Analyst Conference Summary

biotechnology

conference date: October 29, 2026 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2026 (third quarter, Q3)

Forward-looking statements

Overview: Continued strong revenue growth. Profit jump was driven by (non-cash) tax refunds.

Basic data (GAAP):

Revenue was $1.46 billion, up 13% sequentially from $1.29 billion, and up 17% from $1.25 billion year-earlier.

Net income was $2.17 billion, up sequentially from $164 million, and up from $293 million year-earlier. The jump was driven by tax refunds.

Diluted EPS was $15.72, up sequentially from $1.21, and up from $3.19 year-earlier.

Guidance:

Unchanged. 2026 net product revene $4.7 to $5.1 billion.

Conference Highlights:

Yvonne Greenstreet, CEO of Alnylam, said: "Our third quarter results reflect the continued growth of our TTR franchise and advancement of key programs with the potential for transformative patient impact. As we continue through the final months of the year and plan for 2027, we remain laser focused on leveraging our commercial investments to expand the prescriber base, support access, and bring Amvuttra to more patients with ATTR amyloidosis. In line with our goal to build durable leadership in TTR, the expanded enrollment target for TRITON-CM we are announcing today further positions nucresiran for success and strengthens our long-term position. Lastly, we believe the positive initial data for brezosiran in Huntington's disease both support a pathway to initiating a pivotal study in 2027 and reflect the potential of our RNAi platform to create meaningful value beyond our current portfolio." Product revenue was up 52% y/y. Believes has considerable room to drive adoption of Amvuttra for ATTR, which is a growing market.

Discussed the risk of Amvuttra price reduction (currently near $500,000 per year) due to a CMS rule change proposal for Part B medicines. Alnylam anticipates legal challenges, which if they do not work could be dodged by changing to WAC purchasing or using alternative care sites. The rule should be finalized soon and implemented in January 2027. Most patients now pay $0 out of pocket. Untied Health already implemented a more restrictive policy for new Medicare Advantage Amvuttra patients on October 1, 2026. That should not affect existing patients.

Alnylam presented positive initial results from the Phase 1 trial of ALN-HTT02 (brezosiran) in patients with Huntington's disease at EHDN Clinical Research Congress on October 23, 2026. A placebo controlled pivotal study is planned for 2027

In Q4 2026 (today) updated the Phase 3 study of nucresiran for ATTR-CM. Will enlarge trial to 2,250 patients. If trial is positive should launch in 2030.

In Q3 2026 completed a Phase 1 trial of mivelsiran for cerebral amyloid angiopathy. Initiated a Phase 2 Alzheimer's trial in patients with Down syndome. Shared additional Phase 1 Alzheimer's data showed no risk for ARIA but durable reductions in amyloid beta and its precursor.

In Q3 2026 Alnylam presented preclinical data for ALN-5288 for tau and the design for its Phase 1 trial.

The PDUFA date for cemdisiran, for the treatment of adult patients with generalized myasthenia gravis who are anti-acetylcholine receptor antibody-positive, is in November 2026. It is being advanced by Regeneron. Alnylam is eligible to receive tiered, double-digit royalties of up to 15 percent on global net sales.

ALN-6400 Phase 2 results for hereditary hemorrhagic telangiectasia are expected in February 2027.

Alnylam expects Phase 1 results in February 2027 for ALN-2232 for weight management.

Net revenue from collaborations was $71 million, down from $352 million year-earlier. Royalty revenue was $95 million, up from $46 million year-earlier.

Non-GAAP net income $2.24 billion, up sequentially from $252 million, and up from $438 million year-earlier. EPS diluted $16.26, up sequentially from $1.84, and up from $3.19 year-earlier.

Cash and equivalents balance at the end of the quarter was $3.58 billion, up sequentially from $3.3 billion. Net cash provided by operating activities was $na million. Debt was $1.1 billion.

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

Operating expenses of $1.11 billion consisted of: $362 million for cost of goods sold; $409 million for research and development; and $342 million for general and administrative expense; $0 million cost of collaboration. Operating income $346 million. Interest & other expense $50 million. $1.87 billion income tax benefit.

Q&A Selective Summary:

Design changes in nucresiran trial? Nucresiran all-cause mortality endpoint has been explained. Change today is about event rates in background, which is because patients starting earlier in progress of the disease. Event driven study. We could adjust the analytic plan if necessary.

Sales strategy, not translating or just a lag? We are not satisfied with the pace of prescription growth, though it has been strong. Once a therapist has prescribed Amvuttra, they tend to use it. The problem is with those who have never prescibed; they typically have few patient and little understanding of the disease. We don't expect accelerated growth until 2027. They also need help with non-clinical barriers, like reimbursement.

340B change? Our focus now is seeing the final rule. We hope there will be an economically viable path for treating patients. We can support alternate sites of care like infusion clinics and home infusions. There could be impacts on gross to net and on volume. Could shift physicians from making clinical decisions to basing on ease of utilization and the progressive and fatal nature of the disease.

2027 outlook, are you allowed to bypass 340B with your own discounts? 340B is a meaningful portion of our business. Will work with institutions to keep patients on therapy. Could shift to non-340B purchasing.

Huntington's program? Exciting program. We have a differented approach to a deep knockdown, including the shorter isoform. Will move into Phase 3, but still doing dose escalation in Phase 1. Would be an NDA, not a BLA application. Efficacy and safety are primary concerns.

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