Financial Performance - Total revenues for Q3 2025 increased by 1% to $3.75 billion compared to Q3 2024[4] - GAAP net income rose by 9% to $1.46 billion, with GAAP EPS increasing by 18% to $13.62[4] - Net income for Q3 2025 was $1,460.0 million, compared to $1,340.6 million in Q3 2024, reflecting a growth of 8.9%[40] - Non-GAAP net income for Q3 2025 was $1,287.2 million, down from $1,462.4 million in Q3 2024, indicating a decrease of 12.0%[41] - Total revenues for the nine months ended September 30, 2025, were $10,458.6 million, slightly up from $10,412.8 million in the same period of 2024[40] - Free cash flow for the nine months ended September 30, 2025, was $3,158.5 million, compared to $2,601.4 million in the same period of 2024, representing an increase of 21.4%[42] Sales Performance - Dupixent global net sales increased by 27% to $4.86 billion, contributing significantly to revenue growth[5] - EYLEA HD U.S. net sales increased by 10% to $431 million, while total EYLEA net sales decreased by 28% to $1.11 billion[5] - Dupixent sales increased by 27% to $4,857.0 million in Q3 2025 compared to $3,817.2 million in Q3 2024[45] - Libtayo sales rose by 27% to $365.2 million in Q3 2025, up from $288.6 million in Q3 2024[45] - Praluent sales increased by 13% to $215.7 million in Q3 2025, compared to $191.4 million in Q3 2024[45] - Kevzara sales grew by 28% to $154.0 million in Q3 2025, up from $120.1 million in Q3 2024[45] - Total net product sales for EYLEA HD and EYLEA decreased by 20% to $1,965.0 million in Q3 2025 from $2,468.6 million in Q3 2024[45] - Total net product sales for EYLEA HD and EYLEA for the nine months ended September 30, 2025, were $5,990.8 million, a decrease of 16% from $7,162.1 million in the same period of 2024[47] - Dupixent sales for the nine months ended September 30, 2025, reached $12,867.2 million, reflecting a 23% increase from $10,450.4 million in the same period of 2024[47] - Libtayo sales for the nine months ended September 30, 2025, were $1,026.8 million, a 21% increase from $849.9 million in the same period of 2024[47] - Kevzara sales for the nine months ended September 30, 2025, increased by 30% to $422.6 million compared to $323.9 million in the same period of 2024[47] - Other products recorded a slight increase of 5% in sales to $198.6 million for the nine months ended September 30, 2025, from $189.6 million in the same period of 2024[47] Research and Development - Research and development expenses increased by 16% to $1.48 billion, reflecting continued investment in innovation[19] - The company invested nearly $5 billion in R&D and capital expenditures in the first nine months of 2025[6] - GAAP R&D expenses for Q3 2025 rose, driven by advancements in the late-stage clinical pipeline, with acquired IPR&D expenses including an $80 million up-front payment to Hansoh Pharmaceuticals[23] - Research and development expenses for Q3 2025 were $1,475.0 million, an increase of 16.0% from $1,271.5 million in Q3 2024[41] - The updated full year 2025 GAAP R&D guidance is $5.680–$5.750 billion, while non-GAAP R&D guidance is $5.150–$5.200 billion[26] Regulatory and Product Development - The FDA approved Libtayo as the first immunotherapy for high-risk adjuvant cutaneous squamous cell carcinoma[5] - The company plans to submit a regulatory application for DB-OTO, a gene therapy for hearing loss, in Q4 2025[14] Shareholder Returns - The Company repurchased $663 million worth of common stock in Q3 2025, with $2.156 billion remaining available for future repurchases[24] - The Company declared a cash dividend of $0.88 per share, payable on December 5, 2025[25] Tax and Financial Guidance - GAAP other income included net gains on marketable securities of $578 million, compared to $135 million in Q3 2024[20] - The Company's GAAP effective tax rate (ETR) increased to 17.2% in Q3 2025 from 10.2% in Q3 2024, primarily due to a $45 million charge related to the re-measurement of U.S. net deferred tax assets[21] - The Company anticipates a GAAP effective tax rate of approximately 14% for 2025, up from a prior range of 11%–13%[26] Asset and Equity Position - Total assets as of September 30, 2025, were $40,169.4 million, an increase from $37,759.4 million as of December 31, 2024[39] - Stockholders' equity increased to $30,957.8 million as of September 30, 2025, compared to $29,353.6 million at the end of 2024[39] Gross Margin - GAAP gross margin on net product sales is projected to be approximately 82% for 2025, down from approximately 83% previously[26] - Non-GAAP gross margin on net product sales remains unchanged at approximately 86%[26] - The gross margin on net product sales for Q3 2025 was 86%, down from 89% in Q3 2024[42] - GAAP SG&A expenses decreased to $2.775–$2.845 billion for 2025 guidance, down from a prior range of $2.810–$2.940 billion[26]
Regeneron(REGN) - 2025 Q3 - Quarterly Results