Analyst Conference Summary

biotechnology

conference date: July 31, 2025 @ 5:30 AM Pacific Time
for quarter ending: June 30, 2025 (second quarter, Q2)

Forward-looking statements

Overview: Another excellent quarter. GAAP loss, non-GAAP profit.

Basic data (GAAP):

Revenue was $774 million, up 30% sequentially from $594 million, and up 17% from $660 million year-earlier.

Net income was negative $66 million, up sequentially from negative $57 million, and down from negative $17 million year-earlier.

Diluted EPS was negative $0.51, up sequentially from negative $0.44, and up from negative $0.31 year-earlier.

Guidance:

Increased 2025 total product revenue estimate to $2.8 billion. Collaboration and royalty revenue steady at $650 to $750 million. Expects to achieve non-GAAP operating income profitability.

Conference Highlights:

Yvonne Greenstreet, CEO of Alnylam, said: "Our first full quarter of Amvuttra sales in ATTR-CM provided a significant inflection in our TTR franchise revenues, with total net product revenues growing 64% year-over-year. While still early in the launch, we are very encouraged by the initial pace of uptake, evidence of the clear need for a novel mechanism in ATTR-CM and the effectiveness of our broad patient access efforts. Based on the strong progress during the first half of 2025 and our confidence in the overall business for the rest of the year, we are raising our total net product revenue guidance range by 27% at the midpoint, driven by an upward revision to our TTR franchise revenue guidance."

Alnylam will present results from the KARDIA-3 Phase 2 trial of zilebesiran in patients with hypertension at the European Society of Cardiology (ESC) Congress in Madrid, Spain on August 30, 2025.

Amvutra (Vutrisiran) Phase 3 ATTR amyloidosis with cardiomyopathy approved by FDA in March 2025. Believes in the global market 80% of potential ATTR-CM patietns are undiagnosed. Received approval from Brazil and the EU CHMP recommended approval in Q2 2025. Amvutra revenue jumped to $492 million in Q2, with 1,400 patients on it by end of quarter.

In March 2025 fitusiran for hemophilia A and B was approved by the FDA.

In q2 2025 Alnylam's partner, Agios Pharmaceuticals, received IND clearance for AG-236 (ALN-TMP), an RNAi therapeutic targeting TMPRSS6 intended for the treatment of polycythemia vera (PV), and initiated the Phase 1 healthy volunteer study.

In Q1 2025 announced coming Phase 1 trial for ALN-6400 for bleeding disorders without risk of thrombosis.

In Q1 2025 announced initiation of a Phase 1 trial of ALN-4324, with GRB14 as the target, to sensatize patients for insulin in type 2 diabetes.

In Q1 2025 shared encouraging data from the ALN-HTT02 program, which has a highly differentiated exon-1-targeting approach to lower huntingtin (HTT) for Huntington's disease.

Alnylam plans to initiate the TRITON-CM Phase 3 trial of nucresiran in patients with ATTR-CM in 2H 2025.

A newer potential therapy for ATTR-PN and -CM, nucresiran, should enter Phase 3 trials in Q3 2025.

Net revenue from collaborations was $61 million, down from $227 million year-earlier. Royalty revenue was $40 million, up from $22 million year-earlier.

Non-GAAP net income $ million, up sequentially from negative $na million, and up from negative $ million year-earlier. EPS $0.32, up sequentially from negative $0.01, and down from $0.56 year-earlier.

Cash and equivalents balance at the end of the quarter was $2.86 billion, up sequentially from $2.62 billion. Convertible Debt $1.0 billion.

See also Alnylam pipeline. In Q1 2025 had 20 clinical programs including 10 in late stages.

Operating expenses of $790 million consisted of: $142 million for cost of goods sold; $324 million for research and development; and $323 million for general and administrative expense; $1 million cost of collaboration. Operating kiss $16 million. Interest & other expense loss $19 million. $31 million income tax.

Q&A Selective Summary:

Patient profiles for Amvutra? Helios B data is resonating with physicians. Broad uptake among frontline patient as well as those who have progressed on stabilizers.

Amvutra pricing? Reducing net price modestly and gradually over time, mid-single digit reduction y/y. Payer dynamics are as expected. Patients are paying minimal out-of-pocket costs.

We have a high level of confidence in the guidance, including for Amvutra growth.

About one-third to one-half of patients on stabilizer progress, the only option is Amvutra at this point.

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