10-KPeriod: FY2025

ALNYLAM PHARMACEUTICALS, INC. Annual Report, Year Ended Dec 31, 2025

Filed February 12, 2026For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc. (ALNY) has filed its 10-K for the fiscal year ending on December 31, 2025, highlighting a robust portfolio of six approved RNAi therapeutics and a promising clinical pipeline. The company is executing its "Alnylam 2030" strategy, aiming for significant revenue growth and expansion into new therapeutic areas and tissue types. Key advancements include the recent approvals and ongoing launches of AMVUTTRA for ATTR amyloidosis with cardiomyopathy, and Qfitlia for hemophilia. The company also reported positive clinical trial data for nucresiran, a next-generation ATTR therapy, and zilebesiran for hypertension, underscoring its commitment to innovation and continued pipeline progression. Financially, Alnylam has managed its capital structure by issuing convertible notes and repurchasing existing ones, while also establishing a significant revolving credit facility to support ongoing operations and growth. The company's focus on genetically validated targets and advanced delivery technologies, such as GalNAc conjugates and C16 moieties, positions it to address a wide range of diseases with high unmet needs. Investors should monitor the continued commercial success of its approved products, progress in late-stage clinical trials, and the strategic expansion into prevalent diseases.

Financial Highlights

48 data points
Beta

Revenue

$3.71B

81.8% Gross Margin

Net Income

$313.75M

8.4% Net Margin

EPS (Diluted)

$2.33

Total Assets

$4.97B

Cash & Equivalents

$1.66B

Free Cash Flow

$465.38M

Financial Statements
Beta
Revenue$3.71B
Cost of Revenue$677.17M
Gross Profit$3.04B
R&D Expenses$1.32B
SG&A Expenses$1.21B
Operating Expenses$3.21B
Operating Income$501.58M
Net Income$313.75M
EPS (Basic)$2.39
EPS (Diluted)$2.33
Shares Outstanding (Basic)131.00M
Shares Outstanding (Diluted)134.68M

Key Highlights

  • 1Alnylam Pharmaceuticals currently markets six RNAi therapeutics, including AMVUTTRA and ONPATTRO for ATTR amyloidosis, GIVLAARI for AHP, and OXLUMO for PH1, with two additional products (Leqvio and Qfitlia) commercialized through collaborators.
  • 2Significant regulatory advancements in early 2025 and mid-2025 include FDA and EMA approvals for AMVUTTRA for ATTR amyloidosis with cardiomyopathy, and FDA and Chinese NMPA approvals for Qfitlia for hemophilia.
  • 3The company has initiated Phase 3 trials for nucresiran, a next-generation therapy for ATTR amyloidosis, and is advancing zilebesiran for hypertension through Phase 3 trials, following positive Phase 2 data and a strategic collaboration with Roche.
  • 4Alnylam launched its 'Alnylam 2030' strategy, targeting over 25% compound annual revenue growth through 2030, expansion into 10 tissue types, and achieving approximately 30% non-GAAP operating margin.
  • 5The company strengthened its financial position by issuing $661.3 million in 0.00% Convertible Senior Notes due 2028 and establishing a $500 million revolving credit facility.
  • 6Alnylam is actively managing its debt, having repurchased a significant portion of its 1.00% Convertible Senior Notes due 2027.
  • 7The pipeline includes multiple investigational RNAi therapeutics for rare and prevalent diseases, with advancements in cerebral amyloid angiopathy/Alzheimer's disease (mivelsiran) and Huntington's disease (ALN-HTT02).

Frequently Asked Questions

Alnylam's key growth drivers include the expanding commercialization of its approved products, particularly AMVUTTRA for both polyneuropathy and cardiomyopathy indications of ATTR amyloidosis, and the progression of its late-stage pipeline candidates such as nucresiran for ATTR amyloidosis and zilebesiran for hypertension. The 'Alnylam 2030' strategy also emphasizes launching at least two new transformative medicines beyond TTR with blockbuster potential and expanding into new tissue types and indications.

Alnylam has recently issued convertible senior notes and established a substantial revolving credit facility to ensure sufficient liquidity. The company has also actively managed its existing debt by repurchasing a significant principal amount of its 2027 convertible notes. This approach aims to balance funding growth initiatives with maintaining a sound financial structure.

Alnylam has key collaborations with major pharmaceutical companies like Roche (for zilebesiran), Sanofi (for Qfitlia), and Novartis (for Leqvio). These collaborations are crucial for co-development, commercialization, and market access, allowing Alnylam to leverage external expertise and resources to advance its pipeline and expand its global reach. The company also has collaborations focused on research and development, such as with Regeneron and Vir Biotechnology.

As highlighted in the 'Risk Factors' section (though not detailed in the provided excerpt), primary risks for Alnylam likely include the successful commercialization of its existing and pipeline products, competition from other pharmaceutical companies and therapeutic modalities, regulatory approvals and market access challenges, patent expirations, manufacturing and supply chain disruptions, and the inherent risks associated with clinical trial success and drug development.