Financial Performance - Regeneron reported total revenues of $3.75 billion for Q3 2025[8] - The company's Non-GAAP EPS for Q3 2025 was $11.83[8] - Dupixent global net sales reached $4.9 billion in Q3 2025, representing a 26% year-over-year increase[12] - EYLEA HD and EYLEA together held approximately 60% of the U S branded anti-VEGF category share in Q3 2025[26] - Libtayo global net sales for Q3 2025 were $365 million, a 24% increase year-over-year[34] Pipeline Developments and Regulatory Milestones - A positive CHMP opinion was received for CSU, with an EC decision expected soon[8, 12] - FDA approved Libtayo for adjuvant treatment of CSCC with high risk of recurrence[11, 32] - Positive Phase 3 data was announced for cemdisiran in generalized myasthenia gravis, with FDA submission expected in 1Q26[11] - Positive Phase 3 data was announced for garetosmab in FOP, with FDA submission expected by year-end 2025[11] Strategic Initiatives - Regeneron Genetics Center has created a large DNA sequence-linked healthcare database to improve drug discovery and healthcare analytics[6] - The company anticipates reimbursing approximately $1 billion in 2025 towards Sanofi's antibody development balance[18] - The company is investing >$5 billion into R&D in 2025[112]

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]

To ensure this doesn’t happen in the future, please enable Javascript and cookies in your browser.If you have an ad-blocker enabled you may be blocked from proceeding. Please disable your ad-blocker and refresh. ...

Core Insights - Regeneron Pharmaceuticals reported solid financial results for Q3 2025, with total revenues increasing by 1% to $3.75 billion compared to Q3 2024, and GAAP net income rising by 9% to $1.46 billion [3][5][13]. Financial Highlights - Total revenues for Q3 2025 were $3,754 million, up from $3,721 million in Q3 2024, reflecting a 1% increase [3][13]. - GAAP net income reached $1,460 million, a 9% increase from $1,341 million in the same quarter last year [3][13]. - GAAP diluted net income per share was $13.62, an 18% increase from $11.54 in Q3 2024 [3][13]. - Non-GAAP net income decreased by 12% to $1,287 million, with non-GAAP diluted net income per share at $11.83, down 5% from $12.46 [3][13]. Business Highlights - Regeneron made significant progress in its late-stage portfolio, securing new FDA approvals for Libtayo, Evkeeza, and Lynozyfic, and receiving positive CHMP opinions for Libtayo and Dupixent [2][4]. - Dupixent global net sales increased by 27% to $4.86 billion, while EYLEA HD U.S. net sales rose by 10% to $431 million [5][13]. - The company has approximately 45 product candidates in clinical development, with notable updates including positive Phase 3 results for various therapies [4][10]. Pipeline Progress - Dupixent received a positive opinion from the EMA for treating chronic spontaneous urticaria in adults and adolescents [4]. - Libtayo was approved by the FDA as the first immunotherapy for high-risk adjuvant cutaneous squamous cell carcinoma [10]. - Positive Phase 3 results were reported for treatments in generalized myasthenia gravis and fibrodysplasia ossificans progressiva [10][11]. Capital Allocation - In the first nine months of 2025, Regeneron invested nearly $5 billion in R&D and capital expenditures, primarily in the U.S. [3][24]. - The company returned over $3 billion to shareholders through share repurchases and dividends, emphasizing its commitment to long-term value creation [3][24]. Corporate Updates - Regeneron resolved patent infringement litigation related to EYLEA biosimilars, preventing competitors from launching their products until Q4 2026 [12]. - The company plans to submit applications for new manufacturing fillers for EYLEA HD by January 2026 [6][7].

Core Viewpoint - Regeneron Pharmaceuticals (REGN) stock is considered a value investment opportunity as it is trading nearly 38% lower than its one-year peak and at a price to sales multiple below the average of the past three years, while maintaining reasonable fundamentals for its current valuation [1][7]. Company Overview - Regeneron Pharmaceuticals develops innovative medicines globally, focusing on therapies for eye diseases, atopic dermatitis, asthma, and rheumatoid arthritis through discovery, development, manufacturing, and commercialization processes [4]. Product Pipeline and Market Position - The company's core approved medicines, such as Dupixent and Eylea, hold strong market positions. Dupixent is an anti-inflammatory therapy for eczema, asthma, and other allergic conditions, while Eylea is a leading treatment for macular degeneration and diabetic eye disease. Regeneron's pipeline includes multiple therapeutic areas like oncology, rare diseases, immunology, and allergies, with several drugs in late-stage trials indicating significant future growth potential [3][4]. Financial Performance - Regeneron has shown reasonable revenue growth of 5.4% over the last twelve months and an average of 0.3% over the past three years. The company has a free cash flow margin of approximately 25.0% and an operating margin of 27.0% for the last twelve months. There have been no major margin shocks in the past year, and REGN stock is trading at a modest PE multiple of 13.6, which is lower compared to the S&P [7]. Competitive Advantage - Compared to the S&P, Regeneron presents a lower valuation, higher revenue growth, and superior margins, indicating a competitive advantage in the market [7].

Summary of Key Points from the Conference Call on China's Healthcare Industry and Emerging Oral GLP-1 Pipelines Industry Overview - The report focuses on the **emerging oral GLP-1 pipeline** within the **China healthcare industry** and discusses the potential market size exceeding **$45 billion** [1][8][14]. Core Insights and Arguments - The global oral GLP-1 market is projected to peak between **$45 billion and $75 billion**. Recent clinical data from leading companies indicate that emerging pipelines still have opportunities for market entry [8][14]. - Over **20 oral GLP-1 candidates** from Chinese biopharmaceutical companies are in development, with most retaining global rights. This suggests significant potential for future licensing and partnerships [8][18]. - Companies such as **Hengrui/Kailera**, **Huadong Medicine**, and **Regor Therapeutics** are leading in clinical progress and data maturity, with several key catalytic events expected in the next six months [8][18]. - The emerging pipeline is diverse, including candidates from **Hansoh Pharmaceutical**, **China Biologic Products**, **Sino Biopharma**, and several private companies [8][18]. - Variations in patient baseline characteristics and dose escalation strategies complicate direct data comparisons across clinical trials. Other critical factors include data integrity for indications beyond obesity, scalability of production, and patent reviews [8][18]. Additional Important Insights - The oral GLP-1 market is evolving towards a more fragmented competitive landscape, contrary to the previously expected oligopolistic structure. Recent clinical results from leading candidates suggest new entry opportunities for emerging pipelines [15][18]. - The report outlines the competitive landscape and potential collaboration opportunities, highlighting that the U.S. biopharma sector is actively seeking partnerships with Chinese companies due to the evolving market dynamics [18][20]. - The report includes a detailed table of oral GLP-1 candidates, their development phases, and licensing status, providing a comprehensive overview of the competitive landscape [3][20]. Conclusion - The oral GLP-1 market presents a significant opportunity for both established and emerging players, particularly from China. The evolving clinical data and competitive dynamics suggest a promising future for innovative therapies in this space [8][14][15].

​Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) is one of the Most Undervalued Long Term Stocks to Buy Right Now. On October 17, Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) announced that the European Medicines Agency adopted a positive opinion for its Libtayo, which treats adults with cutaneous squamous cell carcinoma. Earlier this month, Libtayo was approved by the FDA to treat patients with cutaneous squamous cell carcinoma who are at high risk of recurrence after surgery and radiation. Management exp ...

Core Insights - Longleaf Partners Fund reported a return of -0.33% in Q3 2025, underperforming the S&P 500's 8.12% and the Russell 1000 Value's 5.33% [1] - The fund focuses on investments in real assets and brands that generate growing free cash flow (FCF) per share, with an expectation that the FCF multiple could rise from ~10x to the mid-teens [1] Fund Performance - The fund's performance in Q3 2025 was disappointing, with a return of -0.33% compared to significant gains in broader indices [1] - The firm is implementing strategies to improve margins and increase share repurchases to enhance future performance [1] Regeneron Pharmaceuticals, Inc. Insights - Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) had a one-month return of 3.19% but experienced a significant decline of 37.64% over the past 52 weeks, closing at $575.69 per share with a market cap of $61.316 billion on October 23, 2025 [2] - The fund views Regeneron as having regained value per share and highlights its strong pipeline candidates and share repurchase activity [3] Market Position and Revenue - Regeneron Pharmaceuticals, Inc. was held by 73 hedge fund portfolios at the end of Q2 2025, an increase from 66 in the previous quarter [4] - The company reported total revenues of $3.7 billion in Q2 2025, reflecting a 4% growth year-over-year [4]