Alnylam reports 2025 profitability as AMVUTTRA drives revenue growth
Alnylam reported full-year 2025 profitability and $2.987 billion in global net product revenues, driven by U.S. approval and growth of AMVUTTRA. The company also outlined 2026 pipeline goals and additional HELIOS-B analyses for vutrisiran.
Alnylam Pharmaceuticals reported fourth quarter and full year 2025 financial results, achieving GAAP and non-GAAP profitability for full year 2025. The company said fourth quarter and full year 2025 global net product revenues were $995 million and $2,987 million, respectively, representing 121% and 81% growth compared to the same periods in 2024. It also said the landmark approval of AMVUTTRA for ATTR-CM in the U.S. drove total net product revenues of nearly $3 billion and propelled it to profitability.
For its total TTR franchise, AMVUTTRA (vutrisiran) and ONPATTRO (patisiran) generated fourth-quarter global net product revenues of $827 million and $32 million, respectively, together representing 151% total TTR growth compared to Q4 2024. Full-year 2025 revenues for AMVUTTRA and ONPATTRO were $2,314 million and $173 million, respectively, together representing 103% total TTR growth compared to full year 2024.
The company said it launched “Alnylam 2030” strategy focused on scaling Alnylam through durable ATTR leadership, long-term sustainable innovation, and exceptional financial results. It also announced 2026 pipeline goals, including 4 clinical readouts, 3 ongoing pivotal studies, 3 Phase 2 study initiations, and 3+ new IND filings.
Recent business highlights included new analyses from the HELIOS-B Phase 3 clinical trial of vutrisiran in patients with ATTR-CM. Cardiovascular magnetic resonance and echocardiographic analyses demonstrated that treatment with vutrisiran resulted in significant changes indicating significant improvement on multiple functional and structural cardiac parameters. CMR imaging showed amyloid regression in 22% of vutrisiran treated patients with no regression found in patients who received placebo. Treatment with vutrisiran also preserved kidney function in HELIOS-B patients, and reduced risk of death and cardiovascular events in patients with advanced chronic kidney disease.
The company said it will present multiple new analyses from the Phase 3 HELIOS-B study of vutrisiran at Heart Failure 2026, taking place May 9-12, 2026, in Barcelona, Spain. Additional analyses being presented include a pharmacodynamic analysis of TTR knockdown with vutrisiran across subgroups, a pooled safety analysis evaluating the incidence of TTR lowering with vitamin-A-related outcomes across clinical trial and real-world datasets, and the design of DemonsTTRate, a global, long-term observational study evaluating real-world use in patients with ATTR-CM.
Outside the TTR franchise, GIVLAARI (givosiran) and OXLUMO (lumasiran) achieved fourth-quarter global net product revenues of $87 million and $50 million, respectively, together representing 26% total Rare growth compared to Q4 2024. Full-year 2025 revenues for GIVLAARI and OXLUMO were $308 million and $191 million, respectively, together representing $500 million in revenues and 18% total Rare growth compared to full year 2024.
The company also said it initiated a Phase 2 clinical trial of ALN-4324 targeting GRB14 for type 2 diabetes mellitus, initiated a Phase 1 clinical trial of ALN-2232 targeting ACVR1C in adipose tissue for obesity and weight management, and advanced ALN-4285 and ALN-4915 into clinical development in healthy volunteers. It announced the planned expansion of its manufacturing facility in Norton, Massachusetts, with a planned $250 million investment to develop a fully dedicated, proprietary siRNA enzymatic-ligation manufacturing facility.