Alnylam 2025-26: Amvuttra Launch +81% Revenue, GAAP Profitable
FY25 revenue $3.71B (+65%); Op income $502M (vs -$177M FY24); NI $314M (vs -$278M FY24); EPS $2.33 (first GAAP profitable year). Amvuttra ATTR cardiomyopathy approval the landmark; combined net product revenues nearly $3B (+81%). Q4 global TTR net revenues $858M (+18% sequential / +151% YoY). Rare disease franchise $136M Q4 (+26% YoY). FY26 guide: combined net product sales $4.9B-$5.3B (+71% midpoint).
Key takeaways
- First full year of GAAP profitability. Op income +$502M (vs -$177M FY24); NI $314M (vs -$278M FY24); EPS $2.33. The Amvuttra ATTR-CM launch flipped the income statement.
- TTR franchise +151% Q4 YoY. Q4 global TTR net revenues $858M (+18% sequential, +151% YoY). Combined product revenue ~$3B (+81%) — the cleanest specialty pharma growth print of FY25.
- FY26 guide: combined product revenue $4.9-$5.3B. +71% growth midpoint vs FY25's ~$3B. Total TTR franchise guide $4.4-$4.7B alone — Amvuttra ATTR-CM is the main vehicle.
- Established innovation engine. Multiple programs in pipeline beyond TTR: rare disease (Givlaari, Oxlumo) + cardiometabolic (zilebesiran for hypertension, fitusiran for hemophilia partnership) + CNS (vutrisiran also being studied in additional indications).
- GAAP profitability changes capital structure narrative. Self-funding R&D + commercial expansion now possible without debt or equity dilution. Total debt $1.28B (-$1.46B from FY24's $2.74B peak).
Business
Alnylam Pharmaceuticals is the leading RNA-interference (RNAi) therapeutics company. Single therapeutic platform (siRNA + chemistry + delivery) producing 4 commercial products + deep pipeline:
- TTR Franchise (~80% of revenue, growing fastest): Onpattro (patisiran, ATTR-PN, hereditary), Amvuttra (vutrisiran, ATTR-PN + ATTR-CM as of FY25 approval). Amvuttra ATTR-cardiomyopathy approval is the major FY25 catalyst — opens the much larger ATTR-CM market vs ATTR-PN.
- Rare Disease (~15% of revenue): Givlaari (givosiran, AHP — acute hepatic porphyria), Oxlumo (lumasiran, PH1 — primary hyperoxaluria type 1).
- Collaborations + Royalties (~5% of revenue): Royalties from Leqvio (inclisiran, partnered with Novartis for hyperlipidemia), other partnered programs.
Pipeline: Zilebesiran (Phase 3 hypertension), fitusiran (Sanofi partnership for hemophilia), vutrisiran additional indications, plus next-gen oligonucleotides + multiple wholly-owned + partnered candidates.
Strategic position: only company with multiple approved RNAi therapeutics. Differentiated mechanism + multi-decade IP position. Amvuttra ATTR-CM expands the addressable market dramatically vs ATTR-PN-only.
FY25 financial performance
| Metric (FY) | 2023 | 2024 | 2025 |
|---|---|---|---|
| Revenue ($B) | 1.83 | 2.25 | 3.71 |
| Gross profit ($B) | 1.52 | 1.92 | 3.04 |
| Op income ($M) | -282 | -177 | 502 |
| Op margin | -15.4% | -7.9% | 13.5% |
| EBITDA ($M) | -258 | -179 | 557 |
| Net income ($M) | -440 | -278 | 314 |
| Diluted EPS ($) | -3.52 | -2.18 | 2.33 |
| FCF ($M) | 42 | -43 | 465 |
| Capex ($M) | -62 | -34 | -59 |
| Total debt ($B) | 1.31 | 2.74 | 1.28 |
| Buyback ($M) | 0 | 0 | 0 |
The transformation: revenue went 4-year compounding from $1.83B → $2.25B → $3.71B (+65% in FY25). Op income flipped from -$282M to +$502M. The Amvuttra ATTR-CM launch explains most of the inflection.
Total debt collapsed from $2.74B FY24 (likely convertible refinancing) to $1.28B FY25.
Capital allocation
- Capex: $-59M FY25 (1.6% of revenue). Light.
- Dividends: zero. Reinvest cash in R&D + commercial expansion.
- Buybacks: zero.
- R&D: meaningfully larger than capex — reinvesting in pipeline.
- Debt: $1.28B (-$1.46B YoY). Major paydown post-profitability.
FY26 outlook (per Q4 2025 call, 2026-02-12)
| FY26 guide | Range |
|---|---|
| Combined net product sales | $4.9B-$5.3B (+71% midpoint) |
| Total TTR franchise | $4.4B-$4.7B |
| Collaboration + royalty revenue | $400-$500M (range partial) |
The +71% net product sales growth is structurally aggressive but reflects: (a) Amvuttra ATTR-CM full-year contribution + indication expansion, (b) continued underlying TTR-PN volume + share, (c) rare disease franchise compounding.
Key risks
- Amvuttra ATTR-CM uptake: Launch trajectory + payer dynamics + competition (BridgeBio's acoramidis, Pfizer's tafamidis incumbents). Speed of adoption.
- Patient identification + diagnosis: ATTR-CM remains underdiagnosed; commercial execution critical.
- Pipeline readouts: Zilebesiran Phase 3 hypertension; multiple early-stage candidates.
- Pricing + reimbursement: Expensive specialty drug economics under pressure (IRA Medicare drug pricing, payer pushback).
- Patent expiration timeline: First-gen patisiran going off patent eventually; Amvuttra has longer runway.
- Competition: BridgeBio, Pfizer, Ionis (similar TTR therapeutics) all in the ATTR space.
Bottom line
ALNY FY25 is the platform inflection year. Revenue +65%, first GAAP profitable year, EPS $2.33, debt -$1.46B. Amvuttra ATTR-CM approval the launch catalyst. FY26 product revenue guide $4.9-5.3B (+71% midpoint). Risks are launch execution + competition + reimbursement. The structural read: only multi-product RNAi company + Amvuttra ATTR-CM as multi-billion-dollar platform.
Citations
- Alnylam Pharmaceuticals Inc. FY25 Form 10-K (filed February 2026, SEC EDGAR).
- ALNY Q4 2025 earnings call, 2026-02-12 — Amvuttra ATTR-CM landmark approval; combined product revenue ~$3B (+81%); first GAAP profitable year; Q4 TTR $858M (+18% sequential / +151% YoY); rare disease $136M Q4 (+26%); FY26 product sales $4.9B-$5.3B (+71% midpoint), TTR franchise $4.4-$4.7B.
- Internal financial_statements view (consolidated annual + cash flow + capital structure).