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]

Investment Rating - The report does not explicitly state an investment rating for the chronic spontaneous urticaria (CSU) drug industry in China. Core Insights - The chronic spontaneous urticaria drug market in China is projected to grow from CNY 12.4 billion in 2019 to CNY 16.9 billion in 2024, with a compound annual growth rate (CAGR) of 6.4%. It is expected to further increase at a CAGR of 16.2%, reaching CNY 41.7 billion by 2030 [5][12][14]. - The existing treatment landscape for CSU primarily includes second-generation antihistamines, with varying sales performance among different drugs. Innovative monoclonal antibody therapies are emerging, with several companies focusing on IL-4R and IgE targets [5][24][30]. Summary by Sections Market Overview - The report focuses on the chronic spontaneous urticaria drug industry in China, exploring disease mechanisms, drug patterns, and research and development progress to understand the current market size and future growth [3][4]. Treatment Patterns - The first-line treatment for CSU is standard-dose second-generation antihistamines. If symptoms are uncontrolled, combination therapy or increased dosage may be considered. If still ineffective, omalizumab can be added [5]. Market Size and Growth - The CSU drug market in China is expected to grow significantly, with a market size of CNY 12.4 billion in 2019, increasing to CNY 16.9 billion by 2024, and projected to reach CNY 41.7 billion by 2030 [12][14]. Drug Sales Performance - Sales of second-generation antihistamines show varied trends: - Loratadine has faced sales fluctuations due to generic competition. - Cetirizine maintains stable sales due to formulation innovations. - Ebastine has seen a significant decline due to national procurement policies. - Desloratadine has experienced continuous growth due to new formulations and market expansion [5][17][20]. Innovation in Drug Development - The report highlights a rich pipeline of innovative monoclonal antibody therapies for CSU treatment, with companies like Sanofi and others focusing on IL-4R and IgE targets, some of which are in clinical phases [5][24][30]. Epidemiology - The number of CSU patients globally and in China is on the rise, with projections indicating 73.5 million cases worldwide and 29.7 million in China by 2030 [8][11]. Competitive Landscape - The competitive landscape for second-generation antihistamines in China is characterized by significant disparities in sales among leading companies, with a clear market hierarchy [20][21]. Monoclonal Antibody Market - In the global CSU monoclonal antibody market, Sanofi's Dupixent shows strong performance, while Novartis's Omalizumab faces challenges and needs optimization to maintain its leading position [24][25][27]. Candidate Drugs in China - The Chinese market for CSU monoclonal antibodies features multiple candidates with diverse targets and clinical stages, indicating a dynamic and competitive environment [30].

Core Insights - Billionaire investor Ray Dalio's Bridgewater Associates has made significant adjustments to its equity holdings in Q3 2025, indicating a strategic shift in investment focus [1][3][6] Group 1: Portfolio Adjustments - The fund has aggressively reduced its stakes in major technology companies, cutting its position in Meta by nearly 50%, Nvidia by over 65%, Alphabet by 52%, and Microsoft by 36% [1][2] - Other large-cap positions such as Uber, PayPal, Comcast, Wells Fargo, and Citigroup were also reduced, reflecting a broader pullback from large-cap tech and financial sectors [2] Group 2: Increased Holdings - Bridgewater has significantly increased its investments in select growth opportunities, raising its stake in Sea Limited by over 83%, Mastercard by 190%, Workday by 131%, Regeneron by 164%, and AMD by 2% [2][3] - The filing also introduced two new positions in Fiserv and Reddit, indicating an interest in digital payments infrastructure and the social-media-to-advertising ecosystem [3] Group 3: Global Market Strategy - The firm has raised its allocation to emerging markets and international funds, increasing its stake in South Korea's EWY fund by 25%, adding 34% to its VWO emerging-markets ETF, and lifting its S&P 500 tracker IVV by over 75% [4] Group 4: Economic Concerns - Dalio has expressed concerns about the U.S. economy nearing a "danger zone" due to rising debt, political conflict, and recession risks, which may have influenced Bridgewater's recent portfolio adjustments [6][7] - The significant reductions in technology holdings suggest a strategy to mitigate exposure to sectors that could be vulnerable in an economic slowdown [7]

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]

Core Insights - Regeneron Pharmaceuticals is showcasing its hematology portfolio at the American Society of Hematology (ASH) 2025 Annual Meeting, with a focus on innovative treatments for blood cancers and disorders [2][3][11] - The company will present data on Lynozyfic™ (linvoseltamab-gcpt) and odronextamab, highlighting their potential as novel therapies in multiple myeloma and diffuse large B-cell lymphoma [3][4][15] Group 1: Lynozyfic™ (linvoseltamab-gcpt) - Lynozyfic is being evaluated in the Phase 1/2 LINKER-MM4 trial as a monotherapy for newly diagnosed multiple myeloma, marking the first trial of a BCMAxCD3 bispecific antibody in this context [3][15] - Additional results from the multicohort Phase 1b LINKER-MM2 trial will be shared, focusing on linvoseltamab combined with anti-CD38 monoclonal antibodies for relapsed/refractory multiple myeloma [3][6] Group 2: Odronextamab - Odronextamab will be featured in six abstracts, including its combination with chemotherapy for previously untreated diffuse large B-cell lymphoma, with initial results from the OLYMPIA-3 trial [4][19] - The program also includes results from two Phase 3 trials evaluating odronextamab in follicular lymphoma, both in combination with chemotherapy and lenalidomide [4][19] Group 3: Investor Engagement - Regeneron will host a virtual 'Regeneron Roundtable' investor event on December 10, 2025, to discuss its multiple myeloma development program [2][9] - This event is part of a series aimed at highlighting the company's innovative investigational pipeline [9][10] Group 4: Company Overview - Regeneron is recognized for its expertise in developing medicines for blood cancers and rare blood disorders, utilizing proprietary technologies like VelociSuite to create fully human antibodies [11][39] - The company is committed to addressing unmet medical needs in hematology through its extensive research and clinical development programs [11][12][39]

Core Viewpoint - The appointment of Richard Pazdur as the new director of the FDA's Center for Drug Evaluation and Research has boosted investor confidence in the pharmaceutical sector, leading to record-high stock prices for major pharmaceutical companies [1][2]. Group 1: Appointment Details - Richard Pazdur, with 26 years of experience at the FDA, has been appointed as the new director, succeeding George Tidmarsh, who resigned following an investigation [1]. - Pazdur will continue to serve as the director of the FDA's Oncology Center of Excellence until a successor is determined [1]. Group 2: Market Reaction - The VanEck Vectors Pharmaceutical ETF, covering 25 global pharmaceutical companies, has seen a three-day rise, reaching an all-time high, with notable gains from companies like Novo Nordisk, Bristol-Myers Squibb, and Gilead [1]. - The SPDR S&P Biotech ETF also recorded a three-day increase, hitting its highest level since January 2022, with strong performances from Regeneron and BioNTech [1]. Group 3: Analyst Sentiment - Analysts generally view Pazdur's appointment positively, with Raymond James analyst Chris Mkins stating he could be the best choice for patients and the industry [2]. - The appointment may signal a significant shift in regulatory strategy from FDA leadership, according to industry experts [2]. - Medical media outlet Stat News welcomed the appointment, highlighting it as a positive development for the FDA during a turbulent period [2].

Group 1 - The article does not provide any specific content related to a company or industry [1]

PresentationWelcome to the Regeneron conference call to discuss its Factor XI development program. My name is Shannon, and I will be your operator for today's call. [Operator Instructions] Please note that this conference call is being recorded. I will now turn the call over to Ryan Crowe, Senior Vice President, Investor Relations. You may begin.Ryan CroweSenior Vice President of Investor Relations & Strategic Analysis Thank you, Shannon. Good morning, and welcome to the inaugural Regeneron Roundtable Inves ...

Regeneron Pharmaceuticals Conference Call Summary Company Overview - **Company**: Regeneron Pharmaceuticals (NasdaqGS:REGN) - **Focus**: Factor XI Development Program, particularly in anticoagulation therapies Key Industry Insights - **Anticoagulation Market**: Approximately $20 billion globally, primarily driven by stroke prevention in patients with atrial fibrillation [9] - **Unmet Need**: About half of patients who should receive anticoagulation therapy do not due to bleeding concerns associated with current treatments [9][11] - **Potential Market Expansion**: A safer therapy could unlock previously untapped opportunities in venous thromboembolism and arterial thrombosis [10][11] Core Program Highlights - **Factor XI Program**: - Two investigational antibodies: REGN7508 (targets catalytic domain) and REGN9933 (targets A2 domain) [7][8] - Designed to provide tailored anticoagulation therapy based on patient risk profiles [8] - **Clinical Data**: - Positive Phase III data for cemdisiran, an siRNA targeting C5, showing a 2.3-point placebo-adjusted improvement in myasthenia gravis activities of daily living [6] - ROCCI VTE1 and VTE2 studies demonstrated efficacy in venous thromboembolism prevention post-knee replacement surgery, with no major bleeding events reported [19][20] Genetic Evidence and Rationale - **Genetic Support**: Individuals with Factor XI deficiencies show reduced risk of venous thromboembolism and cardioembolic stroke, supporting the therapeutic hypothesis that lowering Factor XI levels can reduce thrombotic risk while maintaining hemostasis [12][14] - **Clinical Implications**: Genetic data guides indication selection, focusing on venous thromboembolism and cardioembolic stroke, while further validation is needed for arterial thrombosis [14] Commercial Opportunity - **Target Markets**: - **Total Knee Replacement**: Nearly 2 million procedures annually in the US, presenting a significant opportunity for simplified adherence and improved outcomes [27] - **Cancer-Associated Thrombosis**: Patients face a 50 times higher risk of venous thromboembolism, with nearly 1 million US patients affected annually [28] - **Atrial Fibrillation**: Approximately 8 million patients in the US by 2036, with a significant portion not receiving treatment due to bleeding concerns [29] - **Peripheral Artery Disease**: Only 4% of patients currently receive anticoagulants, despite high risks associated with revascularization procedures [30] Development Strategy - **Pivotal Development Program**: Spanning multiple indications including VTE prevention, cancer-associated VTE, stroke prevention in atrial fibrillation, and PICC-associated thrombosis [23][24] - **Tailored Approach**: The catalytic antibody is pursued across all indications, while the A2 antibody is focused on settings with higher bleeding risk [25] Safety Profile - **Bleeding Risk**: Data suggests that Factor XI antibodies have a favorable safety profile, with lower bleeding risks compared to current standard treatments [22][37] - **Clinical Studies**: Ongoing studies are assessing bleeding risks in various patient populations, including those with higher thrombotic burdens [62][66] Competitive Landscape - **Market Positioning**: Regeneron aims to differentiate its Factor XI program through superior target engagement and a dual antibody strategy, addressing both high potency and high safety segments [27][78] - **Monitoring Competitors**: Upcoming data from competitors like Bayer and Bristol will be critical for validating Regeneron's approach and informing future development strategies [77][78] Conclusion - Regeneron's Factor XI program is positioned to address significant unmet needs in the anticoagulation market, with a focus on safety and efficacy. The dual antibody strategy aims to provide tailored solutions for diverse patient populations, potentially transforming care in various thrombotic conditions.

Factor XI Program Overview - Regeneron is developing two Factor XI antibodies, REGN7508Cat and REGN9933A2, targeting various indications with different bleeding risk profiles[51] - The company aims to address unmet needs in anticoagulation by potentially reducing bleeding risk while maintaining efficacy[64] - Genetics support targeting Factor XI, as lower FXI levels are associated with reduced VTE and cardioembolic stroke risk[16, 20] Clinical Data and Development - ROXI-VTE-I and ROXI-VTE-II studies showed REGN7508Cat had a numerically lower VTE rate compared to apixaban, while REGN9933A2 had a numerically lower VTE rate compared to enoxaparin in TKR patients[33, 36] - In a pooled analysis, REGN7508Cat showed a 13.6% risk difference reduction in VTE incidence compared to pooled enoxaparin[35] - Interim results from the ROXI-CATH study in catheter-associated thrombosis showed a 66% relative risk reduction in VTE with REGN7508Cat versus placebo[40] - A Phase 1 GI bleed study indicated that REGN7508/REGN9933 resulted in 14% less bleeding risk compared to rivaroxaban + aspirin[46] Commercial Opportunity - The current global anticoagulation market is \$20 billion, with standard-of-care DOAC utilization at approximately 50% due to bleeding risk[12] - The U S Factor XI total addressable market in post-TKR VTE is estimated to be ~800K patients, with a ~40% class share anticipated[56, 75] - The U S Factor XI total addressable market in cancer VTE is estimated to be ~300K patients, with a ~30-35% class share anticipated[56, 85]