Analyst Conference Summary

biotechnology

conference date: February 12, 2026 @ 5:30 AM Pacific Time
for quarter ending: December 30, 2025 (fourth quarter, Q4)

Forward-looking statements

Overview: Rapid y/y revenue growth, continuing positive net income.

Basic data (GAAP):

Revenue was $1.10 billion, down 12% sequentially from $1.25 billion, and up 85% from $593 million year-earlier.

Net income was $112 million, down 55% sequentially from $251 million, and up from negative $84 million year-earlier.

Diluted EPS was $0.82, down 55% sequentially from $1.84, and up from negative $0.65 year-earlier.

Guidance:

Full year 2026 product revenue $4.9 to $5.3 billion. Collaboration and royalty revenue $400 to $500 million. Non-GAAP combined R&D and SG&A expense $2.7 to $2.8 billion.

Conference Highlights:

Yvonne Greenstreet, CEO of Alnylam, said: "2025 was a year of key accomplishments for Alnylam, highlighted by the landmark approval of Amvuttra for ATTR-CM in the U.S., which drove total net product revenues of nearly $3 billion, or 81% growth year-over-year, and propelled us to profitability. We also achieved great progress across our portfolio, initiating three Phase 3 studies, expanding our pipeline with four proprietary CTAs, and launching a potential best-in-class enzymatic ligation-based RNAi manufacturing platform. We are excited to have recently unveiled our new set of five-year aspirational goals, Alnylam 2030, under which we aim to achieve global TTR leadership with a durable franchise; grow through innovation by delivering therapies that prevent, halt, or reverse disease; and scale with financial discipline and agility. By pursuing these ambitious goals, we believe Alnylam will drive substantial patient impact by addressing serious unmet medical needs around the world and create substantial long-term shareholder value." Plans heavy investment in R&D for development of new therapies, about 30% of revenue. Expects a low-single digit net price decrease for Amvuttra in 2026.

In Q4 2025 Alnylam began a Phase 2 clinical trial of ALN-4324, an RNAi therapeutic targeting GRB14, for type 2 diabetes mellitus.

In Q4 2025 Alnylam began a Phase 1 clinical trial of ALN-2232, an RNAi therapeutic targeting ACVR1C in adipose tissue for obesity and weight management.

In Q4 2025 Alnylam announced the planned expansion of its manufacturing facility in Norton, Massachusetts. Plans to invest $250 million to develop the industry's first fully dedicated, proprietary siRNA enzymatic-ligation manufacturing facility.

In the first half of 2026 Alnylam expects to complete enrollment in the Phase 2 mivelsiran trial for cerebral amyloid angiopathy. Plans to start a Phase trial of mivelsiran for Alzheimer's.

Alnylam in Q4 2025 initiated the TRITON-CM Phase 3 trial of nucresiran in patients with ATTR-CM.

In Q3 2025 Zilebesiran Phase 2 for hypertension reported positive results. The Phase 3 trial was initiated. It will enroll about 11,000 patients.

In Q3 2025 Alnylam started a Phase 2 trial of ALN-6400 for bleeding disorders from hereditory hemorrhagic telangiectasia. Could eventually be tried for a range of bleeding disorders. Plans to start a Phase 2 trial of ALN-6400 in a second bleeding disorder.

In Q3 2025 Alnylam started a Phase 1 trial of ALN-5288 targetting tau in Alzheimer's.

In Q3 2025 Regeneron reported positive Phase 3 results for cemdisiran for myasthenia gravis. A regulatory submission is planned for Q1 2026.

Net revenue from collaborations was $41 million, down from $107 million year-earlier. Royalty revenue was $61 million, up from $35 million year-earlier.

Non-GAAP net income $170 million, down 57% sequentially from $396 million, and up from $8 million year-earlier. EPS diluted $1.25, down 57% sequentially from $2.90, and up from $0.06 year-earlier.

Cash and equivalents balance at the end of the quarter was $2.91 billion, up sequentially from $2.7 billion. Net cash provided by operating activities was $23 million.

See also Alnylam pipeline. In early 2026 had 25 clinical programs including many in late stages.

Operating expenses of $965 million consisted of: $268 million for cost of goods sold; $372 million for research and development; and $325 million for general and administrative expense; $0 million cost of collaboration. Operating income $132 million. Interest & other expense $45 million. $25 million benefit from income tax.

Full year 2025 revenue was $2.99 billion. Net income was $314 million. Diluted GAAP EPS $2.33.

Q&A Selective Summary:

2026 new Amvuttra patient adds, first line v. switches? Fundamentals are in place to drive growth. We have improved first line access. More patients are entering the market.

Confidence in TTR guidance for 2026? Most patients have access with no out of pocket. We feel really well positioned entering 2026.

Seasonality? Total growth is long-term strong, more important than monthly fluctuations.

We don't know what the competitor data will look like, so impact on 2027 is unknown.

Given our financial strength we are becoming open to external opportunities.

Nucresiran impact on Amvuttra? We believe it will be best in class. So that would help our margin, because we would not owe royalties to Sanofi.

Huntington's? We have high conviction for that program. High unmet need. We are optimistic about our unique approach. Just in Phase 1. Needs high level of knockdown, past attempts had safety concerns. We hope for over 50% knockdown with good safety. But trial is with a modest number of patients.

Weight loss? We are looking at specific patient segments, should have some results by year end.

We have a derisked product engine, giving us scale and a host of mid-term opportunities.

2027 pricing? Likely similar decrease to 2026. We have good access, while there is potential emerging competition, we are comfortable with our pricing. It is difficult to assess their impact without seeing their data. We have a strong headstart in marketing. We expect their study to be positive, we will be looking at the safety and efficacy details. In particular in combination with a stabilizer. We do not see their label being materially different.

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