and issued a total of 127,733,680 ordinary shares as consideration for the acquisition. Following the completion, shareholdings in Chiasma were rounded in being converted to Amryt shares using the exchange ratio of 0.396. Roundings in converting Chiasma shareholdings to Amryt shares were finalized in August 2021 and resulted in an additional 7,015 ordinary shares being allotted and issued by Amryt as consideration for the acquisition. In total, these ordinary shares were issued to the former Chiasma Shareholders in the form of 25,548,139 ADSs at US$10.19 per share, to acquire Chiasma for a value of US$260,336,000. On August 5, 2021, Chiasma had outstanding equity awards that were held by Chiasma employees. The fair value of these awards transferred to Amryt on acquisition were measured in accordance with IFRS 2. The portion of the value of the equity transferred to Amryt attributable to pre-combination service is included in the consideration at the date of acquisition and this amounted to US$10,157,000. On August 5, 2021, the Group repaid US$116,629,000 of Chiasma long term debt. The combined company will be a global leader in rare and orphan diseases with four on-market commercial products, a global commercial and operational footprint and a significant development pipeline of therapies with the financial flexibility to execute its growth plans. The Group incurred acquisition and restructuring related costs of US$9,000 and US$676,000 for the three-month period and nine-month period ended September 30, 2022, respectively, relating to external legal fees, advisory fees, due diligence costs and severance costs related to the acquisition of Chiasma. These costs have been included in operating costs in the Condensed Consolidated Statement of Comprehensive Loss. IFRS 3 Business combinations requires the assignment of fair values to identifiable assets and liabilities acquired to be completed within 12 months of the acquisition date. The initial assignment of fair values was included in the consolidated financial statement for the year ending December 31, 2021, and subsequent consolidated interim financial statements. The Group finalized the fair values of the assets and liabilities of Chiasma in August 2022. The adjustments made in finalizing fair values primarily relate to the measurement of intangible assets separately from goodwill, valuation of inventory and associated deferred tax liabilities. The acquired goodwill is attributable principally to the profit generating potential of the businesses, the assembled workforce and benefits arising from embedded infrastructure, that are expected to be achieved from integrating the acquired businesses into the Group’s existing business. No amount of goodwill is expected to be deductible for tax purposes. Fair Values as at August 5, 2021 As previously reported in Dec 31, 2021, financial statements Adjustments* Fair value US$’000 US$’000 US$’000 Assets Non-current assets Intangible assets 215,000 37,000 252,000 Property, plant and equipment 950 — 950 Other non-current assets 866 — 866 Total non-current assets 216,816 37,000 253,816 Current assets Trade and other receivables 7,180 — 7,180 Inventories 65,907 (33,709) 32,198 Cash and cash equivalents, including restricted cash 107,942 — 107,942 Total current assets 181,029 (33,709) 147,320 Total assets 397,845 3,291 401,136 Non-current liabilities Deferred tax liability 21,478 727 22,205 Total non-current liabilities 21,478 727 22,205 Current liabilities Trade and other payables 144,482 — 144,482 Total current liabilities 144,482 — 144,482 Total liabilities 165,960 727 166,687 Total identifiable net assets at fair value 231,885 2,564 234,449 Goodwill arising on acquisition 38,608 (2,564) 36,044 Consideration 270,493 — 270,493 Consideration Issue of fully paid up ordinary shares 260,336 — 260,336 Chiasma equity awards recognized as consideration transferred upon the acquisition of Chiasma 10,157 — 10,157 Total consideration 270,493 — 270,493 *Adjustments relate to finalization of fair values following completion of the fair value assignment to identifiable assets and liabilities acquired. See Note 16, Restatement of prior year comparatives, for more details on the adjustments. Acquisition of Aegerion Pharmaceuticals On May 20, 2019, Amryt entered into a Restructuring Support Agreement (as subsequently amended on June 12, 2019) and Plan Funding Agreement pursuant to which, among other matters, Amryt agreed to the acquisition of Aegerion Pharmaceuticals, Inc. (‘‘Aegerion’’, subsequently renamed as Amryt Pharmaceuticals Inc.), a former wholly-owned subsidiary of Novelion Therapeutics Inc. (‘‘Novelion’’). On May 20, 2019, Aegerion and its U.S. subsidiary, Aegerion Pharmaceuticals Holdings, Inc., filed voluntary petitions under Chapter 11 of Title 11 of the U.S. Code in the Bankruptcy Court. On September 24, 2019, Amryt completed the acquisition of Aegerion. Amryt acquired Aegerion upon its emergence from bankruptcy in an exchange for ordinary shares and zero cost warrants in Amryt. Amryt issued 85,092,423 effective shares at US$1.793 per share, which is made up of 77,027,423 ordinary shares and 8,065,000 zero cost warrants, to acquire Aegerion for a value of US$152,615,000. As part of the acquisition of Aegerion, it was agreed, for certain Aegerion creditors who wished to restrict their percentage share interest in Amryt’s issued share capital, to issue to the relevant Aegerion creditor, as an alternative to Amryt’s ordinary shares, an equivalent number of new zero cost warrants to subscribe for Amryt’s ordinary shares to be constituted on the terms of the zero cost warrant. As at September 30, 2022, no zero cost warrants were remaining. Contingent Value Rights Related to the transaction, Amryt issued Contingent Value Rights (‘‘CVRs’’) pursuant to which up to US$85,000,000 may become payable to Amryt’s shareholders and optionholders, who were on the register prior to the completion of the acquisition on September 20, 2019, if certain approval and revenue milestones are met in relation Oleogel-S10, Amryt’s lead product candidate. If any such milestone is achieved, Amryt may elect to pay the holders of CVRs by the issue of Amryt shares or loan notes. If Amryt elects to issue Loan Notes to holders of CVRs, it will settle such loan notes in cash 120 days after their issue. If none of the milestones are achieved, scheme shareholders and optionholders will not receive any additional consideration under the terms of the CVRs. In these circumstances, the value of each CVR would be zero. The terms of the CVRs are as follows:  The total CVR payable is up to US$85,000,000  This is divided into three milestones which are related to the success of Oleogel-S10 (the Group’s lead development asset)  Food and Drug Administration (“FDA”) approval o US$35,000,000 upon FDA approval o 100% of the amount due if approval is obtained before December 31, 2021, with a sliding scale on a linear basis to zero if before July 1, 2022. The time line for this milestone has now passed and, therefore, will not be paid.  European Medicines Agency (“EMA”) approval o US$15,000,000 upon EMA approval o 100% of the amount due if approval is obtained before December 31, 2021, with a sliding scale on a linear basis to zero if before July 1, 2022  Revenue targets o US$35,000,000 upon Oleogel-S10 revenues exceeding US$75,000,000 in any 12-month period prior to June 30, 2024  Payment can at the Board’s discretion be in the form of either: o 120-day loan notes (effectively cash), or o Shares valued using the 30 day / 45-day VWAP. The CVRs were contingent on the successful completion of the acquisition and, accordingly, have been based on fair value as at September 24, 2019. The CVRs have been classified as a financial liability in the Condensed Consolidated Statement of Financial Position. Given that CVRs were issued to legacy Amryt shareholders in their capacity as owners of the identified acquirer as opposed to the seller in the transaction, management concluded that the most appropriate classification would be to recognize the CVR as a distribution on consolidation instead of goodwill. Following the EMA approval of Filsuvez (Oleogel S-10) during the period ended September 30, 2022, the EMA CVRs issued to those Amryt shareholders and option holders who held Amryt shares or options prior to the acquisition of Aegerion Pharmaceuticals, Inc. (“CVR Holders”) became payable. Amryt elected to issue Loan Notes in May 2022 that were redeemed in full in September 2022 to the holders of the CVRs. The total amount paid to CVR Holders was US$5,718,000, which was determined with reference to the EMA approval being obtained before December 31, 2021, with a sliding scale on a linear basis to zero if before July 1, 2022. Measurement of Contingent Value Rights As at September 30, 2022, the carrying value of the Contingent Value Rights liability was US$13,394,000 (December 31, 2021: US$19,892,000). As the EMA approval milestone has been triggered and the FDA approval will not be achieved in time for the FDA approval milestone to be triggered, the Contingent Value Rights liability outstanding as at September 30, 2022, relates to the Revenue target milestones and the related expected discounted cash flows. The value of this potential payout was calculated using the probability-weighted expected returns method. Using this method, the potential payment amounts were multiplied by the probability of achievement and discounted to present value. The probability adjusted present values took into account published orphan drug research data and statistics which were adjusted by management to reflect the specific circumstances applicable to the type of product acquired in the Amryt GmbH transaction. The probability chance of success is based on management’s expertise and experience for orphan drugs and takes into account the unique circumstances applying to the approval process of this product. The EMA approval probability was set at 100% following the approval received in 2022 (December 31, 2021: estimated at 100%) and the probability of success for the FDA approval was estimated at 50% (December 31, 2021: 60%) as at September 30, 2022. The EMA approval probability reflects the EMA approval achieved in 2022 and the FDA estimate reflects the current facts and circumstances as of the date of issuance of the Condensed Consolidated Financial Statements. The FDA approval probability chance of success was updated in 2022 following developments related to the receipt of a CRL from the FDA, where Amryt announced in June 2022 its intention to submit a Formal Dispute Resolution Request (FDRR) for the company’s NDA for Filsuvez®. The Company expects to submit the formal dispute resolution in November.Discount rates of 10% and 16.5%, as applicable, were used in the calculation of the present value of the estimated contractual cash flows for the nine month period ended September 30, 2022 (December 31, 2021: 10% and 16.5%, as applicable,), based on the applicable rates determined on the acquisition date. Management was required to make certain estimates and assumptions in relation to revenue forecasts, timing of revenues and probability of achievement of commercialization of Oleogel-S10. However, management notes that, due to issues outside their control (i.e. regulatory requirements and the commercial success of the product), the timing of when such revenue targets may occur may change. Such changes may have a material impact on the assessment of the expected cash flows of the CVRs. Amryt reviews the expected cash flows on a regular basis as the discount on initial recognition is being unwound as financing expenses in the Consolidated Statement of Comprehensive Loss over the life of the obligation. It is reviewed on a quarterly basis and the appropriate finance charge or gain is booked in the Consolidated Statement of Comprehensive Loss on a quarterly basis. The non-cash loss recognized in the Condensed Consolidated Statement of Comprehensive Loss for the three month period ended September 30, 2022, is US$504,000and the non-cash gain for thenine month period ended September 30, 2022 is US$781,000(September 30, 2021: US$1,915,000loss and US$5,515,000 loss, respectively). Acquisition of Amryt GmbH (previously ‘‘Birken’’) Amryt DAC signed a conditional share purchase agreement to acquire Amryt GmbH on October 16, 2015 (‘‘Amryt GmbH SPA’’). The Amryt GmbH SPA was completed on April 18, 2016, with Amryt DAC acquiring the entire issued share capital of Amryt GmbH. The consideration included contingent consideration comprising milestone payments and sales royalties as follows:  Milestone payments of: o €10,000,000 on receipt of marketing approval by the EMA or FDA of a pharmaceutical product containing Betulin as its API for the treatment of EB. Following EMA approval in 2022, this milestone was paid in July 2022; o €10,000,000 once net ex-factory sales/net revenue of Oleogel S-10 first exceed €50,000,000 in any calendar year; o €15,000,000 once net ex-factory sales/ net revenue of Oleogel S-10 first exceed €100,000,000 in any calendar year;  Cash consideration of €150,000, due and paid on the completion date (April 18, 2016); and  Royalties of 9% on sales of Oleogel-S10 products for 10 years from first commercial sale. Fair Value Measurement of Contingent Consideration As at September 30, 2022, the fair value of the contingent consideration was estimated to be US$39,657,000 (December 31, 2021: US$61,221,000). The EMA or FDA marketing approval milestone payment was triggered following the EMA approval of Filsuvez® in 2022 and the liability of $10,490,000 (€10,000,000) was paid in July 2022. The fair value of the remaining contingent consideration includes milestone payments determined using probability adjusted present values and probability weighted revenue forecasts (see Note 15, Fair value measurement and financial risk management, for fair value hierarchy applied and impact of key unobservable impact data). The probability adjusted present values took into account published orphan drug research data and statistics which were adjusted by management to reflect the specific circumstances applicable to the type of product acquired in the Amryt GmbH transaction. The probability chance of success is based on management’s expertise and experience for orphan drugs and takes into account the unique circumstances applying to the approval process of this product. The EMA approval probability was set at 100% following the approval received in 2022 (December 31, 2021: estimated at 100%) and the probability of success for the FDA approval was estimated at 50% (December 31, 2021: 60%) as at September 30, 2022. The EMA approval probability reflects the EMA approval achieved in 2022 and the FDA estimate reflects the current facts and circumstances as of the date of issuance of the Condensed Consolidated Financial Statements. The FDA approval probability chance of success was updated in 2022 following developments related to the receipt of a CRL from the FDA, where Amryt announced in June 2022 its intention to submit a FDRR for the company’s NDA for Filsuvez®. A discount rate of 7.9% was used in the calculation of the fair value of the contingent consideration for the ninemonth period ended September 30, 2022 (December 31, 2021: 7.9%). Amryt reviews the expected cash flows on a regular basis as the discount on initial recognition is being unwound as financing expenses in the Consolidated Statement of Comprehensive Loss over the life of the obligation. It is reviewed on a quarterly basis and the appropriate finance charge or gain is booked in the Consolidated Statement of Comprehensive Loss on a quarterly basis. The non-cash loss recognized in the Condensed Consolidated Statement of Comprehensive Loss for the three month period ended September 30, 2022, is US$771,000and the non-cash gain recognized in the nine months ended September 30, 2022 is US$3,522,000 (September 30, 2021: US$3,030,000loss and US$8,897,000loss, respectively). 6. Loss per share – basic and diluted The weighted average number of shares in the loss per share (‘‘LPS’’) calculation, reflects the weighted average total actual shares of Amryt Pharma plc in issue at September 30, 2022. Issued share capital – ordinary shares of £0.06 each Number of shares Weighted average shares As at September 30, Three months ended September 30, Nine months ended September 30, 2022 (unaudited) 319,858,447 320,232,444 320,514,995 2021 (unaudited) 316,904,642 264,368,691 207,876,731 The calculation of loss per share is based on the following: Three months ended September 30, Nine months ended September 30, 2022 (unaudited) 2021 (unaudited) 2022 (unaudited) 2021 (unaudited) Loss after tax attributable to equity holders of the Company (US$’000) (20,795) (17,209) (42,335) (40,545) Weighted average number of ordinary shares in issue 320,232,444 264,368,691 320,514,995 207,876,731 Fully diluted average number of ordinary shares in issue 320,232,444 264,368,691 320,514,995 207,876,731 Basic and diluted loss per share (US$) (0.06) (0.07) (0.13) (0.20) Where a loss has occurred, basic and diluted LPS are the same because the outstanding share options and warrants are anti-dilutive. Accordingly, diluted LPS equals the basic LPS. The share options, RSUs, PSUs and warrants outstanding as at September 30, 2022, totaled 55,295,549 (September 30, 2021: 47,156,506) and are potentially dilutive. 7. Intangible assets and goodwill The following table summarizes the Group’s intangible assets and goodwill: Developed technology - metreleptin Developed technology - lomitapide Developed technology - Mycapssa® Developed technology -Oleogel-S10 IPRD and Other intangible assets Total intangible assets Goodwill US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 Cost At January 1, 2021 (audited) 176,000 123,000 — — 60,994 359,994 19,131 Additions — — — — 847 847 — Acquired assets, as restated* — — 252,000 — — 252,000 36,044 Other movements — — — — — — (1,051) Foreign exchange movement — — — — (4,752) (4,752) — At December 31, 2021,as restated* 176,000 123,000 252,000 — 57,089 608,089 54,124 Foreign exchange movement — — — — (8,017) (8,017) — Additions — — — — 109 109 — Transfers — — — 47,153 (47,153) — — At September 30, 2022 (unaudited) 176,000 123,000 252,000 47,153 2,028 600,181 54,124 Accumulated amortization At January 1, 2021 (audited) 34,743 19,680 — — 202 54,625 — Amortization charge, as restated* 27,428 15,537 7,008 — 147 50,120 — Foreign exchange movement — — — — 14 14 — At December 31, 2021,as restated* 62,171 35,217 7,008 — 363 104,759 — Amortization charge 20,570 11,653 13,034 231 274 45,762 — Foreign exchange movement — — — — (156) (156) — At September 30, 2022 (unaudited) 82,741 46,870 20,042 231 481 150,365 — Net book value At December 31, 2021,as restated* 113,829 87,783 244,992 — 56,726 503,330 54,124 At September 30, 2022 (unaudited) 93,259 76,130 231,958 46,922 1,547 449,816 54,124 * see Note 16 Developed technology on commercially marketed products In connection with the acquisition of Aegerion in September 2019, the Group acquired developed technology, metreleptin and lomitapide. These intangible assets are amortized over their estimated useful lives and the remaining useful lives for metreleptin and lomitapide are approximately 3.4 and 4.9 years, respectively, as of September 30, 2022 (December 31, 2021: 4.2 and 5.7 years, respectively). In connection with the acquisition of Chiasma in August 2021, the Group acquired developed technology, octreotide. This intangible asset is amortized over its estimated useful life and the remaining useful life is approximately 13.4 years as of September 30, 2022 (December 31, 2021: 14.2). As a result of the acquisition of Amryt GmbH, in 2016, the Group recognized in-process R&D costs of €48,453,000 (US$54,872,000 as of the acquisition date) which is related to the Group’s lead development asset, Oleogel-S10. During the period ended September 30, 2022, the intangible asset commenced amortisation following the EMA approval of Filsuvez® and subsequent launch in 2022. The carrying value of this intangible asset included in developed technology - Oleogel-S10 is equal to US$46,922,000 (December 31, 2021: US$54,871,000). The intangible asset is being amortized over its estimated useful life and the remaining useful life is approximately 17.3 years as of September 30, 2022. In-process R&D The prior year in-process R&D balances have been represented for presentational purposes and have been combined with Other intangible asset balances. Included in the balance in-process R&D and other intangible assets is the in-process R&D acquired as part of the acquisition of Cala Medical Limited in October 2020. Goodwill During 2019, the Group completed the acquisition of Aegerion which resulted in the recognition of goodwill that has a carrying value of US$18,080,000. On August 5, 2021, the Group completed the acquisition of Chiasma, which resulted in aggregate goodwill of US$36,044,000, as restated (See Note 16). The Group reviews events or changes in circumstances that may indicate a triggering event for impairment, at each reporting date, and conducts an annual impairment review to determine any impairment charge required. Management completed an impairment review by determining recoverable amounts from value in use calculations. The recoverable amount of an asset or cash generating unit is estimated in order to determine the extent of an impairment charge. There was no impairment charge recorded during the nine months ended September 30, 2022. 8. Trade and other receivables As at September 30, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Trade receivables 37,604 34,263 Accrued income and other debtors 10,267 12,201 VAT recoverable 2,939 7,444 Trade and other receivables 50,810 53,908 9. Inventories As at September 30, 2022 (unaudited) December 31, 2021 restated* US$’000 US$’000 Raw materials 38,310 35,521 Work in progress 11,061 8,122 Finished goods 40,867 38,192 Inventories 90,238 81,835 *See Note 16 Inventories for the period ended September 30, 2022, includes inventory acquired as part of the acquisition of Chiasma on August 5, 2021, which was fair valued as of the date of the acquisition. The fair value of the acquired inventory amounted to US$32,198,000, as restated. Inventory on hand at the date of acquisition was valued at the expected selling price less the sum of remaining costs of disposal, cost to complete and a reasonable profit margin for the selling effort of the acquiring entity. The costs to complete were calculated based on costs incurred on recently completed finished goods. The costs to dispose include sales and marketing expenses required to sell the product to the customer in addition to certain general and administrative expenses expected to be incurred by Amryt. This resulted in a non-cash step up at the valuation of inventory at August 5, 2021, of US$23,414,000. The non-cash step up in inventory is being unwound to the Condensed Consolidated Statement of Comprehensive Loss over the period in which this saleable inventory is sold. At September 30, 2022, US$13,125,000 of this non-cash inventory step up is included in inventory. 10. Cash and cash equivalents As at September 30, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Cash at bank available on demand 83,250 112,771 Restricted cash 150 261 Total cash and cash equivalents 83,400 113,032 Cash and cash equivalents include cash at bank available on demand and restricted cash. At September 30, 2022, and December 31, 2021, there was US$150,000 and US$261,000 of restricted cash, respectively. The balance at September 30, 2022, consists of a letter of credit related to US customs which was put in place for an amount of US$50,000 and a letter of credit related to a deposit on a company credit card facility for an amount of US$100,000. The balance at December 31, 2021, includes a deposit on a company credit card facility for an amount of US$$126,000, a lease deposit for US$85,000 and a letter of credit related to US customs which was put in place for an amount of US$50,000. 11. Share capital and reserves Details of the number of issued ordinary shares with a nominal value of Sterling 6 pence (2021: 6 pence) each are in the table below. Ordinary shares Treasury shares Total At January 1, 2021 (audited) 178,801,593 4,791,703 183,593,296 Issue of treasury shares in exchange for warrants 283,389 (283,389) — Issue of treasury shares for share options exercised 300,000 (300,000) — Issue of shares in consideration of Chiasma acquisition 127,740,695 — 127,740,695 Issue of shares in exchange for warrants 4,758,206 — 4,758,206 Issue of treasury shares in exchange for warrants 4,208,314 (4,208,314) — Issue of shares for share options exercised and RSUs vesting 3,722,550 — 3,722,550 At December 31, 2021 (audited) 319,814,747 — 319,814,747 Issue of shares for share options exercised and RSUs vesting 1,514,610 — 1,514,610 Share repurchased under share buyback program (1,470,910) 1,470,910 — Share cancelled from treasury shares — (1,187,350) (1,187,350) At September 30, 2022 (unaudited) 319,858,447 283,560 320,142,007 The components of equity are detailed in the Condensed Consolidated Statement of Changes in Equity and described in more detail below. On March 11, 2021, the Company issued 300,000 ordinary shares from treasury shares following the exercise of share options. On March 11, 2021, the Company issued 283,389 ordinary shares from treasury shares in exchange for certain warrants. On August 5, 2021, the Company issued 127,740,695 ordinary shares, in the form of ADSs, as consideration for the acquisition of Chiasma. On August 5, 2021, the Company issued 8,966,520 ordinary shares with 4,208,314 being issued from treasury shares in exchange for warrants. During the year ended December 31, 2021, there were 3,342,680 shares issued following the exercise of share options and 379,870 shares issued following RSUs vesting. During the period ended September 30, 2022, there were 1,028,980 shares issued following the exercise of share options and 485,630 shares issued following RSUs vesting. Share Capital Share capital represents the cumulative par value arising upon issue of ordinary shares of Sterling 6 pence each. The ordinary shares have the right to receive notice of, attend and vote at general meetings and participate in the profits of the Company. Share Premium Share premium represents the consideration that has been received in excess of the nominal value on issue of share capital net of issue costs and transfers to distributable reserves. Warrant reserve The warrant reserve represented zero cost warrants issued as part of the equity raise on September 24, 2019, net of issue costs apportioned to warrants issued and additional warrants issued to certain shareholders on November 14, 2019. Each warrant entitles the holder to subscribe for one ordinary share at zero cost. The Company issued 4,000,000 and 4,229,753 ordinary shares on July 15, 2020, and September 22, 2020, respectively, in exchange for certain warrants. The remaining warrants were exchanged on August 5, 2021, and the Company issued 8,966,520 ordinary shares, 4,208,314 of which were issued from treasury shares and there are no longer any warrants outstanding. Treasury Shares In October 2020, the Company issued 72,953 ordinary shares from treasury shares following the exercise of share options. In March 2021, the Company issued a total of 583,389 ordinary shares from treasury shares, 300,000 ordinary shares relating to the exercise of share options and 283,389 ordinary shares following the exchange of certain warrants. In August 2021, the company issued 4,208,314 ordinary shares from treasury shares in conjunction with the exchange of warrants and since August 2021 there are no longer any treasury shares held. In Q3 2022, the Company repurchased 1,470,910 ordinary shares in conjunction with the share buyback program that was initiated in July 2022. During the same period, the Company cancelled 1,187,350 of the shares repurchased. Share based payment reserve Share based payment reserve relates to the charge for share based payments in accordance with IFRS 2. In March 2021, the Company issued 283,389 ordinary shares in exchange for certain warrants. In April 2021, 62,153 warrants lapsed. During the year ended December 31, 2021, the Company issued 3,722,550 ordinary shares in relation to the exercise of share options and RSUs. During the period ended September 30, 2022, the Company issued 1,514,610 ordinary shares in relation to the exercise of share options and RSUs. As part of the acquisition of Chiasma, the Company replaced share awards that were existing at the time of the acquisition. This resulted in the recognition of a share-based payment reserve of US$10,157,000 on acquisition. Merger reserve The merger reserve was created on the acquisition of Amryt DAC by Amryt Pharma plc in April 2016. Ordinary shares in Amryt Pharma plc were issued to acquire the entire issued share capital of Amryt DAC. Under section 612 of the UK Companies Act 2006, the premium on these shares has been included in a merger reserve. Reverse acquisition reserve The reverse acquisition reserve arose during the period ended December 31, 2016, in respect of the reverse acquisition of Amryt Pharma plc by Amryt DAC. Since the shareholders of Amryt DAC became the majority shareholders of the enlarged Group, the acquisition is accounted for as though there is a continuation of Amryt DAC’s financial statements. The reverse acquisition reserve is created to maintain the equity structure of Amryt Pharma plc in compliance with UK company law. Equity component of convertible notes The equity component of convertible notes represents the equity component of the US$125,000,000 convertible debt and is measured by determining the residual of the fair value of the instrument less the estimated fair value of the liability component. The equity component is recognized in equity and is not subsequently remeasured. Other distributable reserves Other distributable reserves comprise the following:  Distribution of the share premium amount on 6 November 2019 of US$268,505,000. By special resolution of the Company duly passed on 23 September 2019, it was resolved that the entire amount outstanding to the credit of the share premium account and capital redemption reserve of the Company be cancelled. The reduction in capital, amounting to US$268,505,000, representing the entire amount of share premium at that time, was approved by the High Court of Justice of England and Wales on 5 November 2019.  A deemed distribution of US$47,902,000 arising from the issuance of CVRs in September 2019.  A deemed distribution of US$2,969,000 arising from the scheme of arrangement in September 2019 whereby Amryt Pharma plc, which was incorporated in July 2019, became a 100% shareholder of Amryt Pharma Holdings Limited (formerly named Amryt Pharma plc) (the “Acquisition of subsidiary without a change of control”). Currency translation reserve The currency translation reserve arises on the retranslation of non-U.S. dollar denominated foreign subsidiaries. Accumulated deficit Accumulated deficit represents losses accumulated in previous periods and the current year. 12. Long term loan As at September 30, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Long term loan principal 105,000 93,988 Unamortized debt issuance costs (6,055) (593) Long term loan 98,945 93,395 On February 18, 2022, Amryt secured US$125,000,000 of senior credit facilities (“Senior Credit Facility”) from funds managed by the Credit Group of Ares Management Corporation (“Ares”). A portion of the proceeds were used to refinance the previous secured term loan, which had an outstanding balance of US$93,988,000 as at February 22, 2022, an interest rate of 13.00% and a maturity date of September 2024. The new facilities will generate significant annual interest cost savings as well as provide for important strategic flexibility as Amryt looks to continue to grow its global rare disease presence. In repaying the secured term loan, Amryt incurred an exit fee of 5.00% of the outstanding principal amount as at the prepayment date. This amounted to US$4,699,000 and is included in Net finance expense – other in the Condensed Consolidated Statement of Comprehensive Income for the nine month-period ended September 30, 2022. Key features of the new facilities include:  Total new facilities of $125 million, consisting of: o $85 million Term Loan Facility with interest rate of Secured Overnight Financing Rate (“SOFR”)+6.75%, subject to a 0.90% SOFR floor o $40 million Revolving Credit Facility with $20 million drawn at close and interest rate of SOFR+4.00%, subject to a 0.90% SOFR floor o Quarterly blended cash interest rate of SOFR+5.87% (assuming fully drawn), subject to a 0.90% SOFR floor, substantially lower than Amryt’s previous secured term debt facility at 13.00% interest  Requires interest-only payments until facility matures in February 2027  There are no warrants or any equity conversion features associated with the new facilities  The proceeds will be used to refinance existing debt, for general corporate and product development purposes; and potentially for shareholder approved share repurchase programs. As at September 30, 2022, there was unpaid accrued interest of US$1,992,000 and US$344,000 for the Term Loan Facility and Revolving Credit Facility, respectively, recognized in current liabilities within trade and other payables. Charges were taken over certain assets of the company and its material entities as guarantee and collateral for the provision of the debt. In connection with the Secured Credit Facility, the Group incurred approximately US$6,712,000 of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees. These costs are amortized over the expected life of the loan using the effective interest method. The Secured Credit Facility includes affirmative and negative covenants, including prohibitions on the incurrence of additional indebtedness, granting of liens, certain asset dispositions, investments, and restricted payments, in each case, subject to certain exceptions set forth in the loan agreement. The loan agreement also includes customary events of default for a transaction of this type and includes (i) a cross-default to the occurrence of any event of default under material indebtedness of Amryt and certain subsidiaries of the Group and Amryt, including the convertible notes, and (ii) Amryt or any of its subsidiaries being subject to bankruptcy or other insolvency proceedings. Upon the occurrence of an event of default, the lenders may declare all of the outstanding Secured Credit Facility and other obligations under the Secured Credit Facility to be immediately due and payable and exercise all rights and remedies available to the lenders under the Term Loan agreement and related documentation. There were no events of default or breaches of the covenants occurring during the three and nine month period ended September 30, 2022. As part of the acquisition of Aegerion on September 24, 2019, Aegerion entered into a new U.S. dollar denominated US$81,021,000 secured term loan debt facility (‘‘Term Loan’’) with various lenders. The Term Loan was made up of a US$54,469,000 loan that was in place prior to the acquisition which was refinanced as part of the acquisition and a US$26,552,000 additional loan that was drawn down on September 24, 2019. The Term Loan had a five-year term from the date of the draw down, September 24, 2019, and matured on September 24, 2024. Under the Term Loan, interest was payable at the option of the Group at the rate of 11% per annum paid in cash on a quarterly basis or at a rate of 6.5% paid in cash plus 6.5% paid in kind that was to be paid when the principal is repaid, which rolled up and included in the principal balance outstanding, on a quarterly basis. The Term Loan was repayable, in whole or in part, by Amryt at any time subject to payment of an exit fee, which depending on the stage of the loan term, ranged from 5.00% to 0.00% of the principal then outstanding on the Term Loan. On February 18, 2022, the Term Loan was repaid in full and the Group secured a $125,000,000 senior credit facility of which US$105,000,000 was drawn down to facilitate the prepayment of the existing Term Loan. In repaying the Secured Credit Facility, Amryt incurred an exit fee of 5.00% of the outstanding principal amount as at the prepayment date. In connection with the Term Loan, the Group incurred approximately US$870,000 of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees. These costs were amortized over the expected life of the loan using the effective interest method and during the nine month period ended September 30, 2022, were written off to the Condensed Consolidated Statement of Comprehensive Loss as the Term Loan liability was derecognized. The Term Loan was guaranteed by Amryt and certain subsidiaries of the Group. In connection with the loan agreement, fixed and floating charges were placed on property and undertakings of Amryt and certain subsidiaries of the Group. 13. Convertible notes Total US$’000 At January 1, 2021 101,086 Accreted interest 4,702 At December 31, 2021 (audited) 105,788 Accreted interest 3,867 At September 30, 2022 (unaudited) 109,655 As part of the Aegerion acquisition, Aegerion issued convertible notes with an aggregate principal amount of US$125,000,000 to Aegerion creditors. The convertible notes are senior unsecured obligations and bear interest at a rate of 5.0% per year, payable semi-annually in arrears on April 1 and October 1 of each year, beginning on April 1, 2020. The convertible notes will mature on April 1, 2025, unless earlier repurchased or converted. The convertible notes are convertible into Amryt’s ordinary shares at a conversion rate of 386.75 ordinary shares per US$1,000 principal amount of the convertible notes. If the holders elect to convert the convertible notes, Amryt can settle the conversion of the convertible notes through payment or delivery of cash, common shares, or a combination of cash and common shares, at its discretion. As a result of the conversion feature in the convertible notes, the convertible notes were assessed to have both a debt and an equity component. The two components were assessed separately and classified as a financial liability and equity instrument. The financial liability component was measured at fair value based on the discounted cash flows expected over the expected term of the notes using a discount rate based on a market interest rate that a similar debt instrument without a conversion feature would be subject to. Refer to Note 11, Share capital and reserves, for further details on the equity component of the convertible notes. From September 24, 2019, until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of their convertible notes, in multiples of US$1,000 principal amount, at the option of the holder. The indenture does not contain any financial covenants or restrict the Group’s ability to repurchase securities, pay dividends or make restricted payments in the event of a transaction that substantially increases the Group’s level of indebtedness in certain circumstances. The indenture contains customary terms and covenants and events of default. If an event of default (other than certain events of bankruptcy, insolvency or reorganization involving Aegerion, Amryt and certain subsidiaries of the Group) occurs and is continuing, the trustee by notice to Amryt, or the holders of at least 25% in principal amount of the outstanding convertible notes by written notice to Amryt and the trustee, may declare 100% of the principal of and accrued and unpaid interest, if any, on all of the convertible notes to be due and payable. Upon such a declaration of acceleration, such principal and accrued and unpaid interest, if any, will be due and payable immediately. Upon the occurrence of certain events of bankruptcy, insolvency or reorganization involving Amryt, 100% of the principal and accrued and unpaid interest, if any, on the convertible notes will become due and payable automatically. Notwithstanding the foregoing, the indenture provides that, upon Amryt’s election, and for up to 180 days, the sole remedy for an event of default relating to certain failures by Amryt to comply with certain reporting covenants in the indenture consists exclusively of the right to receive additional interest on the convertible notes. There have been no events of default or breaches of the covenants occurring for the period ended September 30, 2022 (2021: no events). 14. Provisions and other liabilities As at September 30, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Non-current liabilities Leases due greater than 1 year 3,225 4,049 3,225 4,049 Current liabilities Provisions and other liabilities 6,000 6,000 Leases due less than 1 year 966 1,545 6,966 7,545 Total provisions and other liabilities 10,191 11,594 Legal matters Prior to the acquisition of Aegerion by Amryt, Aegerion entered into settlement agreements with governmental entities including the Department of Justice (‘‘DOJ’’) and the FDA in connection with Juxtapid investigations. The settlement agreements required Aegerion to pay specified fines and engage in regulatory compliance efforts. Subsequent to the acquisition, Aegerion made US$23,036,000 of settlement payments, including interest. The settlements have been paid in full with the last payment completed in Q1 2021. Other matters The Group recognizes a liability for legal contingencies when it believes that it is both probable that a liability has been incurred and that it can reasonably estimate the amount of the loss. The Group reviews these accruals and adjusts them to reflect ongoing negotiations, settlements, rulings, advice of legal counsel and other relevant information. To the extent new information is obtained and the Group’s views on the probable outcomes of claims, suits, assessments, investigations or legal proceedings change, changes in the Group’s liability accrual would be recorded in the period in which such determination is made. At September 30, 2022, the Group had recognized liabilities of US$6,000,000 in relation to ongoing legal matters (December 31, 2021: US$6,000,000). 15. Fair value measurement and financial risk management Categories of financial instruments As at September 30, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Financial assets (all at amortized cost): Cash and cash equivalents 83,400 113,032 Trade receivables 37,604 34,263 Total financial assets 121,004 147,295 Financial liabilities: At amortized cost Trade payables and accrued expenses 132,849 148,251 Lease liabilities 4,191 5,594 Convertible notes 109,655 105,788 Long term loan 98,945 93,395 Contingent value rights 13,394 19,892 At fair value Contingent consideration 39,657 61,221 Total financial liabilities 398,691 434,141 Net (277,687) (286,846) Financial instruments evaluated at fair value can be classified according to the following valuation hierarchy, which reflects the extent to which the fair value is observable:  Level 1: fair value evaluations using prices listed on active markets (not adjusted) of identical assets or liabilities.  Level 2: fair value evaluations using input data for the asset or liability that are either directly observable (as prices) or indirectly observable (derived from prices), but which do not constitute listed prices pursuant to Level 1.  Level 3: fair value evaluations using input data for the asset or liability that are not based on observable market data (unobservable input data). The contingent consideration has been valued using Level 3. The contingent consideration comprises:  Contingent consideration relating to the acquisition of Amryt GmbH (see Note 5, Business combinations and asset acquisitions) that was measured at US$39,657,000 as at September 30, 2022 (December 31, 2021: US$61,221,000). The fair value comprises royalty payments which was determined using probability weighted revenue forecasts and the fair value of the milestones payments which was determined using probability adjusted present values. It also included a revision to the discount rate used, and revenue and costs forecasts have been amended to reflect management’s current expectations. Impact of key unobservable input data on the contingent consideration:  An increase of 10% in estimated revenue forecasts would result in an increase to the fair value of US$3,001,000. A decrease would have the opposite effect.  A 5% increase in the discount factor used would result in a decrease to the fair value of US$6,507,000. A decrease of 5% would result in an increase to the fair value of US$8,404,000.  A six-month delay in the launch date for Oleogel-S10 would result in a decrease to the fair value of US$3,915,000.  An increase of 20% in the probability of success with the FDA approval would result in a decrease to the fair value of US$11,944,000. 16. Restatement of prior year comparatives As described in Note 5, Business combinations and asset acquisitions, the fair values of the assets and liabilities of Chiasma were finalized in August 2022. IFRS 3 requires fair value adjustments to be recorded with effect from the date of acquisition and consequently result in the restatement of previously reported financial results. The impact on the statement of financial position as at December 31, 2021, is shown below: As previously reported Adjustments Note As Restated US$’000 Assets Non-Current Assets Goodwill 56,688 (2,564) 16a 54,124 Intangible assets - net 467,359 35,971 16b 503,330 Property, plant and equipment 7,416 - 7,416 Other non-current assets 1,885 - 1,885 Total non-current assets 533,348 33,407 566,755 Current assets Trade and other receivables 53,908 - 53,908 Inventories 115,769 (33,934) 16c 81,835 Cash and cash equivalents, including restricted cash 113,032 - 113,032 Total current assets 282,709 (33,934) 248,775 Total assets 816,057 (527) 815,530 Equity and liabilities Equity attributable to owners of the parent Share capital 25,500 - 25,500 Share premium 318,153 - 318,153 Other reserves 246,303 - 246,303 Accumulated deficit (233,295) 2,101 (231,194) Total equity 356,661 2,101 358,762 Non-current liabilities Contingent consideration and contingent value rights 81,113 - 81,113 Deferred tax liability 17,772 (2,628) 16d 15,144 Long term loan 93,395 - 93,395 Convertible notes 105,788 - 105,788 Provisions and other liabilities 4,049 - 4,049 Total non-current liabilities 302,117 (2,628) 299,489 Current liabilities Trade and other payables 149,734 - 149,734 Provisions and other liabilities 7,545 - 7,545 Total current liabilities 157,279 - 157,279 Total liabilities 459,396 (2,628) 456,768 Total equity and liabilities 816,057 (527) 815,530 The above adjustments to the statement of financial position relate to the completion of the fair value assignment to identifiable assets and liabilities acquired as part of the Chiasma acquisition, the following adjustments have been reflected in the condensed consolidated financial statements: a) The adjustments to goodwill are a consequence of the fair value adjustments described in more detail below, which primarily relate to the measurement of intangible assets, valuation of inventory and associated deferred tax liabilities. b) The fair value of intangible assets acquired, consisting of developed technology for Mycapssa®, was adjusted as a consequence of the detailed review and update to the expected future usage of inventory, the valuation of which was a factor in determining the fair value of acquired developed technology. See more detail on the update to the inventory valuation below. c) Fair value of inventory recognized at the date of acquisition was updated to reflect the results of detailed reviews of both raw material, work in process and finished goods acquired. This involved a review of the expected timing of transition from usage of acquired finished goods to usage of new inventory, including the review of expected timing of manufacture runs and the review of expected inventory usage. Additionally, a review was conducted on the demand and production that would be saleable in the future. The review resulted in a change in the assumptions and estimates regarding the usage of acquired inventory, leading to a decrease in the estimated usage of acquired inventory and consequently resulting in a decrease in the fair value of acquired inventory. d) Deferred tax was updated to reflect the above changes to the fair value of the inventory and of intangible assets. As noted above, IFRS 3 requires fair value adjustments to be recorded as if the accounting for the business combination had been completed at the acquisition date. Consequently, the comparative information for prior periods presented in financial statements were revised, including changes in inventory fair value step-up amortization, intangible amortization and deferred tax effects recognized in completing the acquisition accounting. The impact on the income statement of the fair value adjustments for the year ended December 31, 2021, is shown below: Year ended December 31, 2021 As previously reported Adjustments Note As Restated US$’000 Revenue 222,543 - 222,543 Cost of sales (106,119) (1,254) 16e (107,373) Gross profit 116,424 (1,254) 115,170 Research and development expenses (37,729) - (37,729) Selling, general and administrative expenses (91,995) - (91,995) Restructuring and acquisition costs (16,947) - (16,947) Share based payment expenses (8,341) - (8,341) Operating loss before finance expense (38,588) (1,254) (39,842) Non-cash change in fair value of contingent consideration 18,407 - 18,407 Non-cash contingent value rights gain 41,525 - 41,525 Net finance expense - other (27,906) - (27,906) Loss on ordinary activities before taxation (6,562) (1,254) (7,816) Tax credit on loss of ordinary activities 7,562 3,355 16f 10,917 Profit for the year attributable to the equity holders of the Company 1,000 2,101 3,101 Exchange translation differences which may be reclassified through profit or loss 4,423 - 4,423 Total other comprehensive profit 4,423 - 4,423 Total comprehensive income for the year attributable to the equity holders of the Company 5,423 2,101 7,524 The above adjustments relate to the impact on the statement of comprehensive loss as result of the fair value adjustments following the completion of the fair value assignment to identifiable assets and liabilities acquired as part of the Chiasma acquisition. Non-cash adjustments to the statement of comprehensive loss: e) Cost of sales has been adjusted for the impact on the non-cash amortization of inventory fair value step-up and acquired intangibles, for the period from the date of acquisition to the year end, as a result of the update to acquired inventory and intangible fair values following the finalization of acquisition accounting for the Chiasma acquisition. See Note 16b and 16c, above, for further detail on the fair value adjustments to acquired inventory and intangible assets. f) As a result of a change in the measurement of the deferred tax liability at the acquisition date, there was a non-cash adjustment to the tax charge for the period from the date of acquisition to the year end. 17. Events after the reporting period There were no significant events since the end of the reporting period.
AMYT CHMA | globenewswire | about 3 years ago | Neutral

Amryt Reports Record Q2 2022 ResultsAmryt Pharma plc Amryt ReportsRecord Q2 2022 Results 9.2% YoY revenue growth in Q2 to $68.5M 35.3% YoY revenue growth in Q2excluding impact of a sporadic LATAM order in Q2 2021 7.8% growth in metreleptin revenues YoY to$46.4M in Q2 49.9% growth in metreleptin revenuesin Q2 excluding impact of a...
Amryt Pharma plc Amryt ReportsRecord Q2 2022 Results 9.2% YoY revenue growth in Q2 to $68.5M 35.3% YoY revenue growth in Q2excluding impact of a sporadic LATAM order in Q2 2021 7.8% growth in metreleptin revenues YoY to$46.4M in Q2 49.9% growth in metreleptin revenuesin Q2 excluding impact of a sporadic LATAM order in Q2 2021 10th consecutive quarter of positive EBITDA generation Cash of $90.7M at June 3, 2022 Filsuvez®approved in the EUfor the treatment of dystrophic and junctional EB Amryt now has four growing commercial products treating rare diseases Reaffirming FY 2022 revenue guidance to $260M - $270M, representing 17-21% YoY growth Stock repurchase program underway – board approved up to $30M through March 2023 Conference call and webcast today at 0830 ET / 1330 BST DUBLIN, Ireland, and Boston MA, August 4, 2022, Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today provides a business update and announces unaudited financial results for the second quarter ended June 3, 2022. Joe Wiley, CEO of Amryt Pharma, commented:“I am pleased to report today’s very strong operational and financial results which reflect another excellentquarter for Amryt.Our record Q2 revenues of $68.5M demonstratesthe strong performance our business is delivering. In particular, metreleptin continues to grow strongly,delivering49.9% YoY growth in the quarter, excluding the impact of a sporadic LATAM order booked in Q2 2021. Overall, these results demonstrate the robust growth we are experiencing and represent our tenth consecutive quarter of positive EBITDA generation. During the quarter, the European Commission approved Filsuvez® for the treatment of Dystrophic and Junctional EB in patients 6 months and older. Theapproval of Filsuvez® in the EUis one of the most significant milestones in Amryt’s history and represents a major positive development for European patients that suffer from this debilitating condition.Filsuvez® isour fourth commercial product and we have in place the team, financial flexibility and global infrastructure to commercialize it swiftly and to execute our significant growth plans. We also look forward to potentially leveraging our European approval across other jurisdictions globally. Story continues Given the strong underlying performance of our business year to date and notwithstanding the impact of the strengthening US dollar on our Euro revenues, we are today reaffirming our full year 2022 revenue guidance of $260-$270 million which represents growth of 17%-21% over 2021.” Q2 2022 and Recent Business Highlights: Metreleptin Metreleptin continues to deliver significant growth in EMEA driven by market expansion and its broad label covering the treatment of both general and partial lipodystrophy (GL/PL) Growth drivers include ItalianPLreimbursement in Q2 and expansion in the Middle East and Turkey Metreleptin continues to deliver growth in the US; expected patient additions driven by high unmet medical need Lomitapide EMEA lomitapide revenues impacted by strong US dollar despite increasing patient numbers on therapy Successful new tender for lomitapide inSaudi Arabia - $6M expected annualized revenues Mycapssa® Mycapssa® relaunch is progressing well - Greater education and awareness of Mycapssa® has resulted in 58 new prescribers year to date–93% of whom are community-based physicians Presented Mycapssa® data from OPTIMAL and MPOWERED Phase 3 trials at ENDO 2022 meeting Announcedpositive long-term safety and efficacy data for Mycapssa® from the second year of the OPTIMAL open label extension study in acromegaly patients Mycapssa® new patent announced, further strengtheningour IP portfolio with protection to 2040 Received Orphan Drug Designation from the FDA for Mycapssa® for the treatment of carcinoid syndrome associated with neuroendocrine tumors (NET) Pathway agreed with the FDA to initiate a Phase 3 study for NET - expected in Q1 2023 Filsuvez®1 Filsuvez®approved in the EUfor the treatment of dystrophic and junctional EBin patients 6 months and older First ever approved treatment for EB with potential to leverage European approval across other jurisdictions Commercial plans well advanced for Filsuvez® launch in Europe–first shipments to patients in Germany and Greece expected in Q3 Presented new positive Open-Label Phase 12-month data analyses from the EASE Phase 3 trial in EB at SPD 2022 meeting Corporate Amryt initiates stock repurchase program – board has approved repurchases up to $30M through March 2023 FY 2022 revenue guidance of $260M - $270M reaffirmed, representing 17-21% growth over 2021 Q2 2022 Commercial Product Performance: Q2 2022 (unaudited) US$’000 US EMEA Other Total Metreleptin 20,311 24,192 1,895 46,398 Lomitapide 7,585 6,995 2,795 17,375 Mycapssa® 4,499 — — 4,499 Other — 190 74 264 Total revenue 32,395 31,377 4,764 68,536 Q2 2021 (unaudited) US$’000 US EMEA Other Total Metreleptin 17,739 11,005 14,315 43,059 Lomitapide 8,490 7,492 3,468 19,450 Mycapssa® — — — — Other — 193 60 253 Total revenue 26,229 18,690 17,843 62,762 9.2% YoY revenue growth in Q2 2022 to $68.5M (Q2 2021: $62.8M);13.6% YoY revenue growth on a constant currency basis 35.3% YoY revenue growth excluding the impact of a sporadic LATAM order in Q2 2021 7.8% increase in metreleptin revenues YoY to$46.4M in Q2 2022 (Q2 2021: $43.1M); 49.9% YoY growth excluding the impact of a sporadic LATAM order in Q2 2021 US accounted for 43.8% of global metreleptin revenues and EMEA accounted for 52.1% in Q2 2022 US metreleptin revenues grew by 14.5% YoY and EMEA metreleptin revenues grew by119.8% YoY in Q22022 US accounted for 43.7% of global lomitapide revenues and EMEA accounted for 40.3% in Q2 2022 Mycapssa® delivered $4.5Min Q2 2022 as compared to $3.4M in Q1 2022 Q2 2022 Financial Highlights: $6.9Moperating loss before finance expensefor Q2 2022 (Q2 2021: $4.1M operating profit). Excluding non-cash items, share based compensation expenses and Chiasma restructuring and acquisition costs, this resulted in EBITDA3of $13.3M, before restructuring and acquisition costs. Cash of $90.7M at June 30, 2022 (March 31, 2022: $102.2M) IFRS and non-GAAP adjusted Q2 2022results: US$M Q2 2021 (unaudited) Q2 2022 (unaudited) Q2 2022 Non-cash adjustments2 Q2 2022 Non-GAAP Adjusted Revenue 62.8 68.5 - 68.5 Gross profit 36.6 35.2 16.6 51.8 R&D expenses (8.5) (10.7) - (10.7) SG&A expenses (22.0) (28.2) 0.4 (27.8) Restructuring and acquisition costs - (0.3) - (0.3) Share based compensation expenses (2.0) (2.9) 2.9 - Operating (loss) / profit before finance expense 4.1 (6.9) 19.9 13.3 Operating (loss) / profit before finance expense and restructuring and acquisition costs 4.1 (6.6) 19.9 13.33 1 Filsuvez® (birch extract)gel (“Filsuvez®”) has been selected as the brand name for Oleogel-S10. Filsuvez® is approved in the EU for the treatment of partial thickness wounds associated with JEB and DEB in patients 6 months and older. 2 Non-cash items include amortisation of the acquired metreleptin, lomitapide and Mycapssa® intangible assets ($14.4M), amortisation of the inventory fair value step-up related to the acquisition of Chiasma, Inc. ($2.2M), depreciation and amortisation ($0.4M) and share based compensation expenses ($2.9M). 3 EBITDA is earnings before interest, tax, depreciation, amortisation and share based compensation expenses. To supplement Amryt's financial results presented in accordance with IFRS generally accepted accounting principles, the Company uses EBITDA as a key measure of company performance as the Company believes that this measure is most reflective of the operational profitability or loss of the Company and provides management and investors with useful supplementary information which can enhance their ability to evaluate the operating performance of the business. EBITDA, as measured by the Company, is not meant to be considered in isolation or as a substitute to operating profit / loss attributable to Amryt and should be read in conjunction with the Company's condensed consolidated financial statements prepared in accordance with IFRS. Filsuvez®Regulatory Update: On June 23, 2022, Amryt announced the European Commission (EC) approval of Filsuvez® in the European Union (EU) for the treatment of partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa (EB) in patients 6 months and older. EB is a rare and distressing genetic skin disorder affecting young children and adults for which, until now, there has been no approved treatment in any market. The centralised marketing authorisation will be valid in all EU Member States as well as in Iceland, Liechtenstein, and Norway. The authorization of Filsuvez® in the EU provides a regulatory core dossier which can form the basis for future regulatory submissions in LATAM and the Middle East. The EC approval of Filsuvez® is supported by Phase 3 data from the EASE trial which was the largest ever global trial conducted in patients with EB, performed across 58 sites in 28 countries. During Q2 2022, Amryt had a Type A meeting with the FDA to discuss the issues raised in the Complete Response Letter (CRL) received in February 2022 relating to Amryt’s NDA for Oleogel-S10. Following this meeting, Amryt plans to proceed to the Formal Dispute Resolution pathway withthe FDA’s Center for Drug Evaluation and Research (CDER) by which NDA applicants can seek to resolve scientific and/or medical disputes that cannot be resolved at the division level. Guidance & Outlook: Given the continued strong performance of the Company’s commercial productsand notwithstanding the impact of the strengthening US dollar on the Company’s Euro denominated revenues, the board is today reaffirming revenue guidance for FY 2022 in the range of $260M - $270M which represents growth of 17% to 21% on FY 2021. Conference Call & Webcast: Amryt will host a conference call and webcast for analysts and investors today at 0830 ET/1330 GMT. Webcast Player URL:https://edge.media-server.com/mmc/p/ef7uj5u8 Telephone Dial in details: United States +1 646 307 1963 United Kingdom +44 (0) 203 481 4247 Ireland +353 (1) 582 2023 Confirmation Code 9953783 A playback facility will be available from Aug 4, 2022 at 1230 ET/1730 BST – Aug 11, 2022 at 1900 ET/2400 BST. Access details for the playback facility are as follows: Confirmation Code:9953783| US: + 1 609 800 9909 | UK: +44 (0) 203 433 3849. About Amryt Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets. Amryt’s commercial business comprises four orphan disease products – metreleptin (Myalept®/ Myalepta®); oral octreotide (Mycapssa®); lomitapide (Juxtapid®/ Lojuxta®); and Oleogel-S10 (Filsuvez®). Myalept®/Myalepta® (metreleptin) is approved in the US (under the trade name Myalept®) as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in the EU (under the trade name Myalepta®) as an adjunct to diet for the treatment of leptin deficiency in patients with congenital or acquired GL in adults and children two years of age and above and familial or acquired partial lipodystrophy (PL) in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control. For additional information, please follow this link. Mycapssa® (octreotide capsules) is approved in the US for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. Mycapssa® is the first and only oral somatostatin analog approved by the FDA. Mycapssa® has also been submitted to the EMA and is not yet approved in Europe. For additional information, please follow this link. Juxtapid®/Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia ("HoFH") in the US, Canada, Colombia, Argentina and Japan (under the trade name Juxtapid®) and in the EU, Israel, Saudi Arabia and Brazil (under the trade name Lojuxta®). For additional information, please follow this link. Amryt's lead development candidate, Oleogel-S10 is a potential treatment for the cutaneous manifestations of JEB and DEB, a rare and distressing genetic skin disorder affecting young children and adults. Filsuvez® has been selected as the brand name for Oleogel-S10. Filsuvez® is approved in the EU for the treatment of partial thickness wounds associated with JEB and DEB in patients 6 months and older. Amryt’s pre-clinical gene therapy candidate, AP103, offers a potential treatment for patients with Dystrophic EB, and the polymer-based delivery platform has the potential to be developed for the treatment of other genetic disorders. Amryt also intends to develop oral medications that are currently only available as injectable therapies through its Transient Permeability Enhancer (TPE®) technology platform. For more information on Amryt, including products, please visit www.amrytpharma.com. Forward-Looking Statements This announcement may contain forward-looking statements and the words "expect", "anticipate", "intends", "plan", "estimate", "aim", "forecast", "project" and similar expressions (or their negative) identify certain of these forward-looking statements. The forward-looking statements in this announcement are based on numerous assumptions and Amryt's present and future business strategies and the environment in which Amryt expects to operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. These statements are not guarantees of future performance or the ability to identify and consummate investments. Many of these risks and uncertainties relate to factors that are beyond Amryt's ability to control or estimate precisely, such as future market conditions, the course of the COVID-19 pandemic, currency fluctuations, the behaviour of other market participants, the outcome of clinical trials, the actions of regulators and other factors such as Amryt's ability to obtain financing, changes in the political, social and regulatory framework in which Amryt operates or in economic, technological or consumer trends or conditions. Past performance should not be taken as an indication or guarantee of future results, and no representation or warranty, express or implied, is made regarding future performance. No person is under any obligation to update or keep current the information contained in this announcement or to provide the recipient of it with access to any additional relevant information that may arise in connection with it. Such forward-looking statements reflect the Company’s current beliefs and assumptions and are based on information currently available to management. Contacts Joe Wiley, CEO / Rory Nealon, CFO/COO, +353 (1) 518 0200, ir@amrytpharma.com Tim McCarthy, LifeSci Advisors, LLC, +1 (917) 679 9282, tim@lifesciadvisors.com Amryt Pharma plc Condensed Consolidated Statement of Comprehensive Loss Three Months Ended June 30, Six Months Ended June 30, Note 2022 (unaudited) 2021 (unaudited) 2022 (unaudited) 2021 (unaudited) US$’000 US$’000 US$’000 US$’000 Revenue 3 68,536 62,762 127,665 111,194 Cost of sales (33,364) (26,179) (64,139) (49,668) Gross profit 35,172 36,583 63,526 61,526 Research and development expenses (10,670) (8,538) (20,551) (17,454) Selling, general and administrative expenses (28,233) (22,029) (55,942) (40,185) Restructuring and acquisition costs 5 (265) — (667) — Share based payment expenses 4 (2,880) (1,953) (6,028) (3,216) Operating (loss)/profit before finance expense (6,876) 4,063 (19,662) 671 Non-cash change in fair value of contingent consideration 5 4,720 (2,993) 4,293 (5,867) Non-cash contingent value rights gain/(loss) 5 1,967 (1,837) 1,285 (3,600) Net finance expense - other (6,760) (5,841) (17,887) (13,739) Loss on ordinary activities before taxation (6,949) (6,608) (31,971) (22,535) Tax (charge)/credit on loss on ordinary activities (100) (191) 10,431 (801) Loss for the period attributable to the equity holders of the Company (7,049) (6,799) (21,540) (23,336) Exchange translation differences which may be reclassified through profit or loss 30 (204) (369) 2,343 Total other comprehensive income/(loss) 30 (204) (369) 2,343 Total comprehensive loss for the period attributable to the equity holders of the Company (7,019) (7,003) (21,909) (20,993) Loss per share Loss per share - basic and diluted, attributable to ordinary equity holders of the parent (US$) 6 (0.02) (0.04) (0.07) (0.13) Amryt Pharma plc Condensed Consolidated Statement of Financial Position As at, Note June 30, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Assets Non-current assets Goodwill 7 56,688 56,688 Intangible assets 7 433,832 467,359 Property, plant and equipment 7,109 7,416 Other non-current assets 1,770 1,885 Total non-current assets 499,399 533,348 Current assets Trade and other receivables 8 50,427 53,908 Inventories 9 124,185 115,769 Cash and cash equivalents, including restricted cash 10 90,733 113,032 Total current assets 265,345 282,709 Total assets 764,744 816,057 Equity and liabilities Equity attributable to owners of the parent Share capital 11 25,586 25,500 Share premium 11 323,140 318,153 Other reserves 11 242,001 246,303 Accumulated deficit (248,693) (233,295) Total equity 342,034 356,661 Non-current liabilities Contingent consideration and contingent value rights 5 54,833 81,113 Deferred tax liability 6,248 17,772 Long term loan 12 98,726 93,395 Convertible notes 13 108,332 105,788 Provisions and other liabilities 14 3,543 4,049 Total non-current liabilities 271,682 302,117 Current liabilities Trade and other payables 127,909 149,734 Provisions and other liabilities 14 6,911 7,545 Contingent consideration 5 10,490 — Loan notes 5 5,718 — Total current liabilities 151,028 157,279 Total liabilities 422,710 459,396 Total equity and liabilities 764,744 816,057 Amryt Pharma plc Condensed Consolidated Statement of Cash Flows Six months ended June 30, Note 2022 (unaudited) 2021 (unaudited) US$’000 US$’000 Cash flows from operating activities Loss on ordinary activities after taxation (21,540) (23,336) Net finance expense - other 17,887 13,739 Depreciation and amortization 29,695 22,080 Amortization of inventory fair value step-up 3,776 1,205 Share based payment expenses 4 6,028 3,216 Non-cash change in fair value of contingent consideration 5 (4,293) 5,867 Non-cash contingent value rights (gain)/loss 5 (1,285) 3,600 Deferred taxation (credit)/charge (11,524) 336 Movements in working capital and other adjustments: Change in trade and other receivables 8 3,672 1,677 Change in trade and other payables (23,058) 5,726 Change in provision and other liabilities 14 (778) (2,823) Change in inventories (12,193) 1,027 Change in non-current assets 115 122 Net cash flow (used in)/from operating activities (13,498) 32,436 Cash flow from investing activities Payments for property, plant and equipment (668) (76) Payments for intangible assets — (722) Deposit interest received 25 2 Net cash flow used in investing activities (643) (796) Cash flow from financing activities Net proceeds/(costs) from issue of equity instruments 1,063 (175) Proceeds from long term borrowings - net of debt issue costs 98,344 — Repayment of long term debt (98,761) — Interest paid (6,193) (6,047) Payment of leases (608) (526) Net cash flow used in financing activities (6,155) (6,748) Exchange and other movements (2,003) (744) Net change in cash and cash equivalents (22,299) 24,148 Cash and cash equivalents at beginning of the period 113,032 118,798 Restricted cash at end of the period 10 150 — Cash at bank available on demand at end of the period 10 90,583 142,946 Total cash and cash equivalents at end of the period 10 90,733 142,946 Amryt Pharma plc Condensed Consolidated Statement of Changes in Equity For the period ended June 30, 2022 Note Share capital Share premium Warrant reserve Treasury shares Share based payment reserve Merger reserve Reverse acquisition reserve Equity component of convertible notes Other distributable reserves Currency translation reserve Accumulated deficit Total US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 Balance at January 1, 2022 (audited) 25,500 318,153 — — 20,593 42,627 (73,914) 29,210 217,634 10,153 (233,295) 356,661 Loss for the period — — — — — — — — — — (21,540) (21,540) Foreign exchange translation reserve — — — — — — — — — (369) — (369) Total comprehensive loss — — — — — — — — — (369) (21,540) (21,909) Transactions with owners Issue of shares for share options exercised and vesting of RSUs 11 86 4,987 — — (3,819) — — — — — — 1,254 Share based payment expense 4 — — — — 6,028 — — — — — — 6,028 Share based payment expense – Lapsed — — — — (1,878) — — — — — 1,878 — Total transactions with owners 86 4,987 — — 331 — — — — — 1,878 7,282 Balance atJune 30, 2022 (unaudited) 25,586 323,140 — — 20,924 42,627 (73,914) 29,210 217,634 9,784 (252,957) 342,034 For the period ended June 30, 2021 Note Share capital Share premium Warrant reserve Treasury shares Share based payment reserve Merger reserve Reverse acquisition reserve Equity component of convertible notes Other distributable reserves Currency translation reserve Accumulated deficit Total US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 Balance at January 1, 2021 (audited) 13,851 51,408 14,762 (7,421) 7,860 42,627 (73,914) 29,210 217,634 5,730 (235,605) 66,142 Loss for the period — — — — — — — — — — (23,336) (23,336) Foreign exchange translation reserve — — — — — — — — — 2,343 — 2,343 Total comprehensive loss — — — — — — — — — 2,343 (23,336) (20,993) Transactions with owners Issue of treasury shares in exchange for warrants 11 23 99 — 439 — — — — — — — 561 Issue of treasury shares for share options exercised 11 25 89 — 465 (191) — — — — — — 388 Share based payment expense 4 — — — — 3,216 — — — — — — 3,216 Share based payment expense - Lapsed — — — — (54) — — — — — 54 — Total transactions with owners 48 188 — 904 2,971 — — — — — 54 4,165 Balance atJune 30, 2021 (unaudited) 13,899 51,596 14,762 (6,517) 10,831 42,627 (73,914) 29,210 217,634 8,073 (258,887) 49,314 1. General information Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets. As used herein, references to ‘‘we,’’ ‘‘us,’’ ‘‘Amryt’’ or the ‘‘Group’’ in these condensed consolidated interim financial statements shall mean Amryt Pharma plc and its global subsidiaries, collectively. References to the ‘‘Company’’ in these condensed consolidated interim financial statements shall mean Amryt Pharma plc. Amryt Pharma plc is a company incorporated in England and Wales. The Company is listed on Nasdaq (ticker: AMYT). The Company was also listed on the AIM market of the London Stock Exchange (ticker: AMYT) up until January 11, 2022, on which date the Company completed the cancellation its admission to AIM. The cancellation was announced by the Company on November 22, 2021, and following the AIM delisting, the Company’s American Depositary Shares (“ADSs”)remain listed, and will only be tradeable, on Nasdaq. The Company’s last day of trading on AIM was 10 January 2022. Amryt acquired Chiasma, Inc. (“Chiasma”) in August 2021. The combined company will be a global leader in rare and orphan diseases with four on-market commercial products, a global commercial and operational footprint and a significant development pipeline of therapies with the financial flexibility to execute its growth plans. Amryt’s commercial business comprises four orphan disease products – metreleptin (Myalept®/ Myalepta®); oral octreotide (Mycapssa®); lomitapide (Juxtapid®/ Lojuxta®); and Oleogel-S10 (Filsuvez®). Amryt's lead development candidate, Oleogel-S10 is a potential treatment for the cutaneous manifestations of JEB and DEB, a rare and distressing genetic skin disorder affecting young children and adults. Filsuvez® has been selected as the brand name for Oleogel-S10. On June 23, 2022, Amryt announced the European Commission (EC) approval of Filsuvez® in the European Union (EU) for the treatment of partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa (EB) in patients 6 months and older.The centralized marketing authorization will be valid in all EU Member States as well as in Iceland, Liechtenstein, and Norway. The authorization of Filsuvez® in the EU provides a regulatory core dossier which may form the basis for future regulatory submissions in LATAM and the Middle East.The EC approval of Filsuvez® is supported by Phase 3 data from the EASE trial which was the largest ever global trial conducted in patients with EB, performed across 58 sites in 28 countries. During Q2 2022, Amryt had a Type A meeting with the FDA to discuss the issues raised in the Complete Response Letter (CRL) received in February 2022 relating to Amryt’s New Drug Application (NDA) for Oleogel-S10. Following this meeting, Amryt is proceeding to the Formal Dispute Resolution pathway in the FDA’s Center for Drug Evaluation and Research (CDER) by which NDA applicants can seek to resolve scientific and/or medical disputes that cannot be resolved at the division level. 2. Accounting policies Basis of preparation The condensed consolidated interim financial statements of the Group have been prepared in accordance with IAS 34 Interim Financial Reporting. They do not include all the information required in annual financial statements in accordance with International Financial Reporting Standards (‘‘IFRS’’) and should be read in conjunction with the annual consolidated financial statements for the year ended December 31, 2021. Selected explanatory notes are included to explain events and transactions that are significant to an understanding of the Group’s financial position and performance since the last annual financial statements. The accounting policies used in the preparation of the interim financial information are the same as those used in the Group’s audited financial statements for the year ended December 31, 2021, and those which are expected to be used in the financial statements for the year ended December 31, 2022. Results for the six-month period ended June 30, 2022, are not necessarily indicative of the results that may be expected for the financial year ending December 31, 2022. Basis of going concern Having considered the Group’s current financial position and cash flow projections, the Board of Directors believes that the Group will be able to continue in operational existence for at least the next 12 months from the date of approval of these condensed consolidated interim financial statements and that it is appropriate to continue to prepare the condensed consolidated interim financial statements on a going concern basis. As part of their inquiries, the Board of Directors reviewed budgets, projected cash flows, and other relevant information for a period not less than 12 months from the date of approval of the condensed consolidated interim financial statements for the period ended June 30, 2022. Basis of consolidation The condensed consolidated interim financial statements comprise the financial statements of the Group for the period ended June 30, 2022. Subsidiaries are entities controlled by the Company. Where the Company has control over an investee, it is classified as a subsidiary. The Company controls an investee if all three of the following elements are present: power over an investee, exposure or rights to variable returns from its involvement with the investee and the ability to use its power to affect those variable returns. Control is reassessed whenever facts and circumstances indicate that there may be a change in any of these elements of control. Subsidiaries are fully consolidated from the date that control commences until the date that control ceases. Accounting policies of subsidiaries have been changed where necessary to ensure consistency with the policies adopted by the Group. Intergroup balances and any unrealized gains or losses, income or expenses arising from intergroup transactions are eliminated in preparing the condensed consolidated interim financial statements. Presentation of balances The condensed consolidated interim financial statements are presented in U.S. dollars (‘‘US$’’), rounded to the nearest thousand, which is the functional currency of the Company and presentation currency of the Group. The following table discloses the major exchange rates of those currencies other than the functional currency of US$ that are utilized by the Group: Foreign currency units to 1 US$ € £ ILS NOK DKK Average three-month period to June 30, 2022 (unaudited) 0.9381 0.7951 3.3392 9.3988 6.9785 Average six-month period to June 30, 2022 (unaudited) 0.9145 0.7701 3.2680 9.1257 6.8039 AtJune 30, 2022 (unaudited) 0.9533 0.8224 3.4505 9.8488 7.0921 Foreign currency units to 1 US$ € £ ILS NOK DKK Average period to December 31, 2021 (audited) 0.8454 0.7271 3.2322 8.5975 6.2875 At December 31, 2021 (audited) 0.8830 0.7413 3.1115 8.8074 6.5664 Foreign currency units to 1 US$ € £ ILS NOK DKK Average three-month period to June 30, 2021 (unaudited) 0.8292 0.7253 3.2657 8.5171 6.1669 Average six-month period to June 30, 2021 (unaudited) 0.8303 0.7157 3.2688 8.3785 6.1747 AtJune 30, 2021 (unaudited) 0.8400 0.7220 3.2573 8.5546 6.2463 (€ = Euro; £ = Pounds Sterling, ILS = Israeli Shekel, NOK = Norwegian Kroner, DKK = Danish Kroner) Changes in accounting policies and disclosures There are no new standards and amendments to IFRS effective as of January 1, 2022, that are relevant to the Group. Critical accounting judgements and key sources of estimation uncertainty In preparing these condensed consolidated interim financial statements in conformity with IFRS management is required to make judgements, estimates and assumptions that affect the application of policies and amounts reported in the condensed consolidated interim financial statements and accompanying notes. The estimates and associated assumptions are based on historical experience and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis of making the judgements about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates. The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimate is revised if the revision affects only that period or in the period of the revision and future periods if the revision affects both current and future periods. The significant estimates, assumptions or judgements, applied in the condensed consolidated interim financial statements were the same as those applied in the Group’s audited financial statements for the year ended December 31, 2021. Principal accounting policies The condensed consolidated interim financial statements have been prepared in accordance with the accounting policies adopted in the Group’s audited financial statements for the year ended December 31, 2021. 3. Segment information The Group is a global, commercial-stage biopharmaceutical company dedicated to commercializing and developing novel therapeutics to treat patients suffering from serious and life-threatening rare diseases. The Group currently operates as one business segment, pharmaceuticals, and is focused on the development and commercialization of four commercial products and anumber of development products. The Group derives its revenues primarily from one source, being the pharmaceutical sector with high unmet medical need. The Group’s Chief Executive Officer, Joseph Wiley, is currently the Company’s chief operating decision maker (‘‘CODM’’). The Group does not operate any separate lines of business or separate business entities with respect to its products. Accordingly, the Group does not accumulate discrete financial information with respect to separate service lines and does not have separate reportable segments.The following table summarizes total revenues from external customers by product and by geographic region, based on the location of the customer. Three months ended June 30, 2022 (unaudited) U.S. EMEA Other Total US$’000 US$’000 US$’000 US$’000 Metreleptin 20,311 24,192 1,895 46,398 Lomitapide 7,585 6,995 2,795 17,375 Mycapssa® 4,499 — — 4,499 Other — 190 74 264 Total revenue 32,395 31,377 4,764 68,536 Three months ended June 30, 2021 (unaudited) U.S. EMEA Other Total US$’000 US$’000 US$’000 US$’000 Metreleptin 17,739 11,005 14,315 43,059 Lomitapide 8,490 7,492 3,468 19,450 Mycapssa® — — — — Other — 193 6 253 Total revenue 26,229 18,690 17,843 62,762 Six months ended June 30, 2022 (unaudited) U.S. EMEA Other Total US$’000 US$’000 US$’000 US$’000 Metreleptin 40,555 40,114 3,376 84,045 Lomitapide 15,639 14,185 5,367 35,191 Mycapssa® 7,926 — — 7,926 Other — 361 142 503 Total revenue 64,120 54,660 8,885 127,665 Six months ended June 30, 2021 (unaudited) U.S. EMEA Other Total US$’000 US$’000 US$’000 US$’000 Metreleptin 33,978 23,976 15,065 73,019 Lomitapide 16,814 14,932 5,888 37,634 Mycapssa® — — — — Other — 416 125 541 Total revenue 50,792 39,324 21,078 111,194 Major Customers For the three and six months ended June 30, 2022, one customer accounted for 41% and 44% of the Group’s net revenues (2021: 42% and 46%) and accounted for 34% of the Group’s June 30, 2022, accounts receivable balance (December 31, 2021: 36%). 4. Share based payments Share-based Compensation Plans Amryt’s Equity Incentive Plan Amryt’s Equity Incentive Plan was adopted by a special resolution on September 23, 2019. Prior to such date, we granted options under a prior employee share option plan, which had the same terms and conditions as the Equity Incentive Plan. On September 24, 2019, all options held under our prior share option plan were rolled over into options to subscribe for our ordinary shares with the key terms including strike price, vesting and the expiration date of such rolled over options remaining the same as they were on the issue date of the options under the prior share option plan. The Equity Incentive Plan was approved for amendment by the Board on May 18, 2020, August 3, 2021, and November 2, 2021. The purpose of the Plan is to provide for the granting of Equity Incentives to Directors and Employees of, and Consultants to, the Company or any Associated Company. Chiasma Equity Incentive Plan When Amryt acquired Chiasma in August 2021, the Chiasma Stock Option and Incentive Plan transferred across to Amryt. Each outstanding and unexercised Chiasma Stock Option or RSU, whether vested or not vested, ceased to represent a right to acquire shares of Chiasma common stock and were converted into an option to purchase Amryt ADSs on the same terms and conditions as were applicable under such Chiasma Stock Option and Incentive Plan immediately prior to the acquisition. No new stock option or RSUs will be granted under the Chiasma stock option and incentive plan. Terms and Conditions of New Share Option Grants The terms and conditions of new grants are as follows, whereby all options are settled by physical delivery of shares: Vesting conditions The employee share options vest following a period of service by the officer or employee. The required period of service is determined by the Remuneration Committee at the date of grant of the options (usually the date of approval by the Remuneration Committee). There are no market conditions associated with the share option vesting periods. Contractual life The term of an option is determined by the Remuneration Committee provided that the term may not exceed a period of seven to ten years from the date of grant. All options will terminate 90 days after termination of the option holder’s employment, service or consultancy with the Group except in certain circumstances or where a longer period is approved by the Board of Directors. Under certain circumstances involving a change in control of the Group, some options will automatically accelerate and become exercisable in full as of a date specified by the Board of Directors. All share option incentives granted are in the form of ordinary shares. Share option exercise prices below are the exercise price per ordinary share. The ADS equivalent exercise price will be theordinary share exercise price multiplied by five and the number of ADSs will be the number of ordinary shares divided by five. The number and weighted average exercise price (in Sterling pence) of share options per ordinary share granted under Amryt’s Equity Incentive Plan and the Chiasma stock option and incentive plan is as follows: Amryt Equity Incentive Plan Chiasma Stock Option and Incentive Plan Units Weighted average exercise price (Sterling pence) Units Weighted average exercise price (Sterling pence) Balance at January 1, 2021 18,753,648 122.79p — — Granted 11,337,459 190.88p — — Transferred to Amryt on acquisition — — 18,139,060 189.07p Forfeited (1,288,165) 174.97p (4,098,425) 226.22p Exercised (300,000) 93.00p (3,320,515) 116.35p Outstanding at December 31, 2021 (audited) 28,502,942 147.83p 10,720,120 197.40p Exercisable at December 31, 2021 (audited) 9,347,338 118.87p 8,005,390 192.35p Balance at January 1, 2022 28,502,942 147.83p 10,720,120 197.40p Granted 16,209,465 102.58p — — Forfeited (2,285,200) 165.77p (2,826,430) 205.22p Exercised (492,905) 113.22p (411,705) 94.59p Outstanding atJune 30, 2022 (unaudited) 41,934,302 129.77p 7,481,985 200.10p Exercisable atJune 30, 2022 (unaudited) 11,959,144 131.04p 5,902,285 217.78p The fair value of the Amryt equity award is estimated at the date of grant using the Black-Scholes pricing model, taking into account the terms and conditions attached to the grant. The fair value of the Chiasma equity awards transferred to Amryt on acquisition were measured in accordance with IFRS 2. The portion of the value of the equity transferred to Amryt attributable to pre-combination service is included in the consideration at the date of acquisition. The portion of the equity awards transferred to Amryt attributable to post combination service is estimated at the date of transfer using Black Scholes pricing model, taking into account the terms and conditions attached to the grant. The following are the inputs to the model for the equity instruments granted during the period: June 30, 2022 Options Inputs (unaudited) December 31, 2021 Options Inputs (unaudited) Days to Expiration 2,555 2,555 Volatility 39% 32% - 49% Risk free interest rate 1.96% - 2.89% 0.77% - 1.33% Share price at grant per ordinary share 99.9 – 131.7p 146.87 - 201.2p Share price at grant per ADS 499.5 – 658.5p 734.35 - 106.p In the six months endedJune 30, 2022, a total of 16,209,465 share options over ordinary shares exercisable at a weighted average price of US$1.33 (£1.03) were granted. The fair value of share options granted in the period ended June 30, 2022, was US$22,164,723/£16,628,014. The share options outstanding under the Amryt 2021 Equity Incentive Plan as atJune 30, 2022, had a weighted remaining contractual life of 5.34 years with exercise prices ranging from £0.76 to £2.012 per ordinary share. In the six months ended June 30, 2021, a total of 8,872,369 share options exercisable at a weighted average price of US$2.80 (£2.012) were granted. The fair value of share options granted in the six months ended June 30, 2021, was US$24,617,000/£17,845,000. The share options outstanding as atJune 30, 2021, had a weighted remaining contractual life of 5.55 years with exercise prices ranging from £0.76 to £2.012. The share options outstanding under the Chiasma Share Option and Incentive Plan transferred across to Amryt on acquisition. As atJune 30, 2022, they have a weighted remaining contractual life of 4.94 years with exercise prices ranging from £0.54 to £7.41 per ordinary share. No new share options will be granted under the Chiasma Stock Option and Incentive Plan. Restricted Share Units Under the terms of Amryt’s Equity Incentive Plan, restricted share units (“RSUs”) to purchase 3,659,250 ordinary shares were outstanding atJune 30, 2022. Under the terms of this plan, RSUs are granted to officers, consultants and employees of the Group at the discretion of the Remuneration Committee. For the six month period ended June 30, 2022, a total of 2,388,365 RSUs were granted to employees of the Company. For the year ended December 31, 2021, a total of 625,205 RSUs were granted to employees of the Company. The fair value of the RSUs is based on the share price at the date of grant, with the expense spread over the vesting period. The fair value of RSUs granted in the six month period ended June 30, 2022, was US$3,387,000. At June 30, 2022, the total RSUs granted to date have a weighted remaining contractual life of 2.35 years. Under the terms of Chiasma’s Stock Option and Incentive Plan transferred to Amryt on acquisition, restricted share units (“RSUs”) to purchase 48,795 ordinary shares were outstanding at June 30, 2022. At June 30, 2022, the total RSUs granted to date have a weighted remaining contractual life of 1.61 years. No new RSUs will be granted under the Chiasma Stock Option and Incentive Plan. The following table summarizes the RSU activity per ordinary share for the period: Amryt Equity Incentive Plan Chiasma Stock Option and Incentive Plan Units Weighted average fair value (US$) Units Weighted average fair value (US$) Balance at January 1, 2021 1,549,910 $2.34 — — Granted 625,205 $2.62 — — Transferred to Amryt on acquisition — — 202,145 $2.75 Lapsed (243,505) $2.35 (56,405) $2.75 Vested (362,855) $2.34 (39,180) $2.75 Outstanding at December 31, 2021 (audited) 1,568,755 $2.44 106,560 $2.75 Balance at January 1, 2022 1,568,755 $2.44 106,560 $2.75 Granted 2,388,365 $1.42 — — Lapsed (179,725) $1.92 (8,465) $2.75 Vested (118,145) $2.79 (49,300) $2.75 Outstanding atJune 30, 2022 (unaudited) 3,659,25 $1.79 48,795 $2.75 Performance Stock Units Under the terms of Amryt’s Equity Incentive Plan, performance share units (“PSUs”) to purchase 1,961,102 ordinary shares were granted to officers and employees at the discretion of the Remuneration Committee in the six month period to June 30, 2022. Performance conditions determine how many of these performance stock units will vest and, if performance targets are exceeded, additional performance stock units will be issued and vest in accordance with the terms of the relevant performance stock units award. The PSUs vest based on the Total Shareholder Return (“TSR”) of Amryt’s NASDAQ traded common stock relative to the TSRs of the constituents that comprise the NASDAQ Biotechnology Index (the Peer Group) as of January 1, 2022. TSR for Amryt and each peer company will be measured over the period from January 1, 2022, to December 31, 2024. The payout schedule can produce payout percentages ranging from 0% to 150%. The following table summarizes the PSU activity per ordinary share for the period: Amryt Equity Incentive Plan Units Weighted average fair value (US$) Balance at January 1, 2022 — — Granted 1,961,102 $1.42 Lapsed — — Vested — — Outstanding atJune 30, 2022 (unaudited) 1,961,102 $1.42 Warrants There are no outstanding warrants atJune 30, 2022 (December 31, 2021: nil). In August 2021, an Amryt institutional investor exercised subscription rights relating to 8,966,520 zero cost warrants. These warrants were issued in September 2019 as part of the Company’s acquisition of Aegerion. Certain institutional investors elected to receive warrants to subscribe for new ordinary shares of £0.06 each in Amryt (“Ordinary Shares”), in place of the same number of Ordinary Shares, as consideration for the Company’s acquisition of Aegerion and their equity investments in the Company in September 2019. Each warrant entitled the holder to subscribe for one Ordinary Share for no additional consideration. Separate warrants consisting of 345,542 as at December 31, 2020, which were issued in connection with the admission to the AIM in 2016, are no longer outstanding; 283,389 warrants were exercised in March 2021 and 62,153 warrants lapsed in April 2021. The number and weighted average exercise price (in Sterling pence) of warrants per ordinary share is as follows: Warrants Units Weighted average exercise price (Sterling pence) Balance at January 1, 2021 9,312,062 0.05p Granted — — Lapsed (62,153) 1.44p Exercised (9,249,909) 0.05p Outstanding at December 31, 2021 (audited) — 0.00p The value of share options and RSU’s charged to the Condensed Consolidated Statement of Comprehensive Loss during the period is as follows: Three months ended June 30, Six months ended June 30, 2022 (unaudited) 2021 (unaudited) 2022 (unaudited) 2021 (unaudited) US$’000 US$’000 US$’000 US$’000 Share option expense 1,920 1,473 4,579 2,352 RSU expense 683 480 1,112 864 PSU expense 277 — 337 — Total share based payment expenses 2,880 1,953 6,028 3,216 5. Business combinations and asset acquisitions Acquisition of Chiasma On May 5, 2021, Amryt announced that it had signed a definitive agreement to acquire Chiasma, Inc. (Nasdaq: CHMA) in an all-stock combination. Under the terms of the transaction, each share of Chiasma common stock issued and outstanding prior to the consummation of the transaction was exchanged for 0.396 Amryt ADSs, each representing five Amryt ordinary shares. On August 5, 2021, Amryt completed the acquisition of Chiasma, Inc. and, in conjunction with the completion, Amryt allotted and issued a total of 127,733,680 ordinary shares as consideration for the acquisition. Following the completion, shareholdings in Chiasma were rounded in being converted to Amryt shares using the exchange ratio of 0.396. Roundings in converting Chiasma shareholdings to Amryt shares were finalized in August 2021 and resulted in an additional 7,015 ordinary shares being allotted and issued by Amryt as consideration for the acquisition. In total, these ordinary shares were issued to the former Chiasma Shareholders in the form of 25,548,139 ADSs at US$10.19 per share, to acquire Chiasma for a value of US$260,336,000. On August 5, 2021, Chiasma had outstanding equity awards that were held by Chiasma employees. The fair value of these awards transferred to Amryt on acquisition were measured in accordance with IFRS 2. The portion of the value of the equity transferred to Amryt attributable to pre-combination service is included in the consideration at the date of acquisition and this amounted to US$10,157,000. On August 5, 2021, the Group repaid US$116,629,000 of Chiasma long term debt. The combined company will be a global leader in rare and orphan diseases with four on-market commercial products, a global commercial and operational footprint and a significant development pipeline of therapies with the financial flexibility to execute its growth plans. The table below reflects the fair value of the identifiable net assets acquired in respect of the acquisition completed during the period. Any amendments to fair values will be made within the twelve-month period from the date of acquisition, as permitted by IFRS 3: Business Combinations. The acquired goodwill is attributable principally to the profit generating potential of the businesses, the assembled workforce and benefits arising from embedded infrastructure, that are expected to be achieved from integrating the acquired businesses into the Group’s existing business. No amount of goodwill is expected to be deductible for tax purposes. The Group incurred acquisition and restructuring related costs of US$265,000 and US$667,000for the three-month period and six-month period ended June 30, 2022, respectively, relating to external legal fees, advisory fees, due diligence costs and severance costs related to the acquisition of Chiasma. These costs have been included in operating costs in the Condensed Consolidated Statement of Comprehensive Loss. Recognized Fair Values as at August 5, 2021 US$’000 Assets Non-current assets Intangible assets 215,000 Property, plant and equipment 950 Other non-current assets 866 Total non-current assets 216,816 Current assets Trade and other receivables 7,180 Inventories 65,907 Cash and cash equivalents, including restricted cash 107,942 Total current assets 181,029 Total assets 397,845 Non-current liabilities Deferred tax liability 21,478 Total non-current liabilities 21,478 Current liabilities Trade and other payables 144,482 Total current liabilities 144,482 Total liabilities 165,960 Total identifiable net assets at fair value 231,885 Goodwill arising on acquisition 38,608 Consideration 270,493 Consideration Issue of fully paid up ordinary shares 260,336 Chiasma equity awards recognized as consideration transferred upon the acquisition of Chiasma 10,157 Total consideration 270,493 Any amendments to these fair values within the twelve-month timeframe from the date of acquisition will be disclosed in the 2022 consolidated financial statements, as stipulated by IFRS 3. Acquisition of Aegerion Pharmaceuticals On May 20, 2019, Amryt entered into a Restructuring Support Agreement (as subsequently amended on June 12, 2019) and Plan Funding Agreement pursuant to which, among other matters, Amryt agreed to the acquisition of Aegerion Pharmaceuticals, Inc. (‘‘Aegerion’’, subsequently renamed as Amryt Pharmaceuticals Inc.), a former wholly-owned subsidiary of Novelion Therapeutics Inc. (‘‘Novelion’’). On May 20, 2019, Aegerion and its U.S. subsidiary, Aegerion Pharmaceuticals Holdings, Inc., filed voluntary petitions under Chapter 11 of Title 11 of the U.S. Code in the Bankruptcy Court. On September 24, 2019, Amryt completed the acquisition of Aegerion. Amryt acquired Aegerion upon its emergence from bankruptcy in an exchange for ordinary shares and zero cost warrants in Amryt. Amryt issued 85,092,423 effective shares at US$1.793 per share, which is made up of 77,027,423 ordinary shares and 8,065,000 zero cost warrants, to acquire Aegerion for a value of US$152,615,000. As part of the acquisition of Aegerion, it was agreed, for certain Aegerion creditors who wished to restrict their percentage share interest in Amryt’s issued share capital, to issue to the relevant Aegerion creditor, as an alternative to Amryt’s ordinary shares, an equivalent number of new zero cost warrants to subscribe for Amryt’s ordinary shares to be constituted on the terms of the zero cost warrant. As atJune 30, 2022, no zero cost warrants were remaining. Contingent Value Rights Related to the transaction, Amryt issued Contingent Value Rights (‘‘CVRs’’) pursuant to which up to US$85,000,000 may become payable to Amryt’s shareholders and optionholders, who were on the register prior to the completion of the acquisition on September 20, 2019, if certain approval and revenue milestones are met in relation Oleogel-S10, Amryt’s lead product candidate. If any such milestone is achieved, Amryt may elect to pay the holders of CVRs by the issue of Amryt shares or loan notes. If Amryt elects to issue Loan Notes to holders of CVRs, it will settle such loan notes in cash 120 days after their issue. If none of the milestones are achieved, scheme shareholders and optionholders will not receive any additional consideration under the terms of the CVRs. In these circumstances, the value of each CVR would be zero. The terms of the CVRs are as follows: The total CVR payable is up to US$85,000,000 This is divided into three milestones which are related to the success of Oleogel-S10 (the Group’s lead development asset) FDA approval US$35,000,000 upon FDA approval 100% of the amount due if approval is obtained before December 31, 2021, with a sliding scale on a linear basis to zero if before July 1, 2022. The timeline for this milestone has now passed and, therefore, will not be paid. EMA approval US$15,000,000 upon EMA approval 100% of the amount due if approval is obtained before December 31, 2021, with a sliding scale on a linear basis to zero if before July 1, 2022 Revenue targets US$35,000,000 upon Oleogel-S10 revenues exceeding US$75,000,000 in any 12-month period prior to June 30, 2024 Payment can at the Board’s discretion be in the form of either: 120-day loan notes (effectively cash), or Shares valued using the 30 day / 45-day VWAP. The CVRs were contingent on the successful completion of the acquisition and, accordingly, have been based on fair value as at September 24, 2019. The CVRs have been classified as a financial liability in the Condensed Consolidated Statement of Financial Position. Given that CVRs were issued to legacy Amryt shareholders in their capacity as owners of the identified acquirer as opposed to the seller in the transaction, management concluded that the most appropriate classification would be to recognize the CVR as a distribution on consolidation instead of goodwill. Following the EMA approval of Filsuvez (Oleogel S-10) during the period ended June 30, 2022, the EMA CVRs issued to those Amryt shareholders and option holders who held Amryt shares or options prior to the acquisition of Aegerion Pharmaceuticals, Inc. (“CVR Holders”) became payable. Amryt elected to issue Loan Notes that will be redeemed in full in September 2022 to the holders of the CVRs. The total amount payable to CVR Holders is US$5,718,000 for which a liability is recognized in current liabilities in the Condensed Consolidated Statement of Financial Position. Measurement of Contingent Value Rights As atJune 30, 2022, the carrying value of the Contingent Value Rights liability was US$12,889,000 (December 31, 2021: US$19,892,000). As the EMA approval milestone has been triggered and the FDA approval will not be achieved in time for the FDA approval milestone to be triggered, the Contingent Value Rights liability relates to the Revenue target milestones and the related expected discounted cash flows. The value of this potential payout was calculated using the probability-weighted expected returns method. Using this method, the potential payment amounts were multiplied by the probability of achievement and discounted to present value. The probability adjusted present values took into account published orphan drug research data and statistics which were adjusted by management to reflect the specific circumstances applicable to the type of product acquired in the Amryt GmbH transaction. The probability chance of success is based on management’s expertise and experience for orphan drugs and takes into account the unique circumstances applying to approval process of this product. The EMA approval probability was set at 100% following the approval received in 2022 (December 31, 2021: estimated at 100%) and the probability of success for the FDA approval was estimated at 5% (December 31, 2021: 60%) as at June 30, 2022. The EMA approval probability reflects the EMA approval achieved in 2022 and the FDA estimate reflects the current facts and circumstances as of the date of issuance of the Condensed Consolidated Financial Statements. The FDA approval probability chance of success was updated in 2022 following developments related to the receipt of a CRL from the FDA, where Amryt announced in June 2022 its intention to submit a Formal Dispute Resolution Request (FDRR) for the company’s NDA for Filsuvez®. Discount rates of 10% and 16.5%, as applicable, were used in the calculation of the present value of the estimated contractual cash flows for the year ended December 31, 2021, based on the applicable rates determined on the acquisition date. Management was required to make certain estimates and assumptions in relation to revenue forecasts, timing of revenues and probability of achievement of commercialization of Oleogel-S10. However, management notes that, due to issues outside their control (i.e. regulatory requirements and the commercial success of the product), the timing of when such revenue targets may occur may change. Such changes may have a material impact on the assessment of the expected cash flows of the CVRs. Amryt reviews the expected cash flows on a regular basis as the discount on initial recognition is being unwound as financing expenses in the Consolidated Statement of Comprehensive Loss over the life of the obligation. It is reviewed on a quarterly basis and the appropriate finance charge or gain is booked in the Consolidated Statement of Comprehensive Loss on a quarterly basis. The total non-cash gain recognized in the Condensed Consolidated Statement of Comprehensive Loss for the three andsix months ended June 30, 2022, is US$1,967,000 and US$1,285,000 (June 30, 2021: US$1,837,000 charge and US$3,600,000 charge, respectively). Acquisition of Amryt GmbH (previously ‘‘Birken’’) Amryt DAC signed a conditional share purchase agreement to acquire Amryt GmbH on October 16, 2015 (‘‘Amryt GmbH SPA’’). The Amryt GmbHSPA was completed on April 18, 2016, with Amryt DAC acquiring the entire issued share capital of Amryt GmbH. The consideration included contingent consideration comprising milestone payments and sales royalties as follows: Milestone payments of: €10,000,000 on receipt of marketing approval by the EMA or FDA of a pharmaceutical product containing Betulin as its API for the treatment of EB. Following EMA approval in 2022, this milestone was paid in July 2022; €10,000,000 once net ex-factory sales/net revenue of Oleogel S-10 first exceed €50,000,000 in any calendar year; €15,000,000 once net ex-factory sales/ net revenue of Oleogel S-10 first exceed €100,000,000 in any calendar year; Cash consideration of €150,000, due and paid on the completion date (April 18, 2016); and Royalties of 9% on sales of Oleogel-S10 products for 10 years from first commercial sale. Fair Value Measurement of Contingent Consideration As atJune 30, 2022, the fair value of the contingent consideration was estimated to be US$52,434,000 (December 31, 2021: US$61,221,000).The EMA or FDA marketing approval milestone payment was triggered following the EMA approval of Filsuvez® in 2022 and the liability of $10,490,000 (€10,000,000), reflecting the final fair value for this milestone payment, is recognized as contingent consideration in current liabilities on the Condensed Consolidated Statement of Financial Position. The marketing approval milestone payment of€10,000,000 was paid in July 2022. The fair value of the remaining contingent consideration includes milestone payments determined using probability adjusted present values and probability weighted revenue forecasts (see Note 15, Fair value measurement and financial risk management, for fair value hierarchy applied and impact of key unobservable impact data).The probability adjusted present values took into account published orphan drug research data and statistics which were adjusted by management to reflect the specific circumstances applicable to the type of product acquired in the Amryt GmbH transaction. The probability chance of success is based on management’s expertise and experience for orphan drugs and takes into account the unique circumstances applying to approval process of this product. The EMA approval probability was set at 100% following the approval received in 2022 (December 31, 2021: estimated at 100%) and the probability of success for the FDA approval was estimated at 50% (December 31, 2021: 60%) as at June 30, 2022. The EMA approval probability reflects the EMA approval achieved in 2022 and the FDA estimate reflects the current facts and circumstances as of the date of issuance of the Condensed Consolidated Financial Statements. The FDA approval probability chance of success was updated in 2022 following developments related to the receipt of a CRL from the FDA, where Amryt announced in June 2022 its intention to submit a FDRR for the company’s NDA for Filsuvez®. A discount rate of 7.9% was used in the calculation of the fair value of the contingent consideration for the six month period ended June 30, 2022 (December 31, 2021: 7.9%). Amryt reviews the expected cash flows on a regular basis as the discount on initial recognition is being unwound as financing expenses in the Consolidated Statement of Comprehensive Loss over the life of the obligation. It is reviewed on a quarterly basis and the appropriate finance charge or gain is booked in the Consolidated Statement of Comprehensive Loss on a quarterly basis. The total non-cash gain recognized in the Condensed Consolidated Statement of Comprehensive Loss for the three and six months ended June 30, 2022, is US$4,72,000and US$4,293,000 (June 30, 2021: US$2,993,000 charge and US$5,867,000 charge, respectively). 6. Loss per share – basic and diluted The weighted average number of shares in the loss per share (‘‘LPS’’) calculation, reflects the weighted average total actual shares of Amryt Pharma plc in issue atJune 30, 2022. Issued share capital – ordinary shares of £0.06 each Number of shares Weighted average shares As at June 30, Three months ended June 30, Six months ended June 30, 2022 (unaudited) 320,884,822 320,813,045 320,658,612 2021 (unaudited) 179,384,982 179,384,982 179,162,585 The calculation of loss per share is based on the following: Three months ended June 30, Six months ended June 30, 2022 (unaudited) 2021 (unaudited) 2022 (unaudited) 2021 (unaudited) Loss after tax attributable to equity holders of the Company (US$’000) (7,049) (6,799) (21,540) (23,336) Weighted average number of ordinary shares in issue 320,813,045 179,384,982 320,658,612 179,162,585 Fully diluted average number of ordinary shares in issue 320,813,045 179,384,982 320,658,612 179,162,585 Basic and diluted loss per share (US$) (0.02) (0.04) (0.07) (0.13) Where a loss has occurred, basic and diluted LPS are the same because the outstanding share options and warrants are anti-dilutive. Accordingly, diluted LPS equals the basic LPS. The share options, RSUs, PSUs and warrants outstanding as atJune 30, 2022, totaled55,085,434(June 30, 2021: 36,271,387) and are potentially dilutive. 7. Intangible assets and goodwill The following table summarizes the Group’s intangible assets and goodwill: Developed technology - metreleptin Developed technology - lomitapide Developed technology - Mycapssa® In process R&D Other intangible assets Total intangible assets Goodwill US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 Cost At January 1, 2021 (audited) 176,000 123,000 — 60,128 866 359,994 19,131 Additions — — — — 847 847 — Acquired assets — — 215,000 — — 215,000 38,608 Other movements — — — — — — (1,051) Foreign exchange movement — — — (4,691) (61) (4,752) — At December 31, 2021 (audited) 176,000 123,000 215,000 55,437 1,652 571,089 56,688 Foreign exchange movement — — — (4,417) (115) (4,532) — AtJune 30, 2022 (unaudited) 176,000 123,000 215,000 51,020 1,537 566,557 56,688 Accumulated amortization At January 1, 2021 (audited) 34,743 19,680 — — 202 54,625 — Amortization charge 27,428 15,537 5,979 — 147 49,091 — Foreign exchange movement — — — — 14 14 — At December 31, 2021 (audited) 62,171 35,217 5,979 — 363 103,730 — Amortization charge 13,713 7,768 7,414 — 174 29,069 — Foreign exchange movement — — — — (74) (74) — AtJune 30, 2022 (unaudited) 75,884 42,985 13,393 — 463 132,725 — Net book value At December 31, 2021 (audited) 113,829 87,783 209,021 55,437 1,289 467,359 56,688 AtJune 30, 2022 (unaudited) 100,116 80,015 201,607 51,020 1,074 433,832 56,688 Developed technology on commercially marketed products In connection with the acquisition of Aegerion in September 2019, the Group acquired developed technology, metreleptin and lomitapide. These intangible assets are amortized over their estimated useful lives and the remaining useful lives for metreleptin and lomitapide are approximately 3.7 and 5.2 years, respectively, as of June 30, 2022 (December 31, 2021: 4.2 and 5.7 years, respectively). In connection with the acquisition of Chiasma in August 2021, the Group acquired developed technology, octreotide. This intangible asset is amortized over its estimated useful life and the remaining useful life is approximately 13.7 years as of June 30, 2022 (December 31, 2021: 14.2). In-process R&D As a result of the acquisition of Amryt GmbH, in 2016, the Group recognized in-process R&D costs of €48,453,000 (US$54,872,000as of the acquisition date) which is related to the Group’s lead development asset, Oleogel-S10. The remaining in-process R&D is a result of the acquisition of Cala Medical Limited in October 2020. Goodwill During 2019, the Group completed the acquisition of Aegerion which resulted in the recognition of goodwill that has a carrying value of US$18,080,000. On August 5, 2021, the Group completed the acquisition of Chiasma, which resulted in aggregate goodwill of US$38,608,000. The Group reviews events or changes in circumstances that may indicate a triggering event for impairment, at each reporting date, and conducts an annual impairment review to determine any impairment charge required. Management completed an impairment review by determining recoverable amounts from value in use calculations. The recoverable amount of an asset or cash generating unit is estimated in order to determine the extent of an impairment charge. There was no impairment charge recorded during the six months ended June 30, 2022. 8. Trade and other receivables As at June 30, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Trade receivables 37,729 34,263 Accrued income and other debtors 9,104 12,201 VAT recoverable 3,594 7,444 Trade and other receivables 50,427 53,908 9. Inventories As at June 30, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Raw materials 39,640 36,850 Work in progress 17,184 12,986 Finished goods 67,361 65,933 Inventories 124,185 115,769 Inventories for the period ended June 30, 2022, includes inventory acquired as part of the acquisition of Chiasma on August 5, 2021, which was fair valued as of the date of the acquisition. The fair value of the acquired inventory amounted to US$65,907,000. Inventory on hand at the date of acquisition was valued at the expected selling price less the sum of remaining costs of disposal, cost to complete and a reasonable profit margin for the selling effort of the acquiring entity. The costs to complete were calculated based on costs incurred on recently completed finished goods. The costs to dispose include sales and marketing expenses required to sell the product to the customer in addition to certain general and administrative expenses expected to be incurred by Amryt. This resulted in a non-cash step up at the valuation of inventory at August 5, 2021, of US$44,794,000. The non-cash step up in inventory is being unwound to the Condensed Consolidated Statement of Comprehensive Loss over the period in which this saleable inventory is sold. AtJune 30, 2022, US$37,804,000 of this non-cash inventory step up is included in inventory. 10. Cash and cash equivalents As at June 30, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Cash at bank available on demand 90,583 112,771 Restricted cash 150 261 Total cash and cash equivalents 90,733 113,032 Cash and cash equivalents include cash at bank available on demand and restricted cash. AtJune 30, 2022, and December 31, 2021, there was US$150,000 and US$261,000 of restricted cash, respectively. The balance atJune 30, 2022,consists of a letter of credit related to US customs which was put in place for an amount of US$50,000 and a letter of credit related to a deposit on a company credit card facility for an amount of US$100,000. The balance atDecember 31, 2021, includes a deposit on a company credit card facility for an amount of US$$126,000,a lease deposit for US$85,000 and a letter of credit related to US customs which was put in place for an amount of US$50,000. 11. Share capital and reserves Details of the number of issued ordinary shares with a nominal value of Sterling 6 pence (2021: 6 pence) each are in the table below. Ordinary shares Treasury shares Total At January 1, 2021 (audited) 178,801,593 4,791,703 183,593,296 Issue of treasury shares in exchange for warrants 283,389 (283,389) — Issue of treasury shares for share options exercised 300,000 (300,000) — Issue of shares in consideration of Chiasma acquisition 127,740,695 — 127,740,695 Issue of shares in exchange for warrants 4,758,206 — 4,758,206 Issue of treasury shares in exchange for warrants 4,208,314 (4,208,314) — Issue of shares for share options exercised and RSUs vesting 3,722,550 — 3,722,550 At December 31, 2021 (audited) 319,814,747 — 319,814,747 Issue of shares for share options exercised and RSUs vesting 1,070,075 — 1,070,075 AtJune 30, 2022 (unaudited) 320,884,822 — 320,884,822 The components of equity are detailed in the Condensed Consolidated Statement of Changes in Equity and described in more detail below. On March 11, 2021, the Company issued 300,000 ordinary shares from treasury shares following the exercise of share options. On March 11, 2021, the Company issued 283,389 ordinary shares from treasury shares in exchange for certain warrants. On August 5, 2021, the Company issued 127,740,695 ordinary shares, in the form of ADSs, as consideration for the acquisition of Chiasma. On August 5, 2021, the Company issued 8,966,520 ordinary shares with 4,208,314 being issued from treasury shares in exchange for warrants. During the year ended December 31, 2021, there were 3,342,680 shares issued following the exercise of share options and 379,870 shares issued following RSUs vesting.During the period ended June 30, 2022, there were 904,610shares issued following the exercise of share options and 165,465shares issued following RSUs vesting. Share Capital Share capital represents the cumulative par value arising upon issue of ordinary shares of Sterling 6 pence each. The ordinary shares have the right to receive notice of, attend and vote at general meetings and participate in the profits of the Company. Share Premium Share premium represents the consideration that has been received in excess of the nominal value on issue of share capital net of issue costs and transfers to distributable reserves. Warrant reserve The warrant reserve represented zero cost warrants issued as part of the equity raise on September 24, 2019, net of issue costs apportioned to warrants issued and additional warrants issued to certain shareholders on November 14, 2019. Each warrant entitles the holder to subscribe for one ordinary share at zero cost. The Company issued 4,000,000 and 4,229,753 ordinary shares on July 15, 2020, and September 22, 2020, respectively, in exchange for certain warrants. The remaining warrants were exchanged on August 5, 2021, and the Company issued 8,966,520 ordinary shares, 4,208,314 of which were issued from treasury shares and there are no longer any warrants outstanding. Treasury Shares In October 2020, the Company issued 72,953 ordinary shares from treasury shares following the exercise of share options. In March 2021, the Company issued a total of 583,389 ordinary shares from treasury shares, 300,000 ordinary shares relating to the exercise of share options and 283,389 ordinary shares following the exchange of certain warrants.In August 2021, the company issued 4,208,314 ordinary shares from treasury shares in conjunction with the exchange of warrants and since August 2021 there are no longer any treasury shares held. Share based payment reserve Share based payment reserve relates to the charge for share based payments in accordance with IFRS 2. In March 2021, the Company issued 283,389 ordinary shares in exchange for certain warrants. In April 2021, 62,153 warrants lapsed. During the year ended December 31, 2021, the Company issued 3,722,550 ordinary shares in relation to the exercise of share options and RSUs.During the period ended June 30, 2022, the Company issued 1,070,075 ordinary shares in relation to the exercise of share options and RSUs. As part of the acquisition of Chiasma, the Company replaced share awards that were existing at the time of the acquisition. This resulted in the recognition of a share-based payment reserve of US$10,157,000 on acquisition. Merger reserve The merger reserve was created on the acquisition of Amryt DAC by Amryt Pharma plc in April 2016. Ordinary shares in Amryt Pharma plc were issued to acquire the entire issued share capital of Amryt DAC. Under section 612 of the UK Companies Act 2006, the premium on these shares has been included in a merger reserve. Reverse acquisition reserve The reverse acquisition reserve arose during the period ended December 31, 2016, in respect of the reverse acquisition of Amryt Pharma plc by Amryt DAC. Since the shareholders of Amryt DAC became the majority shareholders of the enlarged Group, the acquisition is accounted for as though there is a continuation of Amryt DAC’s financial statements. The reverse acquisition reserve is created to maintain the equity structure of Amryt Pharma plc in compliance with UK company law. Equity component of convertible notes The equity component of convertible notes represents the equity component of the US$125,000,000 convertible debt and is measured by determining the residual of the fair value of the instrument less the estimated fair value of the liability component. The equity component is recognized in equity and is not subsequently remeasured. Other distributable reserves Other distributable reserves comprise the following: Distribution of the share premium amount on 6 November 2019 of US$268,505,000. By special resolution of the Company duly passed on 23 September 2019, it was resolved that the entire amount outstanding to the credit of the share premium account and capital redemption reserve of the Company be cancelled. The reduction in capital, amounting to US$268,505,000, representing the entire amount of share premium at that time, was approved by the High Court of Justice of England and Wales on 5 November 2019. A deemed distribution of US$47,902,000 arising from the issuance of CVRs in September 2019. A deemed distribution of US$2,969,000 arising from the scheme of arrangement in September 2019 whereby Amryt Pharma plc, which was incorporated in July 2019, became a 100% shareholder of Amryt Pharma Holdings Limited (formerly named Amryt Pharma plc) (the “Acquisition of subsidiary without a change of control”). Currency translation reserve The currency translation reserve arises on the retranslation of non-U.S. dollar denominated foreign subsidiaries. Accumulated deficit Accumulated deficit represents losses accumulated in previous periods and the current year. 12. Long term loan As at June 30, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Long term loan principal 105,000 93,988 Unamortized debt issuance costs (6,274) (593) Long term loan 98,726 93,395 On February 18, 2022, Amryt secured US$125,000,000 of senior credit facilities (“Senior Credit Facility”) from funds managed by the Credit Group of Ares Management Corporation (“Ares”). A portion of the proceeds were used to refinance the previous secured term loan, which had an outstanding balance of US$93,988,000 as at February 22, 2022, an interest rate of 13.00% and a maturity date of September 2024. The new facilities will generate significant annual interest cost savings as well as provide for important strategic flexibility as Amryt looks to continue to grow its global rare disease presence.In repaying the secured term loan, Amryt incurred an exit fee of 5.00% of the outstanding principal amount as at the prepayment date. This amounted to US$4,699,000 and is included in Net finance expense – other in the Condensed Consolidated Statement of Comprehensive Income for the six month-period ended June 30, 2022. Key features of the new facilities include: Total new facilities of $125 million, consisting of: $85 million Term Loan Facility with interest rate of Secured Overnight Financing Rate (“SOFR”)+6.75%, subject to a 0.90% SOFR floor $40 million Revolving Credit Facility with $20 million drawn at close and interest rate of SOFR+4.00%, subject to a 0.90% SOFR floor Quarterly blended cash interest rate of SOFR+5.87% (assuming fully drawn), subject to a 0.90% SOFR floor, substantially lower than Amryt’s previous secured term debt facility at 13.00% interest Requires interest-only payments until facility matures in February 2027 There are no warrants or any equity conversion features associated with the new facilities The proceeds will be used to refinance existing debt, for general corporate and product development purposes; and potentially for shareholder approved share repurchase programs. As at June 30, 2022, there was unpaid accrued interest of US$2,402,000 and US$399,000 for the Term Loan Facility and Revolving Credit Facility, respectively, recognized in current liabilities within trade and other payables. Charges were taken over certain assets of the company and its material entities as guarantee and collateral for the provision of the debt. In connection with the Secured Credit Facility, the Group incurred approximately US$6,656,000 of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees. These costs are amortized over the expected life of the loan using the effective interest method. The Secured Credit Facilityincludes affirmative and negative covenants, including prohibitions on the incurrence of additional indebtedness, granting of liens, certain asset dispositions, investments, and restricted payments, in each case, subject to certain exceptions set forth in the loan agreement. The loan agreement also includes customary events of default for a transaction of this type and includes (i) a cross-default to the occurrence of any event of default under material indebtedness of Amryt and certain subsidiaries of the Group and Amryt, including the convertible notes, and (ii) Amryt or any of its subsidiaries being subject to bankruptcy or other insolvency proceedings. Upon the occurrence of an event of default, the lenders may declare all of the outstanding Secured Credit Facilityand other obligations under the Secured Credit Facilityto be immediately due and payable and exercise all rights and remedies available to the lenders under the Term Loan agreement and related documentation. There were no events of default or breaches of the covenants occurring during the three and six month period ended June 30, 2022. As part of the acquisition of Aegerion on September 24, 2019, Aegerion entered into a new U.S. dollar denominated US$81,021,000 secured term loan debt facility (‘‘Term Loan’’) with various lenders. The Term Loan was made up of a US$54,469,000 loan that was in place prior to the acquisition which was refinanced as part of the acquisition and a US$26,552,000 additional loan that was drawn down on September 24, 2019. The Term Loan had a five-year term from the date of the draw down, September 24, 2019, and matured on September 24, 2024. Under the Term Loan, interest was payable at the option of the Group at the rate of 11% per annum paid in cash on a quarterly basis or at a rate of 6.5% paid in cash plus 6.5% paid in kind that was to be paid when the principal is repaid, which rolled up and included in the principal balance outstanding, on a quarterly basis. The Term Loan was repayable, in whole or in part, by Amryt at any time subject to payment of an exit fee, which depending on the stage of the loan term, ranged from 5.00% to 0.00% of the principal then outstanding on the Term Loan. On February 18, 2022, the Term Loan was repaid in full and the Group secured a $125,000,000 senior credit facility of which US$105,000,000 was drawn down to facilitate the prepayment of the existing Term Loan.In repaying the Secured Credit Facility, Amryt incurred an exit fee of 5.00% of the outstanding principal amount as at the prepayment date. In connection with the Term Loan, the Group incurred approximately US$870,000 of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees. These costs were amortized over the expected life of the loan using the effective interest method and during the six month period ended June 30, 2022, were written off to the Condensed Consolidated Statement of Comprehensive Loss as the Term Loan liability was derecognized. The Term Loan wasguaranteed by Amryt and certain subsidiaries of the Group. In connection with the loan agreement, fixed and floating charges were placed on property and undertakings of Amryt and certain subsidiaries of the Group. 13. Convertible notes Total US$’000 At January 1, 2021 101,086 Accreted interest 4,702 At December 31, 2021 (audited) 105,788 Accreted interest 2,544 AtJune 30, 2022 (unaudited) 108,332 As part of the Aegerion acquisition, Aegerion issued convertible notes with an aggregate principal amount of US$125,000,000 to Aegerion creditors. The convertible notes are senior unsecured obligations and bear interest at a rate of 5.0% per year, payable semi-annually in arrears on April 1 and October 1 of each year, beginning on April 1, 2020. The convertible notes will mature on April 1, 2025, unless earlier repurchased or converted. The convertible notes are convertible into Amryt’s ordinary shares at a conversion rate of 386.75 ordinary shares per US$1,000 principal amount of the convertible notes. If the holders elect to convert the convertible notes, Amryt can settle the conversion of the convertible notes through payment or delivery of cash, common shares, or a combination of cash and common shares, at its discretion. As a result of the conversion feature in the convertible notes, the convertible notes were assessed to have both a debt and an equity component. The two components were assessed separately and classified as a financial liability and equity instrument. The financial liability component was measured at fair value based on the discounted cash flows expected over the expected term of the notes using a discount rate based on a market interest rate that a similar debt instrument without a conversion feature would be subject to. Refer to Note 11, Share capital and reserves, for further details on the equity component of the convertible notes. From September 24, 2019, until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of their convertible notes, in multiples of US$1,000 principal amount, at the option of the holder. The indenture does not contain any financial covenants or restrict the Group’s ability to repurchase securities, pay dividends or make restricted payments in the event of a transaction that substantially increases the Group’s level of indebtedness in certain circumstances. The indenture contains customary terms and covenants and events of default. If an event of default (other than certain events of bankruptcy, insolvency or reorganization involving Aegerion, Amryt and certain subsidiaries of the Group) occurs and is continuing, the trustee by notice to Amryt, or the holders of at least 25% in principal amount of the outstanding convertible notes by written notice to Amryt and the trustee, may declare 100% of the principal of and accrued and unpaid interest, if any, on all of the convertible notes to be due and payable. Upon such a declaration of acceleration, such principal and accrued and unpaid interest, if any, will be due and payable immediately. Upon the occurrence of certain events of bankruptcy, insolvency or reorganization involving Amryt, 100% of the principal and accrued and unpaid interest, if any, on the convertible notes will become due and payable automatically. Notwithstanding the foregoing, the indenture provides that, upon Amryt’s election, and for up to 180 days, the sole remedy for an event of default relating to certain failures by Amryt to comply with certain reporting covenants in the indenture consists exclusively of the right to receive additional interest on the convertible notes. There have been no events of default or breaches of the covenants occurring for the period ended June 30, 2022 (2021: no events). 14. Provisions and other liabilities As at June 30, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Non-current liabilities Leases due greater than 1 year 3,543 4,049 3,543 4,049 Current liabilities Provisions and other liabilities 6,000 6,000 Leases due less than 1 year 911 1,545 6,911 7,545 Total provisions and other liabilities 10,454 11,594 Legal matters Prior to the acquisition of Aegerion by Amryt, Aegerion entered into settlement agreements with governmental entities including the Department of Justice (‘‘DOJ’’) and the FDA in connection with Juxtapid investigations. The settlement agreements required Aegerion to pay specified fines and engage in regulatory compliance efforts. Subsequent to the acquisition, Aegerion made US$23,036,000 of settlement payments, including interest. The settlements have been paid in full with the last payment completed in Q1 2021. Other matters The Group recognizes a liability for legal contingencies when it believes that it is both probable that a liability has been incurred and that it can reasonably estimate the amount of the loss. The Group reviews these accruals and adjusts them to reflect ongoing negotiations, settlements, rulings, advice of legal counsel and other relevant information. To the extent new information is obtained and the Group’s views on the probable outcomes of claims, suits, assessments, investigations or legal proceedings change, changes in the Group’s liability accrual would be recorded in the period in which such determination is made. AtJune 30, 2022, the Group had recognized liabilities of US$6,000,000 in relation to ongoing legal matters (December 31, 2021: US$6,000,000). 15. Fair value measurement and financial risk management Categories of financial instruments As at June 30, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Financial assets (all at amortized cost): Cash and cash equivalents 90,733 113,032 Trade receivables 37,729 34,263 Total financial assets 128,462 147,295 Financial liabilities: At amortized cost Trade payables and accrued expenses 125,596 148,251 Lease liabilities 4,454 5,594 Convertible notes 108,332 105,788 Long term loan 98,726 93,395 Contingent value rights 12,889 19,892 Loan Notes 5,718 — At fair value Contingent consideration 52,434 61,221 Total financial liabilities 408,149 434,141 Net (279,687) (286,846) Financial instruments evaluated at fair value can be classified according to the following valuation hierarchy, which reflects the extent to which the fair value is observable: Level 1: fair value evaluations using prices listed on active markets (not adjusted) of identical assets or liabilities. Level 2: fair value evaluations using input data for the asset or liability that are either directly observable (as prices) or indirectly observable (derived from prices), but which do not constitute listed prices pursuant to Level 1. Level 3: fair value evaluations using input data for the asset or liability that are not based on observable market data (unobservable input data). The contingent consideration has been valued using Level 3. The contingent consideration comprises: Contingent consideration relating to the acquisition of Amryt GmbH (see Note 5, Business combinations and asset acquisitions) that was measured at US$52,434,000 as atJune 30, 2022 (December 31, 2021: US$61,221,000). The fair value comprises royalty payments which was determined using probability weighted revenue forecasts and the fair value of the milestones payments which was determined using probability adjusted present values. It also included a revision to the discount rate used, and revenue and costs forecasts have been amended to reflect management’s current expectations. Impact of key unobservable input dataon the contingent consideration: An increase of 10% in estimated revenue forecasts would result in an increase to the fair value of US$3,174,000. A decrease would have the opposite effect. A 5% increase in the discount factor used would result in a decrease to the fair value of US$7,276,000. A decrease of 5% would result in an increase to the fair value of US$9,493,000. A six-month delay in the launch date for Oleogel-S10 would result in a decrease to the fair value of US$4,141,000. An increase of 20% in the probability of success with the FDA approval would result in a decrease to the fair value of US$12,628,000. 16. Events after the reporting period There were no significant events since the end of the reporting period.
AMYT CHMA | finance.yahoo | about 3 years ago | Neutral

Amryt Reports Record Q2 2022 ResultsAmryt ReportsRecord Q2 2022 Results 9.2% YoY revenue growth in Q2 to $68.5M 35.3% YoY revenue growth in Q2excluding impact of a sporadic LATAM order in Q2 2021 7.8% growth in metreleptin revenues YoY to$46.4M in Q2 49.9% growth in metreleptin revenuesin Q2 excluding impact of a sporadic LATAM or...
Amryt ReportsRecord Q2 2022 Results 9.2% YoY revenue growth in Q2 to $68.5M 35.3% YoY revenue growth in Q2excluding impact of a sporadic LATAM order in Q2 2021 7.8% growth in metreleptin revenues YoY to$46.4M in Q2 49.9% growth in metreleptin revenuesin Q2 excluding impact of a sporadic LATAM order in Q2 2021 10th consecutive quarter of positive EBITDA generation Cash of $90.7M at June 3, 2022 Filsuvez®approved in the EUfor the treatment of dystrophic and junctional EB Amryt now has four growing commercial products treating rare diseases Reaffirming FY 2022 revenue guidance to $260M - $270M, representing 17-21% YoY growth Stock repurchase program underway – board approved up to $30M through March 2023 Conference call and webcast today at 0830 ET / 1330 BST DUBLIN, Ireland, and Boston MA, August 4, 2022, Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today provides a business update and announces unaudited financial results for the second quarter ended June 3, 2022. Joe Wiley, CEO of Amryt Pharma, commented:“I am pleased to report today’s very strong operational and financial results which reflect another excellentquarter for Amryt.Our record Q2 revenues of $68.5M demonstratesthe strong performance our business is delivering. In particular, metreleptin continues to grow strongly,delivering49.9% YoY growth in the quarter, excluding the impact of a sporadic LATAM order booked in Q2 2021. Overall, these results demonstrate the robust growth we are experiencing and represent our tenth consecutive quarter of positive EBITDA generation. During the quarter, the European Commission approved Filsuvez® for the treatment of Dystrophic and Junctional EB in patients 6 months and older. Theapproval of Filsuvez® in the EUis one of the most significant milestones in Amryt’s history and represents a major positive development for European patients that suffer from this debilitating condition.Filsuvez® isour fourth commercial product and we have in place the team, financial flexibility and global infrastructure to commercialize it swiftly and to execute our significant growth plans. We also look forward to potentially leveraging our European approval across other jurisdictions globally. Given the strong underlying performance of our business year to date and notwithstanding the impact of the strengthening US dollar on our Euro revenues, we are today reaffirming our full year 2022 revenue guidance of $260-$270 million which represents growth of 17%-21% over 2021.” Q2 2022 and Recent Business Highlights: Metreleptin Metreleptin continues to deliver significant growth in EMEA driven by market expansion and its broad label covering the treatment of both general and partial lipodystrophy (GL/PL)Growth drivers include ItalianPLreimbursement in Q2 and expansion in the Middle East and TurkeyMetreleptin continues to deliver growth in the US; expected patient additions driven by high unmet medical need Lomitapide EMEA lomitapide revenues impacted by strong US dollar despite increasing patient numbers on therapySuccessful new tender for lomitapide inSaudi Arabia - $6M expected annualized revenues Mycapssa® Mycapssa® relaunch is progressing well - Greater education and awareness of Mycapssa® has resulted in 58 new prescribers year to date–93% of whom are community-based physiciansPresented Mycapssa® data from OPTIMAL and MPOWERED Phase 3 trials at ENDO 2022 meetingAnnouncedpositive long-term safety and efficacy data for Mycapssa® from the second year of the OPTIMAL open label extension study in acromegaly patientsMycapssa® new patent announced, further strengtheningour IP portfolio with protection to 2040Received Orphan Drug Designation from the FDA for Mycapssa® for the treatment of carcinoid syndrome associated with neuroendocrine tumors (NET)Pathway agreed with the FDA to initiate a Phase 3 study for NET - expected in Q1 2023 Filsuvez®1 Filsuvez®approved in the EUfor the treatment of dystrophic and junctional EBin patients 6 months and olderFirst ever approved treatment for EB with potential to leverage European approval across other jurisdictionsCommercial plans well advanced for Filsuvez® launch in Europe–first shipments to patients in Germany and Greece expected in Q3 Presented new positive Open-Label Phase 12-month data analyses from the EASE Phase 3 trial in EB at SPD 2022 meeting Corporate Amryt initiates stock repurchase program – board has approved repurchases up to $30M through March 2023FY 2022 revenue guidance of $260M - $270M reaffirmed, representing 17-21% growth over 2021 Q2 2022 Commercial Product Performance: Q2 2022 (unaudited) US$’000 US EMEA Other Total Metreleptin 20,311 24,192 1,895 46,398 Lomitapide 7,585 6,995 2,795 17,375 Mycapssa® 4,499 — — 4,499 Other — 190 74 264 Total revenue 32,395 31,377 4,764 68,536 Q2 2021 (unaudited) US$’000 US EMEA Other Total Metreleptin 17,739 11,005 14,315 43,059 Lomitapide 8,490 7,492 3,468 19,450 Mycapssa® — — — — Other — 193 60 253 Total revenue 26,229 18,690 17,843 62,762 9.2% YoY revenue growth in Q2 2022 to $68.5M (Q2 2021: $62.8M);13.6% YoY revenue growth on a constant currency basis35.3% YoY revenue growth excluding the impact of a sporadic LATAM order in Q2 20217.8% increase in metreleptin revenues YoY to$46.4M in Q2 2022 (Q2 2021: $43.1M); 49.9% YoY growth excluding the impact of a sporadic LATAM order in Q2 2021US accounted for 43.8% of global metreleptin revenues and EMEA accounted for 52.1% in Q2 2022US metreleptin revenues grew by 14.5% YoY and EMEA metreleptin revenues grew by119.8% YoY in Q22022US accounted for 43.7% of global lomitapide revenues and EMEA accounted for 40.3% in Q2 2022Mycapssa® delivered $4.5Min Q2 2022 as compared to $3.4M in Q1 2022 Q2 2022 Financial Highlights: $6.9Moperating loss before finance expensefor Q2 2022 (Q2 2021: $4.1M operating profit). Excluding non-cash items, share based compensation expenses and Chiasma restructuring and acquisition costs, this resulted in EBITDA3of $13.3M, before restructuring and acquisition costs.Cash of $90.7M at June 30, 2022 (March 31, 2022: $102.2M) IFRS and non-GAAP adjusted Q2 2022results: US$M Q2 2021 (unaudited) Q2 2022 (unaudited) Q2 2022 Non-cash adjustments2 Q2 2022 Non-GAAP Adjusted Revenue 62.8 68.5 - 68.5 Gross profit 36.6 35.2 16.6 51.8 R&D expenses (8.5) (10.7) - (10.7) SG&A expenses (22.0) (28.2) 0.4 (27.8) Restructuring and acquisition costs - (0.3) - (0.3) Share based compensation expenses (2.0) (2.9) 2.9 - Operating (loss) / profit before finance expense 4.1 (6.9) 19.9 13.3 Operating (loss) / profit before finance expense and restructuring and acquisition costs 4.1 (6.6) 19.9 13.33 1 Filsuvez® (birch extract)gel (“Filsuvez®”) has been selected as the brand name for Oleogel-S10. Filsuvez® is approved in the EU for the treatment of partial thickness wounds associated with JEB and DEB in patients 6 months and older. 2 Non-cash items include amortisation of the acquired metreleptin, lomitapide and Mycapssa® intangible assets ($14.4M), amortisation of the inventory fair value step-up related to the acquisition of Chiasma, Inc. ($2.2M), depreciation and amortisation ($0.4M) and share based compensation expenses ($2.9M). 3 EBITDA is earnings before interest, tax, depreciation, amortisation and share based compensation expenses. To supplement Amryt's financial results presented in accordance with IFRS generally accepted accounting principles, the Company uses EBITDA as a key measure of company performance as the Company believes that this measure is most reflective of the operational profitability or loss of the Company and provides management and investors with useful supplementary information which can enhance their ability to evaluate the operating performance of the business. EBITDA, as measured by the Company, is not meant to be considered in isolation or as a substitute to operating profit / loss attributable to Amryt and should be read in conjunction with the Company's condensed consolidated financial statements prepared in accordance with IFRS. Filsuvez®Regulatory Update: On June 23, 2022, Amryt announced the European Commission (EC) approval of Filsuvez® in the European Union (EU) for the treatment of partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa (EB) in patients 6 months and older. EB is a rare and distressing genetic skin disorder affecting young children and adults for which, until now, there has been no approved treatment in any market. The centralised marketing authorisation will be valid in all EU Member States as well as in Iceland, Liechtenstein, and Norway. The authorization of Filsuvez® in the EU provides a regulatory core dossier which can form the basis for future regulatory submissions in LATAM and the Middle East. The EC approval of Filsuvez® is supported by Phase 3 data from the EASE trial which was the largest ever global trial conducted in patients with EB, performed across 58 sites in 28 countries. During Q2 2022, Amryt had a Type A meeting with the FDA to discuss the issues raised in the Complete Response Letter (CRL) received in February 2022 relating to Amryt’s NDA for Oleogel-S10. Following this meeting, Amryt plans to proceed to the Formal Dispute Resolution pathway withthe FDA’s Center for Drug Evaluation and Research (CDER) by which NDA applicants can seek to resolve scientific and/or medical disputes that cannot be resolved at the division level. Guidance & Outlook: Given the continued strong performance of the Company’s commercial productsand notwithstanding the impact of the strengthening US dollar on the Company’s Euro denominated revenues, the board is today reaffirming revenue guidance for FY 2022 in the range of $260M - $270M which represents growth of 17% to 21% on FY 2021. Conference Call & Webcast: Amryt will host a conference call and webcast for analysts and investors today at 0830 ET/1330 GMT. Webcast Player URL:https://edge.media-server.com/mmc/p/ef7uj5u8 Telephone Dial in details: United States +1 646 307 1963 United Kingdom +44 (0) 203 481 4247 Ireland +353 (1) 582 2023 Confirmation Code 9953783 A playback facility will be available from Aug 4, 2022 at 1230 ET/1730 BST – Aug 11, 2022 at 1900 ET/2400 BST. Access details for the playback facility are as follows: Confirmation Code:9953783| US: + 1 609 800 9909 | UK: +44 (0) 203 433 3849. About Amryt Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets. Amryt’s commercial business comprises four orphan disease products – metreleptin (Myalept®/ Myalepta®); oral octreotide (Mycapssa®); lomitapide (Juxtapid®/ Lojuxta®); and Oleogel-S10 (Filsuvez®). Myalept®/Myalepta® (metreleptin) is approved in the US (under the trade name Myalept®) as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in the EU (under the trade name Myalepta®) as an adjunct to diet for the treatment of leptin deficiency in patients with congenital or acquired GL in adults and children two years of age and above and familial or acquired partial lipodystrophy (PL) in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control. For additional information, please follow this link. Mycapssa® (octreotide capsules) is approved in the US for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. Mycapssa® is the first and only oral somatostatin analog approved by the FDA. Mycapssa® has also been submitted to the EMA and is not yet approved in Europe. For additional information, please follow this link. Juxtapid®/Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia ("HoFH") in the US, Canada, Colombia, Argentina and Japan (under the trade name Juxtapid®) and in the EU, Israel, Saudi Arabia and Brazil (under the trade name Lojuxta®). For additional information, please follow this link. Amryt's lead development candidate, Oleogel-S10 is a potential treatment for the cutaneous manifestations of JEB and DEB, a rare and distressing genetic skin disorder affecting young children and adults. Filsuvez® has been selected as the brand name for Oleogel-S10. Filsuvez® is approved in the EU for the treatment of partial thickness wounds associated with JEB and DEB in patients 6 months and older. Amryt’s pre-clinical gene therapy candidate, AP103, offers a potential treatment for patients with Dystrophic EB, and the polymer-based delivery platform has the potential to be developed for the treatment of other genetic disorders. Amryt also intends to develop oral medications that are currently only available as injectable therapies through its Transient Permeability Enhancer (TPE®) technology platform. For more information on Amryt, including products, please visit www.amrytpharma.com. Forward-Looking Statements This announcement may contain forward-looking statements and the words "expect", "anticipate", "intends", "plan", "estimate", "aim", "forecast", "project" and similar expressions (or their negative) identify certain of these forward-looking statements. The forward-looking statements in this announcement are based on numerous assumptions and Amryt's present and future business strategies and the environment in which Amryt expects to operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. These statements are not guarantees of future performance or the ability to identify and consummate investments. Many of these risks and uncertainties relate to factors that are beyond Amryt's ability to control or estimate precisely, such as future market conditions, the course of the COVID-19 pandemic, currency fluctuations, the behaviour of other market participants, the outcome of clinical trials, the actions of regulators and other factors such as Amryt's ability to obtain financing, changes in the political, social and regulatory framework in which Amryt operates or in economic, technological or consumer trends or conditions. Past performance should not be taken as an indication or guarantee of future results, and no representation or warranty, express or implied, is made regarding future performance. No person is under any obligation to update or keep current the information contained in this announcement or to provide the recipient of it with access to any additional relevant information that may arise in connection with it. Such forward-looking statements reflect the Company’s current beliefs and assumptions and are based on information currently available to management. Contacts Joe Wiley, CEO / Rory Nealon, CFO/COO, +353 (1) 518 0200, ir@amrytpharma.com Tim McCarthy, LifeSci Advisors, LLC, +1 (917) 679 9282, tim@lifesciadvisors.com Amryt Pharma plc Condensed Consolidated Statement of Comprehensive Loss Three Months Ended June 30, Six Months Ended June 30, Note 2022 (unaudited) 2021 (unaudited) 2022 (unaudited) 2021 (unaudited) US$’000 US$’000 US$’000 US$’000 Revenue 3 68,536 62,762 127,665 111,194 Cost of sales (33,364) (26,179) (64,139) (49,668) Gross profit 35,172 36,583 63,526 61,526 Research and development expenses (10,670) (8,538) (20,551) (17,454) Selling, general and administrative expenses (28,233) (22,029) (55,942) (40,185) Restructuring and acquisition costs 5 (265) — (667) — Share based payment expenses 4 (2,880) (1,953) (6,028) (3,216) Operating (loss)/profit before finance expense (6,876) 4,063 (19,662) 671 Non-cash change in fair value of contingent consideration 5 4,720 (2,993) 4,293 (5,867) Non-cash contingent value rights gain/(loss) 5 1,967 (1,837) 1,285 (3,600) Net finance expense - other (6,760) (5,841) (17,887) (13,739) Loss on ordinary activities before taxation (6,949) (6,608) (31,971) (22,535) Tax (charge)/credit on loss on ordinary activities (100) (191) 10,431 (801) Loss for the period attributable to the equity holders of the Company (7,049) (6,799) (21,540) (23,336) Exchange translation differences which may be reclassified through profit or loss 30 (204) (369) 2,343 Total other comprehensive income/(loss) 30 (204) (369) 2,343 Total comprehensive loss for the period attributable to the equity holders of the Company (7,019) (7,003) (21,909) (20,993) Loss per share Loss per share - basic and diluted, attributable to ordinary equity holders of the parent (US$) 6 (0.02) (0.04) (0.07) (0.13) Amryt Pharma plc Condensed Consolidated Statement of Financial Position As at, Note June 30, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Assets Non-current assets Goodwill 7 56,688 56,688 Intangible assets 7 433,832 467,359 Property, plant and equipment 7,109 7,416 Other non-current assets 1,770 1,885 Total non-current assets 499,399 533,348 Current assets Trade and other receivables 8 50,427 53,908 Inventories 9 124,185 115,769 Cash and cash equivalents, including restricted cash 10 90,733 113,032 Total current assets 265,345 282,709 Total assets 764,744 816,057 Equity and liabilities Equity attributable to owners of the parent Share capital 11 25,586 25,500 Share premium 11 323,140 318,153 Other reserves 11 242,001 246,303 Accumulated deficit (248,693) (233,295) Total equity 342,034 356,661 Non-current liabilities Contingent consideration and contingent value rights 5 54,833 81,113 Deferred tax liability 6,248 17,772 Long term loan 12 98,726 93,395 Convertible notes 13 108,332 105,788 Provisions and other liabilities 14 3,543 4,049 Total non-current liabilities 271,682 302,117 Current liabilities Trade and other payables 127,909 149,734 Provisions and other liabilities 14 6,911 7,545 Contingent consideration 5 10,490 — Loan notes 5 5,718 — Total current liabilities 151,028 157,279 Total liabilities 422,710 459,396 Total equity and liabilities 764,744 816,057 Amryt Pharma plc Condensed Consolidated Statement of Cash Flows Six months ended June 30, Note 2022 (unaudited) 2021 (unaudited) US$’000 US$’000 Cash flows from operating activities Loss on ordinary activities after taxation (21,540) (23,336) Net finance expense - other 17,887 13,739 Depreciation and amortization 29,695 22,080 Amortization of inventory fair value step-up 3,776 1,205 Share based payment expenses 4 6,028 3,216 Non-cash change in fair value of contingent consideration 5 (4,293) 5,867 Non-cash contingent value rights (gain)/loss 5 (1,285) 3,600 Deferred taxation (credit)/charge (11,524) 336 Movements in working capital and other adjustments: Change in trade and other receivables 8 3,672 1,677 Change in trade and other payables (23,058) 5,726 Change in provision and other liabilities 14 (778) (2,823) Change in inventories (12,193) 1,027 Change in non-current assets 115 122 Net cash flow (used in)/from operating activities (13,498) 32,436 Cash flow from investing activities Payments for property, plant and equipment (668) (76) Payments for intangible assets — (722) Deposit interest received 25 2 Net cash flow used in investing activities (643) (796) Cash flow from financing activities Net proceeds/(costs) from issue of equity instruments 1,063 (175) Proceeds from long term borrowings - net of debt issue costs 98,344 — Repayment of long term debt (98,761) — Interest paid (6,193) (6,047) Payment of leases (608) (526) Net cash flow used in financing activities (6,155) (6,748) Exchange and other movements (2,003) (744) Net change in cash and cash equivalents (22,299) 24,148 Cash and cash equivalents at beginning of the period 113,032 118,798 Restricted cash at end of the period 10 150 — Cash at bank available on demand at end of the period 10 90,583 142,946 Total cash and cash equivalents at end of the period 10 90,733 142,946 Amryt Pharma plc Condensed Consolidated Statement of Changes in Equity For the period ended June 30, 2022 Note Share capital Share premium Warrant reserve Treasury shares Share based payment reserve Merger reserve Reverse acquisition reserve Equity component of convertible notes Other distributable reserves Currency translation reserve Accumulated deficit Total US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 Balance at January 1, 2022 (audited) 25,500 318,153 — — 20,593 42,627 (73,914) 29,210 217,634 10,153 (233,295) 356,661 Loss for the period — — — — — — — — — — (21,540) (21,540) Foreign exchange translation reserve — — — — — — — — — (369) — (369) Total comprehensive loss — — — — — — — — — (369) (21,540) (21,909) Transactions with owners Issue of shares for share options exercised and vesting of RSUs 11 86 4,987 — — (3,819) — — — — — — 1,254 Share based payment expense 4 — — — — 6,028 — — — — — — 6,028 Share based payment expense – Lapsed — — — — (1,878) — — — — — 1,878 — Total transactions with owners 86 4,987 — — 331 — — — — — 1,878 7,282 Balance atJune 30, 2022 (unaudited) 25,586 323,140 — — 20,924 42,627 (73,914) 29,210 217,634 9,784 (252,957) 342,034 For the period ended June 30, 2021 Note Share capital Share premium Warrant reserve Treasury shares Share based payment reserve Merger reserve Reverse acquisition reserve Equity component of convertible notes Other distributable reserves Currency translation reserve Accumulated deficit Total US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 Balance at January 1, 2021 (audited) 13,851 51,408 14,762 (7,421) 7,860 42,627 (73,914) 29,210 217,634 5,730 (235,605) 66,142 Loss for the period — — — — — — — — — — (23,336) (23,336) Foreign exchange translation reserve — — — — — — — — — 2,343 — 2,343 Total comprehensive loss — — — — — — — — — 2,343 (23,336) (20,993) Transactions with owners Issue of treasury shares in exchange for warrants 11 23 99 — 439 — — — — — — — 561 Issue of treasury shares for share options exercised 11 25 89 — 465 (191) — — — — — — 388 Share based payment expense 4 — — — — 3,216 — — — — — — 3,216 Share based payment expense - Lapsed — — — — (54) — — — — — 54 — Total transactions with owners 48 188 — 904 2,971 — — — — — 54 4,165 Balance atJune 30, 2021 (unaudited) 13,899 51,596 14,762 (6,517) 10,831 42,627 (73,914) 29,210 217,634 8,073 (258,887) 49,314 1. General information Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets. As used herein, references to ‘‘we,’’ ‘‘us,’’ ‘‘Amryt’’ or the ‘‘Group’’ in these condensed consolidated interim financial statements shall mean Amryt Pharma plc and its global subsidiaries, collectively. References to the ‘‘Company’’ in these condensed consolidated interim financial statements shall mean Amryt Pharma plc. Amryt Pharma plc is a company incorporated in England and Wales. The Company is listed on Nasdaq (ticker: AMYT). The Company was also listed on the AIM market of the London Stock Exchange (ticker: AMYT) up until January 11, 2022, on which date the Company completed the cancellation its admission to AIM. The cancellation was announced by the Company on November 22, 2021, and following the AIM delisting, the Company’s American Depositary Shares (“ADSs”)remain listed, and will only be tradeable, on Nasdaq. The Company’s last day of trading on AIM was 10 January 2022. Amryt acquired Chiasma, Inc. (“Chiasma”) in August 2021. The combined company will be a global leader in rare and orphan diseases with four on-market commercial products, a global commercial and operational footprint and a significant development pipeline of therapies with the financial flexibility to execute its growth plans. Amryt’s commercial business comprises four orphan disease products – metreleptin (Myalept®/ Myalepta®); oral octreotide (Mycapssa®); lomitapide (Juxtapid®/ Lojuxta®); and Oleogel-S10 (Filsuvez®). Amryt's lead development candidate, Oleogel-S10 is a potential treatment for the cutaneous manifestations of JEB and DEB, a rare and distressing genetic skin disorder affecting young children and adults. Filsuvez® has been selected as the brand name for Oleogel-S10. On June 23, 2022, Amryt announced the European Commission (EC) approval of Filsuvez® in the European Union (EU) for the treatment of partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa (EB) in patients 6 months and older.The centralized marketing authorization will be valid in all EU Member States as well as in Iceland, Liechtenstein, and Norway. The authorization of Filsuvez® in the EU provides a regulatory core dossier which may form the basis for future regulatory submissions in LATAM and the Middle East.The EC approval of Filsuvez® is supported by Phase 3 data from the EASE trial which was the largest ever global trial conducted in patients with EB, performed across 58 sites in 28 countries. During Q2 2022, Amryt had a Type A meeting with the FDA to discuss the issues raised in the Complete Response Letter (CRL) received in February 2022 relating to Amryt’s New Drug Application (NDA) for Oleogel-S10. Following this meeting, Amryt is proceeding to the Formal Dispute Resolution pathway in the FDA’s Center for Drug Evaluation and Research (CDER) by which NDA applicants can seek to resolve scientific and/or medical disputes that cannot be resolved at the division level. 2. Accounting policies Basis of preparation The condensed consolidated interim financial statements of the Group have been prepared in accordance with IAS 34 Interim Financial Reporting. They do not include all the information required in annual financial statements in accordance with International Financial Reporting Standards (‘‘IFRS’’) and should be read in conjunction with the annual consolidated financial statements for the year ended December 31, 2021. Selected explanatory notes are included to explain events and transactions that are significant to an understanding of the Group’s financial position and performance since the last annual financial statements. The accounting policies used in the preparation of the interim financial information are the same as those used in the Group’s audited financial statements for the year ended December 31, 2021, and those which are expected to be used in the financial statements for the year ended December 31, 2022. Results for the six-month period ended June 30, 2022, are not necessarily indicative of the results that may be expected for the financial year ending December 31, 2022. Basis of going concern Having considered the Group’s current financial position and cash flow projections, the Board of Directors believes that the Group will be able to continue in operational existence for at least the next 12 months from the date of approval of these condensed consolidated interim financial statements and that it is appropriate to continue to prepare the condensed consolidated interim financial statements on a going concern basis. As part of their inquiries, the Board of Directors reviewed budgets, projected cash flows, and other relevant information for a period not less than 12 months from the date of approval of the condensed consolidated interim financial statements for the period ended June 30, 2022. Basis of consolidation The condensed consolidated interim financial statements comprise the financial statements of the Group for the period ended June 30, 2022. Subsidiaries are entities controlled by the Company. Where the Company has control over an investee, it is classified as a subsidiary. The Company controls an investee if all three of the following elements are present: power over an investee, exposure or rights to variable returns from its involvement with the investee and the ability to use its power to affect those variable returns. Control is reassessed whenever facts and circumstances indicate that there may be a change in any of these elements of control. Subsidiaries are fully consolidated from the date that control commences until the date that control ceases. Accounting policies of subsidiaries have been changed where necessary to ensure consistency with the policies adopted by the Group. Intergroup balances and any unrealized gains or losses, income or expenses arising from intergroup transactions are eliminated in preparing the condensed consolidated interim financial statements. Presentation of balances The condensed consolidated interim financial statements are presented in U.S. dollars (‘‘US$’’), rounded to the nearest thousand, which is the functional currency of the Company and presentation currency of the Group. The following table discloses the major exchange rates of those currencies other than the functional currency of US$ that are utilized by the Group: Foreign currency units to 1 US$ € £ ILS NOK DKK Average three-month period to June 30, 2022 (unaudited) 0.9381 0.7951 3.3392 9.3988 6.9785 Average six-month period to June 30, 2022 (unaudited) 0.9145 0.7701 3.2680 9.1257 6.8039 AtJune 30, 2022 (unaudited) 0.9533 0.8224 3.4505 9.8488 7.0921 Foreign currency units to 1 US$ € £ ILS NOK DKK Average period to December 31, 2021 (audited) 0.8454 0.7271 3.2322 8.5975 6.2875 At December 31, 2021 (audited) 0.8830 0.7413 3.1115 8.8074 6.5664 Foreign currency units to 1 US$ € £ ILS NOK DKK Average three-month period to June 30, 2021 (unaudited) 0.8292 0.7253 3.2657 8.5171 6.1669 Average six-month period to June 30, 2021 (unaudited) 0.8303 0.7157 3.2688 8.3785 6.1747 AtJune 30, 2021 (unaudited) 0.8400 0.7220 3.2573 8.5546 6.2463 (€ = Euro; £ = Pounds Sterling, ILS = Israeli Shekel, NOK = Norwegian Kroner, DKK = Danish Kroner) Changes in accounting policies and disclosures There are no new standards and amendments to IFRS effective as of January 1, 2022, that are relevant to the Group. Critical accounting judgements and key sources of estimation uncertainty In preparing these condensed consolidated interim financial statements in conformity with IFRS management is required to make judgements, estimates and assumptions that affect the application of policies and amounts reported in the condensed consolidated interim financial statements and accompanying notes. The estimates and associated assumptions are based on historical experience and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis of making the judgements about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates. The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimate is revised if the revision affects only that period or in the period of the revision and future periods if the revision affects both current and future periods. The significant estimates, assumptions or judgements, applied in the condensed consolidated interim financial statements were the same as those applied in the Group’s audited financial statements for the year ended December 31, 2021. Principal accounting policies The condensed consolidated interim financial statements have been prepared in accordance with the accounting policies adopted in the Group’s audited financial statements for the year ended December 31, 2021. 3. Segment information The Group is a global, commercial-stage biopharmaceutical company dedicated to commercializing and developing novel therapeutics to treat patients suffering from serious and life-threatening rare diseases. The Group currently operates as one business segment, pharmaceuticals, and is focused on the development and commercialization of four commercial products and anumber of development products. The Group derives its revenues primarily from one source, being the pharmaceutical sector with high unmet medical need. The Group’s Chief Executive Officer, Joseph Wiley, is currently the Company’s chief operating decision maker (‘‘CODM’’). The Group does not operate any separate lines of business or separate business entities with respect to its products. Accordingly, the Group does not accumulate discrete financial information with respect to separate service lines and does not have separate reportable segments.The following table summarizes total revenues from external customers by product and by geographic region, based on the location of the customer. Three months ended June 30, 2022 (unaudited) U.S. EMEA Other Total US$’000 US$’000 US$’000 US$’000 Metreleptin 20,311 24,192 1,895 46,398 Lomitapide 7,585 6,995 2,795 17,375 Mycapssa® 4,499 — — 4,499 Other — 190 74 264 Total revenue 32,395 31,377 4,764 68,536 Three months ended June 30, 2021 (unaudited) U.S. EMEA Other Total US$’000 US$’000 US$’000 US$’000 Metreleptin 17,739 11,005 14,315 43,059 Lomitapide 8,490 7,492 3,468 19,450 Mycapssa® — — — — Other — 193 6 253 Total revenue 26,229 18,690 17,843 62,762 Six months ended June 30, 2022 (unaudited) U.S. EMEA Other Total US$’000 US$’000 US$’000 US$’000 Metreleptin 40,555 40,114 3,376 84,045 Lomitapide 15,639 14,185 5,367 35,191 Mycapssa® 7,926 — — 7,926 Other — 361 142 503 Total revenue 64,120 54,660 8,885 127,665 Six months ended June 30, 2021 (unaudited) U.S. EMEA Other Total US$’000 US$’000 US$’000 US$’000 Metreleptin 33,978 23,976 15,065 73,019 Lomitapide 16,814 14,932 5,888 37,634 Mycapssa® — — — — Other — 416 125 541 Total revenue 50,792 39,324 21,078 111,194 Major Customers For the three and six months ended June 30, 2022, one customer accounted for 41% and 44% of the Group’s net revenues (2021: 42% and 46%) and accounted for 34% of the Group’s June 30, 2022, accounts receivable balance (December 31, 2021: 36%). 4. Share based payments Share-based Compensation Plans Amryt’s Equity Incentive Plan Amryt’s Equity Incentive Plan was adopted by a special resolution on September 23, 2019. Prior to such date, we granted options under a prior employee share option plan, which had the same terms and conditions as the Equity Incentive Plan. On September 24, 2019, all options held under our prior share option plan were rolled over into options to subscribe for our ordinary shares with the key terms including strike price, vesting and the expiration date of such rolled over options remaining the same as they were on the issue date of the options under the prior share option plan. The Equity Incentive Plan was approved for amendment by the Board on May 18, 2020, August 3, 2021, and November 2, 2021. The purpose of the Plan is to provide for the granting of Equity Incentives to Directors and Employees of, and Consultants to, the Company or any Associated Company. Chiasma Equity Incentive Plan When Amryt acquired Chiasma in August 2021, the Chiasma Stock Option and Incentive Plan transferred across to Amryt. Each outstanding and unexercised Chiasma Stock Option or RSU, whether vested or not vested, ceased to represent a right to acquire shares of Chiasma common stock and were converted into an option to purchase Amryt ADSs on the same terms and conditions as were applicable under such Chiasma Stock Option and Incentive Plan immediately prior to the acquisition. No new stock option or RSUs will be granted under the Chiasma stock option and incentive plan. Terms and Conditions of New Share Option Grants The terms and conditions of new grants are as follows, whereby all options are settled by physical delivery of shares: Vesting conditions The employee share options vest following a period of service by the officer or employee. The required period of service is determined by the Remuneration Committee at the date of grant of the options (usually the date of approval by the Remuneration Committee). There are no market conditions associated with the share option vesting periods. Contractual life The term of an option is determined by the Remuneration Committee provided that the term may not exceed a period of seven to ten years from the date of grant. All options will terminate 90 days after termination of the option holder’s employment, service or consultancy with the Group except in certain circumstances or where a longer period is approved by the Board of Directors. Under certain circumstances involving a change in control of the Group, some options will automatically accelerate and become exercisable in full as of a date specified by the Board of Directors. All share option incentives granted are in the form of ordinary shares. Share option exercise prices below are the exercise price per ordinary share. The ADS equivalent exercise price will be theordinary share exercise price multiplied by five and the number of ADSs will be the number of ordinary shares divided by five. The number and weighted average exercise price (in Sterling pence) of share options per ordinary share granted under Amryt’s Equity Incentive Plan and the Chiasma stock option and incentive plan is as follows: Amryt Equity Incentive Plan Chiasma Stock Option and Incentive Plan Units Weighted average exercise price (Sterling pence) Units Weighted average exercise price (Sterling pence) Balance at January 1, 2021 18,753,648 122.79p — — Granted 11,337,459 190.88p — — Transferred to Amryt on acquisition — — 18,139,060 189.07p Forfeited (1,288,165) 174.97p (4,098,425) 226.22p Exercised (300,000) 93.00p (3,320,515) 116.35p Outstanding at December 31, 2021 (audited) 28,502,942 147.83p 10,720,120 197.40p Exercisable at December 31, 2021 (audited) 9,347,338 118.87p 8,005,390 192.35p Balance at January 1, 2022 28,502,942 147.83p 10,720,120 197.40p Granted 16,209,465 102.58p — — Forfeited (2,285,200) 165.77p (2,826,430) 205.22p Exercised (492,905) 113.22p (411,705) 94.59p Outstanding atJune 30, 2022 (unaudited) 41,934,302 129.77p 7,481,985 200.10p Exercisable atJune 30, 2022 (unaudited) 11,959,144 131.04p 5,902,285 217.78p The fair value of the Amryt equity award is estimated at the date of grant using the Black-Scholes pricing model, taking into account the terms and conditions attached to the grant. The fair value of the Chiasma equity awards transferred to Amryt on acquisition were measured in accordance with IFRS 2. The portion of the value of the equity transferred to Amryt attributable to pre-combination service is included in the consideration at the date of acquisition. The portion of the equity awards transferred to Amryt attributable to post combination service is estimated at the date of transfer using Black Scholes pricing model, taking into account the terms and conditions attached to the grant. The following are the inputs to the model for the equity instruments granted during the period: June 30, 2022 Options Inputs (unaudited) December 31, 2021 Options Inputs (unaudited) Days to Expiration 2,555 2,555 Volatility 39% 32% - 49% Risk free interest rate 1.96% - 2.89% 0.77% - 1.33% Share price at grant per ordinary share 99.9 – 131.7p 146.87 - 201.2p Share price at grant per ADS 499.5 – 658.5p 734.35 - 106.p In the six months endedJune 30, 2022, a total of 16,209,465 share options over ordinary shares exercisable at a weighted average price of US$1.33 (£1.03) were granted. The fair value of share options granted in the period ended June 30, 2022, was US$22,164,723/£16,628,014. The share options outstanding under the Amryt 2021 Equity Incentive Plan as atJune 30, 2022, had a weighted remaining contractual life of 5.34 years with exercise prices ranging from £0.76 to £2.012 per ordinary share. In the six months ended June 30, 2021, a total of 8,872,369 share options exercisable at a weighted average price of US$2.80 (£2.012) were granted. The fair value of share options granted in the six months ended June 30, 2021, was US$24,617,000/£17,845,000. The share options outstanding as atJune 30, 2021, had a weighted remaining contractual life of 5.55 years with exercise prices ranging from £0.76 to £2.012. The share options outstanding under the Chiasma Share Option and Incentive Plan transferred across to Amryt on acquisition. As atJune 30, 2022, they have a weighted remaining contractual life of 4.94 years with exercise prices ranging from £0.54 to £7.41 per ordinary share. No new share options will be granted under the Chiasma Stock Option and Incentive Plan. Restricted Share Units Under the terms of Amryt’s Equity Incentive Plan, restricted share units (“RSUs”) to purchase 3,659,250 ordinary shares were outstanding atJune 30, 2022. Under the terms of this plan, RSUs are granted to officers, consultants and employees of the Group at the discretion of the Remuneration Committee. For the six month period ended June 30, 2022, a total of 2,388,365 RSUs were granted to employees of the Company. For the year ended December 31, 2021, a total of 625,205 RSUs were granted to employees of the Company. The fair value of the RSUs is based on the share price at the date of grant, with the expense spread over the vesting period. The fair value of RSUs granted in the six month period ended June 30, 2022, was US$3,387,000. At June 30, 2022, the total RSUs granted to date have a weighted remaining contractual life of 2.35 years. Under the terms of Chiasma’s Stock Option and Incentive Plan transferred to Amryt on acquisition, restricted share units (“RSUs”) to purchase 48,795 ordinary shares were outstanding at June 30, 2022. At June 30, 2022, the total RSUs granted to date have a weighted remaining contractual life of 1.61 years. No new RSUs will be granted under the Chiasma Stock Option and Incentive Plan. The following table summarizes the RSU activity per ordinary share for the period: Amryt Equity Incentive Plan Chiasma Stock Option and Incentive Plan Units Weighted average fair value (US$) Units Weighted average fair value (US$) Balance at January 1, 2021 1,549,910 $2.34 — — Granted 625,205 $2.62 — — Transferred to Amryt on acquisition — — 202,145 $2.75 Lapsed (243,505) $2.35 (56,405) $2.75 Vested (362,855) $2.34 (39,180) $2.75 Outstanding at December 31, 2021 (audited) 1,568,755 $2.44 106,560 $2.75 Balance at January 1, 2022 1,568,755 $2.44 106,560 $2.75 Granted 2,388,365 $1.42 — — Lapsed (179,725) $1.92 (8,465) $2.75 Vested (118,145) $2.79 (49,300) $2.75 Outstanding atJune 30, 2022 (unaudited) 3,659,25 $1.79 48,795 $2.75 Performance Stock Units Under the terms of Amryt’s Equity Incentive Plan, performance share units (“PSUs”) to purchase 1,961,102 ordinary shares were granted to officers and employees at the discretion of the Remuneration Committee in the six month period to June 30, 2022. Performance conditions determine how many of these performance stock units will vest and, if performance targets are exceeded, additional performance stock units will be issued and vest in accordance with the terms of the relevant performance stock units award. The PSUs vest based on the Total Shareholder Return (“TSR”) of Amryt’s NASDAQ traded common stock relative to the TSRs of the constituents that comprise the NASDAQ Biotechnology Index (the Peer Group) as of January 1, 2022. TSR for Amryt and each peer company will be measured over the period from January 1, 2022, to December 31, 2024. The payout schedule can produce payout percentages ranging from 0% to 150%. The following table summarizes the PSU activity per ordinary share for the period: Amryt Equity Incentive Plan Units Weighted average fair value (US$) Balance at January 1, 2022 — — Granted 1,961,102 $1.42 Lapsed — — Vested — — Outstanding atJune 30, 2022 (unaudited) 1,961,102 $1.42 Warrants There are no outstanding warrants atJune 30, 2022 (December 31, 2021: nil). In August 2021, an Amryt institutional investor exercised subscription rights relating to 8,966,520 zero cost warrants. These warrants were issued in September 2019 as part of the Company’s acquisition of Aegerion. Certain institutional investors elected to receive warrants to subscribe for new ordinary shares of £0.06 each in Amryt (“Ordinary Shares”), in place of the same number of Ordinary Shares, as consideration for the Company’s acquisition of Aegerion and their equity investments in the Company in September 2019. Each warrant entitled the holder to subscribe for one Ordinary Share for no additional consideration. Separate warrants consisting of 345,542 as at December 31, 2020, which were issued in connection with the admission to the AIM in 2016, are no longer outstanding; 283,389 warrants were exercised in March 2021 and 62,153 warrants lapsed in April 2021. The number and weighted average exercise price (in Sterling pence) of warrants per ordinary share is as follows: Warrants Units Weighted average exercise price (Sterling pence) Balance at January 1, 2021 9,312,062 0.05p Granted — — Lapsed (62,153) 1.44p Exercised (9,249,909) 0.05p Outstanding at December 31, 2021 (audited) — 0.00p The value of share options and RSU’s charged to the Condensed Consolidated Statement of Comprehensive Loss during the period is as follows: Three months ended June 30, Six months ended June 30, 2022 (unaudited) 2021 (unaudited) 2022 (unaudited) 2021 (unaudited) US$’000 US$’000 US$’000 US$’000 Share option expense 1,920 1,473 4,579 2,352 RSU expense 683 480 1,112 864 PSU expense 277 — 337 — Total share based payment expenses 2,880 1,953 6,028 3,216 5. Business combinations and asset acquisitions Acquisition of Chiasma On May 5, 2021, Amryt announced that it had signed a definitive agreement to acquire Chiasma, Inc. (Nasdaq: CHMA) in an all-stock combination. Under the terms of the transaction, each share of Chiasma common stock issued and outstanding prior to the consummation of the transaction was exchanged for 0.396 Amryt ADSs, each representing five Amryt ordinary shares. On August 5, 2021, Amryt completed the acquisition of Chiasma, Inc. and, in conjunction with the completion, Amryt allotted and issued a total of 127,733,680 ordinary shares as consideration for the acquisition. Following the completion, shareholdings in Chiasma were rounded in being converted to Amryt shares using the exchange ratio of 0.396. Roundings in converting Chiasma shareholdings to Amryt shares were finalized in August 2021 and resulted in an additional 7,015 ordinary shares being allotted and issued by Amryt as consideration for the acquisition. In total, these ordinary shares were issued to the former Chiasma Shareholders in the form of 25,548,139 ADSs at US$10.19 per share, to acquire Chiasma for a value of US$260,336,000. On August 5, 2021, Chiasma had outstanding equity awards that were held by Chiasma employees. The fair value of these awards transferred to Amryt on acquisition were measured in accordance with IFRS 2. The portion of the value of the equity transferred to Amryt attributable to pre-combination service is included in the consideration at the date of acquisition and this amounted to US$10,157,000. On August 5, 2021, the Group repaid US$116,629,000 of Chiasma long term debt. The combined company will be a global leader in rare and orphan diseases with four on-market commercial products, a global commercial and operational footprint and a significant development pipeline of therapies with the financial flexibility to execute its growth plans. The table below reflects the fair value of the identifiable net assets acquired in respect of the acquisition completed during the period. Any amendments to fair values will be made within the twelve-month period from the date of acquisition, as permitted by IFRS 3: Business Combinations. The acquired goodwill is attributable principally to the profit generating potential of the businesses, the assembled workforce and benefits arising from embedded infrastructure, that are expected to be achieved from integrating the acquired businesses into the Group’s existing business. No amount of goodwill is expected to be deductible for tax purposes. The Group incurred acquisition and restructuring related costs of US$265,000 and US$667,000for the three-month period and six-month period ended June 30, 2022, respectively, relating to external legal fees, advisory fees, due diligence costs and severance costs related to the acquisition of Chiasma. These costs have been included in operating costs in the Condensed Consolidated Statement of Comprehensive Loss. Recognized Fair Values as at August 5, 2021 US$’000 Assets Non-current assets Intangible assets 215,000 Property, plant and equipment 950 Other non-current assets 866 Total non-current assets 216,816 Current assets Trade and other receivables 7,180 Inventories 65,907 Cash and cash equivalents, including restricted cash 107,942 Total current assets 181,029 Total assets 397,845 Non-current liabilities Deferred tax liability 21,478 Total non-current liabilities 21,478 Current liabilities Trade and other payables 144,482 Total current liabilities 144,482 Total liabilities 165,960 Total identifiable net assets at fair value 231,885 Goodwill arising on acquisition 38,608 Consideration 270,493 Consideration Issue of fully paid up ordinary shares 260,336 Chiasma equity awards recognized as consideration transferred upon the acquisition of Chiasma 10,157 Total consideration 270,493 Any amendments to these fair values within the twelve-month timeframe from the date of acquisition will be disclosed in the 2022 consolidated financial statements, as stipulated by IFRS 3. Acquisition of Aegerion Pharmaceuticals On May 20, 2019, Amryt entered into a Restructuring Support Agreement (as subsequently amended on June 12, 2019) and Plan Funding Agreement pursuant to which, among other matters, Amryt agreed to the acquisition of Aegerion Pharmaceuticals, Inc. (‘‘Aegerion’’, subsequently renamed as Amryt Pharmaceuticals Inc.), a former wholly-owned subsidiary of Novelion Therapeutics Inc. (‘‘Novelion’’). On May 20, 2019, Aegerion and its U.S. subsidiary, Aegerion Pharmaceuticals Holdings, Inc., filed voluntary petitions under Chapter 11 of Title 11 of the U.S. Code in the Bankruptcy Court. On September 24, 2019, Amryt completed the acquisition of Aegerion. Amryt acquired Aegerion upon its emergence from bankruptcy in an exchange for ordinary shares and zero cost warrants in Amryt. Amryt issued 85,092,423 effective shares at US$1.793 per share, which is made up of 77,027,423 ordinary shares and 8,065,000 zero cost warrants, to acquire Aegerion for a value of US$152,615,000. As part of the acquisition of Aegerion, it was agreed, for certain Aegerion creditors who wished to restrict their percentage share interest in Amryt’s issued share capital, to issue to the relevant Aegerion creditor, as an alternative to Amryt’s ordinary shares, an equivalent number of new zero cost warrants to subscribe for Amryt’s ordinary shares to be constituted on the terms of the zero cost warrant. As atJune 30, 2022, no zero cost warrants were remaining. Contingent Value Rights Related to the transaction, Amryt issued Contingent Value Rights (‘‘CVRs’’) pursuant to which up to US$85,000,000 may become payable to Amryt’s shareholders and optionholders, who were on the register prior to the completion of the acquisition on September 20, 2019, if certain approval and revenue milestones are met in relation Oleogel-S10, Amryt’s lead product candidate. If any such milestone is achieved, Amryt may elect to pay the holders of CVRs by the issue of Amryt shares or loan notes. If Amryt elects to issue Loan Notes to holders of CVRs, it will settle such loan notes in cash 120 days after their issue. If none of the milestones are achieved, scheme shareholders and optionholders will not receive any additional consideration under the terms of the CVRs. In these circumstances, the value of each CVR would be zero. The terms of the CVRs are as follows: The total CVR payable is up to US$85,000,000This is divided into three milestones which are related to the success of Oleogel-S10 (the Group’s lead development asset)FDA approval US$35,000,000 upon FDA approval100% of the amount due if approval is obtained before December 31, 2021, with a sliding scale on a linear basis to zero if before July 1, 2022. The timeline for this milestone has now passed and, therefore, will not be paid. EMA approval US$15,000,000 upon EMA approval100% of the amount due if approval is obtained before December 31, 2021, with a sliding scale on a linear basis to zero if before July 1, 2022Revenue targets US$35,000,000 upon Oleogel-S10 revenues exceeding US$75,000,000 in any 12-month period prior to June 30, 2024Payment can at the Board’s discretion be in the form of either: 120-day loan notes (effectively cash), orShares valued using the 30 day / 45-day VWAP. The CVRs were contingent on the successful completion of the acquisition and, accordingly, have been based on fair value as at September 24, 2019. The CVRs have been classified as a financial liability in the Condensed Consolidated Statement of Financial Position. Given that CVRs were issued to legacy Amryt shareholders in their capacity as owners of the identified acquirer as opposed to the seller in the transaction, management concluded that the most appropriate classification would be to recognize the CVR as a distribution on consolidation instead of goodwill. Following the EMA approval of Filsuvez (Oleogel S-10) during the period ended June 30, 2022, the EMA CVRs issued to those Amryt shareholders and option holders who held Amryt shares or options prior to the acquisition of Aegerion Pharmaceuticals, Inc. (“CVR Holders”) became payable. Amryt elected to issue Loan Notes that will be redeemed in full in September 2022 to the holders of the CVRs. The total amount payable to CVR Holders is US$5,718,000 for which a liability is recognized in current liabilities in the Condensed Consolidated Statement of Financial Position. Measurement of Contingent Value Rights As atJune 30, 2022, the carrying value of the Contingent Value Rights liability was US$12,889,000 (December 31, 2021: US$19,892,000). As the EMA approval milestone has been triggered and the FDA approval will not be achieved in time for the FDA approval milestone to be triggered, the Contingent Value Rights liability relates to the Revenue target milestones and the related expected discounted cash flows. The value of this potential payout was calculated using the probability-weighted expected returns method. Using this method, the potential payment amounts were multiplied by the probability of achievement and discounted to present value. The probability adjusted present values took into account published orphan drug research data and statistics which were adjusted by management to reflect the specific circumstances applicable to the type of product acquired in the Amryt GmbH transaction. The probability chance of success is based on management’s expertise and experience for orphan drugs and takes into account the unique circumstances applying to approval process of this product. The EMA approval probability was set at 100% following the approval received in 2022 (December 31, 2021: estimated at 100%) and the probability of success for the FDA approval was estimated at 5% (December 31, 2021: 60%) as at June 30, 2022. The EMA approval probability reflects the EMA approval achieved in 2022 and the FDA estimate reflects the current facts and circumstances as of the date of issuance of the Condensed Consolidated Financial Statements. The FDA approval probability chance of success was updated in 2022 following developments related to the receipt of a CRL from the FDA, where Amryt announced in June 2022 its intention to submit a Formal Dispute Resolution Request (FDRR) for the company’s NDA for Filsuvez®. Discount rates of 10% and 16.5%, as applicable, were used in the calculation of the present value of the estimated contractual cash flows for the year ended December 31, 2021, based on the applicable rates determined on the acquisition date. Management was required to make certain estimates and assumptions in relation to revenue forecasts, timing of revenues and probability of achievement of commercialization of Oleogel-S10. However, management notes that, due to issues outside their control (i.e. regulatory requirements and the commercial success of the product), the timing of when such revenue targets may occur may change. Such changes may have a material impact on the assessment of the expected cash flows of the CVRs. Amryt reviews the expected cash flows on a regular basis as the discount on initial recognition is being unwound as financing expenses in the Consolidated Statement of Comprehensive Loss over the life of the obligation. It is reviewed on a quarterly basis and the appropriate finance charge or gain is booked in the Consolidated Statement of Comprehensive Loss on a quarterly basis. The total non-cash gain recognized in the Condensed Consolidated Statement of Comprehensive Loss for the three andsix months ended June 30, 2022, is US$1,967,000 and US$1,285,000 (June 30, 2021: US$1,837,000 charge and US$3,600,000 charge, respectively). Acquisition of Amryt GmbH (previously ‘‘Birken’’) Amryt DAC signed a conditional share purchase agreement to acquire Amryt GmbH on October 16, 2015 (‘‘Amryt GmbH SPA’’). The Amryt GmbHSPA was completed on April 18, 2016, with Amryt DAC acquiring the entire issued share capital of Amryt GmbH. The consideration included contingent consideration comprising milestone payments and sales royalties as follows: Milestone payments of: €10,000,000 on receipt of marketing approval by the EMA or FDA of a pharmaceutical product containing Betulin as its API for the treatment of EB. Following EMA approval in 2022, this milestone was paid in July 2022;€10,000,000 once net ex-factory sales/net revenue of Oleogel S-10 first exceed €50,000,000 in any calendar year;€15,000,000 once net ex-factory sales/ net revenue of Oleogel S-10 first exceed €100,000,000 in any calendar year;Cash consideration of €150,000, due and paid on the completion date (April 18, 2016); andRoyalties of 9% on sales of Oleogel-S10 products for 10 years from first commercial sale. Fair Value Measurement of Contingent Consideration As atJune 30, 2022, the fair value of the contingent consideration was estimated to be US$52,434,000 (December 31, 2021: US$61,221,000).The EMA or FDA marketing approval milestone payment was triggered following the EMA approval of Filsuvez® in 2022 and the liability of $10,490,000 (€10,000,000), reflecting the final fair value for this milestone payment, is recognized as contingent consideration in current liabilities on the Condensed Consolidated Statement of Financial Position. The marketing approval milestone payment of€10,000,000 was paid in July 2022. The fair value of the remaining contingent consideration includes milestone payments determined using probability adjusted present values and probability weighted revenue forecasts (see Note 15, Fair value measurement and financial risk management, for fair value hierarchy applied and impact of key unobservable impact data).The probability adjusted present values took into account published orphan drug research data and statistics which were adjusted by management to reflect the specific circumstances applicable to the type of product acquired in the Amryt GmbH transaction. The probability chance of success is based on management’s expertise and experience for orphan drugs and takes into account the unique circumstances applying to approval process of this product. The EMA approval probability was set at 100% following the approval received in 2022 (December 31, 2021: estimated at 100%) and the probability of success for the FDA approval was estimated at 50% (December 31, 2021: 60%) as at June 30, 2022. The EMA approval probability reflects the EMA approval achieved in 2022 and the FDA estimate reflects the current facts and circumstances as of the date of issuance of the Condensed Consolidated Financial Statements. The FDA approval probability chance of success was updated in 2022 following developments related to the receipt of a CRL from the FDA, where Amryt announced in June 2022 its intention to submit a FDRR for the company’s NDA for Filsuvez®. A discount rate of 7.9% was used in the calculation of the fair value of the contingent consideration for the six month period ended June 30, 2022 (December 31, 2021: 7.9%). Amryt reviews the expected cash flows on a regular basis as the discount on initial recognition is being unwound as financing expenses in the Consolidated Statement of Comprehensive Loss over the life of the obligation. It is reviewed on a quarterly basis and the appropriate finance charge or gain is booked in the Consolidated Statement of Comprehensive Loss on a quarterly basis. The total non-cash gain recognized in the Condensed Consolidated Statement of Comprehensive Loss for the three and six months ended June 30, 2022, is US$4,72,000and US$4,293,000 (June 30, 2021: US$2,993,000 charge and US$5,867,000 charge, respectively). 6. Loss per share – basic and diluted The weighted average number of shares in the loss per share (‘‘LPS’’) calculation, reflects the weighted average total actual shares of Amryt Pharma plc in issue atJune 30, 2022. Issued share capital – ordinary shares of £0.06 each Number of shares Weighted average shares As at June 30, Three months ended June 30, Six months ended June 30, 2022 (unaudited) 320,884,822 320,813,045 320,658,612 2021 (unaudited) 179,384,982 179,384,982 179,162,585 The calculation of loss per share is based on the following: Three months ended June 30, Six months ended June 30, 2022 (unaudited) 2021 (unaudited) 2022 (unaudited) 2021 (unaudited) Loss after tax attributable to equity holders of the Company (US$’000) (7,049) (6,799) (21,540) (23,336) Weighted average number of ordinary shares in issue 320,813,045 179,384,982 320,658,612 179,162,585 Fully diluted average number of ordinary shares in issue 320,813,045 179,384,982 320,658,612 179,162,585 Basic and diluted loss per share (US$) (0.02) (0.04) (0.07) (0.13) Where a loss has occurred, basic and diluted LPS are the same because the outstanding share options and warrants are anti-dilutive. Accordingly, diluted LPS equals the basic LPS. The share options, RSUs, PSUs and warrants outstanding as atJune 30, 2022, totaled55,085,434(June 30, 2021: 36,271,387) and are potentially dilutive. 7. Intangible assets and goodwill The following table summarizes the Group’s intangible assets and goodwill: Developed technology - metreleptin Developed technology - lomitapide Developed technology - Mycapssa® In process R&D Other intangible assets Total intangible assets Goodwill US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 Cost At January 1, 2021 (audited) 176,000 123,000 — 60,128 866 359,994 19,131 Additions — — — — 847 847 — Acquired assets — — 215,000 — — 215,000 38,608 Other movements — — — — — — (1,051) Foreign exchange movement — — — (4,691) (61) (4,752) — At December 31, 2021 (audited) 176,000 123,000 215,000 55,437 1,652 571,089 56,688 Foreign exchange movement — — — (4,417) (115) (4,532) — AtJune 30, 2022 (unaudited) 176,000 123,000 215,000 51,020 1,537 566,557 56,688 Accumulated amortization At January 1, 2021 (audited) 34,743 19,680 — — 202 54,625 — Amortization charge 27,428 15,537 5,979 — 147 49,091 — Foreign exchange movement — — — — 14 14 — At December 31, 2021 (audited) 62,171 35,217 5,979 — 363 103,730 — Amortization charge 13,713 7,768 7,414 — 174 29,069 — Foreign exchange movement — — — — (74) (74) — AtJune 30, 2022 (unaudited) 75,884 42,985 13,393 — 463 132,725 — Net book value At December 31, 2021 (audited) 113,829 87,783 209,021 55,437 1,289 467,359 56,688 AtJune 30, 2022 (unaudited) 100,116 80,015 201,607 51,020 1,074 433,832 56,688 Developed technology on commercially marketed products In connection with the acquisition of Aegerion in September 2019, the Group acquired developed technology, metreleptin and lomitapide. These intangible assets are amortized over their estimated useful lives and the remaining useful lives for metreleptin and lomitapide are approximately 3.7 and 5.2 years, respectively, as of June 30, 2022 (December 31, 2021: 4.2 and 5.7 years, respectively). In connection with the acquisition of Chiasma in August 2021, the Group acquired developed technology, octreotide. This intangible asset is amortized over its estimated useful life and the remaining useful life is approximately 13.7 years as of June 30, 2022 (December 31, 2021: 14.2). In-process R&D As a result of the acquisition of Amryt GmbH, in 2016, the Group recognized in-process R&D costs of €48,453,000 (US$54,872,000as of the acquisition date) which is related to the Group’s lead development asset, Oleogel-S10. The remaining in-process R&D is a result of the acquisition of Cala Medical Limited in October 2020. Goodwill During 2019, the Group completed the acquisition of Aegerion which resulted in the recognition of goodwill that has a carrying value of US$18,080,000. On August 5, 2021, the Group completed the acquisition of Chiasma, which resulted in aggregate goodwill of US$38,608,000. The Group reviews events or changes in circumstances that may indicate a triggering event for impairment, at each reporting date, and conducts an annual impairment review to determine any impairment charge required. Management completed an impairment review by determining recoverable amounts from value in use calculations. The recoverable amount of an asset or cash generating unit is estimated in order to determine the extent of an impairment charge. There was no impairment charge recorded during the six months ended June 30, 2022. 8. Trade and other receivables As at June 30, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Trade receivables 37,729 34,263 Accrued income and other debtors 9,104 12,201 VAT recoverable 3,594 7,444 Trade and other receivables 50,427 53,908 9. Inventories As at June 30, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Raw materials 39,640 36,850 Work in progress 17,184 12,986 Finished goods 67,361 65,933 Inventories 124,185 115,769 Inventories for the period ended June 30, 2022, includes inventory acquired as part of the acquisition of Chiasma on August 5, 2021, which was fair valued as of the date of the acquisition. The fair value of the acquired inventory amounted to US$65,907,000. Inventory on hand at the date of acquisition was valued at the expected selling price less the sum of remaining costs of disposal, cost to complete and a reasonable profit margin for the selling effort of the acquiring entity. The costs to complete were calculated based on costs incurred on recently completed finished goods. The costs to dispose include sales and marketing expenses required to sell the product to the customer in addition to certain general and administrative expenses expected to be incurred by Amryt. This resulted in a non-cash step up at the valuation of inventory at August 5, 2021, of US$44,794,000. The non-cash step up in inventory is being unwound to the Condensed Consolidated Statement of Comprehensive Loss over the period in which this saleable inventory is sold. AtJune 30, 2022, US$37,804,000 of this non-cash inventory step up is included in inventory. 10. Cash and cash equivalents As at June 30, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Cash at bank available on demand 90,583 112,771 Restricted cash 150 261 Total cash and cash equivalents 90,733 113,032 Cash and cash equivalents include cash at bank available on demand and restricted cash. AtJune 30, 2022, and December 31, 2021, there was US$150,000 and US$261,000 of restricted cash, respectively. The balance atJune 30, 2022,consists of a letter of credit related to US customs which was put in place for an amount of US$50,000 and a letter of credit related to a deposit on a company credit card facility for an amount of US$100,000. The balance atDecember 31, 2021, includes a deposit on a company credit card facility for an amount of US$$126,000,a lease deposit for US$85,000 and a letter of credit related to US customs which was put in place for an amount of US$50,000. 11. Share capital and reserves Details of the number of issued ordinary shares with a nominal value of Sterling 6 pence (2021: 6 pence) each are in the table below. Ordinary shares Treasury shares Total At January 1, 2021 (audited) 178,801,593 4,791,703 183,593,296 Issue of treasury shares in exchange for warrants 283,389 (283,389) — Issue of treasury shares for share options exercised 300,000 (300,000) — Issue of shares in consideration of Chiasma acquisition 127,740,695 — 127,740,695 Issue of shares in exchange for warrants 4,758,206 — 4,758,206 Issue of treasury shares in exchange for warrants 4,208,314 (4,208,314) — Issue of shares for share options exercised and RSUs vesting 3,722,550 — 3,722,550 At December 31, 2021 (audited) 319,814,747 — 319,814,747 Issue of shares for share options exercised and RSUs vesting 1,070,075 — 1,070,075 AtJune 30, 2022 (unaudited) 320,884,822 — 320,884,822 The components of equity are detailed in the Condensed Consolidated Statement of Changes in Equity and described in more detail below. On March 11, 2021, the Company issued 300,000 ordinary shares from treasury shares following the exercise of share options. On March 11, 2021, the Company issued 283,389 ordinary shares from treasury shares in exchange for certain warrants. On August 5, 2021, the Company issued 127,740,695 ordinary shares, in the form of ADSs, as consideration for the acquisition of Chiasma. On August 5, 2021, the Company issued 8,966,520 ordinary shares with 4,208,314 being issued from treasury shares in exchange for warrants. During the year ended December 31, 2021, there were 3,342,680 shares issued following the exercise of share options and 379,870 shares issued following RSUs vesting.During the period ended June 30, 2022, there were 904,610shares issued following the exercise of share options and 165,465shares issued following RSUs vesting. Share Capital Share capital represents the cumulative par value arising upon issue of ordinary shares of Sterling 6 pence each. The ordinary shares have the right to receive notice of, attend and vote at general meetings and participate in the profits of the Company. Share Premium Share premium represents the consideration that has been received in excess of the nominal value on issue of share capital net of issue costs and transfers to distributable reserves. Warrant reserve The warrant reserve represented zero cost warrants issued as part of the equity raise on September 24, 2019, net of issue costs apportioned to warrants issued and additional warrants issued to certain shareholders on November 14, 2019. Each warrant entitles the holder to subscribe for one ordinary share at zero cost. The Company issued 4,000,000 and 4,229,753 ordinary shares on July 15, 2020, and September 22, 2020, respectively, in exchange for certain warrants. The remaining warrants were exchanged on August 5, 2021, and the Company issued 8,966,520 ordinary shares, 4,208,314 of which were issued from treasury shares and there are no longer any warrants outstanding. Treasury Shares In October 2020, the Company issued 72,953 ordinary shares from treasury shares following the exercise of share options. In March 2021, the Company issued a total of 583,389 ordinary shares from treasury shares, 300,000 ordinary shares relating to the exercise of share options and 283,389 ordinary shares following the exchange of certain warrants.In August 2021, the company issued 4,208,314 ordinary shares from treasury shares in conjunction with the exchange of warrants and since August 2021 there are no longer any treasury shares held. Share based payment reserve Share based payment reserve relates to the charge for share based payments in accordance with IFRS 2. In March 2021, the Company issued 283,389 ordinary shares in exchange for certain warrants. In April 2021, 62,153 warrants lapsed. During the year ended December 31, 2021, the Company issued 3,722,550 ordinary shares in relation to the exercise of share options and RSUs.During the period ended June 30, 2022, the Company issued 1,070,075 ordinary shares in relation to the exercise of share options and RSUs. As part of the acquisition of Chiasma, the Company replaced share awards that were existing at the time of the acquisition. This resulted in the recognition of a share-based payment reserve of US$10,157,000 on acquisition. Merger reserve The merger reserve was created on the acquisition of Amryt DAC by Amryt Pharma plc in April 2016. Ordinary shares in Amryt Pharma plc were issued to acquire the entire issued share capital of Amryt DAC. Under section 612 of the UK Companies Act 2006, the premium on these shares has been included in a merger reserve. Reverse acquisition reserve The reverse acquisition reserve arose during the period ended December 31, 2016, in respect of the reverse acquisition of Amryt Pharma plc by Amryt DAC. Since the shareholders of Amryt DAC became the majority shareholders of the enlarged Group, the acquisition is accounted for as though there is a continuation of Amryt DAC’s financial statements. The reverse acquisition reserve is created to maintain the equity structure of Amryt Pharma plc in compliance with UK company law. Equity component of convertible notes The equity component of convertible notes represents the equity component of the US$125,000,000 convertible debt and is measured by determining the residual of the fair value of the instrument less the estimated fair value of the liability component. The equity component is recognized in equity and is not subsequently remeasured. Other distributable reserves Other distributable reserves comprise the following: Distribution of the share premium amount on 6 November 2019 of US$268,505,000. By special resolution of the Company duly passed on 23 September 2019, it was resolved that the entire amount outstanding to the credit of the share premium account and capital redemption reserve of the Company be cancelled. The reduction in capital, amounting to US$268,505,000, representing the entire amount of share premium at that time, was approved by the High Court of Justice of England and Wales on 5 November 2019.A deemed distribution of US$47,902,000 arising from the issuance of CVRs in September 2019.A deemed distribution of US$2,969,000 arising from the scheme of arrangement in September 2019 whereby Amryt Pharma plc, which was incorporated in July 2019, became a 100% shareholder of Amryt Pharma Holdings Limited (formerly named Amryt Pharma plc) (the “Acquisition of subsidiary without a change of control”). Currency translation reserve The currency translation reserve arises on the retranslation of non-U.S. dollar denominated foreign subsidiaries. Accumulated deficit Accumulated deficit represents losses accumulated in previous periods and the current year. 12. Long term loan As at June 30, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Long term loan principal 105,000 93,988 Unamortized debt issuance costs (6,274) (593) Long term loan 98,726 93,395 On February 18, 2022, Amryt secured US$125,000,000 of senior credit facilities (“Senior Credit Facility”) from funds managed by the Credit Group of Ares Management Corporation (“Ares”). A portion of the proceeds were used to refinance the previous secured term loan, which had an outstanding balance of US$93,988,000 as at February 22, 2022, an interest rate of 13.00% and a maturity date of September 2024. The new facilities will generate significant annual interest cost savings as well as provide for important strategic flexibility as Amryt looks to continue to grow its global rare disease presence.In repaying the secured term loan, Amryt incurred an exit fee of 5.00% of the outstanding principal amount as at the prepayment date. This amounted to US$4,699,000 and is included in Net finance expense – other in the Condensed Consolidated Statement of Comprehensive Income for the six month-period ended June 30, 2022. Key features of the new facilities include: Total new facilities of $125 million, consisting of: $85 million Term Loan Facility with interest rate of Secured Overnight Financing Rate (“SOFR”)+6.75%, subject to a 0.90% SOFR floor$40 million Revolving Credit Facility with $20 million drawn at close and interest rate of SOFR+4.00%, subject to a 0.90% SOFR floorQuarterly blended cash interest rate of SOFR+5.87% (assuming fully drawn), subject to a 0.90% SOFR floor, substantially lower than Amryt’s previous secured term debt facility at 13.00% interestRequires interest-only payments until facility matures in February 2027There are no warrants or any equity conversion features associated with the new facilitiesThe proceeds will be used to refinance existing debt, for general corporate and product development purposes; and potentially for shareholder approved share repurchase programs. As at June 30, 2022, there was unpaid accrued interest of US$2,402,000 and US$399,000 for the Term Loan Facility and Revolving Credit Facility, respectively, recognized in current liabilities within trade and other payables. Charges were taken over certain assets of the company and its material entities as guarantee and collateral for the provision of the debt. In connection with the Secured Credit Facility, the Group incurred approximately US$6,656,000 of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees. These costs are amortized over the expected life of the loan using the effective interest method. The Secured Credit Facilityincludes affirmative and negative covenants, including prohibitions on the incurrence of additional indebtedness, granting of liens, certain asset dispositions, investments, and restricted payments, in each case, subject to certain exceptions set forth in the loan agreement. The loan agreement also includes customary events of default for a transaction of this type and includes (i) a cross-default to the occurrence of any event of default under material indebtedness of Amryt and certain subsidiaries of the Group and Amryt, including the convertible notes, and (ii) Amryt or any of its subsidiaries being subject to bankruptcy or other insolvency proceedings. Upon the occurrence of an event of default, the lenders may declare all of the outstanding Secured Credit Facilityand other obligations under the Secured Credit Facilityto be immediately due and payable and exercise all rights and remedies available to the lenders under the Term Loan agreement and related documentation. There were no events of default or breaches of the covenants occurring during the three and six month period ended June 30, 2022. As part of the acquisition of Aegerion on September 24, 2019, Aegerion entered into a new U.S. dollar denominated US$81,021,000 secured term loan debt facility (‘‘Term Loan’’) with various lenders. The Term Loan was made up of a US$54,469,000 loan that was in place prior to the acquisition which was refinanced as part of the acquisition and a US$26,552,000 additional loan that was drawn down on September 24, 2019. The Term Loan had a five-year term from the date of the draw down, September 24, 2019, and matured on September 24, 2024. Under the Term Loan, interest was payable at the option of the Group at the rate of 11% per annum paid in cash on a quarterly basis or at a rate of 6.5% paid in cash plus 6.5% paid in kind that was to be paid when the principal is repaid, which rolled up and included in the principal balance outstanding, on a quarterly basis. The Term Loan was repayable, in whole or in part, by Amryt at any time subject to payment of an exit fee, which depending on the stage of the loan term, ranged from 5.00% to 0.00% of the principal then outstanding on the Term Loan. On February 18, 2022, the Term Loan was repaid in full and the Group secured a $125,000,000 senior credit facility of which US$105,000,000 was drawn down to facilitate the prepayment of the existing Term Loan.In repaying the Secured Credit Facility, Amryt incurred an exit fee of 5.00% of the outstanding principal amount as at the prepayment date. In connection with the Term Loan, the Group incurred approximately US$870,000 of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees. These costs were amortized over the expected life of the loan using the effective interest method and during the six month period ended June 30, 2022, were written off to the Condensed Consolidated Statement of Comprehensive Loss as the Term Loan liability was derecognized. The Term Loan wasguaranteed by Amryt and certain subsidiaries of the Group. In connection with the loan agreement, fixed and floating charges were placed on property and undertakings of Amryt and certain subsidiaries of the Group. 13. Convertible notes Total US$’000 At January 1, 2021 101,086 Accreted interest 4,702 At December 31, 2021 (audited) 105,788 Accreted interest 2,544 AtJune 30, 2022 (unaudited) 108,332 As part of the Aegerion acquisition, Aegerion issued convertible notes with an aggregate principal amount of US$125,000,000 to Aegerion creditors. The convertible notes are senior unsecured obligations and bear interest at a rate of 5.0% per year, payable semi-annually in arrears on April 1 and October 1 of each year, beginning on April 1, 2020. The convertible notes will mature on April 1, 2025, unless earlier repurchased or converted. The convertible notes are convertible into Amryt’s ordinary shares at a conversion rate of 386.75 ordinary shares per US$1,000 principal amount of the convertible notes. If the holders elect to convert the convertible notes, Amryt can settle the conversion of the convertible notes through payment or delivery of cash, common shares, or a combination of cash and common shares, at its discretion. As a result of the conversion feature in the convertible notes, the convertible notes were assessed to have both a debt and an equity component. The two components were assessed separately and classified as a financial liability and equity instrument. The financial liability component was measured at fair value based on the discounted cash flows expected over the expected term of the notes using a discount rate based on a market interest rate that a similar debt instrument without a conversion feature would be subject to. Refer to Note 11, Share capital and reserves, for further details on the equity component of the convertible notes. From September 24, 2019, until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of their convertible notes, in multiples of US$1,000 principal amount, at the option of the holder. The indenture does not contain any financial covenants or restrict the Group’s ability to repurchase securities, pay dividends or make restricted payments in the event of a transaction that substantially increases the Group’s level of indebtedness in certain circumstances. The indenture contains customary terms and covenants and events of default. If an event of default (other than certain events of bankruptcy, insolvency or reorganization involving Aegerion, Amryt and certain subsidiaries of the Group) occurs and is continuing, the trustee by notice to Amryt, or the holders of at least 25% in principal amount of the outstanding convertible notes by written notice to Amryt and the trustee, may declare 100% of the principal of and accrued and unpaid interest, if any, on all of the convertible notes to be due and payable. Upon such a declaration of acceleration, such principal and accrued and unpaid interest, if any, will be due and payable immediately. Upon the occurrence of certain events of bankruptcy, insolvency or reorganization involving Amryt, 100% of the principal and accrued and unpaid interest, if any, on the convertible notes will become due and payable automatically. Notwithstanding the foregoing, the indenture provides that, upon Amryt’s election, and for up to 180 days, the sole remedy for an event of default relating to certain failures by Amryt to comply with certain reporting covenants in the indenture consists exclusively of the right to receive additional interest on the convertible notes. There have been no events of default or breaches of the covenants occurring for the period ended June 30, 2022 (2021: no events). 14. Provisions and other liabilities As at June 30, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Non-current liabilities Leases due greater than 1 year 3,543 4,049 3,543 4,049 Current liabilities Provisions and other liabilities 6,000 6,000 Leases due less than 1 year 911 1,545 6,911 7,545 Total provisions and other liabilities 10,454 11,594 Legal matters Prior to the acquisition of Aegerion by Amryt, Aegerion entered into settlement agreements with governmental entities including the Department of Justice (‘‘DOJ’’) and the FDA in connection with Juxtapid investigations. The settlement agreements required Aegerion to pay specified fines and engage in regulatory compliance efforts. Subsequent to the acquisition, Aegerion made US$23,036,000 of settlement payments, including interest. The settlements have been paid in full with the last payment completed in Q1 2021. Other matters The Group recognizes a liability for legal contingencies when it believes that it is both probable that a liability has been incurred and that it can reasonably estimate the amount of the loss. The Group reviews these accruals and adjusts them to reflect ongoing negotiations, settlements, rulings, advice of legal counsel and other relevant information. To the extent new information is obtained and the Group’s views on the probable outcomes of claims, suits, assessments, investigations or legal proceedings change, changes in the Group’s liability accrual would be recorded in the period in which such determination is made. AtJune 30, 2022, the Group had recognized liabilities of US$6,000,000 in relation to ongoing legal matters (December 31, 2021: US$6,000,000). 15. Fair value measurement and financial risk management Categories of financial instruments As at June 30, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Financial assets (all at amortized cost): Cash and cash equivalents 90,733 113,032 Trade receivables 37,729 34,263 Total financial assets 128,462 147,295 Financial liabilities: At amortized cost Trade payables and accrued expenses 125,596 148,251 Lease liabilities 4,454 5,594 Convertible notes 108,332 105,788 Long term loan 98,726 93,395 Contingent value rights 12,889 19,892 Loan Notes 5,718 — At fair value Contingent consideration 52,434 61,221 Total financial liabilities 408,149 434,141 Net (279,687) (286,846) Financial instruments evaluated at fair value can be classified according to the following valuation hierarchy, which reflects the extent to which the fair value is observable: Level 1: fair value evaluations using prices listed on active markets (not adjusted) of identical assets or liabilities.Level 2: fair value evaluations using input data for the asset or liability that are either directly observable (as prices) or indirectly observable (derived from prices), but which do not constitute listed prices pursuant to Level 1.Level 3: fair value evaluations using input data for the asset or liability that are not based on observable market data (unobservable input data). The contingent consideration has been valued using Level 3. The contingent consideration comprises: Contingent consideration relating to the acquisition of Amryt GmbH (see Note 5, Business combinations and asset acquisitions) that was measured at US$52,434,000 as atJune 30, 2022 (December 31, 2021: US$61,221,000). The fair value comprises royalty payments which was determined using probability weighted revenue forecasts and the fair value of the milestones payments which was determined using probability adjusted present values. It also included a revision to the discount rate used, and revenue and costs forecasts have been amended to reflect management’s current expectations. Impact of key unobservable input dataon the contingent consideration: An increase of 10% in estimated revenue forecasts would result in an increase to the fair value of US$3,174,000. A decrease would have the opposite effect.A 5% increase in the discount factor used would result in a decrease to the fair value of US$7,276,000. A decrease of 5% would result in an increase to the fair value of US$9,493,000.A six-month delay in the launch date for Oleogel-S10 would result in a decrease to the fair value of US$4,141,000.An increase of 20% in the probability of success with the FDA approval would result in a decrease to the fair value of US$12,628,000. 16. Events after the reporting period There were no significant events since the end of the reporting period.
AMYT CHMA | globenewswire | about 3 years ago | Neutral

Amryt Reports Record Q1 2022 ResultsAmryt ReportsRecord Q1 2022 Results CHMP adopts positive opinion for Filsuvez® for the treatment of Dystrophic and Junctional EB Reaffirming FY 2022 revenue guidance to $260M - $270M, representing 17-21% YoY growth Board approved stock repurchase program of up to $30M Cash of $102.2M at March 31...
Amryt ReportsRecord Q1 2022 Results CHMP adopts positive opinion for Filsuvez® for the treatment of Dystrophic and Junctional EB Reaffirming FY 2022 revenue guidance to $260M - $270M, representing 17-21% YoY growth Board approved stock repurchase program of up to $30M Cash of $102.2M at March 31, 2022 22.1% YoY revenue growth in Q1 to $59.1M 25.7% growth in metreleptin revenues YoY to$37.6M in Q1 9th consecutive quarter of positive EBITDA generation Successful bioavailability study supporting development of Mycapssa® for carcinoid symptoms in NET Conference call and webcast today at 0830 ET / 1330 BST DUBLIN, Ireland, and Boston MA, May 4, 2022, Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today provides a business update and announces unaudited financial results for the first quarter ended March 31, 2022. Joe Wiley, CEO of Amryt Pharma, commented:“Q1 was an extremely busy and productive period for Amryt and I am pleased to report today’s strong operational and financial results. Our record Q1 revenues of $59.1M represent 22.1% YoY revenue growth. Metreleptin continues to grow strongly and delivered 25.7% YoY growth in the quarter andthese results clearly demonstrate the strong performance of metreleptin across all regions. Overall, the results also demonstrate the strong growth we are experiencing across our business and represent our ninth consecutive quarter of positive EBITDA generation. We have also recently reported some very positive news regarding the regulatory pathway for Filsuvez® with the CHMP recommending a positive opinion. This recommendation for the approval of Filsuvez® in Europe is the most significant milestone in Amryt’s history and represents a major positive development for European patients that suffer from this debilitating condition and is the culmination of years of hard work from all the Amryt team. If approved, Filsuvez® would be our fourth commercial product and we already have in place the team, financial flexibility, systems and global infrastructure to bring it to market and to execute our significant growth plan. We are very excited by the potential to deliver Filsuvez® to European patients in need as soon as possible. The relaunch of Mycapssa® is progressing well and we are excited about both the growth opportunity for Mycapssa® in acromegaly and the potential to develop Mycapssa®in carcinoid syndrome associated with neuroendocrine tumors. Given the strong performance of our business year to date, we are today reaffirming our full year 2022 revenue guidance of $260-$270 million which represents growth of 17%-21% over 2021”. Q1 2022 and Recent Business Highlights: Board approves stock repurchase program of up to $30M through March 2023Completed $125M non-dilutive debt refinancing of which $105M is drawn- significantly reducing interest expense and cost of capital and extending term debt maturity through 2027Lancet Diabetes & Endocrinology publishes positive results for the MPOWERED Phase 3 trial for Mycapssa®Announced positive long-term MPOWERED safety and efficacy data confirming the role for Mycapssa® in the management of acromegaly patients who have responded to and tolerated treatment with octreotide and lanreotideAnnouncedpositive long-term safety and efficacy data for Mycapssa® (oral octreotide) from the 2nd Year of OPTIMAL Open Label Extension study in acromegaly patientsAnnounced successful bioavailability study for Mycapssa® Announced positive interim analysis data from Open Label Phase of EASE Phase 3 Trial in EBFilsuvez®1 new patents announced further strengthening IP protectionCommercial plans well advanced for potential Filsuvez® launch in EuropeCHMP adopts positive opinion for Filsuvez® for the treatment of Dystrophic and Junctional EBFilsuvez® FDA briefing document has been filed and end-of-review conference anticipated in Q2 FY 2022 revenue guidance of $260M - $270M reaffirmed, representing 17-21% growth over 2021 Q1 2022 Commercial Product Performance: Q1 2022 (unaudited) US EMEA Other Total US$’000 US$’000 US$’000 US$’000 Metreleptin 20,244 15,922 1,481 37,647 Lomitapide 8,054 7,190 2,572 17,816 Mycapssa® 3,427 - - 3,427 Other - 171 68 239 Total revenue 31,725 23,283 4,121 59,129 Q12021 (unaudited) US EMEA Other Total US$’000 US$’000 US$’000 US$’000 Metreleptin 16,239 12,971 750 29,960 Lomitapide 8,324 7,440 2,420 18,184 Mycapssa® - - - - Other - 223 65 288 Total revenue 24,563 20,634 3,235 48,432 22.1%YoY revenue growth in Q1 2022 to $59.1M (Q1 2021: $48.4M)25.7% increase in metreleptin revenues YoY to$37.6M in Q1 2022 (Q1 2021: $30.0M)US accounted for 53.8% of global metreleptin revenues and EMEA accounted for 42.3% in Q1 2022US metreleptin revenues grew by 24.7% YoY and EMEA metreleptin revenues grew by22.8% YoY in Q1 2022US accounted for 45.2% of global lomitapide revenues and EMEA accounted for 40.4% in Q1 2022Global lomitapide revenues increased by 0.7% QoQMycapssa® delivered $3.4Min Q1 2022Mycapssa® revenues in Q4 2021 were impacted by pre-ordering in the quarter of approx. $1M. Allowing for the impact of pre-ordering, our underlying Mycapssa® business grew 11% sequentially in Q1 2022. Q1 2022 Financial Highlights: $12.8Moperating loss before finance expensefor Q1 2022 (Q1 2021: $3.4M operating loss). Excluding non-cash items, share based compensation expenses and Chiasma restructuring and acquisition costs, this resulted in EBITDA3 before restructuring and acquisition costs of $7.2M.Cash of $102.2M at March 31, 2022 (Dec 31, 2021: $113.0M) IFRS and non-GAAP adjusted Q1 2022results: US$M Q1 2021 (unaudited) Q1 2022 (unaudited) Q1 2022 Non-cash adjustments2 Q1 2022 Non-GAAP Adjusted Revenue 48.4 59.1 - 59.1 Gross profit 24.9 28.4 16.0 44.4 R&D expenses (8.9) (9.9) - (9.9) SG&A expenses (18.2) (27.7) 0.4 (27.3) Restructuring and acquisition costs - (0.4) - (0.4) Share based compensation expenses (1.3) (3.2) 3.2 - Operating (loss) / profit before finance expense (3.4) (12.8) 19.6 6.83 Operating (loss) / profit before finance expense and restructuring and acquisition costs (3.4) (12.4) 19.6 7.23 1 Filsuvez® (birch extract)gel (“Filsuvez®”)has been selected as the brand name for Oleogel-S10 but please note, Amryt does not, as yet, have regulatory approval for Filsuvez®to treat EB. 2 Non-cash items include amortisation of the acquired metreleptin, lomitapide and Mycapssa® intangible assets ($14.4M), amortisation of the inventory fair value step-up related to the acquisition of Chiasma, Inc. ($1.6M), depreciation and amortisation ($0.4M) and share based compensation expenses ($3.2M). 3 EBITDA is earnings before interest, tax, depreciation, amortisation and share based compensation expenses. To supplement Amryt's financial results presented in accordance with IFRS generally accepted accounting principles, the Company uses EBITDA as a key measure of company performance as the Company believes that this measure is most reflective of the operational profitability or loss of the Company and provides management and investors with useful supplementary information which can enhance their ability to evaluate the operating performance of the business. EBITDA, as measured by the Company, is not meant to be considered in isolation or as a substitute to operating profit / loss attributable to Amryt and should be read in conjunction with the Company's condensed consolidated financial statements prepared in accordance with IFRS. Oleogel-S10 (Filsuvez®) Regulatory Update: On February 28, 2022, Amryt announced that the FDA communicated that it had completed its review of the NDA for Oleogel-S10 and has determined that the application cannot be approved in its present form. The FDA has asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in EB. During Q2 2022, Amryt intends to discuss with the FDA the nature of the data required to address the Agency’s concerns.AnFDA briefing document has been filed and anend-of-review conference is anticipated in Q2 2022. On April 22, 2022, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the approval of Filsuvez® in the European Union (EU) for the treatment of partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa (EB) in patients 6 months and older. EB is a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. Based on this CHMP recommendation a decision by the European Commission (EC) is expected on the Filsuvez® application within 67 days of the CHMP opinion. The centralised marketing authorisation would be valid in all EU Member States as well as in Iceland, Liechtenstein, and Norway. The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK is expected to grant authorisation within the same time period. Guidance & Outlook: Given the continued strong performance of the Company’s commercial products, the board is today reaffirming revenue guidance for FY 2022 in the range of $260M - $270M which represents growth of 17% to 21% on FY 2021. Conference Call & Webcast: Amryt will host a conference call and webcast for analysts and investors today at 0830 ET/1330 GMT. Webcast Player URL:https://edge.media-server.com/mmc/p/uso54daj Telephone Dial in details: United States +1 646 7413167 United Kingdom +44 (0) 207192 8338 Ireland +353 (1) 506 0650 Confirmation Code 1698066 A playback facility will be available from May4, 2022 at 1330 ET/1830 BST – May 11, 2022 at 1330 ET/1830 BST. Access details for the playback facility are as follows: Confirmation Code:1698066| US: + 1 917 677 7532 | UK: +44 (0) 333 300 9785 | Ireland : +353 (1) 553 8777. About Amryt Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets. Amryt’s commercial business comprises three orphan disease products – metreleptin (Myalept®/ Myalepta®); oral octreotide (Mycapssa®); and lomitapide (Juxtapid®/ Lojuxta®). Myalept®/Myalepta® (metreleptin) is approved in the US (under the trade name Myalept®) as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in the EU (under the trade name Myalepta®) as an adjunct to diet for the treatment of leptin deficiency in patients with congenital or acquired GL in adults and children two years of age and above and familial or acquired partial lipodystrophy (PL) in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control. For additional information, please follow this link. Mycapssa® (octreotide capsules) is approved in the US for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. Mycapssa® is the first and only oral somatostatin analog approved by the FDA. Mycapssa® has also been submitted to the EMA and is not yet approved in Europe. For additional information, please follow this link. Juxtapid®/Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia ("HoFH") in the US, Canada, Colombia, Argentina and Japan (under the trade name Juxtapid®) and in the EU, Israel, Saudi Arabia and Brazil (under the trade name Lojuxta®). For additional information, please follow this link. Amryt's lead development candidate, Oleogel-S10 is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (EB), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. Filsuvez® has been selected as the brand name for Oleogel-S10. The product does not currently have regulatory approval to treat EB. Amryt’s pre-clinical gene therapy candidate, AP103, offers a potential treatment for patients with Dystrophic EB, and the polymer-based delivery platform has the potential to be developed for the treatment of other genetic disorders. Amryt also intends to develop oral medications that are currently only available as injectable therapies through its Transient Permeability Enhancer (TPE®) technology platform. For more information on Amryt, including products, please visit www.amrytpharma.com. Forward-Looking Statements This announcement may contain forward-looking statements and the words "expect", "anticipate", "intends", "plan", "estimate", "aim", "forecast", "project" and similar expressions (or their negative) identify certain of these forward-looking statements. The forward-looking statements in this announcement are based on numerous assumptions and Amryt's present and future business strategies and the environment in which Amryt expects to operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. These statements are not guarantees of future performance or the ability to identify and consummate investments. Many of these risks and uncertainties relate to factors that are beyond Amryt's ability to control or estimate precisely, such as future market conditions, the course of the COVID-19 pandemic, currency fluctuations, the behaviour of other market participants, the outcome of clinical trials, the actions of regulators and other factors such as Amryt's ability to obtain financing, changes in the political, social and regulatory framework in which Amryt operates or in economic, technological or consumer trends or conditions. Past performance should not be taken as an indication or guarantee of future results, and no representation or warranty, express or implied, is made regarding future performance. No person is under any obligation to update or keep current the information contained in this announcement or to provide the recipient of it with access to any additional relevant information that may arise in connection with it. Such forward-looking statements reflect the Company’s current beliefs and assumptions and are based on information currently available to management. Contacts Joe Wiley, CEO / Rory Nealon, CFO/COO, +353 (1) 518 0200, ir@amrytpharma.com Tim McCarthy, LifeSci Advisors, LLC, +1 (212) 915 2564, tim@lifesciadvisors.com Amryt Pharma plc Condensed Consolidated Statement of Comprehensive Loss Three Months Ended March 31, Note 2022 (unaudited) 2021 (unaudited) US$’000 US$’000 Revenue 3 59,129 48,432 Cost of sales (30,775) (23,489) Gross profit 28,354 24,943 Research and development expenses (9,881) (8,916) Selling, general and administrative expenses (27,709) (18,156) Restructuring and acquisition costs 5 (402) — Share based payment expenses 4 (3,148) (1,263) Operating loss before finance expense (12,786) (3,392) Non-cash change in fair value of contingent consideration 5 (427) (2,874) Non-cash contingent value rights loss 5 (682) (1,763) Net finance expense - other (11,127) (7,898) Loss on ordinary activities before taxation (25,022) (15,927) Tax credit/(charge) on loss on ordinary activities 10,531 (610) Loss for the period attributable to the equity holders of the Company (14,491) (16,537) Exchange translation differences which may be reclassified through profit or loss (399) 2,547 Total other comprehensive (loss)/income (399) 2,547 Total comprehensive loss for the period attributable to the equity holders of the Company (14,890) (13,990) Loss per share Loss per share - basic and diluted, attributable to ordinary equity holders of the parent (US$) 6 (0.05) (0.09) Amryt Pharma plc Condensed Consolidated Statement of Financial Position As at, Note March 31, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Assets Non-current assets Goodwill 7 56,688 56,688 Intangible assets 7 451,575 467,359 Property, plant and equipment 7,110 7,416 Other non-current assets 1,850 1,885 Total non-current assets 517,223 533,348 Current assets Trade and other receivables 8 47,369 53,908 Inventories 9 120,055 115,769 Cash and cash equivalents, including restricted cash 10 102,220 113,032 Total current assets 269,644 282,709 Total assets 786,867 816,057 Equity and liabilities Equity attributable to owners of the parent Share capital 11 25,572 25,500 Share premium 11 319,855 318,153 Other reserves 11 247,231 246,303 Accumulated deficit (246,676) (233,295) Total equity 345,982 356,661 Non-current liabilities Contingent consideration and contingent value rights 5 81,127 81,113 Deferred tax liability 6,665 17,772 Long term loan 12 98,463 93,395 Convertible notes 13 107,043 105,788 Provisions and other liabilities 14 3,878 4,049 Total non-current liabilities 297,176 302,117 Current liabilities Trade and other payables 136,752 149,734 Provisions and other liabilities 14 6,957 7,545 Total current liabilities 143,709 157,279 Total liabilities 440,885 459,396 Total equity and liabilities 786,867 816,057 Amryt Pharma plc Condensed Consolidated Statement of Cash Flows Three months ended March 31, Note 2022 (unaudited) 2021 (unaudited) US$’000 US$’000 Cash flows from operating activities Loss on ordinary activities after taxation (14,491) (16,537) Net finance expense - other 11,127 7,898 Depreciation and amortization 14,830 11,058 Amortization of inventory fair value step-up 1,559 951 Share based payment expenses 4 3,148 1,263 Non-cash change in fair value of contingent consideration 5 427 2,874 Non-cash contingent value rights finance expense 5 682 1,763 Deferred taxation (credit)/charge (11,105) 141 Movements in working capital and other adjustments: Change in trade and other receivables 8 6,538 (778) Change in trade and other payables (13,867) (3,483) Change in provision and other liabilities 14 (577) (3,138) Change in inventories (5,846) 670 Change in non-current assets 34 58 Net cash flow from operating activities (7,541) 2,740 Cash flow from investing activities Payments for property, plant and equipment (423) (71) Payments for intangible assets — (416) Deposit interest received 2 1 Net cash flow used in investing activities (421) (486) Cash flow from financing activities Net costs from issue of equity instruments 1,063 (175) Proceeds from long term borrowings - net of debt issue costs 98,344 — Repayment of long term debt (95,469) — Interest paid (6,308) (1,418) Payment of leases (305) (263) Net cash flow from financing activities (2,675) (1,856) Exchange and other movements (175) (645) Net change in cash and cash equivalents (10,812) (247) Cash and cash equivalents at beginning of the period 113,032 118,798 Restricted cash at end of the period 10 50 29 Cash at bank available on demand at end of the period 10 102,170 118,522 Total cash and cash equivalents at end of the period 10 102,220 118,551 Amryt Pharma plc Condensed Consolidated Statement of Changes in Equity For the period ended March 31, 2022 Note Share capital Share premium Warrant reserve Treasury shares Share based payment reserve Merger reserve Reverse acquisition reserve Equity component of convertible notes Other distributable reserves Currency translation reserve Accumulated deficit Total US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 Balance at January 1, 2022 (audited) 25,500 318,153 — — 20,593 42,627 (73,914) 29,210 217,634 10,153 (233,295) 356,661 Loss for the period — — — — — — — — — — (14,491) (14,491) Foreign exchange translation reserve — — — — — — — — — (399) — (399) Total comprehensive loss — — — — — — — — — (399) (14,491) (14,890) Transactions with owners Issue of shares for share options exercised and vesting of RSUs 11 72 1,702 — — (711) — — — — — — 1,063 Share based payment expense 4 — — — — 3,148 — — — — — — 3,148 Share based payment expense – Lapsed — — — — (1,110) — — — — — 1,110 — Total transactions with owners 72 991 — — 1,327 — — — — — 1,110 4,211 Balance at March 31, 2022 (unaudited) 25,572 319,855 — — 21,920 42,627 (73,914) 29,210 217,634 9,754 (246,676) 345,982 For the period ended March 31, 2021 Note Share capital Share premium Warrant reserve Treasury shares Share based payment reserve Merger reserve Reverse acquisition reserve Equity component of convertible notes Other distributable reserves Currency translation reserve Accumulated deficit Total US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 Balance at January 1, 2021 (audited) 13,851 51,408 14,762 (7,421) 7,860 42,627 (73,914) 29,210 217,634 5,730 (235,605) 66,142 Loss for the period — — — — — — — — — — (16,537) (16,537) Foreign exchange translation reserve — — — — — — — — — 2,547 — 2,547 Total comprehensive loss — — — — — — — — — 2,547 (16,537) (13,990) Transactions with owners Issue of treasury shares in exchange for warrants 11 23 99 — 439 — — — — — — — 561 Issue of treasury shares for share options exercised 11 25 89 — 465 (191) — — — — — — 388 Share based payment expense 4 — — — — 1,263 — — — — — — 1,263 Total transactions with owners 48 188 — 904 1,072 — — — — — — 2,212 Balance at March 31, 2021 (unaudited) 13,899 51,596 14,762 (6,517) 8,932 42,627 (73,914) 29,210 217,634 8,277 (252,142) 54,364 1. General information Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets. As used herein, references to ‘‘we,’’ ‘‘us,’’ ‘‘Amryt’’ or the ‘‘Group’’ in these condensed consolidated interim financial statements shall mean Amryt Pharma plc and its global subsidiaries, collectively. References to the ‘‘Company’’ in these condensed consolidated interim financial statements shall mean Amryt Pharma plc. Amryt Pharma plc is a company incorporated in England and Wales. The Company is listed on Nasdaq (ticker: AMYT). The Company was also listed on the AIM market of the London Stock Exchange (ticker: AMYT) up until January 11, 2022, on which date the Company completed the cancellation its admission to AIM. The cancellation was announced by the Company on November 22, 2021, and following the AIM delisting, the Company’s American Depositary Shares (“ADSs”)will remain listed, and will only be tradeable, on Nasdaq. The Company’s last day of trading on AIM was 10 January 2022. Amryt acquired Chiasma, Inc. (“Chiasma”) in August 2021. The combined company will be a global leader in rare and orphan diseases with three on-market commercial products, a global commercial and operational footprint and a significant development pipeline of therapies with the financial flexibility to execute its growth plans. Amryt’s commercial business comprises three orphan disease products – metreleptin (Myalept®/ Myalepta®); oral octreotide (Mycapssa®); and lomitapide (Juxtapid®/ Lojuxta®). Amryt's lead development candidate, Oleogel-S10 is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (EB), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. Filsuvez® has been selected as the brand name for Oleogel-S10. The product does not currently have regulatory approval to treat EB. On February 28, 2022, Amryt announced that the U.S. Food and Drug Administration (“FDA”) communicated that it had completed its review of the NDA for Oleogel-S10 and has determined that the application cannot be approved in its present form. The FDA has asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in EB. Amryt intends to discuss with the FDA the nature of the data required to address the Agency’s concerns. On April 22, 2022, the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) adopted a positive opinion, recommending the approval of Filsuvez® in the EU for the treatment of partial thickness wounds associated with dystrophic and junctional EB in patients six months and older. Based on this CHMP recommendation a decision by the European Commission (“EC”) is expected on the Filsuvez® application within 67 days. The CHMP positive opinion is supported by Phase 3 data from the EASE trial which was the largest ever global trial conducted in patients with EB, performed across 58 sites in 28 countries. 2. Accounting policies Basis of preparation The condensed consolidated interim financial statements of the Group have been prepared in accordance with IAS 34 Interim Financial Reporting. They do not include all the information required in annual financial statements in accordance with International Financial Reporting Standards (‘‘IFRS’’) and should be read in conjunction with the annual consolidated financial statements for the year ended December 31, 2021. Selected explanatory notes are included to explain events and transactions that are significant to an understanding of the Group’s financial position and performance since the last annual financial statements. The accounting policies used in the preparation of the interim financial information are the same as those used in the Group’s audited financial statements for the year ended December 31, 2021, and those which are expected to be used in the financial statements for the year ended December 31, 2022. Results for the three-month period ended March 31, 2022, are not necessarily indicative of the results that may be expected for the financial year ending December 31, 2022. Basis of going concern Having considered the Group’s current financial position and cash flow projections, the Board of Directors believes that the Group will be able to continue in operational existence for at least the next 12 months from the date of approval of these condensed consolidated interim financial statements and that it is appropriate to continue to prepare the condensed consolidated interim financial statements on a going concern basis. As part of their inquiries, the Board of Directors reviewed budgets, projected cash flows, and other relevant information for a period not less than 12 months from the date of approval of the condensed consolidated interim financial statements for the period ended March 31, 2022. Basis of consolidation The condensed consolidated interim financial statements comprise the financial statements of the Group for the period ended March 31, 2022. Subsidiaries are entities controlled by the Company. Where the Company has control over an investee, it is classified as a subsidiary. The Company controls an investee if all three of the following elements are present: power over an investee, exposure or rights to variable returns from its involvement with the investee and the ability to use its power to affect those variable returns. Control is reassessed whenever facts and circumstances indicate that there may be a change in any of these elements of control. Subsidiaries are fully consolidated from the date that control commences until the date that control ceases. Accounting policies of subsidiaries have been changed where necessary to ensure consistency with the policies adopted by the Group. Intergroup balances and any unrealized gains or losses, income or expenses arising from intergroup transactions are eliminated in preparing the condensed consolidated interim financial statements. Presentation of balances The condensed consolidated interim financial statements are presented in U.S. dollars (‘‘US$’’), rounded to the nearest thousand, which is the functional currency of the Company and presentation currency of the Group. The following table discloses the major exchange rates of those currencies other than the functional currency of US$ that are utilized by the Group: Foreign currency units to 1 US$ € £ ILS NOK DKK Average period to March 31, 2022 (unaudited) 0.8909 0.7451 3.1969 8.8526 6.6292 At March 31, 2022 (unaudited) 0.8979 0.7615 3.1842 8.6186 6.6790 Foreign currency units to 1 US$ € £ ILS NOK DKK Average period to December 31, 2021 (audited) 0.8454 0.7271 3.2322 8.5975 6.2875 At December 31, 2021 (audited) 0.8830 0.7413 3.1115 8.8074 6.5664 Foreign currency units to 1 US$ € £ ILS NOK DKK Average period to March 31, 2021 (unaudited) 0.8292 0.7253 3.2720 8.5171 6.1669 At March 31, 2021 (unaudited) 0.8519 0.7274 3.3330 8.5547 6.3351 (€ = Euro; £ = Pounds Sterling, ILS = Israeli Shekel, NOK = Norwegian Kroner, DKK = Danish Kroner) Changes in accounting policies and disclosures There are no new standards and amendments to IFRS effective as of January 1, 2022, that are relevant to the Group. Critical accounting judgements and key sources of estimation uncertainty In preparing these condensed consolidated interim financial statements in conformity with IFRS management is required to make judgements, estimates and assumptions that affect the application of policies and amounts reported in the condensed consolidated interim financial statements and accompanying notes. The estimates and associated assumptions are based on historical experience and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis of making the judgements about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates. The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimate is revised if the revision affects only that period or in the period of the revision and future periods if the revision affects both current and future periods. The significant estimates, assumptions or judgements, applied in the condensed consolidated interim financial statements were the same as those applied in the Group’s audited financial statements for the year ended December 31, 2021. Principal accounting policies The condensed consolidated interim financial statements have been prepared in accordance with the accounting policies adopted in the Group’s audited financial statements for the year ended December 31, 2021. 3. Segment information The Group is a global, commercial-stage biopharmaceutical company dedicated to commercializing and developing novel therapeutics to treat patients suffering from serious and life-threatening rare diseases. The Group currently operates as one business segment, pharmaceuticals, and is focused on the development and commercialization of three commercial products and a number of development products. The Group derives its revenues primarily from one source, being the pharmaceutical sector with high unmet medical need. The Group’s Chief Executive Officer, Joseph Wiley, is currently the Company’s chief operating decision maker (‘‘CODM’’). The Group does not operate any separate lines of business or separate business entities with respect to its products. Accordingly, the Group does not accumulate discrete financial information with respect to separate service lines and does not have separate reportable segments. The following table summarizes total revenues from external customers by product and by geographic region, based on the location of the customer. Three months ended March 31, 2022 (unaudited) U.S. EMEA Other Total US$’000 US$’000 US$’000 US$’000 Metreleptin 20,244 15,922 1,481 37,647 Lomitapide 8,054 7,190 2,572 17,816 Mycapssa® 3,427 - - 3,427 Other - 171 68 239 Total revenue 31,725 23,283 4,121 59,129 Three months ended March 31, 2021 (unaudited) U.S. EMEA Other Total US$’000 US$’000 US$’000 US$’000 Metreleptin 16,239 12,971 750 29,960 Lomitapide 8,324 7,440 2,420 18,184 Mycapssa® — — — — Other — 223 65 288 Total revenue 24,563 20,634 3,235 48,432 Major Customers For the three months ended March 31, 2022, one customer accounted for 48% of the Group’s net revenues (March 31, 2021: 51%) and accounted for 36% of the Group’s March 31, 2022, accounts receivable balance (December 31, 2021: 36%). 4. Share based payments Share-based Compensation Plans Amryt’s Equity Incentive Plan Amryt’s Equity Incentive Plan was adopted by a special resolution on September 23, 2019. Prior to such date, we granted options under a prior employee share option plan, which had the same terms and conditions as the Equity Incentive Plan. On September 24, 2019, all options held under our prior share option plan were rolled over into options to subscribe for our ordinary shares with the key terms including strike price, vesting and the expiration date of such rolled over options remaining the same as they were on the issue date of the options under the prior share option plan. The Equity Incentive Plan was approved for amendment by the Board on May 18, 2020, August 3, 2021 and November 2, 2021. The purpose of the Plan is to provide for the granting of Equity Incentives to Directors and Employees of, and Consultants to, the Company or any Associated Company. Chiasma Equity Incentive Plan When Amryt acquired Chiasma in August 2021, the Chiasma Stock Option and Incentive Plan transferred across to Amryt. Each outstanding and unexercised Chiasma Stock Option or RSU, whether vested or not vested, ceased to represent a right to acquire shares of Chiasma common stock and were converted into an option to purchase Amryt ADSs on the same terms and conditions as were applicable under such Chiasma Stock Option and Incentive Plan immediately prior to the acquisition. No new stock option or RSUs will be granted under the Chiasma stock option and incentive plan. Terms and Conditions of New Grants The terms and conditions of new grants are as follows, whereby all options are settled by physical delivery of shares: Vesting conditions The employee share options vest following a period of service by the officer or employee. The required period of service is determined by the Remuneration Committee at the date of grant of the options (usually the date of approval by the Remuneration Committee). There are no market conditions associated with the share option vesting periods. Contractual life The term of an option is determined by the Remuneration Committee provided that the term may not exceed a period of seven to ten years from the date of grant. All options will terminate 90 days after termination of the option holder’s employment, service or consultancy with the Group except where a longer period is approved by the Board of Directors. Under certain circumstances involving a change in control of the Group, some options will automatically accelerate and become exercisable in full as of a date specified by the Board of Directors. All equity incentives granted are in the form of ordinary shares. Share option exercise prices below are the exercise price per ordinary share. The ADS equivalent exercise price will be theordinary share exercise price multiplied by five and the number of ADSs will be the number of ordinary shares divided by five. The number and weighted average exercise price (in Sterling pence) of share options per ordinary share granted under Amryt’s Equity Incentive Plan and the Chiasma stock option and incentive plan is as follows: Amryt Equity Incentive Plan Chiasma Stock Option and Incentive Plan Units Weighted average exercise price (Sterling pence) Units Weighted average exercise price (Sterling pence) Balance at January 1, 2021 18,753,648 122.79p — — Granted 11,337,459 190.88p — — Transferred to Amryt on acquisition — — 18,139,060 189.07p Forfeited (1,288,165) 174.97p (4,098,425) 226.22p Exercised (300,000) 93.00p (3,320,515) 116.35p Outstanding at December 31, 2021 (audited) 28,502,942 147.83p 10,720,120 197.40p Exercisable at December 31, 2021 (audited) 9,347,338 118.87p 8,005,390 192.35p Balance at January 1, 2022 28,502,942 147.83p 10,720,120 197.40p Granted 14,849,465 99.91p — — Forfeited (236,300) 172.95p (2,171,425) 211.85p Exercised (492,905) 113.22p (226,690) 97.99p Outstanding at March 31, 2022 (unaudited) 42,623,202 131.40p 8,322,005 196.34p Exercisable at March 31, 2022 (unaudited) 11,435,228 133.34p 6,314,575 195.95p The fair value of the Amryt equity award is estimated at the date of grant using the Black-Scholes pricing model, taking into account the terms and conditions attached to the grant. The fair value of the Chiasma equity awards transferred to Amryt on acquisition were measured in accordance with IFRS 2. The portion of the value of the equity transferred to Amryt attributable to pre-combination service is included in the consideration at the date of acquisition. The portion of the equity awards transferred to Amryt attributable to post combination service is estimated at the date of transfer using Black Scholes pricing model, taking into account the terms and conditions attached to the grant. The following are the inputs to the model for the equity instruments granted during the period: March 31, 2022 Options Inputs (unaudited) December 31, 2021 Options Inputs (unaudited) Days to Expiration 2,555 2,555 Volatility 39% 32% - 49% Risk free interest rate 1.96% 0.77% - 1.33% Share price at grant per ordinary share 99.91p 146.87 - 201.2p Share price at grant per ADS 19.99p 29.37 - 40.2p In the three months ended March 31, 2022, a total of 14,849,465 share options over ordinary shares exercisable at a weighted average price of US$1.42 (£1.00) were granted. The fair value of share options granted in the period ended March 31, 2022, was US$19,911,369/£14,836,439. The share options outstanding under the Amryt 2021 Equity Incentive Plan as at March 31, 2022 had a weighted remaining contractual life of 5.64 years with exercise prices ranging from £0.76 to £2.012 per ordinary share. In the three months ended March 31, 2021, a total of 8,465,644 share options exercisable at a weighted average price of US$2.80 (£2.012) were granted. The fair value of share options granted in the three months ended March 31, 2021, was US$23,479,000/£17,030,000. The share options outstanding as at March 31, 2021, had a weighted remaining contractual life of 5.78 years with exercise prices ranging from £0.76 to £2.012. The share options outstanding under the Chiasma Share Option and Incentive Plan transferred across to Amryt on acquisition. As at March 31, 2022, they have a weighted remaining contractual life of 5.26 years with exercise prices ranging from £0.54 to £7.41 per ordinary share. No new share options will be granted under the Chiasma Stock Option and Incentive Plan. Restricted Share Units Under the terms of Amryt’s Equity Incentive Plan, restricted share units (“RSUs”) to purchase 3,810,660 ordinary shares were outstanding at March 31, 2022. Under the terms of this plan, RSUs are granted to officers, consultants and employees of the Group at the discretion of the Remuneration Committee. For the three month period ended March 31, 2022, a total of 2,388,365 RSUs were granted to employees of the Company. For the year ended December 31, 2021, a total of 625,205 RSUs were granted to employees of the Company. The fair value of the RSUs is based on the share price at the date of grant, with the expense spread over the vesting period. The fair value of RSUs granted in the three month period ended March 31, 2022, was US$3,387,000. At March 31, 2022, the total RSUs granted to date have a weighted remaining contractual life of 2.44 years. Under the terms of Chiasma’s Stock Option and Incentive Plan transferred to Amryt on acquisition, restricted share units (“RSUs”) to purchase 52,655 ordinary shares were outstanding at March 31, 2022. At March 31, 2022, the total RSUs granted to date have a weighted remaining contractual life of 1.86 years. No new RSUs will be granted under the Chiasma Stock Option and Incentive Plan. The following table summarizes the RSU activity per ordinary share for the period: Amryt Equity Incentive Plan Chiasma Stock Option and Incentive Plan Units Weighted average fair value (US$) Units Weighted average fair value (US$) Balance at January 1, 2021 1,549,910 $2.34 — — Granted 625,205 $2.62 — — Transferred to Amryt on acquisition — — 202,145 $2.75 Lapsed (243,505) $2.35 (56,405) $2.75 Vested (362,855) $2.34 (39,180) $2.75 Outstanding at December 31, 2021 (audited) 1,568,755 $2.44 106,560 $2.75 Balance at January 1, 2022 1,568,755 $2.44 106,560 $2.75 Granted 2,388,365 $1.42 — — Lapsed (28,315) $2.35 (4,605) $2.75 Vested (118,145) $2.79 (49,300) $2.75 Outstanding at March 31, 2022 (unaudited) 3,810,660 $1.79 52,655 $2.75 Performance Stock Units Under the terms of Amryt’s Equity Incentive Plan, performance share units (“PSUs”) to purchase 1,851,222 ordinary shares were granted to officers and employees at the discretion of the Remuneration Committee in the three month period to March 31, 2022. Performance conditions determine how many of these performance stock units will vest and, if performance targets are exceeded, additional performance stock units will be issued and vest in accordance with the terms of the relevant performance stock units award. The PSUs vest based on the Total Shareholder Return (“TSR”) of Amryt’s NASDAQ traded common stock relative to the TSRs of the constituents that comprise the NASDAQ Biotechnology Index (the Peer Group) as of January 1, 2022. TSR for Amryt and each peer company will be measured over the period from January 1, 2022, to December 31, 2024. The payout schedule can produce payout percentages ranging from 0% to 150%. The following table summarizes the PSU activity per ordinary share for the period: Amryt Equity Incentive Plan Units Weighted average fair value (US$) Balance at January 1, 2022 — — Granted 1,851,222 $1.42 Lapsed — — Vested — — Outstanding at March 31, 2022 (unaudited) 1,851,222 $1.42 Warrants There are no outstanding warrants at March 31, 2022 (December 31, 2021: nil). In August 2021, an Amryt institutional investor exercised subscription rights relating to 8,966,520 zero cost warrants. These warrants were issued in September 2019 as part of the Company’s acquisition of Aegerion. Certain institutional investors elected to receive warrants to subscribe for new ordinary shares of £0.06 each in Amryt (“Ordinary Shares”), in place of the same number of Ordinary Shares, as consideration for the Company’s acquisition of Aegerion and their equity investments in the Company in September 2019. Each warrant entitled the holder to subscribe for one Ordinary Share for no additional consideration. Separate warrants consisting of 345,542 as at December 31, 2020, which were issued in connection with the admission to the AIM in 2016, are no longer outstanding; 283,389 warrants were exercised in March 2021 and 62,153 warrants lapsed in April 2021. The number and weighted average exercise price (in Sterling pence) of warrants per ordinary share is as follows: Warrants Units Weighted average exercise price (Sterling pence) Balance at January 1, 2021 9,312,062 0.05p Granted — — Lapsed (62,153) 1.44p Exercised (9,249,909) 0.05p Outstanding at December 31, 2021 (audited) — 0.00p The value of share options and RSU’s charged to the Condensed Consolidated Statement of Comprehensive Loss during the period is as follows: Three months ended March 31, 2022 (unaudited) 2021 (unaudited) US$’000 US$’000 Share option expense 2,659 879 RSU expense 429 384 PSU expense 60 — Total share option expense 3,148 1,263 5. Business combinations and asset acquisitions Acquisition of Chiasma On May 5, 2021, Amryt announced that it had signed a definitive agreement to acquire Chiasma, Inc. (Nasdaq: CHMA) in an all-stock combination. Under the terms of the transaction, each share of Chiasma common stock issued and outstanding prior to the consummation of the transaction was exchanged for 0.396 Amryt ADSs, each representing five Amryt ordinary shares. On August 5, 2021, Amryt completed the acquisition of Chiasma, Inc. and, in conjunction with the completion, Amryt allotted and issued a total of 127,733,680 ordinary shares as consideration for the acquisition. Following the completion, shareholdings in Chiasma were rounded in being converted to Amryt shares using the exchange ratio of 0.396. Roundings in converting Chiasma shareholdings to Amryt shares were finalized in August 2021 and resulted in an additional 7,015 ordinary shares being allotted and issued by Amryt as consideration for the acquisition. In total, these ordinary shares were issued to the former Chiasma Shareholders in the form of 25,548,139 ADSs at US$10.19 per share, to acquire Chiasma for a value of US$260,336,000. On August 5, 2021, Chiasma had outstanding equity awards that were held by Chiasma employees. The fair value of these awards transferred to Amryt on acquisition were measured in accordance with IFRS 2. The portion of the value of the equity transferred to Amryt attributable to pre-combination service is included in the consideration at the date of acquisition and this amounted to US$10,157,000. On August 5, 2021, the Group repaid US$116,629,000 of Chiasma long term debt. The combined company will be a global leader in rare and orphan diseases with three on-market commercial products, a global commercial and operational footprint and a significant development pipeline of therapies with the financial flexibility to execute its growth plans. The table below reflects the fair value of the identifiable net assets acquired in respect of the acquisition completed during the period. Any amendments to fair values will be made within the twelve-month period from the date of acquisition, as permitted by IFRS 3: Business Combinations. The acquired goodwill is attributable principally to the profit generating potential of the businesses, the assembled workforce and benefits arising from embedded infrastructure, that are expected to be achieved from integrating the acquired businesses into the Group’s existing business. No amount of goodwill is expected to be deductible for tax purposes. The Group incurred acquisition and restructuring related costs of US$402,000 for the three-month period ended March 31, 2022, relating to external legal fees, advisory fees, due diligence costs and severance costs related to the acquisition of Chiasma. These costs have been included in operating costs in the Condensed Consolidated Statement of Comprehensive Loss. Recognized Fair Values as at August 5, 2021 US$’000 Assets Non-current assets Intangible assets 215,000 Property, plant and equipment 950 Other non-current assets 866 Total non-current assets 216,816 Current assets Trade and other receivables 7,180 Inventories 65,907 Cash and cash equivalents, including restricted cash 107,942 Total current assets 181,029 Total assets 397,845 Non-current liabilities Deferred tax liability 21,478 Total non-current liabilities 21,478 Current liabilities Trade and other payables 144,482 Total current liabilities 144,482 Total liabilities 165,960 Total identifiable net assets at fair value 231,885 Goodwill arising on acquisition 38,608 Consideration 270,493 Consideration Issue of fully paid up ordinary shares 260,336 Chiasma equity awards recognized as consideration transferred upon the acquisition of Chiasma 10,157 Total consideration 270,493 Any amendments to these fair values within the twelve-month timeframe from the date of acquisition will be disclosed in the 2022 consolidated financial statements, as stipulated by IFRS 3. Acquisition of Aegerion Pharmaceuticals On May 20, 2019, Amryt entered into a Restructuring Support Agreement (as subsequently amended on June 12, 2019) and Plan Funding Agreement pursuant to which, among other matters, Amryt agreed to the acquisition of Aegerion Pharmaceuticals, Inc. (‘‘Aegerion’’, subsequently renamed as Amryt Pharmaceuticals Inc.), a former wholly-owned subsidiary of Novelion Therapeutics Inc. (‘‘Novelion’’). On May 20, 2019, Aegerion and its U.S. subsidiary, Aegerion Pharmaceuticals Holdings, Inc., filed voluntary petitions under Chapter 11 of Title 11 of the U.S. Code in the Bankruptcy Court. On September 24, 2019, Amryt completed the acquisition of Aegerion. Amryt acquired Aegerion upon its emergence from bankruptcy in an exchange for ordinary shares and zero cost warrants in Amryt. Amryt issued 85,092,423 effective shares at US$1.793 per share, which is made up of 77,027,423 ordinary shares and 8,065,000 zero cost warrants, to acquire Aegerion for a value of US$152,615,000. As part of the acquisition of Aegerion, it was agreed, for certain Aegerion creditors who wished to restrict their percentage share interest in Amryt’s issued share capital, to issue to the relevant Aegerion creditor, as an alternative to Amryt’s ordinary shares, an equivalent number of new zero cost warrants to subscribe for Amryt’s ordinary shares to be constituted on the terms of the zero cost warrant. As atMarch 31, 2022, no zero cost warrants were remaining. Contingent Value Rights Related to the transaction, Amryt issued Contingent Value Rights (‘‘CVRs’’) pursuant to which up to US$85,000,000 may become payable to Amryt’s shareholders and optionholders, who were on the register prior to the completion of the acquisition on September 20, 2019, if certain approval and revenue milestones are met in relation Oleogel-S10, Amryt’s lead product candidate. If any such milestone is achieved, Amryt may elect to pay the holders of CVRs by the issue of Amryt shares or loan notes. If Amryt elects to issue Loan Notes to holders of CVRs, it will settle such loan notes in cash 120 days after their issue. If none of the milestones are achieved, scheme shareholders and optionholders will not receive any additional consideration under the terms of the CVRs. In these circumstances, the value of each CVR would be zero. The terms of the CVRs are as follows: The total CVR payable is up to US$85,000,000This is divided into three milestones which are related to the success of Oleogel-S10 (the Group’s lead development asset)FDA approval US$35,000,000 upon FDA approval100% of the amount due if approval is obtained before December 31, 2021, with a sliding scale on a linear basis to zero if before July 1, 2022EMA approval US$15,000,000 upon EMA approval100% of the amount due if approval is obtained before December 31, 2021, with a sliding scale on a linear basis to zero if before July 1, 2022Revenue targets US$35,000,000 upon Oleogel-S10 revenues exceeding US$75,000,000 in any 12-month period prior to June 30, 2024Payment can at the Board’s discretion be in the form of either: 120-day loan notes (effectively cash), orShares valued using the 30 day / 45-day VWAP. The CVRs were contingent on the successful completion of the acquisition and, accordingly, have been based on fair value as at September 24, 2019. The CVRs have been classified as a financial liability in the Condensed Consolidated Statement of Financial Position. Given that CVRs were issued to legacy Amryt shareholders in their capacity as owners of the identified acquirer as opposed to the seller in the transaction, management concluded that the most appropriate classification would be to recognize the CVR as a distribution on consolidation instead of goodwill. Measurement of CVRs As at March 31, 2022, the carrying value of the CVRs was US$20,574,000 (December 31, 2021: US$19,892,000). The value of the potential payout was calculated using the probability-weighted expected returns method. Using this method, the potential payment amounts were multiplied by the probability of achievement and discounted to present value. The probability adjusted present values took into account published orphan drug research data and statistics which were adjusted by management to reflect the specific circumstances applicable to the type of product acquired in the Amryt GmbH transaction. The probability chance of success, based on management’s expertise and experience for orphan drugs and taking into account the unique circumstances applying to approval process of this product, was estimated at 60% for the FDA approval (December 31, 2021: 60%) and 100% for the EMA approval (December 31, 2021: 100%) in the three month period ended March 31, 2022. This estimate reflects the current facts and circumstances as of the date of issuance of the Condensed Consolidated Financial Statements. The probability chance of success was updated in the financial year 2021 following the receipt of a CRL from the FDA, which asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in EB, and following positive opinion adopted by the CHMP, recommending the approval of Filsuvez® in the EU for the treatment of partial thickness wounds associated with dystrophic and junctional EB in patients six months and older. Based on this CHMP recommendation a decision by the EC is expected on the Filsuvez® application within 67 days. The CHMP positive opinion is supported by Phase 3 data from the EASE trial which was the largest ever global trial conducted in patientswith EB, performed across 58 sites in 28 countries. Discount rates of 10% and 16.5%, as applicable, were used in the calculation of the present value of the estimated contractual cash flows for the year ended December 31, 2021, based on the applicable rates determined on the acquisition date. Management was required to make certain estimates and assumptions in relation to revenue forecasts, timing of revenues and probability of achievement of commercialization of Oleogel-S10. However, management notes that, due to issues outside their control (i.e. regulatory requirements and the commercial success of the product), the timing of when such revenue targets may occur may change. Such changes may have a material impact on the assessment of the expected cash flows of the CVRs. Amryt reviews the expected cash flows on a regular basis as the discount on initial recognition is being unwound as financing expenses in the Consolidated Statement of Comprehensive Loss over the life of the obligation. It is reviewed on a quarterly basis and the appropriate finance charge or gain is booked in the Consolidated Statement of Comprehensive Loss on a quarterly basis. The Group received positive topline data from the phase 3 EASE trial of Oleogel-S10 in September 2020. The product does not currently have regulatory approval to treat EB but was submitted to the FDA for approval and in June 2021, Amryt received confirmation from the FDA that its NDA for Oleogel-S10 had been accepted and granted priority review. On February 28, 2022, Amryt announced that the FDA communicated that it had completed its review of the NDA for Oleogel-S10 and has determined that the application cannot be approved in its present form. The FDA has asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in EB. Amryt intends to discuss with the FDA the nature of the data required to address the Agency’s concerns. In Europe, a MAA for Oleogel-S10 was accepted for assessment by the EMA in March 2021. The assessment process by EMA was completed on April 22, 2022, when the CHMP adopted a positive opinion. The positive opinion recommends the approval of Filsuvez® in the EU for the treatment of partial thickness wounds associated with dystrophic and junctional EB in patients six months and older. Based on this CHMP recommendation a decision by the EC is expected on the Filsuvez® application within 67 days. The total non-cash finance charge recognized in the Condensed Consolidated Statement of Comprehensive Loss for the three months ended March 31, 2022, is US$682,000 (March 31, 2021: US$1,763,000). Acquisition of Amryt GmbH (previously ‘‘Birken’’) Amryt DAC signed a conditional share purchase agreement to acquire Amryt GmbH on October 16, 2015 (‘‘Amryt GmbH SPA’’). The Amryt GmbHSPA was completed on April 18, 2016, with Amryt DAC acquiring the entire issued share capital of Amryt GmbH. The consideration included contingent consideration comprising milestone payments and sales royalties as follows: Milestone payments of: €10,000,000 on receipt of marketing approval by the EMA or FDA of a pharmaceutical product containing Betulin as its API for the treatment of EB;€10,000,000 once net ex-factory sales/net revenue of Oleogel S-10 first exceed €50,000,000 in any calendar year;€15,000,000 once net ex-factory sales/ net revenue of Oleogel S-10 first exceed €100,000,000 in any calendar year;Cash consideration of €150,000, due and paid on the completion date (April 18, 2016); andRoyalties of 9% on sales of Oleogel-S10 products for 10 years from first commercial sale. Fair Value Measurement of Contingent Consideration As at March 31, 2022, the fair value of the contingent consideration was estimated to be US$60,553,000 (December 31, 2021: US$61,221,000). The fair value of the contingent consideration included milestone payments determined using probability adjusted present values and probability weighted revenue forecasts (see Note 15, Fair value measurement and financial risk management, for fair value hierarchy applied and impact of key unobservable impact data). The probability adjusted present values took into account published orphan drug research data and statistics which were adjusted by management to reflect the specific circumstances applicable to the type of product acquired in the Amryt GmbH transaction. The probability chance of success, based on management’s expertise and experience for orphan drugs and taking into account the unique circumstances applying to approval process of the product, was estimated at 60% for the FDA approval (December 31, 2021: 60%) and 100% for the EMA approval (December 31, 2021: 100%) in the three month period ended March 31, 2022. This estimate reflects the current facts and circumstances as of the date of issuance of the Condensed Consolidated Financial Statements. The probability chance of success was updated in the financial year 2021 following the receipt of a CRL from the FDA, which asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in EB, and following positive opinion adopted by the CHMP, recommending the approval of Filsuvez® in the EU for the treatment of partial thickness wounds associated with dystrophic and junctional EB in patients six months and older. Based on this CHMP recommendation a decision by the EC is expected on the Filsuvez® application within 67 days. The CHMP positive opinion is supported by Phase 3 data from the EASE trial which was the largest ever global trial conducted in patientswith EB, performed across 58 sites in 28 countries. A discount rate of 7.9% was used in the calculation of the fair value of the contingent consideration for the three month period ended March 31, 2022 (December 31, 2021: 7.9%). Amryt reviews the expected cash flows on a regular basis as the discount on initial recognition is being unwound as financing expenses in the Consolidated Statement of Comprehensive Loss over the life of the obligation. It is reviewed on a quarterly basis and the appropriate finance charge or gain is booked in the Consolidated Statement of Comprehensive Loss on a quarterly basis. The Group received positive topline data from the phase 3 EASE trial of Oleogel-S10 in September 2020. The product does not currently have regulatory approval to treat EB but was submitted to the FDA for approval and in June 2021, Amryt received confirmation from the FDA that its NDA for Oleogel-S10 had been accepted and granted priority review. On February 28, 2022, Amryt announced that the FDA communicated that it had completed its review of the NDA for Oleogel-S10 and has determined that the application cannot be approved in its present form. The FDA has asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in EB. Amryt intends to discuss with the FDA the nature of the data required to address the Agency’s concerns. In Europe, a MAA for Oleogel-S10 was accepted for assessment by the EMA in March 2021. The assessment process by EMA was completed on April 22, 2022, when the CHMP adopted a positive opinion. The positive opinion recommends the approval of Filsuvez® in the EU for the treatment of partial thickness wounds associated with dystrophic and junctional EB in patients six months and older. Based on this CHMP recommendation a decision by the EC is expected on the Filsuvez® application within 67 days. The total non-cash finance charge recognized in the Condensed Consolidated Statement of Comprehensive Loss for the three months ended March 31, 2022, is US$427,000 (March 31, 2021: US$2,874,000). 6. Loss per share - basic and diluted The weighted average number of shares in the loss per share (‘‘LPS’’) calculation, reflects the weighted average total actual shares of Amryt Pharma plc in issue at March 31, 2022. Issued share capital - ordinary shares of £0.06 each Number of shares Weighted average shares March 31, 2022 (unaudited) 320,699,807 320,502,464 March 31, 2021 (unaudited) 179,384,982 178,937,717 The calculation of loss per share is based on the following: Three months ended March 31 2022 (unaudited) 2021 (unaudited) Loss after tax attributable to equity holders of the Company (US$’000) (14,491) (16,537) Weighted average number of ordinary shares in issue 320,502,464 178,937,717 Fully diluted average number of ordinary shares in issue 320,502,464 178,937,717 Basic and diluted loss per share (US$) (0.05) (0.09) Where a loss has occurred, basic and diluted LPS are the same because the outstanding share options and warrants are anti-dilutive. Accordingly, diluted LPS equals the basic LPS. The share options, RSUs, PSUs and warrants outstanding as at March 31, 2022 totaled 56,659,744 (March 31, 2021: 37,782,055) and are potentially dilutive. 7. Intangible assets and goodwill The following table summarizes the Group’s intangible assets and goodwill: Developed technology - metreleptin Developed technology - lomitapide Developed technology - Mycapssa® In process R&D Other intangible assets Total intangible assets Goodwill US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 Cost At January 1, 2021 (audited) 176,000 123,000 — 60,128 866 359,994 19,131 Additions — — — — 847 847 — Acquired assets — — 215,000 — — 215,000 38,608 Other movements — — — — — — (1,051) Foreign exchange movement — — — (4,691) (61) (4,752) — At December 31, 2021 (audited) 176,000 123,000 215,000 55,437 1,652 571,089 56,688 Foreign exchange movement — — — (1,250) (24) (1,274) — At March 31, 2022 (unaudited) 176,000 123,000 215,000 54,187 1,628 569,815 56,688 Accumulated amortization At January 1, 2021 (audited) 34,743 19,680 — — 202 54,625 — Amortization charge 27,428 15,537 5,979 — 147 49,091 — Foreign exchange movement — — — — 14 14 — At December 31, 2021 (audited) 62,171 35,217 5,979 — 363 103,730 — Amortization charge 6,856 3,884 3,707 — 24 14,471 — Foreign exchange movement — — — — 39 39 — At March 31, 2022 (unaudited) 69,027 39,101 9,686 — 426 118,240 — Net book value At December 31, 2021 (audited) 113,829 87,783 209,021 55,437 1,289 467,359 56,688 At March 31, 2022 (unaudited) 106,973 83,899 205,314 54,187 1,202 451,575 56,688 Developed technology on commercially marketed products In connection with the acquisition of Aegerion in September 2019, the Group acquired developed technology, metreleptin and lomitapide. These intangible assets are amortized over their estimated useful lives and the remaining useful lives for metreleptin and lomitapide are approximately 3.9 and 5.4 years, respectively, as of March 31, 2022 (December 31, 2021: 4.2 and 5.7 years, respectively). In connection with the acquisition of Chiasma in August 2021, the Group acquired developed technology, octreotide. This intangible asset is amortized over its estimated useful life and the remaining useful life is approximately 13.9 years as of March 31, 2022 (December 31, 2021: 14.2). In-process R&D As a result of the acquisition of Amryt GmbH, in 2016, the Group recognized in-process R&D costs of €48,453,000/US$54,872,000 which is related to the Group’s lead development asset, Oleogel-S10. The remaining in-process R&D is a result of the acquisition of Cala Medical Limited in October 2020. Goodwill During 2019, the Group completed the acquisition of Aegerion which resulted in the recognition of goodwill that has a carrying value of US$18,080,000. On August 5, 2021, the Group completed the acquisition of Chiasma, which resulted in aggregate goodwill of US$38,608,000. The Group reviews events or changes in circumstances that may indicate a triggering event for impairment, at each reporting date, and conducts an annual impairment review to determine any impairment charge required. Management completed an impairment review by determining recoverable amounts from value in use calculations. The recoverable amount of an asset or cash generating unit is estimated in order to determine the extent of an impairment charge. There was no impairment charge recorded during the three months ended March 31, 2022. 8. Trade and other receivables As at March 31, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Trade receivables 32,269 34,263 Accrued income and other debtors 10,353 12,201 VAT recoverable 4,747 7,444 Trade and other receivables 47,369 53,908 9. Inventories As at March 31, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Raw materials 38,918 36,850 Work in progress 11,264 12,986 Finished goods 69,873 65,933 Inventories 120,055 115,769 Inventories for the period ended March 31, 2022, includes inventory acquired as part of the acquisition of Chiasma on August 5, 2021, which was fair valued as of the date of the acquisition. The fair value of the acquired inventory amounted to US$65,907,000. Inventory on hand at the date of acquisition was valued at the expected selling price less the sum of remaining costs of disposal, cost to complete and a reasonable profit margin for the selling effort of the acquiring entity. The costs to complete were calculated based on costs incurred on recently completed finished goods. The costs to dispose include sales and marketing expenses required to sell the product to the customer in addition to certain general and administrative expenses expected to be incurred by Amryt. This resulted in a non-cash step up at the valuation of inventory at August 5, 2021, of US$44,794,000. The non-cash step up in inventory is being unwound to the Condensed Consolidated Statement of Comprehensive Loss over the period in which this saleable inventory is sold. AtMarch 31, 2022, US$4,022,000 of this non-cash inventory step up is included in inventory. 10. Cash and cash equivalents As at March 31, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Cash at bank available on demand 102,170 112,771 Restricted cash 50 261 Total cash and cash equivalents 102,220 113,032 Cash and cash equivalents include cash at bank available on demand and restricted cash. At March 31, 2022, and December 31, 2021, there was US$50,000 and US$261,000 of restricted cash, respectively. The balance atMarch 31, 2022,consists of a letter of credit related to US customs which was put in place for an amount of US$50,000 (December 31, 2021: US$50,000). The balance atDecember 31, 2021, includes a deposit on a company credit card facility for an amount of US$$126,000,a lease deposit for US$85,000 and a letter of credit related to US customs which was put in place for an amount of US$50,000. 11. Share capital and reserves Details of the number of issued ordinary shares with a nominal value of Sterling 6 pence (2021: 6 pence) each are in the table below. Ordinary shares Treasury shares Total At January 1, 2021 (audited) 178,801,593 4,791,703 183,593,296 Issue of treasury shares in exchange for warrants 283,389 (283,389) — Issue of treasury shares for share options exercised 300,000 (300,000) — Issue of shares in consideration of Chiasma acquisition 127,740,695 — 127,740,695 Issue of shares in exchange for warrants 4,758,206 — 4,758,206 Issue of treasury shares in exchange for warrants 4,208,314 (4,208,314) — Issue of shares for share options exercised and RSUs vesting 3,722,550 — 3,722,550 At December 31, 2021 (audited) 319,814,747 — 319,814,747 Issue of shares for share options exercised and RSUs vesting 885,060 — 885,060 At March 31, 2022 (unaudited) 320,699,807 — 320,699,807 The components of equity are detailed in the Condensed Consolidated Statement of Changes in Equity and described in more detail below. On March 11, 2021, the Company issued 300,000 ordinary shares from treasury shares following the exercise of share options. On March 11, 2021, the Company issued 283,389 ordinary shares from treasury shares in exchange for certain warrants. On August 5, 2021, the Company issued 127,740,695 ordinary shares, in the form of ADSs, as consideration for the acquisition of Chiasma. On August 5, 2021, the Company issued 8,966,520 ordinary shares with 4,208,314 being issued from treasury shares in exchange for warrants. During the year ended December 31, 2021, there were 3,342,680 shares issued following the exercise of share options and 379,870 shares issued following RSUs vesting.During the period ended March 31, 2022, there were 719,595 shares issued following the exercise of share options and 165,465 shares issued following RSUs vesting. Share Capital Share capital represents the cumulative par value arising upon issue of ordinary shares of Sterling 6 pence each. The ordinary shares have the right to receive notice of, attend and vote at general meetings and participate in the profits of the Company. Share Premium Share premium represents the consideration that has been received in excess of the nominal value on issue of share capital net of issue costs and transfers to distributable reserves. Warrant reserve The warrant reserve represented zero cost warrants issued as part of the equity raise on September 24, 2019, net of issue costs apportioned to warrants issued and additional warrants issued to certain shareholders on November 14, 2019. Each warrant entitles the holder to subscribe for one ordinary share at zero cost. The Company issued 4,000,000 and 4,229,753 ordinary shares on July 15, 2020, and September 22, 2020, respectively, in exchange for certain warrants. The remaining warrants were exchanged on August 5, 2021, and the Company issued 8,966,520 ordinary shares, 4,208,314 of which were issued from treasury shares and there are no longer any warrants outstanding. Treasury Shares In October 2020, the Company issued 72,953 ordinary shares from treasury shares following the exercise of share options. In March 2021, the Company issued a total of 583,389 ordinary shares from treasury shares, 300,000 ordinary shares relating to the exercise of share options and 283,389 ordinary shares following the exchange of certain warrants.In August 2021, the company issued 4,208,314 ordinary shares from treasury shares in conjunction with the exchange of warrants and since August 2021 there are no longer any treasury shares held. Share based payment reserve Share based payment reserve relates to the charge for share based payments in accordance with IFRS 2. In March 2021, the Company issued 283,389 ordinary shares in exchange for certain warrants. In April 2021, 62,153 warrants lapsed. During the year ended December 31, 2021, the Company issued 3,722,550 ordinary shares in relation to the exercise of share options and RSUs.During the period ended March 31, 2022, the Company issued 885,060 ordinary shares in relation to the exercise of share options and RSUs. As part of the acquisition of Chiasma, the Company replaced share awards that were existing at the time of the acquisition. This resulted in the recognition of a share-based payment reserve of US$10,157,000 on acquisition. Merger reserve The merger reserve was created on the acquisition of Amryt DAC by Amryt Pharma plc in April 2016. Ordinary shares in Amryt Pharma plc were issued to acquire the entire issued share capital of Amryt DAC. Under section 612 of the UK Companies Act 2006, the premium on these shares has been included in a merger reserve. Reverse acquisition reserve The reverse acquisition reserve arose during the period ended December 31, 2016, in respect of the reverse acquisition of Amryt Pharma plc by Amryt DAC. Since the shareholders of Amryt DAC became the majority shareholders of the enlarged Group, the acquisition is accounted for as though there is a continuation of Amryt DAC’s financial statements. The reverse acquisition reserve is created to maintain the equity structure of Amryt Pharma plc in compliance with UK company law. Equity component of convertible notes The equity component of convertible notes represents the equity component of the US$125,000,000 convertible debt and is measured by determining the residual of the fair value of the instrument less the estimated fair value of the liability component. The equity component is recognized in equity and is not subsequently remeasured. Other distributable reserves Other distributable reserves comprise the following: Distribution of the share premium amount on 6 November 2019 of US$268,505,000. By special resolution of the Company duly passed on 23 September 2019, it was resolved that the entire amount outstanding to the credit of the share premium account and capital redemption reserve of the Company be cancelled. The reduction in capital, amounting to US$268,505,000, representing the entire amount of share premium at that time, was approved by the High Court of Justice of England and Wales on 5 November 2019.A deemed distribution of US$47,902,000 arising from the issuance of CVRs in September 2019.A deemed distribution of US$2,969,000 arising from the scheme of arrangement in September 2019 whereby Amryt Pharma plc, which was incorporated in July 2019, became a 100% shareholder of Amryt Pharma Holdings Limited (formerly named Amryt Pharma plc) (the “Acquisition of subsidiary without a change of control”). Currency translation reserve The currency translation reserve arises on the retranslation of non-U.S. dollar denominated foreign subsidiaries. Accumulated deficit Accumulated deficit represents losses accumulated in previous periods and the current year. 12. Long term loan As at March 31, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Long term loan principal 105,000 93,988 Unamortized debt issuance costs (6,537) (593) Long term loan 98,463 93,395 On February 18, 2022, Amryt secured US$125,000,000 of senior credit facilities (“Senior Credit Facility”) from funds managed by the Credit Group of Ares Management Corporation (“Ares”). A portion of the proceeds were used to refinance the previous secured term loan, which had an outstanding balance of US$93,988,000 as at February 22, 2022, an interest rate of 13.00% and a maturity date of September 2024. The new facilities will generate significant annual interest cost savings as well as provide for important strategic flexibility as Amryt looks to continue to grow its global rare disease presence.In repaying the secured term loan, Amryt incurred an exit fee of 5.00% of the outstanding principal amount as at the prepayment date. This amounted to US$4,699,000 and is included in Net finance expense – other in the Condensed Consolidated Statement of Comprehensive Income for the three month-period ended March 31, 2022. Key features of the new facilities include: Total new facilities of $125 million, consisting of: $85 million Term Loan Facility with interest rate of Secured Overnight Financing Rate (“SOFR”)+6.75%, subject to a 0.90% SOFR floor$40 million Revolving Credit Facility with $20 million drawn at close and interest rate of SOFR+4.00%, subject to a 0.90% SOFR floorQuarterly blended cash interest rate of SOFR+5.87% (assuming fully drawn), subject to a 0.90% SOFR floor, substantially lower than Amryt’s previous secured term debt facility at 13.00% interestRequires interest-only payments until facility matures in February 2027There are no warrants or any equity conversion features associated with the new facilitiesThe proceeds will be used to refinance existing debt, for general corporate and product development purposes; and potentially for shareholder approved share repurchase programs. Charges were taken over certain assets of the company and its material entities as guarantee and collateral for the provision of the debt. In connection with the Secured Credit Facility, the Group incurred approximately US$6,656,000 of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees. These costs are amortized over the expected life of the loan using the effective interest method. The Secured Credit Facilityincludes affirmative and negative covenants, including prohibitions on the incurrence of additional indebtedness, granting of liens, certain asset dispositions, investments, and restricted payments, in each case, subject to certain exceptions set forth in the loan agreement. The loan agreement also includes customary events of default for a transaction of this type and includes (i) a cross-default to the occurrence of any event of default under material indebtedness of Amryt and certain subsidiaries of the Group and Amryt, including the convertible notes, and (ii) Amryt or any of its subsidiaries being subject to bankruptcy or other insolvency proceedings. Upon the occurrence of an event of default, the lenders may declare all of the outstanding Secured Credit Facilityand other obligations under the Secured Credit Facilityto be immediately due and payable and exercise all rights and remedies available to the lenders under the Term Loan agreement and related documentation. There were no events of default or breaches of the covenants occurring for duringthree month period ended March 31, 2022. As part of the acquisition of Aegerion on September 24, 2019, Aegerion entered into a new U.S. dollar denominated US$81,021,000 secured term loan debt facility (‘‘Term Loan’’) with various lenders. The Term Loan was made up of a US$54,469,000 loan that was in place prior to the acquisition which was refinanced as part of the acquisition and a US$26,552,000 additional loan that was drawn down on September 24, 2019. The Term Loan had a five-year term from the date of the draw down, September 24, 2019, and matured on September 24, 2024. Under the Term Loan, interest was payable at the option of the Group at the rate of 11% per annum paid in cash on a quarterly basis or at a rate of 6.5% paid in cash plus 6.5% paid in kind that was to be paid when the principal is repaid, which rolled up and included in the principal balance outstanding, on a quarterly basis. There was no unpaid accrued interest of as at March 31, 2021 (December 31, 2020: $1,439,000). The Term Loan was repayable, in whole or in part, by Amryt at any time subject to payment of an exit fee, which depending on the stage of the loan term, ranges from 5.00% to 0.00% of the principal then outstanding on the Term Loan. On February 18, 2022, the Term Loan was repaid in full and the Group secured a $125,000,000 senior credit facility of which US$105,000,000 was drawn down to facilitate the prepayment of the existing Term Loan.In repaying the Secured Credit Facility, Amryt incurred an exit fee of 5.00% of the outstanding principal amount as at the prepayment date. In connection with the Term Loan, the Group incurred approximately US$870,000 of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees. These costs were amortized over the expected life of the loan using the effective interest method and during the three month period ended March 31, 2022, were written off to the Condensed Consolidated Statement of Comprehensive Loss as the Term Loan liability was derecognized. The Term Loan wasguaranteed by Amryt and certain subsidiaries of the Group. In connection with the loan agreement, fixed and floating charges were placed on property and undertakings of Amryt and certain subsidiaries of the Group. 13. Convertible notes Total US$’000 At January 1, 2021 101,086 Accreted interest 4,702 At December 31, 2021 (audited) 105,788 Accreted interest 1,255 At March 31, 2022 (unaudited) 107,043 As part of the Aegerion acquisition, Aegerion issued convertible notes with an aggregate principal amount of US$125,000,000 to Aegerion creditors. The convertible notes are senior unsecured obligations and bear interest at a rate of 5.0% per year, payable semi-annually in arrears on April 1 and October 1 of each year, beginning on April 1, 2020. The convertible notes will mature on April 1, 2025, unless earlier repurchased or converted. The convertible notes are convertible into Amryt’s ordinary shares at a conversion rate of 386.75 ordinary shares per US$1,000 principal amount of the convertible notes. If the holders elect to convert the convertible notes, Amryt can settle the conversion of the convertible notes through payment or delivery of cash, common shares, or a combination of cash and common shares, at its discretion. As a result of the conversion feature in the convertible notes, the convertible notes were assessed to have both a debt and an equity component. The two components were assessed separately and classified as a financial liability and equity instrument. The financial liability component was measured at fair value based on the discounted cash flows expected over the expected term of the notes using a discount rate based on a market interest rate that a similar debt instrument without a conversion feature would be subject to. Refer to Note 11, Share capital and reserves, for further details on the equity component of the convertible notes. From September 24, 2019 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of their convertible notes, in multiples of US$1,000 principal amount, at the option of the holder. The indenture does not contain any financial covenants or restrict the Group’s ability to repurchase securities, pay dividends or make restricted payments in the event of a transaction that substantially increases the Group’s level of indebtedness in certain circumstances. The indenture contains customary terms and covenants and events of default. If an event of default (other than certain events of bankruptcy, insolvency or reorganization involving Aegerion, Amryt and certain subsidiaries of the Group) occurs and is continuing, the trustee by notice to Amryt, or the holders of at least 25% in principal amount of the outstanding convertible notes by written notice to Amryt and the trustee, may declare 100% of the principal of and accrued and unpaid interest, if any, on all of the convertible notes to be due and payable. Upon such a declaration of acceleration, such principal and accrued and unpaid interest, if any, will be due and payable immediately. Upon the occurrence of certain events of bankruptcy, insolvency or reorganization involving Amryt, 100% of the principal and accrued and unpaid interest, if any, on the convertible notes will become due and payable automatically. Notwithstanding the foregoing, the indenture provides that, upon Amryt’s election, and for up to 180 days, the sole remedy for an event of default relating to certain failures by Amryt to comply with certain reporting covenants in the indenture consists exclusively of the right to receive additional interest on the convertible notes. There have been no events of default or breaches of the covenants occurring for the period ended March 31, 2022 (2021: no events). 14. Provisions and other liabilities As at March 31, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Non-current liabilities Provisions and other liabilities — — Leases due greater than 1 year 3,878 4,049 3,878 4,049 Current liabilities Provisions and other liabilities 6,000 6,000 Leases due less than 1 year 957 1,545 6,957 7,545 Total provisions and other liabilities 10,835 11,594 Legal matters Prior to the acquisition of Aegerion by Amryt, Aegerion entered into settlement agreements with governmental entities including the Department of Justice (‘‘DOJ’’) and the FDA in connection with Juxtapid investigations. The settlement agreements required Aegerion to pay specified fines and engage in regulatory compliance efforts. Subsequent to the acquisition, Aegerion made US$23,036,000 of settlement payments, including interest. The settlements have been paid in full with the last payment completed in Q1 2021. Other matters The Group recognizes a liability for legal contingencies when it believes that it is both probable that a liability has been incurred and that it can reasonably estimate the amount of the loss. The Group reviews these accruals and adjusts them to reflect ongoing negotiations, settlements, rulings, advice of legal counsel and other relevant information. To the extent new information is obtained and the Group’s views on the probable outcomes of claims, suits, assessments, investigations or legal proceedings change, changes in the Group’s liability accrual would be recorded in the period in which such determination is made. AtMarch 31, 2022 the Group had recognized liabilities of US$6,000,000 in relation to ongoing legal matters (December 31, 2021: US$6,000,000). 15. Fair value measurement and financial risk management Categories of financial instruments As at March 31, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Financial assets (all at amortized cost): Cash and cash equivalents 102,220 113,032 Trade receivables 32,269 34,263 Total financial assets 134,489 147,295 Financial liabilities: At amortized cost Trade payables and accrued expenses 131,974 148,251 Lease liabilities 4,835 5,594 Convertible notes 107,043 105,788 Long term loan 98,463 93,395 Contingent value rights 20,574 19,892 At fair value Contingent consideration 60,553 61,221 Total financial liabilities 423,442 434,141 Net (288,953) (286,846) Financial instruments evaluated at fair value can be classified according to the following valuation hierarchy, which reflects the extent to which the fair value is observable: Level 1: fair value evaluations using prices listed on active markets (not adjusted) of identical assets or liabilities.Level 2: fair value evaluations using input data for the asset or liability that are either directly observable (as prices) or indirectly observable (derived from prices), but which do not constitute listed prices pursuant to Level 1.Level 3: fair value evaluations using input data for the asset or liability that are not based on observable market data (unobservable input data). The contingent consideration has been valued using Level 3. The contingent consideration comprises: Contingent consideration relating to the acquisition of Amryt GmbH (see Note 5, Business combinations and asset acquisitions) that was measured at US$60,553,000 as at March 31, 2022 (December 31, 2021: US$61,221,000). The fair value comprises royalty payments which was determined using probability weighted revenue forecasts and the fair value of the milestones payments which was determined using probability adjusted present values. It also included a revision to the discount rate used, and revenue and costs forecasts have been amended to reflect management’s current expectations. Impact of key unobservable input dataon the contingent consideration: An increase of 10% in estimated revenue forecasts would result in an increase to the fair value of US$3,681,000. A decrease would have the opposite effect.A 5% increase in the discount factor used would result in a decrease to the fair value of US$9,374,000. A decrease of 5% would result in an increase to the fair value of US$12,449,000.A six-month delay in the launch date for Oleogel-S10 would result in a decrease to the fair value of US$5,319,000.A 20% decrease in the probability of success used would result in a decrease to the fair value of US$17,320,000. An increase of 20% in the probability of success with the FDA approval would result in a decrease to the fair value of US$12,982,000. 16. Events after the reporting period Development Pipeline On April 22, 2022, the CHMP has adopted a positive opinion, recommending the approval of Filsuvez® in the EU for the treatment of partial thickness wounds associated with dystrophic and junctional EB in patients six months and older. Based on this CHMP recommendation a decision by the EC is expected on the Filsuvez® application within 67 days. The CHMP positive opinion is supported by Phase 3 data from the EASE trial which was the largest ever global trial conducted in patients with EB, performed across 58 sites in 28 countries. There were no other significant events since the end of the reporting period.
AMYT CHMA | globenewswire | about 3 years ago | Neutral

Amryt Reports Record Q1 2022 ResultsAmryt Pharma plc Amryt ReportsRecord Q1 2022 Results CHMP adopts positive opinion for Filsuvez® for the treatment of Dystrophic and Junctional EB Reaffirming FY 2022 revenue guidance to $260M - $270M, representing 17-21% YoY growth Board approved stock repurchase program of up to $30M Cash of $...
Amryt Pharma plc Amryt ReportsRecord Q1 2022 Results CHMP adopts positive opinion for Filsuvez® for the treatment of Dystrophic and Junctional EB Reaffirming FY 2022 revenue guidance to $260M - $270M, representing 17-21% YoY growth Board approved stock repurchase program of up to $30M Cash of $102.2M at March 31, 2022 22.1% YoY revenue growth in Q1 to $59.1M 25.7% growth in metreleptin revenues YoY to$37.6M in Q1 9th consecutive quarter of positive EBITDA generation Successful bioavailability study supporting development of Mycapssa® for carcinoid symptoms in NET Conference call and webcast today at 0830 ET / 1330 BST DUBLIN, Ireland, and Boston MA, May 4, 2022, Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today provides a business update and announces unaudited financial results for the first quarter ended March 31, 2022. Joe Wiley, CEO of Amryt Pharma, commented:“Q1 was an extremely busy and productive period for Amryt and I am pleased to report today’s strong operational and financial results. Our record Q1 revenues of $59.1M represent 22.1% YoY revenue growth. Metreleptin continues to grow strongly and delivered 25.7% YoY growth in the quarter andthese results clearly demonstrate the strong performance of metreleptin across all regions. Overall, the results also demonstrate the strong growth we are experiencing across our business and represent our ninth consecutive quarter of positive EBITDA generation. We have also recently reported some very positive news regarding the regulatory pathway for Filsuvez® with the CHMP recommending a positive opinion. This recommendation for the approval of Filsuvez® in Europe is the most significant milestone in Amryt’s history and represents a major positive development for European patients that suffer from this debilitating condition and is the culmination of years of hard work from all the Amryt team. If approved, Filsuvez® would be our fourth commercial product and we already have in place the team, financial flexibility, systems and global infrastructure to bring it to market and to execute our significant growth plan. We are very excited by the potential to deliver Filsuvez® to European patients in need as soon as possible. Story continues The relaunch of Mycapssa® is progressing well and we are excited about both the growth opportunity for Mycapssa® in acromegaly and the potential to develop Mycapssa®in carcinoid syndrome associated with neuroendocrine tumors. Given the strong performance of our business year to date, we are today reaffirming our full year 2022 revenue guidance of $260-$270 million which represents growth of 17%-21% over 2021”. Q1 2022 and Recent Business Highlights: Board approves stock repurchase program of up to $30M through March 2023 Completed $125M non-dilutive debt refinancing of which $105M is drawn- significantly reducing interest expense and cost of capital and extending term debt maturity through 2027 Lancet Diabetes & Endocrinology publishes positive results for the MPOWERED Phase 3 trial for Mycapssa® Announced positive long-term MPOWERED safety and efficacy data confirming the role for Mycapssa® in the management of acromegaly patients who have responded to and tolerated treatment with octreotide and lanreotide Announcedpositive long-term safety and efficacy data for Mycapssa® (oral octreotide) from the 2nd Year of OPTIMAL Open Label Extension study in acromegaly patients Announced successful bioavailability study for Mycapssa® Announced positive interim analysis data from Open Label Phase of EASE Phase 3 Trial in EB Filsuvez®1 new patents announced further strengthening IP protection Commercial plans well advanced for potential Filsuvez® launch in Europe CHMP adopts positive opinion for Filsuvez® for the treatment of Dystrophic and Junctional EB Filsuvez® FDA briefing document has been filed and end-of-review conference anticipated in Q2 FY 2022 revenue guidance of $260M - $270M reaffirmed, representing 17-21% growth over 2021 Q1 2022 Commercial Product Performance: Q1 2022 (unaudited) US EMEA Other Total US$’000 US$’000 US$’000 US$’000 Metreleptin 20,244 15,922 1,481 37,647 Lomitapide 8,054 7,190 2,572 17,816 Mycapssa® 3,427 - - 3,427 Other - 171 68 239 Total revenue 31,725 23,283 4,121 59,129 Q12021 (unaudited) US EMEA Other Total US$’000 US$’000 US$’000 US$’000 Metreleptin 16,239 12,971 750 29,960 Lomitapide 8,324 7,440 2,420 18,184 Mycapssa® - - - - Other - 223 65 288 Total revenue 24,563 20,634 3,235 48,432 22.1%YoY revenue growth in Q1 2022 to $59.1M (Q1 2021: $48.4M) 25.7% increase in metreleptin revenues YoY to$37.6M in Q1 2022 (Q1 2021: $30.0M) US accounted for 53.8% of global metreleptin revenues and EMEA accounted for 42.3% in Q1 2022 US metreleptin revenues grew by 24.7% YoY and EMEA metreleptin revenues grew by22.8% YoY in Q1 2022 US accounted for 45.2% of global lomitapide revenues and EMEA accounted for 40.4% in Q1 2022 Global lomitapide revenues increased by 0.7% QoQ Mycapssa® delivered $3.4Min Q1 2022 Mycapssa® revenues in Q4 2021 were impacted by pre-ordering in the quarter of approx. $1M. Allowing for the impact of pre-ordering, our underlying Mycapssa® business grew 11% sequentially in Q1 2022. Q1 2022 Financial Highlights: $12.8Moperating loss before finance expensefor Q1 2022 (Q1 2021: $3.4M operating loss). Excluding non-cash items, share based compensation expenses and Chiasma restructuring and acquisition costs, this resulted in EBITDA3 before restructuring and acquisition costs of $7.2M. Cash of $102.2M at March 31, 2022 (Dec 31, 2021: $113.0M) IFRS and non-GAAP adjusted Q1 2022results: US$M Q1 2021 (unaudited) Q1 2022 (unaudited) Q1 2022 Non-cash adjustments2 Q1 2022 Non-GAAP Adjusted Revenue 48.4 59.1 - 59.1 Gross profit 24.9 28.4 16.0 44.4 R&D expenses (8.9) (9.9) - (9.9) SG&A expenses (18.2) (27.7) 0.4 (27.3) Restructuring and acquisition costs - (0.4) - (0.4) Share based compensation expenses (1.3) (3.2) 3.2 - Operating (loss) / profit before finance expense (3.4) (12.8) 19.6 6.83 Operating (loss) / profit before finance expense and restructuring and acquisition costs (3.4) (12.4) 19.6 7.23 1Filsuvez® (birch extract)gel (“Filsuvez®”)has been selected as the brand name for Oleogel-S10 but please note, Amryt does not, as yet, have regulatory approval for Filsuvez®to treat EB. 2Non-cash items include amortisation of the acquired metreleptin, lomitapide and Mycapssa® intangible assets ($14.4M), amortisation of the inventory fair value step-up related to the acquisition of Chiasma, Inc. ($1.6M), depreciation and amortisation ($0.4M) and share based compensation expenses ($3.2M). 3EBITDA is earnings before interest, tax, depreciation, amortisation and share based compensation expenses. To supplement Amryt's financial results presented in accordance with IFRS generally accepted accounting principles, the Company uses EBITDA as a key measure of company performance as the Company believes that this measure is most reflective of the operational profitability or loss of the Company and provides management and investors with useful supplementary information which can enhance their ability to evaluate the operating performance of the business. EBITDA, as measured by the Company, is not meant to be considered in isolation or as a substitute to operating profit / loss attributable to Amryt and should be read in conjunction with the Company's condensed consolidated financial statements prepared in accordance with IFRS. Oleogel-S10 (Filsuvez®) Regulatory Update: On February 28, 2022, Amryt announced that the FDA communicated that it had completed its review of the NDA for Oleogel-S10 and has determined that the application cannot be approved in its present form. The FDA has asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in EB. During Q2 2022, Amryt intends to discuss with the FDA the nature of the data required to address the Agency’s concerns.AnFDA briefing document has been filed and anend-of-review conference is anticipated in Q2 2022. On April 22, 2022, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the approval of Filsuvez® in the European Union (EU) for the treatment of partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa (EB) in patients 6 months and older. EB is a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. Based on this CHMP recommendation a decision by the European Commission (EC) is expected on the Filsuvez® application within 67 days of the CHMP opinion. The centralised marketing authorisation would be valid in all EU Member States as well as in Iceland, Liechtenstein, and Norway. The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK is expected to grant authorisation within the same time period. Guidance & Outlook: Given the continued strong performance of the Company’s commercial products, the board is today reaffirming revenue guidance for FY 2022 in the range of $260M - $270M which represents growth of 17% to 21% on FY 2021. Conference Call & Webcast: Amryt will host a conference call and webcast for analysts and investors today at 0830 ET/1330 GMT. Webcast Player URL:https://edge.media-server.com/mmc/p/uso54daj Telephone Dial in details: United States +1 646 7413167 United Kingdom +44 (0) 207192 8338 Ireland +353 (1) 506 0650 Confirmation Code 1698066 A playback facility will be available from May4, 2022 at 1330 ET/1830 BST – May 11, 2022 at 1330 ET/1830 BST. Access details for the playback facility are as follows: Confirmation Code:1698066| US: + 1 917 677 7532 | UK: +44 (0) 333 300 9785 | Ireland : +353 (1) 553 8777. About Amryt Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets. Amryt’s commercial business comprises three orphan disease products – metreleptin (Myalept®/ Myalepta®); oral octreotide (Mycapssa®); and lomitapide (Juxtapid®/ Lojuxta®). Myalept®/Myalepta® (metreleptin) is approved in the US (under the trade name Myalept®) as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in the EU (under the trade name Myalepta®) as an adjunct to diet for the treatment of leptin deficiency in patients with congenital or acquired GL in adults and children two years of age and above and familial or acquired partial lipodystrophy (PL) in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control. For additional information, please follow this link. Mycapssa® (octreotide capsules) is approved in the US for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. Mycapssa® is the first and only oral somatostatin analog approved by the FDA. Mycapssa® has also been submitted to the EMA and is not yet approved in Europe. For additional information, please follow this link. Juxtapid®/Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia ("HoFH") in the US, Canada, Colombia, Argentina and Japan (under the trade name Juxtapid®) and in the EU, Israel, Saudi Arabia and Brazil (under the trade name Lojuxta®). For additional information, please follow this link. Amryt's lead development candidate, Oleogel-S10 is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (EB), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. Filsuvez® has been selected as the brand name for Oleogel-S10. The product does not currently have regulatory approval to treat EB. Amryt’s pre-clinical gene therapy candidate, AP103, offers a potential treatment for patients with Dystrophic EB, and the polymer-based delivery platform has the potential to be developed for the treatment of other genetic disorders. Amryt also intends to develop oral medications that are currently only available as injectable therapies through its Transient Permeability Enhancer (TPE®) technology platform. For more information on Amryt, including products, please visit www.amrytpharma.com. Forward-Looking Statements This announcement may contain forward-looking statements and the words "expect", "anticipate", "intends", "plan", "estimate", "aim", "forecast", "project" and similar expressions (or their negative) identify certain of these forward-looking statements. The forward-looking statements in this announcement are based on numerous assumptions and Amryt's present and future business strategies and the environment in which Amryt expects to operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. These statements are not guarantees of future performance or the ability to identify and consummate investments. Many of these risks and uncertainties relate to factors that are beyond Amryt's ability to control or estimate precisely, such as future market conditions, the course of the COVID-19 pandemic, currency fluctuations, the behaviour of other market participants, the outcome of clinical trials, the actions of regulators and other factors such as Amryt's ability to obtain financing, changes in the political, social and regulatory framework in which Amryt operates or in economic, technological or consumer trends or conditions. Past performance should not be taken as an indication or guarantee of future results, and no representation or warranty, express or implied, is made regarding future performance. No person is under any obligation to update or keep current the information contained in this announcement or to provide the recipient of it with access to any additional relevant information that may arise in connection with it. Such forward-looking statements reflect the Company’s current beliefs and assumptions and are based on information currently available to management. Contacts Joe Wiley, CEO / Rory Nealon, CFO/COO, +353 (1) 518 0200, ir@amrytpharma.com Tim McCarthy, LifeSci Advisors, LLC, +1 (212) 915 2564, tim@lifesciadvisors.com Amryt Pharma plc Condensed Consolidated Statement of Comprehensive Loss Three Months Ended March 31, Note 2022 (unaudited) 2021 (unaudited) US$’000 US$’000 Revenue 3 59,129 48,432 Cost of sales (30,775) (23,489) Gross profit 28,354 24,943 Research and development expenses (9,881) (8,916) Selling, general and administrative expenses (27,709) (18,156) Restructuring and acquisition costs 5 (402) — Share based payment expenses 4 (3,148) (1,263) Operating loss before finance expense (12,786) (3,392) Non-cash change in fair value of contingent consideration 5 (427) (2,874) Non-cash contingent value rights loss 5 (682) (1,763) Net finance expense - other (11,127) (7,898) Loss on ordinary activities before taxation (25,022) (15,927) Tax credit/(charge) on loss on ordinary activities 10,531 (610) Loss for the period attributable to the equity holders of the Company (14,491) (16,537) Exchange translation differences which may be reclassified through profit or loss (399) 2,547 Total other comprehensive (loss)/income (399) 2,547 Total comprehensive loss for the period attributable to the equity holders of the Company (14,890) (13,990) Loss per share Loss per share - basic and diluted, attributable to ordinary equity holders of the parent (US$) 6 (0.05) (0.09) Amryt Pharma plc Condensed Consolidated Statement of Financial Position As at, Note March 31, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Assets Non-current assets Goodwill 7 56,688 56,688 Intangible assets 7 451,575 467,359 Property, plant and equipment 7,110 7,416 Other non-current assets 1,850 1,885 Total non-current assets 517,223 533,348 Current assets Trade and other receivables 8 47,369 53,908 Inventories 9 120,055 115,769 Cash and cash equivalents, including restricted cash 10 102,220 113,032 Total current assets 269,644 282,709 Total assets 786,867 816,057 Equity and liabilities Equity attributable to owners of the parent Share capital 11 25,572 25,500 Share premium 11 319,855 318,153 Other reserves 11 247,231 246,303 Accumulated deficit (246,676) (233,295) Total equity 345,982 356,661 Non-current liabilities Contingent consideration and contingent value rights 5 81,127 81,113 Deferred tax liability 6,665 17,772 Long term loan 12 98,463 93,395 Convertible notes 13 107,043 105,788 Provisions and other liabilities 14 3,878 4,049 Total non-current liabilities 297,176 302,117 Current liabilities Trade and other payables 136,752 149,734 Provisions and other liabilities 14 6,957 7,545 Total current liabilities 143,709 157,279 Total liabilities 440,885 459,396 Total equity and liabilities 786,867 816,057 Amryt Pharma plc Condensed Consolidated Statement of Cash Flows Three months ended March 31, Note 2022 (unaudited) 2021 (unaudited) US$’000 US$’000 Cash flows from operating activities Loss on ordinary activities after taxation (14,491) (16,537) Net finance expense - other 11,127 7,898 Depreciation and amortization 14,830 11,058 Amortization of inventory fair value step-up 1,559 951 Share based payment expenses 4 3,148 1,263 Non-cash change in fair value of contingent consideration 5 427 2,874 Non-cash contingent value rights finance expense 5 682 1,763 Deferred taxation (credit)/charge (11,105) 141 Movements in working capital and other adjustments: Change in trade and other receivables 8 6,538 (778) Change in trade and other payables (13,867) (3,483) Change in provision and other liabilities 14 (577) (3,138) Change in inventories (5,846) 670 Change in non-current assets 34 58 Net cash flow from operating activities (7,541) 2,740 Cash flow from investing activities Payments for property, plant and equipment (423) (71) Payments for intangible assets — (416) Deposit interest received 2 1 Net cash flow used in investing activities (421) (486) Cash flow from financing activities Net costs from issue of equity instruments 1,063 (175) Proceeds from long term borrowings - net of debt issue costs 98,344 — Repayment of long term debt (95,469) — Interest paid (6,308) (1,418) Payment of leases (305) (263) Net cash flow from financing activities (2,675) (1,856) Exchange and other movements (175) (645) Net change in cash and cash equivalents (10,812) (247) Cash and cash equivalents at beginning of the period 113,032 118,798 Restricted cash at end of the period 10 50 29 Cash at bank available on demand at end of the period 10 102,170 118,522 Total cash and cash equivalents at end of the period 10 102,220 118,551 Amryt Pharma plc Condensed Consolidated Statement of Changes in Equity For the period ended March 31, 2022 Note Share capital Share premium Warrant reserve Treasury shares Share based payment reserve Merger reserve Reverse acquisition reserve Equity component of convertible notes Other distributable reserves Currency translation reserve Accumulated deficit Total US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 Balance at January 1, 2022 (audited) 25,500 318,153 — — 20,593 42,627 (73,914) 29,210 217,634 10,153 (233,295) 356,661 Loss for the period — — — — — — — — — — (14,491) (14,491) Foreign exchange translation reserve — — — — — — — — — (399) — (399) Total comprehensive loss — — — — — — — — — (399) (14,491) (14,890) Transactions with owners Issue of shares for share options exercised and vesting of RSUs 11 72 1,702 — — (711) — — — — — — 1,063 Share based payment expense 4 — — — — 3,148 — — — — — — 3,148 Share based payment expense – Lapsed — — — — (1,110) — — — — — 1,110 — Total transactions with owners 72 991 — — 1,327 — — — — — 1,110 4,211 Balance at March 31, 2022 (unaudited) 25,572 319,855 — — 21,920 42,627 (73,914) 29,210 217,634 9,754 (246,676) 345,982 For the period ended March 31, 2021 Note Share capital Share premium Warrant reserve Treasury shares Share based payment reserve Merger reserve Reverse acquisition reserve Equity component of convertible notes Other distributable reserves Currency translation reserve Accumulated deficit Total US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 Balance at January 1, 2021 (audited) 13,851 51,408 14,762 (7,421) 7,860 42,627 (73,914) 29,210 217,634 5,730 (235,605) 66,142 Loss for the period — — — — — — — — — — (16,537) (16,537) Foreign exchange translation reserve — — — — — — — — — 2,547 — 2,547 Total comprehensive loss — — — — — — — — — 2,547 (16,537) (13,990) Transactions with owners Issue of treasury shares in exchange for warrants 11 23 99 — 439 — — — — — — — 561 Issue of treasury shares for share options exercised 11 25 89 — 465 (191) — — — — — — 388 Share based payment expense 4 — — — — 1,263 — — — — — — 1,263 Total transactions with owners 48 188 — 904 1,072 — — — — — — 2,212 Balance at March 31, 2021 (unaudited) 13,899 51,596 14,762 (6,517) 8,932 42,627 (73,914) 29,210 217,634 8,277 (252,142) 54,364 1. General information Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets. As used herein, references to ‘‘we,’’ ‘‘us,’’ ‘‘Amryt’’ or the ‘‘Group’’ in these condensed consolidated interim financial statements shall mean Amryt Pharma plc and its global subsidiaries, collectively. References to the ‘‘Company’’ in these condensed consolidated interim financial statements shall mean Amryt Pharma plc. Amryt Pharma plc is a company incorporated in England and Wales. The Company is listed on Nasdaq (ticker: AMYT). The Company was also listed on the AIM market of the London Stock Exchange (ticker: AMYT) up until January 11, 2022, on which date the Company completed the cancellation its admission to AIM. The cancellation was announced by the Company on November 22, 2021, and following the AIM delisting, the Company’s American Depositary Shares (“ADSs”)will remain listed, and will only be tradeable, on Nasdaq. The Company’s last day of trading on AIM was 10 January 2022. Amryt acquired Chiasma, Inc. (“Chiasma”) in August 2021. The combined company will be a global leader in rare and orphan diseases with three on-market commercial products, a global commercial and operational footprint and a significant development pipeline of therapies with the financial flexibility to execute its growth plans. Amryt’s commercial business comprises three orphan disease products – metreleptin (Myalept®/ Myalepta®); oral octreotide (Mycapssa®); and lomitapide (Juxtapid®/ Lojuxta®). Amryt's lead development candidate, Oleogel-S10 is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (EB), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. Filsuvez® has been selected as the brand name for Oleogel-S10. The product does not currently have regulatory approval to treat EB. On February 28, 2022, Amryt announced that the U.S. Food and Drug Administration (“FDA”) communicated that it had completed its review of the NDA for Oleogel-S10 and has determined that the application cannot be approved in its present form. The FDA has asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in EB. Amryt intends to discuss with the FDA the nature of the data required to address the Agency’s concerns. On April 22, 2022, the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) adopted a positive opinion, recommending the approval of Filsuvez® in the EU for the treatment of partial thickness wounds associated with dystrophic and junctional EB in patients six months and older. Based on this CHMP recommendation a decision by the European Commission (“EC”) is expected on the Filsuvez® application within 67 days. The CHMP positive opinion is supported by Phase 3 data from the EASE trial which was the largest ever global trial conducted in patients with EB, performed across 58 sites in 28 countries. 2. Accounting policies Basis of preparation The condensed consolidated interim financial statements of the Group have been prepared in accordance with IAS 34 Interim Financial Reporting. They do not include all the information required in annual financial statements in accordance with International Financial Reporting Standards (‘‘IFRS’’) and should be read in conjunction with the annual consolidated financial statements for the year ended December 31, 2021. Selected explanatory notes are included to explain events and transactions that are significant to an understanding of the Group’s financial position and performance since the last annual financial statements. The accounting policies used in the preparation of the interim financial information are the same as those used in the Group’s audited financial statements for the year ended December 31, 2021, and those which are expected to be used in the financial statements for the year ended December 31, 2022. Results for the three-month period ended March 31, 2022, are not necessarily indicative of the results that may be expected for the financial year ending December 31, 2022. Basis of going concern Having considered the Group’s current financial position and cash flow projections, the Board of Directors believes that the Group will be able to continue in operational existence for at least the next 12 months from the date of approval of these condensed consolidated interim financial statements and that it is appropriate to continue to prepare the condensed consolidated interim financial statements on a going concern basis. As part of their inquiries, the Board of Directors reviewed budgets, projected cash flows, and other relevant information for a period not less than 12 months from the date of approval of the condensed consolidated interim financial statements for the period ended March 31, 2022. Basis of consolidation The condensed consolidated interim financial statements comprise the financial statements of the Group for the period ended March 31, 2022. Subsidiaries are entities controlled by the Company. Where the Company has control over an investee, it is classified as a subsidiary. The Company controls an investee if all three of the following elements are present: power over an investee, exposure or rights to variable returns from its involvement with the investee and the ability to use its power to affect those variable returns. Control is reassessed whenever facts and circumstances indicate that there may be a change in any of these elements of control. Subsidiaries are fully consolidated from the date that control commences until the date that control ceases. Accounting policies of subsidiaries have been changed where necessary to ensure consistency with the policies adopted by the Group. Intergroup balances and any unrealized gains or losses, income or expenses arising from intergroup transactions are eliminated in preparing the condensed consolidated interim financial statements. Presentation of balances The condensed consolidated interim financial statements are presented in U.S. dollars (‘‘US$’’), rounded to the nearest thousand, which is the functional currency of the Company and presentation currency of the Group. The following table discloses the major exchange rates of those currencies other than the functional currency of US$ that are utilized by the Group: Foreign currency units to 1 US$ € £ ILS NOK DKK Average period to March 31, 2022 (unaudited) 0.8909 0.7451 3.1969 8.8526 6.6292 At March 31, 2022 (unaudited) 0.8979 0.7615 3.1842 8.6186 6.6790 Foreign currency units to 1 US$ € £ ILS NOK DKK Average period to December 31, 2021 (audited) 0.8454 0.7271 3.2322 8.5975 6.2875 At December 31, 2021 (audited) 0.8830 0.7413 3.1115 8.8074 6.5664 Foreign currency units to 1 US$ € £ ILS NOK DKK Average period to March 31, 2021 (unaudited) 0.8292 0.7253 3.2720 8.5171 6.1669 At March 31, 2021 (unaudited) 0.8519 0.7274 3.3330 8.5547 6.3351 (€ = Euro; £ = Pounds Sterling, ILS = Israeli Shekel, NOK = Norwegian Kroner, DKK = Danish Kroner) Changes in accounting policies and disclosures There are no new standards and amendments to IFRS effective as of January 1, 2022, that are relevant to the Group. Critical accounting judgements and key sources of estimation uncertainty In preparing these condensed consolidated interim financial statements in conformity with IFRS management is required to make judgements, estimates and assumptions that affect the application of policies and amounts reported in the condensed consolidated interim financial statements and accompanying notes. The estimates and associated assumptions are based on historical experience and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis of making the judgements about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates. The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimate is revised if the revision affects only that period or in the period of the revision and future periods if the revision affects both current and future periods. The significant estimates, assumptions or judgements, applied in the condensed consolidated interim financial statements were the same as those applied in the Group’s audited financial statements for the year ended December 31, 2021. Principal accounting policies The condensed consolidated interim financial statements have been prepared in accordance with the accounting policies adopted in the Group’s audited financial statements for the year ended December 31, 2021. 3. Segment information The Group is a global, commercial-stage biopharmaceutical company dedicated to commercializing and developing novel therapeutics to treat patients suffering from serious and life-threatening rare diseases. The Group currently operates as one business segment, pharmaceuticals, and is focused on the development and commercialization of three commercial products and a number of development products. The Group derives its revenues primarily from one source, being the pharmaceutical sector with high unmet medical need. The Group’s Chief Executive Officer, Joseph Wiley, is currently the Company’s chief operating decision maker (‘‘CODM’’). The Group does not operate any separate lines of business or separate business entities with respect to its products. Accordingly, the Group does not accumulate discrete financial information with respect to separate service lines and does not have separate reportable segments. The following table summarizes total revenues from external customers by product and by geographic region, based on the location of the customer. Three months ended March 31, 2022 (unaudited) U.S. EMEA Other Total US$’000 US$’000 US$’000 US$’000 Metreleptin 20,244 15,922 1,481 37,647 Lomitapide 8,054 7,190 2,572 17,816 Mycapssa® 3,427 - - 3,427 Other - 171 68 239 Total revenue 31,725 23,283 4,121 59,129 Three months ended March 31, 2021 (unaudited) U.S. EMEA Other Total US$’000 US$’000 US$’000 US$’000 Metreleptin 16,239 12,971 750 29,960 Lomitapide 8,324 7,440 2,420 18,184 Mycapssa® — — — — Other — 223 65 288 Total revenue 24,563 20,634 3,235 48,432 Major Customers For the three months ended March 31, 2022, one customer accounted for 48% of the Group’s net revenues (March 31, 2021: 51%) and accounted for 36% of the Group’s March 31, 2022, accounts receivable balance (December 31, 2021: 36%). 4. Share based payments Share-based Compensation Plans Amryt’s Equity Incentive Plan Amryt’s Equity Incentive Plan was adopted by a special resolution on September 23, 2019. Prior to such date, we granted options under a prior employee share option plan, which had the same terms and conditions as the Equity Incentive Plan. On September 24, 2019, all options held under our prior share option plan were rolled over into options to subscribe for our ordinary shares with the key terms including strike price, vesting and the expiration date of such rolled over options remaining the same as they were on the issue date of the options under the prior share option plan. The Equity Incentive Plan was approved for amendment by the Board on May 18, 2020, August 3, 2021 and November 2, 2021. The purpose of the Plan is to provide for the granting of Equity Incentives to Directors and Employees of, and Consultants to, the Company or any Associated Company. Chiasma Equity Incentive Plan When Amryt acquired Chiasma in August 2021, the Chiasma Stock Option and Incentive Plan transferred across to Amryt. Each outstanding and unexercised Chiasma Stock Option or RSU, whether vested or not vested, ceased to represent a right to acquire shares of Chiasma common stock and were converted into an option to purchase Amryt ADSs on the same terms and conditions as were applicable under such Chiasma Stock Option and Incentive Plan immediately prior to the acquisition. No new stock option or RSUs will be granted under the Chiasma stock option and incentive plan. Terms and Conditions of New Grants The terms and conditions of new grants are as follows, whereby all options are settled by physical delivery of shares: Vesting conditions The employee share options vest following a period of service by the officer or employee. The required period of service is determined by the Remuneration Committee at the date of grant of the options (usually the date of approval by the Remuneration Committee). There are no market conditions associated with the share option vesting periods. Contractual life The term of an option is determined by the Remuneration Committee provided that the term may not exceed a period of seven to ten years from the date of grant. All options will terminate 90 days after termination of the option holder’s employment, service or consultancy with the Group except where a longer period is approved by the Board of Directors. Under certain circumstances involving a change in control of the Group, some options will automatically accelerate and become exercisable in full as of a date specified by the Board of Directors. All equity incentives granted are in the form of ordinary shares. Share option exercise prices below are the exercise price per ordinary share. The ADS equivalent exercise price will be theordinary share exercise price multiplied by five and the number of ADSs will be the number of ordinary shares divided by five. The number and weighted average exercise price (in Sterling pence) of share options per ordinary share granted under Amryt’s Equity Incentive Plan and the Chiasma stock option and incentive plan is as follows: Amryt Equity Incentive Plan Chiasma Stock Option and Incentive Plan Units Weighted average exercise price (Sterling pence) Units Weighted average exercise price (Sterling pence) Balance at January 1, 2021 18,753,648 122.79p — — Granted 11,337,459 190.88p — — Transferred to Amryt on acquisition — — 18,139,060 189.07p Forfeited (1,288,165) 174.97p (4,098,425) 226.22p Exercised (300,000) 93.00p (3,320,515) 116.35p Outstanding at December 31, 2021 (audited) 28,502,942 147.83p 10,720,120 197.40p Exercisable at December 31, 2021 (audited) 9,347,338 118.87p 8,005,390 192.35p Balance at January 1, 2022 28,502,942 147.83p 10,720,120 197.40p Granted 14,849,465 99.91p — — Forfeited (236,300) 172.95p (2,171,425) 211.85p Exercised (492,905) 113.22p (226,690) 97.99p Outstanding at March 31, 2022 (unaudited) 42,623,202 131.40p 8,322,005 196.34p Exercisable at March 31, 2022 (unaudited) 11,435,228 133.34p 6,314,575 195.95p The fair value of the Amryt equity award is estimated at the date of grant using the Black-Scholes pricing model, taking into account the terms and conditions attached to the grant. The fair value of the Chiasma equity awards transferred to Amryt on acquisition were measured in accordance with IFRS 2. The portion of the value of the equity transferred to Amryt attributable to pre-combination service is included in the consideration at the date of acquisition. The portion of the equity awards transferred to Amryt attributable to post combination service is estimated at the date of transfer using Black Scholes pricing model, taking into account the terms and conditions attached to the grant. The following are the inputs to the model for the equity instruments granted during the period: March 31, 2022 Options Inputs (unaudited) December 31, 2021 Options Inputs (unaudited) Days to Expiration 2,555 2,555 Volatility 39% 32% - 49% Risk free interest rate 1.96% 0.77% - 1.33% Share price at grant per ordinary share 99.91p 146.87 - 201.2p Share price at grant per ADS 19.99p 29.37 - 40.2p In the three months ended March 31, 2022, a total of 14,849,465 share options over ordinary shares exercisable at a weighted average price of US$1.42 (£1.00) were granted. The fair value of share options granted in the period ended March 31, 2022, was US$19,911,369/£14,836,439. The share options outstanding under the Amryt 2021 Equity Incentive Plan as at March 31, 2022 had a weighted remaining contractual life of 5.64 years with exercise prices ranging from £0.76 to £2.012 per ordinary share. In the three months ended March 31, 2021, a total of 8,465,644 share options exercisable at a weighted average price of US$2.80 (£2.012) were granted. The fair value of share options granted in the three months ended March 31, 2021, was US$23,479,000/£17,030,000. The share options outstanding as at March 31, 2021, had a weighted remaining contractual life of 5.78 years with exercise prices ranging from £0.76 to £2.012. The share options outstanding under the Chiasma Share Option and Incentive Plan transferred across to Amryt on acquisition. As at March 31, 2022, they have a weighted remaining contractual life of 5.26 years with exercise prices ranging from £0.54 to £7.41 per ordinary share. No new share options will be granted under the Chiasma Stock Option and Incentive Plan. Restricted Share Units Under the terms of Amryt’s Equity Incentive Plan, restricted share units (“RSUs”) to purchase 3,810,660 ordinary shares were outstanding at March 31, 2022. Under the terms of this plan, RSUs are granted to officers, consultants and employees of the Group at the discretion of the Remuneration Committee. For the three month period ended March 31, 2022, a total of 2,388,365 RSUs were granted to employees of the Company. For the year ended December 31, 2021, a total of 625,205 RSUs were granted to employees of the Company. The fair value of the RSUs is based on the share price at the date of grant, with the expense spread over the vesting period. The fair value of RSUs granted in the three month period ended March 31, 2022, was US$3,387,000. At March 31, 2022, the total RSUs granted to date have a weighted remaining contractual life of 2.44 years. Under the terms of Chiasma’s Stock Option and Incentive Plan transferred to Amryt on acquisition, restricted share units (“RSUs”) to purchase 52,655 ordinary shares were outstanding at March 31, 2022. At March 31, 2022, the total RSUs granted to date have a weighted remaining contractual life of 1.86 years. No new RSUs will be granted under the Chiasma Stock Option and Incentive Plan. The following table summarizes the RSU activity per ordinary share for the period: Amryt Equity Incentive Plan Chiasma Stock Option and Incentive Plan Units Weighted average fair value (US$) Units Weighted average fair value (US$) Balance at January 1, 2021 1,549,910 $2.34 — — Granted 625,205 $2.62 — — Transferred to Amryt on acquisition — — 202,145 $2.75 Lapsed (243,505) $2.35 (56,405) $2.75 Vested (362,855) $2.34 (39,180) $2.75 Outstanding at December 31, 2021 (audited) 1,568,755 $2.44 106,560 $2.75 Balance at January 1, 2022 1,568,755 $2.44 106,560 $2.75 Granted 2,388,365 $1.42 — — Lapsed (28,315) $2.35 (4,605) $2.75 Vested (118,145) $2.79 (49,300) $2.75 Outstanding at March 31, 2022 (unaudited) 3,810,660 $1.79 52,655 $2.75 Performance Stock Units Under the terms of Amryt’s Equity Incentive Plan, performance share units (“PSUs”) to purchase 1,851,222 ordinary shares were granted to officers and employees at the discretion of the Remuneration Committee in the three month period to March 31, 2022. Performance conditions determine how many of these performance stock units will vest and, if performance targets are exceeded, additional performance stock units will be issued and vest in accordance with the terms of the relevant performance stock units award. The PSUs vest based on the Total Shareholder Return (“TSR”) of Amryt’s NASDAQ traded common stock relative to the TSRs of the constituents that comprise the NASDAQ Biotechnology Index (the Peer Group) as of January 1, 2022. TSR for Amryt and each peer company will be measured over the period from January 1, 2022, to December 31, 2024. The payout schedule can produce payout percentages ranging from 0% to 150%. The following table summarizes the PSU activity per ordinary share for the period: Amryt Equity Incentive Plan Units Weighted average fair value (US$) Balance at January 1, 2022 — — Granted 1,851,222 $1.42 Lapsed — — Vested — — Outstanding at March 31, 2022 (unaudited) 1,851,222 $1.42 Warrants There are no outstanding warrants at March 31, 2022 (December 31, 2021: nil). In August 2021, an Amryt institutional investor exercised subscription rights relating to 8,966,520 zero cost warrants. These warrants were issued in September 2019 as part of the Company’s acquisition of Aegerion. Certain institutional investors elected to receive warrants to subscribe for new ordinary shares of £0.06 each in Amryt (“Ordinary Shares”), in place of the same number of Ordinary Shares, as consideration for the Company’s acquisition of Aegerion and their equity investments in the Company in September 2019. Each warrant entitled the holder to subscribe for one Ordinary Share for no additional consideration. Separate warrants consisting of 345,542 as at December 31, 2020, which were issued in connection with the admission to the AIM in 2016, are no longer outstanding; 283,389 warrants were exercised in March 2021 and 62,153 warrants lapsed in April 2021. The number and weighted average exercise price (in Sterling pence) of warrants per ordinary share is as follows: Warrants Units Weighted average exercise price (Sterling pence) Balance at January 1, 2021 9,312,062 0.05p Granted — — Lapsed (62,153) 1.44p Exercised (9,249,909) 0.05p Outstanding at December 31, 2021 (audited) — 0.00p The value of share options and RSU’s charged to the Condensed Consolidated Statement of Comprehensive Loss during the period is as follows: Three months ended March 31, 2022 (unaudited) 2021 (unaudited) US$’000 US$’000 Share option expense 2,659 879 RSU expense 429 384 PSU expense 60 — Total share option expense 3,148 1,263 5. Business combinations and asset acquisitions Acquisition of Chiasma On May 5, 2021, Amryt announced that it had signed a definitive agreement to acquire Chiasma, Inc. (Nasdaq: CHMA) in an all-stock combination. Under the terms of the transaction, each share of Chiasma common stock issued and outstanding prior to the consummation of the transaction was exchanged for 0.396 Amryt ADSs, each representing five Amryt ordinary shares. On August 5, 2021, Amryt completed the acquisition of Chiasma, Inc. and, in conjunction with the completion, Amryt allotted and issued a total of 127,733,680 ordinary shares as consideration for the acquisition. Following the completion, shareholdings in Chiasma were rounded in being converted to Amryt shares using the exchange ratio of 0.396. Roundings in converting Chiasma shareholdings to Amryt shares were finalized in August 2021 and resulted in an additional 7,015 ordinary shares being allotted and issued by Amryt as consideration for the acquisition. In total, these ordinary shares were issued to the former Chiasma Shareholders in the form of 25,548,139 ADSs at US$10.19 per share, to acquire Chiasma for a value of US$260,336,000. On August 5, 2021, Chiasma had outstanding equity awards that were held by Chiasma employees. The fair value of these awards transferred to Amryt on acquisition were measured in accordance with IFRS 2. The portion of the value of the equity transferred to Amryt attributable to pre-combination service is included in the consideration at the date of acquisition and this amounted to US$10,157,000. On August 5, 2021, the Group repaid US$116,629,000 of Chiasma long term debt. The combined company will be a global leader in rare and orphan diseases with three on-market commercial products, a global commercial and operational footprint and a significant development pipeline of therapies with the financial flexibility to execute its growth plans. The table below reflects the fair value of the identifiable net assets acquired in respect of the acquisition completed during the period. Any amendments to fair values will be made within the twelve-month period from the date of acquisition, as permitted by IFRS 3: Business Combinations. The acquired goodwill is attributable principally to the profit generating potential of the businesses, the assembled workforce and benefits arising from embedded infrastructure, that are expected to be achieved from integrating the acquired businesses into the Group’s existing business. No amount of goodwill is expected to be deductible for tax purposes. The Group incurred acquisition and restructuring related costs of US$402,000 for the three-month period ended March 31, 2022, relating to external legal fees, advisory fees, due diligence costs and severance costs related to the acquisition of Chiasma. These costs have been included in operating costs in the Condensed Consolidated Statement of Comprehensive Loss. Recognized Fair Values as at August 5, 2021 US$’000 Assets Non-current assets Intangible assets 215,000 Property, plant and equipment 950 Other non-current assets 866 Total non-current assets 216,816 Current assets Trade and other receivables 7,180 Inventories 65,907 Cash and cash equivalents, including restricted cash 107,942 Total current assets 181,029 Total assets 397,845 Non-current liabilities Deferred tax liability 21,478 Total non-current liabilities 21,478 Current liabilities Trade and other payables 144,482 Total current liabilities 144,482 Total liabilities 165,960 Total identifiable net assets at fair value 231,885 Goodwill arising on acquisition 38,608 Consideration 270,493 Consideration Issue of fully paid up ordinary shares 260,336 Chiasma equity awards recognized as consideration transferred upon the acquisition of Chiasma 10,157 Total consideration 270,493 Any amendments to these fair values within the twelve-month timeframe from the date of acquisition will be disclosed in the 2022 consolidated financial statements, as stipulated by IFRS 3. Acquisition of Aegerion Pharmaceuticals On May 20, 2019, Amryt entered into a Restructuring Support Agreement (as subsequently amended on June 12, 2019) and Plan Funding Agreement pursuant to which, among other matters, Amryt agreed to the acquisition of Aegerion Pharmaceuticals, Inc. (‘‘Aegerion’’, subsequently renamed as Amryt Pharmaceuticals Inc.), a former wholly-owned subsidiary of Novelion Therapeutics Inc. (‘‘Novelion’’). On May 20, 2019, Aegerion and its U.S. subsidiary, Aegerion Pharmaceuticals Holdings, Inc., filed voluntary petitions under Chapter 11 of Title 11 of the U.S. Code in the Bankruptcy Court. On September 24, 2019, Amryt completed the acquisition of Aegerion. Amryt acquired Aegerion upon its emergence from bankruptcy in an exchange for ordinary shares and zero cost warrants in Amryt. Amryt issued 85,092,423 effective shares at US$1.793 per share, which is made up of 77,027,423 ordinary shares and 8,065,000 zero cost warrants, to acquire Aegerion for a value of US$152,615,000. As part of the acquisition of Aegerion, it was agreed, for certain Aegerion creditors who wished to restrict their percentage share interest in Amryt’s issued share capital, to issue to the relevant Aegerion creditor, as an alternative to Amryt’s ordinary shares, an equivalent number of new zero cost warrants to subscribe for Amryt’s ordinary shares to be constituted on the terms of the zero cost warrant. As atMarch 31, 2022, no zero cost warrants were remaining. Contingent Value Rights Related to the transaction, Amryt issued Contingent Value Rights (‘‘CVRs’’) pursuant to which up to US$85,000,000 may become payable to Amryt’s shareholders and optionholders, who were on the register prior to the completion of the acquisition on September 20, 2019, if certain approval and revenue milestones are met in relation Oleogel-S10, Amryt’s lead product candidate. If any such milestone is achieved, Amryt may elect to pay the holders of CVRs by the issue of Amryt shares or loan notes. If Amryt elects to issue Loan Notes to holders of CVRs, it will settle such loan notes in cash 120 days after their issue. If none of the milestones are achieved, scheme shareholders and optionholders will not receive any additional consideration under the terms of the CVRs. In these circumstances, the value of each CVR would be zero. The terms of the CVRs are as follows: The total CVR payable is up to US$85,000,000 This is divided into three milestones which are related to the success of Oleogel-S10 (the Group’s lead development asset) FDA approval US$35,000,000 upon FDA approval 100% of the amount due if approval is obtained before December 31, 2021, with a sliding scale on a linear basis to zero if before July 1, 2022 EMA approval US$15,000,000 upon EMA approval 100% of the amount due if approval is obtained before December 31, 2021, with a sliding scale on a linear basis to zero if before July 1, 2022 Revenue targets US$35,000,000 upon Oleogel-S10 revenues exceeding US$75,000,000 in any 12-month period prior to June 30, 2024 Payment can at the Board’s discretion be in the form of either: 120-day loan notes (effectively cash), or Shares valued using the 30 day / 45-day VWAP. The CVRs were contingent on the successful completion of the acquisition and, accordingly, have been based on fair value as at September 24, 2019. The CVRs have been classified as a financial liability in the Condensed Consolidated Statement of Financial Position. Given that CVRs were issued to legacy Amryt shareholders in their capacity as owners of the identified acquirer as opposed to the seller in the transaction, management concluded that the most appropriate classification would be to recognize the CVR as a distribution on consolidation instead of goodwill. Measurement of CVRs As at March 31, 2022, the carrying value of the CVRs was US$20,574,000 (December 31, 2021: US$19,892,000). The value of the potential payout was calculated using the probability-weighted expected returns method. Using this method, the potential payment amounts were multiplied by the probability of achievement and discounted to present value. The probability adjusted present values took into account published orphan drug research data and statistics which were adjusted by management to reflect the specific circumstances applicable to the type of product acquired in the Amryt GmbH transaction. The probability chance of success, based on management’s expertise and experience for orphan drugs and taking into account the unique circumstances applying to approval process of this product, was estimated at 60% for the FDA approval (December 31, 2021: 60%) and 100% for the EMA approval (December 31, 2021: 100%) in the three month period ended March 31, 2022. This estimate reflects the current facts and circumstances as of the date of issuance of the Condensed Consolidated Financial Statements. The probability chance of success was updated in the financial year 2021 following the receipt of a CRL from the FDA, which asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in EB, and following positive opinion adopted by the CHMP, recommending the approval of Filsuvez® in the EU for the treatment of partial thickness wounds associated with dystrophic and junctional EB in patients six months and older. Based on this CHMP recommendation a decision by the EC is expected on the Filsuvez® application within 67 days. The CHMP positive opinion is supported by Phase 3 data from the EASE trial which was the largest ever global trial conducted in patientswith EB, performed across 58 sites in 28 countries. Discount rates of 10% and 16.5%, as applicable, were used in the calculation of the present value of the estimated contractual cash flows for the year ended December 31, 2021, based on the applicable rates determined on the acquisition date. Management was required to make certain estimates and assumptions in relation to revenue forecasts, timing of revenues and probability of achievement of commercialization of Oleogel-S10. However, management notes that, due to issues outside their control (i.e. regulatory requirements and the commercial success of the product), the timing of when such revenue targets may occur may change. Such changes may have a material impact on the assessment of the expected cash flows of the CVRs. Amryt reviews the expected cash flows on a regular basis as the discount on initial recognition is being unwound as financing expenses in the Consolidated Statement of Comprehensive Loss over the life of the obligation. It is reviewed on a quarterly basis and the appropriate finance charge or gain is booked in the Consolidated Statement of Comprehensive Loss on a quarterly basis. The Group received positive topline data from the phase 3 EASE trial of Oleogel-S10 in September 2020. The product does not currently have regulatory approval to treat EB but was submitted to the FDA for approval and in June 2021, Amryt received confirmation from the FDA that its NDA for Oleogel-S10 had been accepted and granted priority review. On February 28, 2022, Amryt announced that the FDA communicated that it had completed its review of the NDA for Oleogel-S10 and has determined that the application cannot be approved in its present form. The FDA has asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in EB. Amryt intends to discuss with the FDA the nature of the data required to address the Agency’s concerns. In Europe, a MAA for Oleogel-S10 was accepted for assessment by the EMA in March 2021. The assessment process by EMA was completed on April 22, 2022, when the CHMP adopted a positive opinion. The positive opinion recommends the approval of Filsuvez® in the EU for the treatment of partial thickness wounds associated with dystrophic and junctional EB in patients six months and older. Based on this CHMP recommendation a decision by the EC is expected on the Filsuvez® application within 67 days. The total non-cash finance charge recognized in the Condensed Consolidated Statement of Comprehensive Loss for the three months ended March 31, 2022, is US$682,000 (March 31, 2021: US$1,763,000). Acquisition of Amryt GmbH (previously ‘‘Birken’’) Amryt DAC signed a conditional share purchase agreement to acquire Amryt GmbH on October 16, 2015 (‘‘Amryt GmbH SPA’’). The Amryt GmbHSPA was completed on April 18, 2016, with Amryt DAC acquiring the entire issued share capital of Amryt GmbH. The consideration included contingent consideration comprising milestone payments and sales royalties as follows: Milestone payments of: €10,000,000 on receipt of marketing approval by the EMA or FDA of a pharmaceutical product containing Betulin as its API for the treatment of EB; €10,000,000 once net ex-factory sales/net revenue of Oleogel S-10 first exceed €50,000,000 in any calendar year; €15,000,000 once net ex-factory sales/ net revenue of Oleogel S-10 first exceed €100,000,000 in any calendar year; Cash consideration of €150,000, due and paid on the completion date (April 18, 2016); and Royalties of 9% on sales of Oleogel-S10 products for 10 years from first commercial sale. Fair Value Measurement of Contingent Consideration As at March 31, 2022, the fair value of the contingent consideration was estimated to be US$60,553,000 (December 31, 2021: US$61,221,000). The fair value of the contingent consideration included milestone payments determined using probability adjusted present values and probability weighted revenue forecasts (see Note 15, Fair value measurement and financial risk management, for fair value hierarchy applied and impact of key unobservable impact data). The probability adjusted present values took into account published orphan drug research data and statistics which were adjusted by management to reflect the specific circumstances applicable to the type of product acquired in the Amryt GmbH transaction. The probability chance of success, based on management’s expertise and experience for orphan drugs and taking into account the unique circumstances applying to approval process of the product, was estimated at 60% for the FDA approval (December 31, 2021: 60%) and 100% for the EMA approval (December 31, 2021: 100%) in the three month period ended March 31, 2022. This estimate reflects the current facts and circumstances as of the date of issuance of the Condensed Consolidated Financial Statements. The probability chance of success was updated in the financial year 2021 following the receipt of a CRL from the FDA, which asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in EB, and following positive opinion adopted by the CHMP, recommending the approval of Filsuvez® in the EU for the treatment of partial thickness wounds associated with dystrophic and junctional EB in patients six months and older. Based on this CHMP recommendation a decision by the EC is expected on the Filsuvez® application within 67 days. The CHMP positive opinion is supported by Phase 3 data from the EASE trial which was the largest ever global trial conducted in patientswith EB, performed across 58 sites in 28 countries. A discount rate of 7.9% was used in the calculation of the fair value of the contingent consideration for the three month period ended March 31, 2022 (December 31, 2021: 7.9%). Amryt reviews the expected cash flows on a regular basis as the discount on initial recognition is being unwound as financing expenses in the Consolidated Statement of Comprehensive Loss over the life of the obligation. It is reviewed on a quarterly basis and the appropriate finance charge or gain is booked in the Consolidated Statement of Comprehensive Loss on a quarterly basis. The Group received positive topline data from the phase 3 EASE trial of Oleogel-S10 in September 2020. The product does not currently have regulatory approval to treat EB but was submitted to the FDA for approval and in June 2021, Amryt received confirmation from the FDA that its NDA for Oleogel-S10 had been accepted and granted priority review. On February 28, 2022, Amryt announced that the FDA communicated that it had completed its review of the NDA for Oleogel-S10 and has determined that the application cannot be approved in its present form. The FDA has asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in EB. Amryt intends to discuss with the FDA the nature of the data required to address the Agency’s concerns. In Europe, a MAA for Oleogel-S10 was accepted for assessment by the EMA in March 2021. The assessment process by EMA was completed on April 22, 2022, when the CHMP adopted a positive opinion. The positive opinion recommends the approval of Filsuvez® in the EU for the treatment of partial thickness wounds associated with dystrophic and junctional EB in patients six months and older. Based on this CHMP recommendation a decision by the EC is expected on the Filsuvez® application within 67 days. The total non-cash finance charge recognized in the Condensed Consolidated Statement of Comprehensive Loss for the three months ended March 31, 2022, is US$427,000 (March 31, 2021: US$2,874,000). 6. Loss per share - basic and diluted The weighted average number of shares in the loss per share (‘‘LPS’’) calculation, reflects the weighted average total actual shares of Amryt Pharma plc in issue at March 31, 2022. Issued share capital - ordinary shares of £0.06 each Number of shares Weighted average shares March 31, 2022 (unaudited) 320,699,807 320,502,464 March 31, 2021 (unaudited) 179,384,982 178,937,717 The calculation of loss per share is based on the following: Three months ended March 31 2022 (unaudited) 2021 (unaudited) Loss after tax attributable to equity holders of the Company (US$’000) (14,491) (16,537) Weighted average number of ordinary shares in issue 320,502,464 178,937,717 Fully diluted average number of ordinary shares in issue 320,502,464 178,937,717 Basic and diluted loss per share (US$) (0.05) (0.09) Where a loss has occurred, basic and diluted LPS are the same because the outstanding share options and warrants are anti-dilutive. Accordingly, diluted LPS equals the basic LPS. The share options, RSUs, PSUs and warrants outstanding as at March 31, 2022 totaled 56,659,744 (March 31, 2021: 37,782,055) and are potentially dilutive. 7. Intangible assets and goodwill The following table summarizes the Group’s intangible assets and goodwill: Developed technology - metreleptin Developed technology - lomitapide Developed technology - Mycapssa® In process R&D Other intangible assets Total intangible assets Goodwill US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 Cost At January 1, 2021 (audited) 176,000 123,000 — 60,128 866 359,994 19,131 Additions — — — — 847 847 — Acquired assets — — 215,000 — — 215,000 38,608 Other movements — — — — — — (1,051) Foreign exchange movement — — — (4,691) (61) (4,752) — At December 31, 2021 (audited) 176,000 123,000 215,000 55,437 1,652 571,089 56,688 Foreign exchange movement — — — (1,250) (24) (1,274) — At March 31, 2022 (unaudited) 176,000 123,000 215,000 54,187 1,628 569,815 56,688 Accumulated amortization At January 1, 2021 (audited) 34,743 19,680 — — 202 54,625 — Amortization charge 27,428 15,537 5,979 — 147 49,091 — Foreign exchange movement — — — — 14 14 — At December 31, 2021 (audited) 62,171 35,217 5,979 — 363 103,730 — Amortization charge 6,856 3,884 3,707 — 24 14,471 — Foreign exchange movement — — — — 39 39 — At March 31, 2022 (unaudited) 69,027 39,101 9,686 — 426 118,240 — Net book value At December 31, 2021 (audited) 113,829 87,783 209,021 55,437 1,289 467,359 56,688 At March 31, 2022 (unaudited) 106,973 83,899 205,314 54,187 1,202 451,575 56,688 Developed technology on commercially marketed products In connection with the acquisition of Aegerion in September 2019, the Group acquired developed technology, metreleptin and lomitapide. These intangible assets are amortized over their estimated useful lives and the remaining useful lives for metreleptin and lomitapide are approximately 3.9 and 5.4 years, respectively, as of March 31, 2022 (December 31, 2021: 4.2 and 5.7 years, respectively). In connection with the acquisition of Chiasma in August 2021, the Group acquired developed technology, octreotide. This intangible asset is amortized over its estimated useful life and the remaining useful life is approximately 13.9 years as of March 31, 2022 (December 31, 2021: 14.2). In-process R&D As a result of the acquisition of Amryt GmbH, in 2016, the Group recognized in-process R&D costs of €48,453,000/US$54,872,000 which is related to the Group’s lead development asset, Oleogel-S10. The remaining in-process R&D is a result of the acquisition of Cala Medical Limited in October 2020. Goodwill During 2019, the Group completed the acquisition of Aegerion which resulted in the recognition of goodwill that has a carrying value of US$18,080,000. On August 5, 2021, the Group completed the acquisition of Chiasma, which resulted in aggregate goodwill of US$38,608,000. The Group reviews events or changes in circumstances that may indicate a triggering event for impairment, at each reporting date, and conducts an annual impairment review to determine any impairment charge required. Management completed an impairment review by determining recoverable amounts from value in use calculations. The recoverable amount of an asset or cash generating unit is estimated in order to determine the extent of an impairment charge. There was no impairment charge recorded during the three months ended March 31, 2022. 8. Trade and other receivables As at March 31, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Trade receivables 32,269 34,263 Accrued income and other debtors 10,353 12,201 VAT recoverable 4,747 7,444 Trade and other receivables 47,369 53,908 9. Inventories As at March 31, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Raw materials 38,918 36,850 Work in progress 11,264 12,986 Finished goods 69,873 65,933 Inventories 120,055 115,769 Inventories for the period ended March 31, 2022, includes inventory acquired as part of the acquisition of Chiasma on August 5, 2021, which was fair valued as of the date of the acquisition. The fair value of the acquired inventory amounted to US$65,907,000. Inventory on hand at the date of acquisition was valued at the expected selling price less the sum of remaining costs of disposal, cost to complete and a reasonable profit margin for the selling effort of the acquiring entity. The costs to complete were calculated based on costs incurred on recently completed finished goods. The costs to dispose include sales and marketing expenses required to sell the product to the customer in addition to certain general and administrative expenses expected to be incurred by Amryt. This resulted in a non-cash step up at the valuation of inventory at August 5, 2021, of US$44,794,000. The non-cash step up in inventory is being unwound to the Condensed Consolidated Statement of Comprehensive Loss over the period in which this saleable inventory is sold. AtMarch 31, 2022, US$4,022,000 of this non-cash inventory step up is included in inventory. 10. Cash and cash equivalents As at March 31, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Cash at bank available on demand 102,170 112,771 Restricted cash 50 261 Total cash and cash equivalents 102,220 113,032 Cash and cash equivalents include cash at bank available on demand and restricted cash. At March 31, 2022, and December 31, 2021, there was US$50,000 and US$261,000 of restricted cash, respectively. The balance atMarch 31, 2022,consists of a letter of credit related to US customs which was put in place for an amount of US$50,000 (December 31, 2021: US$50,000). The balance atDecember 31, 2021, includes a deposit on a company credit card facility for an amount of US$$126,000,a lease deposit for US$85,000 and a letter of credit related to US customs which was put in place for an amount of US$50,000. 11. Share capital and reserves Details of the number of issued ordinary shares with a nominal value of Sterling 6 pence (2021: 6 pence) each are in the table below. Ordinary shares Treasury shares Total At January 1, 2021 (audited) 178,801,593 4,791,703 183,593,296 Issue of treasury shares in exchange for warrants 283,389 (283,389) — Issue of treasury shares for share options exercised 300,000 (300,000) — Issue of shares in consideration of Chiasma acquisition 127,740,695 — 127,740,695 Issue of shares in exchange for warrants 4,758,206 — 4,758,206 Issue of treasury shares in exchange for warrants 4,208,314 (4,208,314) — Issue of shares for share options exercised and RSUs vesting 3,722,550 — 3,722,550 At December 31, 2021 (audited) 319,814,747 — 319,814,747 Issue of shares for share options exercised and RSUs vesting 885,060 — 885,060 At March 31, 2022 (unaudited) 320,699,807 — 320,699,807 The components of equity are detailed in the Condensed Consolidated Statement of Changes in Equity and described in more detail below. On March 11, 2021, the Company issued 300,000 ordinary shares from treasury shares following the exercise of share options. On March 11, 2021, the Company issued 283,389 ordinary shares from treasury shares in exchange for certain warrants. On August 5, 2021, the Company issued 127,740,695 ordinary shares, in the form of ADSs, as consideration for the acquisition of Chiasma. On August 5, 2021, the Company issued 8,966,520 ordinary shares with 4,208,314 being issued from treasury shares in exchange for warrants. During the year ended December 31, 2021, there were 3,342,680 shares issued following the exercise of share options and 379,870 shares issued following RSUs vesting.During the period ended March 31, 2022, there were 719,595 shares issued following the exercise of share options and 165,465 shares issued following RSUs vesting. Share Capital Share capital represents the cumulative par value arising upon issue of ordinary shares of Sterling 6 pence each. The ordinary shares have the right to receive notice of, attend and vote at general meetings and participate in the profits of the Company. Share Premium Share premium represents the consideration that has been received in excess of the nominal value on issue of share capital net of issue costs and transfers to distributable reserves. Warrant reserve The warrant reserve represented zero cost warrants issued as part of the equity raise on September 24, 2019, net of issue costs apportioned to warrants issued and additional warrants issued to certain shareholders on November 14, 2019. Each warrant entitles the holder to subscribe for one ordinary share at zero cost. The Company issued 4,000,000 and 4,229,753 ordinary shares on July 15, 2020, and September 22, 2020, respectively, in exchange for certain warrants. The remaining warrants were exchanged on August 5, 2021, and the Company issued 8,966,520 ordinary shares, 4,208,314 of which were issued from treasury shares and there are no longer any warrants outstanding. Treasury Shares In October 2020, the Company issued 72,953 ordinary shares from treasury shares following the exercise of share options. In March 2021, the Company issued a total of 583,389 ordinary shares from treasury shares, 300,000 ordinary shares relating to the exercise of share options and 283,389 ordinary shares following the exchange of certain warrants.In August 2021, the company issued 4,208,314 ordinary shares from treasury shares in conjunction with the exchange of warrants and since August 2021 there are no longer any treasury shares held. Share based payment reserve Share based payment reserve relates to the charge for share based payments in accordance with IFRS 2. In March 2021, the Company issued 283,389 ordinary shares in exchange for certain warrants. In April 2021, 62,153 warrants lapsed. During the year ended December 31, 2021, the Company issued 3,722,550 ordinary shares in relation to the exercise of share options and RSUs.During the period ended March 31, 2022, the Company issued 885,060 ordinary shares in relation to the exercise of share options and RSUs. As part of the acquisition of Chiasma, the Company replaced share awards that were existing at the time of the acquisition. This resulted in the recognition of a share-based payment reserve of US$10,157,000 on acquisition. Merger reserve The merger reserve was created on the acquisition of Amryt DAC by Amryt Pharma plc in April 2016. Ordinary shares in Amryt Pharma plc were issued to acquire the entire issued share capital of Amryt DAC. Under section 612 of the UK Companies Act 2006, the premium on these shares has been included in a merger reserve. Reverse acquisition reserve The reverse acquisition reserve arose during the period ended December 31, 2016, in respect of the reverse acquisition of Amryt Pharma plc by Amryt DAC. Since the shareholders of Amryt DAC became the majority shareholders of the enlarged Group, the acquisition is accounted for as though there is a continuation of Amryt DAC’s financial statements. The reverse acquisition reserve is created to maintain the equity structure of Amryt Pharma plc in compliance with UK company law. Equity component of convertible notes The equity component of convertible notes represents the equity component of the US$125,000,000 convertible debt and is measured by determining the residual of the fair value of the instrument less the estimated fair value of the liability component. The equity component is recognized in equity and is not subsequently remeasured. Other distributable reserves Other distributable reserves comprise the following: Distribution of the share premium amount on 6 November 2019 of US$268,505,000. By special resolution of the Company duly passed on 23 September 2019, it was resolved that the entire amount outstanding to the credit of the share premium account and capital redemption reserve of the Company be cancelled. The reduction in capital, amounting to US$268,505,000, representing the entire amount of share premium at that time, was approved by the High Court of Justice of England and Wales on 5 November 2019. A deemed distribution of US$47,902,000 arising from the issuance of CVRs in September 2019. A deemed distribution of US$2,969,000 arising from the scheme of arrangement in September 2019 whereby Amryt Pharma plc, which was incorporated in July 2019, became a 100% shareholder of Amryt Pharma Holdings Limited (formerly named Amryt Pharma plc) (the “Acquisition of subsidiary without a change of control”). Currency translation reserve The currency translation reserve arises on the retranslation of non-U.S. dollar denominated foreign subsidiaries. Accumulated deficit Accumulated deficit represents losses accumulated in previous periods and the current year. 12. Long term loan As at March 31, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Long term loan principal 105,000 93,988 Unamortized debt issuance costs (6,537) (593) Long term loan 98,463 93,395 On February 18, 2022, Amryt secured US$125,000,000 of senior credit facilities (“Senior Credit Facility”) from funds managed by the Credit Group of Ares Management Corporation (“Ares”). A portion of the proceeds were used to refinance the previous secured term loan, which had an outstanding balance of US$93,988,000 as at February 22, 2022, an interest rate of 13.00% and a maturity date of September 2024. The new facilities will generate significant annual interest cost savings as well as provide for important strategic flexibility as Amryt looks to continue to grow its global rare disease presence.In repaying the secured term loan, Amryt incurred an exit fee of 5.00% of the outstanding principal amount as at the prepayment date. This amounted to US$4,699,000 and is included in Net finance expense – other in the Condensed Consolidated Statement of Comprehensive Income for the three month-period ended March 31, 2022. Key features of the new facilities include: Total new facilities of $125 million, consisting of: $85 million Term Loan Facility with interest rate of Secured Overnight Financing Rate (“SOFR”)+6.75%, subject to a 0.90% SOFR floor $40 million Revolving Credit Facility with $20 million drawn at close and interest rate of SOFR+4.00%, subject to a 0.90% SOFR floor Quarterly blended cash interest rate of SOFR+5.87% (assuming fully drawn), subject to a 0.90% SOFR floor, substantially lower than Amryt’s previous secured term debt facility at 13.00% interest Requires interest-only payments until facility matures in February 2027 There are no warrants or any equity conversion features associated with the new facilities The proceeds will be used to refinance existing debt, for general corporate and product development purposes; and potentially for shareholder approved share repurchase programs. Charges were taken over certain assets of the company and its material entities as guarantee and collateral for the provision of the debt. In connection with the Secured Credit Facility, the Group incurred approximately US$6,656,000 of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees. These costs are amortized over the expected life of the loan using the effective interest method. The Secured Credit Facilityincludes affirmative and negative covenants, including prohibitions on the incurrence of additional indebtedness, granting of liens, certain asset dispositions, investments, and restricted payments, in each case, subject to certain exceptions set forth in the loan agreement. The loan agreement also includes customary events of default for a transaction of this type and includes (i) a cross-default to the occurrence of any event of default under material indebtedness of Amryt and certain subsidiaries of the Group and Amryt, including the convertible notes, and (ii) Amryt or any of its subsidiaries being subject to bankruptcy or other insolvency proceedings. Upon the occurrence of an event of default, the lenders may declare all of the outstanding Secured Credit Facilityand other obligations under the Secured Credit Facilityto be immediately due and payable and exercise all rights and remedies available to the lenders under the Term Loan agreement and related documentation. There were no events of default or breaches of the covenants occurring for duringthree month period ended March 31, 2022. As part of the acquisition of Aegerion on September 24, 2019, Aegerion entered into a new U.S. dollar denominated US$81,021,000 secured term loan debt facility (‘‘Term Loan’’) with various lenders. The Term Loan was made up of a US$54,469,000 loan that was in place prior to the acquisition which was refinanced as part of the acquisition and a US$26,552,000 additional loan that was drawn down on September 24, 2019. The Term Loan had a five-year term from the date of the draw down, September 24, 2019, and matured on September 24, 2024. Under the Term Loan, interest was payable at the option of the Group at the rate of 11% per annum paid in cash on a quarterly basis or at a rate of 6.5% paid in cash plus 6.5% paid in kind that was to be paid when the principal is repaid, which rolled up and included in the principal balance outstanding, on a quarterly basis. There was no unpaid accrued interest of as at March 31, 2021 (December 31, 2020: $1,439,000). The Term Loan was repayable, in whole or in part, by Amryt at any time subject to payment of an exit fee, which depending on the stage of the loan term, ranges from 5.00% to 0.00% of the principal then outstanding on the Term Loan. On February 18, 2022, the Term Loan was repaid in full and the Group secured a $125,000,000 senior credit facility of which US$105,000,000 was drawn down to facilitate the prepayment of the existing Term Loan.In repaying the Secured Credit Facility, Amryt incurred an exit fee of 5.00% of the outstanding principal amount as at the prepayment date. In connection with the Term Loan, the Group incurred approximately US$870,000 of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees. These costs were amortized over the expected life of the loan using the effective interest method and during the three month period ended March 31, 2022, were written off to the Condensed Consolidated Statement of Comprehensive Loss as the Term Loan liability was derecognized. The Term Loan wasguaranteed by Amryt and certain subsidiaries of the Group. In connection with the loan agreement, fixed and floating charges were placed on property and undertakings of Amryt and certain subsidiaries of the Group. 13. Convertible notes Total US$’000 At January 1, 2021 101,086 Accreted interest 4,702 At December 31, 2021 (audited) 105,788 Accreted interest 1,255 At March 31, 2022 (unaudited) 107,043 As part of the Aegerion acquisition, Aegerion issued convertible notes with an aggregate principal amount of US$125,000,000 to Aegerion creditors. The convertible notes are senior unsecured obligations and bear interest at a rate of 5.0% per year, payable semi-annually in arrears on April 1 and October 1 of each year, beginning on April 1, 2020. The convertible notes will mature on April 1, 2025, unless earlier repurchased or converted. The convertible notes are convertible into Amryt’s ordinary shares at a conversion rate of 386.75 ordinary shares per US$1,000 principal amount of the convertible notes. If the holders elect to convert the convertible notes, Amryt can settle the conversion of the convertible notes through payment or delivery of cash, common shares, or a combination of cash and common shares, at its discretion. As a result of the conversion feature in the convertible notes, the convertible notes were assessed to have both a debt and an equity component. The two components were assessed separately and classified as a financial liability and equity instrument. The financial liability component was measured at fair value based on the discounted cash flows expected over the expected term of the notes using a discount rate based on a market interest rate that a similar debt instrument without a conversion feature would be subject to. Refer to Note 11, Share capital and reserves, for further details on the equity component of the convertible notes. From September 24, 2019 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of their convertible notes, in multiples of US$1,000 principal amount, at the option of the holder. The indenture does not contain any financial covenants or restrict the Group’s ability to repurchase securities, pay dividends or make restricted payments in the event of a transaction that substantially increases the Group’s level of indebtedness in certain circumstances. The indenture contains customary terms and covenants and events of default. If an event of default (other than certain events of bankruptcy, insolvency or reorganization involving Aegerion, Amryt and certain subsidiaries of the Group) occurs and is continuing, the trustee by notice to Amryt, or the holders of at least 25% in principal amount of the outstanding convertible notes by written notice to Amryt and the trustee, may declare 100% of the principal of and accrued and unpaid interest, if any, on all of the convertible notes to be due and payable. Upon such a declaration of acceleration, such principal and accrued and unpaid interest, if any, will be due and payable immediately. Upon the occurrence of certain events of bankruptcy, insolvency or reorganization involving Amryt, 100% of the principal and accrued and unpaid interest, if any, on the convertible notes will become due and payable automatically. Notwithstanding the foregoing, the indenture provides that, upon Amryt’s election, and for up to 180 days, the sole remedy for an event of default relating to certain failures by Amryt to comply with certain reporting covenants in the indenture consists exclusively of the right to receive additional interest on the convertible notes. There have been no events of default or breaches of the covenants occurring for the period ended March 31, 2022 (2021: no events). 14. Provisions and other liabilities As at March 31, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Non-current liabilities Provisions and other liabilities — — Leases due greater than 1 year 3,878 4,049 3,878 4,049 Current liabilities Provisions and other liabilities 6,000 6,000 Leases due less than 1 year 957 1,545 6,957 7,545 Total provisions and other liabilities 10,835 11,594 Legal matters Prior to the acquisition of Aegerion by Amryt, Aegerion entered into settlement agreements with governmental entities including the Department of Justice (‘‘DOJ’’) and the FDA in connection with Juxtapid investigations. The settlement agreements required Aegerion to pay specified fines and engage in regulatory compliance efforts. Subsequent to the acquisition, Aegerion made US$23,036,000 of settlement payments, including interest. The settlements have been paid in full with the last payment completed in Q1 2021. Other matters The Group recognizes a liability for legal contingencies when it believes that it is both probable that a liability has been incurred and that it can reasonably estimate the amount of the loss. The Group reviews these accruals and adjusts them to reflect ongoing negotiations, settlements, rulings, advice of legal counsel and other relevant information. To the extent new information is obtained and the Group’s views on the probable outcomes of claims, suits, assessments, investigations or legal proceedings change, changes in the Group’s liability accrual would be recorded in the period in which such determination is made. AtMarch 31, 2022 the Group had recognized liabilities of US$6,000,000 in relation to ongoing legal matters (December 31, 2021: US$6,000,000). 15. Fair value measurement and financial risk management Categories of financial instruments As at March 31, 2022 (unaudited) December 31, 2021 (audited) US$’000 US$’000 Financial assets (all at amortized cost): Cash and cash equivalents 102,220 113,032 Trade receivables 32,269 34,263 Total financial assets 134,489 147,295 Financial liabilities: At amortized cost Trade payables and accrued expenses 131,974 148,251 Lease liabilities 4,835 5,594 Convertible notes 107,043 105,788 Long term loan 98,463 93,395 Contingent value rights 20,574 19,892 At fair value Contingent consideration 60,553 61,221 Total financial liabilities 423,442 434,141 Net (288,953) (286,846) Financial instruments evaluated at fair value can be classified according to the following valuation hierarchy, which reflects the extent to which the fair value is observable: Level 1: fair value evaluations using prices listed on active markets (not adjusted) of identical assets or liabilities. Level 2: fair value evaluations using input data for the asset or liability that are either directly observable (as prices) or indirectly observable (derived from prices), but which do not constitute listed prices pursuant to Level 1. Level 3: fair value evaluations using input data for the asset or liability that are not based on observable market data (unobservable input data). The contingent consideration has been valued using Level 3. The contingent consideration comprises: Contingent consideration relating to the acquisition of Amryt GmbH (see Note 5, Business combinations and asset acquisitions) that was measured at US$60,553,000 as at March 31, 2022 (December 31, 2021: US$61,221,000). The fair value comprises royalty payments which was determined using probability weighted revenue forecasts and the fair value of the milestones payments which was determined using probability adjusted present values. It also included a revision to the discount rate used, and revenue and costs forecasts have been amended to reflect management’s current expectations. Impact of key unobservable input dataon the contingent consideration: An increase of 10% in estimated revenue forecasts would result in an increase to the fair value of US$3,681,000. A decrease would have the opposite effect. A 5% increase in the discount factor used would result in a decrease to the fair value of US$9,374,000. A decrease of 5% would result in an increase to the fair value of US$12,449,000. A six-month delay in the launch date for Oleogel-S10 would result in a decrease to the fair value of US$5,319,000. A 20% decrease in the probability of success used would result in a decrease to the fair value of US$17,320,000. An increase of 20% in the probability of success with the FDA approval would result in a decrease to the fair value of US$12,982,000. 16. Events after the reporting period Development Pipeline On April 22, 2022, the CHMP has adopted a positive opinion, recommending the approval of Filsuvez® in the EU for the treatment of partial thickness wounds associated with dystrophic and junctional EB in patients six months and older. Based on this CHMP recommendation a decision by the EC is expected on the Filsuvez® application within 67 days. The CHMP positive opinion is supported by Phase 3 data from the EASE trial which was the largest ever global trial conducted in patients with EB, performed across 58 sites in 28 countries. There were no other significant events since the end of the reporting period.
AMYT CHMA | finance.yahoo | about 3 years ago | Neutral

Amryt Announces 22% growth in FY 2021 Revenues to $222.5MAmryt Announces 22% growth in FY 2021 Revenues to $222.5M Issuing FY 2022 revenue guidance of $260M - $270M, representing 17%-21% YoY growth Cash of $113.0M at December 31, 2021 Board approves stock repurchase program of up to $30M 8th consecutive quarter of positive EBITDA generation 32% YoY g...
Amryt Announces 22% growth in FY 2021 Revenues to $222.5M Issuing FY 2022 revenue guidance of $260M - $270M, representing 17%-21% YoY growth Cash of $113.0M at December 31, 2021 Board approves stock repurchase program of up to $30M 8th consecutive quarter of positive EBITDA generation 32% YoY growth in metreleptin revenues Successful bioavailability study supporting development of Mycapssa® for carcinoid symptoms in NET Global NET market opportunity is estimated to be approx. $1.9bn* Conference call and webcast today at 0830 EST / 1330 GMT DUBLIN, Ireland, and Boston MA, March 9, 2022, Amryt (Nasdaq: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today provides a business update and unaudited financial results for Q4 2021 and the full year ended December 31, 2021. Joe Wiley, CEO of Amryt Pharma, commented: “I am very pleased with today’s strong results for 2021 which demonstrate the positive performance and growth that our three commercial products are delivering across a host of metrics including revenue, EBITDA, cash generation and market expansion. Our revenues grew 22% in the year and in particular, metreleptin delivered very impressive 32% revenue growth in 2021. This strong revenue performance drove our eighth consecutive quarter of positive EBITDA and generated full year operating cash flows before Chiasma deal costs of $29.8M. During the year, we completed the acquisition of Chiasma and I am pleased to report that the integration process is well advanced. We are making significant progress both with the relaunch of Mycapssa® and in advancing new growth opportunities for this key product. Yesterday, we announced the completion of a successful bioavailability study for Mycapssa®. These data support a planned Phase 3 study for Mycapssa® in the treatment of patients with carcinoid symptoms due to neuroendocrine tumors (NET). Mycapssa® is the only FDA approved oral formulation of octreotide for the treatment of acromegaly. The current pharmaceutical standard of care for NET patients with carcinoid symptoms is injectable somatostatin anologs (SSAs). This potential additional indication, if approved, creates a substantial new market opportunity for Amryt. We also recently refinanced our term debt facilities which further strengthens our balance sheet, significantly reduces our interest costs and extends the maturity profile of those facilities through 2027. Given the strength of our balance sheet and the sustained performance and growth of our business, the board has approved a share repurchase program of up to $30M that reflects the confidence we have in Amryt’s future. Finally, today we are issuing revenue guidance for FY 2022 of $260M-$270M million which represents growth of 17%-21% on 2021.” FY 2021 Financial Highlights 21.9% growth in FY 2021 revenues YoY to $222.5M (2020: $182.6M) driven by 32.2% increase in metreleptin revenues Operating loss before finance expense for FY 2021 of $71.2M (2020: $46.5M). Excluding non-cash items, acquisition and severance related costs and share based compensation expenses, EBITDA for FY 2021 amounted to $41.9M Strong cash generation during 2021 with $29.8M of cash from operating activities before Chiasma deal costs Cash of $113.0M at December 31, 2021 (2020: $118.8M) FY 2021 & Recent Business Highlights Completed $125M non-dilutive debt refinancing - significantly reducing interest expense and cost of capital and extending term debt maturity through 2027 Chiasma acquisition announced, completed and integration well advanced Completed AIM delisting Reimbursement approval for metreleptin in England, Wales and France Lancet Diabetes & Endocrinology publishes positive results for the MPOWERED Phase 3 trial for Mycapssa® Announced positive long-term safety and efficacy data confirming the role for Mycapssa® in the management of acromegaly patients who have responded to and tolerated treatment with octreotide and lanreotide Successful bioavailability study for Mycapssa® - global NET market opportunity is estimated to be approx. $1.9bn* with US market opportunity estimated to be approx. $1.0bn* Global Phase 3 study to support US label expansion for metreleptin in the treatment of partial lipodystrophy (PL) initiated in Q4 Expected 2022 Newsflow European Medicines Agency (EMA) review of Oleogel-S10 MAA ongoing. Ad-Hoc Expert Group scheduled Mar 15 Oleogel-S10 End of Review conference with FDA anticipated Q2 2022 Mycapssa® NET program - written responses to a Type C meeting request are anticipated to be received Q2 2022 Lomitapide pediatric HoFH top-line data anticipated H2 2022 Mycapssa® EMA MAA CHMP opinion for acromegaly indication anticipated H2 2022 Mycapssa® NET program - Phase 3 study initiation anticipated Q4 2022 IFRS and non-GAAP adjusted Q4 2021 & FY 2021 Results US$MQ4 2020 (unaudited) Q4 2021 (unaudited)Q4 2021 Non-cash adjustments1Q4 2021 Non-GAAP AdjustedFY 2021 (unaudited)FY 2021 Non-cash adjustments2FY 2021 Non-GAAP AdjustedRevenue42.554.8-54.8222.5-222.5Gross profit12.625.617.643.2116.453.4169.8R&D(5.1)(9.3)-(9.3)(37.7)-(37.7)SG&A(19.8)(29.6)0.7(28.9)(92.0)1.8(90.2)Acquisition & severance related costs-(2.3)-(2.3)(16.9)-(16.9)Share based compensation expenses(1.6)(2.4)2.4-(8.3)8.3-Impairment charge-(32.6)32.6-(32.6)32.6-Operating (loss) / profit before finance expense(13.9)(50.5)53.32.73(71.2)96.125.03Operating (loss) / profit before finance expense and restructuring and severance related costs (EBITDA3)(13.9)(48.2)53.35.03(54.3)96.141.93 $50.5M operating loss before finance expense for Q4 2021 (Q4 2020: $13.9M operating loss). Excluding non-cash items, share based compensation expenses, impairment charges and Chiasma restructuring and acquisition costs, this resulted in EBITDA3 before restructuring and acquisition costs of $5.0M3 for Q4 2021 and $41.9M3 for FY 2021. 1Non-cash items in Q4 include amortisation of the acquired metreleptin, lomitapide and Mycapssa® intangible assets ($14.8M), amortisation of the inventory fair value step-up related to the acquisition of Chiasma ($2.8M), depreciation and amortisation ($0.7M), impairment charge ($32.6M) and share based compensation expenses ($2.4M). 2Non-cash items for FY21 include amortisation of the acquired metreleptin, lomitapide and Mycapssa® intangible assets ($49.0M), amortisation of the inventory fair value step-up related to the acquisition of Chiasma and Aegerion ($4.4M), depreciation and amortisation ($1.8M), impairment charge ($32.6M) and share based compensation expenses ($8.3M). 3EBITDA, as applied in the above table, is defined as earnings before interest, tax, depreciation, amortisation, impairment, restructuring and severance related costs and share based compensation expenses. To supplement Amryt's financial results presented in accordance with IFRS generally accepted accounting principles, the Company uses EBITDA as a key measure of company performance as the Company believes that this measure is most reflective of the operational profitability or loss of the Company and provides management and investors with useful supplementary information which can enhance their ability to evaluate the operating performance of the business. EBITDA, as measured by the Company, is not meant to be considered in isolation or as a substitute to operating profit / loss attributable to Amryt and should be read in conjunction with the Company's condensed consolidated financial statements prepared in accordance with IFRS. *Based on management estimates FY 2021 Commercial Product Performance FY 2021 (unaudited)USEMEAOtherTotalUS$’000US$’000US$’000US$’000Metreleptin70,21651,76919,257141,242Lomitapide32,90128,60112,36573,867Mycapssa®6,407——6,407Other—7662611,027Total revenue109,52481,13631,883222,543 FY 2020 (audited)USEMEAOtherTotalUS$’000US$’000US$’000US$’000Metreleptin60,56832,49413,810106,872Lomitapide37,31726,14411,28974,750Mycapssa®————Other—763222985Total revenue97,88559,40125,321182,607 Q4 2021 Commercial Product Performance Q4 2021 (unaudited)USEMEAOtherTotalUS$’000US$’000US$’000US$’000Metreleptin17,49012,1752,26531,930Lomitapide7,5197,2632,91317,695Mycapssa®4,954——4,954Other—18467251Total revenue29,96319,6225,24554,830 Q4 2020 (unaudited)USEMEAOtherTotalUS$’000US$’000US$’000US$’000Metreleptin15,1116,26179622,168Lomitapide9,2707,4613,43320,164Mycapssa®————Other—190—190Total revenue24,38113,9124,22942,522 21.9% revenue growth in FY 2021 YoY to $222.5M (FY 2020: $182.6M) 28.9% revenue growth in Q4 2021 YoY to $54.8M (Q4 2020: $42.5M) 32.2% increase in metreleptin revenues to $141.2M in FY 2021 (2020: $106.9M) Metreleptin grew 15.9% annually in the US, 59.3% in EMEA and 39.4% in ROW US accounted for 49.7% of global metreleptin revenues and EMEA accounted for 36.7% in FY 2021 Metreleptin revenues in Q4 2021 were $31.9M representing a 44.0% increase on Q4 2020 ($22.2M) Relaunch of Mycapssa® initiated - revenues in Q4 were $5.0M (Q3 2021: $1.4M), all of which were US based 1.2% decrease in lomitapide revenues to $73.9M in FY 2021 (2020: $74.8M ) Lomitapide revenues in Q4 2021 were $17.7M (Q4 2020: $20.2M) EMEA lomitapide revenues grew 9.4% YoY in FY 2021 and ROW revenues increased by 9.5% YoY US accounted for 44.5% of global lomitapide revenues and EMEA accounted for 38.7% in FY 2021 Oleogel-S10 On February 28, 2022, Amryt announced that the FDA communicated that it had completed its review of the NDA for Oleogel-S10 and has determined that the application cannot be approved in its present form. The FDA has asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in EB. During Q2 2022, Amryt intends to discuss with the FDA the nature of the data required to address the Agency’s concerns. The EMA review process for Oleogel-S10 in EB is ongoing and Amryt has responded to outstanding questions. Given the rarity of the disease without any approved therapies, the EMA has proposed that an Ad-Hoc Expert Group, comprised of both EB clinical experts and patients with EB, be consulted to provide external and independent EB specific advice. The Ad-Hoc Expert Group is scheduled to meet on March 15, 2022. Financial Position In February 2022, the Company completed a $125M non-dilutive debt refinancing which will generate significant annual interest cost savings and extend the maturity of Amryt’s debt facilities through February 2027. The facilities also provide strategic flexibility as Amryt looks to grow its global rare disease presence. Cash generated from operating activities before Chiasma deal costs in 2021 was $29.8M. During the year, the Company paid $12.3M in net finance payments, $3.9M in residual payments related to legacy fines levied on Aegerion, $116.6M on the payment of Chiasma related debt, $16.9M acquisition & restructuring costs and $1.5M in capital expenditure. Cash of $113.0M at December 31, 2021 (2020: $118.8M) is after repayment of outstanding Chiasma debt, transaction and integration related costs in the period. Share Repurchase Program The board of directors has approved a stock repurchase program for the purchase of up to $30 million of the Company’s shares at any time. The shares may be repurchased from time to time in the open market or in privately negotiated transactions. The timing, number of shares repurchased, and prices paid for the stock under this program will depend on a variety of factors, including general business and market conditions as well as corporate and regulatory limitations. The Company anticipates funding for this program to come from available corporate funds, including cash on hand and future cash flow. The term of the board authorization of the repurchase program is until March 8, 2023. There is no guarantee as to the number of shares that will be repurchased, and the repurchase program may be extended, suspended, or discontinued at any time without prior notice at the Company's discretion. Guidance & Outlook Given the continued strong performance of the Company’s three commercial products, the board is today issuing revenue guidance for FY 2022 in the range of $260M - $270M which represents growth of 17% to 21% on FY 2021. Conference Call & Webcast Amryt will host a conference call and webcast for analysts and investors today at 0830 EST/1330 GMT. Webcast Player URL:https://edge.media-server.com/mmc/p/ebranod7 Telephone Dial in details: United States +1 646 741 3167United Kingdom+44 (0) 207 192 8338Ireland +353 (1) 506 0650 Confirmation Code3077366 A playback facility will be available from March 9, 2022 at 1330 EST / 1830 GMT– March 16, 2022 at 1330 EST / 1830 GMT. Access details for the playback facility are as follows: Confirmation Code: 3077366 | US: + 1 917 677 7532 | UK: +44 (0) 333 300 9785 | Ireland : +353 (1) 553 8777. About Amryt Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets. Amryt’s commercial business comprises three orphan disease products – metreleptin (Myalept®/ Myalepta®); oral octreotide (Mycapssa®); and lomitapide (Juxtapid®/ Lojuxta®). Myalept®/Myalepta® (metreleptin) is approved in the US (under the trade name Myalept®) as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in the EU (under the trade name Myalepta®) as an adjunct to diet for the treatment of leptin deficiency in patients with congenital or acquired GL in adults and children two years of age and above and familial or acquired partial lipodystrophy (PL) in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control. For additional information, please follow this link. Mycapssa® (octreotide capsules) is approved in the US for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. Mycapssa® is the first and only oral somatostatin analogapproved by the FDA. Mycapssa® has also been submitted to the EMA and is not yet approved in Europe. For additional information, please follow this link. Juxtapid®/Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia ("HoFH") in the US, Canada, Colombia, Argentina and Japan (under the trade name Juxtapid®) and in the EU, Israel, Saudi Arabia and Brazil (under the trade name Lojuxta®). For additional information, please follow this link. Amryt's lead development candidate, Oleogel-S10 is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (EB), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. Filsuvez® has been selected as the brand name for Oleogel-S10. The product does not currently have regulatory approval to treat EB. Amryt’s pre-clinical gene therapy candidate, AP103, offers a potential treatment for patients with Dystrophic EB, and the polymer-based delivery platform has the potential to be developed for the treatment of other genetic disorders. Amryt also intends to develop oral medications that are currently only available as injectable therapies through its Transient Permeability Enhancer (TPE®) technology platform. For more information on Amryt, including products, please visit www.amrytpharma.com. Forward-Looking Statements This announcement may contain forward-looking statements and the words "expect", "anticipate", "intends", "plan", "estimate", "aim", "forecast", "project" and similar expressions (or their negative) identify certain of these forward-looking statements. The forward-looking statements in this announcement are based on numerous assumptions and Amryt's present and future business strategies and the environment in which Amryt expects to operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. These statements are not guarantees of future performance or the ability to identify and consummate investments. Many of these risks and uncertainties relate to factors that are beyond Amryt's ability to control or estimate precisely, such as future market conditions, the course of the COVID-19 pandemic, currency fluctuations, the behaviour of other market participants, the outcome of clinical trials, the actions of regulators and other factors such as Amryt's ability to obtain financing, changes in the political, social and regulatory framework in which Amryt operates or in economic, technological or consumer trends or conditions. Past performance should not be taken as an indication or guarantee of future results, and no representation or warranty, express or implied, is made regarding future performance. No person is under any obligation to update or keep current the information contained in this announcement or to provide the recipient of it with access to any additional relevant information that may arise in connection with it. Such forward-looking statements reflect the Company’s current beliefs and assumptions and are based on information currently available to management. Contacts Joe Wiley, CEO / Rory Nealon, CFO/COO, +353 (1) 518 0200, ir@amrytpharma.com Tim McCarthy, LifeSci Advisors, LLC, +1 (212) 915 2564, tim@lifesciadvisors.com Amryt Pharma plc Condensed Consolidated Statement of Comprehensive Income/(Loss) Three Months Ended December 31,Year Ended December 31, Note2021 (unaudited)2020 (unaudited)2021 (unaudited)2020 (audited) US$’000US$’000 US$’000US$’000Revenue354,83042,522 222,543182,607Cost of sales (29,186)(29,881) (106,119)(119,029)Gross profit 25,64412,641 116,42463,578Research and development expenses (9,275)(5,137) (37,729)(27,618)Selling, general and administrative expenses (29,557)(19,790) (91,995)(76,673)Restructuring and acquisition costs5(2,268)(12) (16,947)(1,017)Share based payment expenses4(2,436)(1,593) (8,341)(4,729)Impairment charge7(32,623)— (32,623)—Operating loss before finance expense (50,515)(13,891) (71,211)(46,459)Non-cash change in fair value of contingent consideration535,520(19,677) 26,623(27,827)Non-cash contingent value rights gain/(loss)548,198(7,506) 42,683(12,004)Net finance expense - other (7,743)(4,077) (27,906)(19,569)Profit/(loss) on ordinary activities before taxation 25,460(45,151) (29,811)(105,859)Tax (charge)/credit on loss on ordinary activities (3,086)(1,839) 11,6401,332Profit/(loss) for the year attributable to the equity holders of the Company 22,374(46,990) (18,171)(104,527)Exchange translation differences which may be reclassified through profit or loss 1,797686 4,380(2,164)Total other comprehensive income/(loss) 1,797686 4,380(2,164)Total comprehensive income/(loss) for the year attributable to the equity holders of the Company 24,171(46,304) (13,791) (106,691) Earnings/(loss) per share Basic profit/(loss) per share attributable to ordinary equity holders of the parent (US$)60.07(0.28) (0.08)(0.66)Diluted profit/(loss) per share attributable to ordinary equity holders of the parent (US$)60.07(0.28) (0.08)(0.66) Amryt Pharma plc Condensed Consolidated Statement of Financial Position As at December 31, Note2021 (unaudited) 2020 (audited) US$’000US$’000Assets Non-current assets Goodwill7 56,688 19,131Intangible assets7 434,667 305,369Property, plant and equipment 7,416 7,574Other non-current assets 1,885 1,542Total non-current assets 500,656 333,616Current assets Trade and other receivables8 53,908 43,185Inventories9 115,769 40,992Cash and cash equivalents, including restricted cash10 113,032 118,798Total current assets 282,709 202,975Total assets 783,365 536,591 Equity and liabilities Equity attributable to owners of the parent Share capital11 25,500 13,851Share premium11 318,153 51,408Other reserves11 246,260 236,488Accumulated deficit (252,466) (235,605)Total equity 337,447 66,142Non-current liabilities Contingent consideration and contingent value rights5 71,723 148,323Deferred tax liability 13,684 6,612Long term loan12 93,395 87,302Convertible notes13 105,788 101,086Provisions and other liabilities14 4,049 25,951Total non-current liabilities 288,639 369,274Current liabilities Trade and other payables15 149,734 90,236Provisions and other liabilities14 7,545 10,939Total current liabilities 157,279 101,175Total liabilities 445,918 470,449Total equity and liabilities 783,365 536,591 Amryt Pharma plc Condensed Consolidated Statement of Cash Flows Year ended December 31,Note2021 (unaudited)2020 (audited)US$’000US$’000Cash flows from operating activities Loss on ordinary activities after taxation (18,171) (104,527)Net finance expense - other 27,906 19,569Depreciation and amortization 50,744 44,465Amortization of inventory fair value step-up 4,418 27,617Loss on disposal of fixed assets 173 133Share based payment expenses4 8,341 4,729Non-cash change in fair value of contingent consideration5 (26,623) 27,827Non-cash contingent value rights (gain)/loss5 (42,683) 12,004Impairment of intangible asset7 32,623 —Deferred taxation credit (13,355) (535)Movements in working capital and other adjustments: Change in trade and other receivables8 (3,544) (7,685) Change in trade and other payables 11,758 8,909 Change in provision and other liabilities 14 (3,292) 4,663 Change in inventories (13,288) (10,609) Change in non-current assets 524 331Net cash flow from operating activities 15,531 26,891 Cash flow from investing activities Net cash received on acquisition of subsidiary, less acquisition costs 107,942 —Payments for property, plant and equipment (729) (1,503)Payments for intangible assets (816) (963)Deposit interest received 5 87Net cash flow from/(used in) investing activities 106,402 (2,379) Cash flow from financing activities Proceeds from issue of equity instruments 4,701 37,927Repayment of long-term debt on acquisition of subsidiary5 (116,629) —Interest paid (12,283) (10,780)Payment of leases (1,215) (1,119)Net cash flow (used in)/from financing activities (125,426) 26,028 Exchange and other movements (2,273) 1,029 Net change in cash and cash equivalents (5,766) 51,569Cash and cash equivalents at beginning of the year 118,798 67,229Restricted cash at end of the period10 261 223Cash at bank available on demand at end of the year10 112,771 118,575Total cash and cash equivalents at end of the year10 113,032 118,798 Amryt Pharma plc Condensed Consolidated Statement of Changes in Equity For the year ended December 31, 2021 NoteShare capitalShare premiumWarrant reserveTreasury sharesShare based payment reserveMerger reserveReverse acquisition reserveEquity component of convertible notesOther distributable reservesCurrency translation reserveAccumulated deficitTotal US$’000US$’000US$’000US$’000US$’000US$’000US$’000US$’000US$’000US$’000US$’000US$’000Balance at January 1, 2020 (audited) 11,9182,42229,523(7,534)3,19042,627(73,914)29,210217,6347,894(131,137)131,833Loss for the year ——————————(104,527)(104,527)Foreign exchange translation reserve —————————(2,164)—(2,164)Total comprehensive loss —————————(2,164)(104,527)(106,691)Transactions with owners Issue of shares in exchange for warrants1163014,131(14,761)—————————Issue of shares in equity fund raise 1,30338,697—————————40,000Issue costs associated with equity fund raise —(3,848)—————————(3,848)Issue of treasury shares for share options exercised —6—113———————119Share based payment expense4————4,729——————4,729Share based payment expense – Lapsed ————(59)—————59—Total transactions with owners 1,93348,986(14,761)1134,670—————5941,000Balance at December 31, 2020 (audited) 13,85151,40814,762(7,421)7,86042,627(73,914)29,210217,6345,730(235,605)66,142Balance at January 1, 2021 (audited) 13,85151,40814,762(7,421)7,86042,627(73,914)29,210217,6345,730(235,605)66,142Loss for the year ——————————(18,171)(18,171)Foreign exchange translation reserve —————————4,380—4,380Total comprehensive loss —————————4,380(18,171)(13,791)Transactions with owners Issue of treasury shares in exchange for warrants112399—439———————561Issue of treasury shares for share options exercised112589—465(191)——————388Issue of shares and treasury shares in exchange for warrants 117497,496(14,762)6,517————————Issue of shares in consideration of Chiasma acquisition510,547249,789—————————260,336Share based payment reserve recognized on Chiasma acquisition11————10,157——————10,157Issue of shares for share options exercised and vesting of RSUs113059,272——(4,264)——————5,313Share based payment expense4————8,341——————8,341Share based payment expense – Lapsed ————(1,310)—————1,310—Total transactions with owners 11,649266,745(14,762)7,42112,733—————1,310285,096Balance at December 31, 2021 (unaudited) 25,500318,153——20,59342,627(73,914)29,210217,63410,110(252,466)337,447 1. General information Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets. As used herein, references to ‘‘we,’’ ‘‘us,’’ ‘‘Amryt’’ or the ‘‘Group’’ in these condensed consolidated interim financial statements shall mean Amryt Pharma plc and its global subsidiaries, collectively. References to the ‘‘Company’’ in these condensed consolidated interim financial statements shall mean Amryt Pharma plc. Amryt Pharma plc is a company incorporated in England and Wales. The Company is listed on Nasdaq (ticker: AMYT). Amryt acquired Chiasma, Inc. (“Chiasma”) in August 2021. The combined company will be a global leader in rare and orphan diseases with three on-market commercial products, a global commercial and operational footprint and a significant development pipeline of therapies with the financial flexibility to execute its growth plans. Amryt’s commercial business comprises three orphan disease products – metreleptin (Myalept®/ Myalepta®); oral octreotide (Mycapssa®); and lomitapide (Juxtapid®/ Lojuxta®). Amryt's lead development candidate, Oleogel-S10 is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (EB), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. Filsuvez® has been selected as the brand name for Oleogel-S10. The product does not currently have regulatory approval to treat EB. On February 28, 2022, Amryt announced that the FDA communicated that it had completed its review of the NDA for Oleogel-S10 and has determined that the application cannot be approved in its present form. The FDA has asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in EB. Amryt intends to discuss with the FDA the nature of the data required to address the Agency’s concerns. The European Medicines Agency (“EMA”) review process for Oleogel-S10 in EB is ongoing and Amryt has responded to outstanding questions. Given the rarity of the disease without any approved therapies, the EMA has proposed that an Ad-Hoc Expert Group, comprised of both EB clinical experts and patients with EB, be consulted to provide external and independent EB specific advice. The Committee for Medicinal Products for Human Use (“CHMP”) opinion is now anticipated in March 2022. 2. Accounting policies Basis of preparation The condensed consolidated interim financial statements of the Group have been prepared in accordance with IAS 34: Interim Financial Reporting. They do not include all of the information required in annual financial statements in accordance with International Financial Reporting Standards (‘‘IFRS’’) and should be read in conjunction with the annual consolidated financial statements for the year ended December 31, 2020. Selected explanatory notes are included to explain events and transactions that are significant to an understanding of the Group’s financial position and performance since the last annual financial statements. The accounting policies used in the preparation of the interim financial information are the same as those used in the Group’s audited financial statements for the year ended December 31, 2020, and those which are expected to be used in the financial statements for the year ended December 31, 2021. Basis of going concern Having considered the Group’s current financial position and cash flow projections, the Board of Directors believes that the Group will be able to continue in operational existence for at least the next 12 months from the date of approval of these condensed consolidated interim financial statements and that it is appropriate to continue to prepare the condensed consolidated interim financial statements on a going concern basis. As part of their inquiries, the Board of Directors reviewed budgets, projected cash flows, and other relevant information for a period not less than 12 months from the date of approval of the condensed consolidated interim financial statements for the year ended December 31, 2021. Basis of consolidation The condensed consolidated interim financial statements comprise the financial statements of the Group for the year ended December 31, 2021. Subsidiaries are entities controlled by the Company. Where the Company has control over an investee, it is classified as a subsidiary. The Company controls an investee if all three of the following elements are present: power over an investee, exposure, or rights to variable returns from its involvement with the investee and the ability to use its power to affect those variable returns. Control is reassessed whenever facts and circumstances indicate that there may be a change in any of these elements of control. Subsidiaries are fully consolidated from the date that control commences until the date that control ceases. Accounting policies of subsidiaries have been changed where necessary to ensure consistency with the policies adopted by the Group. Intergroup balances and any unrealized gains or losses, income or expenses arising from intergroup transactions are eliminated in preparing the condensed consolidated interim financial statements. Presentation of balances The condensed consolidated interim financial statements are presented in U.S. dollars (‘‘US$’’), rounded to the nearest thousand, which is the functional currency of the Company and presentation currency of the Group. The following table discloses the major exchange rates of those currencies other than the functional currency of US$ that are utilized by the Group: Foreign currency units to 1 US$ € £ ILS NOK DKKAverage three-month period to December 31, 2021 (unaudited) 0.8743 0.7420 3.1571 8.7336 6.5026Average 12-month period to December 31, 2021 (unaudited) 0.8454 0.7271 3.2322 8.5975 6.2875At December 31, 2021 (unaudited) 0.8830 0.7413 3.1115 8.8074 6.5664 Foreign currency units to 1 US$ € £ ILS NOK DKKAverage three-month period to December 31, 2020 (unaudited) 0.8391 0.7578 3.3123 9.0381 6.2461Average 12-month period to December 31, 2020 (unaudited) 0.8777 0.7799 3.4351 9.4206 6.5432At December 31, 2020 (unaudited) 0.8141 0.7365 3.2148 8.5671 6.0570 (€ = Euro; £ = Pounds Sterling, ILS = Israeli Shekel, NOK = Norwegian Kroner, DKK = Danish Kroner) Changes in accounting policies and disclosures There are no new standards and amendments to IFRS effective as of January 1, 2021, that are relevant to the Group. Critical accounting judgements and key sources of estimation uncertainty In preparing these condensed consolidated interim financial statements in conformity with IFRS management is required to make judgements, estimates and assumptions that affect the application of policies and amounts reported in the condensed consolidated interim financial statements and accompanying notes. The estimates and associated assumptions are based on historical experience and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis of making the judgements about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates. The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimate is revised if the revision affects only that period or in the period of the revision and future periods if the revision affects both current and future periods. The significant estimates, assumptions or judgements, applied in the condensed consolidated interim financial statements were the same as those applied in the Group’s audited financial statements for the year ended December 31, 2020. Principal accounting policies The condensed consolidated interim financial statements have been prepared in accordance with the accounting policies adopted in the Group’s audited financial statements for the year ended December 31, 2020. 3. Segment information The Group is a global, commercial-stage biopharmaceutical company dedicated to commercializing and developing novel therapeutics to treat patients suffering from serious and life-threatening rare diseases. The Group currently operates as one business segment, pharmaceuticals, and is focused on the development and commercialization of three commercial products and a number of development products. The Group derives its revenues primarily from one source, being the pharmaceutical sector with high unmet medical need. The Group’s Chief Executive Officer, Joseph Wiley, is currently the Company’s chief operating decision maker (‘‘CODM’’). The Group does not operate any separate lines of business or separate business entities with respect to its products. Accordingly, the Group does not accumulate discrete financial information with respect to separate service lines and does not have separate reportable segments. The following table summarizes total revenues from external customers by product and by geographic region, based on the location of the customer. Three months ended December 31, 2021 (unaudited) U.S.EMEAOtherTotal US$’000US$’000US$’000US$’000Metreleptin17,49012,1752,26531,930Lomitapide7,5197,2632,91317,695Mycapssa®4,954——4,954Other—18467251Total revenue29,96319,6225,24554,830 Three months ended December 31, 2020 (unaudited) U.S.EMEAOtherTotal US$’000US$’000US$’000US$’000Metreleptin15,1116,26179622,168Lomitapide9,2707,4613,43320,164Mycapssa®————Other—190—190Total revenue24,38113,9124,22942,522 Year ended December 31, 2021 (unaudited) U.S.EMEAOtherTotal US$’000US$’000US$’000US$’000Metreleptin70,21651,76919,257141,242Lomitapide32,90128,60112,36573,867Mycapssa®6,407——6,407Other—7662611,027Total revenue109,52481,13631,883222,543 Year ended December 31, 2020 (audited) U.S.EMEAOtherTotal US$’000US$’000US$’000US$’000Metreleptin60,56832,49413,810106,872Lomitapide37,31726,14411,28974,750Mycapssa®————Other—763222985Total revenue97,88559,40125,321182,607 Major Customers For the three months and year ended December 31, 2021, one customer accounted for 46% of the Group’s net revenues in both periods (2020: 57% and 54%, respectively) and accounted for 36% of the Group’s December 31, 2021, accounts receivable balance (December 31, 2020: 42%). 4. Share based payments Share-based Compensation Plans Amryt’s Equity Incentive Plan Amryt’s Equity Incentive Plan was established by a special resolution on September 23, 2019, and was subsequently amended by the Board on May 18, 2020, and August 3, 2021. The purpose of the Plan is to provide for the granting of Equity Incentives to Directors and Employees of, and Consultants to, the Company or any Associated Company. Chiasma Equity Incentive Plan When Amryt acquired Chiasma in August 2021, the Chiasma Stock Option and Incentive Plan transferred across to Amryt. Each outstanding and unexercised Chiasma Stock Option or RSU, whether vested or not vested, ceased to represent a right to acquire shares of Chiasma common stock and were converted into an option to purchase Amryt ADSs on the same terms and conditions as were applicable under such Chiasma Stock Option and Incentive Plan immediately prior to the acquisition. No new stock option or RSUs will be granted under the Chiasma stock option and incentive plan. Terms and Conditions of New Grants and Grants Under the Chiasma Equity Incentive Plan The terms and conditions of new grants are as follows, whereby all options are settled by physical delivery of shares: Vesting conditions The employee share options vest following a period of service by the officer or employee. The required period of service is determined by the Remuneration Committee at the date of grant of the options (usually the date of approval by the Remuneration Committee). There are no market conditions associated with the share option vesting periods. Contractual life The term of an option is determined by the Remuneration Committee provided that the term may not exceed a period of seven to ten years from the date of grant. All options will terminate 90 days after termination of the option holder’s employment, service or consultancy with the Group except where a longer period is approved by the Board of Directors. Under certain circumstances involving a change in control of the Group, some options will automatically accelerate and become exercisable in full as of a date specified by the Board of Directors. The number and weighted average exercise price (in Sterling pence) of share options per ordinary share granted under Amryt’s Equity Incentive Plan and the Chiasma stock option and incentive plan is as follows: Amryt Equity Incentive PlanChiasma Stock Option and Incentive Plan UnitsWeighted average exercise price (Sterling pence)UnitsWeighted average exercise price (Sterling pence)Balance at 1 January 2020 14,481,720116.00p——Granted 4,432,000144.76p——Lapsed(87,119)113.42p——Exercised(72,953)120.72p——Outstanding at December 31, 2020 (audited)18,753,648122.79p——Exercisable at December 31, 2020 (audited)5,866,152114.24p—— Balance at January 1, 202118,753,648122.79p——Granted11,337,459190.88p——Transferred to Amryt on acquisition——18,139,060189.07pForfeited(1,288,165)174.97p(4,098,425)226.22pExercised(300,000)93.00p(3,320,515)116.35pOutstanding at December 31, 2021 (unaudited) 28,502,942147.83p10,720,120197.40pExercisable at December 31, 2021 (unaudited)9,347,338118.87p8,005,390192.35p The fair value of the Amryt equity award is estimated at the date of grant using the Black-Scholes pricing model, taking into account the terms and conditions attached to the grant. The fair value of the Chiasma equity awards transferred to Amryt on acquisition were measured in accordance with IFRS 2. The portion of the value of the equity transferred to Amryt attributable to pre-combination service is included in the consideration at the date of acquisition. The portion of the equity awards transferred to Amryt attributable to post combination service is estimated at the date of transfer using Black Scholes pricing model, taking into account the terms and conditions attached to the grant. The following are the inputs to the model for the equity instruments granted during the period: December 31, 2021 Options Inputs (unaudited)December 31, 2020 Options Inputs (audited)Days to Expiration2,5552,555Volatility32% - 49%33% - 37%Risk free interest rate0.77% - 1.33%0.39% - 0.46%Share price at grant per ordinary share146.87 - 201.2p123.5p – 178.9pShare price at grant per ADS29.37 - 40.2p24.7p – 35.78p In the year ended December 31, 2021, a total of 11,337,459 share options over ordinary shares exercisable at a weighted average price of £1.91 were granted. The fair value of share options granted in the year ended December 31, 2021, was £21,641,094/US$29,818,000. The share options outstanding under the Amryt 2021 Equity Incentive Plan as at December 31, 2021 have a weighted remaining contractual life of 5.42 years with exercise prices ranging from £0.76 to £2.012 per ordinary share. The share options outstanding under the Chiasma Share Option and Incentive Plan transferred across to Amryt on acquisition. As at December 31, 2021 they have a weighted remaining contractual life of 4.35 years with exercise prices ranging from £0.54 to £7.41 per ordinary share. No new share options will be granted under the Chiasma Stock Option and Incentive Plan. Restricted Share Units Under the terms of Amryt’s Equity Incentive Plan, restricted share units (“RSUs”) to purchase 1,568,755 ordinary shares were outstanding at December 31, 2021. Under the terms of this plan, RSUs are granted to officers, consultants and employees of the Group at the discretion of the Remuneration Committee. For the year ended December 31, 2021, a total of 625,205 RSUs were granted to employees of the Company. For the year ended December 31, 2020, a total of 1,556,960 RSUs were granted to employees of the Company. The fair value of the RSUs is based on the share price at the date of grant, with the expense spread over the vesting period. The fair value of RSUs granted in the year ended December 31, 2021, was US$1,636,000. At December 31, 2021, the total RSUs granted to date have a weighted remaining contractual life of 1.9 years. Under the terms of Chiasma’s Stock Option and Incentive Plan transferred to Amryt on acquisition, restricted share units (“RSUs”) to purchase 106,560 ordinary shares were outstanding at December 31, 2021. At December 31, 2021, the total RSUs granted to date have a weighted remaining contractual life of 1.9 years. No new RSUs will be granted under the Chiasma Stock Option and Incentive Plan. The following table summarizes the RSU activity per ordinary share for the period: Amryt Equity Incentive PlanChiasma Stock Option and Incentive Plan UnitsWeighted average fair value (US$)UnitsWeighted average fair value (US$)Balance at January 1, 2021 1,549,910$2.34——Granted 625,205$2.62——Transferred to Amryt on acquisition——202,145$2.75Lapsed(243,505)$2.35(56,405)$2.75Vested(362,855)$2.34(39,180)$2.75Outstanding at December 31, 2021 (unaudited)1,568,755$2.44106,560$2.75 Warrants There are no outstanding warrants at December 31, 2021 (December 31, 2020: 9,312,062). In August 2021, an Amryt institutional investor exercised subscription rights relating to 8,966,520 zero cost warrants. These warrants were issued in September 2019 as part of the Company’s acquisition of Aegerion. Certain institutional investors elected to receive warrants to subscribe for new ordinary shares of £0.06 each in Amryt (“Ordinary Shares”), in place of the same number of Ordinary Shares, as consideration for the Company’s acquisition of Aegerion and their equity investments in the Company in September 2019. Each warrant entitled the holder to subscribe for one Ordinary Share for no additional consideration. Separate warrants consisting of 345,542 as at December 31, 2020, which were issued in connection with the admission to the AIM in 2016, are no longer outstanding; 283,389 warrants were exercised in March 2021 and 62,153 warrants lapsed in April 2021. The number and weighted average exercise price (in Sterling pence) of warrants per ordinary share is as follows: Warrants UnitsWeighted average exercise price (Sterling pence)Balance at January 1, 2020 17,541,8150.03pGranted ——Lapsed——Exercised(8,229,753)—Outstanding at December 31, 2020 (audited)9,312,0620.05pExercisable at December 31, 2020 (audited)9,312,0620.05pBalance at January 1, 20219,312,0620.05pGranted——Lapsed(62,153)1.44pExercised(9,249,909)0.05pOutstanding at December 31, 2021 (unaudited)—0.00p The value of share options and RSU’s charged to the Condensed Consolidated Statement of Comprehensive Income/(Loss) during the period is as follows: Three months ended December 31,Year ended December 31, 2021 (unaudited) 2020 (unaudited)2021 (unaudited)2020 (audited) US$’000 US$’000US$’000US$’000Share option expense2,006 1,224 6,531 4,134RSU expense430 369 1,810 595Total share option expense2,4361,5938,3414,729 5. Business combinations and asset acquisitions Acquisition of Chiasma On May 5, 2021, Amryt announced that it had signed a definitive agreement to acquire Chiasma, Inc. (Nasdaq: CHMA) in an all-stock combination. Under the terms of the transaction, each share of Chiasma common stock issued and outstanding prior to the consummation of the transaction was exchanged for 0.396 Amryt American Depositary Shares (“ADSs”), each representing five Amryt ordinary shares. On August 5, 2021, Amryt completed the acquisition of Chiasma, Inc. and, in conjunction with the completion, Amryt allotted and issued a total of 127,733,680 ordinary shares as consideration for the acquisition. Following the completion, shareholdings in Chiasma were rounded in being converted to Amryt shares using the exchange ratio of 0.396. Roundings in converting Chiasma shareholdings to Amryt shares were finalized in August 2021 and resulted in an additional 7,015 ordinary shares being allotted and issued by Amryt as consideration for the acquisition. In total, these ordinary shares were issued to the former Chiasma Shareholders in the form of 25,548,139 ADSs at US$10.19 per share, to acquire Chiasma for a value of US$260,336,000. On August 5, 2021, Chiasma had outstanding equity awards that were held by Chiasma employees. The fair value of these awards transferred to Amryt on acquisition were measured in accordance with IFRS 2. The portion of the value of the equity transferred to Amryt attributable to pre-combination service is included in the consideration at the date of acquisition and this amounted to US$10,157,000. On August 5, 2021, the Group repaid US$116,629,000 of Chiasma long term debt. The combined company will be a global leader in rare and orphan diseases with three on-market commercial products, a global commercial and operational footprint and a significant development pipeline of therapies with the financial flexibility to execute its growth plans. The table below reflects the fair value of the identifiable net assets acquired in respect of the acquisition completed during the period. Any amendments to fair values will be made within the twelve-month period from the date of acquisition, as permitted by IFRS 3: Business Combinations. The acquired goodwill is attributable principally to the profit generating potential of the businesses, the assembled workforce and benefits arising from embedded infrastructure, that are expected to be achieved from integrating the acquired businesses into the Group’s existing business. No amount of goodwill is expected to be deductible for tax purposes. In the post-acquisition period to December 31, 2021, the business acquired during the current year contributed revenue of US$6,407,000 and a trading loss of US$22,602,000 including restructuring and acquisition costs, to the Group’s results. The full year unaudited revenue and trading loss for the Group had the acquisitions taken place at the start of the year, would have been US$228,554,000 and US$82,532,000 respectively. The gross contractual value of trade and other receivables as at the dates of acquisition amounted to US$7,180,000, which approximated the fair value of these accounts as the amount not expected to be collected was insignificant. The Group incurred acquisition and restructuring related costs of US$2,268,000 and US$16,947,000 for the three-month period and year ended December 31, 2021, respectively, relating to external legal fees, advisory fees, due diligence costs and severance costs related to the acquisition of Chiasma. These costs have been included in operating costs in the Condensed Consolidated Statement of Comprehensive Income/(Loss). The initial assignment of fair values to identifiable net assets acquired has been performed on a provisional basis due to the relative size of the acquisition and the timing of the transaction. Any amendments to these fair values within the twelve-month timeframe from the date of acquisition will be disclosed in the 2022 consolidated financial statements, as stipulated by IFRS 3. Provisional Fair Value as at August 5, 2021 (unaudited) US$’000Assets Non-current assets Intangible assets 215,000Property, plant and equipment 950Other non-current assets 866Total non-current assets 216,816Current assets Trade and other receivables 7,180Inventories 65,907Cash and cash equivalents, including restricted cash 107,942Total current assets 181,029Total assets 397,845 Non-current liabilities Deferred tax liability 21,478Total non-current liabilities 21,478Current liabilities Trade and other payables 144,482Total current liabilities 144,482Total liabilities 165,960 Total identifiable net assets at fair value 231,885Goodwill arising on acquisition 38,608Consideration 270,493 Consideration Issue of fully paid up ordinary shares 260,336Chiasma equity awards recognized as consideration transferred upon the acquisition of Chiasma 10,157Total consideration 270,493 Acquisition of Aegerion Pharmaceuticals On May 20, 2019, Amryt entered into a Restructuring Support Agreement (as subsequently amended on June 12, 2019) and Plan Funding Agreement pursuant to which, among other matters, Amryt agreed to the acquisition of Aegerion Pharmaceuticals, Inc. (‘‘Aegerion’’, subsequently renamed as Amryt Pharmaceuticals Inc.), a former wholly-owned subsidiary of Novelion Therapeutics Inc. (‘‘Novelion’’). On May 20, 2019, Aegerion and its U.S. subsidiary, Aegerion Pharmaceuticals Holdings, Inc., filed voluntary petitions under Chapter 11 of Title 11 of the U.S. Code in the Bankruptcy Court. On September 24, 2019, Amryt completed the acquisition of Aegerion. Amryt acquired Aegerion upon its emergence from bankruptcy in an exchange for ordinary shares and zero cost warrants in Amryt. Amryt issued 85,092,423 effective shares at US$1.793 per share, which is made up of 77,027,423 ordinary shares and 8,065,000 zero cost warrants, to acquire Aegerion for a value of US$152,615,000. As part of the acquisition of Aegerion, it was agreed, for certain Aegerion creditors who wished to restrict their percentage share interest in Amryt’s issued share capital, to issue to the relevant Aegerion creditor, as an alternative to Amryt’s ordinary shares, an equivalent number of new zero cost warrants to subscribe for Amryt’s ordinary shares to be constituted on the terms of the zero cost warrant. As at December 31, 2021, no zero cost warrants were remaining. During the three-month period and year ended December 31, 2021, the Group incurred no additional acquisition and restructuring related costs relating to external legal fees, advisory fees, due diligence costs and severance costs related to the acquisition of Aegerion (December 31, 2020: US$12,000 and US$1,017,000, respectively). Contingent Value Rights Related to the Aegerion acquisition, Amryt issued Contingent Value Rights (‘‘CVRs’’) pursuant to which up to US$85,000,000 may become payable to Amryt’s shareholders and optionholders, who were on the register prior to the completion of the acquisition on September 20, 2019, if certain approval and revenue milestones are met in relation Oleogel-S10, Amryt’s lead product candidate. If any such milestone is achieved, Amryt may elect to pay the holders of CVRs by the issue of Amryt shares or loan notes. If Amryt elects to issue Loan Notes to holders of CVRs, it will settle such loan notes in cash 120 days after their issue. If none of the milestones are achieved, scheme shareholders and optionholders will not receive any additional consideration under the terms of the CVRs. In these circumstances, the value of each CVR would be zero. The terms of the CVRs are as follows: The total CVR payable is up to US$85,000,000 This is divided into three milestones which are related to the success of Oleogel-S10 (the Group’s lead development asset) FDA approval US$35,000,000 upon FDA approval 100% of the amount due if approval is obtained before December 31, 2021, with a sliding scale on a linear basis to zero if before July 1, 2022 EMA approval US$15,000,000 upon EMA approval 100% of the amount due if approval is obtained before December 31, 2021, with a sliding scale on a linear basis to zero if before July 1, 2022 Revenue targets US$35,000,000 upon Oleogel-S10 revenues exceeding US$75,000,000 in any 12-month period prior to June 30, 2024 Payment can at the Board’s discretion be in the form of either: 120-day loan notes (effectively cash), or Shares valued using the 30 day / 45-day VWAP. The CVRs were contingent on the successful completion of the acquisition and, accordingly, have been based on fair value as at September 24, 2019. The CVRs have been classified as a financial liability in the Condensed Consolidated Statement of Financial Position. Given that CVRs were issued to legacy Amryt shareholders in their capacity as owners of the identified acquirer as opposed to the seller in the transaction, management concluded that the most appropriate classification would be to recognize the CVR as a distribution on consolidation instead of goodwill. Measurement of CVRs As at December 31, 2021, the carrying value of the CVRs was US$18,734,000 (December 31, 2020: US$61,417,000). The value of the potential payout was calculated using the probability-weighted expected returns method. Using this method, the potential payment amounts were multiplied by the probability of achievement and discounted to present value. The probability adjusted present values took into account published orphan drug research data and statistics which were adjusted by management to reflect the specific circumstances applicable to the type of product acquired in the Amryt GmbH transaction. The probability chance of success, based on management’s expertise and experience for orphan drugs and taking into account the unique circumstances applying to approval process of this product, was estimated at 60% in the year ended December 31, 2021 (2020: 89%). This estimate reflects the current facts and circumstances at the time of preparation of the unaudited Condensed Consolidated Financial Statements and may change for updated facts and circumstances up until the point in time of filing the Group’s audited annual Consolidated Financial Statements for the year ended December 31, 2021. Discount rates of 10% and 16.5%, as applicable, were used in the calculation of the present value of the estimated contractual cash flows for the year ended December 31, 2021, based on the applicable rates determined on the acquisition date. Management was required to make certain estimates and assumptions in relation to revenue forecasts, timing of revenues and probability of achievement of commercialization of Oleogel-S10. However, management notes that, due to issues outside their control (i.e. regulatory requirements and the commercial success of the product), the timing of when such revenue targets may occur may change. Such changes may have a material impact on the assessment of the expected cash flows of the CVRs. The impact of a 20% increase in the probability of success used would result in an increase to the fair value of US$6,245,000, whereas a decrease would have the opposite effect. Amryt reviews the expected cash flows on a regular basis as the discount on initial recognition is being unwound as financing expenses in the Condensed Consolidated Statement of Comprehensive Income/(Loss) over the life of the obligation. It is reviewed on a quarterly basis and the appropriate finance charge or gain is booked in the Condensed Consolidated Statement of Comprehensive Income/(Loss) on a quarterly basis. The Group received positive topline data from the phase 3 EASE trial of Oleogel-S10 in September 2020. The product does not currently have regulatory approval to treat EB but has been submitted to the FDA for approval and in June 2021, Amryt received confirmation from the FDA that its NDA for Oleogel-S10 had been accepted and granted priority review. On February 28, 2022, Amryt announced that the FDA communicated that it had completed its review of the NDA for Oleogel-S10 and has determined that the application cannot be approved in its present form. The FDA has asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in EB. Amryt intends to discuss with the FDA the nature of the data required to address the Agency’s concerns. In Europe, a MAA for Oleogel-S10 was accepted for assessment by the EMA in March 2021. The EMA review process for Oleogel-S10 in EB is ongoing and Amryt has responded to outstanding questions. Given the rarity of the disease without any approved therapies, the EMA has proposed that an Ad-Hoc Expert Group, comprised of both EB clinical experts and patients with EB, be consulted to provide external and independent EB specific advice. The CHMP opinion is now anticipated in March 2022. The total non-cash gain recognized in the Condensed Consolidated Statement of Comprehensive Income/(Loss) for the three months and year ended December 31, 2021, is US$48,198,000 and US$42,683,000 (December 31, 2020: charge US$7,506,000 and US$12,004,000, respectively). Acquisition of Amryt GmbH (previously ‘‘Birken’’) Amryt DAC signed a conditional share purchase agreement to acquire Amryt GmbH on October 16, 2015 (‘‘Amryt GmbH SPA’’). The Amryt GmbH SPA was completed on April 18, 2016, with Amryt DAC acquiring the entire issued share capital of Amryt GmbH. The consideration included contingent consideration comprising milestone payments and sales royalties as follows: Milestone payments of: €10,000,000 on receipt of marketing approval by the EMA or FDA of a pharmaceutical product containing Betulin as its API for the treatment of EB; €10,000,000 once net ex-factory sales/net revenue of Oleogel S-10 first exceed €50,000,000 in any calendar year; €15,000,000 once net ex-factory sales/net revenue of Oleogel S-10 first exceed €100,000,000 in any calendar year; Royalties of 9% on sales of Oleogel-S10 products for 10 years from first commercial sale. Fair Value Measurement of Contingent Consideration As at December 31, 2021, the fair value of the contingent consideration was estimated to be US$52,989,000 (December 31, 2020: US$86,906,000). The fair value of the contingent consideration included milestone payments determined using probability adjusted present values and probability weighted revenue forecasts (see Note 16, Fair value measurement and financial risk management, for fair value hierarchy applied and impact of key unobservable impact data). The probability adjusted present values took into account published orphan drug research data and statistics which were adjusted by management to reflect the specific circumstances applicable to the type of product acquired in the Amryt GmbH transaction. The probability chance of success, based on management’s expertise and experience for orphan drugs and taking into account the unique circumstances applying to approval process of the product, was estimated at 60% for the period ended December 31, 2021 (December 31, 2020: 89%). This estimate reflects the current facts and circumstances at the time of preparation of the unaudited Condensed Consolidated Financial Statements and may change for updated facts and circumstances up until the point in time of filing the Group’s audited annual Consolidated Financial Statements for the year ended December 31, 2021. A discount rate of 7.9% was used in the calculation of the fair value of the contingent consideration for the year ended December 31, 2021 (December 31, 2020: 14.4%). Amryt reviews the expected cash flows on a regular basis as the discount on initial recognition is being unwound as financing expense/gain in the Condensed Consolidated Statement of Comprehensive Income/(Loss) over the life of the obligation. It is reviewed on a quarterly basis and the appropriate finance charge or gain is booked in the Condensed Consolidated Statement of Comprehensive Income/(Loss) on a quarterly basis. The Group received positive topline data from the phase 3 EASE trial of Oleogel-S10 in September 2020. The product does not currently have regulatory approval to treat EB but has been submitted to the FDA for approval and in June 2021, Amryt received confirmation from the FDA that its NDA for Oleogel-S10 had been accepted and granted priority review. On February 28, 2022, Amryt announced that the FDA communicated that it had completed its review of the NDA for Oleogel-S10 and has determined that the application cannot be approved in its present form. The FDA has asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in EB. Amryt intends to discuss with the FDA the nature of the data required to address the Agency’s concerns. In Europe, a MAA for Oleogel-S10 was accepted for assessment by the EMA in March 2021. The EMA review process for Oleogel-S10 in EB is ongoing and Amryt has responded to outstanding questions. Given the rarity of the disease without any approved therapies, the EMA has proposed that an Ad-Hoc Expert Group, comprised of both EB clinical experts and patients with EB, be consulted to provide external and independent EB specific advice. The CHMP opinion is now anticipated in March 2022. The total non-cash finance gain recognized in the Condensed Consolidated Statement of Comprehensive Income/(Loss) for the three months and year ended December 31, 2021, is US$35,520,000 and US$26,623,000 (December 31, 2020: charge of US$19,677,000 and US$27,827,000, respectively). 6. Earnings/(loss) per share – basic and diluted The weighted average number of shares in the earnings and loss per share (‘‘LPS’’) calculation, reflects the weighted average total actual shares of Amryt Pharma plc in issue at December 31, 2021. Issued share capital – ordinary shares of £0.06 each Number of shares Weighted average shares As at December 31 Three months ended December 31,Year ended December 31,2021 (unaudited)319,814,747 318,881,440 235,852,0232020 (unaudited)178,801,593 166,974,713 158,591,356 The calculation of earnings/(loss) per share is based on the following: Three months ended December 31,Year ended December 31, 2021 (unaudited) 2020 (unaudited)2021 (unaudited)2020 (audited)Profit/(loss) after tax attributable to equity holders of the Company (US$’000)22,374 (46,990) (18,171) (104,527)Weighted average number of ordinary shares in issue318,881,440 166,974,713 235,852,023 158,591,356Fully diluted average number of ordinary shares in issue328,050,794 166,974,713 235,852,023 158,591,356Basic earnings/(loss) per share (US$)0.07 (0.28)(0.08)(0.66)Diluted earnings/(loss) per share (US$)0.07 (0.28)(0.08)(0.66) Where a loss has occurred, basic and diluted LPS are the same because the outstanding share options and warrants are anti-dilutive. Accordingly, diluted LPS equals the basic LPS. The share options, RSUs and warrants outstanding as at December 31, 2021, totaled 40,898,377 (December 31, 2020: 29,615,620) and are potentially dilutive. 7. Intangible assets and goodwill The following table summarizes the Group’s intangible assets and goodwill: Developed technology - metreleptinDeveloped technology - lomitapideDeveloped technology - Mycapssa®In process R&DOther intangible assetsTotal intangible assetsGoodwill US$’000US$’000US$’000US$’000US$’000US$’000US$’000Cost At January 1, 2020 (audited)176,000123,000—54,261701353,96219,131Additions————372372—Acquired assets———591—591—Disposals————(246)(246)—Foreign exchange movement———5,276395,315—At December 31, 2020 (audited)176,000123,000—60,128866359,99419,131Additions————847847—Acquired assets——215,000——215,00038,608Other movements——————(1,051)Foreign exchange movement———(4,691)(61)(4,752)—At December 31, 2021 (unaudited)176,000123,000215,00055,4371,652571,08956,688 Accumulated amortization At January 1, 2020 (audited)7,3144,143——17811,635—Amortization charge27,42915,537——20243,168—Accumulated amortization on disposals————(246)(246)—Foreign exchange movement————6868—At December 31, 2020 (audited)34,74319,680——20254,625—Amortization charge27,42815,5375,979—14749,091—Impairment charge———32,623—32,623—Foreign exchange movement———701383—At December 31, 2021 (unaudited)62,17135,2175,97932,693362136,422— Net book value At December 31, 2020 (audited)141,257103,320—60,128664305,36919,131At December 31, 2021 (unaudited)113,82987,783209,02122,7441,290434,66756,688 Developed technology on commercially marketed products In connection with the acquisition of Aegerion in September 2019, the Group acquired developed technology, metreleptin and lomitapide. These intangible assets are amortized over their estimated useful lives and the remaining useful lives for metreleptin and lomitapide are approximately 4.2 and 5.7 years, respectively, as of December 31, 2021 (December 31, 2020: 5.2 and 6.7 years, respectively). In connection with the acquisition of Chiasma in August 2021, the Group acquired developed technology, octreotide. This intangible asset is amortized over its estimated useful life and the remaining useful life is approximately 14.2 years as of December 31, 2021. In-process R&D As a result of the acquisition of Amryt GmbH, in 2016, the Group recognized in-process R&D costs of €48,453,000/US$54,872,000 which is related to the Group’s lead development asset, Oleogel-S10. During the three-month period and year ended December 31, 2021, an impairment charge was recognized on the in-process R&D intangible asset related to Oleogel-S10. This was determined following the receipt of a Complete Response Letter (CRL) from the FDA, in which the FDA communicated that it had completed its review of the NDA for Oleogel-S10 and has determined that the application cannot be approved in its present form. The impairment charge recognized in the Condensed Consolidated Statement of Comprehensive Income/(Loss) was €28,867,000/US$32,623,000, there was no impairment charge recognized in the three-month period and year ended December 31, 2020. The remaining in-process R&D is a result of the acquisition of Cala Medical Limited in October 2020. Goodwill During 2019, the Group completed the acquisition of Aegerion which resulted in the recognition of goodwill that has a carrying value of US$18,080,000. On August 5, 2021, the Group completed the acquisition of Chiasma, which resulted in aggregate goodwill of US$38,608,000. The Group reviews events or changes in circumstances that may indicate a triggering event for impairment, at each reporting date, and conducts an annual impairment review to determine any impairment charge required. Management completed an impairment review by determining recoverable amounts from value in use calculations. The recoverable amount of an asset or cash generating unit is estimated in order to determine the extent of an impairment charge. As noted above, in the three months and year ended December 31, 2021, there was an impairment charge recognized on In-process R&D intangible assets related to Oleogel-S10. There was no other impairment charge recognized during the three months and year ended December 31, 2021. 8. Trade and other receivables As at December 31, 2021 (unaudited) December 31, 2020 (audited) US$’000 US$’000Trade receivables34,263 33,057Accrued income and other debtors12,201 8,423VAT recoverable7,444 1,705Trade and other receivables53,908 43,185 9. Inventories As at December 31, 2021 (unaudited) December 31, 2020 (audited) US$’000 US$’000Raw materials36,850 25,462Work in progress12,986 3,903Finished goods65,933 11,627Inventories115,769 40,992 The increase in inventories for the year ended December 31, 2021, reflected the fair value of inventory acquired as part of the acquisition of Chiasma on August 5, 2021. The fair value of the acquired inventory amounted to US$65,907,000. Inventory on hand at the date of acquisition was valued at the expected selling price less the sum of remaining costs of disposal, cost to complete and a reasonable profit margin for the selling effort of the acquiring entity. The costs to complete were calculated based on costs incurred on recently completed finished goods. The costs to dispose include sales and marketing expenses required to sell the product to the customer in addition to certain general and administrative expenses expected to be incurred by Amryt. This resulted in a non-cash step up at the valuation of inventory at August 5, 2021, of US$44,794,000. The non-cash step up in inventory is being unwound to the Condensed Consolidated Statement of Comprehensive Income/(Loss) over the period in which this saleable inventory is sold. At December 31, 2021, US$41,581,000 of this non-cash inventory step up is included in inventory. 10. Cash and cash equivalents As at December 31, 2021 (unaudited) December 31, 2020 (audited) US$’000 US$’000Cash at bank available on demand112,771 118,575Restricted cash261 223Total cash and cash equivalents113,032 118,798 Cash and cash equivalents include cash at bank available on demand and restricted cash. At December 31, 2021, there was US$261,000 restricted cash (December 31, 2020: US$223,000). The restricted cash balance as at December 31, 2021, consists of a deposit on a company credit card facility for an amount of US$126,000 (December 31, 2020: US$150,000), a lease deposit for US$85,000 (December 31, 2020: nil) and a letter of credit related to US customs which was put in place for an amount of US$50,000 (December 31, 2020: nil). The restricted cash balance as at December 31, 2020, included US$73,000 held by a third-party distributor that was received in January 2021. There was no cash in transit held by a third-party distributor as at December 31, 2021. 11. Share capital and reserves Details of the number of issued ordinary shares with a nominal value of Sterling 6 pence (2020: 6 pence) each are in the table below. Ordinary sharesTreasury sharesTotalAt January 1, 2020 (audited)154,498,8874,864,656159,363,543Issue of shares in exchange for warrants8,229,753—8,229,753Issue of shares in equity fund raises16,000,000—16,000,000Issue of treasury shares for share options exercised72,953(72,953)—At December 31, 2020 (audited)178,801,5934,791,703183,593,296Issue of treasury shares in exchange for warrants283,389(283,389)—Issue of treasury shares for share options exercised300,000(300,000)—Issue of shares in consideration of Chiasma acquisition127,740,695—127,740,695Issue of shares in exchange for warrants4,758,206—4,758,206Issue of treasury shares in exchange for warrants4,208,314(4,208,314)—Issue of shares for share options exercised and RSUs vesting3,722,550—3,722,550At December 31, 2021 (unaudited)319,814,747—319,814,747 The components of equity are detailed in the Condensed Consolidated Statement of Changes in Equity and described in more detail below. As at December 31, 2021 there were 319,814,747 ordinary shares issued with no treasury shares held (December 31, 2020: 183,593,296 of which 4,791,703 were treasury shares). In December 2020, the Company issued 16,000,000 ordinary shares in the form of ADSs, as part of a US$40,000,000 private placement equity raise to existing and new shareholders. The Company issued 4,000,000 and 4,229,753 ordinary shares on July 15, 2020, and September 22, 2020, respectively, in exchange for certain warrants. On March 11, 2021, the Company issued 300,000 ordinary shares from treasury shares following the exercise of share options. On March 11, 2021, the Company issued 283,389 ordinary shares from treasury shares in exchange for certain warrants. On August 5, 2021, the Company issued 127,740,695 ordinary shares, in the form of ADSs, as consideration for the acquisition of Chiasma. On August 5, 2021, the Company issued 8,966,520 ordinary shares with 4,208,314 being issued from treasury shares in exchange for warrants. During the year ended December 31, 2021, there were 3,342,680 shares issued following the exercise of share options and 379,870 shares issued following RSUs vesting. Share Capital Share capital represents the cumulative par value arising upon issue of ordinary shares of Sterling 6 pence each. The ordinary shares have the right to receive notice of, attend and vote at general meetings and participate in the profits of the Company. Share Premium Share premium represents the consideration that has been received in excess of the nominal value on issue of share capital net of issue costs and transfers to distributable reserves. Warrant reserve The warrant reserve represents zero cost warrants issued as part of the equity raise on September 24, 2019, net of issue costs apportioned to warrants issued and additional warrants issued to certain shareholders on November 14, 2019. Each warrant entitles the holder to subscribe for one ordinary share at zero cost. The Company issued 4,000,000 and 4,229,753 ordinary shares on July 15, 2020, and September 22, 2020, respectively, in exchange for certain warrants. The remaining warrants were exchanged on August 5, 2021, and the Company issued 8,966,520 ordinary shares, 4,208,314 of which were issued from treasury shares. There were no remaining warrants outstanding as at December 31, 2021. Treasury Shares In October 2020, the Company issued 72,953 ordinary shares from treasury shares following the exercise of share options. In March 2021, the Company issued a total of 583,389 ordinary shares from treasury shares, 300,000 ordinary shares relating to the exercise of share options and 283,389 ordinary shares following the exchange of certain warrants. In August 2021, the company issued 4,208,314 ordinary shares from treasury shares in conjunction with the exchange of warrants. There were no treasury shares held as at December 31, 2021. Share based payment reserve Share based payment reserve relates to the charge for share based payments in accordance with IFRS 2. In March 2021, the Company issued 283,389 ordinary shares in exchange for certain warrants. In April 2021, 62,153 warrants lapsed. During the year ended December 31, 2021, the Company issued 3,722,550 ordinary shares in relation to the exercise of share options and RSUs. As part of the acquisition of Chiasma, the Company replaced share awards that were existing at the time of the acquisition. This resulted in the recognition of a share-based payment reserve of US$10,157,000 on acquisition. Merger reserve The merger reserve was created on the acquisition of Amryt DAC by Amryt Pharma plc in April 2016. Ordinary shares in Amryt Pharma plc were issued to acquire the entire issued share capital of Amryt DAC. Under section 612 of the UK Companies Act 2006, the premium on these shares has been included in a merger reserve. Reverse acquisition reserve The reverse acquisition reserve arose during the period ended December 31, 2016, in respect of the reverse acquisition of Amryt Pharma plc by Amryt DAC. Since the shareholders of Amryt DAC became the majority shareholders of the enlarged Group, the acquisition is accounted for as though there is a continuation of Amryt DAC’s financial statements. The reverse acquisition reserve is created to maintain the equity structure of Amryt Pharma plc in compliance with UK company law. Equity component of convertible notes The equity component of convertible notes represents the equity component of the US$125,000,000 convertible debt and is measured by determining the residual of the fair value of the instrument less the estimated fair value of the liability component. The equity component is recognized in equity and is not subsequently remeasured. Other distributable reserves Other distributable reserves comprise the following: Distribution of the share premium amount on 6 November 2019 of US$268,505,000. By special resolution of the Company duly passed on 23 September 2019, it was resolved that the entire amount outstanding to the credit of the share premium account and capital redemption reserve of the Company be cancelled. The reduction in capital, amounting to US$268,505,000, representing the entire amount of share premium at that time, was approved by the High Court of Justice of England and Wales on 5 November 2019. A deemed distribution of US$47,902,000 arising from the issuance of CVRs in September 2019. A deemed distribution of US$2,969,000 arising from the scheme of arrangement in September 2019 whereby Amryt Pharma plc, which was incorporated in July 2019, became a 100% shareholder of Amryt Pharma Holdings Limited (formerly named Amryt Pharma plc) (the “Acquisition of subsidiary without a change of control”) Currency translation reserve The currency translation reserve arises on the retranslation of non-U.S. dollar denominated foreign subsidiaries. Accumulated deficit Accumulated deficit represents losses accumulated in previous periods and the current year. 12. Long term loan As at December 31, 2021 (unaudited) December 31, 2020 (audited) US$’000 US$’000Long term loan principal93,988 88,037Unamortized debt issuance costs(593) (735)Long term loan 93,395 87,302 As part of the acquisition of Aegerion on September 24, 2019, Aegerion entered into a new U.S. dollar denominated US$81,021,000 secured term loan debt facility (‘‘Term Loan’’) with various lenders. The Term Loan was made up of a US$54,469,000 loan that was in place prior to the acquisition, which was refinanced as part of the acquisition, and a US$26,552,000 additional loan that was drawn down on September 24, 2019. The Term Loan had a five-year term from the date of the draw down, September 24, 2019, and a maturity date of September 24, 2024. Under the Term Loan, interest was payable at the option of the Group at the rate of 11% per annum paid in cash on a quarterly basis or at a rate of 6.5% paid in cash plus 6.5% paid in kind, which rolls up and is included in the principal balance outstanding, on a quarterly basis. Unpaid accrued interest of US$1,536,000 as at December 31, 2021 is recognized in current liabilities within trade and other payables (December 31, 2020: $1,439,000). The Term Loan agreement includes an option to prepay the loan in whole or in part at any time subject to payment of an exit fee, which depending on the stage of the loan term, ranges from 5.00% to 0.00% of the principal then outstanding on the Term Loan. On February 18, 2022, the Term Loan was repaid in full and the Group secured a $125,000,000 senior credit facility of which US$105,000,000 was drawn down to facilitate the prepayment of the existing Term Loan. See further details on the $125,000,000 senior credit facility entered into by Amryt in Note 16, Events after the reporting period. In connection with the Term Loan, the Group incurred approximately US$870,000 of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees. These costs are amortized over the expected life of the loan using the effective interest method. The Term Loan was guaranteed by Amryt and certain subsidiaries of the Group. In connection with the loan agreement, fixed and floating charges have been placed on property and undertakings of Amryt and certain subsidiaries of the Group. The Term Loan agreement included affirmative and negative covenants, including prohibitions on the incurrence of additional indebtedness, granting of liens, certain asset dispositions, investments, and restricted payments, in each case, subject to certain exceptions set forth in the Loan Agreement. The Term Loan agreement also includes customary events of default for a transaction of this type and includes (i) a cross-default to the occurrence of any event of default under material indebtedness of Amryt and certain subsidiaries of the Group and Amryt, including the convertible notes, and (ii) Amryt or any of its subsidiaries being subject to bankruptcy or other insolvency proceedings. Upon the occurrence of an event of default, the lenders may declare all of the outstanding Term Loan and other obligations under the Term Loan agreement to be immediately due and payable and exercise all rights and remedies available to the lenders under the Term Loan agreement and related documentation. There were no events of default or breaches of the covenants occurring for the three months and year ended December 31, 2021 (December 31, 2020: no events). 13. Convertible notes Total US$’000At January 1, 202096,856Accreted interest4,230At December 31, 2020 (audited)101,086Accreted interest4,702At December 31, 2021 (unaudited)105,788 As part of the Aegerion acquisition, Aegerion issued convertible notes with an aggregate principal amount of US$125,000,000 to Aegerion creditors. The convertible notes are senior unsecured obligations and bear interest at a rate of 5.0% per year, payable semi-annually in arrears on April 1 and October 1 of each year, beginning on April 1, 2020. The convertible notes will mature on April 1, 2025, unless earlier repurchased or converted. The convertible notes are convertible into Amryt’s ordinary shares at a conversion rate of 386.75 ordinary shares per US$1,000 principal amount of the convertible notes. If the holders elect to convert the convertible notes, Amryt can settle the conversion of the convertible notes through payment or delivery of cash, common shares, or a combination of cash and common shares, at its discretion. As a result of the conversion feature in the convertible notes, the convertible notes were assessed to have both a debt and an equity component. The two components were assessed separately and classified as a financial liability and equity instrument. The financial liability component was measured at fair value based on the discounted cash flows expected over the expected term of the notes using a discount rate based on a market interest rate that a similar debt instrument without a conversion feature would be subject to. Refer to Note 11, Share capital and reserves, for further details on the equity component of the convertible notes. From September 24, 2019, until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of their convertible notes, in multiples of US$1,000 principal amount, at the option of the holder. The indenture does not contain any financial covenants or restrict the Group’s ability to repurchase securities, pay dividends or make restricted payments in the event of a transaction that substantially increases the Group’s level of indebtedness in certain circumstances. The indenture contains customary terms and covenants and events of default. If an event of default (other than certain events of bankruptcy, insolvency or reorganization involving Aegerion, Amryt and certain subsidiaries of the Group) occurs and is continuing, the trustee by notice to Amryt, or the holders of at least 25% in principal amount of the outstanding convertible notes by written notice to Amryt and the trustee, may declare 100% of the principal of and accrued and unpaid interest, if any, on all of the convertible notes to be due and payable. Upon such a declaration of acceleration, such principal and accrued and unpaid interest, if any, will be due and payable immediately. Upon the occurrence of certain events of bankruptcy, insolvency or reorganization involving Amryt, 100% of the principal and accrued and unpaid interest, if any, on the convertible notes will become due and payable automatically. Notwithstanding the foregoing, the indenture provides that, upon Amryt’s election, and for up to 180 days, the sole remedy for an event of default relating to certain failures by Amryt to comply with certain reporting covenants in the indenture consists exclusively of the right to receive additional interest on the convertible notes. There have been no events of default or breaches of the covenants occurring for the year ended December 31, 2021 (2020: no events). 14. Provisions and other liabilities As at December 31, 2021 (unaudited) December 31, 2020 (audited) US$’000 US$’000Non-current liabilities Provisions and other liabilities— 21,382Leases due greater than 1 year4,049 4,569 4,049 25,951Current liabilities Provisions and other liabilities6,000 9,976Leases due less than 1 year1,545 963 7,545 10,939Total provisions and other liabilities11,594 36,890 Legal matters Prior to the acquisition of Aegerion by Amryt, Aegerion entered into settlement agreements with governmental entities including the Department of Justice (‘‘DOJ’’) and the FDA in connection with Juxtapid investigations. The settlement agreements require Aegerion to pay specified fines and engage in regulatory compliance efforts. Subsequent to the acquisition, Aegerion made US$23,036,000 of settlement payments, including interest. The settlements have been paid in full with the last payment completed in Q1 2021. As at December 31, 2021, there is no DOJ liability outstanding. The remaining liability outstanding as at December 31, 2020, of US$3,976,000 was included in current provisions and other liabilities. Other matters The Group recognizes a liability for legal contingencies when it believes that it is both probable that a liability has been incurred and that it can reasonably estimate the amount of the loss. The Group reviews these accruals and adjusts them to reflect ongoing negotiations, settlements, rulings, advice of legal counsel and other relevant information. To the extent new information is obtained and the Group’s views on the probable outcomes of claims, suits, assessments, investigations or legal proceedings change, changes in the Group’s liability accrual would be recorded in the period in which such determination is made. At December 31, 2021 the Group had recognized liabilities of US$6,000,000 in relation to ongoing legal matters (2020: US$6,000,000). At December 31, 2020, the Group had recognized liabilities of $6,000,000 in relation to ongoing legal matters as well as a non-current liability of US$21,382,000 for revenue rebates due on metreleptin sales in a country in the EMEA region following on from agreeing a reimbursement price with the government authorities. The reimbursement agreement, which was agreed in March 2021, results in a one-off revenue rebate payment on sales up to the date of approval. The one-off payment is due to be paid to the authorities in July 2022 and this is included within accrued expenses, see Note 15, Trade and other payables. 15. Trade and other payables As at December 31, 2021 (unaudited) December 31, 2020 (audited) US$’000 US$’000Trade payables41,057 23,595Accrued expenses107,194 65,705Social security costs and other taxes1,483 936Total trade and other payables149,734 90,236 The Group has a liability, included in accrued expenses above, for revenue rebates due on Myalepta sales in a country in the EMEA region from agreeing a reimbursement price with the government authorities resulting in a one-off payment related to sales up to the date of approval, which occurred in March 2021. The Group has recognized a liability of US$21,348,000 as at December 31, 2021. At December 31, 2020 the liability was included in provisions as the underlying agreement was not finalized and it was recognized as a non-current liability for an amount of US$21,382,000 as payment was agreed to be made in July 2022. Other accruals mainly consist of costs related to government revenue rebates due within one year, convertible note interest, term loan interest, royalty expenses, restructuring costs, clinical and R&D activities. 16. Fair value measurement and financial risk management Categories of financial instruments As at December 31, 2021 (unaudited) December 31, 2020 (audited) US$’000 US$’000Financial assets (all at amortized cost): Cash and cash equivalents113,032 118,798Trade receivables34,263 33,057Total financial assets147,295 151,855 Financial liabilities: At amortized cost Trade payables and accrued expenses148,251 89,300Lease liabilities5,594 5,532Other liabilities— 25,358Convertible notes105,788 101,086Long term loan93,395 87,302Contingent value rights18,734 61,417At fair value Contingent consideration52,989 86,906Total financial liabilities424,751 456,901Net(277,456) (305,046) Financial instruments evaluated at fair value can be classified according to the following valuation hierarchy, which reflects the extent to which the fair value is observable: Level 1: fair value evaluations using prices listed on active markets (not adjusted) of identical assets or liabilities. Level 2: fair value evaluations using input data for the asset or liability that are either directly observable (as prices) or indirectly observable (derived from prices), but which do not constitute listed prices pursuant to Level 1. Level 3: fair value evaluations using input data for the asset or liability that are not based on observable market data (unobservable input data). The contingent consideration has been valued using Level 3. The contingent consideration comprises: Contingent consideration relating to the acquisition of Amryt GmbH (see Note 5, Business combinations and asset acquisitions) that was measured at US$52,989,000 as at December 31, 2021 (December 31, 2020: US$86,906,000). The fair value comprises royalty payments which was determined using probability weighted revenue forecasts and the fair value of the milestones payments which was determined using probability adjusted present values. It also included a revision to the discount rate used, and revenue and costs forecasts have been amended to reflect management’s current expectations. Impact of key unobservable input data on the contingent consideration: An increase of 10% in estimated revenue forecasts would result in an increase to the fair value of US$3,359,000. A decrease would have the opposite effect. A 5% increase in the discount factor used would result in a decrease to the fair value of US$8,826,000. A decrease of 5% would result in an increase to the fair value of US$11,696,000. A six-month delay in the launch date for Oleogel-S10 would result in a decrease to the fair value of US$4,770,000. A 20% increase in the probability of success used would result in an increase to the fair value of US$17,660,000. A decrease would have the opposite effect. 17. Events after the reporting period Development Pipeline As noted above, Amryt received a Complete Response Letter from the (FDA) regarding its (NDA) for Oleogel-S10, for the treatment of the cutaneous manifestations of EB, a rare, genetic skin disease characterized by extremely fragile skin that blisters and tears from minor friction or trauma for which there are no approved treatment options. The FDA communicated that it had completed its review of the application and has determined that the application cannot be approved in its present form. The FDA has asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in EB. Amryt intends to discuss with the FDA the nature of the data required to address the Agency’s concerns. On March 8, 2022, Amryt announces the completion of a successful pharmacokinetic (PK) study for Mycapssa® (oral octreotide). The data supports a planned Phase 3 study of Mycapssa® in the treatment of patients with carcinoid symptoms due to Neuroendocrine Tumors (NET). Debt refinancing On February 22, 2022, Amryt announced that it secured US$125,000,000 of senior credit facilities from funds managed by the Credit Group of Ares Management Corporation (“Ares”). Amryt used a portion of the proceeds to refinance its previous secured term debt facility, which has an outstanding balance of US$93,988,000 as at February 22, 2022, an interest rate of 13.00% and a maturity date of September 2024. The new facilities will generate significant annual interest cost savings as well as provide for important strategic flexibility as Amryt looks to continue to grow its global rare disease presence. Key features of the new facilities include: Total new facilities of $125 million, consisting of: $85 million Term Loan Facility with interest rate of Secured Overnight Financing Rate (“SOFR”)+6.75%, subject to a 0.90% SOFR floor $40 million Revolving Credit Facility with $20 million drawn at close and interest rate of SOFR+4.00%, subject to a 0.90% SOFR floor Quarterly blended cash interest rate of SOFR+5.87% (assuming fully drawn), subject to a 0.90% SOFR floor, substantially lower than Amryt’s current secured term debt facility at 13.00% interest Requires interest-only payments until facility matures in February 2027 There are no warrants or any equity conversion features associated with the new facilities The proceeds will be used to refinance existing debt, for general corporate and product development purposes; and potentially for shareholder approved share repurchase programs. Charges were taken over certain assets of the company and its material entities as guarantee and collateral for the provision of the debt. There were no other significant events since the end of the reporting period.
AMYT CHMA | globenewswire | about 4 years ago | Neutral

Amryt Reports Strong Q3 2021 ResultsAmryt Reports Strong Q3 2021 Results 14.6% YoY revenue growth in Q3 to $56.5M 21.5% growth in metreleptin revenues YoY to$36.3M in Q3; 51.6% growth YoY excluding the impact of sporadic LATAM orders 7th consecutive quarter of positive EBITDA generation excluding Chiasma transaction costs Cash of ...
Amryt Reports Strong Q3 2021 Results 14.6% YoY revenue growth in Q3 to $56.5M 21.5% growth in metreleptin revenues YoY to$36.3M in Q3; 51.6% growth YoY excluding the impact of sporadic LATAM orders 7th consecutive quarter of positive EBITDA generation excluding Chiasma transaction costs Cash of $123.2M at September 30, 2021 Reaffirming FY 2021 revenue guidance to $220M - $225M, representing 20-23% YoY growth Conference call and webcast today at 0830 EDT / 1230 GMT DUBLIN, Ireland, and Boston MA, November 3, 2021, Amryt (Nasdaq: AMYT, AIM: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today provides a business update and announces unaudited financial results for the third quarter ended September 30, 2021. Joe Wiley, CEO of Amryt Pharma, commented: “Q3 was an extremely busy and productive period for Amryt and I am excited to report today’s strong operational and financial results. Our Q3 revenues of $56.5M represent 14.6% YoY revenue growth. Metreleptin continues to grow strongly and delivered 21.5% YoY growth in the quarter and grew 51.6% during the period excluding the impact of sporadic LATAM ordering. These results clearly demonstrate the strong performance of metreleptin in all regions. Overall, the results also demonstrate the strong growth we are experiencing across our business and represent our seventh consecutive quarter of positive EBITDA generation and this performance has been delivered despite the challenging COVID pandemic. We have also continued to progress the regulatory pathway and filed marketing applications for Oleogel-S10 in both the US and Europe and a target PDUFA date for Oleogel-S10 has been set for November 30, 2021. Oleogel-S10 is eligible for a Priority Review Voucher if approved under priority review by the FDA. If Oleogel-S10 is approved, we will have four commercial products and the team, financial flexibility, systems and global infrastructure in place to bring Oleogel-S10 to market and to execute our significant growth plans. We completed the acquisition of Chiasma on August 5, 2021 and since then we have made significant progress integrating the Chiasma operations and portfolio into Amryt and we are very excited about both the growth opportunities for Mycapssa® and the potential to develop the underlying TPE platform in other areas. Given the strong performance of our business year to date, we are reaffirming our full year 2021 revenue guidance of $220-$225 million, issued on September 13, 2021 which represents growth of 20%-23% over 2020.” Q3 2021 and Recent Business Highlights: Chiasma, Inc. acquisition completed on August 5, 2021 and integration proceeding well Oleogel-S101 target PDUFA date set by the FDA for November 30, 2021 Oleogel-S10 MAA accepted by EMA and CHMP opinion expected in Q4 2021 Commercial launch plans well advanced for Oleogel-S10 launch, if approved FY 2021 revenue guidance increased in September to $220M - $225M, representing 20-23% growth over 2020 Q3 2021 Commercial Product Performance: Q3 2021 (unaudited)USEMEAOtherTotalUS$’000US$’000US$’000US$’000Metreleptin18,74815,6181,92736,293Lomitapide8,5686,4063,56418,538Mycapssa®1,453--1,453Other-16669235Total revenue28,76922,1905,56056,519 Q3 2020 (unaudited)USEMEAOtherTotalUS$’000US$’000US$’000US$’000Metreleptin15,8776,4237,57829,878Lomitapide9,2337,1092,77119,113Mycapssa®----Other-201134335Total revenue25,11013,73310,48349,326 14.6% YoY revenue growth in Q3 2021 to $56.5M (Q3 2020: $49.3M) Excluding the impact of sporadic LATAM ordering and Mycapssa®, revenues grew 26.3% YoY and 5.7% QoQ 21.5% increase in metreleptin revenues YoY to $36.3M in Q3 2021 (Q3 2020: $29.9M). Excluding the impact of sporadic LATAM ordering, metreleptin revenue growth was 51.6% YoY. US accounted for 51.7% of global metreleptin revenues and EMEA accounted for 43.0% in Q3 2021 EMEA metreleptin revenues grew 143.2% YoY in Q3 US accounted for 46.2% of global lomitapide revenues and EMEA accounted for 34.6% in Q3 2021 Mycapssa® delivered $1.45M in Q3 (from August 5 when Chiasma was acquired) Mycapssa® revenues in Q3 were impacted by pre-ordering in Q2; normalised ordering patterns have returned in September with Mycapssa® delivering $1.14M in the month The integration of Chiasma is significantly advanced and we continue to extract cost synergies Q3 2021 Financial Highlights: $21.4M operating loss before finance expense for Q3 2021 (Q3 2020: $3.6M operating loss). Excluding non-cash items, share based compensation expenses and Chiasma restructuring and acquisition costs, this resulted in EBITDA3 before restructuring and acquisition costs of $6.2M. Cash of $123.2M at September 30, 2021 (June 30, 2021: $142.9M) post repayment of outstanding Chiasma revenue interest financing debt and transaction related costs in the period IFRS and non-GAAP adjusted Q3 2021 results: US$MQ3 2020 (unaudited) Q3 2021 (unaudited)Q3 2021 Non-cash adjustments2Q3 2021 Non-GAAP AdjustedRevenue49.356.5-56.5Gross profit22.329.313.142.4R&D expenses(7.4)(11.0)-(11.0)SG&A expenses(16.9)(25.7)0.5(25.2)Restructuring and acquisitioncosts(0.1)(11.3)-(11.3)Share based compensation expenses(1.5)(2.7)2.7-Operating (loss) / profit before finance expense(3.6)(21.4)16.3(5.1)3 Operating (loss) / profit before finance expense and restructuring and acquisition costs(3.5)(10.1)16.36.2 1 For the purposes of this announcement, we use the name Oleogel-S10. Filsuvez® has been selected as the brand name for the product but please note, Amryt does not, as yet, have regulatory approval for Filsuvez® to treat EB. 2Non-cash items include amortisation of the acquired metreleptin, lomitapide and Mycapssa® intangible assets ($12.7M), amortisation of the inventory fair value step-up related to the acquisition of Chiasma, Inc. ($0.4M), depreciation and amortisation ($0.5M) and share based compensation expenses ($2.7M). 3 EBITDA is earnings before interest, tax, depreciation, amortisation and share based compensation expenses. To supplement Amryt's financial results presented in accordance with IFRS generally accepted accounting principles, the Company uses EBITDA as a key measure of company performance as the Company believes that this measure is most reflective of the operational profitability or loss of the Company and provides management and investors with useful supplementary information which can enhance their ability to evaluate the operating performance of the business. EBITDA, as measured by the Company, is not meant to be considered in isolation or as a substitute to operating profit / loss attributable to Amryt and should be read in conjunction with the Company's condensed consolidated financial statements prepared in accordance with IFRS. Guidance & Outlook: Given the continued strong performance of the Company’s commercial products, the board is today reaffirming revenue guidance for FY 2021 in the range of $220M - $225M which represents growth of 20% to 23% on FY 2020. Conference Call & Webcast: Amryt will host a conference call and webcast for analysts and investors today at 0830 EDT/1230 GMT. Webcast Player URL:https://edge.media-server.com/mmc/p/yn6ztxz9 Telephone Dial in details: United States +1 646 787 1226United Kingdom+44 (0) 203 009 5709Ireland +353 (1) 506 0626Confirmation Code9357809 A playback facility will be available from November 3, 2021 at 1430 EDT / 1830 GMT – November 10, 2021 at 1330 EST / 1830 GMT. Access details for the playback facility are as follows: Confirmation Code: 9357809 | US: + 1 917 677 7532 | UK: +44 (0) 333 300 9785 | Ireland : +353 (1) 553 8777. About Amryt Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets. Amryt’s commercial business comprises three orphan disease products – metreleptin (Myalept®/ Myalepta®); oral octreotide (Mycapssa®); and lomitapide (Juxtapid®/ Lojuxta®). Myalept®/Myalepta® (metreleptin) is approved in the US (under the trade name Myalept®) as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in the EU (under the trade name Myalepta®) as an adjunct to diet for the treatment of leptin deficiency in patients with congenital or acquired GL in adults and children two years of age and above and familial or acquired partial lipodystrophy (PL) in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control. For additional information, please follow this link. Mycapssa® (oral octreotide) is approved in the US for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. Mycapssa® is the first and only oral somatostatin analogapproved by the FDA. Mycapssa® has also been submitted to the EMA for regulatory approval. For additional information, please follow this link. Juxtapid®/Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia ("HoFH") in the US, Canada, Colombia, Argentina and Japan (under the trade name Juxtapid®) and in the EU, Israel and Brazil (under the trade name Lojuxta®). For additional information, please follow this link. Amryt's lead development candidate, Oleogel-S10 (Filsuvez®) is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (“EB”), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. Filsuvez® has been selected as the brand name for Oleogel-S10. The product does not currently have regulatory approval to treat EB but has been submitted to the FDA for approval and in June 2021, Amryt received confirmation from the FDA that its NDA for Oleogel-S10 had been accepted and granted priority review. The FDA also set a target PDUFA date of November 30, 2021. In Europe, a MAA for Oleogel-S10 was accepted for assessment by the EMA in March 2021. Amryt’s pre-clinical gene therapy candidate, AP103, offers a potential treatment for patients with Dystrophic EB, and the polymer-based delivery platform has the potential to be developed for the treatment of other genetic disorders. Amryt also intends to develop oral medications that are currently only available as injectable therapies through its Transient Permeability Enhancer (TPE®) technology platform. For more information on Amryt, including products, please visit www.amrytpharma.com. Financial Advisors Shore Capital (Daniel Bush, Mark Percy, John More) are NOMAD and Joint Broker to Amryt in the UK. Stifel (Ben Maddison) are Joint Broker to the company in the UK. Forward-Looking Statements This announcement may contain forward-looking statements and the words "expect", "anticipate", "intends", "plan", "estimate", "aim", "forecast", "project" and similar expressions (or their negative) identify certain of these forward-looking statements. The forward-looking statements in this announcement are based on numerous assumptions and Amryt's present and future business strategies and the environment in which Amryt expects to operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. These statements are not guarantees of future performance or the ability to identify and consummate investments. Many of these risks and uncertainties relate to factors that are beyond Amryt's ability to control or estimate precisely, such as future market conditions, the course of the COVID-19 pandemic, currency fluctuations, the behaviour of other market participants, the outcome of clinical trials, the actions of regulators and other factors such as Amryt's ability to obtain financing, changes in the political, social and regulatory framework in which Amryt operates or in economic, technological or consumer trends or conditions. Past performance should not be taken as an indication or guarantee of future results, and no representation or warranty, express or implied, is made regarding future performance. No person is under any obligation to update or keep current the information contained in this announcement or to provide the recipient of it with access to any additional relevant information that may arise in connection with it. Such forward-looking statements reflect the Company’s current beliefs and assumptions and are based on information currently available to management. Contacts Joe Wiley, CEO / Rory Nealon, CFO/COO, +353 (1) 518 0200, ir@amrytpharma.com Daniel Bush, Shore Capital, NOMAD +44 (0) 207 408 4090, amrytcorporate@shorecap.co.uk Tim McCarthy, LifeSci Advisors, LLC, +1 (212) 915 2564, tim@lifesciadvisors.com Amber Fennell, Consilium Strategic Communications, +44 (0) 203 709 5700, fennell@consilium-comms.com Amryt Pharma plc Condensed Consolidated Statement of Comprehensive Loss Three Months Ended September 30,Nine Months Ended September 30, Note2021 (unaudited)2020 (unaudited)2021 (unaudited)2020 (unaudited) US$’000US$’000 US$’000US$’000Revenue356,51949,326 167,713140,085Cost of sales (27,265)(27,057) (76,933)(89,148)Gross profit 29,25422,269 90,78050,937Research and development expenses (11,000)(7,350) (28,454)(22,481)Selling, general and administrative expenses (25,706)(16,889) (62,438)(56,883)Restructuring and acquisition costs5(11,226)(105) (14,679)(1,005)Share based payment expenses4(2,689)(1,533) (5,905)(3,136)Operating loss before finance expense (21,367)(3,608) (20,696)(32,568)Non-cash change in fair value of contingent consideration5(3,030)(2,126) (8,897)(8,150)Non-cash contingent value rights finance expense5(1,915)(1,557) (5,515)(4,498)Net finance expense - other (6,424)(1,359) (20,163)(15,492)Loss on ordinary activities before taxation (32,736)(8,650) (55,271)(60,708)Tax credit/(charge) on loss on ordinary activities 15,527(1,821) 14,7263,171Loss for the year attributable to the equity holders of the Company (17,209)(10,471) (40,545)(57,537)Exchange translation differences which may be reclassified through profit or loss 240(1,921) 2,583(2,850)Total other comprehensive income/(loss) 240(1,921) 2,583(2,850)Total comprehensive loss for the year attributable to the equity holders of the Company (16,696)(12,392) (37,962) (60,387) Loss per share Loss per share - basic and diluted, attributable to ordinary equity holders of the parent (US$)6(0.07)(0.07) (0.20)(0.37) Amryt Pharma plc Condensed Consolidated Statement of Financial Position As at, NoteSeptember 30, 2021 (unaudited)December 31, 2020 (audited) US$’000US$’000Assets Non-current assets Goodwill7 79,874 19,131Intangible assets7 488,733 305,369Property, plant and equipment 8,402 7,574Other non-current assets 1,646 1,542Total non-current assets 578,655 333,616Current assets Trade and other receivables8 52,793 43,185Inventories9 100,839 40,992Cash and cash equivalents, including restricted cash10 123,177 118,798Total current assets 276,809 202,975Total assets 855,464 536,591 Equity and liabilities Equity attributable to owners of the parent Share capital11 25,261 13,851Share premium11 310,778 51,408Other reserves11 246,080 236,488Accumulated deficit (276,096) (235,605)Total equity 306,023 66,142Non-current liabilities Contingent consideration and contingent value rights5 157,999 148,323Deferred tax liability 37,001 6,612Long term loan12 91,820 87,302Convertible notes13 104,566 101,086Provisions and other liabilities14 4,213 25,951Total non-current liabilities 395,599 369,274Current liabilities Trade and other payables 124,315 90,236Provisions and other liabilities14 29,527 10,939Total current liabilities 153,842 101,175Total liabilities 549,441 470,449Total equity and liabilities 855,464 536,591 Amryt Pharma plc Condensed Consolidated Statement of Cash Flows Nine months ended September 30,Note2021 (unaudited)2020 (unaudited)US$’000US$’000Cash flows from operating activities Loss on ordinary activities after taxation (40,545) (57,537)Net finance expense - other 20,163 15,492Depreciation and amortization 35,238 33,313Amortization of inventory fair value step-up 1,641 21,015Share based payment expenses4 5,905 3,136Non-cash change in fair value of contingent consideration5 8,897 8,150Non-cash contingent value rights finance expense5 5,515 4,498Deferred taxation charge/(credit) (15,677) (2,452)Movements in working capital and other adjustments: Change in trade and other receivables8 (2,609) (6,695) Change in trade and other payables (108,468) 21,875 Change in provision and other liabilities 14 (2,756) (12,328) Change in inventories 39 (7,948) Change in non-current assets 763 596Net cash flow from operating activities (91,894) 21,115 Cash flow from investing activities Net cash received on acquisition of subsidiary 107,942 —Payments for property, plant and equipment (92) (147)Payments for intangible assets (830) (298)Deposit interest received 3 86Net cash flow (used in)/from investing activities 107,023 (359) Cash flow from financing activities Net costs from issue of equity instruments (116) —Interest paid (7,597) (6,190)Payment of leases (789) (846)Net cash flow from financing activities (8,502) (7,036) Exchange and other movements (2,248) (5,567) Net change in cash and cash equivalents 4,379 8,153Cash and cash equivalents at beginning of the period 118,798 67,229Restricted cash at end of the period10 50 792Cash at bank available on demand at end of the period10 123,127 74,590Total cash and cash equivalents at end of the period10 123,177 75,382 Amryt Pharma plc Condensed Consolidated Statement of Changes in Equity For the period ended September 30, 2021 (unaudited) NoteShare capitalShare premiumWarrant reserveTreasury sharesShare based payment reserveMerger reserveReverse acquisition reserveEquity component of convertible notesOther distributable reservesCurrency translation reserveAccumulated deficitTotal US$’000US$’000US$’000US$’000US$’000US$’000US$’000US$’000US$’000US$’000US$’000US$’000Balance at January 1, 2021 (audited) 13,85151,40814,762(7,421)7,86042,627(73,914)29,210217,6345,730(235,605)66,142Loss for the period ——————————(40,545)(40,545)Foreign exchange translation reserve —————————2,583—2,583Total comprehensive loss —————————2,583(40,545)(37,962)Transactions with owners Issue of treasury shares in exchange for warrants112399—439———————561Issue of treasury shares for share options exercised112589—465(191)——————388Issue of shares and treasury shares in exchange for warrants 117497,496(14,762)6,517————————Issue of shares in consideration of Chiasma Acquisition510,547249,789—————————260,336Share based payment reserve recognized on Chiasma acquisition11————10,157——————10,157Issue of shares for share options exercised and vesting of RSUs11661,897——(1,467)——————496Share based payment expense4————5,905——————5,905Share based payment expense – Lapsed ————(54)—————54—Total transactions with owners 11,410259,370(14,762)7,42114,350—————54277,843Balance at September 30, 2021 (unaudited) 25,261310,778——22,21042,627(73,914)29,210217,6348,313(276,096)306,023 For the period ended September 30, 2020 (unaudited) NoteShare capitalShare premiumWarrant reserveTreasury sharesShare based payment reserveMerger reserveReverse acquisition reserveEquity component of convertible notesOther distributable reservesCurrency translation reserveAccumulated deficitTotal US$’000US$’000US$’000US$’000US$’000US$’000US$’000US$’000US$’000US$’000US$’000US$’000Balance at January 1, 2020 (audited) 11,9182,42229,523(7,534)3,19042,627(73,914)29,210217,6347,894(131,137)131,833Loss for the period ——————————(57,537)(57,537)Foreign exchange translation reserve —————————(2,850)—(2,850)Total comprehensive loss —————————(2,850)(57,537)(60,387)Transactions with owners Issue of shares in exchange for warrants1163014,131(14,761)————————Share based payment expense4————3,136——————3,136Share based payment expense – Lapsed ————(56)—————56—Total transactions with owners 63014,131(14,761)—3,080—————563,136Balance at September 30, 2020 (unaudited) 12,54816,55314,762(7,534)6,27042,627(73,914)29,210217,6345,044(188,618)74,582 1. General information Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets. As used herein, references to ‘‘we,’’ ‘‘us,’’ ‘‘Amryt’’ or the ‘‘Group’’ in these condensed consolidated interim financial statements shall mean Amryt Pharma plc and its global subsidiaries, collectively. References to the ‘‘Company’’ in these condensed consolidated interim financial statements shall mean Amryt Pharma plc. Amryt Pharma plc is a company incorporated in England and Wales. The Company is listed on Nasdaq (ticker: AMYT) and the AIM market of the London Stock Exchange (ticker: AMYT). Amryt acquired Chiasma, Inc. (“Chiasma”) in August 2021. The combined company will be a global leader in rare and orphan diseases with three on-market commercial products, a global commercial and operational footprint and a significant development pipeline of therapies with the financial flexibility to execute its growth plans. Amryt’s commercial business comprises three orphan disease products – metreleptin (Myalept®/ Myalepta®); oral octreotide (Mycapssa®); and lomitapide (Juxtapid®/ Lojuxta®). Amryt's lead development candidate, Oleogel-S10 (Filsuvez®) is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (“EB”), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. Filsuvez® has been selected as the brand name for Oleogel-S10. The product does not currently have regulatory approval to treat EB but has been submitted to the FDA for approval and in June 2021, Amryt received confirmation from the FDA that its NDA for Oleogel-S10 had been accepted and granted priority review. The FDA also set a target PDUFA date of November 30, 2021. In Europe, a MAA for Oleogel-S10 was accepted for assessment by the EMA in March 2021. 2. Accounting policies Basis of preparation The condensed consolidated interim financial statements of the Group have been prepared in accordance with IAS 34 Interim Financial Reporting. They do not include all of the information required in annual financial statements in accordance with International Financial Reporting Standards (‘‘IFRS’’) and should be read in conjunction with the annual consolidated financial statements for the year ended December 31, 2020. Selected explanatory notes are included to explain events and transactions that are significant to an understanding of the Group’s financial position and performance since the last annual financial statements. The accounting policies used in the preparation of the interim financial information are the same as those used in the Group’s audited financial statements for the year ended December 31, 2020 and those which are expected to be used in the financial statements for the year ended December 31, 2021. Results for the nine-month period ended September 30, 2021 are not necessarily indicative of the results that may be expected for the financial year ending December 31, 2021. Basis of going concern Having considered the Group’s current financial position and cash flow projections, the Board of Directors believes that the Group will be able to continue in operational existence for at least the next 12 months from the date of approval of these condensed consolidated interim financial statements and that it is appropriate to continue to prepare the condensed consolidated interim financial statements on a going concern basis. As part of their inquiries, the Board of Directors reviewed budgets, projected cash flows, and other relevant information for a period not less than 12 months from the date of approval of the condensed consolidated interim financial statements for the period ended September 30, 2021. Basis of consolidation The condensed consolidated interim financial statements comprise the financial statements of the Group for the period ended September 30, 2021. Subsidiaries are entities controlled by the Company. Where the Company has control over an investee, it is classified as a subsidiary. The Company controls an investee if all three of the following elements are present: power over an investee, exposure or rights to variable returns from its involvement with the investee and the ability to use its power to affect those variable returns. Control is reassessed whenever facts and circumstances indicate that there may be a change in any of these elements of control. Subsidiaries are fully consolidated from the date that control commences until the date that control ceases. Accounting policies of subsidiaries have been changed where necessary to ensure consistency with the policies adopted by the Group. Intergroup balances and any unrealized gains or losses, income or expenses arising from intergroup transactions are eliminated in preparing the condensed consolidated interim financial statements. Presentation of balances The condensed consolidated interim financial statements are presented in U.S. dollars (‘‘US$’’), rounded to the nearest thousand, which is the functional currency of the Company and presentation currency of the Group. The following table discloses the major exchange rates of those currencies other than the functional currency of US$ that are utilized by the Group: Foreign currency units to 1 US$ € £ CHF SEK NOK DKKAverage three-month period to September 30, 2021 (unaudited) 0.8292 0.7253 0.9043 8.3868 8.5171 6.1669Average nine-month period to September 30, 2021 (unaudited) 0.8303 0.7157 0.9116 8.4230 8.3785 6.1747At September 30, 2021 (unaudited) 0.8589 0.7417 0.9314 8.7634 8.7140 6.3870 Foreign currency units to 1 US$ € £ CHF SEK NOK DKKAverage year ended December 31, 2020 (audited) 0.8777 0.7799 0.9391 9.2135 9.4206 6.5432At December 31, 2020 (audited) 0.8141 0.7365 0.8829 8.1885 8.5671 6.0570 Foreign currency units to 1 US$ € £ CHF SEK NOK DKKAverage three-month period to September 30, 2020 (unaudited) 0.8905 0.7873 0.9508 9.4111 9.5480 6.6422Average nine-month period to September 30, 2020 (unaudited) 0.8562 0.7749 0.9203 8.8756 9.1384 6.3740At September 30, 2020 (unaudited) 0.8543 0.7777 0.9220 9.0060 9.4528 6.3604 (€ = Euro; £ = Pounds Sterling, CHF = Swiss Franc, SEK = Swedish Kroner, NOK = Norwegian Kroner, DKK = Danish Kroner) Changes in accounting policies and disclosures There are no new standards and amendments to IFRS effective as of January 1, 2021 that are relevant to the Group. Critical accounting judgements and key sources of estimation uncertainty In preparing these condensed consolidated interim financial statements in conformity with IFRS management is required to make judgements, estimates and assumptions that affect the application of policies and amounts reported in the condensed consolidated interim financial statements and accompanying notes. The estimates and associated assumptions are based on historical experience and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis of making the judgements about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates. The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimate is revised if the revision affects only that period or in the period of the revision and future periods if the revision affects both current and future periods. The significant estimates, assumptions or judgements, applied in the condensed consolidated interim financial statements were the same as those applied in the Group’s audited financial statements for the year ended December 31, 2020. Principal accounting policies The condensed consolidated interim financial statements have been prepared in accordance with the accounting policies adopted in the Group’s audited financial statements for the year ended December 31, 2020 other than for those applied in the acquisition accounting for the Chiasma acquisition (see Note 5, Business combinations and asset acquisitions). 3. Segment information The Group is a global, commercial-stage biopharmaceutical company dedicated to commercializing and developing novel therapeutics to treat patients suffering from serious and life-threatening rare diseases. The Group currently operates as one business segment, pharmaceuticals, and is focused on the development and commercialization of three commercial products and a number of development products. The Group derives its revenues primarily from one source, being the pharmaceutical sector with high unmet medical need. The Group’s Chief Executive Officer, Joseph Wiley, is currently the Company’s chief operating decision maker (‘‘CODM’’). The Group does not operate any separate lines of business or separate business entities with respect to its products. Accordingly, the Group does not accumulate discrete financial information with respect to separate service lines and does not have separate reportable segments. The following table summarizes total revenues from external customers by product and by geographic region, based on the location of the customer. Three months ended September 30, 2021 (unaudited) U.S.EMEAOtherTotal US$’000US$’000US$’000US$’000Metreleptin18,74815,6181,92736,293Lomitapide8,5686,4063,56418,538Mycapssa®1,453——1,453Other—16669235Total revenue28,76922,1905,56056,519 Three months ended September 30, 2020 (unaudited) U.S.EMEAOtherTotal US$’000US$’000US$’000US$’000Metreleptin15,8776,4237,57829,878Lomitapide9,2337,1092,77119,113Mycapssa®————Other—201134335Total revenue25,11013,73310,48349,326 Nine months ended September 30, 2021 (unaudited) U.S.EMEAOtherTotal US$’000US$’000US$’000US$’000Metreleptin52,72639,59416,992109,312Lomitapide25,38221,3389,45256,172Mycapssa®1,453——1,453Other—582194776Total revenue79,56161,51426,638167,713 Nine months ended September 30, 2020 (unaudited) U.S.EMEAOtherTotal US$’000US$’000US$’000US$’000Metreleptin45,45726,23313,01484,704Lomitapide28,04718,6837,85654,586Mycapssa®————Other—573222795Total revenue73,50445,48921,092140,085 Major Customers For the three and nine months ended September 30, 2021, one customer accounted for 47% and 48%, respectively, of the Group’s net revenues (2020: 51% and 52%, respectively) and accounted for 42% of the Group’s September 30, 2021 accounts receivable balance (December 31, 2020: 42%). 4. Share based payments Share-based Compensation Plans Amryt’s Equity Incentive Plan Amryt’s Equity Incentive Plan was established by a special resolution on 23 September 2019 and was subsequently amended by the Board on 18 May 2020 and 3 August 2021. The purpose of the Plan is to provide for the granting of Equity Incentives to Directors and Employees of, and Consultants to, the Company or any Associated Company. Chiasma Equity Incentive Plan When Amryt acquired Chiasma in August 2021, the Chiasma Stock Option and Incentive Plan transferred across to Amryt. Each outstanding and unexercised Chiasma Stock Option or RSU, whether or not vested, ceased to represent a right to acquire shares of Chiasma common stock and were converted into an option to purchase Amryt ADSs on the same terms and conditions as were applicable under such Chiasma Stock Option and Incentive Plan immediately prior to the acquisition. No new stock option or RSUs will be granted under the Chiasma stock option and incentive plan. Terms and Conditions of New Grants and Grants Under the Chiasma Equity Incentive Plan The terms and conditions of new grants are as follows, whereby all options are settled by physical delivery of shares: Vesting conditions The employee share options vest following a period of service by the officer or employee. The required period of service is determined by the Remuneration Committee at the date of grant of the options (usually the date of approval by the Remuneration Committee). There are no market conditions associated with the share option vesting periods. Contractual life The term of an option is determined by the Remuneration Committee provided that the term may not exceed a period of seven to ten years from the date of grant. All options will terminate 90 days after termination of the option holder’s employment, service or consultancy with the Group except where a longer period is approved by the Board of Directors. Under certain circumstances involving a change in control of the Group, some options will automatically accelerate and become exercisable in full as of a date specified by the Board of Directors. The number and weighted average exercise price (in Sterling pence) of share options granted under Amryt’s Equity Incentive Plan and the Chiasma stock option and incentive plan is as follows: Amryt Equity Incentive PlanChiasma Stock Option and Incentive Plan UnitsWeighted average exercise price (Sterling pence)UnitsWeighted average exercise price (Sterling pence)Balance at 1 January 2020 14,481,720116.00p——Granted 4,432,000144.76p——Lapsed(87,119)113.42p——Exercised(72,953)120.72p——Outstanding at 31 December 2020 (audited)18,753,648122.79p——Exercisable at 31 December 2020 (audited)5,866,152114.24p—— Balance at 1 January 202118,753,648122.79p——Granted10,663,959192.40p——Transferred to Amryt on acquisition— 18,139,060189.07pForfeited(1,162,976)175.91p(257,335)183.64pExercised(300,000)93.00p(441,280)0.98pOutstanding at September 30, 2021 (unaudited)27,954,631147.45p17,440,445191.46pExercisable at September 30, 2021 (unaudited)6,938,801118.56p13,552,670185.75p The fair value of the Amryt equity award is estimated at the date of grant using the Black-Scholes pricing model, taking into account the terms and conditions attached to the grant. The fair value of the Chiasma equity awards transferred to Amryt on acquisition were measured in accordance with IFRS 2. The portion of the value of the equity transferred to Amryt attributable to pre-combination service is included in the consideration at the date of acquisition. The portion of the equity awards transferred to Amryt attributable to post combination service is estimated at the date of transfer using Black Scholes pricing model, taking into account the terms and conditions attached to the grant. The following are the inputs to the model for the equity instruments granted during the period: September 30, 2021 Options Inputs (unaudited)December 31, 2020 Options Inputs (audited)Days to Expiration2,5552,555Volatility32% - 49%33% - 37%Risk free interest rate0.77% - 0.94%0.39% - 0.46%Share price at grant146.87 - 201.2p123.5p – 178.9p In the nine months ended September 30, 2021, a total of 10,663,959 share options over ordinary shares exercisable at a weighted average price of £1.92 were granted. The fair value of share options granted in the nine months ended September 30, 2021 was £20,517,000/US$28,302,000. The share options outstanding under the Amryt 2021 Equity Incentive Plan as at September 30, 2021 have a weighted remaining contractual life of 5.32 years with exercise prices ranging from £0.76 to £2.012 per ordinary share. The share options outstanding under the Chiasma Share Option and Incentive Plan transferred across to Amryt on acquisition. As at September 30, 2021 they have a weighted remaining contractual life of 3.23 years with exercise prices ranging from £0.54 to £9.35 per ordinary share. No new share options will be granted under the Chiasma Stock Option and Incentive Plan. Restricted Share Units Under the terms of Amryt’s Equity Incentive Plan, restricted share units (“RSUs”) to purchase 1,604,205 ordinary shares were outstanding at September 30, 2021. Under the terms of this plan, RSUs are granted to officers, consultants and employees of the Group at the discretion of the Remuneration Committee. For the period ended September 30, 2021, a total of 551,405 RSUs were granted to employees of the company. For the year ended December 31, 2020, a total of 1,556,960 RSUs were granted to employees of the company. The fair value of the RSUs is based on the share price at the date of grant, with the expense spread over the vesting period. The fair value of RSUs granted in the period ended September 30, 2021 was US$1,358,000. At September 30, 2021, the total RSUs granted to date have a weighted remaining contractual life of 2.1 years. Under the terms of Chiasma’s Stock Option and Incentive Plan transferred to Amryt on acquisition, restricted share units (“RSUs”) to purchase 157,225 ordinary shares were outstanding at September 30, 2021. At September 30, 2021, the total RSUs granted to date have a weighted remaining contractual life of 2.3 years. No new RSUs will be granted under the Chiasma Stock Option and Incentive Plan. The following table summarizes the RSU activity for the period: Amryt Equity Incentive PlanChiasma Stock Option and Incentive Plan UnitsWeighted average fair value (US$)UnitsWeighted average fair value (US$)Balance at 1 January 2021 1,549,910$2.35——Granted 551,405$2.66——Transferred to Amryt on acquisition——202,145$2.75Lapsed(134,255)$2.39(36,610)$2.75Vested(362,855)$2.34(8,310)$2.75Outstanding at 30 September 2021 (unaudited)1,604,205$2.44157,225$2.75 Warrants There are no outstanding warrants at September 30, 2021 (December 31, 2020: 9,312,062). In August 2021, an Amryt institutional investor exercised subscription rights relating to 8,966,520 zero cost warrants. These warrants were issued in September 2019 as part of the Company’s acquisition of Aegerion. Certain institutional investors elected to receive warrants to subscribe for new ordinary shares of £0.06 each in Amryt (“Ordinary Shares”), in place of the same number of Ordinary Shares, as consideration for the Company’s acquisition of Aegerion and their equity investments in the Company in September 2019. Each warrant entitled the holder to subscribe for one Ordinary Share for no additional consideration. Separate warrants consisting of 345,542 as at December 31, 2020, which were issued in connection with the admission to the AIM in 2016, are no longer outstanding; 283,389 warrants were exercised in March 2021 and 62,153 warrants lapsed in April 2021. The number and weighted average exercise price (in Sterling pence) of warrants per ordinary share is as follows: Warrants UnitsWeighted average exercise price (Sterling pence)Balance at 1 January 2020 17,541,8150.03pGranted ——Lapsed——Exercised(8,229,753)—Outstanding at 31 December 2020 (audited)9,312,0620.05pExercisable at 31 December 2020 (audited)9,312,0620.05p Balance at 1 January 20219,312,0620.05pGranted——Lapsed(62,153)1.44pExercised(9,249,909)0.05pOutstanding at September 30, 2021 (unaudited)—0.00p The value of share options and RSU’s charged to the Condensed Consolidated Statement of Comprehensive Loss during the period is as follows: Three months ended September 30,Nine months ended September 30, 2021 (unaudited) 2020 (unaudited)2021 (unaudited)2020 (audited) US$’000 US$’000US$’000US$’000Share option expense2,173 1,307 4,525 2,910RSU expense516 226 1,380 226Total share option expense2,689 1,5335,9053,136 5. Business combinations and asset acquisitions Acquisition of Chiasma On May 5, 2021, Amryt announced that it had signed a definitive agreement to acquire Chiasma, Inc. (Nasdaq: CHMA) in an all-stock combination. Under the terms of the transaction, each share of Chiasma common stock issued and outstanding prior to the consummation of the transaction was exchanged for 0.396 Amryt American Depositary Shares (“ADSs”), each representing five Amryt ordinary shares. On August 5, 2021, Amryt completed the acquisition of Chiasma, Inc and in conjunction with the completion Amryt allotted and issued a total of 127,733,680 ordinary shares as consideration for the acquisition. Following the completion, shareholdings in Chiasma were rounded in being converted to Amryt shares using the exchange ratio of 0.396. The roundings in converting Chiasma shareholdings to Amryt shares were finalized in August 2021 and resulted in an additional 7,015 ordinary shares being allotted and issued by Amryt as consideration for the acquisition. In total, these ordinary shares were issued to the former Chiasma Shareholders in the form of 25,548,139 ADSs at US$10.19 per share, to acquire Chiasma for a value of US$260,336,000. On August 5, 2021, Chiasma had outstanding equity awards that were held by Chiasma employees, the fair value of these awards transferred to Amryt on acquisition were measured in accordance with IFRS 2. The portion of the value of the equity transferred to Amryt attributable to pre-combination service is included in the consideration at the date of acquisition and this amounted to US$10,157,000. The combined company will be a global leader in rare and orphan diseases with three on-market commercial products, a global commercial and operational footprint and a significant development pipeline of therapies with the financial flexibility to execute its growth plans. The table below reflects the fair value of the identifiable net assets acquired in respect of the acquisition completed during the period. Any amendments to fair values will be made within the twelve-month period from the date of acquisition, as permitted by IFRS 3 Business Combinations. The acquired goodwill is attributable principally to the profit generating potential of the businesses, the assembled workforce and benefits arising from embedded infrastructure, that are expected to be achieved from integrating the acquired businesses into the Group’s existing business. No amount of goodwill is expected to be deductible for tax purposes. In the post-acquisition period to September 30, 2021, the business acquired during the current year contributed revenue of US$1,453,000 and a trading loss of US$11,994,000 to the Group’s results. The full year unaudited revenue and trading loss had the acquisition taken place at the start of the year has not been disclosed as the initial accounting is incomplete. The gross contractual value of trade and other receivables as at the dates of acquisition amounted to US$7,000,000, which approximated the fair value of these accounts as the amount not expected to be collected was insignificant. The Group incurred acquisition and restructuring related costs of US$14,679,000 in the nine months ended September 30,2021, relating to external legal fees, advisory fees, due diligence costs and severance costs related to the acquisition of Chiasma. These costs have been included in operating costs in the Condensed Consolidated Statement of Comprehensive Loss. The initial assignment of fair values to identifiable net assets acquired has been performed on a provisional basis due to the relative size of the acquisition and the timing of the transaction. Any amendments to these fair values within the twelve-month timeframe from the date of acquisition will be disclosed in the 2022 consolidated financial statements, as stipulated by IFRS 3. Provisional Fair Value as at August 5, 2021 (unaudited) US$’000Assets Non-current assets Intangible assets 220,000Property, plant and equipment 950Other non-current assets 866Total non-current assets 221,816Current assets Trade and other receivables 7,000Inventories 61,527Cash and cash equivalents, including restricted cash 107,942Total current assets 176,469Total assets 398,285 Non-current liabilities Deferred tax liability 47,117Total non-current liabilities 47,117Current liabilities Trade and other payables 142,469Total current liabilities 142,469Total liabilities 189,586 Total identifiable net assets at fair value 208,699Goodwill arising on acquisition 61,794Consideration 270,493 Consideration Issue of fully paid up ordinary shares 260,336Chiasma equity awards recognized as consideration transferred upon the acquisition of Chiasma 10,157Total consideration 270,493 Acquisition of Aegerion Pharmaceuticals On May 20, 2019, Amryt entered into a Restructuring Support Agreement (as subsequently amended on June 12, 2019) and Plan Funding Agreement pursuant to which, among other matters, Amryt agreed to the acquisition of Aegerion Pharmaceuticals, Inc. (‘‘Aegerion’’, subsequently renamed as Amryt Pharmaceuticals Inc.), a former wholly-owned subsidiary of Novelion Therapeutics Inc. (‘‘Novelion’’). On May 20, 2019, Aegerion and its U.S. subsidiary, Aegerion Pharmaceuticals Holdings, Inc., filed voluntary petitions under Chapter 11 of Title 11 of the U.S. Code in the Bankruptcy Court. On September 24, 2019, Amryt completed the acquisition of Aegerion. Amryt acquired Aegerion upon its emergence from bankruptcy in an exchange for ordinary shares and zero cost warrants in Amryt. Amryt issued 85,092,423 effective shares at US$1.793 per share, which is made up of 77,027,423 ordinary shares and 8,065,000 zero cost warrants, to acquire Aegerion for a value of US$152,615,000. As part of the acquisition of Aegerion, it was agreed, for certain Aegerion creditors who wished to restrict their percentage share interest in Amryt’s issued share capital, to issue to the relevant Aegerion creditor, as an alternative to Amryt’s ordinary shares, an equivalent number of new zero cost warrants to subscribe for Amryt’s ordinary shares to be constituted on the terms of the zero cost warrant. As at 30 September, 2021, no zero cost warrants were remaining and the remaining balance of zero cost warrants were exercised during the three-month period ended June 30, 2021. During the three-month and nine-month periods ended September 30, 2021, the Group incurred no additional acquisition and restructuring related costs relating to external legal fees, advisory fees, due diligence costs and severance costs related to the acquisition of Aegerion (September 30, 2020: US$105,000 and US$1,005,000, respectively). Contingent Value Rights Related to the Aegerion acquisition, Amryt issued Contingent Value Rights (‘‘CVRs’’) pursuant to which up to US$85,000,000 may become payable to Amryt’s shareholders and optionholders, who were on the register prior to the completion of the acquisition on September 20, 2019, if certain approval and revenue milestones are met in relation Oleogel-S10, Amryt’s lead product candidate. If any such milestone is achieved, Amryt may elect to pay the holders of CVRs by the issue of Amryt shares or loan notes. If Amryt elects to issue Loan Notes to holders of CVRs, it will settle such loan notes in cash 120 days after their issue. If none of the milestones are achieved, scheme shareholders and optionholders will not receive any additional consideration under the terms of the CVRs. In these circumstances, the value of each CVR would be zero. The terms of the CVRs are as follows: The total CVR payable is up to US$85,000,000 This is divided into three milestones which are related to the success of Oleogel-S10 (the Group’s lead development asset) FDA approval US$35,000,000 upon FDA approval 100% of the amount due if approval is obtained before December 31, 2021, with a sliding scale on a linear basis to zero if before July 1, 2022 EMA approval US$15,000,000 upon EMA approval 100% of the amount due if approval is obtained before December 31, 2021, with a sliding scale on a linear basis to zero if before July 1, 2022 Revenue targets US$35,000,000 upon Oleogel-S10 revenues exceeding US$75,000,000 in any 12-month period prior to June 30, 2024 Payment can at the Board’s discretion be in the form of either: 120-day loan notes (effectively cash), or Shares valued using the 30 day / 45-day VWAP. The CVRs were contingent on the successful completion of the acquisition and, accordingly, have been based on fair value as at September 24, 2019. The CVRs have been classified as a financial liability in the Condensed Consolidated Statement of Financial Position. Given that CVRs were issued to legacy Amryt shareholders in their capacity as owners of the identified acquirer as opposed to the seller in the transaction, management concluded that the most appropriate classification would be to recognize the CVR as a distribution on consolidation instead of goodwill. Measurement of CVRs As at September 30, 2021, the carrying value of the CVRs was US$66,932,000 (December 31, 2020: US$61,417,000). The value of the potential payout was calculated using the probability-weighted expected returns method. Using this method, the potential payment amounts were multiplied by the probability of achievement and discounted to present value. The probability adjusted present values took into account published orphan drug research data and statistics which were adjusted by management to reflect the specific circumstances applicable to the type of product acquired in the Amryt GmbH transaction. The market-based probability chance of success is based on market benchmarks for orphan drugs was estimated at 89% in the period ended September 30, 2021 (2020: 89%). Discount rates of 10% and 16.5%, as applicable, were used in the calculation of the present value of the estimated contractual cash flows for the period ended September 30, 2021 (December 31, 2020: 10% and 16.5%). Management was required to make certain estimates and assumptions in relation to revenue forecasts, timing of revenues and probability of achievement of commercialization of Oleogel-S10. However, management notes that, due to issues outside their control (i.e. regulatory requirements and the commercial success of the product), the timing of when such revenue targets may occur may change. Such changes may have a material impact on the assessment of the expected cash flows of the CVRs. Amryt reviews the expected cash flows on a regular basis as the discount on initial recognition is being unwound as financing expenses in the Condensed Consolidated Statement of Comprehensive Loss over the life of the obligation. It is reviewed on a quarterly basis and the appropriate finance charge is booked in the Condensed Consolidated Statement of Comprehensive Loss on a quarterly basis. The Group received positive topline data from the phase 3 EASE trial of Oleogel-S10 in September 2020. The product does not currently have regulatory approval to treat EB but has been submitted to the FDA for approval and in June 2021, Amryt received confirmation from the FDA that its NDA for Oleogel-S10 had been accepted and granted priority review. The FDA also set a target PDUFA date of November 30, 2021. In Europe, a MAA for Oleogel-S10 was accepted for assessment by the EMA in March 2021. The total non-cash finance charge recognized in the Condensed Consolidated Statement of Comprehensive Loss for the three and nine months ended September 30, 2021 is US$1,915,000 and US$5,515,000 (September 30, 2020: US$1,557,000 and US$4,498,000, respectively). Acquisition of Amryt GmbH (previously ‘‘Birken’’) Amryt DAC signed a conditional share purchase agreement to acquire Amryt GmbH on October 16, 2015 (‘‘Amryt GmbH SPA’’). The Amryt GmbH SPA was completed on April 18, 2016 with Amryt DAC acquiring the entire issued share capital of Amryt GmbH. The consideration included contingent consideration comprising milestone payments and sales royalties as follows: Milestone payments of: €10,000,000 on receipt of first marketing approval by the EMA of Episalvan, paid on the completion date (April 18, 2016); Either (i) €5,000,000 once net ex-factory sales of Episalvan have been at least €100,000 or (ii) if no commercial sales are made within 24 months of EMA first marketing approval (being January 14, 2016), €2,000,000 24 months after receipt of such approval, which was paid in January 2018, and €3,000,000 following the first commercial sale of Episalvan; €10,000,000 on receipt of marketing approval by the EMA or FDA of a pharmaceutical product containing Betulin as its API for the treatment of EB; €10,000,000 once net ex-factory sales/net revenue of Oleogel S-10 first exceed €50,000,000 in any calendar year; €15,000,000 once net ex-factory sales/ net revenue of Oleogel S-10 first exceed €100,000,000 in any calendar year; Cash consideration of €150,000, due and paid on the completion date (April 18, 2016); and Royalties of 9% on sales of Oleogel-S10 products for 10 years from first commercial sale. Fair Value Measurement of Contingent Consideration As at September 30, 2021, the fair value of the contingent consideration was estimated to be US$91,067,000 (December 31, 2020: US$86,906,000). The fair value of the contingent consideration included milestone payments determined using probability adjusted present values and probability weighted revenue forecasts (see Note 15, Fair value measurement and financial risk management, for fair value hierarchy applied and impact of key unobservable impact data). The probability adjusted present values took into account published orphan drug research data and statistics which were adjusted by management to reflect the specific circumstances applicable to the type of product acquired in the Amryt GmbH transaction. The market-based probability chance of success is based on market benchmarks for orphan drugs was estimated at 89% for the period ended September 30, 2021 (December 31, 2020: 89%) following the positive results from our phase 3 EASE trial of Oleogel-S10 earlier in the year. A discount rate of 14.4% was used in the calculation of the fair value of the contingent consideration for the three months ended September 30, 2021 (December 31, 2020: 14.4%). The Group received positive top line results from the phase 3 EASE trial of Oleogel-S10 in September 2020. The product does not currently have regulatory approval to treat EB but has been submitted to the FDA for approval and in June 2021, Amryt received confirmation from the FDA that its NDA for Oleogel-S10 had been accepted and granted priority review. The FDA also set a target PDUFA date of November 30, 2021. In Europe, a MAA for Oleogel-S10 was accepted for assessment by the EMA in March 2021. Amryt reviews the contingent consideration on a regular basis as the probability adjusted fair values are being unwound as financing expenses in the Condensed Consolidated Statement of Comprehensive Loss over the life of the obligation. The finance charge is being unwound as a financing expense in the Condensed Consolidated Statement of Comprehensive Loss on a quarterly basis. The total non-cash finance charge recognized in the Condensed Consolidated Statement of Comprehensive Loss for the three and nine months ended September 30, 2021 is US$3,030,000 and US$8,897,000 (September 30, 2020: US$2,126,000 and US$8,150,000, respectively). 6. Loss per share - basic and diluted The weighted average number of shares in the loss per share (‘‘LPS’’) calculation, reflects the weighted average total actual shares of Amryt Pharma plc in issue at September 30, 2021. Issued share capital - ordinary shares of £0.06 each Number of shares Weighted average shares As at September 30, Three months ended September 30,Nine months ended September 30,2021 (unaudited)316,904,642 264,368,691 207,876,7312020 (unaudited)162,718,438 158,303,972 155,776,507 The calculation of loss per share is based on the following: Three months ended September 30,Nine months ended September 30, 2021 (unaudited) 2020 (unaudited)2021 (unaudited)2020 (unaudited)Loss after tax attributable to equity holders of the Company (US$’000)(17,209) (10,471) (40,545) (57,537)Weighted average number of ordinary shares in issue264,368,691 158,303,972 207,876,731 155,776,507Fully diluted average number of ordinary shares in issue264,368,691 158,303,972 207,876,731 155,776,507Basic and diluted loss per share (US$)(0.07) (0.07)(0.20)(0.37) Where a loss has occurred, basic and diluted LPS are the same because the outstanding share options and warrants are anti-dilutive. Accordingly, diluted LPS equals the basic LPS. The share options, RSUs and warrants outstanding as at September 30, 2021 totaled 47,156,506 (September 30, 2020: 28,065,710) and are potentially dilutive. 7. Intangible assets and goodwill The following table summarizes the Group’s intangible assets and goodwill: Developed technology - metreleptinDeveloped technology - lomitapideDeveloped technology - Mycapssa®In process R&DOther intangible assetsTotal intangible assetsGoodwill US$’000US$’000US$’000US$’000US$’000US$’000US$’000Cost At January 1, 2020 (audited)176,000123,000—54,261701353,96219,131Additions————372372—Acquired assets———591—591—Disposals————(246)(246)—Foreign exchange movement———5,276395,315—At December 31, 2020 (audited)176,000123,000—60,128866359,99419,131Additions————830830—Acquired assets——220,000——220,00061,794Other movements——————(1,051)Foreign exchange movement———(3,137)(40)(3,177)—At September 30, 2021 (unaudited)176,000123,000220,00056,9911,656577,64779,874 Accumulated amortization At January 1, 2020 (audited)7,3144,143——17811,635—Amortization charge27,42915,537——20243,168—Accumulated amortization on disposals————(246)(246)—Foreign exchange movement————6868—At December 31, 2020 (audited)34,74319,680——20254,625—Amortization charge20,57111,6531,960—9034,274—Foreign exchange movement————1515—At September 30, 2021 (unaudited)55,31431,3331,960—30788,914— Net book value At December 31, 2020 (audited)141,257103,320—60,128664305,36919,131At September 30, 2021 (unaudited)120,68691,667218,04056,9911,349488,73379,874 Developed technology on commercially marketed products In connection with the acquisition of Aegerion in September 2019, the Group acquired developed technology, metreleptin and lomitapide. These intangible assets are amortized over their estimated useful lives and the remaining useful lives for metreleptin and lomitapide are approximately 4.4 and 6.0 years, respectively, as of September 30, 2021 (December 31, 2020: 5.2 and 6.7 years, respectively). In connection with the acquisition of Chiasma in August 2021, the Group acquired developed technology, octreotide. This intangible asset is amortized over its estimated useful life and the remaining useful life is approximately 14.3 years as of September 30, 2021. In-process R&D As a result of the acquisition of Amryt GmbH, in 2016, the Group recognized in-process R&D costs of €48,453,000/US$56,409,000 which is related to the Group’s lead development asset, Oleogel-S10. The remaining in-process R&D is a result of the acquisition of Cala Medical Limited in October 2020. Goodwill During 2019, the Group completed the acquisition of Aegerion, which resulted in aggregate goodwill of US$18,080,000. On August 5, 2021, the Group completed the acquisition of Chiasma, which resulted in aggregate goodwill of US$61,794,000. The Group reviews events or changes in circumstances that may indicate a triggering event for impairment. Management applied its judgment in determining that there were no events or changes in circumstances causing any impairment triggers as of September 30, 2021. As such there was no impairment charge recorded during the three and nine months ended September 30, 2021. 8. Trade and other receivables As at September 30, 2021 (unaudited) December 31, 2020 (audited) US$’000 US$’000Trade receivables37,458 33,057Accrued income and other debtors9,808 8,423VAT recoverable5,527 1,705Trade and other receivables52,793 43,185 9. Inventories As at September 30, 2021 (unaudited) December 31, 2020 (audited) US$’000 US$’000Raw materials29,462 25,462Work in progress31,550 3,903Finished goods39,827 11,627Inventories100,839 40,992 The increase in inventories for the nine months ended September 30, 2021, reflected the fair value of inventory acquired as part of the acquisition of Chiasma on August 5, 2021. The fair value of the acquired inventory amounted to US$61,527,000. Inventory on hand at the date of acquisition was valued at the expected selling price less the sum of remaining costs of disposal, cost to complete and a reasonable profit margin for the selling effort of the acquiring entity based on the EBITDA margin as a percentage of sales. The costs to complete were calculated based on costs incurred on recently completed finished goods. The costs to dispose were calculated based on the average costs as a percentage of revenue through the period in which the current finished goods inventory is expected to be sold. This resulted in a non-cash step up at the valuation of inventory at August 5, 2021 of US$40,414,000. The non-cash step up in inventory is being unwound to the Condensed Consolidated Statement of Comprehensive Loss over the period in which this saleable inventory is sold. At September 30, 2021, US$39,978,000 of this non-cash inventory step up is included in inventory. 10. Cash and cash equivalents As at September 30, 2021 (unaudited) December 31, 2020 (audited) US$’000 US$’000Cash at bank available on demand123,127 118,575Restricted cash50 223Total cash and cash equivalents123,177 118,798 Cash and cash equivalents include cash at bank available on demand and restricted cash. At September 30, 2021 there was US$50,000 restricted cash (December 31, 2020: US$223,000). The balance at December 31, 2020 includes a deposit on a company credit card facility for an amount of US$150,000. As at September 30, 2021 a letter of credit related to US customs was put in place for an amount of US$50,000. 11. Share capital and reserves Details of the number of issued ordinary shares with a nominal value of Sterling 6 pence (2020: 6 pence) each are in the table below. Ordinary sharesTreasury sharesTotalAt January 1, 2020154,498,8874,864,656159,363,543Issue of shares in exchange for warrants8,229,753—8,229,753Issue of shares in equity fund raises16,000,000—16,000,000Issue of treasury shares for share options exercised72,953(72,953)—At December 31, 2020 (audited)178,801,5934,791,703183,593,296Issue of treasury shares in exchange for warrants283,389(283,389)—Issue of treasury shares for share options exercised300,000(300,000)—Issue of shares in consideration of Chiasma acquisition127,740,695—127,740,695Issue of shares in exchange for warrants4,758,206—4,758,206Issue of treasury shares in exchange for warrants4,208,314(4,208,314)—Issue of shares for share options exercised and RSUs vesting812,445—812,445At September 30, 2021 (unaudited)316,904,642—316,904,642 The components of equity are detailed in the Condensed Consolidated Statement of Changes in Equity and described in more detail below. As at September 30, 2021 there were 316,904,642 ordinary shares issued with no treasury shares held (December 31, 2020: 183,593,296; 4,791,703). In December 2020, the Company issued 16,000,000 ordinary shares in the form of ADSs, as part of a US$40,000,000 private placement equity raise to existing and new shareholders. The Company issued 4,000,000 and 4,229,753 ordinary shares on July 15, 2020, and September 22, 2020, respectively, in exchange for certain warrants. On March 11, 2021, the Company issued 300,000 ordinary shares from treasury shares following the exercise of share options. On March 11, 2021, the Company issued 283,389 ordinary shares from treasury shares in exchange for certain warrants. On August 5, 2021, the Company issued 127,740,695 ordinary shares, in the form of ADSs, as consideration for the acquisition of Chiasma. On August 5, 2021, the Company issued 8,966,520 ordinary shares with 4,208,314 being issued from treasury shares in exchange for warrants. During the three month period ended September 30, 2021, there were 441,280 shares issued following the exercise of share options and 371,165 shares issued following RSU vesting. Share Capital Share capital represents the cumulative par value arising upon issue of ordinary shares of Sterling 6 pence each. The ordinary shares have the right to receive notice of, attend and vote at general meetings and participate in the profits of the Company. Share Premium Share premium represents the consideration that has been received in excess of the nominal value on issue of share capital net of issue costs and transfers to distributable reserves. Warrant reserve The warrant reserve represents zero cost warrants issued as part of the equity raise on September 24, 2019 net of issue costs apportioned to warrants issued and additional warrants issued to certain shareholders on November 14, 2019. Each warrant entitles the holder to subscribe for one ordinary share at zero cost. The Company issued 4,000,000 and 4,229,753 ordinary shares on July 15, 2020 and September 22, 2020, respectively, in exchange for certain warrants. The remaining warrants were exchanged on August 5, 2021, and the Company issued 8,966,520 ordinary shares, 4,208,314 of which were issued from treasury shares. There were no remaining warrants outstanding as at September 30, 2021. Treasury Shares In October 2020, the Company issued 72,953 ordinary shares from treasury shares following the exercise of share options. In March 2021, the Company issued a total of 583,389 ordinary shares from treasury shares, 300,000 ordinary shares relating to the exercise of share options and 283,389 ordinary shares following the exchange of certain warrants. In August 2021, the company issued 4,208,314 ordinary shares from treasury shares in conjunction with the exchange of warrants. There were no treasury shares held as at September 30, 2021. Share based payment reserve Share based payment reserve relates to the charge for share based payments in accordance with IFRS 2. In March 2021, the Company issued 283,389 ordinary shares in exchange for certain warrants, respectively. In April 2021, 62,153 warrants lapsed. During the nine month period ended September 30, 2021, the Company issued 741,280 ordinary shares in relation to the exercise of share options and RSUs. As part of the acquisition of Chiasma, the Company replaced share awards that were existing at the time of the acquisition. This resulted in the recognition of a share-based payment reserve of US$10,157,000 on acquisition. Merger reserve The merger reserve was created on the acquisition of Amryt DAC by Amryt Pharma plc in April 2016. Ordinary shares in Amryt Pharma plc were issued to acquire the entire issued share capital of Amryt DAC. Under section 612 of the UK Companies Act 2006, the premium on these shares has been included in a merger reserve. Reverse acquisition reserve The reverse acquisition reserve arose during the period ended December 31, 2016 in respect of the reverse acquisition of Amryt Pharma plc by Amryt DAC. Since the shareholders of Amryt DAC became the majority shareholders of the enlarged Group, the acquisition is accounted for as though there is a continuation of Amryt DAC’s financial statements. The reverse acquisition reserve is created to maintain the equity structure of Amryt Pharma plc in compliance with UK company law. Equity component of convertible notes The equity component of convertible notes represents the equity component of the US$125,000,000 convertible debt and is measured by determining the residual of the fair value of the instrument less the estimated fair value of the liability component. The equity component is recognized in equity and is not subsequently remeasured. Other distributable reserves Other distributable reserves comprise the following: Distribution of the share premium amount on 6 November 2019 of US$268,505,000. By special resolution of the Company duly passed on 23 September 2019, it was resolved that the entire amount outstanding to the credit of the share premium account and capital redemption reserve of the Company be cancelled. The reduction in capital, amounting to US$268,505,000, representing the entire amount of share premium at that time, was approved by the High Court of Justice of England and Wales on 5 November 2019. A deemed distribution of US$47,902,000 arising from the issuance of CVRs. A deemed distribution of US$2,969,000 arising from the scheme of arrangement in September 2019 whereby Amryt Pharma plc, which was incorporated in July 2019, became a 100% shareholder of Amryt Pharma Holdings Limited (formerly named Amryt Pharma plc) (the “Acquisition of subsidiary without a change of control”) Currency translation reserve The currency translation reserve arises on the retranslation of non-U.S. dollar denominated foreign subsidiaries. Accumulated deficit Accumulated deficit represents losses accumulated in previous periods and the current year. 12. Long term loan As at September 30, 2021 (unaudited) December 31, 2020 (audited) US$’000 US$’000Long term loan principal92,453 88,037Unamortized debt issuance costs(633) (735)Long term loan 91,820 87,302 As part of the acquisition of Aegerion on September 24, 2019, Aegerion entered into a new U.S. dollar denominated US$81,021,000 secured term loan debt facility (‘‘Term Loan’’) with various lenders. The Term Loan is made up of a US$54,469,000 loan that was in place prior to the acquisition which was refinanced as part of the acquisition and a US$26,552,000 additional loan that was drawn down on September 24, 2019. The Term Loan has a five-year term from the date of the draw down, September 24, 2019 and matures on September 24, 2024. Under the Term Loan, interest will be payable at the option of the Group at the rate of 11% per annum paid in cash on a quarterly basis or at a rate of 6.5% paid in cash plus 6.5% paid in kind that will be paid when the principal is repaid, which rolls up and is included in the principal balance outstanding, on a quarterly basis. Unpaid accrued interest of US$1,511,000 as at September 30, 2021 is recognized in current liabilities with trade and other payables (December 31, 2020: $1,439,000). The Term Loan may be prepaid, in whole or in part, by Aegerion at any time subject to payment of an exit fee, which depending on the stage of the loan term, ranges from 5.00% to 0.00% of the principal then outstanding on the Term Loan. In connection with the Term Loan, the Group incurred approximately US$870,000 of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees. These costs are being amortized over the expected life of the loan using the effective interest method. The Term Loan is guaranteed by Amryt and certain subsidiaries of the Group. In connection with the loan agreement, fixed and floating charges have been placed on property and undertakings of Amryt and certain subsidiaries of the Group. The Term Loan agreement includes affirmative and negative covenants, including prohibitions on the incurrence of additional indebtedness, granting of liens, certain asset dispositions, investments, and restricted payments, in each case, subject to certain exceptions set forth in the Loan Agreement. The Term Loan agreement also includes customary events of default for a transaction of this type and includes (i) a cross-default to the occurrence of any event of default under material indebtedness of Aegerion and certain subsidiaries of the Group and Amryt, including the convertible notes, and (ii) Amryt or any of its subsidiaries being subject to bankruptcy or other insolvency proceedings. Upon the occurrence of an event of default, the lenders may declare all of the outstanding Term Loan and other obligations under the Term Loan agreement to be immediately due and payable and exercise all rights and remedies available to the lenders under the Term Loan agreement and related documentation. There have been no events of default or breaches of the covenants occurring for the three and nine months ended September 30, 2021 (December 31, 2020: no events). 13. Convertible notes Total US$’000At January 1, 202096,856Accreted interest4,230At December 31, 2020 (audited)101,086Accreted interest3,480At September 30, 2021 (unaudited)104,566 As part of the Aegerion acquisition, Aegerion issued convertible notes with an aggregate principal amount of US$125,000,000 to Aegerion creditors. The convertible notes are senior unsecured obligations and bear interest at a rate of 5.0% per year, payable semi-annually in arrears on April 1 and October 1 of each year, beginning on April 1, 2020. The convertible notes will mature on April 1, 2025, unless earlier repurchased or converted. The convertible notes are convertible into Amryt’s ordinary shares at a conversion rate of 386.75 ordinary shares per US$1,000 principal amount of the convertible notes. If the holders elect to convert the convertible notes, Aegerion can settle the conversion of the convertible notes through payment or delivery of cash, common shares, or a combination of cash and common shares, at its discretion. As a result of the conversion feature in the convertible notes, the convertible notes were assessed to have both a debt and an equity component. The two components were assessed separately and classified as a financial liability and equity instrument. The financial liability component was measured at fair value based on the discounted cash flows expected over the expected term of the notes using a discount rate based on a market interest rate that a similar debt instrument without a conversion feature would be subject to. Refer to Note 11, Share capital and reserves, for further details on the equity component of the convertible notes. From September 24, 2019 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of their convertible notes, in multiples of US$1,000 principal amount, at the option of the holder. The indenture does not contain any financial covenants or restrict the Group’s ability to repurchase securities, pay dividends or make restricted payments in the event of a transaction that substantially increases the Group’s level of indebtedness in certain circumstances. The indenture contains customary terms and covenants and events of default. If an event of default (other than certain events of bankruptcy, insolvency or reorganization involving Aegerion, Amryt and certain subsidiaries of the Group) occurs and is continuing, the trustee by notice to Aegerion, or the holders of at least 25% in principal amount of the outstanding convertible notes by written notice to Aegerion and the trustee, may declare 100% of the principal of and accrued and unpaid interest, if any, on all of the convertible notes to be due and payable. Upon such a declaration of acceleration, such principal and accrued and unpaid interest, if any, will be due and payable immediately. Upon the occurrence of certain events of bankruptcy, insolvency or reorganization involving Aegerion, 100% of the principal and accrued and unpaid interest, if any, on the convertible notes will become due and payable automatically. Notwithstanding the foregoing, the indenture provides that, upon Aegerion’s election, and for up to 180 days, the sole remedy for an event of default relating to certain failures by Aegerion to comply with certain reporting covenants in the indenture consists exclusively of the right to receive additional interest on the convertible notes. There have been no events of default or breaches of the covenants occurring for the period ended September 30, 2021 (2020: no events). 14. Provisions and other liabilities As at September 30, 2021 (unaudited) December 31, 2020 (audited) US$’000 US$’000Non-current liabilities Provisions and other liabilities— 21,382Leases due greater than 1 year4,213 4,569 4,213 25,951Current liabilities Provisions and other liabilities27,998 9,976Leases due less than 1 year1,529 963 29,527 10,939Total provisions and other liabilities33,740 36,890 Legal matters Prior to the acquisition of Aegerion by Amryt, Aegerion entered into settlement agreements with governmental entities including the Department of Justice (‘‘DOJ’’) and the FDA in connection with Juxtapid investigations. The settlement agreements require Aegerion to pay specified fines and engage in regulatory compliance efforts. Subsequent to the acquisition, Aegerion made US$23,036,000 of settlement payments, including interest. The settlements have been paid in full with the last payment completed in Q1 2021. There is no current liability recognized as at September 30, 2021 (December 31, 2020: US$3,976,000). There is no non-current liability at September 30, 2021 (December 31, 2020: nil). Other matters The Group recognizes a liability for legal contingencies when it believes that it is both probable that a liability has been incurred and that it can reasonably estimate the amount of the loss. The Group reviews these accruals and adjusts them to reflect ongoing negotiations, settlements, rulings, advice of legal counsel and other relevant information. To the extent new information is obtained and the Group’s views on the probable outcomes of claims, suits, assessments, investigations or legal proceedings change, changes in the Group’s liability accrual would be recorded in the period in which such determination is made. At September 30, 2021 the Group had recognized liabilities of US$6,000,000 in relation to ongoing legal matters (December 31, 2020 US$6,000,000). 15. Fair value measurement and financial risk management Categories of financial instruments As at September 30, 2021 (unaudited) December 31, 2020 (audited) US$’000 US$’000Financial assets (all at amortized cost): Cash and cash equivalents123,177 118,798Trade receivables37,458 33,057Total financial assets160,635 151,855 Financial liabilities: At amortized cost Trade payables and accrued expenses123,095 89,300Lease liabilities5,742 5,532Other liabilities21,998 25,358Convertible notes104,566 101,086Long term loan91,820 87,302Contingent value rights66,932 61,417At fair value Contingent consideration91,067 86,906Total financial liabilities505,220 456,901Net(344,585) (305,046) Financial instruments evaluated at fair value can be classified according to the following valuation hierarchy, which reflects the extent to which the fair value is observable: Level 1: fair value evaluations using prices listed on active markets (not adjusted) of identical assets or liabilities. Level 2: fair value evaluations using input data for the asset or liability that are either directly observable (as prices) or indirectly observable (derived from prices), but which do not constitute listed prices pursuant to Level 1. Level 3: fair value evaluations using input data for the asset or liability that are not based on observable market data (unobservable input data). The contingent consideration has been valued using Level 3. The contingent consideration comprises: Contingent consideration relating to the acquisition of Amryt GmbH (see Note 5, Business combinations and asset acquisitions) that was measured at US$91,067,000 as at September 30, 2021 (December 31, 2020: US$86,906,000). The fair value comprises royalty payments which was determined using probability weighted revenue forecasts and the fair value of the milestones payments which was determined using probability adjusted present values. It also included a revision to the discount rate used, and revenue and costs forecasts have been amended to reflect management’s current expectations. Impact of key unobservable input data An increase of 10% in estimated revenue forecasts would result in an increase to the fair value of US$6,370,000. A decrease would have the opposite effect. A 5% increase in the discount factor used would result in a decrease to the fair value of US$13,979,000. A decrease of 5% would result in an increase to the fair value of US$18,253,000. A six-month delay in the launch date for Oleogel-S10 would result in a decrease to the fair value of US$9,095,000. 16. Events after the reporting period There were no significant events since the end of the reporting period.
AMYT CHMA | globenewswire | about 4 years ago | Neutral

Amryt Reports Strong Q3 2021 ResultsAmryt Reports Strong Q3 2021 Results 14.6% YoY revenue growth in Q3 to $56.5M 21.5% growth in metreleptin revenues YoY to$36.3M in Q3; 51.6% growth YoY excluding the impact of sporadic LATAM orders 7th consecutive quarter of positive EBITDA generation excluding Chiasma transaction costs Cash of ...
Amryt Reports Strong Q3 2021 Results 14.6% YoY revenue growth in Q3 to $56.5M 21.5% growth in metreleptin revenues YoY to$36.3M in Q3; 51.6% growth YoY excluding the impact of sporadic LATAM orders 7th consecutive quarter of positive EBITDA generation excluding Chiasma transaction costs Cash of $123.2M at September 30, 2021 Reaffirming FY 2021 revenue guidance to $220M - $225M, representing 20-23% YoY growth Conference call and webcast today at 0830 EDT / 1230 GMT DUBLIN, Ireland, and Boston MA, November 3, 2021, Amryt (Nasdaq: AMYT, AIM: AMYT), a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing and commercializing novel treatments for rare diseases, today provides a business update and announces unaudited financial results for the third quarter ended September 30, 2021. Joe Wiley, CEO of Amryt Pharma, commented:“Q3 was an extremely busy and productive period for Amryt and I am excited to report today’s strong operational and financial results. Our Q3 revenues of $56.5M represent 14.6% YoY revenue growth. Metreleptin continues to grow strongly and delivered 21.5% YoY growth in the quarter and grew 51.6% during the period excluding the impact of sporadic LATAM ordering. These results clearly demonstrate the strong performance of metreleptin in all regions. Overall, the results also demonstrate the strong growth we are experiencing across our business and represent our seventh consecutive quarter of positive EBITDA generation and this performance has been delivered despite the challenging COVID pandemic. We have also continued to progress the regulatory pathway and filed marketing applications for Oleogel-S10 in both the US and Europe and a target PDUFA date for Oleogel-S10 has been set for November 30, 2021. Oleogel-S10 is eligible for a Priority Review Voucher if approved under priority review by the FDA. If Oleogel-S10 is approved, we will have four commercial products and the team, financial flexibility, systems and global infrastructure in place to bring Oleogel-S10 to market and to execute our significant growth plans. Story continues We completed the acquisition of Chiasma on August 5, 2021 and since then we have made significant progress integrating the Chiasma operations and portfolio into Amryt and we are very excited about both the growth opportunities for Mycapssa® and the potential to develop the underlying TPE platform in other areas. Given the strong performance of our business year to date, we are reaffirming our full year 2021 revenue guidance of $220-$225 million, issued on September 13, 2021 which represents growth of 20%-23% over 2020.” Q3 2021 and Recent Business Highlights: Chiasma, Inc. acquisition completed on August 5, 2021 and integration proceeding well Oleogel-S101 target PDUFA date set by the FDA for November 30, 2021 Oleogel-S10 MAA accepted by EMA and CHMP opinion expected in Q4 2021 Commercial launch plans well advanced for Oleogel-S10 launch, if approved FY 2021 revenue guidance increased in September to $220M - $225M, representing 20-23% growth over 2020 Q3 2021 Commercial Product Performance: Q3 2021 (unaudited) US EMEA Other Total US$’000 US$’000 US$’000 US$’000 Metreleptin 18,748 15,618 1,927 36,293 Lomitapide 8,568 6,406 3,564 18,538 Mycapssa® 1,453 - - 1,453 Other - 166 69 235 Total revenue 28,769 22,190 5,560 56,519 Q3 2020 (unaudited) US EMEA Other Total US$’000 US$’000 US$’000 US$’000 Metreleptin 15,877 6,423 7,578 29,878 Lomitapide 9,233 7,109 2,771 19,113 Mycapssa® - - - - Other - 201 134 335 Total revenue 25,110 13,733 10,483 49,326 14.6% YoY revenue growth in Q3 2021 to $56.5M (Q3 2020: $49.3M) Excluding the impact of sporadic LATAM ordering and Mycapssa®, revenues grew 26.3% YoY and 5.7% QoQ 21.5% increase in metreleptin revenues YoY to $36.3M in Q3 2021 (Q3 2020: $29.9M). Excluding the impact of sporadic LATAM ordering, metreleptin revenue growth was 51.6% YoY. US accounted for 51.7% of global metreleptin revenues and EMEA accounted for 43.0% in Q3 2021 EMEA metreleptin revenues grew 143.2% YoY in Q3 US accounted for 46.2% of global lomitapide revenues and EMEA accounted for 34.6% in Q3 2021 Mycapssa® delivered $1.45M in Q3 (from August 5 when Chiasma was acquired) Mycapssa® revenues in Q3 were impacted by pre-ordering in Q2; normalised ordering patterns have returned in September with Mycapssa® delivering $1.14M in the month The integration of Chiasma is significantly advanced and we continue to extract cost synergies Q3 2021 Financial Highlights: $21.4M operating loss before finance expense for Q3 2021 (Q3 2020: $3.6M operating loss). Excluding non-cash items, share based compensation expenses and Chiasma restructuring and acquisition costs, this resulted in EBITDA3 before restructuring and acquisition costs of $6.2M. Cash of $123.2M at September 30, 2021 (June 30, 2021: $142.9M) post repayment of outstanding Chiasma revenue interest financing debt and transaction related costs in the period IFRS and non-GAAP adjusted Q3 2021 results: US$M Q3 2020 (unaudited) Q3 2021 (unaudited) Q3 2021 Non-cash adjustments2 Q3 2021 Non-GAAP Adjusted Revenue 49.3 56.5 - 56.5 Gross profit 22.3 29.3 13.1 42.4 R&D expenses (7.4) (11.0) - (11.0) SG&A expenses (16.9) (25.7) 0.5 (25.2) Restructuring and acquisitioncosts (0.1) (11.3) - (11.3) Share based compensation expenses (1.5) (2.7) 2.7 - Operating (loss) / profit before finance expense (3.6) (21.4) 16.3 (5.1)3 Operating (loss) / profit before finance expense and restructuring and acquisition costs (3.5) (10.1) 16.3 6.2 1 For the purposes of this announcement, we use the name Oleogel-S10. Filsuvez® has been selected as the brand name for the product but please note, Amryt does not, as yet, have regulatory approval for Filsuvez® to treat EB. 2 Non-cash items include amortisation of the acquired metreleptin, lomitapide and Mycapssa® intangible assets ($12.7M), amortisation of the inventory fair value step-up related to the acquisition of Chiasma, Inc. ($0.4M), depreciation and amortisation ($0.5M) and share based compensation expenses ($2.7M). 3 EBITDA is earnings before interest, tax, depreciation, amortisation and share based compensation expenses. To supplement Amryt's financial results presented in accordance with IFRS generally accepted accounting principles, the Company uses EBITDA as a key measure of company performance as the Company believes that this measure is most reflective of the operational profitability or loss of the Company and provides management and investors with useful supplementary information which can enhance their ability to evaluate the operating performance of the business. EBITDA, as measured by the Company, is not meant to be considered in isolation or as a substitute to operating profit / loss attributable to Amryt and should be read in conjunction with the Company's condensed consolidated financial statements prepared in accordance with IFRS. Guidance & Outlook: Given the continued strong performance of the Company’s commercial products, the board is today reaffirming revenue guidance for FY 2021 in the range of $220M - $225M which represents growth of 20% to 23% on FY 2020. Conference Call & Webcast: Amryt will host a conference call and webcast for analysts and investors today at 0830 EDT/1230 GMT. Webcast Player URL: https://edge.media-server.com/mmc/p/yn6ztxz9 Telephone Dial in details: United States +1 646 787 1226 United Kingdom +44 (0) 203 009 5709 Ireland +353 (1) 506 0626 Confirmation Code 9357809 A playback facility will be available from November 3, 2021 at 1430 EDT / 1830 GMT – November 10, 2021 at 1330 EST / 1830 GMT. Access details for the playback facility are as follows: Confirmation Code: 9357809 | US: + 1 917 677 7532 | UK: +44 (0) 333 300 9785 | Ireland : +353 (1) 553 8777. About Amryt Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets. Amryt’s commercial business comprises three orphan disease products – metreleptin (Myalept®/ Myalepta®); oral octreotide (Mycapssa®); and lomitapide (Juxtapid®/ Lojuxta®). Myalept®/Myalepta® (metreleptin) is approved in the US (under the trade name Myalept®) as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in the EU (under the trade name Myalepta®) as an adjunct to diet for the treatment of leptin deficiency in patients with congenital or acquired GL in adults and children two years of age and above and familial or acquired partial lipodystrophy (PL) in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control. For additional information, please follow this link. Mycapssa® (oral octreotide) is approved in the US for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. Mycapssa® is the first and only oral somatostatin analogapproved by the FDA. Mycapssa® has also been submitted to the EMA for regulatory approval. For additional information, please follow this link. Juxtapid®/Lojuxta® (lomitapide) is approved as an adjunct to a low-fat diet and other lipid-lowering medicinal products for adults with the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia ("HoFH") in the US, Canada, Colombia, Argentina and Japan (under the trade name Juxtapid®) and in the EU, Israel and Brazil (under the trade name Lojuxta®). For additional information, please follow this link. Amryt's lead development candidate, Oleogel-S10 (Filsuvez®) is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (“EB”), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. Filsuvez® has been selected as the brand name for Oleogel-S10. The product does not currently have regulatory approval to treat EB but has been submitted to the FDA for approval and in June 2021, Amryt received confirmation from the FDA that its NDA for Oleogel-S10 had been accepted and granted priority review. The FDA also set a target PDUFA date of November 30, 2021. In Europe, a MAA for Oleogel-S10 was accepted for assessment by the EMA in March 2021. Amryt’s pre-clinical gene therapy candidate, AP103, offers a potential treatment for patients with Dystrophic EB, and the polymer-based delivery platform has the potential to be developed for the treatment of other genetic disorders. Amryt also intends to develop oral medications that are currently only available as injectable therapies through its Transient Permeability Enhancer (TPE®) technology platform. For more information on Amryt, including products, please visit www.amrytpharma.com. Financial Advisors Shore Capital (Daniel Bush, Mark Percy, John More) are NOMAD and Joint Broker to Amryt in the UK. Stifel (Ben Maddison) are Joint Broker to the company in the UK. Forward-Looking Statements This announcement may contain forward-looking statements and the words "expect", "anticipate", "intends", "plan", "estimate", "aim", "forecast", "project" and similar expressions (or their negative) identify certain of these forward-looking statements. The forward-looking statements in this announcement are based on numerous assumptions and Amryt's present and future business strategies and the environment in which Amryt expects to operate in the future. Forward-looking statements involve inherent known and unknown risks, uncertainties and contingencies because they relate to events and depend on circumstances that may or may not occur in the future and may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. These statements are not guarantees of future performance or the ability to identify and consummate investments. Many of these risks and uncertainties relate to factors that are beyond Amryt's ability to control or estimate precisely, such as future market conditions, the course of the COVID-19 pandemic, currency fluctuations, the behaviour of other market participants, the outcome of clinical trials, the actions of regulators and other factors such as Amryt's ability to obtain financing, changes in the political, social and regulatory framework in which Amryt operates or in economic, technological or consumer trends or conditions. Past performance should not be taken as an indication or guarantee of future results, and no representation or warranty, express or implied, is made regarding future performance. No person is under any obligation to update or keep current the information contained in this announcement or to provide the recipient of it with access to any additional relevant information that may arise in connection with it. Such forward-looking statements reflect the Company’s current beliefs and assumptions and are based on information currently available to management. Contacts Joe Wiley, CEO / Rory Nealon, CFO/COO, +353 (1) 518 0200, ir@amrytpharma.com Daniel Bush, Shore Capital, NOMAD +44 (0) 207 408 4090, amrytcorporate@shorecap.co.uk Tim McCarthy, LifeSci Advisors, LLC, +1 (212) 915 2564, tim@lifesciadvisors.com Amber Fennell, Consilium Strategic Communications, +44 (0) 203 709 5700, fennell@consilium-comms.com Amryt Pharma plc Condensed Consolidated Statement of Comprehensive Loss Three Months Ended September 30, Nine Months Ended September 30, Note 2021 (unaudited) 2020 (unaudited) 2021 (unaudited) 2020 (unaudited) US$’000 US$’000 US$’000 US$’000 Revenue 3 56,519 49,326 167,713 140,085 Cost of sales (27,265) (27,057) (76,933) (89,148) Gross profit 29,254 22,269 90,780 50,937 Research and development expenses (11,000) (7,350) (28,454) (22,481) Selling, general and administrative expenses (25,706) (16,889) (62,438) (56,883) Restructuring and acquisition costs 5 (11,226) (105) (14,679) (1,005) Share based payment expenses 4 (2,689) (1,533) (5,905) (3,136) Operating loss before finance expense (21,367) (3,608) (20,696) (32,568) Non-cash change in fair value of contingent consideration 5 (3,030) (2,126) (8,897) (8,150) Non-cash contingent value rights finance expense 5 (1,915) (1,557) (5,515) (4,498) Net finance expense - other (6,424) (1,359) (20,163) (15,492) Loss on ordinary activities before taxation (32,736) (8,650) (55,271) (60,708) Tax credit/(charge) on loss on ordinary activities 15,527 (1,821) 14,726 3,171 Loss for the year attributable to the equity holders of the Company (17,209) (10,471) (40,545) (57,537) Exchange translation differences which may be reclassified through profit or loss 240 (1,921) 2,583 (2,850) Total other comprehensive income/(loss) 240 (1,921) 2,583 (2,850) Total comprehensive loss for the year attributable to the equity holders of the Company (16,696) (12,392) (37,962) (60,387) Loss per share Loss per share - basic and diluted, attributable to ordinary equity holders of the parent (US$) 6 (0.07) (0.07) (0.20) (0.37) Amryt Pharma plc Condensed Consolidated Statement of Financial Position As at, Note September 30, 2021 (unaudited) December 31, 2020 (audited) US$’000 US$’000 Assets Non-current assets Goodwill 7 79,874 19,131 Intangible assets 7 488,733 305,369 Property, plant and equipment 8,402 7,574 Other non-current assets 1,646 1,542 Total non-current assets 578,655 333,616 Current assets Trade and other receivables 8 52,793 43,185 Inventories 9 100,839 40,992 Cash and cash equivalents, including restricted cash 10 123,177 118,798 Total current assets 276,809 202,975 Total assets 855,464 536,591 Equity and liabilities Equity attributable to owners of the parent Share capital 11 25,261 13,851 Share premium 11 310,778 51,408 Other reserves 11 246,080 236,488 Accumulated deficit (276,096) (235,605) Total equity 306,023 66,142 Non-current liabilities Contingent consideration and contingent value rights 5 157,999 148,323 Deferred tax liability 37,001 6,612 Long term loan 12 91,820 87,302 Convertible notes 13 104,566 101,086 Provisions and other liabilities 14 4,213 25,951 Total non-current liabilities 395,599 369,274 Current liabilities Trade and other payables 124,315 90,236 Provisions and other liabilities 14 29,527 10,939 Total current liabilities 153,842 101,175 Total liabilities 549,441 470,449 Total equity and liabilities 855,464 536,591 Amryt Pharma plc Condensed Consolidated Statement of Cash Flows Nine months ended September 30, Note 2021 (unaudited) 2020 (unaudited) US$’000 US$’000 Cash flows from operating activities Loss on ordinary activities after taxation (40,545) (57,537) Net finance expense - other 20,163 15,492 Depreciation and amortization 35,238 33,313 Amortization of inventory fair value step-up 1,641 21,015 Share based payment expenses 4 5,905 3,136 Non-cash change in fair value of contingent consideration 5 8,897 8,150 Non-cash contingent value rights finance expense 5 5,515 4,498 Deferred taxation charge/(credit) (15,677) (2,452) Movements in working capital and other adjustments: Change in trade and other receivables 8 (2,609) (6,695) Change in trade and other payables (108,468) 21,875 Change in provision and other liabilities 14 (2,756) (12,328) Change in inventories 39 (7,948) Change in non-current assets 763 596 Net cash flow from operating activities (91,894) 21,115 Cash flow from investing activities Net cash received on acquisition of subsidiary 107,942 — Payments for property, plant and equipment (92) (147) Payments for intangible assets (830) (298) Deposit interest received 3 86 Net cash flow (used in)/from investing activities 107,023 (359) Cash flow from financing activities Net costs from issue of equity instruments (116) — Interest paid (7,597) (6,190) Payment of leases (789) (846) Net cash flow from financing activities (8,502) (7,036) Exchange and other movements (2,248) (5,567) Net change in cash and cash equivalents 4,379 8,153 Cash and cash equivalents at beginning of the period 118,798 67,229 Restricted cash at end of the period 10 50 792 Cash at bank available on demand at end of the period 10 123,127 74,590 Total cash and cash equivalents at end of the period 10 123,177 75,382 Amryt Pharma plc Condensed Consolidated Statement of Changes in Equity For the period ended September 30, 2021 (unaudited) Note Share capital Share premium Warrant reserve Treasury shares Share based payment reserve Merger reserve Reverse acquisition reserve Equity component of convertible notes Other distributable reserves Currency translation reserve Accumulated deficit Total US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 Balance at January 1, 2021 (audited) 13,851 51,408 14,762 (7,421) 7,860 42,627 (73,914) 29,210 217,634 5,730 (235,605) 66,142 Loss for the period — — — — — — — — — — (40,545) (40,545) Foreign exchange translation reserve — — — — — — — — — 2,583 — 2,583 Total comprehensive loss — — — — — — — — — 2,583 (40,545) (37,962) Transactions with owners Issue of treasury shares in exchange for warrants 11 23 99 — 439 — — — — — — — 561 Issue of treasury shares for share options exercised 11 25 89 — 465 (191) — — — — — — 388 Issue of shares and treasury shares in exchange for warrants 11 749 7,496 (14,762) 6,517 — — — — — — — — Issue of shares in consideration of Chiasma Acquisition 5 10,547 249,789 — — — — — — — — — 260,336 Share based payment reserve recognized on Chiasma acquisition 11 — — — — 10,157 — — — — — — 10,157 Issue of shares for share options exercised and vesting of RSUs 11 66 1,897 — — (1,467) — — — — — — 496 Share based payment expense 4 — — — — 5,905 — — — — — — 5,905 Share based payment expense – Lapsed — — — — (54) — — — — — 54 — Total transactions with owners 11,410 259,370 (14,762) 7,421 14,350 — — — — — 54 277,843 Balance at September 30, 2021 (unaudited) 25,261 310,778 — — 22,210 42,627 (73,914) 29,210 217,634 8,313 (276,096) 306,023 For the period ended September 30, 2020 (unaudited) Note Share capital Share premium Warrant reserve Treasury shares Share based payment reserve Merger reserve Reverse acquisition reserve Equity component of convertible notes Other distributable reserves Currency translation reserve Accumulated deficit Total US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 Balance at January 1, 2020 (audited) 11,918 2,422 29,523 (7,534) 3,190 42,627 (73,914) 29,210 217,634 7,894 (131,137) 131,833 Loss for the period — — — — — — — — — — (57,537) (57,537) Foreign exchange translation reserve — — — — — — — — — (2,850) — (2,850) Total comprehensive loss — — — — — — — — — (2,850) (57,537) (60,387) Transactions with owners Issue of shares in exchange for warrants 11 630 14,131 (14,761) — — — — — — — — Share based payment expense 4 — — — — 3,136 — — — — — — 3,136 Share based payment expense – Lapsed — — — — (56) — — — — — 56 — Total transactions with owners 630 14,131 (14,761) — 3,080 — — — — — 56 3,136 Balance at September 30, 2020 (unaudited) 12,548 16,553 14,762 (7,534) 6,270 42,627 (73,914) 29,210 217,634 5,044 (188,618) 74,582 1. General information Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets. As used herein, references to ‘‘we,’’ ‘‘us,’’ ‘‘Amryt’’ or the ‘‘Group’’ in these condensed consolidated interim financial statements shall mean Amryt Pharma plc and its global subsidiaries, collectively. References to the ‘‘Company’’ in these condensed consolidated interim financial statements shall mean Amryt Pharma plc. Amryt Pharma plc is a company incorporated in England and Wales. The Company is listed on Nasdaq (ticker: AMYT) and the AIM market of the London Stock Exchange (ticker: AMYT). Amryt acquired Chiasma, Inc. (“Chiasma”) in August 2021. The combined company will be a global leader in rare and orphan diseases with three on-market commercial products, a global commercial and operational footprint and a significant development pipeline of therapies with the financial flexibility to execute its growth plans. Amryt’s commercial business comprises three orphan disease products – metreleptin (Myalept®/ Myalepta®); oral octreotide (Mycapssa®); and lomitapide (Juxtapid®/ Lojuxta®). Amryt's lead development candidate, Oleogel-S10 (Filsuvez®) is a potential treatment for the cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa (“EB”), a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment. Filsuvez® has been selected as the brand name for Oleogel-S10. The product does not currently have regulatory approval to treat EB but has been submitted to the FDA for approval and in June 2021, Amryt received confirmation from the FDA that its NDA for Oleogel-S10 had been accepted and granted priority review. The FDA also set a target PDUFA date of November 30, 2021. In Europe, a MAA for Oleogel-S10 was accepted for assessment by the EMA in March 2021. 2. Accounting policies Basis of preparation The condensed consolidated interim financial statements of the Group have been prepared in accordance with IAS 34 Interim Financial Reporting. They do not include all of the information required in annual financial statements in accordance with International Financial Reporting Standards (‘‘IFRS’’) and should be read in conjunction with the annual consolidated financial statements for the year ended December 31, 2020. Selected explanatory notes are included to explain events and transactions that are significant to an understanding of the Group’s financial position and performance since the last annual financial statements. The accounting policies used in the preparation of the interim financial information are the same as those used in the Group’s audited financial statements for the year ended December 31, 2020 and those which are expected to be used in the financial statements for the year ended December 31, 2021. Results for the nine-month period ended September 30, 2021 are not necessarily indicative of the results that may be expected for the financial year ending December 31, 2021. Basis of going concern Having considered the Group’s current financial position and cash flow projections, the Board of Directors believes that the Group will be able to continue in operational existence for at least the next 12 months from the date of approval of these condensed consolidated interim financial statements and that it is appropriate to continue to prepare the condensed consolidated interim financial statements on a going concern basis. As part of their inquiries, the Board of Directors reviewed budgets, projected cash flows, and other relevant information for a period not less than 12 months from the date of approval of the condensed consolidated interim financial statements for the period ended September 30, 2021. Basis of consolidation The condensed consolidated interim financial statements comprise the financial statements of the Group for the period ended September 30, 2021. Subsidiaries are entities controlled by the Company. Where the Company has control over an investee, it is classified as a subsidiary. The Company controls an investee if all three of the following elements are present: power over an investee, exposure or rights to variable returns from its involvement with the investee and the ability to use its power to affect those variable returns. Control is reassessed whenever facts and circumstances indicate that there may be a change in any of these elements of control. Subsidiaries are fully consolidated from the date that control commences until the date that control ceases. Accounting policies of subsidiaries have been changed where necessary to ensure consistency with the policies adopted by the Group. Intergroup balances and any unrealized gains or losses, income or expenses arising from intergroup transactions are eliminated in preparing the condensed consolidated interim financial statements. Presentation of balances The condensed consolidated interim financial statements are presented in U.S. dollars (‘‘US$’’), rounded to the nearest thousand, which is the functional currency of the Company and presentation currency of the Group. The following table discloses the major exchange rates of those currencies other than the functional currency of US$ that are utilized by the Group: Foreign currency units to 1 US$ € £ CHF SEK NOK DKK Average three-month period to September 30, 2021 (unaudited) 0.8292 0.7253 0.9043 8.3868 8.5171 6.1669 Average nine-month period to September 30, 2021 (unaudited) 0.8303 0.7157 0.9116 8.4230 8.3785 6.1747 At September 30, 2021 (unaudited) 0.8589 0.7417 0.9314 8.7634 8.7140 6.3870 Foreign currency units to 1 US$ € £ CHF SEK NOK DKK Average year ended December 31, 2020 (audited) 0.8777 0.7799 0.9391 9.2135 9.4206 6.5432 At December 31, 2020 (audited) 0.8141 0.7365 0.8829 8.1885 8.5671 6.0570 Foreign currency units to 1 US$ € £ CHF SEK NOK DKK Average three-month period to September 30, 2020 (unaudited) 0.8905 0.7873 0.9508 9.4111 9.5480 6.6422 Average nine-month period to September 30, 2020 (unaudited) 0.8562 0.7749 0.9203 8.8756 9.1384 6.3740 At September 30, 2020 (unaudited) 0.8543 0.7777 0.9220 9.0060 9.4528 6.3604 (€ = Euro; £ = Pounds Sterling, CHF = Swiss Franc, SEK = Swedish Kroner, NOK = Norwegian Kroner, DKK = Danish Kroner) Changes in accounting policies and disclosures There are no new standards and amendments to IFRS effective as of January 1, 2021 that are relevant to the Group. Critical accounting judgements and key sources of estimation uncertainty In preparing these condensed consolidated interim financial statements in conformity with IFRS management is required to make judgements, estimates and assumptions that affect the application of policies and amounts reported in the condensed consolidated interim financial statements and accompanying notes. The estimates and associated assumptions are based on historical experience and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis of making the judgements about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates. The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimate is revised if the revision affects only that period or in the period of the revision and future periods if the revision affects both current and future periods. The significant estimates, assumptions or judgements, applied in the condensed consolidated interim financial statements were the same as those applied in the Group’s audited financial statements for the year ended December 31, 2020. Principal accounting policies The condensed consolidated interim financial statements have been prepared in accordance with the accounting policies adopted in the Group’s audited financial statements for the year ended December 31, 2020 other than for those applied in the acquisition accounting for the Chiasma acquisition (see Note 5, Business combinations and asset acquisitions). 3. Segment information The Group is a global, commercial-stage biopharmaceutical company dedicated to commercializing and developing novel therapeutics to treat patients suffering from serious and life-threatening rare diseases. The Group currently operates as one business segment, pharmaceuticals, and is focused on the development and commercialization of three commercial products and a number of development products. The Group derives its revenues primarily from one source, being the pharmaceutical sector with high unmet medical need. The Group’s Chief Executive Officer, Joseph Wiley, is currently the Company’s chief operating decision maker (‘‘CODM’’). The Group does not operate any separate lines of business or separate business entities with respect to its products. Accordingly, the Group does not accumulate discrete financial information with respect to separate service lines and does not have separate reportable segments. The following table summarizes total revenues from external customers by product and by geographic region, based on the location of the customer. Three months ended September 30, 2021 (unaudited) U.S. EMEA Other Total US$’000 US$’000 US$’000 US$’000 Metreleptin 18,748 15,618 1,927 36,293 Lomitapide 8,568 6,406 3,564 18,538 Mycapssa® 1,453 — — 1,453 Other — 166 69 235 Total revenue 28,769 22,190 5,560 56,519 Three months ended September 30, 2020 (unaudited) U.S. EMEA Other Total US$’000 US$’000 US$’000 US$’000 Metreleptin 15,877 6,423 7,578 29,878 Lomitapide 9,233 7,109 2,771 19,113 Mycapssa® — — — — Other — 201 134 335 Total revenue 25,110 13,733 10,483 49,326 Nine months ended September 30, 2021 (unaudited) U.S. EMEA Other Total US$’000 US$’000 US$’000 US$’000 Metreleptin 52,726 39,594 16,992 109,312 Lomitapide 25,382 21,338 9,452 56,172 Mycapssa® 1,453 — — 1,453 Other — 582 194 776 Total revenue 79,561 61,514 26,638 167,713 Nine months ended September 30, 2020 (unaudited) U.S. EMEA Other Total US$’000 US$’000 US$’000 US$’000 Metreleptin 45,457 26,233 13,014 84,704 Lomitapide 28,047 18,683 7,856 54,586 Mycapssa® — — — — Other — 573 222 795 Total revenue 73,504 45,489 21,092 140,085 Major Customers For the three and nine months ended September 30, 2021, one customer accounted for 47% and 48%, respectively, of the Group’s net revenues (2020: 51% and 52%, respectively) and accounted for 42% of the Group’s September 30, 2021 accounts receivable balance (December 31, 2020: 42%). 4. Share based payments Share-based Compensation Plans Amryt’s Equity Incentive Plan Amryt’s Equity Incentive Plan was established by a special resolution on 23 September 2019 and was subsequently amended by the Board on 18 May 2020 and 3 August 2021. The purpose of the Plan is to provide for the granting of Equity Incentives to Directors and Employees of, and Consultants to, the Company or any Associated Company. Chiasma Equity Incentive Plan When Amryt acquired Chiasma in August 2021, the Chiasma Stock Option and Incentive Plan transferred across to Amryt. Each outstanding and unexercised Chiasma Stock Option or RSU, whether or not vested, ceased to represent a right to acquire shares of Chiasma common stock and were converted into an option to purchase Amryt ADSs on the same terms and conditions as were applicable under such Chiasma Stock Option and Incentive Plan immediately prior to the acquisition. No new stock option or RSUs will be granted under the Chiasma stock option and incentive plan. Terms and Conditions of New Grants and Grants Under the Chiasma Equity Incentive Plan The terms and conditions of new grants are as follows, whereby all options are settled by physical delivery of shares: Vesting conditions The employee share options vest following a period of service by the officer or employee. The required period of service is determined by the Remuneration Committee at the date of grant of the options (usually the date of approval by the Remuneration Committee). There are no market conditions associated with the share option vesting periods. Contractual life The term of an option is determined by the Remuneration Committee provided that the term may not exceed a period of seven to ten years from the date of grant. All options will terminate 90 days after termination of the option holder’s employment, service or consultancy with the Group except where a longer period is approved by the Board of Directors. Under certain circumstances involving a change in control of the Group, some options will automatically accelerate and become exercisable in full as of a date specified by the Board of Directors. The number and weighted average exercise price (in Sterling pence) of share options granted under Amryt’s Equity Incentive Plan and the Chiasma stock option and incentive plan is as follows: Amryt Equity Incentive Plan Chiasma Stock Option and Incentive Plan Units Weighted average exercise price (Sterling pence) Units Weighted average exercise price (Sterling pence) Balance at 1 January 2020 14,481,720 116.00p — — Granted 4,432,000 144.76p — — Lapsed (87,119) 113.42p — — Exercised (72,953) 120.72p — — Outstanding at 31 December 2020 (audited) 18,753,648 122.79p — — Exercisable at 31 December 2020 (audited) 5,866,152 114.24p — — Balance at 1 January 2021 18,753,648 122.79p — — Granted 10,663,959 192.40p — — Transferred to Amryt on acquisition — 18,139,060 189.07p Forfeited (1,162,976) 175.91p (257,335) 183.64p Exercised (300,000) 93.00p (441,280) 0.98p Outstanding at September 30, 2021 (unaudited) 27,954,631 147.45p 17,440,445 191.46p Exercisable at September 30, 2021 (unaudited) 6,938,801 118.56p 13,552,670 185.75p The fair value of the Amryt equity award is estimated at the date of grant using the Black-Scholes pricing model, taking into account the terms and conditions attached to the grant. The fair value of the Chiasma equity awards transferred to Amryt on acquisition were measured in accordance with IFRS 2. The portion of the value of the equity transferred to Amryt attributable to pre-combination service is included in the consideration at the date of acquisition. The portion of the equity awards transferred to Amryt attributable to post combination service is estimated at the date of transfer using Black Scholes pricing model, taking into account the terms and conditions attached to the grant. The following are the inputs to the model for the equity instruments granted during the period: September 30, 2021 Options Inputs (unaudited) December 31, 2020 Options Inputs (audited) Days to Expiration 2,555 2,555 Volatility 32% - 49% 33% - 37% Risk free interest rate 0.77% - 0.94% 0.39% - 0.46% Share price at grant 146.87 - 201.2p 123.5p – 178.9p In the nine months ended September 30, 2021, a total of 10,663,959 share options over ordinary shares exercisable at a weighted average price of £1.92 were granted. The fair value of share options granted in the nine months ended September 30, 2021 was £20,517,000/US$28,302,000. The share options outstanding under the Amryt 2021 Equity Incentive Plan as at September 30, 2021 have a weighted remaining contractual life of 5.32 years with exercise prices ranging from £0.76 to £2.012 per ordinary share. The share options outstanding under the Chiasma Share Option and Incentive Plan transferred across to Amryt on acquisition. As at September 30, 2021 they have a weighted remaining contractual life of 3.23 years with exercise prices ranging from £0.54 to £9.35 per ordinary share. No new share options will be granted under the Chiasma Stock Option and Incentive Plan. Restricted Share Units Under the terms of Amryt’s Equity Incentive Plan, restricted share units (“RSUs”) to purchase 1,604,205 ordinary shares were outstanding at September 30, 2021. Under the terms of this plan, RSUs are granted to officers, consultants and employees of the Group at the discretion of the Remuneration Committee. For the period ended September 30, 2021, a total of 551,405 RSUs were granted to employees of the company. For the year ended December 31, 2020, a total of 1,556,960 RSUs were granted to employees of the company. The fair value of the RSUs is based on the share price at the date of grant, with the expense spread over the vesting period. The fair value of RSUs granted in the period ended September 30, 2021 was US$1,358,000. At September 30, 2021, the total RSUs granted to date have a weighted remaining contractual life of 2.1 years. Under the terms of Chiasma’s Stock Option and Incentive Plan transferred to Amryt on acquisition, restricted share units (“RSUs”) to purchase 157,225 ordinary shares were outstanding at September 30, 2021. At September 30, 2021, the total RSUs granted to date have a weighted remaining contractual life of 2.3 years. No new RSUs will be granted under the Chiasma Stock Option and Incentive Plan. The following table summarizes the RSU activity for the period: Amryt Equity Incentive Plan Chiasma Stock Option and Incentive Plan Units Weighted average fair value (US$) Units Weighted average fair value (US$) Balance at 1 January 2021 1,549,910 $2.35 — — Granted 551,405 $2.66 — — Transferred to Amryt on acquisition — — 202,145 $2.75 Lapsed (134,255) $2.39 (36,610) $2.75 Vested (362,855) $2.34 (8,310) $2.75 Outstanding at 30 September 2021 (unaudited) 1,604,205 $2.44 157,225 $2.75 Warrants There are no outstanding warrants at September 30, 2021 (December 31, 2020: 9,312,062). In August 2021, an Amryt institutional investor exercised subscription rights relating to 8,966,520 zero cost warrants. These warrants were issued in September 2019 as part of the Company’s acquisition of Aegerion. Certain institutional investors elected to receive warrants to subscribe for new ordinary shares of £0.06 each in Amryt (“Ordinary Shares”), in place of the same number of Ordinary Shares, as consideration for the Company’s acquisition of Aegerion and their equity investments in the Company in September 2019. Each warrant entitled the holder to subscribe for one Ordinary Share for no additional consideration. Separate warrants consisting of 345,542 as at December 31, 2020, which were issued in connection with the admission to the AIM in 2016, are no longer outstanding; 283,389 warrants were exercised in March 2021 and 62,153 warrants lapsed in April 2021. The number and weighted average exercise price (in Sterling pence) of warrants per ordinary share is as follows: Warrants Units Weighted average exercise price (Sterling pence) Balance at 1 January 2020 17,541,815 0.03p Granted — — Lapsed — — Exercised (8,229,753) — Outstanding at 31 December 2020 (audited) 9,312,062 0.05p Exercisable at 31 December 2020 (audited) 9,312,062 0.05p Balance at 1 January 2021 9,312,062 0.05p Granted — — Lapsed (62,153) 1.44p Exercised (9,249,909) 0.05p Outstanding at September 30, 2021 (unaudited) — 0.00p The value of share options and RSU’s charged to the Condensed Consolidated Statement of Comprehensive Loss during the period is as follows: Three months ended September 30, Nine months ended September 30, 2021 (unaudited) 2020 (unaudited) 2021 (unaudited) 2020 (audited) US$’000 US$’000 US$’000 US$’000 Share option expense 2,173 1,307 4,525 2,910 RSU expense 516 226 1,380 226 Total share option expense 2,689 1,533 5,905 3,136 5. Business combinations and asset acquisitions Acquisition of Chiasma On May 5, 2021, Amryt announced that it had signed a definitive agreement to acquire Chiasma, Inc. (Nasdaq: CHMA) in an all-stock combination. Under the terms of the transaction, each share of Chiasma common stock issued and outstanding prior to the consummation of the transaction was exchanged for 0.396 Amryt American Depositary Shares (“ADSs”), each representing five Amryt ordinary shares. On August 5, 2021, Amryt completed the acquisition of Chiasma, Inc and in conjunction with the completion Amryt allotted and issued a total of 127,733,680 ordinary shares as consideration for the acquisition. Following the completion, shareholdings in Chiasma were rounded in being converted to Amryt shares using the exchange ratio of 0.396. The roundings in converting Chiasma shareholdings to Amryt shares were finalized in August 2021 and resulted in an additional 7,015 ordinary shares being allotted and issued by Amryt as consideration for the acquisition. In total, these ordinary shares were issued to the former Chiasma Shareholders in the form of 25,548,139 ADSs at US$10.19 per share, to acquire Chiasma for a value of US$260,336,000. On August 5, 2021, Chiasma had outstanding equity awards that were held by Chiasma employees, the fair value of these awards transferred to Amryt on acquisition were measured in accordance with IFRS 2. The portion of the value of the equity transferred to Amryt attributable to pre-combination service is included in the consideration at the date of acquisition and this amounted to US$10,157,000. The combined company will be a global leader in rare and orphan diseases with three on-market commercial products, a global commercial and operational footprint and a significant development pipeline of therapies with the financial flexibility to execute its growth plans. The table below reflects the fair value of the identifiable net assets acquired in respect of the acquisition completed during the period. Any amendments to fair values will be made within the twelve-month period from the date of acquisition, as permitted by IFRS 3 Business Combinations. The acquired goodwill is attributable principally to the profit generating potential of the businesses, the assembled workforce and benefits arising from embedded infrastructure, that are expected to be achieved from integrating the acquired businesses into the Group’s existing business. No amount of goodwill is expected to be deductible for tax purposes. In the post-acquisition period to September 30, 2021, the business acquired during the current year contributed revenue of US$1,453,000 and a trading loss of US$11,994,000 to the Group’s results. The full year unaudited revenue and trading loss had the acquisition taken place at the start of the year has not been disclosed as the initial accounting is incomplete. The gross contractual value of trade and other receivables as at the dates of acquisition amounted to US$7,000,000, which approximated the fair value of these accounts as the amount not expected to be collected was insignificant. The Group incurred acquisition and restructuring related costs of US$14,679,000 in the nine months ended September 30,2021, relating to external legal fees, advisory fees, due diligence costs and severance costs related to the acquisition of Chiasma. These costs have been included in operating costs in the Condensed Consolidated Statement of Comprehensive Loss. The initial assignment of fair values to identifiable net assets acquired has been performed on a provisional basis due to the relative size of the acquisition and the timing of the transaction. Any amendments to these fair values within the twelve-month timeframe from the date of acquisition will be disclosed in the 2022 consolidated financial statements, as stipulated by IFRS 3. Provisional Fair Value as at August 5, 2021 (unaudited) US$’000 Assets Non-current assets Intangible assets 220,000 Property, plant and equipment 950 Other non-current assets 866 Total non-current assets 221,816 Current assets Trade and other receivables 7,000 Inventories 61,527 Cash and cash equivalents, including restricted cash 107,942 Total current assets 176,469 Total assets 398,285 Non-current liabilities Deferred tax liability 47,117 Total non-current liabilities 47,117 Current liabilities Trade and other payables 142,469 Total current liabilities 142,469 Total liabilities 189,586 Total identifiable net assets at fair value 208,699 Goodwill arising on acquisition 61,794 Consideration 270,493 Consideration Issue of fully paid up ordinary shares 260,336 Chiasma equity awards recognized as consideration transferred upon the acquisition of Chiasma 10,157 Total consideration 270,493 Acquisition of Aegerion Pharmaceuticals On May 20, 2019, Amryt entered into a Restructuring Support Agreement (as subsequently amended on June 12, 2019) and Plan Funding Agreement pursuant to which, among other matters, Amryt agreed to the acquisition of Aegerion Pharmaceuticals, Inc. (‘‘Aegerion’’, subsequently renamed as Amryt Pharmaceuticals Inc.), a former wholly-owned subsidiary of Novelion Therapeutics Inc. (‘‘Novelion’’). On May 20, 2019, Aegerion and its U.S. subsidiary, Aegerion Pharmaceuticals Holdings, Inc., filed voluntary petitions under Chapter 11 of Title 11 of the U.S. Code in the Bankruptcy Court. On September 24, 2019, Amryt completed the acquisition of Aegerion. Amryt acquired Aegerion upon its emergence from bankruptcy in an exchange for ordinary shares and zero cost warrants in Amryt. Amryt issued 85,092,423 effective shares at US$1.793 per share, which is made up of 77,027,423 ordinary shares and 8,065,000 zero cost warrants, to acquire Aegerion for a value of US$152,615,000. As part of the acquisition of Aegerion, it was agreed, for certain Aegerion creditors who wished to restrict their percentage share interest in Amryt’s issued share capital, to issue to the relevant Aegerion creditor, as an alternative to Amryt’s ordinary shares, an equivalent number of new zero cost warrants to subscribe for Amryt’s ordinary shares to be constituted on the terms of the zero cost warrant. As at 30 September, 2021, no zero cost warrants were remaining and the remaining balance of zero cost warrants were exercised during the three-month period ended June 30, 2021. During the three-month and nine-month periods ended September 30, 2021, the Group incurred no additional acquisition and restructuring related costs relating to external legal fees, advisory fees, due diligence costs and severance costs related to the acquisition of Aegerion (September 30, 2020: US$105,000 and US$1,005,000, respectively). Contingent Value Rights Related to the Aegerion acquisition, Amryt issued Contingent Value Rights (‘‘CVRs’’) pursuant to which up to US$85,000,000 may become payable to Amryt’s shareholders and optionholders, who were on the register prior to the completion of the acquisition on September 20, 2019, if certain approval and revenue milestones are met in relation Oleogel-S10, Amryt’s lead product candidate. If any such milestone is achieved, Amryt may elect to pay the holders of CVRs by the issue of Amryt shares or loan notes. If Amryt elects to issue Loan Notes to holders of CVRs, it will settle such loan notes in cash 120 days after their issue. If none of the milestones are achieved, scheme shareholders and optionholders will not receive any additional consideration under the terms of the CVRs. In these circumstances, the value of each CVR would be zero. The terms of the CVRs are as follows: The total CVR payable is up to US$85,000,000 This is divided into three milestones which are related to the success of Oleogel-S10 (the Group’s lead development asset) FDA approval US$35,000,000 upon FDA approval 100% of the amount due if approval is obtained before December 31, 2021, with a sliding scale on a linear basis to zero if before July 1, 2022 EMA approval US$15,000,000 upon EMA approval 100% of the amount due if approval is obtained before December 31, 2021, with a sliding scale on a linear basis to zero if before July 1, 2022 Revenue targets US$35,000,000 upon Oleogel-S10 revenues exceeding US$75,000,000 in any 12-month period prior to June 30, 2024 Payment can at the Board’s discretion be in the form of either: 120-day loan notes (effectively cash), or Shares valued using the 30 day / 45-day VWAP. The CVRs were contingent on the successful completion of the acquisition and, accordingly, have been based on fair value as at September 24, 2019. The CVRs have been classified as a financial liability in the Condensed Consolidated Statement of Financial Position. Given that CVRs were issued to legacy Amryt shareholders in their capacity as owners of the identified acquirer as opposed to the seller in the transaction, management concluded that the most appropriate classification would be to recognize the CVR as a distribution on consolidation instead of goodwill. Measurement of CVRs As at September 30, 2021, the carrying value of the CVRs was US$66,932,000 (December 31, 2020: US$61,417,000). The value of the potential payout was calculated using the probability-weighted expected returns method. Using this method, the potential payment amounts were multiplied by the probability of achievement and discounted to present value. The probability adjusted present values took into account published orphan drug research data and statistics which were adjusted by management to reflect the specific circumstances applicable to the type of product acquired in the Amryt GmbH transaction. The market-based probability chance of success is based on market benchmarks for orphan drugs was estimated at 89% in the period ended September 30, 2021 (2020: 89%). Discount rates of 10% and 16.5%, as applicable, were used in the calculation of the present value of the estimated contractual cash flows for the period ended September 30, 2021 (December 31, 2020: 10% and 16.5%). Management was required to make certain estimates and assumptions in relation to revenue forecasts, timing of revenues and probability of achievement of commercialization of Oleogel-S10. However, management notes that, due to issues outside their control (i.e. regulatory requirements and the commercial success of the product), the timing of when such revenue targets may occur may change. Such changes may have a material impact on the assessment of the expected cash flows of the CVRs. Amryt reviews the expected cash flows on a regular basis as the discount on initial recognition is being unwound as financing expenses in the Condensed Consolidated Statement of Comprehensive Loss over the life of the obligation. It is reviewed on a quarterly basis and the appropriate finance charge is booked in the Condensed Consolidated Statement of Comprehensive Loss on a quarterly basis. The Group received positive topline data from the phase 3 EASE trial of Oleogel-S10 in September 2020. The product does not currently have regulatory approval to treat EB but has been submitted to the FDA for approval and in June 2021, Amryt received confirmation from the FDA that its NDA for Oleogel-S10 had been accepted and granted priority review. The FDA also set a target PDUFA date of November 30, 2021. In Europe, a MAA for Oleogel-S10 was accepted for assessment by the EMA in March 2021. The total non-cash finance charge recognized in the Condensed Consolidated Statement of Comprehensive Loss for the three and nine months ended September 30, 2021 is US$1,915,000 and US$5,515,000 (September 30, 2020: US$1,557,000 and US$4,498,000, respectively). Acquisition of Amryt GmbH (previously ‘‘Birken’’) Amryt DAC signed a conditional share purchase agreement to acquire Amryt GmbH on October 16, 2015 (‘‘Amryt GmbH SPA’’). The Amryt GmbH SPA was completed on April 18, 2016 with Amryt DAC acquiring the entire issued share capital of Amryt GmbH. The consideration included contingent consideration comprising milestone payments and sales royalties as follows: Milestone payments of: €10,000,000 on receipt of first marketing approval by the EMA of Episalvan, paid on the completion date (April 18, 2016); Either (i) €5,000,000 once net ex-factory sales of Episalvan have been at least €100,000 or (ii) if no commercial sales are made within 24 months of EMA first marketing approval (being January 14, 2016), €2,000,000 24 months after receipt of such approval, which was paid in January 2018, and €3,000,000 following the first commercial sale of Episalvan; €10,000,000 on receipt of marketing approval by the EMA or FDA of a pharmaceutical product containing Betulin as its API for the treatment of EB; €10,000,000 once net ex-factory sales/net revenue of Oleogel S-10 first exceed €50,000,000 in any calendar year; €15,000,000 once net ex-factory sales/ net revenue of Oleogel S-10 first exceed €100,000,000 in any calendar year; Cash consideration of €150,000, due and paid on the completion date (April 18, 2016); and Royalties of 9% on sales of Oleogel-S10 products for 10 years from first commercial sale. Fair Value Measurement of Contingent Consideration As at September 30, 2021, the fair value of the contingent consideration was estimated to be US$91,067,000 (December 31, 2020: US$86,906,000). The fair value of the contingent consideration included milestone payments determined using probability adjusted present values and probability weighted revenue forecasts (see Note 15, Fair value measurement and financial risk management, for fair value hierarchy applied and impact of key unobservable impact data). The probability adjusted present values took into account published orphan drug research data and statistics which were adjusted by management to reflect the specific circumstances applicable to the type of product acquired in the Amryt GmbH transaction. The market-based probability chance of success is based on market benchmarks for orphan drugs was estimated at 89% for the period ended September 30, 2021 (December 31, 2020: 89%) following the positive results from our phase 3 EASE trial of Oleogel-S10 earlier in the year. A discount rate of 14.4% was used in the calculation of the fair value of the contingent consideration for the three months ended September 30, 2021 (December 31, 2020: 14.4%). The Group received positive top line results from the phase 3 EASE trial of Oleogel-S10 in September 2020. The product does not currently have regulatory approval to treat EB but has been submitted to the FDA for approval and in June 2021, Amryt received confirmation from the FDA that its NDA for Oleogel-S10 had been accepted and granted priority review. The FDA also set a target PDUFA date of November 30, 2021. In Europe, a MAA for Oleogel-S10 was accepted for assessment by the EMA in March 2021. Amryt reviews the contingent consideration on a regular basis as the probability adjusted fair values are being unwound as financing expenses in the Condensed Consolidated Statement of Comprehensive Loss over the life of the obligation. The finance charge is being unwound as a financing expense in the Condensed Consolidated Statement of Comprehensive Loss on a quarterly basis. The total non-cash finance charge recognized in the Condensed Consolidated Statement of Comprehensive Loss for the three and nine months ended September 30, 2021 is US$3,030,000 and US$8,897,000 (September 30, 2020: US$2,126,000 and US$8,150,000, respectively). 6. Loss per share - basic and diluted The weighted average number of shares in the loss per share (‘‘LPS’’) calculation, reflects the weighted average total actual shares of Amryt Pharma plc in issue at September 30, 2021. Issued share capital - ordinary shares of £0.06 each Number of shares Weighted average shares As at September 30, Three months ended September 30, Nine months ended September 30, 2021 (unaudited) 316,904,642 264,368,691 207,876,731 2020 (unaudited) 162,718,438 158,303,972 155,776,507 The calculation of loss per share is based on the following: Three months ended September 30, Nine months ended September 30, 2021 (unaudited) 2020 (unaudited) 2021 (unaudited) 2020 (unaudited) Loss after tax attributable to equity holders of the Company (US$’000) (17,209) (10,471) (40,545) (57,537) Weighted average number of ordinary shares in issue 264,368,691 158,303,972 207,876,731 155,776,507 Fully diluted average number of ordinary shares in issue 264,368,691 158,303,972 207,876,731 155,776,507 Basic and diluted loss per share (US$) (0.07) (0.07) (0.20) (0.37) Where a loss has occurred, basic and diluted LPS are the same because the outstanding share options and warrants are anti-dilutive. Accordingly, diluted LPS equals the basic LPS. The share options, RSUs and warrants outstanding as at September 30, 2021 totaled 47,156,506 (September 30, 2020: 28,065,710) and are potentially dilutive. 7. Intangible assets and goodwill The following table summarizes the Group’s intangible assets and goodwill: Developed technology - metreleptin Developed technology - lomitapide Developed technology - Mycapssa® In process R&D Other intangible assets Total intangible assets Goodwill US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 US$’000 Cost At January 1, 2020 (audited) 176,000 123,000 — 54,261 701 353,962 19,131 Additions — — — — 372 372 — Acquired assets — — — 591 — 591 — Disposals — — — — (246) (246) — Foreign exchange movement — — — 5,276 39 5,315 — At December 31, 2020 (audited) 176,000 123,000 — 60,128 866 359,994 19,131 Additions — — — — 830 830 — Acquired assets — — 220,000 — — 220,000 61,794 Other movements — — — — — — (1,051) Foreign exchange movement — — — (3,137) (40) (3,177) — At September 30, 2021 (unaudited) 176,000 123,000 220,000 56,991 1,656 577,647 79,874 Accumulated amortization At January 1, 2020 (audited) 7,314 4,143 — — 178 11,635 — Amortization charge 27,429 15,537 — — 202 43,168 — Accumulated amortization on disposals — — — — (246) (246) — Foreign exchange movement — — — — 68 68 — At December 31, 2020 (audited) 34,743 19,680 — — 202 54,625 — Amortization charge 20,571 11,653 1,960 — 90 34,274 — Foreign exchange movement — — — — 15 15 — At September 30, 2021 (unaudited) 55,314 31,333 1,960 — 307 88,914 — Net book value At December 31, 2020 (audited) 141,257 103,320 — 60,128 664 305,369 19,131 At September 30, 2021 (unaudited) 120,686 91,667 218,040 56,991 1,349 488,733 79,874 Developed technology on commercially marketed products In connection with the acquisition of Aegerion in September 2019, the Group acquired developed technology, metreleptin and lomitapide. These intangible assets are amortized over their estimated useful lives and the remaining useful lives for metreleptin and lomitapide are approximately 4.4 and 6.0 years, respectively, as of September 30, 2021 (December 31, 2020: 5.2 and 6.7 years, respectively). In connection with the acquisition of Chiasma in August 2021, the Group acquired developed technology, octreotide. This intangible asset is amortized over its estimated useful life and the remaining useful life is approximately 14.3 years as of September 30, 2021. In-process R&D As a result of the acquisition of Amryt GmbH, in 2016, the Group recognized in-process R&D costs of €48,453,000/US$56,409,000 which is related to the Group’s lead development asset, Oleogel-S10. The remaining in-process R&D is a result of the acquisition of Cala Medical Limited in October 2020. Goodwill During 2019, the Group completed the acquisition of Aegerion, which resulted in aggregate goodwill of US$18,080,000. On August 5, 2021, the Group completed the acquisition of Chiasma, which resulted in aggregate goodwill of US$61,794,000. The Group reviews events or changes in circumstances that may indicate a triggering event for impairment. Management applied its judgment in determining that there were no events or changes in circumstances causing any impairment triggers as of September 30, 2021. As such there was no impairment charge recorded during the three and nine months ended September 30, 2021. 8. Trade and other receivables As at September 30, 2021 (unaudited) December 31, 2020 (audited) US$’000 US$’000 Trade receivables 37,458 33,057 Accrued income and other debtors 9,808 8,423 VAT recoverable 5,527 1,705 Trade and other receivables 52,793 43,185 9. Inventories As at September 30, 2021 (unaudited) December 31, 2020 (audited) US$’000 US$’000 Raw materials 29,462 25,462 Work in progress 31,550 3,903 Finished goods 39,827 11,627 Inventories 100,839 40,992 The increase in inventories for the nine months ended September 30, 2021, reflected the fair value of inventory acquired as part of the acquisition of Chiasma on August 5, 2021. The fair value of the acquired inventory amounted to US$61,527,000. Inventory on hand at the date of acquisition was valued at the expected selling price less the sum of remaining costs of disposal, cost to complete and a reasonable profit margin for the selling effort of the acquiring entity based on the EBITDA margin as a percentage of sales. The costs to complete were calculated based on costs incurred on recently completed finished goods. The costs to dispose were calculated based on the average costs as a percentage of revenue through the period in which the current finished goods inventory is expected to be sold. This resulted in a non-cash step up at the valuation of inventory at August 5, 2021 of US$40,414,000. The non-cash step up in inventory is being unwound to the Condensed Consolidated Statement of Comprehensive Loss over the period in which this saleable inventory is sold. At September 30, 2021, US$39,978,000 of this non-cash inventory step up is included in inventory. 10. Cash and cash equivalents As at September 30, 2021 (unaudited) December 31, 2020 (audited) US$’000 US$’000 Cash at bank available on demand 123,127 118,575 Restricted cash 50 223 Total cash and cash equivalents 123,177 118,798 Cash and cash equivalents include cash at bank available on demand and restricted cash. At September 30, 2021 there was US$50,000 restricted cash (December 31, 2020: US$223,000). The balance at December 31, 2020 includes a deposit on a company credit card facility for an amount of US$150,000. As at September 30, 2021 a letter of credit related to US customs was put in place for an amount of US$50,000. 11. Share capital and reserves Details of the number of issued ordinary shares with a nominal value of Sterling 6 pence (2020: 6 pence) each are in the table below. Ordinary shares Treasury shares Total At January 1, 2020 154,498,887 4,864,656 159,363,543 Issue of shares in exchange for warrants 8,229,753 — 8,229,753 Issue of shares in equity fund raises 16,000,000 — 16,000,000 Issue of treasury shares for share options exercised 72,953 (72,953) — At December 31, 2020 (audited) 178,801,593 4,791,703 183,593,296 Issue of treasury shares in exchange for warrants 283,389 (283,389) — Issue of treasury shares for share options exercised 300,000 (300,000) — Issue of shares in consideration of Chiasma acquisition 127,740,695 — 127,740,695 Issue of shares in exchange for warrants 4,758,206 — 4,758,206 Issue of treasury shares in exchange for warrants 4,208,314 (4,208,314) — Issue of shares for share options exercised and RSUs vesting 812,445 — 812,445 At September 30, 2021 (unaudited) 316,904,642 — 316,904,642 The components of equity are detailed in the Condensed Consolidated Statement of Changes in Equity and described in more detail below. As at September 30, 2021 there were 316,904,642 ordinary shares issued with no treasury shares held (December 31, 2020: 183,593,296; 4,791,703). In December 2020, the Company issued 16,000,000 ordinary shares in the form of ADSs, as part of a US$40,000,000 private placement equity raise to existing and new shareholders. The Company issued 4,000,000 and 4,229,753 ordinary shares on July 15, 2020, and September 22, 2020, respectively, in exchange for certain warrants. On March 11, 2021, the Company issued 300,000 ordinary shares from treasury shares following the exercise of share options. On March 11, 2021, the Company issued 283,389 ordinary shares from treasury shares in exchange for certain warrants. On August 5, 2021, the Company issued 127,740,695 ordinary shares, in the form of ADSs, as consideration for the acquisition of Chiasma. On August 5, 2021, the Company issued 8,966,520 ordinary shares with 4,208,314 being issued from treasury shares in exchange for warrants. During the three month period ended September 30, 2021, there were 441,280 shares issued following the exercise of share options and 371,165 shares issued following RSU vesting. Share Capital Share capital represents the cumulative par value arising upon issue of ordinary shares of Sterling 6 pence each. The ordinary shares have the right to receive notice of, attend and vote at general meetings and participate in the profits of the Company. Share Premium Share premium represents the consideration that has been received in excess of the nominal value on issue of share capital net of issue costs and transfers to distributable reserves. Warrant reserve The warrant reserve represents zero cost warrants issued as part of the equity raise on September 24, 2019 net of issue costs apportioned to warrants issued and additional warrants issued to certain shareholders on November 14, 2019. Each warrant entitles the holder to subscribe for one ordinary share at zero cost. The Company issued 4,000,000 and 4,229,753 ordinary shares on July 15, 2020 and September 22, 2020, respectively, in exchange for certain warrants. The remaining warrants were exchanged on August 5, 2021, and the Company issued 8,966,520 ordinary shares, 4,208,314 of which were issued from treasury shares. There were no remaining warrants outstanding as at September 30, 2021. Treasury Shares In October 2020, the Company issued 72,953 ordinary shares from treasury shares following the exercise of share options. In March 2021, the Company issued a total of 583,389 ordinary shares from treasury shares, 300,000 ordinary shares relating to the exercise of share options and 283,389 ordinary shares following the exchange of certain warrants. In August 2021, the company issued 4,208,314 ordinary shares from treasury shares in conjunction with the exchange of warrants. There were no treasury shares held as at September 30, 2021. Share based payment reserve Share based payment reserve relates to the charge for share based payments in accordance with IFRS 2. In March 2021, the Company issued 283,389 ordinary shares in exchange for certain warrants, respectively. In April 2021, 62,153 warrants lapsed. During the nine month period ended September 30, 2021, the Company issued 741,280 ordinary shares in relation to the exercise of share options and RSUs. As part of the acquisition of Chiasma, the Company replaced share awards that were existing at the time of the acquisition. This resulted in the recognition of a share-based payment reserve of US$10,157,000 on acquisition. Merger reserve The merger reserve was created on the acquisition of Amryt DAC by Amryt Pharma plc in April 2016. Ordinary shares in Amryt Pharma plc were issued to acquire the entire issued share capital of Amryt DAC. Under section 612 of the UK Companies Act 2006, the premium on these shares has been included in a merger reserve. Reverse acquisition reserve The reverse acquisition reserve arose during the period ended December 31, 2016 in respect of the reverse acquisition of Amryt Pharma plc by Amryt DAC. Since the shareholders of Amryt DAC became the majority shareholders of the enlarged Group, the acquisition is accounted for as though there is a continuation of Amryt DAC’s financial statements. The reverse acquisition reserve is created to maintain the equity structure of Amryt Pharma plc in compliance with UK company law. Equity component of convertible notes The equity component of convertible notes represents the equity component of the US$125,000,000 convertible debt and is measured by determining the residual of the fair value of the instrument less the estimated fair value of the liability component. The equity component is recognized in equity and is not subsequently remeasured. Other distributable reserves Other distributable reserves comprise the following: Distribution of the share premium amount on 6 November 2019 of US$268,505,000. By special resolution of the Company duly passed on 23 September 2019, it was resolved that the entire amount outstanding to the credit of the share premium account and capital redemption reserve of the Company be cancelled. The reduction in capital, amounting to US$268,505,000, representing the entire amount of share premium at that time, was approved by the High Court of Justice of England and Wales on 5 November 2019. A deemed distribution of US$47,902,000 arising from the issuance of CVRs. A deemed distribution of US$2,969,000 arising from the scheme of arrangement in September 2019 whereby Amryt Pharma plc, which was incorporated in July 2019, became a 100% shareholder of Amryt Pharma Holdings Limited (formerly named Amryt Pharma plc) (the “Acquisition of subsidiary without a change of control”) Currency translation reserve The currency translation reserve arises on the retranslation of non-U.S. dollar denominated foreign subsidiaries. Accumulated deficit Accumulated deficit represents losses accumulated in previous periods and the current year. 12. Long term loan As at September 30, 2021 (unaudited) December 31, 2020 (audited) US$’000 US$’000 Long term loan principal 92,453 88,037 Unamortized debt issuance costs (633) (735) Long term loan 91,820 87,302 As part of the acquisition of Aegerion on September 24, 2019, Aegerion entered into a new U.S. dollar denominated US$81,021,000 secured term loan debt facility (‘‘Term Loan’’) with various lenders. The Term Loan is made up of a US$54,469,000 loan that was in place prior to the acquisition which was refinanced as part of the acquisition and a US$26,552,000 additional loan that was drawn down on September 24, 2019. The Term Loan has a five-year term from the date of the draw down, September 24, 2019 and matures on September 24, 2024. Under the Term Loan, interest will be payable at the option of the Group at the rate of 11% per annum paid in cash on a quarterly basis or at a rate of 6.5% paid in cash plus 6.5% paid in kind that will be paid when the principal is repaid, which rolls up and is included in the principal balance outstanding, on a quarterly basis. Unpaid accrued interest of US$1,511,000 as at September 30, 2021 is recognized in current liabilities with trade and other payables (December 31, 2020: $1,439,000). The Term Loan may be prepaid, in whole or in part, by Aegerion at any time subject to payment of an exit fee, which depending on the stage of the loan term, ranges from 5.00% to 0.00% of the principal then outstanding on the Term Loan. In connection with the Term Loan, the Group incurred approximately US$870,000 of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees. These costs are being amortized over the expected life of the loan using the effective interest method. The Term Loan is guaranteed by Amryt and certain subsidiaries of the Group. In connection with the loan agreement, fixed and floating charges have been placed on property and undertakings of Amryt and certain subsidiaries of the Group. The Term Loan agreement includes affirmative and negative covenants, including prohibitions on the incurrence of additional indebtedness, granting of liens, certain asset dispositions, investments, and restricted payments, in each case, subject to certain exceptions set forth in the Loan Agreement. The Term Loan agreement also includes customary events of default for a transaction of this type and includes (i) a cross-default to the occurrence of any event of default under material indebtedness of Aegerion and certain subsidiaries of the Group and Amryt, including the convertible notes, and (ii) Amryt or any of its subsidiaries being subject to bankruptcy or other insolvency proceedings. Upon the occurrence of an event of default, the lenders may declare all of the outstanding Term Loan and other obligations under the Term Loan agreement to be immediately due and payable and exercise all rights and remedies available to the lenders under the Term Loan agreement and related documentation. There have been no events of default or breaches of the covenants occurring for the three and nine months ended September 30, 2021 (December 31, 2020: no events). 13. Convertible notes Total US$’000 At January 1, 2020 96,856 Accreted interest 4,230 At December 31, 2020 (audited) 101,086 Accreted interest 3,480 At September 30, 2021 (unaudited) 104,566 As part of the Aegerion acquisition, Aegerion issued convertible notes with an aggregate principal amount of US$125,000,000 to Aegerion creditors. The convertible notes are senior unsecured obligations and bear interest at a rate of 5.0% per year, payable semi-annually in arrears on April 1 and October 1 of each year, beginning on April 1, 2020. The convertible notes will mature on April 1, 2025, unless earlier repurchased or converted. The convertible notes are convertible into Amryt’s ordinary shares at a conversion rate of 386.75 ordinary shares per US$1,000 principal amount of the convertible notes. If the holders elect to convert the convertible notes, Aegerion can settle the conversion of the convertible notes through payment or delivery of cash, common shares, or a combination of cash and common shares, at its discretion. As a result of the conversion feature in the convertible notes, the convertible notes were assessed to have both a debt and an equity component. The two components were assessed separately and classified as a financial liability and equity instrument. The financial liability component was measured at fair value based on the discounted cash flows expected over the expected term of the notes using a discount rate based on a market interest rate that a similar debt instrument without a conversion feature would be subject to. Refer to Note 11, Share capital and reserves, for further details on the equity component of the convertible notes. From September 24, 2019 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of their convertible notes, in multiples of US$1,000 principal amount, at the option of the holder. The indenture does not contain any financial covenants or restrict the Group’s ability to repurchase securities, pay dividends or make restricted payments in the event of a transaction that substantially increases the Group’s level of indebtedness in certain circumstances. The indenture contains customary terms and covenants and events of default. If an event of default (other than certain events of bankruptcy, insolvency or reorganization involving Aegerion, Amryt and certain subsidiaries of the Group) occurs and is continuing, the trustee by notice to Aegerion, or the holders of at least 25% in principal amount of the outstanding convertible notes by written notice to Aegerion and the trustee, may declare 100% of the principal of and accrued and unpaid interest, if any, on all of the convertible notes to be due and payable. Upon such a declaration of acceleration, such principal and accrued and unpaid interest, if any, will be due and payable immediately. Upon the occurrence of certain events of bankruptcy, insolvency or reorganization involving Aegerion, 100% of the principal and accrued and unpaid interest, if any, on the convertible notes will become due and payable automatically. Notwithstanding the foregoing, the indenture provides that, upon Aegerion’s election, and for up to 180 days, the sole remedy for an event of default relating to certain failures by Aegerion to comply with certain reporting covenants in the indenture consists exclusively of the right to receive additional interest on the convertible notes. There have been no events of default or breaches of the covenants occurring for the period ended September 30, 2021 (2020: no events). 14. Provisions and other liabilities As at September 30, 2021 (unaudited) December 31, 2020 (audited) US$’000 US$’000 Non-current liabilities Provisions and other liabilities — 21,382 Leases due greater than 1 year 4,213 4,569 4,213 25,951 Current liabilities Provisions and other liabilities 27,998 9,976 Leases due less than 1 year 1,529 963 29,527 10,939 Total provisions and other liabilities 33,740 36,890 Legal matters Prior to the acquisition of Aegerion by Amryt, Aegerion entered into settlement agreements with governmental entities including the Department of Justice (‘‘DOJ’’) and the FDA in connection with Juxtapid investigations. The settlement agreements require Aegerion to pay specified fines and engage in regulatory compliance efforts. Subsequent to the acquisition, Aegerion made US$23,036,000 of settlement payments, including interest. The settlements have been paid in full with the last payment completed in Q1 2021. There is no current liability recognized as at September 30, 2021 (December 31, 2020: US$3,976,000). There is no non-current liability at September 30, 2021 (December 31, 2020: nil). Other matters The Group recognizes a liability for legal contingencies when it believes that it is both probable that a liability has been incurred and that it can reasonably estimate the amount of the loss. The Group reviews these accruals and adjusts them to reflect ongoing negotiations, settlements, rulings, advice of legal counsel and other relevant information. To the extent new information is obtained and the Group’s views on the probable outcomes of claims, suits, assessments, investigations or legal proceedings change, changes in the Group’s liability accrual would be recorded in the period in which such determination is made. At September 30, 2021 the Group had recognized liabilities of US$6,000,000 in relation to ongoing legal matters (December 31, 2020 US$6,000,000). 15. Fair value measurement and financial risk management Categories of financial instruments As at September 30, 2021 (unaudited) December 31, 2020 (audited) US$’000 US$’000 Financial assets (all at amortized cost): Cash and cash equivalents 123,177 118,798 Trade receivables 37,458 33,057 Total financial assets 160,635 151,855 Financial liabilities: At amortized cost Trade payables and accrued expenses 123,095 89,300 Lease liabilities 5,742 5,532 Other liabilities 21,998 25,358 Convertible notes 104,566 101,086 Long term loan 91,820 87,302 Contingent value rights 66,932 61,417 At fair value Contingent consideration 91,067 86,906 Total financial liabilities 505,220 456,901 Net (344,585) (305,046) Financial instruments evaluated at fair value can be classified according to the following valuation hierarchy, which reflects the extent to which the fair value is observable: Level 1: fair value evaluations using prices listed on active markets (not adjusted) of identical assets or liabilities. Level 2: fair value evaluations using input data for the asset or liability that are either directly observable (as prices) or indirectly observable (derived from prices), but which do not constitute listed prices pursuant to Level 1. Level 3: fair value evaluations using input data for the asset or liability that are not based on observable market data (unobservable input data). The contingent consideration has been valued using Level 3. The contingent consideration comprises: Contingent consideration relating to the acquisition of Amryt GmbH (see Note 5, Business combinations and asset acquisitions) that was measured at US$91,067,000 as at September 30, 2021 (December 31, 2020: US$86,906,000). The fair value comprises royalty payments which was determined using probability weighted revenue forecasts and the fair value of the milestones payments which was determined using probability adjusted present values. It also included a revision to the discount rate used, and revenue and costs forecasts have been amended to reflect management’s current expectations. Impact of key unobservable input data An increase of 10% in estimated revenue forecasts would result in an increase to the fair value of US$6,370,000. A decrease would have the opposite effect. A 5% increase in the discount factor used would result in a decrease to the fair value of US$13,979,000. A decrease of 5% would result in an increase to the fair value of US$18,253,000. A six-month delay in the launch date for Oleogel-S10 would result in a decrease to the fair value of US$9,095,000. 16. Events after the reporting period There were no significant events since the end of the reporting period.
AMYT CHMA | finance.yahoo | about 4 years ago | Neutral

When Will Chiasma, Inc. (NASDAQ:CHMA) Breakeven?Chiasma, Inc. (NASDAQ:CHMA) is possibly approaching a major achievement in its business, so we would like to shine some light on the company. Chiasma, Inc., a commercial-stage biopharmaceutical company, focuses on developing and commercializing oral medications using transient permeability enhancer ...
Chiasma, Inc. (NASDAQ:CHMA) is possibly approaching a major achievement in its business, so we would like to shine some light on the company. Chiasma, Inc., a commercial-stage biopharmaceutical company, focuses on developing and commercializing oral medications using transient permeability enhancer technology platform for the treatment of rare and serious chronic disease worldwide. The US$240m market-cap company posted a loss in its most recent financial year of US$75m and a latest trailing-twelve-month loss of US$90m leading to an even wider gap between loss and breakeven. Many investors are wondering about the rate at which Chiasma will turn a profit, with the big question being “when will the company breakeven?” In this article, we will touch on the expectations for the company's growth and when analysts expect it to become profitable. View our latest analysis for Chiasma Consensus from 5 of the American Pharmaceuticals analysts is that Chiasma is on the verge of breakeven. They anticipate the company to incur a final loss in 2022, before generating positive profits of US$16m in 2023. So, the company is predicted to breakeven approximately 2 years from now. In order to meet this breakeven date, we calculated the rate at which the company must grow year-on-year. It turns out an average annual growth rate of 68% is expected, which is rather optimistic! Should the business grow at a slower rate, it will become profitable at a later date than expected. earnings-per-share-growth Given this is a high-level overview, we won’t go into details of Chiasma's upcoming projects, however, keep in mind that typically a pharma company has lumpy cash flows which are contingent on the drug and stage of product development the business is in. So, a high growth rate is not out of the ordinary, particularly when a company is in a period of investment. One thing we’d like to point out is that Chiasma has no debt on its balance sheet, which is rare for a loss-making pharma, which typically has high debt relative to its equity. The company currently operates purely off its shareholder funding and has no debt obligation, reducing concerns around repayments and making it a less risky investment. Story continues Next Steps: There are key fundamentals of Chiasma which are not covered in this article, but we must stress again that this is merely a basic overview. For a more comprehensive look at Chiasma, take a look at Chiasma's company page on Simply Wall St. We've also compiled a list of relevant aspects you should look at: Historical Track Record: What has Chiasma's performance been like over the past? Go into more detail in the past track record analysis and take a look at the free visual representations of our analysis for more clarity. Management Team: An experienced management team on the helm increases our confidence in the business – take a look at who sits on Chiasma's board and the CEO’s background. Other High-Performing Stocks: Are there other stocks that provide better prospects with proven track records? Explore our free list of these great stocks here. This article by Simply Wall St is general in nature. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Have feedback on this article? Concerned about the content?Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com.
CHMA | finance.yahoo | about 4 years ago | Neutral

Pulmatrix appoints Director Anand VaradanLEXINGTON, Mass., July 27, 2021 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE™ technology, today announced the appointment of Anand V...
LEXINGTON, Mass., July 27, 2021 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE™ technology, today announced the appointment of Anand Varadan to its Board of Directors, effective July 26, 2021. Mr. Varadan brings expertise in commercialization and successful product launches. In addition, Mark Iwicki stepped down from his role on the Board of Directors effective July 23, 2021. (PRNewsfoto/Pulmatrix, Inc.) "We are delighted to welcome Anand to the Pulmatrix Board," said Ted Raad, Chief Executive Officer of Pulmatrix. "Anand is a recognized leader in the biotech industry and his extensive experience in corporate strategy and commercialization will be invaluable to Pulmatrix's future growth and success. I look forward to Anand's guidance as we execute on our vision to bring iSPERSE enabled inhaled therapies to patients with a broad range of large market indications. I'd also like to thank Mark for his invaluable contributions to Pulmatrix during his time on the Board." Mr. Varadan currently serves as an Executive Vice President, Chief Commercial Officer at Chiasma (NYSE: CHMA), a clinical, late-stage biopharmaceutical company, where he leads commercial strategy and operations. Mr. Varadan previously served as Chiasma's strategic advisors, and earlier as Chiasma's Chief Commercial Officer. Before joining Chiasma, Mr. Varadan served as Executive Vice President, Chief Commercial Officer of Karyopharm Therapeutics, Inc, an oncology-focused pharmaceutical company, where he led a successful launch of Xpovio for multiple myeloma. Mr. Varadan also provides commercial and strategic consultancy services through his consulting firm, Ignition Insights, LLC. Earlier in his career, Mr. Varadan held management and commercial leadership roles at Amgen Inc., a biopharmaceutical company, in the U.S., E.U., and Canada including Vice President, Inflammation and Nephrology Business Unit. Prior to Amgen, Mr. Varadan was a brand manager at Procter and Gamble Company. Story continues Mr. Vardan added, "I am excited about joining the Pulmatrix Board at such an exciting time in the Company's evolution as they expand to non-respiratory indications. I look forward to contributing to Pulmatrix's mission to advance and commercialize their differentiated iSPERSE pipeline, collaborating with management and fellow Board members." About Pulmatrix Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE™ technology. The Company's proprietary product pipeline includes treatments for serious lung diseases such as allergic bronchopulmonary aspergillosis ("ABPA"), COPD, and neurologic disorders such as acute migraine. Pulmatrix's product candidates are based on iSPERSE™, its proprietary engineered dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes. FORWARD-LOOKING STATEMENTS Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements of historical fact, and may be identified by words such as "anticipates," "assumes," "believes," "can," "could," "estimates," "expects," "forecasts," "guides," "intends," "is confident that", "may," "plans," "seeks," "projects," "targets," and "would," and their opposites and similar expressions are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the impact of the novel coronavirus (COVID-19) on the Company's ongoing and planned clinical trials; the geographic, social and economic impact of COVID-19 on the Company's ability to conduct its business and raise capital in the future when needed; delays in planned clinical trials; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company's ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; the ability to secure and enforce legal rights related to the Company's products, including patent protection; and the outcome of the Company's dispute with Cipla regarding the continued development of Pulmazole. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company's filings with the SEC, including its most recent annual report on Form 10-K, as amended, as may be supplemented or amended by the Company's Quarterly Reports on Form 10-Q. The Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Investor Contact Timothy McCarthy, CFA 212.915.2564 Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/pulmatrix-appoints-director-anand-varadan-301342205.html SOURCE Pulmatrix, Inc.
CHMA PULM | finance.yahoo | about 4 years ago | Neutral

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Chiasma Inc (CHMA)

Chiasma, Inc., a commercial-stage biopharmaceutical company, focuses on developing and commercializing oral medications using transient permeability enhancer technology platform for the treatment of rare and serious chronic disease worldwide. The company offers MYCAPSSA, an oral octreotide capsule for the long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. It also develops MPOWERED, an oral octreotide capsule, which has completed Phase III clinical trials for the maintenance treatment of adult patients with acromegaly. Chiasma, Inc. was incorporated in 2001 and is headquartered in Needham, Massachusetts.

Exchange: NASDAQ

IPO Date: 7/16/2015

Sector: Healthcare

Industry: Biotechnology

Employees: 84

Address: Building C East, Needham, MA, United States, 02494

http://www.chiasma.com

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