01—Abstract
Summary
Summary of the 10-K filed February 13, 2025. Cited figures are marked; the original filing is the authoritative source.
Alnylam Pharmaceuticals (ALNY) enters 2025 as a commercial-stage RNAi company with five approved products and a stated goal of becoming a self-sustainable, top-tier biotech by the end of 2025 under its Alnylam P5x25 strategy.
FY2024 total revenues rose 23% to $2.25 billiona, driven by net product revenues of $1.65 billion (up 33%), led by AMVUTTRA at $970.5 million (up 74%). ONPATTRO declined 29% to $252.9 million as patients switched to AMVUTTRA, while GIVLAARI ($255.9 million) and OXLUMO ($167.1 million) grew. Collaboration revenue fell 7% to $510.2 million, largely because of a one-time Roche license recognition in 2023, and royalty revenue more than doubled to $91.8 million on Leqvio sales by Novartis.
Profitability improved sharply but the company remains unprofitable. The net loss narrowed to $278.2 millionb from $440.2 million, helped by a $99.2 million tax benefit from releasing a Swiss valuation allowance, and operating loss narrowed to $176.9 million. Operating cash flow was roughly breakeven at negative $8.3 million, and cash, equivalents and marketable securities reached $2.69 billion against $1.04 billion of 1% convertible notes due 2027 and a $1.45 billion liability related to the Blackstone royalty sale.
Management believes existing cash supports operations for at least 12 months and expects to reach self-sustainability by end-2025 without equity financing, though that depends on product and royalty growth. Key near-term catalysts and risks include the March 23, 2025 PDUFA date for AMVUTTRA in ATTR cardiomyopathy following positive HELIOS-B data, the March 28, 2025 PDUFA for Sanofi's fitusiran, a July 2025 trial date in the Pfizer/BioNTech patent litigation, and a new University of Texas patent suit against ONPATTRO. Heavy reliance on collaborators, a 2023 FDA CRL for patisiran in ATTR-CM, and a Blackstone royalty step-up risk if Leqvio sales lag are also material.
02—Key points
Key Highlights
- Total FY2024 revenues rose 23% to $2.25 billion; net product revenues grew 33% to $1.65 billion, led by AMVUTTRA at $970.5 million (up 74%).
- Net loss narrowed to $278.2 million (from $440.2 million), aided by a $99.2 million income tax benefit from releasing a Swiss deferred tax asset valuation allowance.
- Operating cash flow was approximately breakeven (-$8.3 million), and cash, equivalents and marketable securities totaled $2.69 billion at year-end 2024.
- Key 2025 catalyst: FDA PDUFA action date of March 23, 2025 for AMVUTTRA in ATTR amyloidosis with cardiomyopathy, based on positive HELIOS-B Phase 3 results (28% reduction in all-cause mortality and recurrent CV events).
- Collaboration revenue declined 7% to $510.2 million after a one-time $310 million Roche license recognition in 2023, but Roche and Regeneron revenue is expected to rise in 2025, and royalty revenue on Leqvio more than doubled to $91.8 million.
- Balance sheet carries $1.04 billion of 1% convertible notes due 2027 and a $1.45 billion liability related to the Blackstone sale of Leqvio royalties, with a royalty step-up risk if Leqvio sales fall short of $1.00 billion by end-2029.
- Pending litigation includes patent infringement suits against Pfizer/BioNTech and Moderna (trial set for July 7, 2025) and a new University of Texas suit alleging infringement by ONPATTRO.
03—One dollar
Follow one dollar
For each $1.00 of revenue in FY2024, Alnylam Pharmaceuticals, Inc. lost $0.12.
- Revenue$2.25B100.0%
- Cost of revenue−$306.5M13.6%
- Gross profit$1.94B86.4%
- Operating costs−$2.12B94.2%
- Operating income−$176.9M7.9%
- Interest, other & tax−$101.3M4.5%
- Net income−$278.2M12.4%
04—Financials
Financial Highlights
Figures from 10-KFY2024filed February 13, 2025Financial Statements
FY2024 against FY2023
| Line item | FY2024FY2023 | Change |
|---|---|---|
| Revenue | $2.25B$1.83B | +23.0% |
| Cost of Revenue | $306.51M$268.22M | +14.3% |
| Gross Profit | $1.94B$1.56B | +24.5% |
| R&D Expenses | $1.13B$1.00B | +12.1% |
| SG&A Expenses | $975.53M$795.65M | +22.6% |
| Operating Expenses | $2.43B$2.11B | +14.9% |
| Operating Income | -$176.88M-$282.18M | +37.3% |
| Net Income | -$278.16M-$440.24M | +36.8% |
| EPS (Basic) | $-2.18$-3.52 | +38.1% |
| EPS (Diluted) | $-2.18$-3.52 | +38.1% |
| Shares Outstanding (Basic) | 127.65M124.91M | +2.2% |
| Shares Outstanding (Diluted) | 127.65M124.91M | +2.2% |
05—Questions
Frequently Asked Questions
Is Alnylam on track to become self-sustainable by the end of 2025 without raising equity?
Management says its current cash, marketable securities, product sales and collaboration and royalty revenues, including Leqvio milestones and royalties, should enable a self-sustainable profile by end-2025 without future equity financing. However, the company still reported a $278.2 million net loss and a near-zero operating cash flow in 2024, so the goal depends on continued growth in AMVUTTRA sales and on collaboration receipts, including the Roche zilebesiran milestones.
How important is AMVUTTRA to the company's revenue outlook?
AMVUTTRA is now the largest driver of revenue, generating $970.5 million in 2024 (about 59% of net product revenue), up from $557.8 million in 2023. The company expects continued growth, and a cardiomyopathy label would add a large new indication, but the PDUFA date is March 23, 2025, and the FDA previously issued a complete response letter for the related patisiran sNDA in 2023, so approval is not assured.
Why did collaboration revenue decline in 2024 even though royalties rose?
Collaboration revenue fell 7% to $510.2 million because 2023 included $310 million recognized upon transfer of the Roche zilebesiran license, which had no equivalent in 2024. Partly offsetting this were $185 million from the June 2024 Regeneron cemdisiran modification and $65 million from the KARDIA-3 development milestone, while royalty revenue on Leqvio sales by Novartis rose to $91.8 million from $40.6 million.
What are the main debt and financing obligations investors should understand?
Alnylam has $1.04 billion of 1% convertible senior notes due September 2027, which may require cash settlement on conversion or repurchase upon a fundamental change. It also carries a $1.45 billion liability related to the Blackstone sale of Leqvio royalties and milestones, with an effective interest rate of 10%. If Leqvio royalties paid to Blackstone do not reach $1.00 billion by the end of 2029, Blackstone's share increases from 50% to 55% starting in 2030, reducing Alnylam's royalty retention.
What litigation and regulatory risks could materially affect the company?
The company is pursuing patent infringement suits against Pfizer/BioNTech and Moderna over its lipid patents, with a trial set for July 7, 2025, and faces a December 2024 lawsuit from the University of Texas alleging that ONPATTRO infringes a patent. An Acuitas declaratory judgment action seeks to add co-inventors to its patents. Regulatory risks include the FDA's pending review of AMVUTTRA and Sanofi's fitusiran, the partial clinical hold on mivelsiran, and evolving U.S. drug pricing rules under the Inflation Reduction Act.
06—Continue