Alnylam Pharmaceuticals Q1 2024 Financial Results and Recent Activities

Alnylam Pharmaceuticals, Inc., a leader in RNA interference (RNAi) therapeutics, has released its financial results for the first quarter of 2024, which ended on March 31. The company reported impressive global net product revenues of $365 million, marking a 32% year-over-year increase compared to the same period in 2023. This growth was driven by the strong performance of its four wholly owned products and significant advancements in its research and development pipeline.

Key Highlights:

1. Commercial Success:
- Total TTR therapies (ONPATTRO® and AMVUTTRA®): Achieved combined global net product revenues of $69 million for ONPATTRO and $195 million for AMVUTTRA. This represents a 4% quarterly growth from Q4 2023 and a 29% annual growth from Q1 2023.
- Total Rare diseases therapies (GIVLAARI® and OXLUMO®): Recorded net product revenues of $58 million for GIVLAARI and $43 million for OXLUMO. This signifies a 9% quarterly growth from Q4 2023 and a 40% annual growth from Q1 2023.

2. Pipeline Progress:
- Zilebesiran for Hypertension: Alnylam reported positive outcomes from the KARDIA-2 Phase 2 study and announced the initiation of the KARDIA-3 Phase 2 study. This progress triggered a $65 million milestone payment from Roche.
- Vutrisiran for ATTR Amyloidosis: The company remains on track to report topline results from the HELIOS-B Phase 3 study in late June or early July. Adjustments were made to the study's statistical analysis plan, focusing on primary and secondary endpoints and analysis period.
- Mivelsiran for Early Onset Alzheimer’s Disease: The U.S. Food and Drug Administration (FDA) cleared the multiple-dose part (Part B) of the ongoing Phase 1 study.

3. Upcoming Milestones:
- Reporting of topline results from the HELIOS-B Phase 3 study of vutrisiran.
- Initiation of a Phase 2 study of mivelsiran targeting cerebral amyloid angiopathy.
- Commencement of Part B of the Phase 1 study of ALN-KHK for Type 2 diabetes mellitus.
- Initiation of a Phase 1 study of ALN-BCAT for hepatocellular carcinoma.

4. Financial Performance:
- Revenues: Total net product revenues for the quarter reached $365 million, up from $276 million in Q1 2023. This was primarily driven by the increased patient demand for AMVUTTRA and higher utilization of GIVLAARI and OXLUMO.
- Collaborations: Revenues from collaborations rose significantly by 225% compared to the same period last year, bolstered by milestone payments and increased activities with partners like Roche and Regeneron.
- Costs and Expenses: The cost of goods sold remained consistent with 15% of net product revenues. Research and development (R&D) expenses increased due to ongoing clinical studies and preclinical activities. Selling, general, and administrative (SG&A) expenses rose as well, driven by enhanced marketing efforts for TTR therapies and strategic investments.

5. Future Financial Guidance:
- Alnylam reiterated its 2024 financial guidance, projecting combined net product revenues between $1,400 million and $1,500 million. Net revenues from collaborations and royalties are expected to range between $325 million and $425 million.
- The company anticipates GAAP R&D and SG&A expenses to be between $1,900 million and $2,050 million, while non-GAAP expenses are projected to be between $1,675 million and $1,775 million.

Overall, Alnylam's robust financial performance and strategic advancements in its R&D pipeline underscore its commitment to becoming a top-tier biotech company. The company's focus on RNAi therapeutics continues to drive innovation, aiming to deliver transformative medicines across both rare and common diseases.

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