Did Alnylam become profitable in 2025?

Yes. The company reported full-year 2025 GAAP income from operations of $501.6 million and GAAP net income of $313.7 million, compared with a GAAP operating loss of $176.9 million and a net loss of $278.2 million in 2024. On a non-GAAP basis, operating income was $849.8 million and net income was $683.6 million. Management expects sustainable growth in operating income going forward.

How much of the growth came from AMVUTTRA?

AMVUTTRA was the dominant driver. Full-year 2025 AMVUTTRA net product revenues were $2.31 billion, up 138% from $970 million in 2024, and it accounted for roughly 78% of total net product revenues. ONPATTRO declined 32% to $173 million over the same period, and Rare products (GIVLAARI and OXLUMO) grew 18% to $500 million.

What is the 2026 revenue outlook?

The company guided to total net product revenues of $4.9 billion to $5.3 billion for 2026, representing 64% to 77% growth. TTR net product revenues are expected at $4.4 billion to $4.7 billion and Rare net product revenues at $500 million to $600 million. Net revenues from collaborations and royalties are projected at $400 million to $500 million, and non-GAAP R&D and SG&A expenses at $2.7 billion to $2.8 billion.

What are the main risks or pressures visible in the results?

Several pressures stand out. Cost of goods sold as a share of net product revenues rose in Q4 because the blended royalty rate payable on AMVUTTRA increased with sales. Collaboration revenue fell 62% in Q4 and 2025 results included one-time milestone recognition, so this line may be lumpy. The company also carries significant liabilities tied to sale-of-royalty and development-funding arrangements, totaling about $1.69 billion at year-end, and recorded $253 million of interest expense in 2025. Dependence on AMVUTTRA's ATTR-CM franchise and third-party partners such as Roche, Novartis and Regeneron are additional concentration risks.

What catalysts should investors watch in 2026?

Near-term items include a March 24, 2026 investor webinar marking the one-year anniversary of AMVUTTRA's ATTR-CM approval, completion of enrollment in the cAPPricorn-1 Phase 2 mivelsiran trial in cerebral amyloid angiopathy in the first half, and initiation of a Phase 2 mivelsiran trial in Alzheimer's disease. Second-half catalysts include Phase 1 and Phase 2 ALN-6400 data, a Phase 1 ALN-HTT02 readout in Huntington's disease, and a Phase 1 ALN-2232 obesity readout.

ALNY 8-K: Earnings & Results

01—Abstract

Summary

Summary of the 8-K filed February 12, 2026. Cited figures are marked; the original filing is the authoritative source.

Alnylam reported fourth quarter and full year 2025 results on February 12, 2026, marking a major inflection point: the company reached GAAP and non-GAAP profitability for the full year.

Q4 2025 total net product revenues were $995 million^a, up 121% year over year (119% at constant exchange rates), driven overwhelmingly by AMVUTTRA's ATTR-CM launch in the U.S. AMVUTTRA alone generated $827 million in Q4 and $2.31 billion for the full year. Full-year total revenues reached $3.71 billion, up 65%, and GAAP income from operations swung to $502 million from a $177 million loss in 2024. Q4 GAAP net income was $112 million, or $0.82 per diluted share.

The balance sheet strengthened meaningfully, with cash, cash equivalents and marketable securities of $2.91 billion^b at year-end, up from $2.69 billion. Stockholders' equity rose to $789 million from $67 million. Management also introduced its five-year "Alnylam 2030" strategy and provided 2026 guidance calling for total net product revenues of $4.9 billion to $5.3 billion (64% to 77% growth), with Rare product revenues of $500 million to $600 million and collaboration and royalty revenues of $400 million to $500 million.

Non-GAAP R&D and SG&A expenses are guided to $2.7 billion to $2.8 billion^c, excluding $300 million to $400 million of stock-based compensation. Key considerations for investors include the concentration of growth in AMVUTTRA, rising cost of goods sold as a share of product sales due to the associated increase in the blended royalty rate payable on AMVUTTRA, and continued reliance on sale-of-royalty and development-funding liabilities (about $1.69 billion combined at year-end). The company also disclosed a planned $250 million investment in a new enzymatic-ligation manufacturing facility in Norton, Massachusetts, and a 2026 pipeline slate of clinical readouts and new trial initiations, with several key data updates expected in the second half of the year.

02—Key points

Key Highlights

Full-year 2025 GAAP profitability: GAAP income from operations of $501.6 million versus a $176.9 million loss in 2024; GAAP net income of $313.7 million ($2.33 diluted EPS).
Q4 2025 total net product revenues of $994.7 million, up 121% year over year; AMVUTTRA contributed $826.6 million (up 189%) in the quarter.
Full-year 2025 total revenues of $3.71 billion, up 65%, with net product revenues of $2.99 billion (up 81%).
2026 guidance: total net product revenues of $4.9 billion to $5.3 billion (64%-77% growth), including TTR revenues of $4.4 billion to $4.7 billion and Rare revenues of $500 million to $600 million.
Cash, cash equivalents and marketable securities rose to $2.91 billion at December 31, 2025, from $2.69 billion a year earlier, and stockholders' equity improved to $789 million from $67 million.
Cost of goods sold rose to 26.9% of Q4 net product revenues (from 22.8%) due to a higher blended royalty rate on AMVUTTRA sales; full-year COGS was 22.7% of net product revenues.
Launched the 'Alnylam 2030' five-year strategy and announced a $250 million Norton, Massachusetts manufacturing expansion built around the siRELIS enzymatic-ligation platform.

03—Questions

Frequently Asked Questions

Did Alnylam become profitable in 2025?
Yes. The company reported full-year 2025 GAAP income from operations of $501.6 million and GAAP net income of $313.7 million, compared with a GAAP operating loss of $176.9 million and a net loss of $278.2 million in 2024. On a non-GAAP basis, operating income was $849.8 million and net income was $683.6 million. Management expects sustainable growth in operating income going forward.
How much of the growth came from AMVUTTRA?
AMVUTTRA was the dominant driver. Full-year 2025 AMVUTTRA net product revenues were $2.31 billion, up 138% from $970 million in 2024, and it accounted for roughly 78% of total net product revenues. ONPATTRO declined 32% to $173 million over the same period, and Rare products (GIVLAARI and OXLUMO) grew 18% to $500 million.
What is the 2026 revenue outlook?
The company guided to total net product revenues of $4.9 billion to $5.3 billion for 2026, representing 64% to 77% growth. TTR net product revenues are expected at $4.4 billion to $4.7 billion and Rare net product revenues at $500 million to $600 million. Net revenues from collaborations and royalties are projected at $400 million to $500 million, and non-GAAP R&D and SG&A expenses at $2.7 billion to $2.8 billion.
What are the main risks or pressures visible in the results?
Several pressures stand out. Cost of goods sold as a share of net product revenues rose in Q4 because the blended royalty rate payable on AMVUTTRA increased with sales. Collaboration revenue fell 62% in Q4 and 2025 results included one-time milestone recognition, so this line may be lumpy. The company also carries significant liabilities tied to sale-of-royalty and development-funding arrangements, totaling about $1.69 billion at year-end, and recorded $253 million of interest expense in 2025. Dependence on AMVUTTRA's ATTR-CM franchise and third-party partners such as Roche, Novartis and Regeneron are additional concentration risks.
What catalysts should investors watch in 2026?
Near-term items include a March 24, 2026 investor webinar marking the one-year anniversary of AMVUTTRA's ATTR-CM approval, completion of enrollment in the cAPPricorn-1 Phase 2 mivelsiran trial in cerebral amyloid angiopathy in the first half, and initiation of a Phase 2 mivelsiran trial in Alzheimer's disease. Second-half catalysts include Phase 1 and Phase 2 ALN-6400 data, a Phase 1 ALN-HTT02 readout in Huntington's disease, and a Phase 1 ALN-2232 obesity readout.

04—Continue

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