Alnylam Reports Q4 and Full Year 2024 Revenue and 2025 Guidance
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a pioneer in RNA interference (RNAi) therapeutics, today announced preliminary global net product revenues for the fourth quarter and full year of 2024, covering its key products: ONPATTRO (patisiran), AMVUTTRA (vutrisiran), GIVLAARI (givosiran), and OXLUMO (lumasiran). The company also provided guidance for 2025, covering combined net product revenue, non-GAAP operating income profitability, and key pipeline milestones.
Alnylam’s CEO, Yvonne Greenstreet, highlighted the company’s impressive growth in 2024, setting the stage for even more transformative developments in 2025. “We generated net product revenues exceeding $1.6 billion in 2024, marking a 33% increase compared to the previous year, at the high end of our revised guidance. This underscores the strength of our hATTR-PN and Rare disease franchises,” said Dr. Greenstreet. “As we look ahead, 2025 will be a pivotal year for our transthyretin (TTR) franchise, especially with the potential launch of vutrisiran in ATTR-CM, which will significantly contribute to our topline growth. We are also poised to achieve non-GAAP profitability in 2025, further solidifying our financial trajectory.”
Preliminary Fourth Quarter and Full Year 2024 Commercial and Financial Performance
TTR Franchise: ONPATTRO and AMVUTTRA
For the fourth quarter of 2024, Alnylam reported preliminary global net product revenues for ONPATTRO at approximately $56 million and AMVUTTRA at $287 million, reflecting a combined growth of 35% compared to the fourth quarter of 2023. For the full year, ONPATTRO generated $253 million, and AMVUTTRA delivered $970 million in revenue, together reflecting a total annual growth of 34% compared to 2023.
Rare Disease Franchise: GIVLAARI and OXLUMO
GIVLAARI and OXLUMO also performed strongly in the fourth quarter of 2024, with preliminary global net product revenues for GIVLAARI at $65 million and OXLUMO at $44 million, resulting in a combined growth of 18% compared to the same period in 2023. Full-year revenues for 2024 were approximately $256 million for GIVLAARI and $167 million for OXLUMO, representing a combined annual growth of 29%.
2025 Combined Net Product Revenue Guidance and Non-GAAP Operating Income
Looking forward to 2025, Alnylam provided combined net product revenue guidance for its key products: ONPATTRO, AMVUTTRA (for both polyneuropathy (PN) and cardiomyopathy (CM)), GIVLAARI, and OXLUMO. The company expects total combined net product revenues for 2025 to range from $2.05 billion to $2.25 billion, representing a 31% increase at the midpoint compared to 2024. The breakdown for the guidance includes:
- Total TTR (ONPATTRO, AMVUTTRA for both PN and CM): $1.6 billion to $1.725 billion, reflecting 36% growth at the midpoint compared to 2024.
- Total Rare (GIVLAARI, OXLUMO): $450 million to $525 million, representing 15% growth at the midpoint compared to 2024.
In addition, Alnylam expects to achieve non-GAAP operating income profitability in 2025, further strengthening its financial outlook.
Key 2025 Product and Pipeline Goals
Alnylam’s pipeline continues to progress with several key milestones in 2025, positioning the company for sustained innovation. Among the highlights:
- Vutrisiran (ALN-TTRsc02) – This RNAi therapeutic is marketed for the treatment of hATTR amyloidosis with polyneuropathy and is in development for the treatment of ATTR amyloidosis with cardiomyopathy. Alnylam anticipates:
- FDA approval of the supplemental New Drug Application (sNDA) for the treatment of ATTR amyloidosis with cardiomyopathy by March 23, 2025.
- Additional global approvals and reimbursement in Japan and the EU in the second half of 2025.
- Nucresiran (ALN-TTRsc04) – Alnylam expects to initiate a Phase 3 study in patients with ATTR amyloidosis with cardiomyopathy in the first half of 2025.
- Zilebesiran – An investigational RNAi therapeutic in development for hypertension, in collaboration with Roche. Alnylam plans to:
- Report results from the KARDIA-3 Phase 2 study in the second half of 2025.
- Initiate a Phase 3 cardiovascular outcomes trial in the same period.
- Mivelsiran – In development for Alzheimer’s disease and cerebral amyloid angiopathy (CAA). Key milestones include:
- Reporting interim results from Part B of the Phase 1 study in Alzheimer’s disease in the second half of 2025.
- Initiating a Phase 2 study in Alzheimer’s disease in the same period.
- ALN-6400 – A therapeutic for bleeding disorders, with a Phase 2 study expected to begin in the second half of 2025.
Alnylam is also preparing to file Investigational New Drug (IND) applications for four new RNAi programs by the end of 2025.
Partner-Led Program Highlights
Alnylam’s collaborations continue to drive progress in key areas, including:
- Fitusiran – Partnered with Sanofi, this RNAi therapeutic is in development for hemophilia A and B with or without inhibitors. Sanofi expects FDA approval by March 28, 2025.
- Elebsiran – Partnered with Vir Biotechnology for chronic hepatitis B and hepatitis delta, with Phase 3 studies and functional cure results expected in 2025.
