Regeneron(US:REGN)2025-10-28 10:56Financial Performance - Regeneron reported revenues of $3,754.3 million for the three months ended September 30, 2025, compared to $3,720.7 million for the same period in 2024, reflecting a year-over-year increase of approximately 0.9%[99] - Net income for the three months ended September 30, 2025, was $1,460.0 million, up from $1,340.6 million in the same period of 2024, representing an increase of about 8.9%[99] - Diluted net income per share increased to $13.62 for the three months ended September 30, 2025, compared to $11.54 for the same period in 2024, marking a growth of approximately 18.1%[99] - For the nine months ended September 30, 2025, total revenues reached $10,458.6 million, slightly up from $10,412.8 million in the same period of 2024, indicating a growth of about 0.4%[99] - The net income for the nine months ended September 30, 2025, was $3,660.3 million, compared to $3,494.9 million in the same period of 2024, which is an increase of approximately 4.8%[99] Product Sales - Total sales for EYLEA HD and EYLEA decreased by 20% to $1,965.0 million in Q3 2025 compared to $2,468.6 million in Q3 2024[106] - Dupixent sales increased by 27% to $4,857.0 million in Q3 2025 from $3,817.2 million in Q3 2024[106] - EYLEA HD sales in the U.S. rose by 42% to $430.6 million in Q3 2025, compared to $392.3 million in Q3 2024[106] - Total sales for EYLEA HD and EYLEA for the nine months ended September 30, 2025, were $5,990.8 million, down 16% from $7,162.1 million in the same period of 2024[108] - Dupixent sales for the nine months ended September 30, 2025, reached $12,867.2 million, a 23% increase from $10,450.4 million in the same period of 2024[108] - Libtayo sales increased by 27% to $365.2 million in Q3 2025 compared to $288.6 million in Q3 2024[106] - Kevzara sales grew by 28% to $154.0 million in Q3 2025 from $120.1 million in Q3 2024[106] - EYLEA HD sales for the nine months ended September 30, 2025, were $1,751.1 million, a 67% increase from $1,046.0 million in the same period of 2024[108] Research and Development - Regeneron continues to focus on developing treatments for serious diseases, including eye diseases, cancer, and rare diseases, leveraging its proprietary technologies[97] - The company aims to maintain a strong foundation in scientific research and drug development, enhancing its clinical and commercial capabilities[98] - The company is awaiting FDA decisions on supplemental Biologics License Applications for EYLEA HD and Dupixent in November 2025[113] - The company has presented positive data from various clinical trials, including EYLEA HD and Dupixent, at major medical meetings in 2025[113] - Fianlimab (REGN3767) Phase 2/3 studies in first-line advanced NSCLC will continue unchanged, with results expected in the first half of 2026[115] - Ubamatamab (REGN4018) presented additional data from Phase 2 study in platinum-resistant ovarian cancer at ESMO 2025 Meeting[116] - Pozelimab (REGN3918) reported that Phase 3 cemdisiran combination trial in myasthenia gravis met its primary and key secondary endpoints[116] - Garetosmab (REGN2477) reported that Phase 3 trial in FOP met its primary endpoint, with BLA submission expected in the fourth quarter of 2025[117] - REGN9933 to initiate Phase 3 studies in thrombosis in the first half of 2026[117] - Lynozyfic (linvoseltamab) completed enrollment in Phase 3 confirmatory trial in relapsed/refractory multiple myeloma[116] Financial Obligations and Expenses - The total amount of the company's contingent reimbursement obligation to Sanofi was approximately $905 million as of September 30, 2025[126] - The FDA issued a Complete Response Letter (CRL) for the pre-filled syringe sBLA of EYLEA HD on October 27, 2025, due to unresolved inspection findings at the manufacturing site[121] - The company plans to submit an application by January 2026 to include a new pre-filled syringe manufacturing filler in the EYLEA HD BLA[121] - The company expects to continue incurring substantial expenses related to research and development activities, impacting future profitability[137] - Total operating expenses for Q3 2025 were $2,727.5 million, an increase from $2,541.2 million in Q3 2024[150] - Research and development expenses for Q3 2025 were $1,475.0 million, up from $1,271.5 million in Q3 2024[150] - Total direct research and development expenses for the three months ended September 30, 2025, were $454.3 million, an increase of $67.9 million compared to $386.4 million in 2024[152] Cash Flow and Capital Management - Cash flows provided by operating activities increased to $3,808.2 million for the nine months ended September 30, 2025, up by $650.5 million from $3,157.7 million in 2024[163] - The company had cash and cash equivalents of $2,506.4 million as of September 30, 2025, an increase of $18.2 million from $2,488.2 million in 2024[162] - The company expects to incur capital expenditures of $850 million to $890 million for the full year of 2025, primarily for the expansion of research and manufacturing facilities[164] - The board of directors authorized an additional share repurchase program for up to $3.0 billion in April 2024 and February 2025, totaling up to $6.0 billion, with $2.156 billion remaining available as of September 30, 2025[166] - Quarterly cash dividends of $0.88 per share were declared for the first, second, and third quarters of 2025, with the same amount declared in October 2025, payable on December 5, 2025[167][168] Market Risks and Accounting - There have been no material changes to critical accounting estimates during the nine months ended September 30, 2025[169] - No material changes to market risks or management of such risks as of September 30, 2025[171]