Alnylam Reiterates 2026 Guidance After TTR Slowdown
Global net product revenues were $1.29 billion in the third quarter, up 52% from a year earlier, as AMVUTTRA reached $1.13 billion.
Alnylam Pharmaceuticals (ALNY), the RNAi therapeutics company, reported global net product revenues of $1.29 billion for the third quarter ended September 30, 2026, up 52% from a year earlier. Growth slowed from 74% in the second quarter and 121% in the first.
Total TTR net product revenues were $1.15 billion, up 59% versus the year-ago quarter, after 89% growth in the second quarter and 153% in the first. AMVUTTRA (vutrisiran) accounted for $1.13 billion of that total, up 65% from a year earlier. ONPATTRO (patisiran) was $20 million, down 50%.
U.S. TTR net product revenues increased $99 million from the second quarter, which the company said was driven by an $81 million increase in demand, a $17 million inventory benefit, and a modest increase in net price, with the quarter aided by about $10 million in favorable gross-to-net adjustments. International TTR net product revenues increased $20 million from the second quarter, driven primarily by ongoing ATTR-CM launches in Japan, Germany, and Italy and the timing of orders in partner markets.
Total Rare net product revenues were $142 million, up 12% from a year earlier. GIVLAARI (givosiran) was $89 million and OXLUMO (lumasiran) was $53 million.
Total revenues were $1.46 billion, up 17% from the three months ended September 30, 2025. Net revenues from collaborations were $71 million, down 80%, primarily because of $300.0 million of Roche milestone revenue recognized in September 2025 for first-patient dosing in the ZENITH Phase 3 trial of zilebesiran. Roche collaboration revenue was $39 million versus $327 million a year earlier. Royalty revenue was $95 million, up 105%, due to increased volume and rate of royalties from global net sales of Leqvio by Novartis.
GAAP income from operations was $346 million, down 6% from a year earlier. Non-GAAP income from operations was $425 million, down 11%. GAAP net income was $2.17 billion, or $15.72 a share diluted, versus $293 million, or $2.14 a share diluted, a year earlier. Non-GAAP net income was $2.24 billion, or $16.26 a share diluted. The company recorded a $1.9 billion benefit from income taxes, primarily related to the release of valuation allowances on certain U.S. federal and state deferred tax assets.
Cost of goods sold was $362 million, up 83%, and rose to 28.0% of net product revenues from 23.2%, which the company attributed primarily to increased AMVUTTRA sales and a higher blended royalty rate on AMVUTTRA net sales. GAAP research and development expenses were $409 million, up 14%, and non-GAAP R&D was $376 million, up 21%, primarily from the ZENITH, TRITON-CM, and TRITON-PN Phase 3 trials and preclinical programs. GAAP selling, general and administrative expenses were $342 million, up 6%, and non-GAAP SG&A was $296 million, up 13%, primarily from sales and marketing for the global AMVUTTRA ATTR-CM launch.
Interest expense was $84 million, including $58 million on the sale of future Leqvio royalties and $23 million on vutrisiran and zilebesiran development-funding liabilities. Cash, cash equivalents and marketable securities were $3.6 billion as of September 30, 2026, compared with $2.9 billion as of December 31, 2025, with the increase primarily driven by net cash inflows from operating activities.
The company said it is on track to achieve 2026 financial guidance and reiterated full-year ranges after lowering TTR guidance in the second quarter: total TTR net product revenues of $4.20 billion to $4.50 billion, total Rare of $500 million to $600 million, and total net product revenues of $4.70 billion to $5.10 billion.
Alnylam expanded TRITON-CM target enrollment for nucresiran from 1,750 to approximately 2,250 patients, after a first-quarter expansion from 1,250 to about 1,750. It still expects to launch nucresiran in ATTR-CM by 2030, assuming positive data and regulatory approval. Phase 1 brezosiran data showed a mean reduction of CSF mutant huntingtin of 60–64% from baseline at month 3 in the highest dose group, with a maximum individual reduction of 83%. The company expects to initiate a pivotal study in 2027.