Alnylam Pharmaceuticals, Inc.
ALNY · Nasdaq
Sep 2026
Next quarter
Reports Oct 29, 2026.
Consensus is $1.68 EPS for Sep 2026 across 9 estimates, ranging $1.27 to $2.87.
ALNY Jun 2026
- 15.97%
- +0.02%
- $1.44
- $1.21
- —
- $1.29B
Reported results
- $1.29B
- 76.90%
- $231.44M
- 17.93%
- $164.49M
- $1.21
Highlights
- AMVUTTRA demand: Second-quarter AMVUTTRA revenue reached $1.012 billion, up 106% year over year, driving total TTR revenue of $1.030 billion, up 89%.
- Guidance reset: Alnylam cut 2026 TTR revenue guidance to $4.2-$4.5 billion from $4.4-$4.7 billion, citing normalized U.S. second-line demand after launch-related pent-up demand.
- Earnings miss: Diluted GAAP EPS was $1.21 versus consensus of $1.44, a 15.97% miss; net income was $164.5 million versus $206.0 million in Q1 2026.
- Revenue growth: Total revenue rose 67% year over year to $1.291 billion, including $1.172 billion of product revenue, up 74% from $672.2 million.
- Profitability: GAAP operating income was $231.4 million versus a $16.2 million operating loss a year ago, while non-GAAP operating income rose 233% to $318.1 million.
- Margin pressure: Cost of goods sold increased to 25.4% of product revenue from 21.1%, primarily because AMVUTTRA carries a higher blended royalty rate payable to Sanofi.
- Pipeline investment: R&D expense increased 28% to $413.1 million as spending rose on the ZENITH, TRITON-CM and TRITON-PN Phase 3 trials; SG&A rose 8% to $347.9 million.
- Other products and royalties: GIVLAARI and OXLUMO generated $89.8 million and $52.1 million, respectively, up 11% each, while royalty revenue rose 79% to $71.7 million.
- Liquidity: Cash, cash equivalents and marketable securities totaled $3.3 billion at June 30, 2026, up from $2.9 billion at year-end, with six-month operating cash flow of $397.2 million.
Analysis
Alnylam’s second quarter was defined by the scale of AMVUTTRA’s ATTR-CM launch and a reset in the pace investors should expect from it. Revenue of $1.291 billion increased 67% from $773.7 million a year ago, and GAAP operating income reached $231.4 million versus a $16.2 million loss. However, diluted EPS of $1.21 missed the $1.44 consensus estimate by 15.97%, and net income declined to $164.5 million from $206.0 million in the first quarter. The company therefore delivered strong top-line growth but weaker sequential earnings and lower-than-expected per-share results.
AMVUTTRA supplied most of the momentum: revenue rose 106% year over year to $1.012 billion, with U.S. demand increasing $129 million sequentially, partly offset by roughly $20 million of inventory impact and modestly lower net price. Management said second-line growth normalized after an initial burst of pent-up demand and reduced full-year TTR guidance by $200 million at both ends of the range. At the same time, Alnylam is spending into the opportunity and future pipeline: R&D rose 28% and SG&A 8%, while higher AMVUTTRA royalties lifted cost of goods sold to 25.4% of product revenue. The quarter also brought continued pipeline advancement, including new Phase 2 starts and ongoing Phase 3 investment in zilebesiran and nucresiran.
AMVUTTRA launch trajectory
- Commercial scale: AMVUTTRA generated $1.012 billion of global net product revenue, up 106% from $492.0 million in Q2 2025. U.S. revenue was $809.1 million, Europe was $119.0 million and the rest of the world was $83.7 million.
- Sequential demand: U.S. TTR revenue increased $106 million from Q1, consisting of a $129 million increase in demand, partly offset by approximately $20 million of inventory impact and a modest net-price reduction. Management said second-quarter demand growth was more than twice the Q1-over-Q4 increase.
- Guidance change: Full-year TTR revenue guidance moved to $4.2-$4.5 billion from $4.4-$4.7 billion. The revised midpoint of $4.35 billion implies 75% growth over 2025, but reflects management’s view that early second-line demand benefited from patients waiting for a new treatment option and was not a sustainable run rate.
- Evidence and access: New HELIOS-B analyses showed maintained reductions in all-cause mortality and recurrent cardiovascular events across key heart-failure-therapy subgroups. Alnylam also began a planned observational study of more than 2,000 ATTR-CM patients and partnered with a California health system on AI-enabled cardiac amyloidosis screening.
Revenue mix and earnings
- Product-led growth: Product revenue rose 74% to $1.172 billion, led by $1.030 billion of TTR revenue, up 89%. ONPATTRO declined 65% to $18.5 million as patients shifted toward AMVUTTRA.
- Rare franchise: GIVLAARI revenue increased 11% to $89.8 million and OXLUMO revenue increased 11% to $52.1 million, taking total Rare revenue to $141.9 million, up 11%.
- Collaborations and royalties: Collaboration revenue fell 23% to $47.2 million as Regeneron revenue declined to $5.0 million from $32.5 million, partly offset by Roche revenue rising 129% to $41.9 million. Royalty revenue increased 79% to $71.7 million, driven primarily by higher Leqvio sales.
- GAAP result: Net income was $164.5 million, or $1.21 diluted EPS, compared with a $72.2 million loss and negative $0.55 EPS a year ago. Non-GAAP net income was $251.8 million, or $1.84 diluted EPS, versus $38.2 million, or $0.28, in Q2 2025.
Costs and margin pressure
- Gross margin: Cost of goods sold rose 110% to $298.3 million, reaching 25.4% of product revenue versus 21.1% a year ago. The increase was primarily tied to the higher blended Sanofi royalty rate on AMVUTTRA sales.
- Pipeline spending: GAAP R&D increased 28% to $413.1 million, with clinical research and outside services up 74% to $244.2 million. The principal drivers were the ZENITH Phase 3 trial of zilebesiran and the TRITON-CM and TRITON-PN Phase 3 trials of nucresiran.
- Commercial buildout: SG&A rose 8% to $347.9 million, reflecting marketing for the global ATTR-CM launch and investment in IT infrastructure. Non-GAAP R&D and SG&A were $377.2 million and $297.2 million, respectively.
- Below operating income: Net interest expense increased to $53.6 million from $25.1 million, including $82.1 million of interest expense and $28.1 million of interest income. The increase was mainly associated with liabilities tied to sold Leqvio royalties and development funding.
Pipeline and partnerships
- New clinical starts: Alnylam initiated Phase 2 studies of ALN-6400 in von Willebrand disease and mivelsiran in Down syndrome-associated Alzheimer’s disease, and began a Phase 1 study of ALN-6222 in obesity.
- Mivelsiran progress: Enrollment was completed in the Phase 2 cAPPricorn-1 study in cerebral amyloid angiopathy. Additional Phase 1 data showed durable reductions in CSF biomarkers through up to 30 months of exposure and no evidence of increased ARIA risk in the reported analysis.
- Regeneron catalyst: Regulatory applications for cemdisiran in anti-AChR-antibody-positive generalized myasthenia gravis were accepted by the FDA and EMA. The FDA’s Priority Review has a target action date in November 2026.
- External innovation: Alnylam entered a three-year research collaboration with Inceptive to apply generative AI to RNAi discovery and purchased $15 million of Inceptive preferred stock. It also expanded its Komodo Health analytics partnership and agreed with BeOne Medicines to commercialize AMVUTTRA in mainland China and Macao, subject to approval.
Cash and capital structure
- Cash generation: Six-month operating cash flow was $397.2 million, compared with $9.5 million in the prior-year period, helped by stronger product-sales receipts. Cash, cash equivalents and marketable securities were $3.3 billion at June 30, versus $2.9 billion at December 31, 2025.
- Funding capacity: Alnylam had no borrowings under its $500 million revolving credit facility and $17.5 million of letters of credit outstanding. Management said available liquidity and expected operating inflows should cover near-term needs for at least 12 months from the filing date.
- Royalty obligations: Interest expense includes the accretion of liabilities tied to the sale of future Leqvio royalties and Blackstone funding of vutrisiran and zilebesiran development. The carrying value of the Leqvio royalty liability was $1.52 billion at quarter-end, while the vutrisiran development-funding liability was $181.1 million.
