Alnylam Pharmaceuticals(ALNY) - 2025 Q3 - Quarterly Results

Financial Performance - Generated Q3 2025 total net product revenues of $851 million, representing a 103% growth compared to Q3 2024, driven primarily by total TTR revenues of $724 million, which grew by 135% year-over-year[1]. - Total revenues for Q3 2025 reached $1,249 million, a 149% increase from $501 million in Q3 2024[11]. - Alnylam reported net product revenues of $851,082 thousand for Q3 2025, a 102.5% increase from $420,146 thousand in Q3 2024[47]. - Total revenues for the nine months ended September 30, 2025, reached $2,616,904 thousand, up 58.2% from $1,655,077 thousand in the same period of 2024[47]. - The company achieved a net income of $251,084 thousand in Q3 2025, compared to a net loss of $111,570 thousand in Q3 2024[47]. - GAAP net income for Q3 2025 was $251 million, compared to a loss of $112 million in Q3 2024[11]. - The company reported a non-GAAP net income of $396,180 thousand for Q3 2025, compared to a non-GAAP net loss of $64,199 thousand in Q3 2024[48]. Revenue Guidance - Raised 2025 guidance for TTR franchise net revenues to between $2,475 million and $2,525 million, and total net product revenues to between $2,950 million and $3,050 million, indicating a $275 million or 10% increase at midpoint[1]. - Updated full-year 2025 total net product revenues guidance is $2,950 million - $3,050 million, an increase from the prior guidance of $2,650 million - $2,800 million[26]. - The company expects net product revenues growth of 79% to 85% compared to 2024 at currency exchange rates as of September 30, 2025, up from the previous estimate of 61% to 70%[26]. Product Performance - Achieved global net product revenues for GIVLAARI and OXLUMO of $74 million and $53 million, respectively, totaling $127 million in total Rare net product revenue, reflecting a 14% growth compared to Q3 2024[4]. - AMVUTTRA's patient demand approximately doubled in Q3 2025 compared to Q2 2025, with broad uptake and the majority of patients paying $0 in out-of-pocket costs[6]. - AMVUTTRA net product revenue growth reported at 165%, with a constant currency growth of 162%[50]. - ONPATTRO net product revenue growth reported at (22)%, with a constant currency growth of (25)%[50]. - Total TTR net product revenue growth reported at 135%, with a constant currency growth of 131%[50]. - GIVLAARI net product revenue growth reported at 4%, with a constant currency growth of 2%[50]. - OXLUMO net product revenue growth reported at 31%, with a constant currency growth of 27%[50]. - Total Rare net product revenue growth reported at 14%, with a constant currency growth of 11%[50]. - Total net product revenue growth reported at 103%, with a constant currency growth of 99%[50]. - Total revenue growth reported at 149%, with a constant currency growth of 147%[50]. Research and Development - Presented new data from the HELIOS-B Phase 3 study showing vutrisiran reduced the risk of all-cause mortality or first cardiovascular event by 37% in the overall population[6]. - Initiated the TRITON-PN Phase 3 trial of nucresiran in patients with hATTR-PN, with topline results expected in 2028[6]. - Research and development expenses for Q3 2025 were $358,814 thousand, up 32.3% from $270,926 thousand in Q3 2024[48]. - Non-GAAP R&D and SG&A expenses guidance for full-year 2025 is updated to $2,150 million - $2,200 million, compared to the prior guidance of $2,100 million - $2,200 million[26]. - The company has a deep pipeline of investigational medicines, including multiple product candidates in late-stage development[40]. Financial Position - Total cash, cash equivalents, and marketable securities decreased to $2.7 billion as of September 30, 2025, down from $2.9 billion as of June 30, 2025, primarily due to the partial repurchase of convertible senior notes[25]. - Alnylam's cash and cash equivalents increased to $1,490,249 thousand as of September 30, 2025, from $966,428 thousand at the end of 2024[45]. - Alnylam's total assets increased to $4,851,662 thousand as of September 30, 2025, compared to $4,239,983 thousand at the end of 2024[45]. - Alnylam's total liabilities increased to $4,617,768 thousand as of September 30, 2025, from $4,172,895 thousand at the end of 2024[45]. - Net cash used in financing activities for the three months ended September 30, 2025, included $1.1 billion paid to repurchase $638 million of convertible senior notes due 2027[25]. Tax and Other Financial Matters - The company recorded a benefit from income taxes of $12 million during the three months ended September 30, 2025, primarily due to a reduction in pre-tax loss in the U.S.[23]. - Total other expense, net for the three months ended September 30, 2025, was $129 million, which included a $65 million charge related to the change in fair value of the development derivative liability[22]. - The company maintains a full valuation allowance against net deferred tax assets in the U.S. and certain deferred tax assets in Switzerland[24]. Strategic Goals - The company expects to achieve sustainable profitability and aims to deliver transformational innovation to patients as part of its Alnylam P5x25 strategy[42]. - The company plans to continue advancing its pipeline of RNAi therapeutics and successfully launch its approved products globally[42].