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Alnylam Pharmaceuticals (NASDAQ:ALNY) reported strong first-quarter 2025 financial results on May 1, with shares trading up 2.02% in premarket activity. The company’s presentation highlighted robust revenue growth across its portfolio, particularly in its TTR franchise, while maintaining profitability and advancing its pipeline.
Quarterly Performance Highlights
Alnylam delivered combined net product revenues of $469 million in Q1 2025, representing a 28% year-over-year increase and a 4% sequential improvement from Q4 2024. The company reported non-GAAP operating income of $75 million, continuing its profitability trend.
"We achieved strong Q1 2025 financial results and are making progress towards becoming the global TTR leader," said Yvonne Greenstreet, M.D., MBA, Chief Executive Officer, as highlighted in the presentation.
The company’s financial summary shows a balanced performance across key metrics, with growth in product revenues offsetting a slight decline in collaboration and royalty revenues.
Net revenues from collaborations and royalties reached $126 million, representing a 3% decrease compared to the prior year. Non-GAAP combined R&D and SG&A expenses increased by 5% to $448 million, reflecting continued investment in the company’s pipeline and commercial infrastructure.
Product Portfolio Performance
The TTR franchise emerged as the primary growth driver, with global revenues of $359 million, up 36% year-over-year and 5% quarter-over-quarter. U.S. TTR revenues showed particularly strong performance with 45% year-over-year growth.
As shown in the following detailed breakdown of TTR franchise performance:
Meanwhile, the Rare franchise, which includes GIVLAARI and OXLUMO, generated $109 million in Q1 2025, representing 8% year-over-year growth and 1% sequential growth. GIVLAARI led this segment with 15% year-over-year growth, while OXLUMO experienced a slight 1% decline.
AMVUTTRA continues to gain market share in hATTR-PN, capturing approximately 70% of new patient starts in Q1 2025 in the U.S. market. This dominant position underscores the product’s strong clinical profile and commercial execution.
ATTR-CM Launch and Strategic Initiatives
A significant focus of the presentation was the recent U.S. launch of AMVUTTRA for ATTR-CM (transthyretin amyloidosis with cardiomyopathy), which received FDA approval in March 2025. The company reported that the launch is off to a strong start, with rapid progress on formulary inclusion.
The presentation highlighted that AMVUTTRA’s therapeutic profile is resonating with healthcare providers, with approximately 60% of HCPs agreeing that silencing TTR gives ATTR patients optimal outcomes. The company has expanded treatment sites by 2x since Q4 2024, achieving over 2,000 sites.
On the regulatory front, AMVUTTRA has received approvals for ATTR-CM in the U.S. and Brazil, with a positive CHMP opinion in the European Union. Additional approvals are expected in Japan (Q2 2025), United Kingdom (TADAWUL:4280) (Q3 2025), and Canada (Q4 2025).
Pipeline Progress and Future Catalysts
Alnylam continues to advance its pipeline, with the Nucresiran Phase 3 program set to initiate in the first half of 2025 for ATTR-CM and in the second half for hATTR-PN. This next-generation TTR silencer could potentially offer improved efficacy and convenience.
The company’s 2025 goals include several important milestones across its portfolio, as illustrated in this timeline:
Alnylam’s robust pipeline spans multiple therapeutic areas, including TTR, rare diseases, cardiovascular, metabolic, and neurologic conditions, positioning the company for sustained long-term growth.
Financial Outlook
Alnylam reiterated its 2025 full-year guidance, projecting total combined net product revenues between $2,050 million and $2,250 million. This includes TTR net product revenues of $1,600 million to $1,725 million and Rare net product revenues of $450 million to $525 million.
The company expects to maintain non-GAAP operating income profitability throughout 2025, continuing the positive trend established in the previous year. This guidance reflects confidence in the continued growth of the TTR franchise, particularly with the ATTR-CM launch, as well as stable performance in the Rare franchise.
Alnylam also reaffirmed its commitment to its "P5x25" goals, which include having over 0.5 million patients on Alnylam RNAi therapeutics globally, 6+ marketed products, over 20 clinical programs, revenue CAGR of ≥40% through year-end 2025, and achieving sustainable non-GAAP profitability.
The company’s strong Q1 2025 performance, successful ATTR-CM launch, and advancing pipeline position Alnylam well to achieve these ambitious targets and maintain its leadership in RNAi therapeutics.
Full presentation:
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