Key Metrics

Market Cap	31.30B
Total Shares Outstanding	129.46M
Book Value	0.52
PE Ratio	-

PS Ratio	13.92
PB Ratio	467.81
Forward PE Ratio	909.09
ROIC	-38.34

Return on Aseets	-2.74
Return on Equity	-1.50K
Dividend	-
Dividend Yield	-

Balancesheet Metrics

Total Assets	4.24B
Total Liability	4.17B
Assets-to-Libability Ratio	1.02

Total Current Assets	3.30B
Total Current Liability	1.19B
Current Ratio	2.78

Quick Ratio	2.71
Debt to Equity Ratio	15.9

Income Statement Metrics

Net Income	-852.82M
EPS	-2.18
EBITA	-996.52M

Gross Profit	704.14M
Gross Profit Margin	-12.37%
Operating Margin	-17.73%

Net Profit Margin

-101.01%

Price Metrics

5 Days MA	240.1
10 Days MA	243.11
20 Days MA	246.48
50 Days MA	254.22
200 Days MA	249.27

52 Weeks High	304.39
52 Weeks low	141.98
All Time High	304.39

RSI	42.94
MACD	-5.14

Share Stats

Shares Float	124.46M
Shares Short	3.22M

% Short	0.0221%
% Insider	3.896%

% Institutions	96.884%

% Institutions

96.884%

News

Alnylam to Webcast Presentation at Stifel 2025 Virtual CNS ForumCAMBRIDGE, Mass., March 11, 2025--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that management will present a company overview at the Stifel 2025 Virtual CNS Forum on Tuesday, March 18, 2025 at 3:00 pm ET. A live audio webcast...
CAMBRIDGE, Mass., March 11, 2025--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that management will present a company overview at the Stifel 2025 Virtual CNS Forum on Tuesday, March 18, 2025 at 3:00 pm ET. A live audio webcast of the presentation will be available on the Investors section of the Company’s website, www.alnylam.com/events. A replay will be available on the Alnylam website within 48 hours after the event. About Alnylam Pharmaceuticals Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and prevalent diseases with unmet need. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach yielding transformative medicines. Since its founding in 2002, Alnylam has led the RNAi Revolution and continues to deliver on a bold vision to turn scientific possibility into reality. Alnylam’s commercial RNAi therapeutic products are ONPATTRO® (patisiran), AMVUTTRA® (vutrisiran), GIVLAARI® (givosiran), OXLUMO® (lumasiran), and Leqvio® (inclisiran), which is being developed and commercialized by Alnylam’s partner, Novartis. Alnylam has a deep pipeline of investigational medicines, including multiple product candidates that are in late-stage development. Alnylam is executing on its "Alnylam P5x25" strategy to deliver transformative medicines in both rare and common diseases benefiting patients around the world through sustainable innovation and exceptional financial performance, resulting in a leading biotech profile. Alnylam is headquartered in Cambridge, MA. For more information about our people, science and pipeline, please visit www.alnylam.com and engage with us on X (formerly Twitter) at @Alnylam, or on LinkedIn, Facebook, or Instagram. View source version on businesswire.com: https://www.businesswire.com/news/home/20250311789872/en/ Contacts Alnylam Pharmaceuticals, Inc. Christine Regan Lindenboom (Investors and Media) 617-682-4340 Josh Brodsky (Investors) 617-551-8276 View Comments
ALNY | finance.yahoo | about 3 days ago | Neutral

Dr. Phillip A. Sharp Retirement From Alnylam Pharmaceuticals (NasdaqGS:ALNY) Board AnnouncedAlnylam Pharmaceuticals's share price increased by 2.2% last week, a rise that coincided with the announcement of Dr. Phillip A. Sharp's upcoming retirement from the Board of Directors. Dr. Sharp, a co-founder and long-standing advisor, significantly impacted the company's trajectory. Despite broade...
Alnylam Pharmaceuticals's share price increased by 2.2% last week, a rise that coincided with the announcement of Dr. Phillip A. Sharp's upcoming retirement from the Board of Directors. Dr. Sharp, a co-founder and long-standing advisor, significantly impacted the company's trajectory. Despite broader market challenges, such as tariff-related sell-offs that caused the Nasdaq Composite to decline by 1.1%, Alnylam maintained resilient performance. The general market saw a 1.9% drop over the same period, primarily affected by U.S. tariff uncertainties impacting tech stocks. However, Alnylam's strategic positioning and investor confidence in its leadership contributed to a positive price move. As Dr. Sharp transitions to Alnylam's Scientific Advisory Board, the company's ability to retain his expertise while navigating executive changes may have bolstered investor sentiment, contrasting with broader market turbulence. Click here and access our complete analysis report to understand the dynamics of Alnylam Pharmaceuticals.NasdaqGS:ALNY Revenue & Expenses Breakdown as at Mar 2025 Over the last five years, Alnylam Pharmaceuticals' total shareholder returns, combining share price and dividends, surged by 144.61%. This growth significantly outperformed many peers, with the company's stock appreciating despite broader market volatility. Key developments underpinning this performance include Alnylam's impressive revenue growth, with annual increases of 15.8% over the period and expectations for continued revenue growth at 22.9% annually. These factors have bolstered investor confidence even as the company remains in growth mode rather than profit maximization. Significant advances in Alnylam's product pipeline also supported its long-term growth. The successful HELIOS-B Phase 3 study for vutrisiran, which showed improvements in cardiac outcomes, and the ongoing FDA review anticipated for late March 2025, have positioned the company well for future innovations. Additionally, strategic partnerships, like the expansion with Medison Pharma and the collaboration with Dicerna Pharmaceuticals, have established a strong foundation for market innovation and penetration in various regions. Discover whether Alnylam Pharmaceuticals is fairly priced, undervalued, or overvalued in our comprehensive valuation breakdown. Assess the downside scenarios for Alnylam Pharmaceuticals with our risk evaluation. Invested in Alnylam Pharmaceuticals? Simplify your portfolio management with Simply Wall St and stay ahead with our alerts for any critical updates on your stocks. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. 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. Story Continues Companies discussed in this article include NasdaqGS:ALNY. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com View Comments
ALNY | finance.yahoo | about 7 days ago | Neutral

High Growth Tech Stocks Leading The US MarketOver the last 7 days, the United States market has dropped 1.9%, yet over the longer term, it has risen by 14% in the last year with earnings forecasted to grow by 14% annually. In this context of fluctuating short-term performance and promising long-term growth, identifying high growth tech stocks ...
Over the last 7 days, the United States market has dropped 1.9%, yet over the longer term, it has risen by 14% in the last year with earnings forecasted to grow by 14% annually. In this context of fluctuating short-term performance and promising long-term growth, identifying high growth tech stocks that demonstrate strong innovation and adaptability can be crucial for investors looking to capitalize on emerging opportunities within the US market. Top 10 High Growth Tech Companies In The United States Name Revenue Growth Earnings Growth Growth Rating Super Micro Computer 25.26% 29.10% ★★★★★★ TG Therapeutics 26.19% 37.78% ★★★★★★ Alkami Technology 21.95% 85.17% ★★★★★★ Travere Therapeutics 28.43% 65.01% ★★★★★★ AVITA Medical 27.78% 55.33% ★★★★★★ Clene 61.16% 59.11% ★★★★★★ Alnylam Pharmaceuticals 22.90% 58.64% ★★★★★★ Alvotech 31.17% 100.18% ★★★★★★ Zai Lab 28.33% 68.55% ★★★★★★ Lumentum Holdings 21.24% 119.37% ★★★★★★ Click here to see the full list of 239 stocks from our US High Growth Tech and AI Stocks screener. Let's dive into some prime choices out of from the screener. Organogenesis Holdings Simply Wall St Growth Rating: ★★★★☆☆ Overview: Organogenesis Holdings Inc. is a regenerative medicine company that develops, manufactures, and commercializes solutions for advanced wound care, surgical, and sports medicine markets in the United States with a market cap of $639.21 million. Operations: The company generates revenue primarily from its regenerative medicine segment, with reported earnings of $482.04 million. Organogenesis Holdings, transitioning towards profitability, has demonstrated a robust annual earnings growth forecast at 71.83%, signaling potential in an otherwise challenging biotech sector. With a recent surge in quarterly sales to $126.66 million from $99.65 million the previous year and a shift from a net loss to a net income of $7.67 million, the company's financial health appears to be strengthening. Despite its current unprofitability and highly volatile share price, Organogenesis is expected to outpace the US market with an anticipated revenue growth of 9.2% annually compared to the market's 8.5%. This performance is underpinned by significant R&D investments aimed at driving future innovations and maintaining competitive edge in regenerative medicine—a field poised for substantial growth given aging populations and advanced treatment technologies. Click to explore a detailed breakdown of our findings in Organogenesis Holdings' health report. Understand Organogenesis Holdings' track record by examining our Past report.NasdaqCM:ORGO Revenue and Expenses Breakdown as at Mar 2025 Alnylam Pharmaceuticals Simply Wall St Growth Rating: ★★★★★★ Story Continues Overview: Alnylam Pharmaceuticals, Inc. focuses on the discovery, development, and commercialization of therapeutics utilizing ribonucleic acid interference technology and has a market cap of approximately $31.45 billion. Operations: Alnylam Pharmaceuticals generates revenue primarily through the discovery, development, and commercialization of RNAi therapeutics, amounting to $2.25 billion. The company's financial performance is closely tied to its innovative approach in leveraging ribonucleic acid interference technology for therapeutic solutions. Alnylam Pharmaceuticals, showcasing a robust trajectory in the biotech sector, reported a significant revenue jump to $2.25 billion in 2024, up from $1.83 billion the previous year. This growth is underpinned by its aggressive R&D strategy, which saw expenses of $593 million last year alone, aimed at pioneering RNAi therapeutics across various tissues. The firm's recent advancements include promising updates on nucresiran and partnerships like that with Regeneron for ALN-HTT02 targeting Huntington's disease. With Dr. Phillip Sharp’s transition to the Scientific Advisory Board after his retirement from the board of directors, Alnylam continues to leverage deep scientific expertise to drive innovation and address unmet medical needs in novel therapeutic areas. Get an in-depth perspective on Alnylam Pharmaceuticals' performance by reading our health report here. Review our historical performance report to gain insights into Alnylam Pharmaceuticals''s past performance.NasdaqGS:ALNY Earnings and Revenue Growth as at Mar 2025 Nutanix Simply Wall St Growth Rating: ★★★★★☆ Overview: Nutanix, Inc. is a company that offers an enterprise cloud platform across various regions including North America, Europe, the Asia Pacific, the Middle East, Latin America, and Africa with a market capitalization of approximately $20.65 billion. Operations: The company generates revenue primarily from its Internet Software & Services segment, totaling approximately $2.32 billion. Nutanix has demonstrated a robust performance with its recent earnings, marking a significant year-over-year revenue increase to $654.72 million in Q2 2025, up from $565.23 million. This growth is complemented by an impressive surge in net income to $56.43 million from $32.8 million, reflecting strong operational efficiency and market demand for its cloud services solutions. The company's forward-looking statements suggest continued expansion with projected full-year revenues reaching up to $2.515 billion, indicating confidence in sustained growth and innovation in the tech sector amidst evolving digital transformations. In addition to financial achievements, Nutanix's strategic movements include entering into a substantial credit agreement aimed at bolstering their working capital and supporting general corporate activities, ensuring they remain agile in a competitive landscape marked by rapid technological advancements and shifting enterprise needs towards hybrid multicloud environments. This approach not only underscores their commitment to scaling operations efficiently but also highlights their proactive stance on leveraging financial structures to maintain momentum within the high-growth tech arena. Click here and access our complete health analysis report to understand the dynamics of Nutanix. Examine Nutanix's past performance report to understand how it has performed in the past.NasdaqGS:NTNX Earnings and Revenue Growth as at Mar 2025 Where To Now? Delve into our full catalog of 239 US High Growth Tech and AI Stocks here. Got skin in the game with these stocks? Elevate how you manage them by using Simply Wall St's portfolio, where intuitive tools await to help optimize your investment outcomes. Enhance your investing ability with the Simply Wall St app and enjoy free access to essential market intelligence spanning every continent. Ready For A Different Approach? Explore high-performing small cap companies that haven't yet garnered significant analyst attention. Fuel your portfolio with companies showing strong growth potential, backed by optimistic outlooks both from analysts and management. Find companies with promising cash flow potential yet trading below their fair value. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. 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. Companies discussed in this article include NasdaqCM:ORGONasdaqGS:ALNY and NasdaqGS:NTNX. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com View Comments
ALNY NTNX | finance.yahoo | about 8 days ago | Neutral

Alnylam Announces Retirement of Longtime Board Member, Dr. Phillip A. Sharp, Company Co-Founder and Industry LuminaryCAMBRIDGE, Mass., March 05, 2025--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the retirement of Dr. Phillip A. Sharp, Ph.D., from the Company’s Board of Directors, effective as of May 8, 2025. Dr. Sharp has served as a key adv...
CAMBRIDGE, Mass., March 05, 2025--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the retirement of Dr. Phillip A. Sharp, Ph.D., from the Company’s Board of Directors, effective as of May 8, 2025. Dr. Sharp has served as a key advisor to Alnylam since he co-founded the Company in 2002. Dr. Sharp will remain a member of the Alnylam Scientific Advisory Board. "Phil helped pioneer the RNAi revolution, sparking the scientific collaboration that led to Alnylam’s founding and the development of a transformative new class of medicines," said Yvonne Greenstreet, MBChB, Chief Executive Officer of Alnylam. "He has provided invaluable guidance over the past twenty-two years that has shaped the remarkable company we have built. On behalf of Alnylam – and in honor of the tens of thousands of patients worldwide who have benefitted from RNAi therapeutics – I want to thank Phil for his incredible vision and lasting impact on the field of medicine." "Phil has made so many important scientific discoveries and his role at Alnylam has been a critical one," said Amy W. Schulman, Chair of the Alnylam Board of Directors. "The Board and I want to thank him – we are so grateful to Phil for his role in shaping not only Alnylam but also an entire industry." Dr. Sharp is a distinguished scientific leader who holds a multitude of positions and honors throughout academia and industry. He was awarded a Nobel Prize in Physiology or Medicine in 1993 for the discovery of RNA splicing. Additionally, he was awarded the 2004 National Medal of Science and the American Association for Cancer Research (AACR) Award for Lifetime Achievement in Cancer Research in 2020. Dr. Sharp is an Institute Professor Emeritus of the Koch Institute for Integrative Cancer Research at MIT and the Founding Director of the McGovern Institute for Brain Research at MIT. He is a member of the National Academy of Sciences, the Institute of Medicine, and the American Academy of Arts and Sciences. In addition to co-founding Alnylam, Dr. Sharp also co-founded Biogen and has served as a director for numerous other biotechnology companies. About RNAi RNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today. Its discovery has been heralded as "a major scientific breakthrough that happens once every decade or so," and was recognized with the award of the 2006 Nobel Prize for Physiology or Medicine. By harnessing the natural biological process of RNAi occurring in our cells, a new class of medicines known as RNAi therapeutics is now a reality. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam's RNAi therapeutic platform, function upstream of today’s medicines by potently silencing messenger RNA (mRNA) – the genetic precursors – that encode for disease-causing or disease pathway proteins, thus preventing them from being made. This is a revolutionary approach with the potential to transform the care of patients with genetic and other diseases. Story Continues About Alnylam Pharmaceuticals Alnylam (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and prevalent diseases with unmet need. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach yielding transformative medicines. Since its founding in 2002, Alnylam has led the RNAi Revolution and continues to deliver on a bold vision to turn scientific possibility into reality. Alnylam’s commercial RNAi therapeutic products are ONPATTRO® (patisiran), AMVUTTRA® (vutrisiran), GIVLAARI® (givosiran), OXLUMO® (lumasiran), and Leqvio® (inclisiran), which is being developed and commercialized by Alnylam’s partner, Novartis. Alnylam has a deep pipeline of investigational medicines, including multiple product candidates that are in late-stage development. Alnylam is executing on its "Alnylam P5x25" strategy to deliver transformative medicines in both rare and common diseases benefiting patients around the world through sustainable innovation and exceptional financial performance, resulting in a leading biotech profile. Alnylam is headquartered in Cambridge, MA. For more information about our people, science and pipeline, please visit www.alnylam.com and engage with us on X (formerly Twitter) at @Alnylam, or on LinkedIn, Facebook, or Instagram. View source version on businesswire.com: https://www.businesswire.com/news/home/20250305875945/en/ Contacts Alnylam Pharmaceuticals, Inc. Christine Regan Lindenboom (Investors and Media) 617-682-4340 Josh Brodsky (Investors) 617-551-8276 View Comments
ALNY | finance.yahoo | about 9 days ago | Neutral

Q4 2024 Vir Biotechnology Inc Earnings CallParticipants Richard Lepke; Senior Director of Investor Relations; Vir Biotechnology Inc Marianne De Backer; Chief Executive Officer, Director; Vir Biotechnology Inc Mark Eisner; Executive Vice President & Chief Medical Officer; Vir Biotechnology Inc Jason O'Byrne; Executive Vice President & Chi...
Participants Richard Lepke; Senior Director of Investor Relations; Vir Biotechnology Inc Marianne De Backer; Chief Executive Officer, Director; Vir Biotechnology Inc Mark Eisner; Executive Vice President & Chief Medical Officer; Vir Biotechnology Inc Jason O'Byrne; Executive Vice President & Chief Financial Officer; Vir Biotechnology Inc Mika Derynck; Executive Vice President, Therapeutic Area Head Oncology; Vir Biotechnology Inc Hang Hu; Analyst; Barclays Paul Choi; Analyst; Goldman Sachs & Company, Inc. Avraham Novick; Analyst; Morgan Stanley & Co. LLC Mazahir Alimohamed; Analyst; Leerink Partners Phil Nadeau; Analyst; TD Cowen Alec Stranahan; Analyst; BofA Global Research (US) Joseph Stringer; Analyst; Needham & Company Patrick Trucchio; Analyst; H.C. Wainwright & Co., LLC Presentation Operator Hello. Welcome to Vir Biotechnologies' fourth-quarter and full-year 2024 financial results and business update call. As a reminder, this conference call is being recorded. (Operator Instructions) I will now turn the call over to Rich Lepke, Senior Director, Investor Relations. You may begin, Mr. Lepke. Richard Lepke Thank you, and good afternoon. With me today are Dr. Marianne De Backer, our Chief Executive Officer; Dr. Mark Eisner, our Chief Medical Officer; Jason O'Byrne, our Chief Financial Officer; and Dr. Mika Derynck, our Executive Vice President of Oncology, will be available during the Q&A session. Before we begin, I would like to remind everyone that some of the statements we are making today are forward-looking statements under the securities laws. These forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by such forward-looking statements. These risks and uncertainties and risks associated with our business are described in the company's reports filed with the Securities and Exchange Commission, including Forms 10-K, 10-Q and 8-K. Please note that any cross-trial comparisons discussed today are not based on head-to-head studies and have inherent limitations and caution should be exercised when interpreting such comparisons. With that, I'll now turn the call over to our CEO, Marianne De Backer. Marianne De Backer Thank you, Rich, and good afternoon, everyone. Thank you for joining us for our fourth-quarter and full-year 2024 earnings call. I'm truly excited to share our progress with you today. 2024 was nothing short of transformative for Vir Biotechnology. As I reflect on the past year, I'm incredibly proud of what we've accomplished. We've made significant strides in our oncology and infectious disease programs, positioning Vir Bio at the forefront of innovative therapies in these areas of critical unmet medical need. Our strategic focus on T-cell engagers and hepatitis has not only yielded promising results but has also positioned us well for future growth and value creation. This focused approach allows us to allocate our resources efficiently and make meaningful progress across our pipeline. Now let me start with our infectious disease portfolio. We are moving full steam ahead with preparations for our ECLIPSE Phase 3 program in hepatitis delta, which we expect to initiate in the first half of the year. The regulatory designations we've received -- US FDA breakthrough therapy and fast track designation as well as EMA PRIME designation and orphan drug status -- underscore the potential impact of our combination regimen and the significant unmet medical need. We believe the market for hepatitis delta therapies shares characteristics with orphan diseases, including lack of efficacious treatment options, severe clinical outcomes, and the potential for value-based pricing that appropriately reflects the clinical benefit our therapy may offer. Current treatment options are limited, especially in the US, where there are no approved therapies. Hepatitis delta virus requires hepatitis B surface antigen to complete its life cycle. Our combination therapy of tobevibart and elebsiran offers a unique approach by reducing hepatitis B surface antigen through two distinct and complementary mechanisms. Tobevibart, an Fc-engineered monoclonal antibody is designed to block viral entry and neutralize virions, while elebsiran, a small interfering RNA, aims to reduce hepatitis B surface antigen production by degrading HBV mRNA. This dual-pronged strategy addresses both hepatitis delta and hepatitis B replication simultaneously, potentially offering comprehensive and durable viral suppression. We believe this approach has the potential to address the significant unmet need in chronic hepatitis delta and become a new standard of care. Now turning to our exciting progress in oncology; as many of you know, we held a successful T-cell engager investor event on January 8. The data we presented for VIR-5818, a HER2 targeted T-cell engager was very promising. We saw promising early signs of clinical activity, particularly in colorectal cancer with an encouraging safety profile. Our PSMA targeted T-cell engager, VIR-5500 also showed strong early results in prostate cancer with impressive PSA responses and a favorable safety profile. The activity we observed clinically is a clear indication that our dual mask construct is being cleaved and activated as intended. These results now across two clinical programs validate the potential of the PRO-XTEN platform to address significant unmet needs in solid metastatic tumors. We are also making great progress with VIR-5525, our EGFR-targeted T-cell engager. We are on track to initiate a Phase 1 study in the first half of this year. Importantly, we have secured worldwide rights to the PRO-XTEN platform in both oncology and infectious diseases. This gives us a powerful foundation for future growth as the platform's universal plug-and-play masking technology can be applied to both existing as well as novel targets. This capability not only supports our current pipeline but also provides us with significant flexibility to expand into additional high-value indications in the future. In hepatitis B, we're looking forward to sharing functional cure data in the second quarter. It's important to note that we would take this program forward only with the commercialization and development partner. Our financial position remains strong with a cash runway extending into mid-2027. This solid foundation is the result of our achievements since late-2023, where we significantly reduced our operating expenses and cash burn. We are maintaining a disciplined approach to capital allocation, focusing our resources on our most promising programs. At the same time, we are actively exploring partnership opportunities to maximize the value of our broader pipeline. As you'll hear in more detail shortly, our 2024 financial results reflect both our strategic investments and our commitment to fiscal responsibility. As we look to 2025, I'm confident that our strategy sets us up for long-term success and value creation. With that, I'll now turn the call over to Mark to provide an update on our clinical development programs. Story Continues Mark Eisner Thank you, Marianne. We've made significant progress in clinical stage programs, and I'm looking forward to sharing the details with you today. Let's start with our hepatitis delta program, which continues to be a key focus for us. We're making excellent progress towards initiating our ECLIPSE Phase 3 program in the first half of this year. These studies will form the basis of our marketing applications. Before we dive into the ECLIPSE program, let me briefly recap our SOLSTICE Phase 2 data, which has given us confidence to move forward with our Phase 3 program. We saw impressive virologic responses across multiple cohorts. To provide some context, when we refer to HDV RNA target not detected or TND, we mean there is no measurable presence of the virus in the blood. This is the most stringent measure of viral suppression we can achieve with current testing methods. In our de novo combination therapy arm at 24 weeks, 41% of patients achieved HDV RNA levels below the target not detected threshold. Even more impressively, this increased to 64% of patients at week 36. In our rollover cohort, which provides our longest follow-up data, we saw even more encouraging results. At week 60, four out of five patients or 80% achieved target not detected levels. This suggests the potential for durable and deepening responses with our combination therapy over time. Importantly, we also observed significant declines in hepatitis B surface antigen levels. At week 24, approximately 90% of participants receiving the combination of tobevibart and elebsiran achieved surface antigen levels below 10 IU per ml. This is a crucial finding because reducing hepatitis B surface antigen is essential for controlling both hepatitis B and hepatitis B virus replication. Additionally, the combination of tobevibart and elebsiran demonstrated a favorable safety profile across all the cohorts. Our approach has garnered significant regulatory support, which speaks to the potential impact of our therapy. We've received breakthrough therapy designation and fast track designation from the FDA. The EMA has granted us PRIME designation and orphan drug status. These designations could help accelerate our development and review process, potentially bringing this much-needed therapy to patients sooner. Turning to our hepatitis B program; we are looking forward to sharing functional cure data in the second quarter of this year. This functional cure data will be a crucial milestone for this program. I want to reiterate that we would pursue the development of this program only with a partner. I'm very excited about the progress we've made in our infectious disease programs. We're on the cusp of potentially changing the treatment landscape for hepatitis delta, and we're looking forward to sharing our hepatitis B functional cure data. Now let me shift gears to discuss our oncology portfolio to discuss the significant progress we've made with the PRO-XTEN platform. As Marianne mentioned, we've shared compelling data at our investor event in January, and I'd like to dive deeper into those results. Before we get into the specifics of each program, let me briefly recap the PRO-XTEN platform. This innovative technology allows us to create dual masked T-cell engagers designed to be selectively activated in the tumor microenvironment. The key advantage is the potential for a wider therapeutic window, allowing for higher dosing and improved efficacy with reduced systemic toxicity. The PRO-XTEN masks are unstructured and hydrophilic, acting as a shield to prevent T-cell engagement in normal tissues expressing the target antigen. Importantly, their fluid nature also allows access to the cleavable linkers, enabling efficient activation when in the protease-rich tumor microenvironment. The PRO-XTEN masks are universal and have been clinically validated as seen in ALTUVIIIO, an approved therapy for hemophilia. ALTUVIIIO contains three protease cleavage sites that are quickly cleaved in a high protease microenvironment of a clot during the clotting cascade, demonstrating the ability of the PRO-XTEN system to enable efficient and tightly regulated unmasking. We believe this approach could overcome many limitations seen with traditional unmasked T-cell engagers, and the validated nature of the platform gives us confidence in its potential application across our oncology programs. Let's start with the VIR-5818, our HER2-targeted T-cell engager. We've seen encouraging efficacy signals across multiple HER2-positive tumors, particularly in colorectal cancer. At doses of 400 micrograms per kilogram and above, we observed a 33% confirmed partial response rate in colorectal cancer patients. It is important to note that these patients had exhausted all standard of care options and were heavily pre-treated with many having received multiple prior lines of therapy, including HER2-targeted treatments. Additionally, one of these three responses was observed in a patient on the every three-week dosing schedule. I'd also like to highlight a compelling case we presented at our recent investor event, which speaks to the potential for durable responses. A patient with HER2-positive colorectal cancer, who progressed through six prior lines of therapy, including HER2-targeted agents, achieved a partial response. Remarkably, this response has been sustained for over 18 months with the patients still on study as of our last data cutoff. Crucially, we've observed efficacy in microsatellite stable or MSS colorectal cancer tumors, which typically are resistant to immunotherapies. This suggests VIR-5818's ability to overcome the immunosuppressive tumor microenvironment in these hard-to-treat patients. To put these results in context, it's important to note that for patients who have exhausted multiple lines of treatment, current regimens like LONSURF plus bevacizumab typically show objective response rates in the single digits. Our early results, therefore, are particularly encouraging in this heavily pretreated population. The safety profile of VIR-5818 has been favorable with no high-grade cytokine release syndrome or CRS and without mandatory prophylactic corticosteroids. We're continuing dose escalation on an every three-week schedule to optimize efficacy while maintaining this favorable safety profile. We're also exploring combination strategies, including with pembrolizumab. It's worth noting that VIR-5818 utilizes the pertuzumab binding epitope, which enables potential combination strategies with trastuzumab-based therapies in an earlier-line setting. Turning to VIR-5500, our PSMA-targeted T-cell engager for prostate cancer, we've seen impressive early results in our ongoing Phase 1 dose escalation study. Among the 12 patients treated in the efficacious dose range, 100% experienced PSA declines with 58% achieving PSA50 response and 8% achieving PSA90 response. This is particularly encouraging given the heavily pretreated nature of this population and the early stage of dose escalation. Like VIR-5818, VIR-5500 in early dose escalation has a favorable safety profile with minimal high-grade adverse events and no Grade 3 or higher CRS. Notably, these results have been achieved without the use of prophylactic corticosteroids or anti-IL-6 therapies, which are often required with other T-cell engagers, including masked T-cell engagers. Importantly, we have not observed any cases of on-target, off-tumor toxicities such as hearing loss, which have been reported with other PSMA-targeted therapies. We're continuing dose escalation and based on our favorable safety profile, we believe there's significant room to potentially improve efficacy further. As we move to higher doses, we expect to see deeper and more durable responses, which could significantly improve outcomes for patients with prostate cancer. We're also actively exploring every three-week dosing, which could be a significant advantage, especially in earlier lines of therapy. This potential for less frequent dosing is supported by VIR-5500's pharmacokinetic profile, which shows a half-life of 8 to 10 days. The potential for less frequent dosing combined with the encouraging efficacy and safety profile we've observed could offer meaningful benefit to patients across various stages of prostate cancer treatment. Importantly, these results have been achieved without the need for prophylactic corticosteroids or anti-IL-6 therapies. For VIR-5525, our EGFR-targeted T-cell engager, we're on track to initiate the Phase 1 study in the first half of this year. This program has potential to address multiple high-value indications, including non-small cell lung cancer, colorectal cancer and head and neck cancer. We're leveraging our learnings from VIR-5818 and VIR-5500 to optimize the study design and dosing strategy. Based on our experience with the PRO-XTEN platform and the successes we've seen with our other T-cell engagers, we're confident in our ability to achieve a broad therapeutic index with VIR-5525. Looking ahead, we anticipate sharing additional data from our ongoing dose escalation studies for VIR-5818 and VIR-5500. While the exact timing is still to be announced, we expect to present more mature data at higher doses for both programs. This will include results from both weekly and every three-week dosing schedules, which we believe will provide valuable insights into the optimal dosing regimens for these therapies. In conclusion, I'm very excited about the progress we're making across our oncology portfolio. The early data from our T-cell engager programs are further validating the potential of the PRO-XTEN platform, demonstrating both efficacy and the ability to dose higher than traditional unmasked approaches. We believe we're well-positioned to redefine the treatment landscape for several challenging solid tumors. Our team remains focused on executing our clinical development plans and unlocking the full potential of these promising therapies. With that, I'll now hand the call over to Jason. Jason O'Byrne Thank you, Mark. I'm really pleased to share that our hard work on rightsizing the cost structure, improving efficiencies, and making thoughtful investment is paying off. Since late 2023, we've taken significant steps to streamline operations and focus on our most promising programs. We've implemented two restructurings, closed two sites and deprioritized certain programs. Then in September, we executed the agreement with Sanofi to license three dual mask T-cell engagers and the PRO-XTEN technology. While this added modestly to our cost structure, including approximately 50 new team members from Sanofi, it significantly expanded our pipeline and brought in critical expertise in oncology, T-cell engager clinical development, and masking technology. This, combined with our existing expertise in protein engineering and immunology, positions us well for future growth and innovation. During our budget process last fall, we applied further financial discipline, culminating in our January 8 announcement to advance our HBV program only with a development and commercialization partner. Many of these actions have led to substantial improvements in our financial performance. Let me highlight a few key financial metrics for 2024 compared to 2023. R&D expenses for 2024 were $507 million compared to $580 million in 2023. This decrease was achieved despite absorbing approximately $103 million in Sanofi transaction expenses related to our licensing agreement. Excluding this one-time transaction-related expense, our R&D spending decreased by approximately $176 million or about 30% year over year, reflecting our continued focus on cost management and program prioritization. G&A expenses decreased to $119 million in 2024 from $174 million in the prior year. This significant reduction, reflecting a 32% decrease year over year was primarily achieved through multiple cost-saving initiatives implemented since late 2023. As a result, our net loss for 2024 was $522 million compared to $615 million in 2023. Excluding the $103 million Sanofi R&D transaction expense, our net loss for 2024 was $419 million, representing a decline of approximately 32% from the previous year. We ended 2024 with 408 employees compared to 587 at the end of 2023, representing about a 30% year-over-year reduction. It's important to note that the 408 includes approximately 50 employees, who joined us from Sanofi as part of our licensing agreement. Now turning to cash. Our 2024 net cash consumption was roughly $532 million. Excluding approximately $179 million of Sanofi transaction-related items, the decrease to cash and investments for 2024 was approximately $354 million. We're starting 2025 with a strong financial position of $1.1 billion in cash, cash equivalents and investments. It's important to note that this $1.1 billion figure already excludes the $75 million pending EGFR milestone, which is currently in escrow and classified as restricted cash. Based on our current operating plan, we anticipate this will provide runway into mid-2027. As we look ahead to 2025, I want to emphasize that our capital deployment strategy remains focused on our most promising programs. Our priorities for the year are, first, we'll accelerate ECLIPSE clinical enrollment and initiate activities toward registration; second, we'll invest in VIR-5500 to rapidly advance the program, capitalizing on the very encouraging PSMA data that was shared in January; third, we'll continue enrolling patients in VIR-5818, potentially leveraging the promising early data we see in HER2-positive colorectal cancer; fourth, we'll initiate the Phase 1study for VIR-5525 in patients with EGFR-expressing solid tumors; and finally, for our hepatitis B program, we continue to pursue a partnership strategy. We believe this approach will maximize the value of the asset while allowing us to focus our internal resources on our lead programs. In closing, I'm confident that our $1.1 billion in cash will fund these priorities into mid-2027 based on our current operating plan. This reflects our ongoing commitment to disciplined capital allocation, ensuring we have the resources to advance our key programs while maintaining financial flexibility. With that, I'll hand it back to Rich to initiate the Q&A session. Question and Answer Session Richard Lepke Thank you, Jason. This concludes our prepared remarks, and we will now start the Q&A section. (Event Instructions) I’ll turn it over to you, operator. Operator (Operator instructions) Gena Wang, Barclays. Hang Hu Hi. This is Hang Hu on behalf of Gena Wang from Barclays. So we have two questions. First one is for T-cell engager. So you are using the cleavable linker. So can you elaborate the mechanism for the cleavage and how efficient is the cleavage in the tumor microenvironment, for instance, for the single cleavage and for dual cleavage? And the second question is for HDV. So regarding the ECLIPSE registrational study starts in the first half of the year. So what additional steps you need to start this trial? And we understand this is event driven, but what is your estimated timing to complete the enrollment? Thanks. Marianne De Backer Thank you very much for that question. I'll ask Mika to address the first one related to the mechanism of action related to cleavage of the linkers. Mika Derynck Yeah. Thank you for that question. So we believe that we're getting efficiently cleavage for both masks. And the reasons for this is that we've seen really nice activity in both the HER2 program as well as the PSMA program, both having the double mask and both having the same PRO-XTEN masking technology as well as both having the same protease linkers on both sides of the linkers. In addition to that, seeing that activity that appears to be tumor-specific as we've not seen any significant toxicity in the periphery, very minimal CRS, and the absence of prophylactic -- widespread prophylactic corticosteroids, we're really seeing that tumor-specific cleavage. Besides that, the same exact XTEN masking technology is used in an approved drug, ALTUVIIIO, as Mark had mentioned. This drug is a hemophilia drug. It has the same XTEN mask, and it uses three thrombin cleavage sites. And it is efficiently cleaved, three sites in the setting of a clot where you have efficient thrombin activation, efficient cleavage and clotting as needed as well as not having clotting in the state where there is no clotting -- activated clotting cascade. So the efficiency of being able to cleave three sites, there's nothing about the XTEN masks in of itself that prevents access to the cleavage sites. Three sites versus two sites versus one site, tumor microenvironment is known to have very high protease activity. So we don't think that the number of sites is really an issue in terms of efficiency of cleavage. Marianne De Backer Thank you, Mika. So as to your second question relates to additional steps before starting on the ECLIPSE trial, I will ask Mark to address that. Mark Eisner Sure. Thank you for the question. So we are on track to initiate the ECLIPSE program in the first half of this year. The team is working with a high sense of urgency and excitement to get these trials up and running. We're confident that we will be able to initiate these trials in the near-term and efficiently recruit patients because of the high unmet need in HDV and our very compelling SOLSTICE Phase 2 data. So we're working quickly to get these studies up and running, and we will provide some updated guidance at a future point. Operator Paul Choi, Goldman Sachs. Paul Choi Hi, thank you. Good afternoon, and thank you for taking our questions. My first question is on the 5525 EGFR TCE program. Can you maybe paint for us a picture of what sort of patients you're envisioning for your Phase 1study? Are you going to allow sort of MET treatment experienced patients or patients who have been treated with J&J's RYBREVANT bispecific be enrolled into your study? Any sort of color to understand what population you'll be there would be great. And my second question is on the hep B program. I realize that the MARCH B data is coming up here next quarter fairly soon. But as you sort of think about go/no-go criteria for the future, even though you plan to partner it, can you maybe just again refresh your views on what you think is sort of clinically meaningful here and what you think would potentially be attractive to a theoretical development partner? Thank you. Marianne De Backer Yes. Thank you, Paul. On the hepatitis B program and our go/no-go criteria, I'll ask Mark to address. Mark Eisner Sure. Thanks for the question, Paul. So as you said, we will have our functional cure rate data second quarter of this year in particular. Is going to be the functional cure data 24 weeks of treatment. We had compelling results at the end of treatment at 48 weeks in the surface antigen low patients with 39% as loss in the doublet with the tobevibart, elebsiran, and 46% as loss in the triplet including pegylated interferon. In terms of go/no-go criteria, what we said before is we're looking for a 30% functional cure in the triplet, 20% in the doublet, generally speaking, that's based on our KOL interactions and what could be clinically meaningful. I think it's also maybe worth mentioning that GSK's bepirovirsen had a 16% functional cure, and they're in Phase 3 based on that. So their Phase 3 program will read out early next year, but that kind of gives you a little bit of context for what's been achieved so far. So we will be partnering this program and engaging with partners once we have the functional cure data. And I hope gives you a little bit of context for what we're looking for. Mika Derynck So I can answer the EGFR question. So this is a pretty standard first-in-human Phase 1 study. And in such that patients must have exhausted all current standard of care to be enrolled on study, which means that they must have exhausted standard approved drugs, but we will allow for patients, who may have been on any prior experimental drugs as well. So we typically do get a smattering of different types of patients. We are enriching for patients who have EGFR as a target that's important such as lung cancer, head and neck, pancreas and colorectal cancer. But other than that, we're probably going to have patients with a variety of different prior treatments. Operator Mike Ulz, Morgan Stanley. Avraham Novick Hey. It's Avi Novick on the line from Mike. Thank you for taking our questions. So I guess, number one, on 5525, given the strong safety profile you've seen in the Phase 1studies of 5818 and 5500, do you see a read-through to 5525? And do you believe you can possibly more aggressively escalate doses in the upcoming Phase 1 study? And then my second question is what are you thinking with respect to disclosing data for 5525? Do you think you would maybe plan to do an initial data update as you did for 5818 and 5500 or await for more mature data? Thanks. Marianne De Backer Yeah. Thank you for that question. As you know, there have been significant learnings from the HER2 program that were translated the 5500 program and the PSMA program could start at the higher dose and escalate more swiftly compared to the original 5818 program. So we expect that we will continue to learn across the clinical programs and that these learnings will benefit us also as we go into the 5525 program. Anything you want to add here, Mark or Mika? Mark Eisner I mean the only thing is that EGFR is broadly expressed in normal tissue, which makes it different from the PSMA program where, of course, there is PSMA expressed outside the prostate. And then the HER2, there is HER2 expressed in lung and heart and other normal tissues, but EGFR is broadly expressed. So we're looking forward to this program because it will be a really rigorous test of our dual masking approach and the specificity for unmasking the tumor microenvironment, whether we can achieve an excellent therapeutic index in EGFR-positive tumors, as Mika alluded to before. But to Marianne's point, yes, the learnings from the earlier two programs have and will continue to inform 5525 and further programs. So we do expect to be efficient in how we conduct that. Mika Derynck Yeah. And I might just also add in that from the HER2 program, again, the EGFR molecules will use the same PRO-XTEN technology, the same protease linkers, et cetera. But with the HER2 program, we've seen a prior naked HER2 T-cell engager that had a Grade 4 CRS at 0.5 micrograms per kg and IL-6 levels in the 10,000 picomole per ml range, suggesting that there's plenty of normal expression of HER2, enabling that significant CRS. But when you look at our 818 double masked molecule, we -- our start dose was 1 microgram per kg. So higher than this fully unmasked HER2 drug, GBR 1302, that was in the clinic many years ago. So we do believe with that very wide therapeutic index that we've seen for the HER2 double mask that that will give us confidence on the 5525. Operator Roanna Ruiz, Leerink Partners. Mazahir Alimohamed Hi, this is [Mazie] Alimohamed on for Roanna Ruiz. Thanks for taking our questions. But first, so given the early clinical response signals in the heavily pretreated patients, what are your thoughts of potentially moving the T-cell engagers into earlier lines of therapy in future trials? And also, could you elaborate on how machine learning and antibody engineering -- your background in that and those capabilities are being applied to optimize the design and efficacy of your T-cell engagers? Marianne De Backer Yeah. Thank you for that question. As we move into earlier lines, maybe Mark, you can address that. Mark Eisner Sure. So yes, you are correct that in both the HER2 and PSMA programs, the basket trial for HER2, PSMA is all metastatic castration-resistant prostate cancer, but they're heavily pre-treated patient population, very heterogeneous in terms of their clinical features and prior treatment history. So that is where we are starting. For the PSMA program, of course, we are interested in getting into earlier lines of treatment. This is something that we will talk more about in the future time, but clearly, that is of interest. In terms of your question about the dAIsY machine learning and how to optimize the TCE platform, I think one of the beautiful parts about this deal, bringing in the Amunix platform and the people with it is that we can apply our antibody discovery platform and our dAIsY AI abilities to optimize the next generation of T-cell engagers. So we are using that to more rapidly identify and optimize the binders for the next generation of T-cell engagers. So I think there's a real synergy there between our peer's antibody discovery and optimization platform that's AI-driven and the T-cell engager platform that we now have in-house. Marianne De Backer Yeah. I would just add that our protein engineering platform is really such that we start with a starting point of a protein. It could be an antibody; it could be a BiTE or single or whatever it might be. And then we deploy basically a population of different models to come up with molecules that have increased characteristics, better potency, increased developability, and so on. And it's a combination of both internal models and external models, so large protein models and a lot of internal data that we have generated over the years that together gives us an output that we can quickly test in biological models and that sort of feeds back into the database. Operator Eric Joseph, JPMorgan. This is Billy on for Eric. Thanks for taking our questions. Quick one on the dosing frequency for the EGFR. You've pushed to go to two, three weeks with the other two. Is this something that you continue with the EGFR? Mika Derynck Yeah. So we are looking at both Q week and Q3 week for both the HER2 and the PSMA program, and we are planning to do the same for the EGFR. We're encouraged that the half-life so far for both of our clinical programs are very encouraging and that for the HER2 program appears to be safe and efficacious at both schedules. Operator Phil Nadeau, TD Cowen. Phil Nadeau Good afternoon. Thanks for taking our questions. Two from us. The most common question we currently get on Vir is about the expectations for a dose response for 5500. I'm sure you get that same question. Can you talk a little bit more about what gives you confidence that higher doses will produce deeper, more durable PSA responses given that there wasn't a clear dose response in the initial data? That's the first question. Second question on the timing of the next updates for 5500 and 5818, we appreciate it's too early to give a specific timing guidance, but could you speak to what you hope to have in the next update in terms of quality and quantity of data? Will you wait for some certain number of patients in the trials or do you want to wait for the Phase 2 dose? Some sense of kind of what you hope to accomplish before giving us the next update would be helpful. Thank you. Marianne De Backer Yeah. Thank you, Phil. I mean we are really trying to, as you mentioned, right, balance communication of data that is really meaningful with the need to draw important conclusions as to our next steps from the data. And as you know, both programs are in dose escalation. We just discussed, we are exploring two different dosing frequency models. We are exploring in combination with pembro. So a lot of data that needs to read out of safety, efficacy, durability and so on. So as that data develops, we will -- as soon as we have really meaningful updates, of course, share that with you all. As it relates to the dose response, yes, we do get that question quite often. So either Mark or Mika, you want to address it. Mark Eisner Yeah. I think what we tried to emphasize in our investor event in last January is that this is very early in the PSMA program in terms of dose escalation. And we believe we've presented compelling early signs of efficacy in terms of PSMA -- I'm sorry, PSA declines and excellent safety with minimal CRS and minimal toxicity. So we have a lot of room to move on the dose. So we've been escalating the dose both in Q week and Q3 weeks, and we are anticipating to see deeper and more sustained efficacy as we escalate the dose in that program. The other thing maybe to mention is that we have now shown good compelling early signs of efficacy and safety of both the HER2 and PSMA program. So we're really validated, we think, the platform and the masked, dual masked nature of the platform and the specificity of our ability to unmask these molecules in the tumor while maintaining a very high safety profile. Maybe just to mention one other thing, which is in that colorectal cancer patient we referred to today and that we presented in our investor event in the HER2 program that when we escalate the dose from 60 micrograms to 600 micrograms per kilo in that patient, we saw a deepening antitumor responses. So that patient is an example of what can happen as we escalate the dose. Now of course, the PSMA program is even earlier, and we're continuing to escalate the dose. But we anticipate with higher doses, we'll see better efficacy with acceptable safety. Operator Alec Stranahan, Bank of America. Alec Stranahan Hey, guys. Thanks for taking our questions. Just two quick ones from us. First on 5525, apologies if this was already asked, but just on the need for steroid prophylaxis, do you think you'd approach this similarly to studies for your other two assets or maybe a different approach just given the breadth of the EGFR expression? And secondly, I appreciate that the additional pre-clinical mask TE targets are undisclosed. But I guess as you're approaching maximizing the value of the PRO-XTEN platform in oncology, is your development process driven more by de-risked targets or areas of high unmet need maybe with a novel target? Thank you. Marianne De Backer Thank you, Alex. Maybe I'll address the second question. So since we announced the data on January 8, there has been quite a bit of outreach as it relates to our platform. And so we have for ourselves defined a set of targets that we would believe would be highly valuable as next programs, but we also are getting educated on what some potential partners might be interested in. So we will certainly share going forward some more insight into how we are thinking about what next pre-clinical programs could be that really take advantage of the PRO-XTEN platform, because we do want to make sure we extract that value out of the platform. And again, with promising data across two clinical programs, we think there's a high belief in the potential there. As it relates to the need for prophylactic corticosteroids, just clarifying that we did not use any in our prior program and for 5525, the same is true. I don't know Mark, Mika, anything to add? Mika Derynck Yeah. So we've built quite a bit of confidence with this platform with the other two drugs, again, not using -- not having to use prophylactic steroids with really minimal CRS and very minimal IL-6 levels. So for the 5525, we are starting that study without any prophylactic steroids. Operator Joseph Stringer, Needham. Joseph Stringer Hi, thanks for taking our questions. Financial one from us. Can you just remind us of the details of the collaboration agreement with Alnylam on the elebsiran component? I believe it's a cost profit share, but just want to make sure of the details on the cost share. I guess my question is around the financial impact of this. Does Alnylam have optionality coming up for that asset? And is that potential decision built into some of your OpEx and cash burn assumptions over the next few years? And then as a follow-up, how does that current collaboration agreement impact your potential partnership negotiations for the HBV program? Thank you. Marianne De Backer Yes. Thank you for that question. So our collaboration agreement with Alnylam stemming from 2017 is a pure financial arrangement. So there's no operational role that Alnylam is playing in the development nor the commercialization. Alnylam does have an option to either step into the program and share 50% of the cost that it relates to the electron component of the regimen and then, of course, also share the commensurate percentage of the profit or opt out and have a typical type of milestone and royalty deal. So that is an option that Alnylam still needs to decide on. The impact from any partnership related to HBV, both are possible. Again, because the nature of the deal with Alnylam is a pure financial one, it doesn't preclude from a large pharma partner to step in and take an operational role on the clinical development and commercialization. Obviously, it would be easier if there was sort of one partner for the program that both are possible. Jason O'Byrne Can I just add, yeah, on this? Further details will be in the 10-K on the Alnylam agreement. And just as you think about our runway, we have sort of assumed the worst case in the shorter term, which is that Alnylam opts out. In the shorter term, if they opt in and do a profit share, that would potentially be upside. Operator Patrick Trucchio, H.C. Wainwright. Patrick Trucchio Thanks. Good afternoon. Just a couple of follow-ups from me on the HDV program. I'm wondering now as more time has passed and you've had more time to kind of digest the data from SOLSTICE if there's been any further learnings that could help inform the ECLIPSE program? And then separately, I was just curious if you could talk more about the relative importance of demonstrating that robust reduction in HB surface antigen in the hepatitis delta setting and how we should think about this reduction for combination treatment relative to the monotherapy antibody, particularly as we think about long-term outcomes in this chronic treatment setting with delta? Mark Eisner Yeah, thanks for the question. So in terms of SOLSTICE, just to recap for everyone, we did see at 24 weeks, 41% of patients reaching complete viral suppression or target not detected at 24 weeks, 64% at 36 weeks, and in the 80% range at 60 weeks in the rollover cohort. So I think we're really seeing unprecedented levels of viral suppression of the delta virus. So we're very excited about that, and we're very keen to move into the ECLIPSE program. Obviously, we've learned a lot about delta, both in terms of the data, but importantly, about the demographics of the disease, where the patients reside. And I think those learnings have really informed how we've approach site selection, investigator selection and things of that nature. So we're not prepared to share more details about that today, but essentially, that's going to help us, I think, really optimize our Phase 3 program. In terms of your question about hepatitis B surface antigen reduction, yes, in the combination of tobevibart and elebsiran, we are seeing a 3-log reduction in hepatitis B surface antigen, which is much, much greater than our monotherapy with the antibody tobevibart, which is a 1-log reduction. We think this is really important because it shows the potency and the depth of antiviral effect of our combination therapy. It shows that we are as hepatitis B surface antigen is critical for a delta or a life cycle of forming a virion that this just really taken together with a very profound viral suppression data that we really think we have a very, very good chance of long-term viral suppression for patients. In terms of long-term outcomes, I can speculate that because we can achieve such deep and durable suppression of delta virus and HBV surface antigen that we hope that will translate into better outcomes for patients, less progression to cirrhosis, less progression to liver cancer and other poor outcomes. Of course, we have to demonstrate that. But the virus does drive those poor outcomes. So we do think that suppressing the virus as well as we can with our combination should lead to better outcomes for patients. So we're very excited about the program, and we're moving with all pace to our Phase 3 initiation. Operator This concludes the Q&A session of the call. Thank you for participating. And I'll turn the call back over to Marianne De Backer. Marianne De Backer Thank you, operator. As we conclude, I'd like to emphasize the significant strides that we have made in 2024 and our exciting path forward. We've successfully transformed Vir Biotechnology into now a dual platform company with promising advancements, as you have heard, in both infectious diseases and in oncology. Our hepatitis delta program, as Mark just mentioned, is poised to enter Phase 3 trials, while our innovative T-cell engager platform has shown those really encouraging early results across multiple solid tumor types. Our strong financial position with a runway extending into mid-2027 also provides us with the resources to advance our key programs through critical value and inflection points. So we remain committed to our mission of harnessing the power of the immune system to transform patients' lives, and we are more confident than ever in our ability to deliver on this promise. Thank you, all, for your continued support and for joining us today. We look forward to updating you on our progress in the coming months. Operator, you may end the call. Operator Ladies and gentlemen, that concludes today's call. Thank you all for joining, and you may now disconnect. View Comments
ALNY SNY SNYNF | finance.yahoo | about 14 days ago | Neutral

Alnylam Highlights Significant Pipeline Progress and Platform Innovation at R&D Day– Showcases multiple potentially transformative near- and mid-stage therapies in ATTR amyloidosis, Cardiovascular Disease, and Neuroscience, each representing a blockbuster opportunity – – Announces TRITON Phase 3 program for next-generation TTR silencer nucresiran in ATTR-CM and hATTR-PN, targetin...
– Showcases multiple potentially transformative near- and mid-stage therapies in ATTR amyloidosis, Cardiovascular Disease, and Neuroscience, each representing a blockbuster opportunity – – Announces TRITON Phase 3 program for next-generation TTR silencer nucresiran in ATTR-CM and hATTR-PN, targeting durable franchise leadership – – Provides details about Phase 3 cardiovascular outcomes trial for zilebesiran, poised to transform the treatment of hypertension in patients with high CV risk – – Highlights new clinical programs, including for Huntington’s disease, bleeding disorders, and type 2 diabetes – – Shares platform advances, including potential best-in-class delivery solutions for adipose, muscle, heart, and kidney, and for crossing the blood-brain barrier, as well as manufacturing innovations to improve efficiency – – Company will webcast its R&D Day event today at 9:00 a.m. E.T – CAMBRIDGE, Mass., February 25, 2025--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, is hosting an R&D Day today in New York City and will also webcast the event. The Company plans to showcase its R&D progress and platform innovation, including updates on multiple near- and mid-stage potentially transformative therapies that represent blockbuster opportunities as its pipeline rapidly expands across multiple therapeutic areas. "Alnylam is driving the field of RNAi therapeutics into the future, with a sustainable innovation engine that continues to generate transformative medicines while simultaneously expanding what’s possible for RNAi with platform advances," said Pushkal Garg, M.D., Chief Medical Officer of Alnylam. "As we advance our flagship TTR franchise, we are excited to share Phase 3 development plans for our next-generation TTR silencer, nucresiran, which has best-in-class potential. We are also providing updates on multiple potential blockbuster opportunities in cardiovascular disease and neuroscience, areas where we believe our investigational RNAi therapeutics may transform the treatment of devastating conditions that claim millions of lives each year. In addition, we are on track to meet our ambitious pipeline and platform expansion goals as we seek to address additional diseases, to deliver RNAi therapeutics to all major tissue types by 2030, and to realize the full potential of our pioneering technology." Nucresiran and Vutrisiran Advancements Demonstrate Durable Leadership in TTR Alnylam scientists will provide an update on the TRITON Phase 3 program for its next-generation transthyretin (TTR) silencer, nucresiran, which has the potential for greater than 95% knockdown with twice-annual dosing. TRITON-PN will be conducted in patients with hATTR amyloidosis with polyneuropathy, with a goal of bringing nucresiran to the market as rapidly as possible. TRITON-CM will be an event-driven cardiovascular outcomes trial in patients with ATTR amyloidosis with cardiomyopathy that, if successful, is anticipated to lead to regulatory approval in approximately 2030. TRITON-CM will enroll approximately 1,200 patients with wild-type TTR or any TTR variant and confirmed cardiomyopathy, including patients on background stabilizer therapy. The primary endpoint will be a composite of all-cause mortality and cardiovascular events. Story Continues Alnylam scientists will also share new data from the landmark HELIOS-B study of vutrisiran in ATTR amyloidosis with cardiomyopathy. In prespecified analyses with near complete data through month 42, vutrisiran reduced all-cause mortality, as compared to placebo, by 36% in the overall population and by 39% in the monotherapy population, further supporting the primary analysis presented last year at the European Society of Cardiology and published in The New England Journal of Medicine. Vutrisiran is currently under review for the treatment of ATTR amyloidosis with cardiomyopathy by the U.S. Food and Drug Administration, with a Prescription Drug User Fee Act (PDUFA) target action date of March 23, 2025. Studies Position Zilebesiran to Transform the Treatment of Hypertension Alnylam scientists will share key design elements of a pivotal Phase 3 trial of zilebesiran, set to begin later this year, to explore the impact of continuous control of blood pressure on cardiovascular outcomes. The Phase 3 trial will be a global, event-driven trial that will enroll up to 11,000 patients in more than 30 countries. Participants must be on at least two background antihypertensive agents, have uncontrolled hypertension, and have established cardiovascular disease or be at risk of developing cardiovascular disease. The primary endpoint will be 4-point MACE, a composite of non-fatal myocardial infarctions, non-fatal strokes, cardiovascular deaths, and hospitalizations for heart failure or urgent heart failure visits. Enrollment is now complete for the KARDIA-3 Phase 2 trial evaluating zilebesiran in combination with at least two antihypertensives in high cardiovascular risk patients with uncontrolled hypertension. This patient population in KARDIA-3 is similar to the one currently planned for the Phase 3 cardiovascular outcomes trial. The results of KARDIA-3 – expected in the second half of 2025 – will further inform the design of the Phase 3 trial. Zilebesiran is being co-developed and co-commercialized by Alnylam and Roche. Neuroscience Franchise Expands as Encouraging Clinical Data Continue to Emerge Alnylam scientists will share additional data from both the single-ascending dose and multiple dose parts of its Phase 1 study of mivelsiran in early-onset Alzheimer’s disease, which further demonstrate potent and durable reduction of soluble APPβ – a key marker of target engagement – in the cerebrospinal fluid as well as an encouraging safety profile. Alnylam is also evaluating mivelsiran as a potential treatment for cerebral amyloid angiopathy, a major cause of hemorrhagic stroke, which is the most severe form of stroke. Alnylam scientists will also present an update on the new ALN-HTT02 program, which has a highly differentiated exon-1-targeting approach to lower huntingtin (HTT) for Huntington’s disease, a progressive, fatal disorder. The Phase 1b single-ascending-dose study in adult patients with Huntington’s disease continues to progress. Alnylam expects to share substantial progress from the study at a medical congress in 2026. ALN-HTT02 is being developed in partnership with Regeneron. Emerging Clinical Programs Position Alnylam for Sustained Growth Alnylam scientists will share updates on several other programs that recently entered the clinic. Alnylam is on track to meet its ambitious "2-2-5" pipeline and platform expansion goal announced at R&D Day in 2023. This includes filing Investigational New Drug (IND) applications for nine new Alnylam-led programs by the end of 2025, including two in new tissues, two in the central nervous system (CNS), and five in the liver. Metabolic Disorders Alnylam scientists will share data on ALN-4324, which targets GRB14 for the treatment of type 2 diabetes and has the potential to be the first insulin sensitizer approved in more than 30 years. At R&D Day, Alnylam will present preclinical data that demonstrate the potential for a highly desirable product profile, including approximately 90% knockdown of the target 22 days after a low-dose, subcutaneous injection, and improved insulin sensitivity without weight gain. Alnylam will also present updates on several obesity programs: INHBE in the liver, and its first adipose-directed target, ACVR1C, as well as combinations of targets. These programs have the potential to improve on the tolerability and quality of weight loss achieved by currently available therapies. ALN-6400 and Bleeding Disorders Alnylam scientists will present an update on ALN-6400, which targets liver-derived plasminogen and could represent a potential universal hemostatic agent for the treatment of bleeding disorders without the risk of thrombosis. More than 3 million people in the U.S. are affected by bleeding disorders, and treatment options are limited. Data will be shared from the first cohort of participants in the Phase 1 study, demonstrating favorable impact on an ex-vivo hemostasis assay. Alnylam Platform Innovation Will Drive the RNAi Revolution into the Future Alnylam will strive to continue to provide best-in-class delivery solutions as it extends the applications for RNAi therapeutics. The Company’s vision is to unlock every major tissue for RNAi therapeutics by 2030. Alnylam scientists will present new preclinical data on delivery solutions with best-in-class potential for adipose, muscle, heart, and kidney tissue. The Company will also share an update on its approach to crossing the blood-brain barrier, as well as emerging technology to enable combination therapy and innovation in manufacturing with enzymatic ligation. Enzymatic ligation has the potential to revolutionize the manufacturing of RNAi therapeutics to meet growing demand and improve efficiency. R&D Day Webcast Information The Company’s R&D Day event will be held today, Tuesday, February 25, from 9:00 a.m. to 1:00 p.m. ET and will include a live video stream on the Investors section of the Company’s website, investors.alnylam.com/events. A replay will be available on the Alnylam website within 48 hours after the event. Presentations showcased during the event will be featured on the Capella section of Alnylam’s website. About RNAi Therapeutics RNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today. Its discovery has been heralded as "a major scientific breakthrough that happens once every decade or so," and was recognized with the award of the 2006 Nobel Prize for Physiology or Medicine. By harnessing the natural biological process of RNAi occurring in our cells, a new class of medicines known as RNAi therapeutics is now a reality. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam’s RNAi therapeutic platform, function upstream of today’s medicines by potently silencing messenger RNA (mRNA) – the genetic precursors – that encode for disease-causing or disease pathway proteins, thus preventing them from being made. This is a revolutionary approach with the potential to transform the care of patients with genetic and other diseases. About Alnylam Pharmaceuticals Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and prevalent diseases with unmet need. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach yielding transformative medicines. Since its founding in 2002, Alnylam has led the RNAi Revolution and continues to deliver on a bold vision to turn scientific possibility into reality. Alnylam’s commercial RNAi therapeutic products are ONPATTRO® (patisiran), AMVUTTRA® (vutrisiran), GIVLAARI® (givosiran), OXLUMO® (lumasiran), and Leqvio® (inclisiran), which is being developed and commercialized by Alnylam’s partner, Novartis. Alnylam has a deep pipeline of investigational medicines, including multiple product candidates that are in late-stage development. Alnylam is executing on its "Alnylam P5x25" strategy to deliver transformative medicines in both rare and common diseases benefiting patients around the world through sustainable innovation and exceptional financial performance, resulting in a leading biotech profile. Alnylam is headquartered in Cambridge, MA. For more information about our people, science and pipeline, please visit www.alnylam.com and engage with us on X (formerly Twitter) at @Alnylam, or on LinkedIn, Facebook, or Instagram. Alnylam Forward Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements other than historical statements of fact regarding Alnylam’s expectations, beliefs, goals, plans or prospects, including, without limitation, statements regarding the potential for Alnylam to identify new potential drug development candidates and to advance its research and development programs, including statements regarding the number of INDs that Alnylam intends to file, the timing of initiation of any of Alnylam’s clinical trials, and the achievement of pipeline milestones and data, including relating to ongoing or planned clinical trials of nucresiran, zilebesiran, mivelsrian, ALN-HTT02, ALN-6400 and other product candidates; Alnylam’s planned achievement of its "Alnylam P5x25" strategy; Alnylam’s ability to obtain approval for new commercial products or additional indications for its existing products, including AMVUTTRA in ATTR-CM; Alnylam’s expectations regarding the safety and efficacy of AMVUTTRA for the treatment of ATTR-CM and the potential for TTR silencers to become a standard of care treatment for ATTR-CM; the potential for additional classes of therapeutics to complement silencer treatment for ATTR amyloidosis; the size of the commercial opportunities for Alnylam’s current and any future products, and the addressable markets for such products; the potential attributes and product profiles of any of Alnylam’s product candidates, including statements regarding the potential efficacy and safety of any of Alnylam’s product candidates, the potential for any of Alnylam’s product candidates to be a transformative therapy and to represent a potential blockbuster opportunity, the potential for zilebesiran to continuously control blood pressure and to transform the treatment of hypertension in patients with high CV risk, the potential of nucresiran to be a best-in-class therapeutic, the potential of ALN-4324 to be the first insulin sensitizer approved in more than 30 years, the potential for any of Alnylam’s obesity programs to improve on the tolerability and quality of weight loss achieved by currently available therapies, and the potential for ALN-6400 to represent a universal hemostatic agent for the treatment of bleeding disorders without the risk of thrombosis; Alnylam’s ability to address additional diseases and to deliver RNAi therapeutics to all major tissue types by 2030 and to realize the full potential of its pioneering technology; Alnylam’s ability to develop best-in-class delivery solutions for adipose, muscle, heart, and kidney, and for crossing the blood-brain barrier; Alnylam’s ability to further innovation and improve efficiency in manufacturing with enzymatic ligation; and the potential of enzymatic ligation to revolutionize the manufacturing of RNAi therapeutics to meet growing demand and improve efficiency, should be considered forward-looking statements. Actual results and future plans may differ materially from those indicated by these forward-looking statements as a result of various important risks, uncertainties and other factors, including, without limitation, risks and uncertainties relating to Alnylam’s ability to successfully execute on its "Alnylam P5x25" goals; Alnylam’s ability to discover and develop novel drug candidates and delivery approaches and successfully demonstrate the efficacy and safety of its product candidates; the pre-clinical and clinical results for Alnylam’s product candidates; actions or advice of regulatory agencies and Alnylam’s ability to obtain and maintain regulatory approval for its product candidates, as well as favorable pricing and reimbursement; successfully launching, marketing and selling Alnylam’s approved products globally and successfully competing against companies commercializing products competitive with our approved products; delays, interruptions or failures in the manufacture and supply of Alnylam’s product candidates or its marketed products; obtaining, maintaining and protecting intellectual property; Alnylam’s ability to successfully expand the approved indications for AMVUTTRA; Alnylam’s ability to manage its growth and operating expenses through disciplined investment in operations and its ability to achieve a self-sustainable financial profile in the future; Alnylam’s ability to maintain strategic business collaborations; Alnylam’s dependence on third parties for the development and commercialization of certain products, including Roche, Novartis, Sanofi, Regeneron and Vir; the outcome of litigation; the potential risk of future government investigations; the potential risk of delays with research collaborators and government agencies that Alnylam depends on arising from decisions by the U.S federal government to decrease financial support and staffing; as well as those risks more fully discussed in the "Risk Factors" filed with Alnylam’s most recent Annual Report on Form 10-K filed with the SEC and in its other SEC filings. In addition, any forward-looking statements represent Alnylam’s views only as of the date of this presentation and should not be relied upon as representing Alnylam’s views as of any subsequent date. Alnylam explicitly disclaims any obligation, except to the extent required by law, to update any forward-looking statements. View source version on businesswire.com: https://www.businesswire.com/news/home/20250225255910/en/ Contacts Alnylam Pharmaceuticals, Inc. Christine Regan Lindenboom (Investors and Media) 617-682-4340 Josh Brodsky (Investors) 617-551-8276 View Comments
ALNY | finance.yahoo | about 17 days ago | Neutral

Alnylam Pharmaceuticals (ALNY): Among the Oversold Biotech Stocks to Buy NowWe recently published a list of 10 Oversold Biotech Stocks to Buy Now. In this article, we are going to take a look at where Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) stands against other oversold biotech stocks to buy now. Biotech Sector Performance and Challenges in 2024: Biotechnology stocks ...
We recently published a list of 10 Oversold Biotech Stocks to Buy Now. In this article, we are going to take a look at where Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) stands against other oversold biotech stocks to buy now. Biotech Sector Performance and Challenges in 2024: Biotechnology stocks are among the most volatile in the market, primarily due to the high risks associated with their performance. The success or failure of FDA clinical trials and the real-world effectiveness of therapies often lead to significant price fluctuations. The biotech sector gained widespread attention in 2020, with the rapid development of COVID-19 vaccinations catapulting the industry into the spotlight. As major pharmaceutical companies began pursuing acquisitions, investor interest surged in late 2023 and early 2024. However, the momentum soon faded, leading to a stagnation in biotech stocks. For months, the market saw little movement, with few mergers and acquisitions (M&A) or initial public offerings (IPOs) breaking the silence. The second quarter of 2024 experienced a sharp decline in biopharma deal activity, following a robust first quarter where pharmaceutical giants utilized their large cash reserves for acquisitions. Despite the challenges biotech companies faced in 2024, JPMorgan maintains an optimistic outlook, forecasting significant growth for some firms in the coming months. Johan Hueffer, senior partner and principal of investments at Novo Holdings, addressed this shift on CNBC on November 28. While acknowledging the difficulties biotechs have had in raising funds over the past few years, Hueffer noted that recent quarters have seen a positive change, with investment conditions improving. The impact of these fluctuations has also extended to companies that support the pharmaceutical industry, including contract research organizations (CROs), contract manufacturing organizations (CMOs), and providers of tools for research and development. Similarly, firms that manufacture production tools for the pharmaceutical and biotech sectors have faced similar challenges. Although these industries have experienced their share of ups and downs over the past two years, trends are beginning to stabilize. Hueffer believes that the sector is now on the verge of considerable opportunity, with conditions starting to normalize and potential for growth emerging once again. Growth Potential and Investment Opportunities: Goldman Sachs clarified biotech as a frequently disregarded area of the investment world. John Flood, Head of Americas Equities Sales Trading at Goldman, wrote in a letter to clients that biotech equities offered an unnoticed opportunity for investors hoping to profit from the Fed’s recent rate decreases. Because biotech equities are sensitive to interest rate changes and frequently depend on anticipated future revenues, they are particularly impacted. The cost of capital has a significant effect on these equities as well. These equities have substantial upside potential and, should clinical studies be successful, offer an “option-like structure,” even though they are now quite unprofitable. Because of this, they are particularly sensitive to shifts in interest rates. Story Continues The Fed has lowered the funds rate by one full point since September. The present market pricing indicates that there will only be one or two additional declines in 2025, according to CNBC. The Federal Open Market Committee (FOMC) members voted to lower the central bank’s benchmark borrowing rate to the 4.25%–4.5% target range, according to a January 8 CNBC report. But they also trimmed their projections for anticipated rate cuts in 2025, assuming quarter-point increases, from four to two. Biotech stocks are anticipated to be impacted by these changes. Precedence Research projects that the worldwide biotech market will reach a valuation of $4.61 trillion by 2034, growing at a compound annual growth rate of 11.5%. This growth is expected to be fueled by favorable government laws, more investment, the need for synthetic biology, and an increase in chronic diseases such as high blood pressure, heart disease, and cancer. Government initiatives to modernize laws and enhance reimbursement practices are driving market growth. IQVIA projects that global pharma spending will reach $2.30 trillion by 2028, growing at a compound annual growth rate (CAGR) of 5% to 8%. While immunology spending may decrease as biosimilars become accessible, obesity and cancer treatments are expected to be the primary drivers of this expansion. It is anticipated that biotech will reach $892 billion by 2028, or 39% of total spending, with the highest growth occurring in cell and gene therapies. The biotechnology sector in the United States, in particular, was estimated to be worth $246.18 billion in 2023 and is projected to rise at a compound annual growth rate (CAGR) of 11.6% between 2024 and 2034, reaching over $830.31 billion. Asia Pacific had a revenue proportion of 23.99%, whereas North America had a revenue share of 37.79%. While the bioindustry application category generated 24.33% of total revenue in 2023, the biopharmacy segment held a 41.73% revenue share by application. Our Methodology For our methodology, we selected stocks with a market cap over 2 billion and Relative Strength Index (RSI) of 40, and strong hedge fund sentiment and then ranked these stocks based on their RSI values. At Insider Monkey we are obsessed with the stocks that hedge funds pile into. The reason is simple: our research has shown that we can outperform the market by imitating the top stock picks of the best hedge funds. Our quarterly newsletter’s strategy selects 14 small-cap and large-cap stocks every quarter and has returned 373.4% since May 2014, beating its benchmark by 218 percentage points (see more details here).Is Alnylam Pharmaceuticals, Inc. (ALNY) The Oversold Biotech Stock to Buy Now? A researcher studying genetic medicines under a microscope in a biopharmaceutical laboratory. Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) Relative Strength Index (RSI): 38.51 Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) is a biopharmaceutical company that develops RNA interference (RNAi) therapies to treat rare genetic diseases. Its medicines, including ONPATTRO, GIVLAARI, OXLUMO, and AMVUTTRA, target and silence specific genes that cause conditions like hereditary ATTR amyloidosis and acute hepatic porphyria. Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) reported strong financial growth in its Q4 2024 results. The company’s total net product revenue for 2024 reached $1.646 billion, a 33% increase from 2023. Its TTR franchise generated $343 million in Q4, reflecting 35% year-over-year growth, while full-year TTR revenue in the U.S. rose to $705 million, a 39% increase. Notably, the company achieved a non-GAAP operating income of $95 million, marking its first profitable year. The company’s success highlights its ability to commercialize RNAi therapeutics effectively. The recent positive results from the HELIOS-B Phase III study for vutrisiran in ATTR cardiomyopathy have led to global regulatory filings, potentially expanding its market. This could significantly grow Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY)’s presence in the ATTR amyloidosis space. Looking ahead, Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) expects 2025 product sales between $2.05 billion and $2.25 billion, with TTR revenue projected at $1.6 billion to $1.725 billion, assuming AMVUTTRA is approved for ATTR cardiomyopathy. The company also anticipates growth in its rare disease franchise. Overall, ALNY ranks 5th on our list of oversold biotech stocks to buy now. While we acknowledge the potential of biotech companies, our conviction lies in the belief that AI stocks hold greater promise for delivering higher returns, and doing so within a shorter time frame. If you are looking for an AI stock that is more promising than ALNY but that trades at less than 5 times its earnings, check out our report about the cheapest AI stock. READ NEXT: 20 Best AI Stocks To Buy Now and Complete List of 59 AI Companies Under $2 Billion in Market Cap Disclosure: None. This article is originally published at Insider Monkey. View Comments
ALNY | finance.yahoo | about 17 days ago | Neutral

SNY and REGN's Dupixent sBLA for Skin Disease Gets FDA's Priority TagSanofi SNY and partner Regeneron REGN announced that the FDA has accepted their supplemental biologics license application (sBLA) seeking approval for Dupixent for treating bullous pemphigoid (BP), a chronic, debilitating and relapsing skin disease. With the FDA granting a priority review status to...
Sanofi SNY and partner Regeneron REGN announced that the FDA has accepted their supplemental biologics license application (sBLA) seeking approval for Dupixent for treating bullous pemphigoid (BP), a chronic, debilitating and relapsing skin disease. With the FDA granting a priority review status to the sBLA, a decision is expected by June 20, 2025. The sBLA is based on data from a pivotal study that demonstrated that Dupixent led to significant improvements in sustained disease remission compared to placebo in adult patients with moderate-to-severe BP. Sanofi’s stock has risen 18% in the past year against a decrease of 7.9% for the industry.Zacks Investment Research Image Source: Zacks Investment Research BP is an inflammatory skin condition primarily occurring due to type 2 inflammation. The disease, which mostly occurs in older adults, is characterized by large fluid-filled blisters on the skin which can be itchy and painful, reddening of the skin and painful lesions. If approved for BP, Dupixent will become the first medicine approved as a targeted treatment for BP in the United States. At present, there is no targeted cure for BP and corticosteroids, immunosuppressants and antibiotics are prescribed to relieve symptoms and prevent new blisters from forming. Dupixent – Key Top-Line Driver for SNY & REGN Dupixent is now approved in several countries, including the United States and EU, for six type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis, prurigo nodularis and chronic obstructive pulmonary disease. It is being jointly marketed by Regeneron and Sanofi under a global collaboration agreement. Sanofi records global net product sales of Dupixent, while Regeneron records its share of profits/losses in connection with the global sales of the drug. The drug is a key top-line driver for both Sanofi and Regeneron on strong demand trends. Dupixent’s strong sales growth is being driven by demand across all geographies, newly approved indications and demographics. New uses, increased penetration in approved indications and further geographic expansion are expected to drive Dupixent’s sales in future quarters. An sBLA seeking approval of Dupixent for chronic spontaneous urticaria is also under review in the United States and EU. A decision in the United States on this sBLA is expected on April 18. Phase III studies are ongoing on Dupixent for chronic pruritus of unknown origin and lichen simplex chronicus. In 2024, Dupixent generated global product sales of $€13.07 billion ($14.15 billion), which were recorded by Sanofi, representing growth of 23.1% at a constant exchange rate. Sanofi expects Dupixent to achieve around €22 billion in sales in 2030. Story Continues For Regeneron, Dupixent generated collaboration revenues of $4.53 billion in 2024, up 19% year over year. SNY’s Zacks Rank and Stocks to Consider Sanofi currently has a Zacks Rank #3 (Hold). Sanofi Price and ConsensusSanofi Price and Consensus Sanofi price-consensus-chart | Sanofi Quote Some top-ranked drug/biotech companies are Gilead GILD and Alnylam Pharmaceuticals ALNY, both with a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Estimates for Gilead’s 2025 earnings have risen from $7.55 to $7.80 per share over the past 30 days. For 2026, earnings estimates have risen from $7.76 to $8.12 per share over the same timeframe.In the past year, Gilead’s stock has risen 45.4%. Gilead beat estimates in each of the last four reported quarters, delivering an average earnings surprise of 19.47%. Estimates for Alnylam’s 2025 earnings have improved from a loss of 12 cents to earnings of 41 cents per share over the past 30 days. For 2026, earnings estimates have risen from $5.04 to $5.06 per share over the same timeframe. In the past year, Alnylam’s stock has risen 74.4%. Alnylam beat estimates in three of the last four quarters while matching the same once, delivering a four-quarter average earnings surprise of 95.73%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report Sanofi (SNY) : Free Stock Analysis Report Alnylam Pharmaceuticals, Inc. (ALNY) : Free Stock Analysis Report Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research View Comments
ALNY REGN SNY SNYNF | finance.yahoo | about 24 days ago | Neutral

Alnylam Q4 Earnings Beat Estimates, Product Revenues Rise Y/YAlnylam Pharmaceuticals ALNY reported fourth-quarter 2024 adjusted earnings of 6 cents per share, in contrast with the Zacks Consensus Estimate of a loss of 21 cents. The company had incurred a loss of 77 cents per share in the year-ago quarter. The adjusted figure excluded items like stock-based co...
Alnylam Pharmaceuticals ALNY reported fourth-quarter 2024 adjusted earnings of 6 cents per share, in contrast with the Zacks Consensus Estimate of a loss of 21 cents. The company had incurred a loss of 77 cents per share in the year-ago quarter. The adjusted figure excluded items like stock-based compensation expenses and realized and unrealized loss on marketable equity securities. See the Zacks Earnings Calendar to stay ahead of market-making news. Alnylam recorded total revenues of $593.2 million in the quarter, which surpassed the Zacks Consensus Estimate of $570 million. In the year-ago quarter, total revenues were $439.7 million. The top line rose 35% year over year, mainly driven by increased product sales. Net product revenues were $450.8 million, up 30% year over year on a reported basis and 29% at a constant exchange rate, driven by strong growth in patient demand for the newly approved drug, Amvuttra (vutrisiran), as well as for Givlaari (givosiran) and Oxlumo (lumasiran). Net revenues from collaborators were $106.9 million, up 40% from the year-ago quarter, primarily driven by revenues recognized under Alnylam’s ongoing collaborations with Regeneron REGN and Novartis NVS. The company also recognizes collaboration revenues from Roche RHHBY. In the past three months, shares of Alnylam have gained 12.5% compared with the industry’s growth of 7.7%.Zacks Investment Research Image Source: Zacks Investment Research Alnylam, in collaboration with REGN, is advancing cemdisiran, an investigational RNAi therapeutic for the treatment of complement-mediated diseases. The agreement regarding cemdisiran underwent a modification. Per the modified agreement, Alnylam granted exclusive rights to Regeneron to develop cemdisiran as monotherapy and in combination with anti-C5 antibodies for complement-mediated indications. Alnylam regained full global development and commercialization rights to mivelsiran in all indications in 2024, after Regeneron opted out of further co-development and co-commercialization of mivelsiran, in development for cerebral amyloid angiopathy and Alzheimer's disease. However, Regeneron will be eligible to receive low double-digit royalties on sales of mivelsiran, if approved. Alnylam has granted Novartis exclusive global rights to manufacture and commercialize RNAi therapeutics targeting PCSK9, including Leqvio (inclisiran), for hypercholesterolemia and other diseases. The FDA has approved Leqvio for earlier use in high-risk patients alongside diet and statins. As of January 2025, Leqvio is approved in over 100 countries, with ongoing late-stage studies for further label expansion. Story Continues Alnylam, in collaboration with Roche, is developing zilebesiran in a mid-stage study to treat hypertension. ALNY’s Q4 Results in Detail Onpattro (patisiran) is approved for the treatment of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. The injection recorded sales of $56.1 million in the reported quarter, down 29% on a reported basis. Onpattro sales beat the Zacks Consensus Estimate of $47.7 million as well as our model estimate of $55.5 million. In 2022, the FDA approved Alnylam’s RNAi therapeutic, Amvuttra, for the treatment of adult patients with polyneuropathy of hATTR amyloidosis. The European Commission also approved Amvuttra for treating hATTR amyloidosis in adult patients with stage 1 or 2 polyneuropathy. Amvuttra generated sales worth $286.5 million in the fourth quarter, up 63% on a reported basis. The uptake for the product has been encouraging, with new patients starting treatment as well as several patients switching from Onpattro. Amvuttra sales beat the Zacks Consensus Estimate of $280 million and matched our model estimate. Givlaari, approved for the treatment of acute hepatic porphyria, recorded sales of $64.6 million, reflecting a year-over-year increase of 9% on a reported basis. Givlaari sales missed the Zacks Consensus Estimate of $69 million but matched our model estimate. Oxlumo recorded global net product revenues of $43.6 million in the reported quarter, reflecting a year-over-year increase of 33% on a reported basis. However, Oxlumo sales missed the Zacks Consensus Estimate of $44.8 million as well as our estimate of $44 million. Adjusted research and development (R&D) expenses increased 3% year over year to $259.5 million, primarily driven by a rise in expenses associated with the KARDIA-3 clinical study evaluating zilebesiran to treat patients with hypertension at high cardiovascular risk, in partnership with Roche. Increased pre-clinical activities and expenses associated with mivelsiran cAPPRicorn-1 clinical studies also hiked R&D costs. Adjusted selling, general and administrative (SG&A) expenses increased 39% year over year to $244.3 million, mainly due to ramped-up marketing activities for the promotion of Onpattro and Amvuttra globally, along with preparations for the potential launch of Amvuttra for ATTR amyloidosis with cardiomyopathy, subject to successful label expansion. Cash, cash equivalents and marketable securities as of Dec. 31, 2024, amounted to $$2.69 billion compared with $2.78 billion recorded as of Sept. 30, 2024. ALNY’s Full-Year 2024 Results For 2024, Alnylam generated total revenues of $2.25 billion compared with $1.83 billion recorded in 2023. The figure beat the Zacks Consensus Estimate of $2.23 billion. For the full-year 2024, the company reported a loss of 2 cents per share, narrower than a loss of $1.61 reported in 2023 due to higher revenues. The reported figure was also narrower than the Zacks Consensus Estimate of a loss of 39 cents per share. ALNY’s 2025 Financial Guidance Alnylam expects net product revenues for Onpattro, Amvuttra, Givlaari and Oxlumo in the range of $2.05-$2.25 billion for 2025. Net revenues from collaborations and royalties are expected in the range of $650-$750 million. Adjusted R&D and SG&A expenses are anticipated in the band of $2.1-$2.2 billion. Alnylam Pharmaceuticals, Inc. Price, Consensus and EPS SurpriseAlnylam Pharmaceuticals, Inc. Price, Consensus and EPS Surprise Alnylam Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Alnylam Pharmaceuticals, Inc. Quote ALNY’s Key Pipeline Updates Alnylam has submitted regulatory applications in both the United States (using a Priority Review Voucher) and EU, seeking the label expansion of Amvuttra to treat ATTR amyloidosis with cardiomyopathy. Additional filings in other major geographies across the globe have also been completed. A final decision from the FDA is expected on March 23, 2025. ALNY’s Zacks Rank Alnylam currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report Alnylam Pharmaceuticals, Inc. (ALNY) : Free Stock Analysis Report Novartis AG (NVS) : Free Stock Analysis Report Roche Holding AG (RHHBY) : Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research View Comments
ALNY REGN | finance.yahoo | about 28 days ago | Neutral

Alnylam Pharmaceuticals Full Year 2024 Earnings: EPS Misses ExpectationsAlnylam Pharmaceuticals (NASDAQ:ALNY) Full Year 2024 Results Key Financial Results Revenue: US$2.25b (up 23% from FY 2023). Net loss: US$278.2m (loss narrowed by 37% from FY 2023). US$2.18 loss per share (improved from US$3.53 loss in FY 2023).NasdaqGS:ALNY Earnings and Revenue Growth February 14t...

ALNY | finance.yahoo | about 28 days ago | Neutral

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Alnylam Pharmaceuticals Inc (ALNY)

Alnylam Pharmaceuticals, Inc. discovers, develops, and commercializes therapeutics based on ribonucleic acid interference. It offers ONPATTRO and AMVUTTRA for hereditary transthyretin-mediated amyloidosis; GIVLAARI for acute hepatic porphyria; OXLUMO for primary hyperoxaluria type 1; and Leqvio for hypercholesterolemia. It also develops vutrisiran, which is in phase III clinical trial for transthyretin amyloidosis (ATTR) with cardiomyopathy; Nucresiran that is in phase I clinical trial for ATTR amyloidosis; Fitusiran, which is in phase III clinical trial for hemophilia; cemdisiran that is in phase III clinical trial for Myasthenia Gravis and paroxysmal nocturnal hemoglobinuria, and geographic atrophy; and ALN-6400, which is in phase I clinical trial for bleeding disorders. In addition, the company is also developing Zilebesiran, which is in phase II clinical trial for hypertension; Rapirosiran that is in phase II clinical trial for Metabolic dysfunction-associated steatohepatitis; ALN-4324, which is in phase I clinical trial for type 2 diabetes mellitus; ALN-PNP that is in phase I clinical trial for non-alcoholic fatty liver disease; ALN-APOC3, which is in phase I clinical trial for dyslipidemia; Mivelsiran that is in phase II clinical trial for cerebral amyloid angiopathy, and phase I clinical trial for Alzheimer's disease; and ALN-HTT02 that is in phase I clinical trial for Huntington's disease. Further, it develops ALN-SOD, which is in phase II clinical trial for SOD1 Amyotrophic lateral sclerosis; Elebsiran that is in phase II clinical trial for Hepatitis B and D virus infections; ALN-BCAT that is in phase I clinical trial for hepatocellular carcinoma; and ALN-ANG3. It has collaborations with Regeneron Pharmaceuticals, Inc.; Roche Holding AG; Regeneron Pharmaceuticals, Inc.; Sanofi S.A.; Novartis AG; PeptiDream, Inc; Dicerna Pharmaceuticals, Inc.; and Ionis Pharmaceuticals, Inc. The company was founded in 2002 and is headquartered in Cambridge, Massachusetts.

Exchange: NASDAQ

IPO Date: 5/28/2004

Sector: Healthcare

Industry: Biotechnology

Employees: 2230

Address: 675 West Kendall Street, Cambridge, MA, United States, 02142

https://www.alnylam.com

Quarterly Yearly

&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;	12/31/2024	09/30/2024	06/30/2024	03/31/2024	12/31/2023	09/30/2023	06/30/2023	03/31/2023	12/31/2022	09/30/2022	Totals
	12/31/2024	09/30/2024	06/30/2024	03/31/2024	12/31/2023	09/30/2023	06/30/2023	03/31/2023	12/31/2022	09/30/2022	Totals
Assets	4.24M	4.21M	4.01M	3.82M	3.83M	3.84M	3.40M	3.39M	3.55M	3.54M	108.82M
Current Assets	3.30M	3.36M	3.17M	2.99M	2.98M	2.99M	2.52M	2.54M	2.69M	2.69M	79.85M
Cash And Short Term Investments	2.69M	2.77M	2.62M	2.37M	2.44M	2.41M	2.06M	2.07M	2.19M	2.27M	69.34M
Net Receivables	405.31K	353.85K	309.48K	321.38K	327.79K	325.44K	220.63K	219.43K	237.96K	184.51K	5.08M
Inventory	78.51K	75.99K	83.98K	93.99K	89.15K	95.77K	100.45K	131.88K	128.96K	115.49K	2.01M
Other Current Assets	116.96K	153.67K	154.75K	201.96K	126.38K	157.96K	145.45K	119.03K	132.92K	125.52K	3.42M
Non Current Assets	944.70K	849.62K	836.78K	835.78K	847.18K	853.62K	878.35K	850.92K	854.11K	844.41K	28.97M
Property Plant Equipment	-	-	-	-	-	729.08K	527.47K	523.03K	523.49K	514.82K	12.10M
Long Term Investments	-	-	-	-	-	-	-	-	-	-	4.69M
Non Currrent Assets Other	133.90K	146.21K	69.22K	64.62K	-3.53M	134.96K	169.33K	138.70K	115.48K	110.78K	3.12M
Liabilities	4.17M	4.17M	4.01M	4.04M	4.05M	4.00M	3.81M	3.65M	3.70M	3.60M	70.81M
Current Liabilities	1.19M	1.22M	1.06M	941.71K	967.79K	949.78K	769.38K	673.39K	767.91K	772.79K	17.78M
Accounts Payable	88.42K	70.81K	73.98K	78.15K	55.52K	73.84K	59.75K	62.24K	98.09K	40.57K	4.05M
Short Long Term Debt	-	-	-	-	-	-	-	-	-	-	706.98K
Other Current Liabilities	1.00M	1.04M	808.64K	698.87K	713.01K	757.29K	632.18K	532.30K	585.75K	546.43K	11.46M
Non Current Liabilities	2.99M	2.95M	2.96M	3.10M	3.08M	3.06M	3.04M	2.98M	2.94M	2.83M	53.03M
Long Term Debt	-	-	-	-	-	-	1.02M	1.02M	1.02M	1.02M	6.05M
Other Liabilities	-	-	-	-	-	476.82K	-	-	-	1.55M	16.89M
Stockholder Equity	67.09K	32.35K	-3.07K	-219.27K	-220.64K	-165.87K	-408.13K	-259.24K	-158.22K	-67.64K	38.02M
Preferred Stock Equity	-	-	-	-	-	-	-	-	-	-	-
Liabilities And Stockholders Equity	4.24M	4.21M	4.01M	3.82M	3.83M	3.84M	3.40M	3.39M	3.55M	3.54M	108.82M
Common Equity	-	-	-	-	-	-	1.25K	1.24K	1.24K	1.23K	38.76K
Retained Earnings	-	-	-	-	-	-	-7.02M	-6.74M	-6.57M	-6.36M	-121.06M
Totals		25.65M	25.60M	24.18M	23.17M	19.59M	24.52M	15.33M	15.29M	16.35M	17.85M	15.90M	16.20M	18.19M	16.74M	17.03M	15.52M	16.64M	16.23M	16.45M	9.07M	9.89M	10.85M	11.98M	7.72M	5.58M	6.14M	6.89M	7.76M	8.31M	5.54M	6.06M	4.66M	5.49M	5.62M	6.04M	5.49M	5.93M	6.25M	6.80M	7.37M	4.70M	4.16M	4.45M	4.81M	523.99M

&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;	12/31/2024	12/31/2023	12/31/2022	12/31/2021	12/31/2020	12/31/2019	12/31/2018	12/31/2017	12/31/2016	12/31/2015	Totals
	12/31/2024	12/31/2023	12/31/2022	12/31/2021	12/31/2020	12/31/2019	12/31/2018	12/31/2017	12/31/2016	12/31/2015	Totals
Assets	4.24M	3.83M	3.55M	3.64M	3.41M	2.40M	1.57M	1.99M	1.26M	1.39M	28.36M
Current Assets	3.30M	2.98M	2.69M	2.87M	2.16M	1.73M	1.20M	1.76M	671.88K	1.11M	21.22M
Cash And Short Term Investments	2.69M	2.44M	2.19M	2.44M	1.87M	1.54M	1.08M	1.69M	626.80K	1.08M	18.35M
Net Receivables	405.31K	327.79K	237.96K	198.57K	102.41K	43.01K	18.76K	34.00K	23.33K	8.30K	1.44M
Inventory	78.51K	89.15K	128.96K	122.70K	92.30K	56.35K	24.07K	-	-	-	592.04K
Other Current Assets	116.96K	126.38K	132.92K	88.08K	625.53K	98.41K	73.71K	40.12K	21.74K	16.56K	1.35M
Non Current Assets	944.70K	847.18K	854.11K	774.52K	1.25M	661.20K	374.11K	229.99K	590.93K	281.12K	7.14M
Property Plant Equipment	-	-	523.49K	501.96K	465.03K	425.18K	320.66K	181.90K	114.57K	27.81K	2.58M
Long Term Investments	-	-	-	-	-	14.82K	-	13.92K	324.80K	251.84K	885.20K
Non Currrent Assets Other	133.90K	-576.39K	115.48K	40.89K	500.00K	18.07K	53.45K	34.17K	151.56K	1.47K	472.61K
Liabilities	4.17M	4.05M	3.70M	3.06M	2.39M	956.44K	272.84K	228.30K	342.59K	121.80K	19.44M
Current Liabilities	1.19M	967.79K	767.91K	1.19M	1.13M	956.44K	179.49K	144.25K	131.70K	62.10K	6.81M
Accounts Payable	88.42K	55.52K	98.09K	73.43K	51.97K	49.88K	59.71K	28.36K	96.58K	45.59K	717.99K
Short Long Term Debt	-	-	-	-	-	-	-	30.00K	150.00K	-	180.00K
Other Current Liabilities	1.00M	713.01K	545.46K	395.17K	355.91K	206.53K	116.29K	74.19K	35.12K	16.51K	3.48M
Non Current Liabilities	2.99M	3.08M	2.94M	1.86M	1.26M	603.85K	93.34K	84.05K	210.89K	59.70K	13.23M
Long Term Debt	-	-	1.02M	675.70K	191.28K	-	30.00K	30.00K	150.00K	-	2.09M
Other Liabilities	-	-	406.37K	1.40M	352.30K	327.71K	63.34K	54.05K	60.89K	59.70K	2.77M
Stockholder Equity	67.09K	-220.64K	-158.22K	588.20K	1.02M	1.44M	1.30M	1.77M	920.22K	1.26M	8.92M
Preferred Stock Equity	-	-	-	-	-	-	-	-	-	-	-
Liabilities And Stockholders Equity	4.24M	3.83M	3.55M	3.64M	3.41M	2.40M	1.57M	1.99M	1.26M	1.39M	28.36M
Common Equity	-	-	1.24K	1.20K	1.16K	1.12K	1.01K	997	859	851	9.22K
Retained Earnings	-	-	-6.57M	-5.44M	-4.59M	-3.73M	-2.84M	-2.15M	-1.66M	-1.25M	-29.17M
Totals		25.65M	22.54M	16.72M	18.13M	16.05M	10.19M	5.58M	8.27M	5.49M	5.93M	4.70M	139.25M

&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;	06/30/2022	03/31/2022	12/31/2021	09/30/2021	06/30/2021	03/31/2021	12/31/2020	09/30/2020	06/30/2020	03/31/2020	Totals
	06/30/2022	03/31/2022	12/31/2021	09/30/2021	06/30/2021	03/31/2021	12/31/2020	09/30/2020	06/30/2020	03/31/2020	Totals
Revenue	224.82K	213.26K	258.54K	187.63K	220.55K	177.57K	163.56K	125.85K	103.96K	99.48K	2.30M
Cost Of Revenue	40.81K	35.63K	37.66K	32.66K	38.76K	31.06K	23.02K	21.80K	19.93K	13.30K	2.28M
Gross Profit	184.01K	177.63K	220.87K	154.97K	181.80K	146.50K	140.54K	104.06K	84.03K	86.17K	1.98M
Operating Expenses	375.70K	324.36K	555.58K	336.65K	327.96K	332.76K	334.76K	329.25K	282.89K	296.33K	7.15M
Selling General Administrative	169.98K	154.47K	186.38K	142.07K	145.32K	146.86K	166.29K	167.47K	127.90K	126.76K	2.79M
Research Development	205.71K	169.89K	229.05K	194.57K	182.63K	185.90K	168.47K	161.78K	155.00K	169.57K	4.22M
Other Operating Expenses	416.50K	359.99K	453.10K	369.31K	366.71K	363.82K	357.78K	351.05K	302.82K	309.63K	7.33M
Operating Income	-191.69K	-146.73K	-194.56K	-181.68K	-146.16K	-186.25K	-194.22K	-225.20K	-198.86K	-210.16K	-5.03M
Net Interest Income	-40.71K	-41.35K	-36.32K	-40.05K	-33.01K	-32.06K	-27.43K	-26.66K	-24.08K	5.48K	-262.74K
Interest Income	1.90K	1.01K	495	225	409	450	1.09K	2.07K	3.17K	5.48K	49.75K
Interest Expense	42.61K	42.36K	-249.23K	40.27K	33.42K	32.52K	28.52K	28.73K	27.25K	-	26.05K
Other Income Expense Net	-82.99K	-92.62K	-65.74K	-22.56K	-42.17K	-13.02K	49.38K	27.25K	-20.96K	-28.51K	-213.36K
Income Before Tax	-274.67K	-239.36K	-260.30K	-204.24K	-188.33K	-199.28K	-243.60K	-252.45K	-177.90K	-181.65K	-5.46M
Tax Provision	2.73K	985	-1.84K	278	1.23K	1.02K	-59	839	1.33K	575	7.94K
NetIncome	-277.40K	-240.34K	-258.46K	-204.51K	-189.56K	-200.29K	-243.54K	-253.29K	-179.23K	-182.22K	-5.43M
NetIncome Applicable To Common Shares	-277.40K	-240.34K	-258.46K	-204.51K	-189.56K	-200.29K	-243.54K	-253.29K	-179.23K	-182.22K	-5.43M
Ebit	-232.06K	-196.99K	-510.89K	-163.96K	-154.91K	-166.76K	-215.08K	-223.72K	-150.66K	-181.65K	-5.46M
Basic EPS	-2.29	-2	-2.16	-1.72	-1.61	-1.71	-2.09	-2.18	-1.56	-1.62	-50.11999999999999
Totals		287.84K	281.86K	105.87K	437.13K	555.08K	420.49K	265.94K	85.55K	177.35K	146.38K	-182.72K	-50.44K	-187.77K	-180.74K	-311.77K	-470.77K	71.31K	-679.41	87.48K	-21.09K	-23.84K	2.69K	-8.53K	-22.76K	-38.87K	-56.45K	-49.89K	-42.58K	-21.94K	59.21K	144.74K	21.21K	6.15K	-634.83K	850.60K

&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;	12/31/2021	12/31/2020	12/31/2019	12/31/2018	12/31/2017	12/31/2016	12/31/2015	12/31/2014	Totals
	12/31/2021	12/31/2020	12/31/2019	12/31/2018	12/31/2017	12/31/2016	12/31/2015	12/31/2014	Totals
Revenue	844.29K	492.85K	219.75K	74.91K	89.91K	47.16K	41.10K	50.56K	1.86M
Cost Of Revenue	140.14K	78.05K	25.06K	1.80K	578.10K	462.15K	330.40K	229.78K	1.85M
Gross Profit	704.14K	414.80K	194.69K	73.11K	89.91K	47.16K	41.10K	50.56K	1.62M
Operating Expenses	1.55M	1.24M	1.13M	887.78K	590.00K	471.75K	337.11K	234.78K	6.45M
Selling General Administrative	620.64K	588.42K	479.00K	382.36K	199.37K	89.35K	60.61K	44.53K	2.46M
Research Development	792.16K	654.82K	655.11K	505.42K	390.63K	382.39K	276.50K	190.25K	3.85M
Other Operating Expenses	1.55M	1.32M	1.16M	889.58K	590.00K	471.75K	337.11K	234.78K	6.56M
Operating Income	-708.65K	-828.44K	-939.43K	-814.67K	-500.09K	-424.59K	-296.01K	-184.21K	-4.70M
Net Interest Income	-141.44K	-72.69K	33.45K	29.26K	12.24K	8.31K	-	-	-130.88K
Interest Income	1.58K	11.81K	33.45K	29.26K	12.24K	8.31K	5.86K	-	102.50K
Interest Expense	-143.02K	84.50K	-	-	800	1.20K	-1.20K	-1.20K	-58.92K
Other Income Expense Net	-143.49K	-27.16K	54.18K	54.00K	-9.21K	-14.48K	-5.93K	216.39K	124.28K
Income Before Tax	-852.14K	-855.60K	-885.25K	-760.67K	-490.87K	-410.11K	-290.07K	-400.60K	-4.95M
Tax Provision	680	2.68K	863	823	-	-	-	-	5.05K
NetIncome	-852.82K	-858.28K	-886.12K	-761.50K	-490.87K	-410.11K	-290.07K	-360.39K	-4.91M
NetIncome Applicable To Common Shares	-852.82K	-858.28K	-886.12K	-761.50K	-490.87K	-410.11K	-290.07K	-360.39K	-4.91M
Ebit	-996.52K	-771.10K	-885.25K	-760.67K	-490.87K	-424.59K	-296.01K	-400.60K	-5.03M
Basic EPS	-7.2	-7.45	-8.14	-7.56	-5.41	-4.79	-3.45	-1.83	-45.83
Totals		1.52M	620.90K	-493.32K	-930.72K	80.39K	-104.46K	-39.60K	-455.80K	195.96K

&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;	12/31/2024	09/30/2024	06/30/2024	03/31/2024	12/31/2023	09/30/2023	06/30/2023	03/31/2023	12/31/2022	09/30/2022	Totals
	12/31/2024	09/30/2024	06/30/2024	03/31/2024	12/31/2023	09/30/2023	06/30/2023	03/31/2023	12/31/2022	09/30/2022	Totals
Cash From Operating Activities	-94.66K	43.71K	124.16K	-81.52K	-29.80K	359.41K	-58.99K	-166.47K	-131.98K	-115.28K	-3.59M
Net Income	-83.76K	-111.57K	-16.89K	-65.94K	-137.87K	147.75K	-276.02K	-174.10K	-207.49K	-405.92K	-6.76M
Depreciation	-20.55K	48.70K	15.00K	13.52K	13.48K	23.53K	23.45K	26.08K	24.89K	20.65K	482.05K
Extraordinary Items	-	-	-	-	-	-	-	-	-	-	-
Change Receivables	-	-	-	-	-	-	-2.97K	19.15K	-53.27K	-38.42K	-226.20K
Change To Inventory	849	5.92K	6.79K	22	11.99K	4.79K	1.99K	-403	-18.98K	-7.88K	-207.72K
Change To Liabilities	-	-	-	-	-	143.21K	82.74K	-81.97K	102.62K	69.75K	758.93K
Change To Net Income	-	-	-	-	-	162.60K	73.83K	33.67K	22.64K	161.79K	1.61M
ChangeToOperatingActivities	-	-	-	-	-	-14.48K	-38.89K	-	-	-6.32K	-163.82K
Cash flows From Investing Activities	-	-	-	-	-	-10.76K	-8.71K	-76.22K	-139.91K	313.89K	-1.80M
Capital Expenditures	-9.09K	-4.19K	-8.02K	-12.97K	-15.31K	-17.09K	-15.92K	-13.89K	-21.64K	-16.51K	-809.27K
Other Cashflows From Investing Activities	-117	-	-	-	-	-4.44K	-4.44K	-	381	-5.00K	-86.64K
Cash From Financing Activities	31.00K	102.75K	131.50K	28.91K	39.23K	33.14K	53.39K	46.37K	63.44K	297.02K	6.68M
Net Borrowings	-	-	-	-	-	-	-	-	-777	254.78K	2.34M
Sale Purchase Of Stock	-	-	-	-	-	-	49.39K	42.37K	56.71K	153.02K	1.53M
Dividends Paid	-	-	-	-	-	-	-	-	-	-	-
Other Cashflows From Financing Activities	31.00K	-5.28K	131.50K	28.91K	39.23K	8.33K	4.00K	19.25K	-195.92K	297.02K	2.77M
Cash And Cash Equivalents Changes	-	-	-	-	-	-	-14.30K	-196.32K	-208.45K	495.63K	614.90K
Totals		-145.34K	80.04K	384.04K	-89.06K	-79.05K	835.99K	-131.46K	-522.49K	-707.74K	1.47M	16.41K	-615.05K	-171.84K	1.44M	1.25M	-145.41K	244.31K	-210.17K	1.08M	-97.01K	-930.70K	-612.13K	735.75K	501.83K	72.72K	-235.96K	-178.41K	-670.26K	692.20K	-618.98K	269.72K	-298.84K	-57.50K	-294.53K	151.16K	157.09K	139.12K	-58.94K	-358.37K	1.05M	105.22K	-34.69K	-572.02K	303.30K	3.14M

&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;&ebsp;	12/31/2024	12/31/2023	12/31/2022	12/31/2021	12/31/2020	12/31/2019	12/31/2018	12/31/2017	12/31/2016	12/31/2015	Totals
	12/31/2024	12/31/2023	12/31/2022	12/31/2021	12/31/2020	12/31/2019	12/31/2018	12/31/2017	12/31/2016	12/31/2015	Totals
Cash From Operating Activities	-8.31K	104.16K	-541.27K	-641.69K	-614.96K	-278.43K	-562.62K	-382.79K	-307.70K	-189.14K	-3.59M
Net Income	-278.16K	-440.24K	-1.13M	-852.82K	-858.28K	-886.12K	-761.50K	-490.87K	-410.11K	-290.07K	-6.76M
Depreciation	56.67K	97.03K	85.55K	89.69K	74.44K	54.37K	6.43K	13.37K	15.13K	19.05K	523.66K
Extraordinary Items	-	-	-	-	-	-	-	-	-	-	-
Change Receivables	-	-	-45.60K	-101.80K	-56.24K	-24.24K	15.24K	-10.67K	-15.04K	31.64K	-242.38K
Change To Inventory	13.59K	18.37K	-34.14K	-26.41K	-35.43K	-32.41K	-22.64K	-22.64K	-22.64K	-22.64K	-187.01K
Change To Liabilities	-	-	191.77K	88.24K	143.73K	92.35K	74.83K	28.48K	35.39K	9.92K	674.89K
Change To Net Income	-	-	307.71K	223.39K	156.68K	201.82K	186.26K	97.62K	72.20K	46.77K	1.29M
ChangeToOperatingActivities	-	-	-81.68K	-72.44K	-20.81K	-25.57K	-9.72K	-20.71K	7.54K	-103	-218.26K
Cash flows From Investing Activities	-	-	169.35K	-273.30K	-435.52K	-417.68K	272.94K	-290.36K	142.59K	-321.32K	-1.70M
Capital Expenditures	-34.28K	-62.21K	-72.06K	-76.37K	-70.36K	-140.16K	-126.89K	-104.21K	-64.56K	-12.95K	-773.00K
Other Cashflows From Investing Activities	57.76K	-	-13.19K	-4.36K	-31.20K	23.00K	-14.82K	120.00K	-150.00K	-308.37K	-346.20K
Cash From Financing Activities	294.16K	172.13K	425.75K	1.25M	994.98K	823.18K	65.47K	1.12M	177.83K	616.18K	6.68M
Net Borrowings	-	-	254.00K	500.00K	200.00K	-30.00K	-30.00K	-120.00K	150.00K	150.00K	1.22M
Sale Purchase Of Stock	-	-	259.36K	246.27K	299.98K	853.18K	-3.47K	-257	-596	-378	1.64M
Dividends Paid	-	-	-	-	-	-	-	-	-	-	-
Other Cashflows From Financing Activities	294.16K	172.13K	171.75K	747.12K	695.48K	71.28K	68.94K	84.14K	164.13K	31.14K	2.53M
Cash And Cash Equivalents Changes	-	-	53.83K	332.13K	-55.50K	127.08K	-224.20K	451.74K	12.72K	105.72K	825.53K
Totals		395.59K	61.36K	-8	1.42M	387.00K	411.67K	-1.07M	477.73K	-193.11K	-134.57K	-201.86K	1.56M

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