Regeneron Pharmaceuticals Conference Call Summary Company Overview - **Company**: Regeneron Pharmaceuticals (NasdaqGS:REGN) - **Focus**: Linvoseltamab Development Program in multiple myeloma and precursor conditions Key Points Industry and Market Context - The multiple myeloma treatment landscape is complex, with a need for simplified and effective treatment options [6][8] - The estimated market for multiple myeloma is approximately $30 billion, with first-line and second-line settings each representing over $10 billion [27][28] Linvoseltamab Development Program - **Linvoseltamab**: A BCMA x CD3 bispecific antibody aimed at revolutionizing multiple myeloma treatment [4][6] - **Approval**: Accelerated approval received in July 2025 based on LINKER-MM1 study results [12] - **Clinical Data**: - LINKER-MM1 study showed an overall response rate of 71% and a complete response rate of 52% at 20 months of follow-up [11] - In the second-line setting, a combination with Carfilzomib showed an overall response of 90% and a complete response of 76% [16] - In the first-line setting, LINKER-MM4 study reported an overall response rate of 86% and a complete response rate of 43% with only nine months of follow-up [18] Development Strategy - **Late-Line Setting**: Establishing Linvoseltamab in late-line therapy to build market share [8][9] - **Early-Line Therapy**: Plans to advance into early lines with differentiated development strategies [9][14] - **Precursor Conditions**: Aiming to treat high-risk smoldering multiple myeloma and MGUS to potentially eliminate myeloma [24][25] Safety and Efficacy - Linvoseltamab demonstrated a manageable safety profile with the lowest rates of cytokine release syndrome (CRS) compared to other bispecifics [10][11] - Infections decreased over time in patients treated with Linvoseltamab, indicating a potential improvement in immune function [52][53] Commercial Opportunities - Strong early momentum in the launch of Linvoseltamab, with over 300 institutions certified for the REMS program [27] - Positive physician feedback on Linvoseltamab's differentiated clinical profile and patient-centric dosing [27][28] - Potential for significant commercial opportunities in precursor conditions and related diseases [28][29] Future Studies and Trials - Ongoing and upcoming pivotal studies, including LINKER-MM3, LINKER-MM5, LINKER-MM6, LINKER-MM7, LINKER-MM8, and LINKER-SMM2, are expected to provide critical data in the coming years [12][21][25][30] - Anticipated results from LINKER-MM3 in 2027 and LINKER-SMM2 in the first half of 2026 [13][25] Conclusion - Regeneron is positioned to simplify the treatment landscape for multiple myeloma with Linvoseltamab, aiming to establish it as the therapy of choice across various treatment lines and precursor conditions [30][31]

Financial Data and Key Metrics Changes - The company announced a $7 billion commitment to expand R&D capabilities and domestic manufacturing [6] - The cash balance remains substantial, with ongoing dividends and buybacks, but the company is open to M&A opportunities if the right conditions arise [11][12] Business Line Data and Key Metrics Changes - Eylea HD received recent approvals for RVO and Q4 dosing, with expectations for commercial impact starting in 2026 [17] - Dupixent continues to grow robustly, treating over 1.3 million patients globally, with significant market expansion opportunities in atopic dermatitis and asthma [30][31] Market Data and Key Metrics Changes - The company is actively monitoring the impact of biosimilars on Eylea, noting that any conversions to biosimilars still position patients as candidates for Eylea HD [24] - The COPD launch has shown strong performance, with Dupixent being the best-performing respiratory launch for the company [34] Company Strategy and Development Direction - The company is committed to domestic manufacturing and enhancing internal capabilities while exploring external opportunities for growth [6][12] - The focus remains on investing in the pipeline and fostering innovation to drive long-term shareholder value [10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, particularly regarding the Eylea HD enhancements and the ongoing growth of Dupixent [21][30] - The company is closely watching policy changes related to drug pricing and their potential impact on Eylea and other products [26] Other Important Information - The company is preparing for a submission for a prefilled syringe for Eylea HD, expected in the second quarter [18] - Linvoseltamab has shown promising data in the myeloma market, with plans for further studies in earlier lines of therapy [63] Q&A Session Summary Question: Update on policy and macro environment - The company has committed to domestic manufacturing and is in active negotiations regarding drug pricing policies [6][9] Question: Thoughts on M&A and business development - The company is open to M&A opportunities but prioritizes internal investments and collaborations [12][13] Question: Eylea HD commercial impact and competition - Eylea HD enhancements are expected to drive growth starting in 2026, despite current payer issues [21][24] Question: Dupixent growth drivers - Dupixent is benefiting from market expansion in atopic dermatitis and asthma, with significant room for growth [30][31] Question: Linvoseltamab in myeloma - Linvoseltamab has shown best-in-class data among BCMA bispecifics, with ongoing studies to simplify treatment algorithms [62][63]

Financial Data and Key Metrics Changes - The company announced a $7 billion commitment to expand R&D capabilities and domestic manufacturing, indicating a strong focus on internal growth and innovation [6][9] - The company has a substantial cash balance and has initiated dividends and buybacks, reflecting a solid financial position [11] Business Line Data and Key Metrics Changes - Eylea HD received recent approvals for RVO and Q4 dosing, with expectations for commercial impact starting in 2026 [17][18] - Dupixent continues to grow robustly, treating over 1.3 million patients globally, with significant market expansion opportunities in atopic dermatitis and asthma [30][31] Market Data and Key Metrics Changes - The company is actively monitoring the impact of biosimilars on Eylea, noting that while they present challenges, Eylea HD remains a strong competitor [24] - The COPD launch has been successful, with Dupixent showing a significant reduction in exacerbation rates compared to competitors [33][34] Company Strategy and Development Direction - The company is committed to domestic manufacturing and enhancing its R&D capabilities, aiming to meet the demands of its growing pipeline [6][15] - There is an openness to exploring external opportunities for M&A, although the focus remains on internal capabilities and collaborations [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the alignment with government goals regarding drug pricing and innovation, emphasizing the importance of fostering a supportive environment for the industry [9] - The company is optimistic about the future growth of its products, particularly with the enhancements to Eylea and the ongoing success of Dupixent [22][30] Other Important Information - The company is awaiting the first round of Part B IRA drug selections, which could impact Eylea's market position [26][28] - Linvoseltamab is showing promising results in a crowded myeloma market, with best-in-class data among BCMA bispecifics [62] Q&A Session Summary Question: Update on manufacturing and policy context - The company has committed to expanding domestic manufacturing and is in active negotiations regarding drug pricing with the administration [6][7] Question: Future M&A considerations - The company is open to external opportunities but prioritizes internal investments and collaborations [12][13] Question: Eylea HD commercial impact - Eylea HD enhancements are expected to have a significant impact starting in 2026, with ongoing efforts to convert patients from Eylea 2 mg to Eylea HD [21][22] Question: Competition from biosimilars - Biosimilars present challenges, but Eylea HD is positioned as a strong competitor with unique advantages [24] Question: Growth drivers for Dupixent - Dupixent continues to grow due to its market-leading position and under-penetrated opportunities in atopic dermatitis and asthma [30][31] Question: COPD launch and patient adoption - The COPD launch has been successful, with significant patient adoption and positive feedback on efficacy [33][34] Question: Future pipeline developments - The company is focused on advancing its pipeline, including LAG-3 and Linvoseltamab, with promising data expected in the near future [40][62]

Financial Data and Key Metrics Changes - The company announced a $7 billion commitment to expand R&D capabilities and domestic manufacturing, indicating a strong focus on internal growth and innovation [6][8] - The company has a substantial cash balance and has initiated dividends and buybacks, but historically has not engaged in significant M&A activity [10][12] Business Line Data and Key Metrics Changes - Eylea received recent approvals for RVO and Q4 dosing, with expectations for commercial impact starting in 2026 [17][18] - Dupixent is actively treating over 1.3 million patients globally, with significant growth potential in atopic dermatitis and asthma markets [30][31] - Linvoseltamab has shown best-in-class data among BCMA bispecifics, with response rates around 70% and complete response rates around 50% [63] Market Data and Key Metrics Changes - The company is expanding its manufacturing capabilities in the U.S. to meet growing pipeline demands, including a fill-finish facility to diversify supply chain risks [6][7] - The company is closely monitoring the impact of biosimilars on Eylea, particularly in the context of competition from products like Vabysmo [22][23] Company Strategy and Development Direction - The company is committed to investing in internal capabilities while remaining open to external opportunities for M&A, focusing on late-stage opportunities with high revenue potential [11][12] - The strategy includes enhancing the Eylea brand through new product enhancements and addressing patient affordability issues [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the long-term shareholder value driven by investments in the pipeline and domestic manufacturing [6][9] - The company is aligned with government goals regarding drug pricing and innovation, indicating a proactive approach to policy changes [8][9] Other Important Information - The company is awaiting the first round of Part B IRA drug selections, which could impact Eylea's market position [25][27] - Upcoming data presentations from ongoing studies, including those for Linvoseltamab and LAG-3, are anticipated to provide insights into future growth opportunities [66][71] Q&A Session Summary Question: What is the company's approach to M&A and external opportunities? - The company is open to exploring external opportunities for M&A, focusing on late-stage opportunities that align with their internal capabilities and scientific rigor [11][12] Question: How does the company plan to address competition from biosimilars? - The company believes that Eylea HD's differentiated profile and dosing flexibility will help it compete effectively against biosimilars [23][24] Question: What are the growth drivers for Dupixent moving forward? - Dupixent continues to benefit from market expansion in atopic dermatitis and asthma, with significant room for growth due to low penetration rates [30][31] Question: What is the outlook for Linvoseltamab in the myeloma market? - Linvoseltamab has shown compelling efficacy and safety data, positioning it well in a competitive myeloma landscape [63][64] Question: How is the company preparing for upcoming regulatory decisions? - The company is actively preparing for FDA submissions and anticipates positive outcomes from ongoing studies, which will inform future strategies [42][66]

Regeneron Pharmaceuticals FY Conference Summary Company Overview - **Company**: Regeneron Pharmaceuticals (NasdaqGS:REGN) - **Date of Conference**: December 02, 2025 Key Accomplishments in 2025 - **Eylea HD**: Significant growth noted, with recent label enhancements for Q4 weekly dosing and RVO indication expected to drive future uptake. The RVO indication represents about 20% of the overall market and 17-18% of Eylea's business [6][7][17] - **Dupixent**: Expanded to eight indications in the U.S., with strong international performance. Recent approvals include COPD, bullous pemphigoid, and CSU, with a total potential patient population of approximately 927,000 [7][11][39] - **Libtayo**: Successful label expansion for adjuvant CSCC, with positive reception from the KOL community. The launch is progressing well, with a focus on early treatment paradigms [8][50] - **Linvoseltamab**: Launched for advanced treatment indications, showing early interest and uptake in the community [9][53] - **Ultra-Rare Disease Portfolio**: Continued advancements in the ultra-rare disease space, including Evkeeza for HoFH [10] Pipeline and Future Developments - **Immunology**: Positive data for Dupixent in allergic fungal rhinosinusitis, with a PDUFA date in February. Ongoing expansion in various indications [11][12] - **Neurology**: Cemdisiran for generalized myasthenia gravis shows potential in a $5 billion market, expected to double by 2030 [67][68] - **Oncology**: Libtayo's adjuvant CSCC indication is expected to have a gradual uptake, with significant investment in marketing to relevant medical professionals [50][51] - **Ophthalmology**: Eylea HD is positioned strongly against competitors, with ongoing development of new therapies targeting glaucoma and other conditions [35][36] Financial Highlights - **Capital Allocation**: Initiated a dividend with a modest yield, returning approximately $4 billion through dividends and share repurchases in 2025. Increased share repurchase from $2.6 billion in 2024 to an anticipated $3.6 billion in 2025 [13][14] - **Investment in U.S. Manufacturing**: Committed over $7 billion to enhance manufacturing and research capabilities in the U.S. [14] Market Dynamics and Competitive Landscape - **Biosimilars Impact**: Eylea's business has shifted towards Eylea HD, with some episodic uptake of biosimilars. The market is complicated by affordability issues, impacting brand selection [26][28] - **Next-Gen Products**: Regeneron is monitoring competition from bispecifics and multispecifics but remains confident in Eylea HD's competitive profile [30][34] Lifecycle Management and Future Strategies - **Dupixent Lifecycle Management**: Exploring ways to extend dosing intervals and develop adjacent pathways, with a broad pipeline of over 45 clinical candidates [44][46] - **Business Development**: Active in seeking collaborations and partnerships, including a recent $150 million deal with Tessera for gene editing opportunities [75] Conclusion - Regeneron Pharmaceuticals has had a productive year in 2025, with significant advancements in product performance, pipeline development, and capital allocation. The company is well-positioned for continued growth in 2026, focusing on optimizing existing products and advancing innovative therapies across various therapeutic areas [78][80]

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]

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 Viewpoint - Regeneron and Johnson & Johnson face challenges in the early intervention field for smoldering multiple myeloma (SMM), despite promising new data. The adoption of Regeneron's Lynozyfic and Johnson's Darzalex may be slow due to the need for physicians to balance the risks of overtreatment with the difficulty in identifying high-risk patients who may benefit [3][4]. Group 1: Regeneron's Lynozyfic - Lynozyfic shows a total response rate (ORR) of 100% and a complete response rate (CR) of 36.8% for high-risk SMM, but these rates may not be as significant for active myeloma. The key measure of success is whether the drug can delay disease progression and improve survival [4][5]. - The safety profile of Lynozyfic raises concerns, with a 12.5% incidence of grade 3-4 infections and a 25% incidence of grade 3-4 neutropenia, alongside a 42% occurrence of any grade cytokine release syndrome [4][5]. Group 2: Johnson & Johnson's Darzalex - The AQUILA trial indicates that Darzalex monotherapy extends progression-free survival (PFS) and overall survival (OS) for high-risk SMM patients, reducing disease progression rates from 41.8% in the observation group to 21.8%. This has led to EU approval and potential FDA approval [8]. - There are concerns regarding the definition of "high-risk" SMM in the AQUILA trial compared to existing SLiM standards, which may hinder the widespread application of Darzalex due to the asymptomatic nature of the disease [8]. Group 3: Patient Identification and Treatment Concerns - The Quiredex trial shows that lenalidomide combined with dexamethasone significantly delays the progression to multiple myeloma, with a PFS of 9.5 years compared to 2.1 years for the control group. However, many physicians remain cautious about early intervention due to overtreatment risks and challenges in accurately identifying high-risk patients [6][8]. - The use of circulating tumor DNA (ctDNA) detection technology is suggested to better identify patients at high risk of progressing to multiple myeloma, aiming to minimize overtreatment [6].