Regeneron Pharmaceuticals FY Conference Summary Company Overview - **Company**: Regeneron Pharmaceuticals (NasdaqGS:REGN) - **Date of Conference**: September 24, 2025 Key Points Commercial Performance - **EYLEA HD Performance**: - 5% sequential growth in demand in Q1 and 16% in Q2 attributed to effective commercial execution and physician-patient education [4][5] - Demand is expected to increase further once headwinds are resolved, particularly regarding reimbursement and prefilled syringe preferences [5][6] - Upcoming PDUFA dates: late October for prefilled syringe and late November for RVO and Q4 dosing [8] Pipeline Developments - **DUPIXENT**: - Strong performance across all eight approved indications, with ongoing growth in established indications like asthma and new launches in COPD, CSU, and bullous pemphigoid [15][16] - 70% of top-tier pulmonologists have prescribed DUPIXENT for COPD, indicating positive reception [18] - Strategic focus on lifecycle opportunities and adjacent type 2 pathways to maintain growth post-DUPIXENT exclusivity expiration in 2031 [21][23] - **Oncology Pipeline**: - Recent approvals for bispecifics, with a focus on Linezyth for multiple myeloma [24] - Plans to launch studies in earlier lines of treatment, combining Linezyth with carfilzomib, expected by the end of 2025 [26][28] - **Complement and Factor XI Programs**: - Promising data in myasthenia gravis (MG) with a focus on quarterly dosing advantages [35] - Factor XI program aims to reduce bleeding risks associated with anticoagulants, with ongoing Phase 3 studies [39][40] R&D and Capital Allocation - **R&D Investment Strategy**: - Focus on internal R&D as a primary capital allocation priority, with a robust pipeline driving long-term shareholder value [50][52] - Share repurchase program and dividend implementation to enhance shareholder returns [51] - **External Innovation**: - Active exploration of licensing and collaboration opportunities, though M&A remains a secondary focus [50][55] Market Outlook and Strategic Vision - **Pipeline Potential**: - The breadth and depth of the pipeline are viewed as unprecedented, with confidence in the ability to drive future growth [57][58] - Ongoing preclinical opportunities in various therapeutic areas, including genetics and rare diseases, are expected to yield significant advancements [59] Regulatory and Competitive Landscape - **Biosimilars Impact**: - Gradual uptake of existing biosimilars noted, with potential for increased pricing pressure as more entrants are expected in 2026 [11][12] - **DTC Advertising Restrictions**: - Generalized communication from the administration regarding DTC advertising, with no specific implications for Regeneron noted [19] Conclusion - Regeneron Pharmaceuticals is positioned for continued growth through its strong product pipeline, strategic R&D investments, and proactive market engagement. The company remains focused on addressing competitive pressures while leveraging its innovative capabilities to enhance patient outcomes and shareholder value.

Core Viewpoint - The U.S. FDA issued a Complete Response Letter (CRL) for Scholar Rock's apitegromab Biologics License Application (BLA) due to observations from a routine inspection of Catalent Indiana LLC, which is not specific to the drug itself [1][2]. Group 1: FDA Response and Observations - The CRL did not raise any concerns regarding the efficacy and safety data of apitegromab or the third-party drug substance manufacturer [2]. - Catalent Indiana submitted a comprehensive response to the FDA's observations in early August 2025 and is actively working on corrective actions [4]. - Scholar Rock plans to resubmit the apitegromab BLA following Catalent Indiana's remediation of the FDA observations [4]. Group 2: Market Authorization and Future Plans - Outside the U.S., the apitegromab marketing authorization application (MAA) is under review by the European Medicines Agency, with a decision expected by mid-2026 [5]. - The European launch of apitegromab is anticipated in the second half of 2026, with Germany expected to be the first market for patient access [5]. Group 3: Related Industry Developments - Regeneron Pharmaceuticals anticipates delays in regulatory approvals for its EYLEA HD applications due to observations from an FDA inspection at Catalent Indiana, which also affects Scholar Rock [6]. - Scholar Rock's stock price increased by 1.24% to $32.99 following the news [7].

Financial Data and Key Metrics Changes - Regeneron reported a strong quarter with EYLEA HD showing the strongest growth in the branded category within the anti-VEGF category, with demand growth of approximately 16% in the quarter compared to 5% in the previous quarter [7][12] - The overall franchise performance of EYLEA and EYLEA HD accounts for 60% of the anti-VEGF branded category, indicating a stable growth trajectory [25] Business Line Data and Key Metrics Changes - EYLEA HD has been in the market for about two years and is less impacted by affordability challenges compared to EYLEA, which is a larger product [15][21] - The introduction of a prefilled syringe for EYLEA HD is expected to enhance convenience for busy retina practices, which treat many patients daily [10][33] Market Data and Key Metrics Changes - The market for EYLEA HD is complicated, with affordability issues affecting the branded category due to high out-of-pocket costs for patients on Medicare plans [12][21] - Regeneron has launched a program to match donations to help patients offset these costs, although contributions have been lower than in previous years [12][13] Company Strategy and Development Direction - Regeneron aims to broaden the label for EYLEA HD, including potential enhancements such as Q4 weekly dosing and the RVO indication, which was a $1 billion indication for EYLEA in 2024 [11][34] - The company is focused on maintaining competitive readiness across its product lines, particularly with DUPIXENT, which continues to grow despite increasing competition [46][61] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of EYLEA HD and DUPIXENT, highlighting the importance of upcoming regulatory approvals and market expansions [41][86] - The company is actively working on resolving manufacturing issues with its partner, Catalent, to ensure timely FDA approvals for new product submissions [35][36] Other Important Information - Regeneron is exploring additional indications for its C5 franchise, with ongoing studies in myasthenia gravis and geographic atrophy, indicating a strong pipeline for future growth [70] - The company is also considering a potential third Phase III study for itapacumab, pending discussions with regulatory authorities [76] Q&A Session Summary Question: How has the strength of high dose EYLEA been impacted by charity contributions? - Management indicated that the strength seen in high dose EYLEA is primarily due to the product's performance rather than charity contributions, which have not yet significantly impacted sales [14][15] Question: How is Regeneron addressing competition from biosimilars? - Management noted that while there is selective interest in biosimilars, many practices prefer EYLEA and EYLEA HD due to their established efficacy and safety profiles [27][30] Question: What are the expectations for upcoming PDUFAs? - Management confirmed that all submissions for Q4 dosing, RVO, and prefilled syringe approvals have been delayed due to manufacturing issues, but they remain confident in the outcomes once resolved [35][40] Question: What is the growth outlook for DUPIXENT? - Management highlighted that DUPIXENT continues to grow at over 20%, with multiple indications contributing to its success, and they expect this trend to continue [43][46] Question: How does Regeneron plan to position its new product in a crowded market? - Management expressed excitement about the clinical data for their new product and emphasized the importance of efficacy and convenience in positioning against competitors [63][64]

Financial Data and Key Metrics Changes - Regeneron reported a demand growth of approximately 16% for EYLEA HD in the latest quarter, compared to a 5% growth in the previous quarter [7][12] - The overall franchise performance of EYLEA and EYLEA HD accounts for 60% of the anti-VEGF branded category, indicating strong market presence [26] Business Line Data and Key Metrics Changes - EYLEA HD has shown the strongest growth within the branded anti-VEGF category, with a stable and steady growth trajectory [12][26] - Dupixent continues to grow at over 20%, with eight indications in the U.S. and four at blockbuster status, indicating robust market demand [45][46] Market Data and Key Metrics Changes - The affordability challenges faced by patients on Medicare plans have impacted the branded category, but EYLEA HD has been less affected compared to EYLEA [13][22] - The competitive landscape includes biosimilars, but current payer management has not favored them significantly, allowing EYLEA HD to maintain its market position [28] Company Strategy and Development Direction - Regeneron is focused on expanding the label for EYLEA HD, including potential enhancements such as Q4 weekly dosing and prefilled syringes, which are expected to improve convenience and patient care [10][35] - The company is actively preparing for the commercialization of new products, including a focus on building a sales force for upcoming launches in neurology and other therapeutic areas [68][70] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming PDUFA dates for EYLEA HD enhancements and the potential for regulatory approvals to accelerate market uptake [36][42] - The company remains committed to long-term growth and innovation, with ongoing evaluations of business development opportunities despite recent study setbacks [79][81] Other Important Information - Regeneron is preparing for potential new indications and has seen strong early uptake in COPD, which is expected to continue as awareness grows [51][54] - The company is also exploring additional therapeutic areas, including genetic medicine and oncology, to diversify its portfolio [90] Q&A Session Summary Question: How has the strength of high dose EYLEA been impacted by charity contributions? - Management indicated that the strength seen in high dose EYLEA is primarily due to the product's performance rather than charity contributions, which have not yet significantly impacted sales [15][16] Question: How is Regeneron addressing competition from biosimilars? - Management noted that while biosimilars exist, current payer management has not favored them, and many practices continue to prefer EYLEA and EYLEA HD due to their established efficacy and safety profiles [28][31] Question: What are the expectations for Dupixent's growth moving forward? - Management highlighted that Dupixent continues to perform well across multiple indications, with strong market leadership and ongoing efforts to expand its reach [45][46] Question: What are the next steps for the C5 franchise? - Management is excited about the clinical data for the C5 franchise and is preparing for a launch, focusing on efficacy, safety, and dosing convenience [64][66] Question: How does Regeneron plan to approach business development? - Management emphasized a long-term vision for business development, focusing on earlier-stage opportunities that complement their strengths while remaining open to later-stage options [79][81]

Regeneron Pharmaceuticals (REGN) Conference Call Summary Company Overview - **Company**: Regeneron Pharmaceuticals (REGN) - **Event**: Cantor Global Healthcare Conference - **Date**: September 3, 2025 Key Financial Performance - **DUPIXENT**: Achieved 21% growth worldwide year-over-year [7] - **Libtayo**: Recorded 25% growth year-over-year [7] - **EYLEA HD**: Experienced approximately 29% growth in the US [7] - **Overall Revenue Growth**: Top line growth at 4%, with EPS increasing by 12% to $12.89 [8] - **Share Buybacks**: $1.1 billion in Q2 and $2.2 billion in the first half of the year, reducing common shares outstanding by 3.2 million [8] Pipeline Developments - **Cemdisiran**: Positive data in myasthenia gravis with a 2.3 reduction in the MG ADL scale, positioning it as a competitive option in a $5 billion market [12][13] - **Market Growth**: The category is expected to double to $10 billion by the end of the decade [13] - **Upcoming PDUFA Dates**: Anticipated for Libtayo and EYLEA HD, with significant patient populations targeted [9] - **Combination Therapies**: Cemdisiran plus pozilimab showed promising results, allowing for price discrimination in the market [19] Regulatory and Manufacturing Updates - **EYLEA PDUFA Delays**: Three-month extension due to third-party manufacturing issues; confidence in resolution and approval remains [25][26] - **Investment in R&D**: $7 billion allocated to enhance R&D and manufacturing capabilities, including an in-house fill-finish facility expected to be operational in 2026 [29][30] Competitive Landscape - **EYLEA Competition**: Facing pricing pressures and competition from products like Pavlue and biosimilars [33][35] - **DUPIXENT Launch in COPD**: Strong initial performance with over 70% of top pulmonologists prescribing the product; significant unmet medical need remains [50][51] - **Future Growth**: Anticipated continued growth in DUPIXENT across various indications, including chronic spontaneous urticaria and bolas pemphigoid [55][56] Strategic Outlook - **Life Post-DUPIXENT**: Ongoing investments in the pipeline to ensure revenue generation beyond DUPIXENT's lifecycle, with several INDs expected in the next six to nine months [63][64] - **Regulatory Discussions**: Plans to engage with regulators regarding the path forward for itepecumab, with clarity expected before year-end [46][47] Conclusion - Regeneron Pharmaceuticals is experiencing strong financial performance driven by key products like DUPIXENT, Libtayo, and EYLEA HD. The company is actively expanding its pipeline and investing in R&D and manufacturing capabilities to sustain growth and navigate competitive pressures in the biopharma landscape.

Financial Performance - Regeneron Pharmaceuticals reported adjusted earnings of $12.89 per share, a 12% increase year-over-year, surpassing the consensus estimate of $8.57 [1] - The company achieved sales of $3.68 billion, reflecting a 4% year-over-year growth, exceeding the consensus of $3.29 billion [1] Future Guidance - For 2025, Regeneron expects a GAAP gross margin of approximately 83%, slightly lower than the previous guidance of 83%-84% [2] - The adjusted gross margin is anticipated to be around 86%, compared to the prior guidance of 86%-87% [2] Market Reaction - Following the earnings announcement, Regeneron Pharmaceuticals shares increased by 0.9%, trading at $563.62 [3] Analyst Ratings and Price Targets - Guggenheim analyst Yatin Suneja maintained a Buy rating and raised the price target from $810 to $815 [5] - RBC Capital analyst Brian Abrahams maintained a Sector Perform rating and increased the price target from $688 to $695 [5] - Morgan Stanley analyst Matthew Harrison maintained an Overweight rating and raised the price target from $754 to $761 [5]

Core Insights - Regeneron reported strong Q2 2025 earnings, with Non-GAAP EPS of $12.89, exceeding the consensus estimate by 52.9% [1] - GAAP revenue reached $3.68 billion, surpassing projections of $3.29 billion and reflecting a 3.6% year-over-year increase [1][2] - The company faced manufacturing and regulatory challenges, particularly in its retinal disease portfolio, but continued to see momentum from collaborations and immunology therapies [1] Financial Performance - Non-GAAP EPS increased by 11.5% year-over-year from $11.56 to $12.89 [2] - GAAP revenue rose 3.7% year-over-year from $3.55 billion to $3.68 billion [2] - Non-GAAP net income grew by 5.2% to $1.42 billion, while GAAP net income decreased by 2.8% to $1.39 billion [2] - Gross margin on net product sales (Non-GAAP) fell to 86%, down 3 percentage points from the previous year [2][6] Strategic Focus - Regeneron focuses on developing treatments for serious diseases, emphasizing immunology, ophthalmology, oncology, and rare conditions [3] - The company relies on R&D and strategic partnerships, particularly with Sanofi and Bayer, to share costs and expand market access [4] Operational Highlights - Collaboration revenue increased by 29.7% year-over-year, with Regeneron's share of Dupixent profits rising 30% to $1.28 billion [5] - Libtayo's global net product sales grew by 27% [5] - Despite a decline in U.S. net product sales for EYLEA, collaboration revenues offset these losses [5] Challenges and Regulatory Environment - Regulatory delays impacted approvals for EYLEA HD enhancements and other pipeline products due to inspection findings at a third-party supplier [8] - The EYLEA franchise faced significant sales erosion, with legacy EYLEA U.S. net product sales down 39% year-over-year [9] - Regeneron committed $200 million in matching funds to support patient assistance amid affordability issues [9] Future Outlook - Management updated R&D expense guidance to $5.10–$5.20 billion and set a Non-GAAP gross margin target of 86% for fiscal 2025 [12] - No formal revenue or EPS guidance was provided, but management expressed confidence in collaboration income and Dupixent growth [12]

Financial Data and Key Metrics Changes - Regeneron's total revenues for Q2 2025 were $3.7 billion, reflecting a 4% increase compared to the prior year, driven by higher collaboration revenue from Sanofi and growth in net sales of EYLEA HD and Libtayo [50][51] - Diluted net income per share grew 12% year-over-year to $12.89, with net income reaching $1.4 billion [51] - The gross margin on net product sales was 86%, with a decrease attributed to ongoing investments in manufacturing operations and higher inventory write-offs [54] Business Line Data and Key Metrics Changes - Worldwide net product sales for Dupixent increased by 21% to $4.3 billion, while Libtayo's sales grew by 25% on a constant currency basis [9][13] - EYLEA's U.S. net product sales were $754 million, down 39% year-over-year, but EYLEA HD's sales reached an all-time high of $393 million, driven by a 16% increase in unit demand [10][11][39] - Libtayo's global net sales were $377 million, with a 36% increase in the U.S. driven by growth in non-melanoma skin and lung cancer indications [43][44] Market Data and Key Metrics Changes - Dupixent continues to lead in new-to-brand and total prescriptions across seven of its eight FDA-approved indications, with a total addressable population in the U.S. exceeding four million patients [13][41] - EYLEA's branded share in the anti-VEGF category was just over 60%, with a decline in overall branded anti-VEGF category volume attributed to increased use of Avastin due to affordability issues [75] Company Strategy and Development Direction - The company plans to invest over $7 billion in the U.S. to expand R&D capabilities and manufacturing networks, including a new fill-finish manufacturing facility [16] - Regeneron is focused on internal R&D investments while also considering opportunities for business development that can enhance existing capabilities [17] - The pipeline includes approximately 45 product candidates in various stages of clinical development, with significant investments in R&D yielding notable progress [14][35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing growth of Dupixent and EYLEA HD, despite competitive pressures and pricing challenges [9][10] - The company anticipates a resolution of manufacturing issues related to EYLEA HD and expects favorable FDA actions once these issues are addressed [73] - Management highlighted the importance of maintaining innovation and addressing affordability issues to ensure continued growth and market leadership [60][92] Other Important Information - The FDA issued a Complete Response Letter (CRL) for the BLA of ogeneximab due to the Catalent site inspection, impacting timelines for regulatory approvals [12] - The company is exploring opportunities in the obesity market with a recently licensed GLP-1 GIP receptor agonist [31] Q&A Session Summary Question: Insights on potential policy impacts related to EYLEA - Management noted no unique insights into policy impacts but emphasized the need for fair pricing across markets to support innovation [60] Question: Factors driving the rebound in EYLEA HD sales - The increase in EYLEA HD sales was attributed to physician appreciation for its product profile, including clinical efficacy and safety [68] Question: Updates on PDUFAs and share erosion dynamics - Management expressed confidence in receiving favorable FDA actions post-resolution of manufacturing issues and noted that branded share erosion is primarily due to affordability issues with Avastin [73][75] Question: ROI on prioritizing R&D assets - Management acknowledged the broad pipeline and indicated a willingness to consider out-licensing non-core assets if it makes strategic sense [78] Question: Early results from the matching program with Good Days - Management indicated it is still early to assess the impact of the matching program on commercial performance [85] Question: Competitive landscape regarding OX40 Ligand data - Management highlighted Dupixent's unique safety profile and efficacy, suggesting that competing products may take time to match its established comfort level [90][92]

Financial Data and Key Metrics Changes - Regeneron reported total revenues of $3.7 billion for Q2 2025, a 4% increase compared to the prior year, driven by higher collaboration revenue from Sanofi, particularly from Dupixent [49] - Diluted net income per share grew 12% year-over-year to $12.89, with net income reaching $1.4 billion [49] - Gross margin on net product sales was 86%, reflecting ongoing investments in manufacturing operations and higher inventory write-offs [54] Business Line Data and Key Metrics Changes - Worldwide net product sales for Dupixent increased by 21% on a constant currency basis, reaching $4.3 billion, with U.S. sales growing 23% [10][39] - EYLEA U.S. net product sales were $754 million, down 39% year-over-year, while EYLEA HD reached an all-time high of $393 million in U.S. sales, driven by a 16% increase in unit demand [8][37] - Libtayo's global net sales grew 25% on a constant currency basis, totaling $377 million, with U.S. sales increasing 36% [43] Market Data and Key Metrics Changes - The branded anti-VEGF category volume decreased by 1.2%, primarily due to increased competition from Avastin [73] - EYLEA HD's market share in the anti-VEGF category is over 60%, but the overall branded share is under pressure from affordability issues [73] Company Strategy and Development Direction - Regeneron plans to invest over $7 billion in the U.S. to expand R&D capabilities and manufacturing networks, including a new fill-finish facility [14] - The company is focused on internal R&D investments while also considering share repurchases and dividends to return capital to shareholders [14][56] - Regeneron aims to maintain its leadership in the market by maximizing growth from existing brands and launching new products [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing growth of Dupixent, with potential to treat over 4 million patients in the U.S. [11] - The company anticipates challenges for EYLEA due to competitive pressures and patient affordability issues, but expects EYLEA HD to continue its strong performance [8][38] - Management remains optimistic about the pipeline, with several key programs expected to deliver significant advancements in the coming months [34] Other Important Information - The FDA's site inspection at Catalent, which impacted EYLEA HD and ogeneximab, is expected to be resolved expeditiously, with no major structural changes required [10][65] - Regeneron has approximately $2.8 billion available for share repurchases as of June 30, 2025 [55] Q&A Session Summary Question: Insights on the relationship with Trump and potential policy impacts - Management indicated no frequent visits to Mar A Lago and emphasized the need for equitable pricing across markets to support innovation [59][60] Question: Factors behind EYLEA HD's quarter-over-quarter rebound - Management attributed the growth to physician appreciation for EYLEA HD's product profile and expected further growth with upcoming label enhancements [64][67] Question: Updates on PDUFAs and branded share erosion - Management expressed confidence in receiving favorable FDA actions once manufacturing issues are resolved and noted that branded share erosion is primarily due to Avastin's affordability issues [71][73] Question: ROI on prioritizing R&D assets - Management acknowledged the broad pipeline and indicated a willingness to consider out-licensing non-core assets if it aligns with strategic goals [77][79] Question: Impact of the matching program with Good Days - Management stated it is too early to assess the impact of the matching program on commercial performance [82] Question: Competitive landscape regarding OX40 Ligand data - Management noted that current data does not suggest advantages over Dupixent, emphasizing Dupixent's unique safety profile [87][89]

Financial Performance - Regeneron reported total revenues of $3.68 billion for Q2 2025[8] - Non-GAAP EPS for Q2 2025 was $12.89[8] - Dupixent global net sales reached $4.3 billion in Q2 2025, representing a 21% year-over-year increase[9] - EYLEA HD and EYLEA together held approximately 61% of the U S branded anti-VEGF category share in Q2 2025[22] - Libtayo global net sales for Q2 2025 were $377 million, a 25% year-over-year increase[30] Dupixent Expansion - Dupixent is approved for eight indications globally and has reached approximately 12 million patients worldwide[9] - The U S FDA approved Dupixent for chronic spontaneous urticaria (CSU) in April 2025 and bullous pemphigoid (BP) in June 2025[9, 19] - Dupixent was approved by the FDA in late September 2024 for COPD[11] Pipeline Developments - Lynozyfic received approval in the U S and Europe for relapsed/refractory multiple myeloma and was added to NCCN treatment guidelines[8] - The company initiated the first Phase 3 study for Factor XI (REGN7508) in VTE prevention after total knee replacement surgery[8] - Regeneron in-licensed olatorepatide/HS-20094 (dual GLP-1/GIP receptor agonist) to evaluate as a monotherapy and study combinations to address muscle loss and other comorbidities of obesity[8] Reimbursement and Development Balance - Reimbursement of Sanofi's antibody development balance is expected to average approximately $800 million per year in 2025 and 2026[15] - As of June 30, 2025, the antibody development balance stood at approximately $1.2 billion[17]