Record Quarterly Product Revenues
Combined net product revenues of $1.036 billion in Q1 2026 — the company's first quarter exceeding $1 billion; +121% year-over-year and +4% sequentially versus Q4 2025.
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The call presented a strong commercial and financial quarter highlighted by record product revenues, robust TTR franchise growth, profitability and substantial pipeline progress including accelerated Phase III enrollment and supportive real-world evidence. Challenges noted were margin pressure from rising royalties, higher R&D/SG&A investments, an expected Germany pricing adjustment that transiently impacted international results, and typical seasonal/operational phasing headwinds. Management reiterated full-year guidance and communicated confidence in ongoing launch dynamics and pipeline execution, while acknowledging competitive and timing uncertainties.
Alnylam reiterated its full‑year 2026 guidance, reiterating $4.4–$4.7 billion in TTR product sales and noting it expects significantly higher quarter‑over‑quarter TTR revenue growth for the balance of the year to reach that range; Q1 provides the starting base with combined net product revenues of $1.036 billion (first quarter in company history >$1B), TTR net revenues of $910 million (up 153% YoY and 6% QoQ), rare disease revenue of $126 million (up 15% YoY), collaboration revenue of $82 million (down 17% YoY), and royalty revenue of $49 million (up 85% YoY). Financials also showed an 80% gross margin on product sales (down 5% YoY) with the company warning average royalties to Sanofi on AMVUTTRA will rise as sales grow (pressuring margins), non‑GAAP R&D of $335 million (up 39% YoY), non‑GAAP SG&A of $283 million (up 36% YoY), non‑GAAP operating income of $339 million (>4x YoY), and cash, cash equivalents and marketable securities of $3.0 billion (vs. $2.9 billion at 12/31/25); management also cited a modest Q1 selling‑week timing headwind (12 Wednesdays vs 14 in Q4) that it expects will normalize across upcoming quarters.
Combined net product revenues of $1.036 billion in Q1 2026 — the company's first quarter exceeding $1 billion; +121% year-over-year and +4% sequentially versus Q4 2025.
Global TTR net revenues of $910 million in Q1 2026; +153% year-over-year and +6% quarter-over-quarter. U.S. TTR revenues grew ~9% vs Q4 and >230% year-over-year, with $59 million U.S. revenue growth over Q4 despite seasonal shipping and reauthorization dynamics.
Rare disease net revenues of $126 million, +15% year-over-year. Royalty revenues of $49 million, up 85% year-over-year driven by higher global LEQVIO sales.
Non-GAAP operating income of $339 million — more than 4x increase year-over-year. Third consecutive quarter of both GAAP and non-GAAP profitability. Cash, cash equivalents and marketable securities of $3.0 billion (up from $2.9 billion at year-end 2025).
More than 25 clinical programs in development. Initiated Phase I trial of ALN-2232 (adipose-directed RNAi). Presented impactful vutrisiran and zilebesiran data at ACC. Advanced nucresiran TRITON-CM Phase III with enrollment accelerating and protocol expansion from ~1,250 to ~1,750 patients.
Retrospective real-world data (~4 years) showing >93% adherence to vutrisiran (>=80% days covered) and >85% persistence at >1 year. HELIOS-B post-hoc analyses showed vutrisiran reduced risk of worsening diastolic dysfunction and lowered all-cause mortality and cardiovascular events irrespective of baseline DDG.
More than 1,200 unique new U.S. prescribers since last March. Adherence for AMVUTTRA exceeded 90% and first-line access coverage over 90% with most patients facing $0 out-of-pocket; international reimbursement wins and AMVUTTRA launches in Austria, U.K., Switzerland, Italy and strong execution in Japan.
Reiterated full-year guidance (including $4.4B–$4.7B TTR product sales expectation) and reiterated Alnylam 2030 strategic goals: deliver ≥2 transformative medicines beyond TTR, RNAi delivery to ≥10 tissue types, >40 programs in clinic by 2030 and invest ~30% of revenues in non-GAAP R&D across the period.
Hello, and thank you for standing by. My name is Ian, and I will be your conference operator today. At this time, I would like to welcome everyone to the Alnylam Pharmaceuticals Q1 Earnings Conference Call. [Operator Instructions] I would now like to turn this call over to the company. Please go ahead.
Good morning. I'm Christine Akinc, Chief Corporate Communications Officer at Alnylam, with me today are Yvonne Greenstreet, Chief Executive Officer; Tolga Tanguler, Chief Commercial Officer; Pushkal Garg, Chief Research and Development Officer; and Jeff Poulton, Chief Financial Officer. For those of you participating via conference call, the accompanying slides can be accessed by going to the Events section of the Investors page of our website, investors.alnylam.com/events. During today's call as outlined in Slide 2, Yvonne will offer introductory remarks and provide some general context. Tolga will provide an update on our global commercial progress. Pushkal will review pipeline updates, clinical progress and upcoming milestones, and Jeff will review our financials and guidance before we open the call to your questions. I'd like to remind you that this call will contain remarks concerning Alnylam's future expectations, plans and prospects, which constitute forward-looking statements for the purposes of the safe harbor provision under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those in our most recent periodic report on f...
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