Financial Data and Key Metrics Changes - Regeneron reported total revenues of $3.8 billion for Q3 2025, reflecting a 1% increase compared to the prior year, driven by higher collaboration revenue from Sanofi and growth in net sales of Dupixent and LIBTAYO, partially offset by lower EYLEA sales [39][40] - Diluted net income per share was $11.83, with net income reaching $1.3 billion [39] - Gross margin on net product sales was 86%, lower than the previous year due to a changing product mix and increased investments in manufacturing operations [41] Business Line Data and Key Metrics Changes - Dupixent achieved worldwide net sales of $4.9 billion in Q3 2025, a 26% increase year-over-year at constant currency, with U.S. sales growing 28% [7][35] - LIBTAYO's global net sales were $365 million, up 24% on a constant currency basis, with U.S. sales growing 12% [9][36] - EYLEA HD reached U.S. net sales of $431 million, an all-time high, while EYLEA sales decreased 10% to $681 million due to competitive dynamics and patient affordability issues [10][33] Market Data and Key Metrics Changes - Dupixent is positioned to address over 4 million patients in the U.S., with more than 1.3 million patients currently treated globally [8] - LIBTAYO is the market leader in advanced non-melanoma skin cancers and has recently been approved for high-risk adjuvant cutaneous squamous cell carcinoma, with an estimated 10,000 eligible patients in the U.S. [9][37] - EYLEA HD now represents approximately 40% of Regeneron's U.S. retina franchise, with expectations for moderate to high single-digit demand growth in the upcoming quarter [34] Company Strategy and Development Direction - Regeneron is focused on maximizing growth from existing brands while launching new products and indications, with significant investments in R&D to support its pipeline [16][39] - The company is engaged in discussions with the U.S. government to lower drug costs while preserving innovation and has committed over $7 billion to infrastructure and manufacturing in the U.S. [15][39] - The pipeline includes advancements in immunology, oncology, and rare diseases, with positive Phase III data for several programs [12][30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing discussions with the U.S. government regarding drug pricing and the importance of U.S. manufacturing for national security [15] - The company anticipates continued growth across its commercial portfolio, with a focus on addressing unmet patient needs and expanding treatment options [16][39] - Regeneron expects to advance multiple registrational programs in 2026, with a mid-teens percentage increase in R&D expenses planned [43] Other Important Information - The FDA issued a complete response letter for the prefilled syringe supplemental BLA for EYLEA HD due to unresolved inspection findings at a third-party facility [11] - Regeneron is advancing its siRNA portfolio and has made significant progress in clinical trials for various conditions, including ultra-rare diseases [29][30] Q&A Session Summary Question: Changes in EYLEA commercial strategy and pricing - Management acknowledged competitive issues and emphasized the importance of EYLEA HD's clinical efficacy and safety in driving its performance [45][48] Question: Future balance sheet utilization for large deals - Management indicated openness to using the balance sheet for strategic opportunities and highlighted ongoing investments in domestic manufacturing [54][56] Question: Importance of label enhancements for EYLEA HD - Management noted that label enhancements are crucial for providing dosing flexibility and improving market share [59][60] Question: Insights from IL-33 COPD trials - Management refrained from commenting on specific insights but indicated plans for further discussions with the FDA [63][64] Question: Probability of approval for RVO and dosing filing - Management discussed the complexities of the approval process and the timeline for the new filler, expressing cautious optimism [66][68] Question: Internal changes to prevent CRLs - Management clarified that issues were not due to internal regulatory problems but rather manufacturing challenges, emphasizing ongoing efforts to rectify the situation [72][75] Question: Factor XI antibody program and future opportunities - Management highlighted the focus on understanding the benefit-risk ratio and the potential for broader applications of the Factor XI antibodies [78][80]

Financial Data and Key Metrics Changes - Regeneron reported total revenues of $3.8 billion for Q3 2025, reflecting a 1% increase compared to the prior year, driven by higher collaboration revenue from Sanofi and growth in net sales of Libtayo and EYLEA HD, partially offset by lower EYLEA sales [34][35] - Diluted net income per share was $11.83, with net income of $1.3 billion [34] - Gross margin on net product sales was 86%, lower than the previous year due to a changing product mix and higher investments in manufacturing operations [36] Business Line Data and Key Metrics Changes - Dupixent achieved worldwide net sales of $4.9 billion, growing 26% year-over-year at constant currency, with U.S. sales reaching $3.6 billion, reflecting a 28% increase [28][29] - Libtayo's global net sales were $365 million, up 24% on a constant currency basis, with U.S. sales growing 12% year-over-year [27][30] - EYLEA HD U.S. net sales reached $431 million, an all-time high, driven by robust physician demand, while EYLEA sales decreased 10% to $681 million [27][28] Market Data and Key Metrics Changes - Dupixent is positioned to address over 4 million patients in the U.S., with more than 1.3 million patients currently treated globally [6] - Libtayo is now the second most commonly prescribed immunotherapy for newly diagnosed lung cancer patients, with strong demand in non-melanoma skin cancers [31] - EYLEA HD represents approximately 40% of Regeneron's U.S. retina franchise, with expectations for continued demand growth [28] Company Strategy and Development Direction - Regeneron is focused on maximizing growth from existing brands while launching new products and indications, with significant investments in R&D to support its pipeline [13][39] - The company is committed to discussions with the U.S. government to lower drug costs while preserving innovation and has plans to invest over $7 billion in manufacturing infrastructure [12][39] - Future product enhancements for EYLEA HD are anticipated to unlock its commercial potential, including a four-week dosing interval and new indications [8][27] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about ongoing discussions with the U.S. administration regarding drug pricing and the importance of U.S. manufacturing for national security [12] - The company expects continued growth in its commercial portfolio, driven by strong performance across Dupixent, Libtayo, and EYLEA HD [13][39] - Regeneron anticipates a mid-teens percentage increase in R&D expenses in 2026 to support its innovative pipeline [39] Other Important Information - Regeneron generated $3.2 billion in free cash flow through the first nine months of 2025 and repurchased approximately $2.8 billion of its shares [37] - The company plans to submit a U.S. regulatory application for cimdisiren in the first quarter of 2026, pending FDA discussions [22] Q&A Session Summary Question: Changes in EYLEA commercial strategy and pricing - Management acknowledged competitive issues and emphasized the importance of EYLEA HD's clinical efficacy and safety in driving its performance [41][43][45] Question: Future manufacturing expansion plans - Management indicated openness to using the balance sheet for large deals if the right opportunity arises and highlighted ongoing investments in domestic manufacturing [50][52] Question: Importance of label enhancements for EYLEA HD - Management noted that label enhancements are crucial for clinics to have dosing flexibility and improve inventory management [55][56] Question: Insights from IL-33 COPD trials - Management refrained from commenting on specific insights but mentioned upcoming discussions with the FDA to determine the strategy for future trials [59][60] Question: Probability of approval for RVO and dosing filing - Management discussed the complexities of the approval timeline and the need for the new filler to undergo review before resubmission [62][63] Question: Changes to regulatory manufacturing teams - Management clarified that issues were not due to internal regulatory problems but rather manufacturing challenges, emphasizing the need for their own filling capabilities [66][68]

Core Insights - Regeneron Pharmaceuticals reported third-quarter adjusted earnings of $11.83 per share, a 5% decrease year-over-year, surpassing the consensus estimate of $9.59 [1] - The company achieved sales of $3.75 billion, reflecting a 1% year-over-year increase and exceeding the consensus of $3.59 billion [1] - U.S. net sales for Eylea HD and Eylea fell 28% year-over-year to $1.12 billion, with Eylea HD contributing $431 million and Eylea contributing $681 million [1] Sales Performance - Eylea HD sales increased due to higher volumes driven by stronger demand, although this was partially offset by a lower net selling price [2] - Eylea sales were negatively impacted by lower volumes due to competitive pressures, market share loss to compounded bevacizumab, and patient transitions to Eylea HD [2] Collaboration Revenue - Sanofi collaboration revenue rose 28% to $1.62 billion, primarily due to increased profits from antibody commercialization, which amounted to $1.46 billion in Q3 2025 compared to $1.09 billion in Q3 2024 [3] Pipeline Developments - The FDA issued a Complete Response Letter (CRL) for the prefilled syringe supplemental BLA, citing unresolved inspection findings at Catalent [4] - Regeneron plans to submit an application by January 2026 to include a new prefilled syringe manufacturing filler in the Eylea HD BLA [4] - A supplement application is under FDA review for EYLEA HD every-four-week dosing, with a target action date in late November 2025 [5] Financial Outlook - Regeneron expects a 2025 GAAP gross margin of approximately 82%, down from prior guidance of 83%, while reaffirming an adjusted gross margin of approximately 86% [6] - REGN stock rose 3.96% to $608.50 in premarket trading [6]

ANALYSIS: Are Prediction Markets Turning Brokers Into Bookies? Regeneron stock jumped on Tuesday after the biotech company reported adjusted earnings of $11.83 per share on $3.75 billion in third-quarter sales. Analysts polled by FactSet expected Regeneron Pharmaceuticals (REGN) to earn $9.65 a share and report $3.59 billion in sales. Notably, third-quarter earnings took a 68-cent hit thanks to a tax charge, and still came in well above forecasts. YOU MAY ALSO LIKE: GSK Crumbles As Blood Cancer Comeback Fa ...

Core Insights - Regeneron reported quarterly earnings of $11.83 per share, exceeding the Zacks Consensus Estimate of $9.44 per share, but down from $12.46 per share a year ago, resulting in an earnings surprise of +25.32% [1] - The company achieved revenues of $3.75 billion for the quarter ended September 2025, surpassing the Zacks Consensus Estimate by 4.38% and showing a slight increase from $3.72 billion year-over-year [2] - Regeneron has outperformed consensus EPS estimates three times in the last four quarters and has also topped revenue estimates three times during the same period [2] Earnings Outlook - The future performance of Regeneron shares will largely depend on management's commentary during the earnings call and the sustainability of the stock's price movement based on recent earnings and future expectations [3][4] - The current consensus EPS estimate for the upcoming quarter is $9.35 on revenues of $3.67 billion, while for the current fiscal year, the estimate is $40.08 on revenues of $13.95 billion [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Regeneron belongs, is currently ranked in the top 37% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked using tools like the Zacks Rank [5][6]

Regeneron Corporate Presentation O C T O B E R 2 0 2 5 This non-promotional presentation contains investigational data as well as forward-looking statements; actual results may vary materially. Note regarding forward-looking statements and non-GAAP financial measures This presentation includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may ...

Core Insights - Regeneron Pharmaceuticals exceeded Wall Street expectations for its third-quarter results, driven by robust demand for its eczema treatment, Dupixent, and cancer treatment, Libtayo [1] Financial Performance - The strong performance in the third quarter was primarily attributed to the sales growth of Dupixent and Libtayo, indicating a positive trend in the company's product portfolio [1] Market Reaction - Following the announcement of the earnings report, Regeneron's shares experienced an upward movement, reflecting investor confidence in the company's growth prospects [1]

Financial 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]

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]

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