Alnylam Pharmaceuticals, Inc.
ALNY · NASDAQ-GS
Next quarter
Expected to report Feb 11, 2027 — estimated from last year’s reporting date.
Consensus is $1.80 EPS for Dec 2026 across 9 estimates, ranging $1.22 to $2.31.
ALNY Sep 2026
- 976.71%
- $1.46
- $15.72
- —
- $1.46B
Reported results
- $1.46B
- 75.19%
- $345.80M
- 23.72%
- $2.17B
- $15.72
Highlights
- TTR-led sales: Q3 net product revenue rose 52% year over year to $1.292 billion; AMVUTTRA contributed $1.130 billion, up 65%, and total TTR sales reached $1.150 billion, up 59%.
- EPS and tax benefit: Diluted GAAP EPS of $15.72 topped the $1.46 consensus by 976.71%, but included a $1.872 billion income tax benefit, primarily from releasing valuation allowances on deferred tax assets.
- Demand and guidance: Management reiterated 2026 guidance but expects TTR product revenue at the low end of its $4.2 billion-$4.5 billion range; it said expanded sales-force activity has not yet translated into demand growth at the expected pace.
- Quarterly financials: Total revenue was $1.458 billion, up 17% year over year and 13% from Q2’s $1.29 billion; operating income fell 6% year over year to $345.8 million, while non-GAAP operating income fell 11% to $424.9 million.
- Q3 TTR drivers: U.S. TTR revenue increased about $100 million sequentially, including $81 million from demand, $17 million from inventory, and roughly $10 million from favorable one-time gross-to-net adjustments; inventory and price are expected to weigh on Q4 reported growth.
- TRITON-CM expansion: Alnylam raised the nucresiran Phase 3 study’s target enrollment from 1,750 to approximately 2,250, citing potential lower event rates, while maintaining an expected ATTR-CM launch by 2030 if results are positive and the drug is approved.
- Brezosiran data: Phase 1 results showed 60%-64% mean CSF mutant huntingtin reductions at month three in the highest dose group reported, with an individual reduction up to 83%; a pivotal study is planned for 2027, pending regulatory alignment.
- Liquidity and rare products: Cash, cash equivalents and marketable securities totaled $3.6 billion, up from $2.9 billion at year-end 2025; Rare product revenue was $142.0 million, up 12% year over year.
Analysis
Alnylam reported a strong commercial quarter but a headline EPS result dominated by tax accounting. Revenue of $1.458 billion rose 17% from Q3 2025 and 13% from Q2 2026; diluted EPS of $15.72 was far above the $1.46 consensus, largely because a $1.872 billion tax benefit followed the release of valuation allowances. The operating picture was less dramatic: GAAP operating income declined 6% year over year to $345.8 million, and non-GAAP operating income fell 11% to $424.9 million, partly reflecting the absence of a $300 million Roche milestone recognized a year earlier and higher operating costs.
The central story remains AMVUTTRA’s rapid growth alongside management’s concern that demand is not accelerating as hoped. Total TTR revenue increased 59% year over year to $1.150 billion, but sequential U.S. growth included inventory and one-time pricing benefits, and management expects TTR sales to land at the low end of its unchanged 2026 range. The quarter also brought a larger nucresiran Phase 3 study, with target enrollment increased to 2,250 while the company retained its expected 2030 launch timing. Initial brezosiran data offered a potential growth avenue beyond TTR, with a pivotal study planned for 2027, subject to regulatory alignment.
AMVUTTRA demand
AMVUTTRA drove the print: revenue was $1.130 billion, up 65% year over year, while ONPATTRO declined 50% to $19.6 million. Together, TTR products generated $1.150 billion, up 59%. Rare products contributed $142.0 million, up 12%, with GIVLAARI up 21% to $89.5 million and OXLUMO roughly flat at $52.5 million. Total product revenue grew 52% to $1.292 billion.
The sequential TTR growth needs context. U.S. TTR revenue rose about $99 million from Q2, supported by $81 million of demand growth and a $17 million inventory benefit as distributor inventory rose from 19 to 21 days. A roughly $10 million favorable one-time gross-to-net adjustment also helped reported revenue. International TTR revenue grew $20 million sequentially, reflecting launches and order timing. Management said expanded field engagement is not yet translating into demand at the desired pace: more than 2,000 new unique prescribers have tried AMVUTTRA since the U.S. ATTR-CM launch, but only about one-third of category prescribers have used it. AMVUTTRA represented 24% of total TTR prescriptions, while about 80% of prevalent U.S. ATTR-CM patients remain untreated.
Guidance and access
Alnylam reiterated full-year guidance, including $4.2 billion-$4.5 billion of TTR product revenue, $500 million-$600 million of Rare product revenue, and $4.7 billion-$5.1 billion of total product revenue. On the call, management said it expects TTR sales near the low end of the range and does not expect the expanded field force to contribute materially to 2026 revenue. It also does not expect demand growth to accelerate in Q4. Inventory and U.S. pricing are expected to be headwinds to reported Q4 growth.
The company cited two additional uncertainties: the pending CMS 340B reimbursement rule and UnitedHealth’s more restrictive first-line AMVUTTRA policy for Medicare Advantage, effective October 1. Alnylam expects the 340B proposal could create Q4 ordering volatility and may affect price or volume depending on provider responses; the ultimate effect is not yet known. It said existing UnitedHealth patients are not expected to be affected, though new starts may face delays. Management will provide 2027 guidance with full-year results in February rather than at the January JPMorgan conference, allowing more time to assess ordering and site-of-care changes.
Earnings and tax
Total revenue of $1.458 billion was up from $1.249 billion a year earlier and $1.29 billion in Q2. Product growth and higher royalties helped offset collaboration revenue falling 80% year over year to $71.5 million, primarily because Q3 2025 included a $300 million Roche milestone. Royalty revenue more than doubled to $94.7 million, driven by Leqvio sales.
Operating income was $345.8 million, down 6% year over year, as operating expenses rose 26% to $1.112 billion. Cost of goods sold increased to 28.0% of product revenue from 23.2%, reflecting the higher blended royalty rate on AMVUTTRA sales. R&D rose 14% to $408.5 million and SG&A rose 6% to $342.0 million, reflecting Phase 3 trial spending and commercial-launch investment. Net income of $2.167 billion and diluted EPS of $15.72 included a $1.872 billion income tax benefit, primarily related to valuation-allowance releases; the $1.46 consensus EPS comparison therefore does not represent the quarter’s operating performance. Cash, cash equivalents and marketable securities were $3.6 billion at quarter-end.
Nucresiran trial
Alnylam increased TRITON-CM’s target enrollment from 1,750 to approximately 2,250 patients, adding 500 participants to protect statistical power against potentially lower event rates as ATTR-CM diagnosis and background treatment evolve. The company plans to further enrich for earlier-stage patients using NT-proBNP inclusion criteria. Management said the event-driven study’s primary endpoint— all-cause mortality and recurrent cardiovascular events—remains unchanged, and the enrollment increase is not expected to alter the anticipated ATTR-CM launch by 2030, assuming positive data and regulatory approval. Nucresiran is positioned as a next-generation TTR silencer, with the potential for deeper TTR lowering and twice-yearly dosing.
Pipeline beyond TTR
Initial Phase 1 brezosiran results in Huntington’s disease showed dose-dependent CSF mutant huntingtin lowering. At month three, the highest dose group reported a mean reduction of 60%-64% across two assays, with a maximum individual reduction of 83%. Alnylam reported no dose-dependent increases to date in CSF inflammatory markers or neurofilament light chain, or evidence of ventricular enlargement. It plans a placebo-controlled pivotal study in 2027, pending regulatory alignment; the program is being developed with Regeneron.
Other pipeline updates included completed enrollment in the mivelsiran Phase 2 CAA study and initiation of a Phase 2 study in Down syndrome-associated Alzheimer’s disease. The company also expects to present Phase 1 healthy-volunteer data for ALN-6400 at the December ASH meeting and to report Phase 2 HHT data for ALN-6400 and Phase 1 obesity data for ALN-2232 with its Q4 and full-year results in February 2027.
