Alnylam Pharmaceuticals Q3 Earnings Call Highlights

Key Points

• Q3 revenue rose 52% year over year to approximately $1.3 billion, driven by the TTR franchise, which generated $1.15 billion in revenue. However, Alnylam said AMVUTTRA demand growth in ATTR cardiomyopathy remains below expectations despite expanded sales efforts.
• Alnylam is monitoring potential reimbursement changes to the 340B program and a more restrictive UnitedHealthcare Medicare Advantage policy, both of which could delay new-patient starts or affect pricing and volume.
• The company expanded enrollment in its Phase III TRITON-CM study of nucresiran but maintained an expected cardiomyopathy launch around 2030. It also reported promising early brezosiran data in Huntington’s disease and reiterated 2026 TTR sales guidance of $4.2 billion to $4.5 billion, expected at the low end.

Alnylam Pharmaceuticals NASDAQ: ALNY reported third-quarter 2026 global net product revenue of approximately $1.3 billion, up 52% from a year earlier and 10% sequentially, as growth in its transthyretin, or TTR, franchise continued to drive results.

Chief Executive Officer Yvonne Greenstreet said the company generated $1.15 billion in TTR revenue during the quarter, representing nearly 60% year-over-year growth. The franchise includes AMVUTTRA, which is used in patients with ATTR cardiomyopathy and ATTR polyneuropathy.

Greenstreet said Alnylam sees a substantial opportunity to expand treatment in ATTR cardiomyopathy, where the company estimates roughly 80% of prevalent patients remain untreated. However, she said the company was “not yet satisfied” with the pace of underlying demand growth for AMVUTTRA, despite growth in physician engagement following a sales-force expansion.

TTR Franchise Growth and Commercial Execution

Chief Commercialization Officer Tolga Tanguler said TTR product revenue rose 12% from the second quarter and 59% year over year. In the U.S., TTR revenue increased by approximately $100 million sequentially, including an $81 million increase in demand and a $17 million benefit from higher inventory in the distribution channel.

Tanguler said U.S. net pricing rose modestly from the prior quarter and benefited from approximately $10 million in one-time gross-to-net adjustments. Outside the U.S., TTR revenue grew 10% sequentially and 28% from the prior-year period, driven primarily by ATTR cardiomyopathy uptake in Japan and Germany, partly offset by launch price reductions.

AMVUTTRA accounted for approximately 24% of total TTR-category prescriptions, including cardiomyopathy and polyneuropathy, through the end of the third quarter, Tanguler said. The company reported that more than 2,000 new unique prescribers have written prescriptions for AMVUTTRA since its U.S. ATTR cardiomyopathy launch, though only about one-third of active category prescribers have used the medicine.

Management said expanded customer-facing teams have increased healthcare-provider engagement, but those interactions have not yet translated into faster patient starts. Greenstreet said newer prescribers may have fewer cardiomyopathy patients, less familiarity with the disease and more established prescribing habits. Tanguler also cited perceived administrative barriers, including buy-and-bill processes, prior authorizations and patient coordination.

Alnylam said AMVUTTRA has access for approximately 99% of covered lives, with about 90% of patients able to receive treatment within roughly 10 miles of where they live.

340B Rule and Payer Changes

The company is monitoring a proposed Centers for Medicare & Medicaid Services rule that, if finalized as proposed, would reduce Medicare reimbursement for Part B medicines acquired through the 340B drug discount program. The final rule was expected imminently during the call and, if implemented, would take effect Jan. 1, 2027, according to Tanguler.

Chief Financial Officer Jeff Poulton said 340B represents a meaningful portion of Alnylam’s business, though he did not quantify the exposure. He said the company could contract with health systems to support economically viable access or use alternative sites of care, including third-party infusion clinics and home treatment.

Poulton said the ultimate effect could include changes to gross-to-net deductions, net price and volume depending on how health systems respond. He said health systems could continue using 340B purchasing, shift to wholesale acquisition cost purchasing, or move patients to outside sites of care.

Separately, UnitedHealth implemented a more restrictive first-line AMVUTTRA policy for its Medicare Advantage business on Oct. 1. Alnylam said the policy is not expected to affect existing patients, though it could delay access for some new patients. The company noted an exception process remains available for appropriate first-line use.

Pipeline Updates and Financial Outlook

Alnylam expanded enrollment in its Phase III TRITON-CM study of investigational TTR silencer nucresiran by 500 patients, bringing planned enrollment to about 2,250 patients. Chief Research and Development Officer Pushkal Garg said the additional enrollment is intended to preserve study power amid lower expected event rates as patients are diagnosed earlier and receive more background therapies.

The company said it does not expect the enrollment expansion to change its anticipated ATTR cardiomyopathy launch timing of approximately 2030, subject to positive data and regulatory approval.

Garg also highlighted interim Phase I results for brezosiran in Huntington’s disease. After a single dose, the company observed mean maximum reductions in cerebrospinal-fluid mutant huntingtin of 60% to 64% across two assays, with individual reductions of up to 83%. Alnylam said no dose-dependent safety signals were observed across the five cohorts included in the analysis.

Pending regulatory alignment, Alnylam plans to initiate a large placebo-controlled pivotal study of brezosiran in 2027. The company also expects to report Phase I healthy-volunteer data for ALN-6400 in bleeding disorders at the American Society of Hematology meeting in December, followed by Phase II hereditary hemorrhagic telangiectasia data for ALN-6400 and Phase I obesity data for ALN-2232 during its fourth-quarter and full-year results call in February.

For 2026, Alnylam reiterated its guidance and said it expects TTR product sales to finish at the low end of its $4.2 billion to $4.5 billion range. Poulton said the outlook assumes no material fourth-quarter contribution from the expanded field force and reflects potential ordering volatility related to the pending 340B rule as well as the UnitedHealth policy change.

The company said it will not provide 2027 product revenue guidance at the JPMorgan conference in January, as it has in prior years. Instead, it plans to provide that outlook with fourth-quarter and full-year 2026 results in mid-February after gaining more clarity on health-system behavior under any finalized 340B framework.

About Alnylam Pharmaceuticals (NASDAQ:ALNY)

Alnylam Pharmaceuticals, Inc is a biopharmaceutical company focused on developing and commercializing medicines based on RNA interference (RNAi). The company's therapies are designed to silence specific genes involved in disease, with the goal of addressing the underlying causes of genetic and other serious conditions.

Alnylam's marketed products include ONPATTRO (patisiran) and AMVUTTRA (vutrisiran) for hereditary transthyretin-mediated amyloidosis, GIVLAARI (givosiran) for acute hepatic porphyria, and OXLUMO (lumasiran) for primary hyperoxaluria type 1.

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