Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, has announced its financial results for the first quarter ending March 31, 2024, along with notable recent business achievements.
Yvonne Greenstreet, MBChB, Chief Executive Officer of Alnylam, commented, “The year 2024 has begun on a strong note, marked by exceptional commercial performance with global net product revenues totaling $365 million, signifying a 32% year-over-year growth for our four wholly owned products. Progress in our pipeline is also notable, particularly with the zilebesiran program in hypertension, where positive results from the KARDIA-2 Phase 2 study have been reported, and the initiation of the KARDIA-3 Phase 2 study.”
Greenstreet added, “We eagerly anticipate topline results from the HELIOS-B Phase 3 study of vutrisiran in late June or early July, which could further solidify our leadership in ATTR amyloidosis. Additionally, we are looking forward to commencing a Phase 2 study of mivelsiran (formerly ALN-APP) in cerebral amyloid angiopathy in the coming months. These achievements position us well to meet our Alnylam P5x25 goals of becoming a top-tier biotech company delivering sustained innovation and exceptional financial results.”
Key Highlights from the First Quarter of 2024 and Recent Corporate Developments:
Commercial Performance:
Total TTR (Transthyretin Amyloidosis) Net Product Revenues:
Continued growth momentum, with global net product revenues for ONPATTRO and AMVUTTRA reaching $69 million and $195 million, respectively, in the first quarter. This represents a 4% total TTR quarterly growth compared to Q4 2023 and a 29% annual growth compared to Q1 2023.
Total Rare Diseases Net Product Revenues:
GIVLAARI and OXLUMO achieved global net product revenues of $58 million and $43 million, respectively, in the first quarter. This represents a 9% total Rare quarterly growth compared to Q4 2023 and a 40% annual growth compared to Q1 2023.
Research & Development (R&D) Highlights:
Updates to the statistical analysis plan for the HELIOS-B Phase 3 study of vutrisiran have been announced, including adjustments to primary and secondary endpoints and analysis period. Topline results are expected to be reported in late June or early July.
Positive results from the KARDIA-2 Phase 2 study of zilebesiran in patients with inadequately controlled hypertension have been reported.
Initiation of the global KARDIA-3 Phase 2 study of zilebesiran in adult patients with high cardiovascular risk and uncontrolled hypertension, triggering a $65 million milestone payment from Roche.
Publication of results from the Phase 2 KARDIA-1 study of zilebesiran in the Journal of the American Medical Association (JAMA).
Clearance from the U.S. Food and Drug Administration (FDA) to initiate Part B of the ongoing Phase 1 study of mivelsiran in early onset Alzheimer’s disease.
Presentation of new preclinical data for ALN-HTT02, an investigational RNAi therapeutic targeting huntingtin (HTT) for the treatment of Huntington’s disease.
Upcoming Events:
Reporting of topline results from the HELIOS-B Phase 3 study of vutrisiran in late June or early July.
Initiation of a Phase 2 study of mivelsiran in patients with cerebral amyloid angiopathy.
Initiation of Part B of the Phase 1 study of ALN-KHK, in development for the treatment of Type 2 diabetes mellitus.
Initiation of a Phase 1 study of ALN-BCAT, in development for the treatment of hepatocellular carcinoma.
Financial Results for the Quarter Ended March 31, 2024:
Please refer to the original article for detailed financial results for the quarter ended March 31, 2024.
2024 Financial Guidance:
Alnylam has reiterated its full-year 2024 financial guidance, including projections for combined net product revenues and net revenues from collaborations and royalties.
Use of Non-GAAP Financial Measures:
The press release contains non-GAAP financial measures to provide useful information to management and investors regarding the company’s financial condition and results of operations.
Conference Call Information:
Management will discuss the first quarter 2024 results and future expectations via conference call on Thursday, May 2, 2024, at 8:30 am ET. A live audio webcast of the call will be available on the Investors section of the Company’s website.
For further details and information, please refer to the original article.
