Summary of Regeneron Pharmaceuticals Conference Call Company Overview - **Company**: Regeneron Pharmaceuticals (NasdaqGS:REGN) - **Date of Conference**: November 17, 2025 - **Key Speakers**: Justin Holco (Global Oncology Hematology Commercial Business Unit Lead), Izzy Lowy (Clinical Development Unit Head), Mark Hudson (Investor Relations) Key Industry Insights Oncology Developments - Regeneron is positioning itself as a serious player in oncology, particularly with the development of Libtayo and its bispecific antibodies in hematologic malignancies [3][4] - The upcoming readout of the LAG-3 and PD-1 combination study is viewed as a significant milestone for the company [3] Clinical Trial Results - The LAG-3 antibody showed a high response rate of nearly 60% in PD-1 naive patients, leading to a phase three study to compare it against pembrolizumab (Keytruda) [4][5] - The study is designed to test two doses of fianlimab in combination with cemiplimab (Libtayo) versus pembrolizumab, with a focus on progression-free survival (PFS) [5][6] - The expected PFS for pembrolizumab is around 4-5 months, but Regeneron has set conservative expectations for their study [6][7] Market Potential - The global metastatic melanoma market is estimated to be around $4 billion to $5 billion [17] - Regeneron aims to leverage its existing leadership in non-melanoma skin cancers to expand into the melanoma market, which could significantly enhance its portfolio [17] Commercial Strategy - Libtayo has recently received approval for adjuvant treatment in cutaneous squamous cell carcinoma (CSCC), representing a potential market of approximately 10,000 patients in the U.S. [23][30] - The company is focusing on educating various specialties about the benefits of adjuvant treatment to ensure patients complete the full 48-week regimen [30][31] Pipeline and Future Prospects Ongoing Studies - Regeneron is conducting a phase two study in non-small cell lung cancer, with results expected in the first half of 2026 [20][22] - The company is also exploring neoadjuvant perioperative studies in both melanoma and lung cancer, indicating a data-rich period ahead [22] New Developments - Regeneron is advancing a range of new agents, including bispecific antibodies and PD-1 directed IL-2, which are showing early signs of efficacy [40][42] - The company is also launching Linvoseltamab in relapsed refractory multiple myeloma, with significant investment in clinical studies [44] Conclusion - Regeneron is optimistic about its future in oncology, with multiple studies and a strong pipeline that could lead to significant market opportunities. The focus on education and expanding treatment options is expected to enhance patient outcomes and drive growth in the coming years [45]

Core Insights - Regeneron Pharmaceuticals stock increased by 19% over the past month due to strong third-quarter earnings and robust sales of its flagship drugs, Dupixent and Libtayo [1] - Gilead Sciences presents a more favorable investment option compared to Regeneron, with superior revenue growth and profitability metrics [3][4] Revenue Growth Comparison - Gilead Sciences reported a quarterly revenue growth of 3.0%, while Regeneron achieved only 0.9% [3] - Over the last three years, Gilead's average revenue growth was 2.3%, surpassing Regeneron's 1.4% [3] Profitability Metrics - Gilead outperformed Regeneron in profitability, with a last twelve months margin of 38.3% and a three-year average margin of 39.2% [4] Valuation and Performance Overview - A detailed comparison of financials indicates that Gilead's fundamentals are stronger in terms of growth, margins, momentum, and valuation multiples compared to Regeneron [4][5] Investment Strategy - Asset allocation is recommended as a more prudent strategy than merely selecting individual stocks, with Trefis' High Quality Portfolio showing positive results during market downturns [5][8]

Nvidia - Nvidia shares surged 5% to an all-time high following CEO Jensen Huang's keynote at the developers conference, highlighting the company's pivotal role in the AI boom [3][7] - The company announced a $1 billion investment in Nokia, which saw its shares increase by nearly 23%, and a collaboration with Oracle to build AI supercomputers for the U.S. Department of Energy [3][7] - Nvidia is also partnering with Palantir Technologies to develop an integrated AI technology stack [3] Regeneron Pharmaceuticals - Regeneron shares rose close to 12% after reporting stronger-than-expected quarterly earnings, driven by robust sales of eczema treatment Dupixent and skin cancer treatment Libtayo [4] Skyworks Solutions and Qorvo - Skyworks Solutions and Qorvo announced a merger plan, with both companies' shares increasing by about 6% amid challenges from major customer Apple, which is developing its own modem chips [5] United Parcel Service (UPS) - UPS shares increased by 8% after exceeding analysts' estimates for third-quarter revenue and adjusted earnings per share, indicating progress on a turnaround plan that includes operational streamlining and workforce reduction [6][8] Alexandria Real Estate Equities - Alexandria Real Estate Equities missed estimates for third-quarter revenue and adjusted funds from operations (AFFO), leading to a nearly 20% drop in shares, the largest decline among S&P 500 constituents [9] Royal Caribbean Cruises - Royal Caribbean shares fell 8.5% after reporting third-quarter revenue slightly below expectations and a weaker-than-expected outlook for the fourth quarter, impacted by weather disruptions and increased operating costs [10]

Core Insights - Regeneron Pharmaceuticals reported Q3 2025 adjusted EPS of $11.83, exceeding the Zacks Consensus Estimate of $9.44, but down 5% from $12.46 in the previous year due to higher expenses [1][8] - Total revenues increased by 1% year over year to $3.7 billion, driven by higher sales of Eylea HD and increased profits from Dupixent, surpassing the Zacks Consensus Estimate of $3.6 billion [1][8] Revenue Breakdown - Eylea sales in the U.S. fell 41% year over year to $681 million, primarily due to increased competition and market share loss, missing the Zacks Consensus Estimate of $686 million [4] - Eylea HD generated $431 million in the U.S., up 10% year over year, exceeding the Zacks Consensus Estimate of $414 million [6] - Dupixent sales surged 27% year over year to $4.86 billion, contributing significantly to total revenues [10] - Total collaboration revenues reached $2 billion, an increase of 18.6% from the previous year, surpassing the Zacks Consensus Estimate of $1.8 billion [9] Cost and Margin Analysis - Gross margin on net product sales decreased to 86% from 89% due to ongoing investments in manufacturing operations [12] - Adjusted R&D expenses rose 18% year over year to $1.3 billion, reflecting advancements in the company's pipeline [12] - Adjusted SG&A expenses decreased by 12% to $541 million [12] Pipeline and Regulatory Updates - The FDA approved a label expansion for Libtayo as an adjuvant treatment for high-risk adult patients with cutaneous squamous cell carcinoma [16] - A positive opinion was adopted by the EMA for Dupixent for chronic spontaneous urticaria treatment in the EU, with a decision expected soon [14] - Regeneron plans to submit an application for a new pre-filled syringe manufacturing filler for Eylea HD by January 2026 [15] - A phase III study of cemdisiran met its primary and key secondary endpoints, with a regulatory submission planned for Q1 2026 [17] Market Performance - Regeneron's shares have increased following the better-than-expected quarterly results, although they have lost 17.8% year to date compared to the industry's growth of 10.3% [2]

Core Insights - Regeneron Pharmaceuticals exceeded Wall Street expectations for Q3 results, driven by strong demand for Dupixent and Libtayo, resulting in an 8% increase in shares [1] - The company plans to resubmit the marketing application for Eylea HD after a previous FDA rejection [1][3] Financial Performance - Total revenue for Q3 reached $3.75 billion, surpassing analysts' average estimate of $3.59 billion [4] - Sales of Dupixent rose 27% to $4.86 billion, exceeding the estimate of $4.54 billion [4] - Libtayo generated sales of $365 million, above the estimated $343.75 million [4] - The company reported a quarterly profit of $11.83 per share on an adjusted basis, compared to expectations of $9.59 [5] Regulatory Challenges - Regeneron has faced regulatory setbacks due to issues at Catalent's Bloomington filling facility, delaying three pending applications for Eylea with the FDA [2] - The company aims to submit a new filler application by January 2026, with potential FDA approval by mid-2026 [3]

Regeneron (REGN) reported $3.75 billion in revenue for the quarter ended September 2025, representing a year-over-year increase of 0.9%. EPS of $11.83 for the same period compares to $12.46 a year ago.The reported revenue compares to the Zacks Consensus Estimate of $3.6 billion, representing a surprise of +4.38%. The company delivered an EPS surprise of +25.32%, with the consensus EPS estimate being $9.44.While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall S ...

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 on a constant currency basis compared to the prior year, with U.S. sales growing 28% to $3.6 billion [35][39] - Libtayo's global net sales were $365 million, up 24% year-over-year on a constant currency basis, with U.S. sales growing 12% [36][39] - EYLEA HD U.S. net sales reached $431 million, an all-time high, while EYLEA sales decreased 10% to $681 million due to competitive dynamics and patient affordability issues [10][32] 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 being 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 [32] 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 innovative pipeline [16][39] - The company is engaged in discussions with the U.S. government to lower drug costs while preserving innovation and has committed to investing over $7 billion in infrastructure and manufacturing facilities [15][39] - The pipeline includes advancements in immunology, oncology, and rare diseases, with multiple positive Phase III data readouts expected to drive future growth [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 equitable global systems for innovation [14][15] - The company anticipates continued growth across its commercial portfolio, particularly from Dupixent, Libtayo, and EYLEA HD, while preparing for upcoming label enhancements [16][32] - Regeneron expects a mid-teens percentage increase in R&D expenses in 2026 to support its innovative pipeline [43] Other Important Information - The FDA issued a complete response letter for EYLEA HD's prefilled syringe supplemental BLA due to unresolved inspection findings at a contract manufacturing facility [11] - Regeneron has made significant progress in its clinical trials for various programs, including a promising Phase III trial for a treatment addressing fibrodysplasia ossificans progressiva [30] Q&A Session Summary Question: Changes in EYLEA's 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 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 [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 previous IL-33 trials for COPD - Management refrained from commenting on specific insights but mentioned upcoming discussions with the FDA to guide future strategies [63][64] Question: Probability of approval for RVO and four-week dosing filing - Management discussed the complexities of the approval timeline and the need for the new filler to undergo review before resubmission [66][68] Question: Changes to regulatory manufacturing teams to prevent CRLs - Management clarified that issues were not due to internal regulatory problems but rather manufacturing challenges, emphasizing the need for their own filling capabilities [72][74] Question: Factor XI antibody program and future opportunities - Management highlighted the focus on understanding the benefit-risk ratio for their antibodies and the potential for broader applications beyond current indications [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 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]

Third quarter 2025 revenues increased 1% to $3.75 billion versus third quarter 2024Dupixent® global net sales (recorded by Sanofi) increased 27% to $4.86 billion EYLEA HD® U.S. net sales increased 10% to $431 million; total EYLEA HD and EYLEA® U.S. net sales decreased 28% to $1.11 billion GAAP EPS of $13.62 and non-GAAP EPS(a) of $11.83; third quarter 2025 includes unfavorable $0.68 impact from acquired IPR&D chargeFDA approved Libtayo® as the first and only immunotherapy for high-risk adjuvant cutaneous sq ...