Alnylam Pharmaceuticals(US:ALNY)2025-10-30 12:16Financial Performance - The company has an accumulated deficit of $7.16 billion as of September 30, 2025, primarily due to research and development costs and general administrative expenses [156]. - Total revenues for Q3 2025 reached $1,249.0 million, a 149% increase from $500.9 million in Q3 2024 [186]. - Net product revenues increased by 103% to $851.1 million in Q3 2025, compared to $420.1 million in Q3 2024 [187]. - Collaboration revenues surged by 512% to $351.7 million in Q3 2025, driven by a $300.0 million milestone from Roche [190]. - Royalty revenue rose by 98% to $46.2 million in Q3 2025, up from $23.4 million in Q3 2024 [190]. - Net income for Q3 2025 was $251.1 million, a significant recovery from a loss of $111.6 million in Q3 2024 [186]. - The company reported global net product revenues of $685.3 million for AMVUTTRA and $39.1 million for ONPATTRO in Q3 2025 [168]. - Global net product revenues for GIVLAARI and OXLUMO in Q3 2025 were $73.9 million and $52.8 million, respectively [169]. Research and Development - The company launched the Alnylam P x25 strategy in early 2021, aiming to transition to a top-tier biotech company by the end of 2025, with a focus on delivering transformative medicines [142]. - As of September 30, 2025, the company has six marketed products and over 20 clinical programs, including several in late-stage development [142]. - The company is advancing mivelsiran for Alzheimer's disease, with a Phase 2 clinical trial expected to start in Q4 2025 [151]. - Nucresiran demonstrated mean reductions of serum TTR of greater than 90% from baseline in a Phase 1 clinical trial, with ongoing Phase 3 trials for ATTR amyloidosis [150]. - The company initiated the TRITON-PN Phase 3 trial of nucresiran and reported positive results from the Phase 3 NIMBLE trial of cemdisiran [175]. - The company expects research and development expenses to continue increasing in 2025 as it builds out its global commercial infrastructure and prepares for future product launches [202]. Financial Position and Cash Flow - The company issued $661.25 million in Convertible Senior Notes in September 2025, maturing in 2028, with specific conversion rights for holders [158]. - A $500.0 million revolving line of credit was established, with a $150.0 million letter of credit sublimit, allowing for incremental commitments [161]. - Net cash provided by operating activities increased to $360,525,000 for the nine months ended September 30, 2025, compared to $86,350,000 in 2024, driven by stronger cash receipts from increased product sales [209]. - Net cash provided by investing activities was $473,495,000 for the nine months ended September 30, 2025, compared to a cash outflow of $(63,930,000) in 2024, primarily due to the timing of marketable securities transactions [210]. - The company believes its cash, cash equivalents, marketable securities, and available borrowing capacity will satisfy near-term capital needs for at least the next 12 months [218]. Expenses and Costs - Total operating costs and expenses for Q3 2025 were $881.0 million, a 52% increase from $577.8 million in Q3 2024 [186]. - Cost of goods sold increased by 141% to $197,231,000 for the three months ended September 30, 2025, compared to $81,980,000 in 2024, and by 101% to $409,443,000 for the nine months ended September 30, 2025, compared to $203,864,000 in 2024 [192]. - Research and development expenses rose by 32% to $358,814,000 for the three months ended September 30, 2025, compared to $270,926,000 in 2024, and by 15% to $947,557,000 for the nine months ended September 30, 2025, compared to $826,063,000 in 2024 [198]. - Selling, general and administrative expenses increased by 46% to $322,076,000 for the three months ended September 30, 2025, compared to $220,993,000 in 2024, and by 30% to $885,339,000 for the nine months ended September 30, 2025, compared to $680,187,000 in 2024 [199]. Collaborations and Partnerships - Collaboration revenues from partnerships with Roche, Regeneron, and Novartis have been a significant source of income in recent years [157]. - Roche made an upfront payment of $310.0 million for the zilebesiran collaboration, with potential contingent payments of up to $2.15 billion based on milestones [174]. - The company recognized $300,000,000 in milestone revenue from collaboration with Roche in September 2025 related to the ZENITH Phase 3 clinical trial of zilebesiran [193]. - The company retains broad global rights to liver-directed clinical and preclinical pipeline programs not part of the Regeneron Collaboration [178]. - The company is eligible for tiered, low double-digit royalties based on net sales of zilebesiran outside the U.S. [176]. - Regeneron provided an upfront payment of $10.0 million under the Amended C5 License Agreement, with potential milestone payments of up to $325.0 million [181]. - Sanofi is eligible to receive tiered royalties up to 30% on global annual net sales of AMVUTTRA exceeding $1.5 billion [183]. Debt and Financing - The company paid $35.3 million for capped call transactions related to the issuance of the 2028 Notes, which are expected to reduce potential dilution upon conversion [159]. - The company repurchased approximately $637.8 million of its 1.00% Convertible Senior Notes due 2027 for a total cost of approximately $1,105.8 million [160]. - Net cash used in financing activities increased, with $1.10 billion paid for the repurchase of $637.8 million of 2027 Notes, offset by $646.4 million from the 2028 Notes offering [211]. - The total repurchase cost for the 2027 Notes was approximately $1.11 billion, with $397.2 million remaining outstanding as of September 30, 2025 [215]. - A $500.0 million Revolving Credit Agreement was established, maturing in September 2030, with no borrowings and $17.5 million of letters of credit outstanding as of September 30, 2025 [216]. - Interest on borrowings under the Revolving Credit Agreement ranges from 1.50% to 2.50% based on the Total Leverage Ratio, with a commitment fee of 0.20% to 0.35% on unused commitments [162]. Market Outlook - The company anticipates continued fluctuations in operating results and plans to target financial self-sustainability by the end of 2025 [156]. - The company expects an increase in cost of goods sold in 2025 due to anticipated higher sales of AMVUTTRA and associated royalties [195]. - Financial market risks related to interest rates remain unchanged since December 31, 2024, with no anticipated near-term changes [219].