Alnylam Pharmaceuticals Reports $278.1M Net Loss and 23% Revenue Growth in 2024

Alnylam Pharmaceuticals, Inc. reported a net loss of $278.1 million for the year ended December 31, 2024, compared to a net loss of $440.2 million in 2023. Total revenues increased by 23% to $2.25 billion in 2024, driven by a 33% increase in net product revenues to $1.65 billion. This increase was primarily due to growth in sales of AMVUTTRA, partially offset by a decrease in ONPATTRO sales resulting from patient switches to AMVUTTRA and increased sales of GIVLAARI and OXLUMO. Net revenues from collaborations decreased by 7% to $510.2 million, while royalty revenue increased by 126% to $91.8 million, primarily due to increased royalties from Leqvio sales by Novartis.

Significant changes compared to the previous year include the submission of a supplemental New Drug Application (sNDA) to the FDA for vutrisiran (AMVUTTRA) for the treatment of ATTR amyloidosis with cardiomyopathy, with an action date set for March 23, 2025. Positive topline results were also reported from the HELIOS-B clinical trial of vutrisiran for this indication in June 2024. The company also reported positive interim Phase 1 data for nucresiran, an investigational RNAi therapeutic for ATTR amyloidosis, and positive initial results from the Phase 1 clinical trial of mivelsiran for Alzheimer's disease. Alnylam ended 2024 with $2.69 billion in cash, cash equivalents, and marketable securities.

Strategic developments included the continued launch of Leqvio by Novartis, focusing on increasing account and patient adoption. Alnylam also entered into a collaboration and license agreement with Roche for the joint development and commercialization of zilebesiran for hypertension, receiving a $310 million upfront payment and a $65 million milestone payment in 2024. The company also initiated Phase 1 studies of zilebesiran plus a reversal agent and a Phase 1 study of ALN-HTT02 for Huntington's disease. Regeneron opted out of further co-development of mivelsiran, leaving Alnylam with full global rights.

Operational developments included the continued global expansion of ONPATTRO, AMVUTTRA, GIVLAARI, and OXLUMO, with regulatory filings pending or planned in additional territories. Alnylam's employee headcount increased by approximately 200 in 2024 to approximately 2,230 full-time employees. The company also continued to build its global commercial infrastructure and compliance program. Alnylam reported entering into value-based agreements with multiple commercial payers for ONPATTRO, AMVUTTRA, GIVLAARI, and OXLUMO.

Alnylam's outlook includes plans to file four or more new investigational new drug applications in 2025 and to initiate a Phase 3 cardiovascular outcomes trial for zilebesiran in the second half of 2025. The company expects to initiate a Phase 3 clinical trial of nucresiran and a Phase 2 clinical trial of mivelsiran in the first and second half of 2025, respectively. Alnylam believes its current cash balance should enable it to achieve a self-sustainable profile without the need for future equity financing. However, the company acknowledges numerous risks, including those related to the success of its product candidates, competition, regulatory approvals, and market conditions, as detailed in the 10-K filing.