01—Abstract
Summary
Summary of the 8-K filed July 31, 2025. Cited figures are marked; the original filing is the authoritative source.
Alnylam Pharmaceuticals reported second quarter 2025 results on July 31, 2025, showing a strong commercial inflection driven by the first full quarter of AMVUTTRA sales in ATTR-CM.
Total net product revenues rose 64% year-over-year to $672 milliona, and total TTR net product revenues reached $544 million (up 77%), with AMVUTTRA contributing $492 million (up 114%) while ONPATTRO declined 32% as patients switched to AMVUTTRA. Total revenues grew 17% to $774 million, though collaboration revenue fell 73% to $61 million because Q2 2024 included $185 million of Regeneron revenue tied to a one-time license modification. Rare disease products (GIVLAARI and OXLUMO) grew 24% to $128 million.
Profitability remained mixed. GAAP operating results swung to a loss of $16 millionb from income of $49 million a year earlier, while non-GAAP operating income fell 31% to $95 million. GAAP net loss was $66 million ($0.51 per share) versus a $17 million loss in the prior-year quarter, driven by higher SG&A (up 30%), R&D (up 10%), and cost of goods sold (up 111%), along with a $31 million tax provision and $40 million of interest expense, including accretion on the Leqvio royalty liability.
Stock-based compensation of $112 millionc was a significant contributor to the GAAP-to-non-GAAP gap. Cash, cash equivalents and marketable securities rose to $2.86 billion from $2.63 billion in the prior quarter. Management raised full-year 2025 guidance meaningfully: total net product revenues are now expected at $2.65-$2.80 billion (up from $2.05-$2.25 billion, roughly a 27% increase at the midpoint), with TTR revenues at $2.175-$2.275 billion.
Management reiterated collaboration and royalty revenue guidance, non-GAAP operating expense guidance, and the goal of achieving non-GAAP operating profitability, while GAAP R&D and SG&A guidance was increased to $2.445d-$2.575 billion, mainly reflecting higher stock-based compensation. Investors will be watching whether AMVUTTRA ATTR-CM uptake continues at its early pace and whether the company converts that growth into sustained profitability.
02—Key points
Key Highlights
- Total net product revenues of $672 million, up 64% year-over-year (62% at constant exchange rates), led by AMVUTTRA at $492 million (up 114%).
- Full-year 2025 total net product revenue guidance raised to $2.65-$2.80 billion from $2.05-$2.25 billion, a 27% increase at the midpoint; TTR guidance raised to $2.175-$2.275 billion.
- Approximately 1,400 ATTR-CM patients on AMVUTTRA as of June 30, 2025, with new approvals in the EU, UK, Japan, and Brazil for the cardiomyopathy indication.
- GAAP operating loss of $16 million versus income of $49 million a year earlier; non-GAAP operating income declined 31% to $95 million, partly due to higher SG&A and cost of goods sold.
- Collaboration revenue fell 73% to $61 million, reflecting the non-recurring $185 million Regeneron license recognized in Q2 2024.
- Cash, cash equivalents and marketable securities of $2.86 billion at June 30, 2025, up from $2.63 billion at March 31, 2025.
- Initiated the event-driven TRITON-CM Phase 3 trial of nucresiran in ATTR-CM (about 1,200 patients), which received FDA Fast Track designation; ONPATTRO revenue declined 32% due to switches to AMVUTTRA.
03—Questions
Frequently Asked Questions
How strong was AMVUTTRA's growth, and what is driving it?
AMVUTTRA generated $492 million in Q2 2025 net product revenue, up 114% year-over-year. Growth was driven mainly by increased demand in ATTR-CM patients in the U.S. Management said early uptake is encouraging, with about 1,400 ATTR-CM patients on therapy as of June 30, 2025. Part of this growth came at the expense of ONPATTRO, which fell 32% as patients switched to AMVUTTRA.
Why did GAAP results weaken despite strong revenue growth?
GAAP operating income moved to a $16 million loss from $49 million income a year earlier. Costs rose faster than revenue: cost of goods sold increased 111% (partly from higher AMVUTTRA royalties), SG&A rose 30% on launch marketing and stock-based compensation, and R&D rose 10% on Phase 3 startup activities. Stock-based compensation of $112 million was a major reconciling item, and GAAP net loss was $66 million ($0.51 per share).
Did the company change its 2025 outlook?
Yes. Total net product revenue guidance was raised to $2.65-$2.80 billion from $2.05-$2.25 billion, with TTR revenue raised to $2.175-$2.275 billion and Rare revenue set at $475-$525 million. Collaboration and royalty revenue guidance and non-GAAP operating expense and profitability targets were reiterated. GAAP R&D and SG&A guidance was increased to $2.445-$2.575 billion, reflecting higher expected stock-based compensation.
Why did total revenue growth look modest compared with product revenue growth?
Total revenues rose 17% to $774 million, well below the 64% product revenue growth. The gap reflects a 73% decline in collaboration revenue, which in Q2 2024 included $185 million recognized from the June 2024 modification of the Regeneron agreement. This was a one-time item, so the comparison is distorted.
What pipeline and regulatory events could matter next?
Key near-term events include the KARDIA-3 Phase 2 zilebesiran data at the ESC Congress on August 30, 2025, and planned second-half 2025 starts for the zilebesiran cardiovascular outcomes trial, the TRITON-PN Phase 3 trial of nucresiran in hATTR-PN, and a Phase 2 mivelsiran trial in Alzheimer's disease. Regeneron also plans to report Phase 3 cemdisiran data in myasthenia gravis in the second half of 2025.
04—Continue