10-QPeriod: Q3 FY2025

ALNYLAM PHARMACEUTICALS, INC. Quarterly Report for Q3 Ended Sep 30, 2025

Filed October 30, 2025For Securities:ALNY

Summary

Alnylam Pharmaceuticals, Inc. (ALNY) reported a strong third quarter of 2025, showcasing significant revenue growth driven by its TTR franchise, particularly AMVUTTRA, and substantial increases in collaboration revenues, largely due to a significant milestone payment from Roche for the zilebesiran program. Total revenues more than doubled year-over-year for both the quarter and the nine-month period, indicating robust commercial execution and successful strategic partnerships. The company demonstrated substantial progress in its financial position, with a significant increase in cash and cash equivalents, largely due to proceeds from the issuance of new convertible senior notes and strong operating cash flow. Despite increased operating costs and expenses, including higher R&D and SG&A spending to support pipeline advancement and commercial expansion, Alnylam achieved operating income and net income for the quarter, a notable improvement from the prior year's loss. The company also strategically managed its debt by repurchasing a portion of its 2027 convertible notes and issuing new 2028 notes, alongside establishing a new revolving credit facility, enhancing its financial flexibility. Key developments in the pipeline include positive results and initiation of Phase 3 trials for nucresiran and zilebesiran, respectively, alongside continued progress in other key programs. The company's commercial products, particularly AMVUTTRA, are showing strong growth, and collaborations with partners like Roche and Regeneron are contributing significantly to revenue, underscoring Alnylam's strategy of building a multi-product, global biopharmaceutical company.

Financial Statements
Beta

Key Highlights

  • 1Total revenues surged by 149% to $1.25 billion for the three months ended September 30, 2025, and by 58% to $2.62 billion for the nine months ended September 30, 2025, driven by strong net product revenues and significant collaboration revenues.
  • 2Net product revenues nearly doubled year-over-year to $851.1 million in Q3 2025, primarily due to strong growth in AMVUTTRA sales, partially offset by a decline in ONPATTRO.
  • 3Collaboration revenues saw a substantial increase, driven by a $300 million milestone payment from Roche related to the zilebesiran program.
  • 4The company reported income from operations of $368 million and net income of $251.1 million for Q3 2025, a significant turnaround from the operational loss of $76.9 million and net loss of $111.6 million in Q3 2024.
  • 5Cash, cash equivalents, and restricted cash increased significantly to $1.49 billion as of September 30, 2025, bolstered by net proceeds from convertible note issuance and operating cash flows.
  • 6Alnylam issued $661.3 million in 0.00% convertible senior notes due 2028 and utilized net proceeds, along with cash on hand, to repurchase $637.8 million of its 1.00% convertible senior notes due 2027.
  • 7A new $500 million revolving credit facility was established, providing additional financial flexibility and liquidity.

Frequently Asked Questions

Alnylam's revenue growth in Q3 2025 was primarily driven by a significant increase in net product revenues, particularly from AMVUTTRA, and a substantial rise in net revenues from collaborations. The collaboration revenue was boosted by a $300 million milestone payment from Roche related to the zilebesiran development program.

Alnylam strategically managed its debt by issuing $661.3 million in new 0.00% convertible senior notes due 2028 and using the proceeds, along with existing cash, to repurchase $637.8 million of its 1.00% convertible senior notes due 2027. Additionally, the company established a new $500 million revolving credit facility, enhancing its financial flexibility.

The company is making significant progress with its pipeline. For zilebesiran, Phase 3 trials (ZENITH) have been initiated following positive Phase 2 data. Nucresiran has shown strong reductions in serum TTR in Phase 1 trials, and Phase 3 trials (TRITON-CM and TRITON-PN) are now underway. Cemdisiran, in collaboration with Regeneron, has shown positive results in Phase 3 trials for generalized myasthenia gravis, with a planned U.S. regulatory submission in Q1 2026.

Alnylam demonstrated a strong financial turnaround in Q3 2025 compared to Q3 2024. The company reported a significant net income of $251.1 million, a substantial improvement from a net loss of $111.6 million in the prior year. This was supported by a 149% increase in total revenues and improved operational efficiency, despite higher R&D and SG&A investments.