Analyst Conference Summary

biotechnology

conference date: October 30, 2025 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2025 (third quarter, Q3)

Forward-looking statements

Overview: Fantastic 149% revenue growth. Clearly profitable.

Basic data (GAAP):

Revenue was $1.25 billion, up 61% sequentially from $774 million, and up 149% from $501 million year-earlier.

Net income was $251 million, up sequentially from negative $66 million, and up from negative $112 million year-earlier.

Diluted EPS was $1.84, up sequentially from negative $0.51, and up from negative $0.87 year-earlier.

Guidance:

Increased 2025 total product revenue guidance to between $2.95 and $3.05 billion.

Conference Highlights:

Yvonne Greenstreet, CEO of Alnylam, said: "While only in our second full quarter of the Amvuttra ATTR-CM launch, the TTR franchise saw remarkable year-over-year growth. Amvuttra’s robust clinical profile, convenient quarterly administration, and broad payer coverage all continue to drive this encouraging pace of uptake and further position Alnylam as a leader in TTR. Based on the ATTR-CM launch trajectory, we are again raising our guidance and expect total net product revenues of $2.95 billion to $3.05 billion for 2025."

Revenue in Q3 2025 includes a $300 million milestone payment from Roche for zilebesiran. But main driver was greatly increased Amvuttra product revenue.

Amvuttra (Vutrisiran) Phase 3 ATTR amyloidosis with cardiomyopathy approved by FDA in March 2025. Believes in the global market 80% of potential ATTR-CM patients are undiagnosed. New analyses in Q3 showed reduced risk of mortality and a lower rate of GI events. Amvutra revenue jumped to $685 million in Q3.

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.

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.

In Q3 2025 Alnylam received a subpoena from the U.S. Attorney's Office for the District of Massachusetts seeking documents on government price reporting for Amvuttra, Onpattro, Oxlumo and Givlaari, including distributor fee and discount arrangements.

Net revenue from collaborations was $352 million, up from $57 million year-earlier. Royalty revenue was $46 million, up from $23 million year-earlier.

Non-GAAP net income $396 million, up sequentially from $na million, and up from negative $64 million year-earlier. EPS diluted $2.90, up sequentially from $0.32, and up from negative $0.50 year-earlier.

Cash and equivalents balance at the end of the quarter was $2.7 billion, down sequentially from $2.86 billion. Convertible Debt $ billion. Repurchased $1.1 billion in 2027 senior notes in Q3 2025, but issued $646 million in new senior 2028 notes. There was a $39 million other expense related to convertible debt.

See also Alnylam pipeline. In 2025 had 20 clinical programs including 10 in late stages.

Operating expenses of $881 million consisted of: $197 million for cost of goods sold; $359 million for research and development; and $322 million for general and administrative expense; $3 million cost of collaboration. Operating income $368 million. Interest & other expense $129 million. $12 million income tax.

Q&A Selective Summary:

Amvuttra momentum, combo use, ex-US pricing? CM demand doubled in quarter. Wide range of settings, prescribers, and patient types. Competitive in first line, growing there, while leading in second line. So confident going forward. Negotiating pricing in each nation. Seeing some combination use, but mostly monotherapy. When tafamadis goes generic we expect to see more combo use.

Onpattro q/q decline was from a Medicaid change. Underlying business remains stable.

ALN-5288 (MAPT)? We would like to help Alzheimer's patients. Optimistic about our overall neurologic pipeline.

Payers for Amvuttra? No payer headwinds. Payer understand the value of the product, including v. tafamadis. 2026 policies are almost final, very similar to 2025.

EU ramp up? For Q4 we expect a very modest ex-US contibution. Still working on pricing in Germany. Japan pricing in, but modest contribution. We continue to do well in PN market even with a new competitor.

Subpoena? We will cooperate with the U.S. Attorney, providing documentation on pricing.

Pricing color? We anticipate our net price to gradually go down over time. But not significantly. We will provide more details on Europe as the negotiations complete later in 2026.

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