Alnylam Q3 2026 Earnings: AMVUTTRA Drives 52% Product Revenue Growth

Alnylam Pharmaceuticals (NASDAQ: ALNY) reported Q3 2026 revenue of $1.458 billion, up 17% from $1.249 billion a year earlier, while diluted GAAP EPS increased to $15.72 from $2.14. Net product revenue rose 52% on AMVUTTRA growth, but GAAP operating income fell 6% as product costs and development and commercial spending increased; the sharp net-income increase primarily reflected a $1.9 billion tax benefit.

Core Financial Results

For the quarter ended September 30, commercial growth was partly offset by an 80% decline in collaboration revenue, which faced a difficult comparison with a $300 million Roche milestone recognized in Q3 2025. Higher costs also prevented product growth from translating into operating-income growth.

The $1.9 billion benefit from income taxes, primarily from releasing valuation allowances on certain U.S. deferred tax assets, drove the increase in reported net income and EPS. As a result, the bottom-line comparison does not reflect the underlying operating trend by itself.

*Operating margins are calculated from reported GAAP operating income and total revenue; changes are approximate.

Commercial and Revenue Mix Performance

AMVUTTRA remained the main growth engine, with revenue increasing 65% to $1.130 billion. The broader TTR franchise generated about 89% of total product revenue, while ONPATTRO continued to contract and the Rare portfolio recorded more moderate growth.

U.S. TTR revenue increased by $99 million from Q2 2026. Alnylam attributed $81 million to higher demand and $17 million to inventory, while the quarter also benefited from approximately $10 million of favorable gross-to-net adjustments. International TTR revenue increased by $20 million sequentially, driven primarily by ATTR-CM launches in Japan, Germany, and Italy and the timing of partner-market orders.

GIVLAARI benefited from an increased number of treated patients, while ONPATTRO’s decline reflected fewer patients receiving the product. Royalty revenue more than doubled because of higher Leqvio sales volume and royalty rates.

Product Growth Did Not Translate Into Operating Profit Growth

Cost of goods sold increased 83% to $361.8 million and rose to 28.0% of net product revenue from 23.2%. Alnylam attributed this increase primarily to the growing contribution from AMVUTTRA and the associated increase in its blended royalty rate.

GAAP R&D expense increased 14% to $408.5 million, reflecting higher spending on the ZENITH, TRITON-CM, and TRITON-PN Phase 3 trials and preclinical programs. GAAP SG&A expense increased 6% to $342.0 million as the company invested in the global commercial launch of AMVUTTRA for ATTR-CM. These costs, combined with the absence of the prior-year Roche milestone, explain why operating income declined despite rapid product growth.

Cash, cash equivalents, and marketable securities reached $3.6 billion at quarter-end, up from $2.9 billion at December 31, 2025, primarily because of operating cash inflows. Interest expense totaled $84 million, including $58 million related to the sale of future Leqvio royalties and $23 million associated with development-funding liabilities.

Pipeline Developments and Upcoming Milestones

Alnylam increased the target enrollment for the TRITON-CM Phase 3 study of nucresiran from 1,750 to approximately 2,250 patients. The expansion is weighted toward patients with earlier disease and is intended to preserve adequate statistical power under conservative event-rate assumptions. Despite the larger enrollment target, the company continues to expect a potential ATTR-CM launch by 2030, assuming positive trial results and regulatory approval.

Brezosiran’s Phase 1 Huntington’s disease data showed mean cerebrospinal-fluid mutant huntingtin reductions of 60% to 64% at month three in the highest-dose group, with a maximum individual reduction of 83%. Alnylam plans to begin a placebo-controlled pivotal study in 2027, pending regulatory alignment.

Other upcoming items include the November 2026 PDUFA target date for Regeneron-partnered cemdisiran and additional clinical data for ALN-6400 in hereditary hemorrhagic telangiectasia and ALN-2232 in obesity and weight management, expected with the Q4 and full-year 2026 results in February 2027.

Full-Year 2026 Guidance

Alnylam reiterated its full-year outlook, indicating that the company remains on track against its existing product-revenue and spending ranges. The guidance continues to imply that TTR products will account for most of annual commercial revenue.

The currency-based guidance uses June 30, 2026 exchange rates of 1 euro to $1.14 and $1 to 162 Japanese yen. Non-GAAP expense guidance excludes an estimated $330 million to $380 million of stock-based compensation.

Recent Insider Transactions

The supplied insider data show two sales totaling 5,588 shares over the latest six-month period. The same data categorize 21,393 shares across 12 transactions as purchases or acquisitions, but recent records include zero-price stock awards, so that figure should not be interpreted as open-market buying.

These transactions are presented as reported and do not by themselves establish insiders’ views on Alnylam’s prospects.

Risks Investors Need to Watch

• Dependence on the TTR franchise: TTR products generated about 89% of quarterly product revenue, leaving overall commercial growth closely tied to AMVUTTRA’s uptake and durability.
• Operating-margin pressure: The cost-of-goods ratio increased by 4.8 percentage points, while R&D and commercial spending also rose. Continued cost growth could limit operating leverage.
• Revenue-mix volatility: Collaboration revenue fell 80% because the prior-year period included a $300 million milestone. The timing of future collaboration payments may continue to affect comparisons.
• Pipeline execution: The larger TRITON-CM study, the planned brezosiran pivotal trial, and other late-stage programs require continued spending and depend on favorable clinical and regulatory outcomes.
• Earnings comparability: The $1.9 billion tax benefit materially increased Q3 net income and EPS, making reported bottom-line growth less representative of recurring operations.

Summary

Alnylam’s Q3 2026 results showed continued commercial expansion led by AMVUTTRA, but higher product costs, clinical investment, commercial spending, and a difficult collaboration-revenue comparison reduced operating profit. The reiterated guidance signals no change in the company’s 2026 expectations, while future performance will depend on sustaining ATTR-CM demand, managing the rising cost base, and executing the expanded late-stage pipeline.