Key Takeaways ALNY secured EC approval to expand Amvuttra's use to treat ATTR-CM in adult patients. Approval was based on HELIOS-B data showing mortality, CV event and symptom improvement. Amvuttra is now the first RNAi therapy approved in the EU for both ATTR-CM and hATTR-PN.Alnylam Pharmaceuticals, Inc. (ALNY) announced that the European Commission (EC) has approved a label expansion of its RNAi therapeutic Amvuttra.The EC has now approved Amvuttra for the treatment of wild-type or hereditary transthyre ...

Alnylam Pharmaceuticals (ALNY) FY Conference June 09, 2025 09:20 AM ET Speaker0 Great. Good morning, everyone. Thank you so much for joining us. I'm Salveen Richter, biotechnology analyst at Goldman Sachs. We're really pleased to be joined by the Alnylam team. With me, we have Yvonne Greenstreet, CEO, and John Kennedy, head of the TTR franchise. So Yvonne, before we even start, you know, you announced some news this morning, so maybe this is a perfect time point to maybe speak to the European approval that ...

Summary of Alnylam Pharmaceuticals (ALNY) 2025 Conference Call Company Overview - **Company**: Alnylam Pharmaceuticals (ALNY) - **Event**: Bank of America Healthcare Conference - **Date**: May 14, 2025 Key Industry Insights - **Impact of Executive Orders**: The recent executive order regarding most favored nation pricing is still developing, making it difficult to assess its implications for Alnylam. However, the company benefits from having orphan drugs in the U.S., which may exempt them from future price negotiations under the IRA [3][4] - **Tariffs**: Current tariffs do not materially impact Alnylam's guidance, as the majority of their manufacturing is done in the U.S. through contract manufacturing organizations (CMOs) [8][9] Product Launch and Market Dynamics - **Cardiomyopathy Launch**: The launch of the cardiomyopathy product is a significant focus. Initial metrics show that 50% of health systems have completed the PNT process and are on formulary within five weeks of launch, which is faster than anticipated [18][19] - **Revenue Guidance**: Alnylam has guided for TTR revenue between $1.6 billion and $1.725 billion for the year, representing a 36% growth at the midpoint [23] - **Patient Access**: Approximately 70% of patients on the drug have zero out-of-pocket costs, primarily due to Medicare fee-for-service coverage [30] Competitive Landscape - **Market Size and Segmentation**: There are about 18,000 new patients initiating therapy annually, with a significant opportunity to increase diagnosis rates, currently at a 20% diagnosis rate [48] - **First-Line vs. Second-Line Treatment**: Alnylam is focused on first-line treatment due to the progressive nature of the disease and the need for effective early intervention [49] Patient and Physician Engagement - **Patient Compliance**: Alnylam has observed good compliance rates with their injectable therapies, which may be more effective than oral alternatives in ensuring patients receive the necessary treatment [58][60] - **Physician Awareness**: There is a good level of awareness among physicians regarding Alnylam's products, but further education is needed as the company expands its prescriber base [74] Future Outlook - **Revenue Reporting**: Alnylam will not be able to report revenue separately for Ambutra PN and Ambutra Centimeters due to them being the same product under one SKU [67] - **Market Positioning**: Alnylam is uniquely positioned to capture a broad patient base, including both hereditary and wild-type patients, due to its comprehensive label [72][73] Additional Considerations - **Direct-to-Consumer (DTC) Marketing**: Alnylam is engaging in targeted DTC marketing but is not heavily investing in broad campaigns like some competitors [65] - **Value-Based Agreements (VBAs)**: The company is extending its VBAs to ensure adherence and compliance, which is favorable for both patients and payers [60][61]

Alnylam Pharmaceuticals (ALNY) reported first-quarter 2025 adjusted loss of 1 cent per share, narrower than the Zacks Consensus Estimate of a loss of 56 cents. The company had incurred a loss of 16 cents per share in the year-ago quarter. The adjusted figure excluded items like stock-based compensation expenses and unrealized loss on marketable equity securities.Alnylam recorded total revenues of $594.2 million in the quarter, which surpassed the Zacks Consensus Estimate of $588.2 million. In the year-ago q ...

First Quarter 2025 Financial Results May 1, 2025 © 2025 Alnylam Pharmaceuticals, Inc. 1 Agenda Welcome • Christine Lindenboom Chief Corporate Communications Officer Overview • Yvonne Greenstreet, M.D., MBA Chief Executive Officer Commercial Highlights • Tolga Tanguler Chief Commercial Officer Pipeline • Pushkal Garg, M.D. Chief Medical Officer Financial Summary and Upcoming Milestones • Jeff Poulton Chief Financial Officer Q&A Session 2 Alnylam Forward Looking Statements This presentation contains forward-l ...

Alnylam Pharmaceuticals (ALNY) Q1 2025 Earnings Call May 01, 2025 08:30 AM ET Speaker0 Good morning, ladies and gentlemen, and welcome to the Alnylam Pharmaceuticals Q1 twenty twenty five Earnings Conference Call. At this time, all lines are in a listen only mode. Following the presentation, we will conduct a question and answer session. This call is being recorded on Thursday, 05/01/2025. I would now like to turn the conference over to Alnylam. Please go ahead. Speaker1 Good morning. I'm Christine Lindenbo ...

Alnylam Pharmaceuticals (ALNY) Q1 2025 Earnings Call May 01, 2025 08:30 AM ET Company Participants Christine Lindenboom - Chief Corporate Communications OfficerYvonne Greenstreet - Chief Executive OfficerTolga Tanguler - Executive VP & Chief Commercial OfficerPushkal Garg - Chief Medical Officer and Executive VP of Development & Medical AffairsJeff Poulton - Chief Financial OfficerGena Wang - MD - Biotech Equity ResearchTeraesa Vitelli - Equity Research AssociateGary Nachman - Managing Director - Equity Res ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________________________________ FORM 10-Q ____________________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number 001-36407 ___________________ ...

Wall Street analysts forecast that Alnylam Pharmaceuticals (ALNY) will report quarterly loss of $0.56 per share in its upcoming release, pointing to a year-over-year decline of 250%. It is anticipated that revenues will amount to $588.18 million, exhibiting an increase of 19% compared to the year-ago quarter.The consensus EPS estimate for the quarter has undergone a downward revision of 4.6% in the past 30 days, bringing it to its present level. This represents how the covering analysts, as a whole, have re ...

The market expects Alnylam Pharmaceuticals (ALNY) to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended March 2025. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to b ...