Alnylam Pharmaceuticals Reports Preliminary 2024 Financials, 2025 Revenue and Pipeline Guidance
Alnylam Pharmaceuticals Reports a global leader in RNA interference (RNAi) therapeutics, today released preliminary financial results for the fourth quarter and full year 2024, alongside its guidance for 2025 net product revenues, profitability, and pipeline advancements.
CEO’s Statement: Focus on Growth and Innovation
Yvonne Greenstreet, MBChB, Chief Executive Officer of Alnylam Reports, expressed optimism about the company’s future, highlighting the remarkable progress made in 2024. She emphasized the 33% year-over-year revenue growth, with over $1.6 billion in net product revenues—at the high end of the revised guidance range. This growth underscores the strong performance of Alnylam’s hereditary transthyretin amyloidosis (hATTR) polyneuropathy (PN) and rare disease businesses.
Looking ahead, Greenstreet noted that 2025 would mark a pivotal year for Alnylam’s transthyretin (TTR) franchise, with the potential launch of vutrisiran for the treatment of transthyretin amyloidosis with cardiomyopathy (ATTR-CM), which is expected to drive significant revenue growth. “If we meet our 2025 product revenue guidance, we anticipate achieving non-GAAP operating income profitability,” she added.
Furthermore, Greenstreet highlighted Alnylam’s commitment to advancing its RNAi platform, with key pipeline milestones slated for 2025. The company’s integrated approach, combining global commercial infrastructure and a diverse pipeline, positions Alnylam to deliver sustained innovation and value for patients worldwide.
Preliminary 2024 Commercial and Financial Reports Performance
TTR Franchise: ONPATTRO and AMVUTTRA
Alnylam’s TTR franchise, consisting of ONPATTRO® (patisiran) and AMVUTTRA® (vutrisiran), showed robust growth in 2024. Preliminary global net product revenues for ONPATTRO and AMVUTTRA in Q4 were approximately $56 million and $287 million, respectively, representing a combined 35% annual growth compared to Q4 2023. For the full year, ONPATTRO and AMVUTTRA generated approximately $253 million and $970 million in net product revenues, respectively, reflecting a 34% total TTR growth compared to 2023.
Rare Diseases: GIVLAARI and OXLUMO
Alnylam’s Reports rare disease portfolio, which includes GIVLAARI® (givosiran) and OXLUMO® (lumasiran), also showed strong performance in 2024. Preliminary global net product revenues for GIVLAARI and OXLUMO in Q4 were approximately $65 million and $44 million, respectively, representing a combined 18% growth compared to Q4 2023. For the full year, the two products generated approximately $256 million and $167 million, respectively, marking a 29% increase over 2023.
2025 Revenue and Operating Income Guidance
For 2025, Alnylam Reports has set its combined net product revenue guidance for ONPATTRO, AMVUTTRA (PN & CM), GIVLAARI, and OXLUMO between $2.05 billion and $2.25 billion. This reflects an anticipated 31% year-over-year growth, based on the midpoint of the guidance range. Specifically:
- Total TTR (ONPATTRO, AMVUTTRA): Expected revenue of $1.60 billion to $1.73 billion, a 36% increase compared to 2024.
- Total Rare (GIVLAARI, OXLUMO): Expected revenue of $450 million to $525 million, a 15% increase compared to 2024.
Additionally, Alnylam Reports expects to achieve non-GAAP operating income profitability in 2025.
Alnylam intends to provide further details on collaboration and royalty revenues, as well as operating expenses, during the fourth-quarter and full-year 2024 earnings release.
2025 Product and Pipeline Milestones
Alnylam has outlined an ambitious set of goals for 2025, with multiple critical milestones across its product portfolio and pipeline:
Vutrisiran: A treatment for hATTR amyloidosis with polyneuropathy, now marketed globally, and in development for ATTR amyloidosis with cardiomyopathy.
- FDA Approval: Alnylam aims to secure FDA approval for vutrisiran in ATTR-CM by the PDUFA target action date of March 23, 2025.
- Global Expansion: The company plans to secure additional approvals and reimbursement in Japan and the EU for ATTR-CM in the second half of 2025.
Nucresiran (ALN-TTRsc04): An investigational RNAi therapeutic for the treatment of ATTR amyloidosis.
- Phase 3 Study: Alnylam expects to initiate a Phase 3 trial in patients with ATTR amyloidosis with cardiomyopathy in the first half of 2025.
Zilebesiran: An investigational RNAi therapeutic for hypertension, in collaboration with Roche.
- KARDIA-3 Results: Alnylam Reports plans to report Phase 2 results from the KARDIA-3 study in the second half of 2025.
- Phase 3 Trial: A Phase 3 cardiovascular outcomes trial is expected to be initiated in the second half of 2025.
Mivelsiran: An investigational RNAi therapeutic for Alzheimer’s disease and cerebral amyloid angiopathy (CAA).
- Phase 1 Results: Interim results from Part B of the Phase 1 study in Alzheimer’s disease are expected in the second half of 2025.
- Phase 2 Study: A Phase 2 study in Alzheimer’s disease is anticipated to begin in the second half of 2025.
ALN-6400: An investigational RNAi therapeutic for bleeding disorders.
- Phase 2 Study: Alnylam plans to initiate a Phase 2 study in a bleeding disorder in the second half of 2025.
In addition to these ongoing programs, Alnylam intends to file Investigational New Drug (IND) applications for four new programs by the end of 2025.
Partner-Led Program Highlights
Alnylam’s Reports partnered programs continue to make significant progress. Some key developments include:
Fitusiran: In partnership with Sanofi, fitusiran is an investigational RNAi therapeutic for the treatment of hemophilia A and B, with or without inhibitors. Sanofi expects to secure FDA approval by the PDUFA target action date of March 28, 2025.
Elebsiran: In partnership with Vir Biotechnology, Elebsiran is an RNAi therapeutic in development for chronic hepatitis B and hepatitis delta. In 2025, Vir expects to initiate a Phase 3 chronic hepatitis delta registrational study and report results from a Phase 2 chronic hepatitis B study.
