01—Abstract
Summary
Summary of the 8-K filed April 30, 2026. Cited figures are marked; the original filing is the authoritative source.
Alnylam Pharmaceuticals reported first quarter 2026 results on April 30, 2026, with total revenues of $1,167 milliona, up 96% year over year (93% at constant exchange rates).
Total net product revenues reached $1,036 millionb, up 121%, driven by AMVUTTRA (vutrisiran) for ATTR-CM, which generated $890 million, up 187%. Management highlighted that this was the first quarter in company history with over $1 billion in product revenue, marking one year since the U.S. launch of AMVUTTRA for ATTR-CM. Total TTR net product revenue was $910 million, while Rare disease products (GIVLAARI and OXLUMO) contributed $126 million, up 15%.
ONPATTRO declined 59% to $20 millionc as patients shifted to AMVUTTRA. Profitability improved sharply. GAAP income from operations rose to $269 million from $18 million a year earlier, and GAAP net income was $206 million, or $1.51 per diluted share, versus a net loss of $18 million in the prior-year period.
Non-GAAP net income was $273 milliond, or $1.99 per diluted share. Gross margin pressure is visible, with cost of goods sold rising to 20% of net product revenues from 15%, reflecting higher AMVUTTRA royalty obligations. R&D and SG&A expenses increased, driven by Phase 3 trials (ZENITH, TRITON-CM, TRITON-PN) and commercial launch spending.
Cash, cash equivalents and marketable securities totaled $3.0 billion at quarter end, and stockholders' equity rose to $1,075 million from $789 million. Management reiterated full-year 2026 guidance: total net product revenues of $4.9 billion to $5.3 billion, including $4.4 billion to $4.7 billion from TTR products, and non-GAAP R&D and SG&A expenses of $2.7 billion to $2.8 billion.
The company also expanded the TRITON-CM Phase 3 trial of nucresiran from 1,250 to about 1,750 patients due to faster-than-expected enrollment, while still targeting a 2030 launch. Several clinical readouts are expected in the second half of 2026.
02—Key points
Key Highlights
- Total revenues of $1,167 million, up 96% year over year; total net product revenues of $1,036 million, up 121%, surpassing $1 billion in quarterly product revenue for the first time.
- AMVUTTRA net product revenue of $890 million (up 187%) drove growth in ATTR-CM; ONPATTRO fell 59% to $20 million.
- GAAP net income of $206 million ($1.51 per diluted share) versus a net loss of $18 million in Q1 2025; GAAP operating income of $269 million versus $18 million.
- Cost of goods sold rose to 20% of net product revenues from 15%, due to higher AMVUTTRA sales and a higher blended royalty rate.
- Cash, cash equivalents and marketable securities of $3.0 billion at March 31, 2026, up from $2.9 billion at year-end 2025, driven by operating cash inflows.
- Full-year 2026 guidance reiterated: total net product revenues of $4.9–$5.3 billion and non-GAAP R&D plus SG&A of $2.7–$2.8 billion.
- TRITON-CM Phase 3 enrollment for nucresiran expanded from 1,250 to about 1,750 patients, with the 2030 ATTR-CM launch target maintained; several pipeline readouts expected in 2H 2026.
03—Questions
Frequently Asked Questions
How much did Alnylam's revenue grow in Q1 2026, and what drove it?
Total revenues grew 96% to $1,167 million (93% at constant currency). The growth was driven primarily by AMVUTTRA, whose net product revenue rose 187% to $890 million on increased patient demand for ATTR-CM in the U.S. Rare disease products grew 15%, and royalty revenue rose 85% on higher Leqvio royalties from Novartis. Collaboration revenue declined 17%, largely because of a $30 million Vir Biotechnology payment recognized in Q1 2025 that did not recur.
Is Alnylam now profitable on a GAAP basis?
Yes, for this quarter. GAAP net income was $206 million, or $1.51 per diluted share, compared with a net loss of $18 million in Q1 2025. GAAP operating income was $269 million. Stock-based compensation of $70 million is a significant item excluded from the non-GAAP figures, which showed net income of $273 million, or $1.99 per diluted share.
What are the main risks to margins and expenses going forward?
Cost of goods sold increased to 20% of net product revenues from 15%, reflecting a higher blended royalty rate on AMVUTTRA sales. R&D and SG&A are rising because of Phase 3 trials (ZENITH, TRITON-CM, TRITON-PN) and commercial launch spending. Interest expense of $69 million, including payments tied to royalty sale and development funding liabilities, also weighs on earnings. Management's guidance calls for non-GAAP R&D and SG&A of $2.7–$2.8 billion for 2026, excluding $300–$400 million of stock-based compensation.
Did management change 2026 financial guidance?
No. Management reiterated full-year 2026 guidance: total net product revenues of $4.9–$5.3 billion, TTR net product revenues of $4.4–$4.7 billion, Rare net product revenues of $500–$600 million, and net collaboration and royalty revenues of $400–$500 million. Q1 results were strong relative to this range, but the company did not raise guidance in the release.
What catalysts should investors watch in the rest of 2026?
In the first half, Alnylam expects to complete enrollment in the cAPPricorn-1 Phase 2 trial of mivelsiran in cerebral amyloid angiopathy, initiate a Phase 2 trial of mivelsiran in Alzheimer's disease, and start a Phase 2 trial of ALN-6400 in a second bleeding disorder. In the second half, it expects clinical data from ALN-6400 (Phase 1 and Phase 2 in HHT), ALN-HTT02 in Huntington's disease, and ALN-2232 in obesity. Regeneron has also submitted an NDA for cemdisiran in generalized myasthenia gravis.
04—Continue