Key TakeawaysAlnylam Pharmaceuticals announced a Phase-3 study of its treatment for a rare heart condition showed a significant reduction in deaths and recurrent cardiovascular events.The biopharmaceutical company said it would be seeking regulatory approval later this year, including asking the Food and Drug Administration for a priority review.The news sent shares of Alnylam soaring over 31% in early trading Monday. Shares of Alnylam Pharmaceuticals (ALNY) skyrocketed over 31% in early trading Monday afte ...

Follow Invezz on Telegram , Twitter , and Google News for instant updates >Alnylam Pharmaceuticals Inc (NASDAQ: ALNY) opened more than 30% up on Monday after reporting promising results from a late-stage trial of its heart drug. Are you looking for signals & alerts from pro-traders? Sign-up to Invezz Signals™ for FREE. Takes 2 mins.Shares of the biopharmaceutical company are now trading at a year-to-date high of $220.  Why is it significant for Alnylam Pharmaceuticals stock?Copy link to sectionVutrisiran de ...

Alnylam Pharmaceuticals (ALNY) shares ended the last trading session 5.3% higher at $165.70. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 5.4% gain over the past four weeks.The sudden rise in the stock price has likely been driven by the growing optimism of investors regarding Amvuttra’s (vutrisiran) potential to earn increasing revenues for the company. The drug, approved for treating adult patients with polyne ...

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Wall Street regards the healthcare sector as a constant source of innovation, while biotechnology stands at the pinnacle of groundbreaking medical advancements. The long-term potential of robust biotech stocks to buy remains undeniable for investors. As the summer season kicks in, several biotech companies exhibit characteristics that could ignite this potential summertime surge. Promising clinical trial results, significant product launches, or strategic partnerships could drive this momentum.We should not ...

Financial Data and Key Metrics Changes - In Q1 2024, Alnylam Pharmaceuticals reported total product revenues of $365 million, reflecting a 32% year-over-year growth compared to Q1 2023 [7][26] - The gross margin on product sales was 85%, consistent with Q1 2023, but expected to decrease for the remainder of 2024 due to higher royalties on AMVUTTRA [27][28] - Non-GAAP R&D expenses increased by 13% year-over-year, driven by investments in zilebesiran and the HELIOS-B trial [27] - Non-GAAP SG&A expenses rose by 15% year-over-year, indicating operating leverage as product sales grew by 32% [27] Business Line Data and Key Metrics Changes - The TTR franchise achieved $264 million in global net product revenues, representing a 29% growth year-over-year [11][12] - The rare franchise delivered $101 million in combined global net product revenue, marking a 40% increase compared to Q1 2023 [16][17] - AMVUTTRA's U.S. sales increased by 35% year-over-year, driven by strong patient uptake [11][12] Market Data and Key Metrics Changes - The U.S. TTR sales saw a 39% increase in total demand compared to Q1 2023, despite a decrease in patients switching from ONPATTRO to AMVUTTRA [12][14] - International TTR franchise growth increased by 23% year-over-year, primarily due to AMVUTTRA demand in newly launched markets [13][14] Company Strategy and Development Direction - Alnylam aims to position itself as a leader in treating cardiovascular disease through its zilebesiran hypertension program, which has shown positive results in clinical trials [8][21] - The company is focused on advancing its pipeline with plans to file proprietary INDs for nine programs by the end of 2025, aiming to double its clinical pipeline [24][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in a strong start to 2024, with expectations for continued revenue growth and successful outcomes from ongoing clinical trials [7][9] - The company remains optimistic about the HELIOS-B Phase 3 study results, which are expected to support a supplemental NDA filing by the end of 2024 if positive [9][20] Other Important Information - Alnylam ended Q1 2024 with cash, cash equivalents, and marketable securities of $2.4 billion, indicating a stable financial position [28] - The company reiterated its 2024 guidance for combined net product revenues between $1.4 billion and $1.5 billion, reflecting a growth rate of 13% to 21% [29] Q&A Session Summary Question: What is the relevant improvement over the control arm for HELIOS-B? - Management emphasized that delivering outcomes in the HELIOS-B study is crucial and that they are focused on demonstrating clinical significance in terms of mortality and hospitalization [34][36] Question: What would be the organizational changes if HELIOS-B succeeds or fails? - If HELIOS-B succeeds, no changes to spending guidance are anticipated. However, if it fails, prioritization across the business would be necessary [40][41] Question: How important is the ratio between hospitalization events and deaths in HELIOS-B? - Management indicated that both hospitalization and mortality events are clinically meaningful and should trend in the same direction [70][72] Question: What proportion of patients are mixed phenotype in ATTR? - It was noted that a significant proportion of patients with wild type ATTR may have concomitant polyneuropathy, highlighting the complexity of the disease [75][76] Question: Will subgroup information be shared in the top line release for HELIOS-B? - Management confirmed that they plan to provide information on primary and secondary endpoints, including subgroup analyses, during the top line results presentation [61][80]

First Quarter 2024 Financial Results May 2, 2024 1 © 2024 Alnylam Pharmaceuticals, Inc. Agenda Welcome • Christine Lindenboom ...

Alnylam Pharmaceuticals (ALNY) reported $494.33 million in revenue for the quarter ended March 2024, representing a year-over-year increase of 54.8%. EPS of -$0.16 for the same period compares to -$1.40 a year ago.The reported revenue represents a surprise of +17.39% over the Zacks Consensus Estimate of $421.1 million. With the consensus EPS estimate being -$0.75, the EPS surprise was +78.67%.While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they com ...

Alnylam Pharmaceuticals (ALNY) came out with a quarterly loss of $0.16 per share versus the Zacks Consensus Estimate of a loss of $0.75. This compares to loss of $1.40 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 78.67%. A quarter ago, it was expected that this RNA interference drug developer would post a loss of $1.20 per share when it actually produced a loss of $1.10, delivering a surprise of 8.33%.Over the last four qua ...

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 Title of Each Class Trading Symbol(s) Name of Each Exchange on Which Registered Common Stock, $0.01 par value per share ALNY The Nasdaq Stock Market LLC For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 ...