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Alnylam's Amvuttra Makes Powerful Entrance, Eyes First-Line Dominance
Benzinga· 2025-08-01 18:28
Core Viewpoint - Alnylam Pharmaceuticals reported strong second-quarter earnings and raised its 2025 sales guidance, indicating positive momentum in its product launches and overall financial performance [1][3]. Financial Performance - The company reported adjusted earnings of 32 cents for Q2 2025, a decrease from 56 cents year-over-year, but significantly better than analysts' expectations of a loss of 79 cents [1]. - Quarterly sales reached $773.69 million, reflecting a 17% year-over-year increase and surpassing the consensus estimate of $638.55 million [1]. Product Revenue - Global net product revenues for Amvuttra and Onpattro were $492 million and $53 million, respectively, while Givlaari and Oxlumo generated $81 million and $47 million in revenue for the same quarter [2]. - The launch of Amvuttra for ATTR-CM has been particularly successful, with approximately 1,400 patients treated by June 30, 2025, contributing to an estimated $150 million increase in revenue [4]. Guidance and Analyst Outlook - Alnylam raised its fiscal 2025 sales guidance from $2.7 billion-$3 billion to $3.3 billion-$3.55 billion, exceeding the consensus of $2.89 billion [3]. - Analysts from Chardan Research and William Blair expressed positive outlooks, with Chardan highlighting the strong start of Amvuttra's launch [3][6]. Analyst Ratings and Price Forecasts - Various analysts have upgraded their price forecasts for Alnylam, with Chardan raising its target from $325 to $400, and UBS increasing its forecast from $403 to $550 [5][8]. - Morgan Stanley maintained an Equal-Weight rating while increasing its price forecast from $312 to $405, and Piper Sandler raised its target from $304 to $449 [7].
ALNY Q2 Earnings Top Estimates on Higher Amvuttra Revenues, Stock Up
ZACKS· 2025-08-01 16:51
Core Insights - Alnylam Pharmaceuticals reported second-quarter 2025 earnings of $0.32 per share, significantly surpassing the Zacks Consensus Estimate of a loss of $0.03, primarily due to increased revenues from its lead drug, Amvuttra [1][11] - Total revenues for the quarter reached $773.7 million, exceeding the Zacks Consensus Estimate of $673 million, and reflecting a 17% year-over-year increase [2] - The company's net product revenues were $672.2 million, a 64% increase year-over-year, driven by strong demand for Amvuttra, Givlaari, and Oxlumo [3] Revenue Breakdown - Alnylam's net product revenues from Amvuttra amounted to $492 million, representing a 114% increase year-over-year, aided by expanded label use and patient switches from Onpattro [8][11] - Givlaari generated sales of $80.8 million, a 30% year-over-year increase, while Oxlumo recorded revenues of $46.9 million, up 15% year-over-year [9] - Net revenues from collaborators were $61.5 million, down 73% from the previous year, primarily due to a significant milestone payment received in the prior quarter [4] Financial Guidance - Alnylam raised its 2025 product revenue guidance to a range of $2.65 billion to $2.8 billion, up from the previous range of $2.05 billion to $2.25 billion [11][16] - The guidance for net revenues from collaborations and royalties remains unchanged at $650 million to $750 million [16] Research and Development - Adjusted R&D expenses increased by 11% year-over-year to $274.1 million, reflecting costs associated with new studies in partnership with Roche [13] - Adjusted SG&A expenses rose by 26% year-over-year to $261.2 million, driven by higher employee compensation and marketing investments related to Amvuttra [14] Cash Position - As of June 30, 2025, Alnylam's cash, cash equivalents, and marketable securities totaled $2.86 billion, an increase from $2.63 billion as of March 31, 2025, primarily due to net cash inflows from operating activities [15]
Alnylam (ALNY) Q2 Earnings: Taking a Look at Key Metrics Versus Estimates
ZACKS· 2025-07-31 15:31
Core Insights - Alnylam Pharmaceuticals reported a revenue of $773.69 million for the quarter ended June 2025, reflecting a year-over-year increase of 17.3% and a surprise of +14.96% over the Zacks Consensus Estimate of $673 million [1] - The company's EPS was $0.32, down from $0.56 in the same quarter last year, with an EPS surprise of +1166.67% compared to the consensus estimate of -$0.03 [1] Revenue Breakdown - Product revenues were $672.21 million, exceeding the average estimate of $540.14 million by analysts, representing a year-over-year increase of +63.9% [4] - Royalty revenue reached $39.98 million, surpassing the average estimate of $32.74 million, with a year-over-year change of +78.5% [4] - Net Product Revenue from Oxlumo was $46.87 million, slightly above the estimated $46.64 million, marking a +15.4% change year over year [4] - Net Product Revenue from Givlaari was $80.85 million, exceeding the average estimate of $72.59 million, reflecting a +30.1% year-over-year increase [4] - Net Product Revenue from Amvuttra was $491.95 million, significantly higher than the estimated $365.41 million, showing a +113.8% change compared to the previous year [4] - Net Product Revenue from Onpattro was $52.24 million, below the average estimate of $45.89 million, indicating a -32.4% year-over-year decline [4] Research Collaborator Revenues - Net revenues from research collaborators totaled $61.5 million, falling short of the average estimate of $90.07 million, representing a -73% change year over year [4] - Other net revenues from research collaborators were $10.69 million, exceeding the estimated $3 million, with a remarkable +872.4% change compared to the previous year [4] - Net revenues from Regeneron Pharmaceuticals were $32.54 million, significantly lower than the estimated $17.5 million, reflecting an -84.3% change year over year [4] - Net revenues from Roche were $18.27 million, surpassing the average estimate of $12 million, with a +10.7% year-over-year change [4] Stock Performance - Alnylam's shares returned +3% over the past month, outperforming the Zacks S&P 500 composite's +2.7% change [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating potential performance in line with the broader market in the near term [3]
Alnylam Wins EC Nod for Label Expansion of Amvuttra for ATTR-CM
ZACKS· 2025-06-10 14:11
Core Insights - Alnylam Pharmaceuticals has received European Commission approval for the label expansion of its RNAi therapeutic Amvuttra to treat wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy [1][9] - Year-to-date, Alnylam's stock has increased by 29.1%, significantly outperforming the industry, which has seen a decline of 0.9% [2] Approval Details - The European Commission's approval was based on positive results from the late-stage HELIOS-B study, where Amvuttra met all 10 pre-specified primary and secondary endpoints [3][9] - The HELIOS-B trial demonstrated statistically significant reductions in all-cause mortality and recurrent cardiovascular events, along with major improvements in functional capacity, health status, and heart failure symptoms [4][9] Competitive Advantage - Amvuttra is administered quarterly via subcutaneous injection, providing an advantage over existing therapies that require daily oral dosing [5] - The drug's novel RNAi mechanism allows for rapid knockdown of transthyretin (TTR), addressing the disease at its source [6] Market Impact - The approval in the EU follows similar approvals in the United States and Brazil, expanding Amvuttra's global footprint [6] - Alnylam reported better-than-expected first-quarter 2025 results, with revenue growth driven by increasing Amvuttra sales due to heightened patient demand [10][11]