Alnylam Pharmaceuticals (ALNY) Earnings Date & Reports

Key Takeaways

• Total revenue rose to $1.458 billion, up roughly 17% year over year, driven by 52% growth in net product revenue to about $1.29 billion.
• The TTR (transthyretin amyloidosis) franchise generated $1.15 billion, up 59% year over year, with flagship therapy AMVUTTRA up 65% to $1.13 billion.
• Non-GAAP diluted earnings per share (EPS) jumped to $16.26, but the figure was inflated by a roughly $1.9 billion non-cash tax benefit from releasing U.S. valuation allowances.
• Non-GAAP operating income fell 11% to $425 million, reflecting a tough comparison against a prior-year $300 million Roche milestone.
• Management reiterated 2026 guidance but signaled TTR revenue will likely land near the low end of its $4.2 billion–$4.5 billion range, and the stock fell sharply after the report.
• For deeper coverage, explore Alnylam's Major News, Today's Price Move, Price Targets, and Forecast on its dedicated pages.
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Earnings Context and Why It Matters

Alnylam's third-quarter 2026 report carried outsized weight because the company is a bellwether for RNAi (RNA interference) therapeutics and because its flagship AMVUTTRA launch in ATTR cardiomyopathy (a progressive heart condition caused by misfolded transthyretin protein) remains central to its growth story. Heading into the print, shares had already fallen sharply during 2026 following earlier guidance cuts, leaving investors less focused on headline profit and more on underlying demand. The quarter would test whether commercial investments and a field-force expansion were converting physician interest into new patient starts, and whether the company could defend its full-year outlook.

Reported Results

Alnylam reported total revenue of $1.458 billion for the third quarter ended September 30, 2026, up roughly 17% year over year and ahead of the approximately $1.43 billion consensus. Net product revenue climbed 52% to about $1.29 billion, led by the TTR franchise at $1.15 billion (up 59%) and AMVUTTRA at $1.13 billion (up 65%).

On the bottom line, GAAP (Generally Accepted Accounting Principles) net income reached $2.17 billion, or $15.72 per diluted share, while non-GAAP diluted EPS came in at $16.26. That headline number was heavily boosted by a roughly $1.9 billion non-cash income tax benefit tied to the release of valuation allowances on U.S. deferred tax assets. Stripping out that distortion, non-GAAP operating income fell 11% to $425 million, pressured by an 80% drop in collaboration revenue (to $71 million) against a prior-year $300 million Roche milestone. Product gross margin slipped five points to 72% on higher AMVUTTRA royalty tiers. The company ended the quarter with $3.6 billion in cash and marketable securities.

On guidance, Alnylam reiterated full-year 2026 total net product revenue of $4.7 billion–$5.1 billion and its $4.2 billion–$4.5 billion TTR range, though management said it now expects TTR revenue near the low end. Collaboration and royalty guidance was trimmed slightly to $575 million–$625 million.

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Market Reaction and Investor Sentiment

Despite a headline EPS beat, Alnylam shares fell sharply after the report, approaching 52-week lows. The market largely looked past the tax-boosted profit figure and instead focused on the quality of the quarter. Management acknowledged that underlying AMVUTTRA demand growth had not met expectations and that the expanded sales force had not yet translated into additional patient starts. Guidance pointing to the low end of the TTR range, combined with fourth-quarter inventory and pricing headwinds, reinforced a cautious tone among investors already skeptical after the stock's steep 2026 decline.

Forward Outlook and Key Factors to Monitor

Investors will be watching several near-term variables. Management flagged fourth-quarter headwinds from U.S. inventory and pricing dynamics, including the reversal of roughly $17 million in inventory benefits and about $10 million in one-time gross-to-net adjustments recorded in the third quarter.

Regulatory and payer developments also loom large. A proposed CMS (Centers for Medicare & Medicaid Services) 340B rule — tied to the federal drug discount program — could reshape Medicare Part B reimbursement as soon as January 2027, introducing uncertainty around net price and volume. Separately, UnitedHealth's more restrictive Medicare Advantage policy on first-line AMVUTTRA took effect October 1 and may delay new patient starts.

On the pipeline front, management expanded enrollment in the TRITON-CM Phase 3 trial of nucresiran to roughly 2,250 patients while maintaining a 2030 launch target for ATTR cardiomyopathy. Additional catalysts include a November 2026 PDUFA (Prescription Drug User Fee Act) decision date for cemdisiran, partnered with Regeneron, and planned pivotal development of brezosiran in Huntington's disease in 2027. Alnylam also said it will delay 2027 product revenue guidance to mid-February 2027, alongside readouts from its obesity and bleeding-disorder programs.

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