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 (NasdaqGS:REGN) Update / Briefing November 10, 2025 08:30 AM ET Company ParticipantsGeoff Meacham - Managing DirectorBrian Abrahams - Managing Director and Global Sector HeadRyan Crowe - SVP of Investor RelationsL. Andres Sirulnik - SVP and Clinical Development Unit HeadGeorge Yancopoulos - President and Chief Scientific OfficerDave Reisinger - Responsible for Diversified Biopharma ResearchEvan Seigerman - Managing Director and Head of Healthcare ResearchSimon Baker - Head of Globa ...

ROUNDTABLE Factor XI Speakers Regeneron Roundtable – Factor XI George Yancopoulos Board co-Chair President Chief Scientific Officer NOVEMBER 10, 2025 Andres Sirulnik Senior Vice President Clinical Development Unit Head Hematology David Gutstein Vice President Global Program Head Hematology Ryan Crowe Senior Vice President Investor Relations & Strategic Analysis 2 This presentation includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of ...

Core Insights - Regeneron Pharmaceuticals has reported positive Phase 2 trial results for two investigational factor XI antibodies, REGN7508 and REGN9933, aimed at preventing blood clotting in patients undergoing total knee replacement surgery [2][3][5] - The antibodies are designed to have distinct profiles, with REGN7508 providing stronger anticoagulation and REGN9933 offering a lower risk of bleeding, allowing for tailored anticoagulant therapy based on patient risk profiles [2][3][12] Trial Results - The trials included two open-label, active-controlled Phase 2 studies: ROXI-VTE-I and ROXI-VTE-II, evaluating the efficacy of a single intravenous dose of REGN7508 and REGN9933 for preventing venous thromboembolism (VTE) after knee arthroplasty [4][11] - REGN7508 reduced VTE rates to 7.1%, superior to apixaban's rate of 12.4%, while REGN9933 decreased VTE rates to 17.2%, superior to enoxaparin's rate of 20.6% [5][7] Safety Profile - Both antibodies demonstrated robust anti-clotting effects with no clinically relevant bleeding reported in any treatment arm, indicating a favorable safety profile [5][8][13] - The only treatment-related adverse event was minimal bleeding in the enoxaparin arm, with overall adverse event rates being similar across treatment groups [7][8] Future Development - Regeneron is advancing its factor XI program with ongoing Phase 3 trials for REGN7508, including ROXI-APEX and ROXI-ASPEN, and plans to initiate additional trials for various indications in 2026 [14][12] - The company aims to explore the use of these antibodies in other clinical settings, including atrial fibrillation and cancer-associated thrombosis [14][12]

Core Insights - Dupixent (dupilumab) has shown significant efficacy in reducing key nasal signs and symptoms in patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) compared to placebo, as demonstrated in the LIBERTY-AFRS-AIMS Phase 3 trial [1][2][4] - The U.S. FDA has accepted Dupixent's supplemental Biologics License Application (sBLA) for priority review, with a target action date of February 28, 2026, which could make it the first and only approved treatment specifically for AFRS [2][4] - If approved, this would mark Dupixent's ninth FDA-approved indication, expanding its use in various atopic and type 2 inflammatory diseases [2][10] Company Overview - Regeneron Pharmaceuticals, Inc. and Sanofi are jointly developing Dupixent, which is a fully human monoclonal antibody targeting IL-4 and IL-13 pathways, key drivers of type 2 inflammation [9][14] - Dupixent has been approved in over 60 countries for multiple indications, treating more than 1,000,000 patients globally [10][28] - The companies are also exploring Dupixent's efficacy in other type 2 inflammatory diseases, indicating a broad potential market for the drug [15][28] Clinical Trial Details - The LIBERTY-AFRS-AIMS trial was a randomized, double-blind, placebo-controlled study involving 62 patients, which demonstrated significant improvements in sinus opacification, nasal congestion, and nasal polyp size [4][8][11] - Primary endpoint results showed a 50.0% improvement in sinus opacification scores for Dupixent compared to 9.8% for placebo at 52 weeks [5][11] - Secondary endpoints included a 66.7% improvement in patient-reported nasal congestion at 24 weeks and a 60.8% reduction in nasal polyp size at the same time point [11][12] Safety Profile - The safety profile of Dupixent in the trial was consistent with its known profile in other approved indications, with overall adverse event rates of 70% for Dupixent and 79% for placebo [6][7] - Serious adverse events were reported in 0% of Dupixent patients compared to 7% in the placebo group, indicating a favorable safety profile [6][11] Market Implications - The potential approval of Dupixent for AFRS could significantly impact treatment options for patients suffering from this chronic condition, which currently has limited effective therapies [3][4] - The drug's ability to reduce the need for systemic corticosteroids and surgery by 92% highlights its potential to improve patient quality of life and reduce healthcare costs associated with surgical interventions [11][12]

Core Insights - The pivotal LIBERTY-AFRS-AIMS phase 3 study of Dupixent (dupilumab) showed significant improvements in allergic fungal rhinosinusitis (AFRS) symptoms, meeting all primary and secondary endpoints [1][5][6] - The FDA has accepted the supplemental biologics license application (sBLA) for Dupixent in treating AFRS, which could become its ninth approved indication [2][5] Study Results - The study demonstrated a 50.0% improvement in sinus opacification scores for Dupixent compared to 9.8% for placebo at 52 weeks, with a significant reduction observed at 24 weeks [6] - Patient-reported nasal congestion improved by 66.7% at 24 weeks and 80.6% at 52 weeks in the Dupixent group compared to 25.3% and 11.1% in the placebo group, respectively [6][13] - Nasal polyp size reduced by 60.8% at 24 weeks and 62.5% at 52 weeks in the Dupixent group compared to 15.2% and 3.6% in the placebo group [13] Safety Profile - The overall rates of adverse events were 70% for Dupixent and 79% for placebo, with serious adverse events reported in 0% of Dupixent patients compared to 7% for placebo [7] - Common treatment-emergent adverse events included COVID-19 and nosebleeds, with similar rates between Dupixent and placebo [7] Background on AFRS - AFRS is a chronic type 2 inflammatory disease of the sinuses caused by allergic hypersensitivity to fungi, primarily affecting individuals in warm, humid climates [3][5] - Current treatment options are limited, often involving surgery and prolonged systemic steroids, with a high rate of disease recurrence [3][4] Dupixent Overview - Dupixent is a fully human monoclonal antibody that inhibits IL4 and IL13 signaling pathways, showing significant clinical benefits in various type 2 inflammatory diseases [10][11] - The drug has received regulatory approvals in over 60 countries for multiple indications, with more than one million patients treated globally [11][12]

Core Insights - Sanofi and Regeneron's Dupixent has shown positive results in the LIBERTY-AFRS-AIMS phase 3 study for allergic fungal rhinosinusitis (AFRS), meeting all primary and secondary endpoints [1][5] - The FDA has accepted the supplemental biologics license application (sBLA) for Dupixent in treating AFRS, which could become its ninth approved indication [2][5] Study Results - The LIBERTY-AFRS-AIMS study demonstrated a 50.0% improvement in sinus opacification scores for Dupixent compared to 9.8% for placebo at 52 weeks [4][12] - Patient-reported nasal congestion improved by 66.7% at 24 weeks and 80.6% at 52 weeks in the Dupixent group compared to 25.3% and 11.1% in the placebo group, respectively [4][12] - Nasal polyp size reduced by 60.8% at 24 weeks and 62.5% at 52 weeks in the Dupixent group compared to 15.2% and 3.6% in the placebo group [12] Safety Profile - The overall rates of adverse events were 70% for Dupixent and 79% for placebo, with serious adverse events reported in 0% of Dupixent patients compared to 7% for placebo [6] - Common treatment-emergent adverse events included COVID-19 (15% Dupixent, 14% placebo) and nosebleed (12% Dupixent, 4% placebo) [6] Disease Background - AFRS is a chronic type 2 inflammatory disease of the sinuses caused by allergic hypersensitivity to fungi, primarily affecting individuals in warm, humid climates [3][5] - Current treatment options are limited, often involving surgery and prolonged systemic steroids, with a high rate of disease recurrence [3][4] Regulatory and Market Implications - If approved, Dupixent would be the first and only medicine specifically indicated for AFRS, enhancing its market position [2][5] - The study results provide strong evidence that IL4 and IL13 are key drivers of type 2 inflammation in AFRS, aligning with findings in other related diseases [4][12]

Group 1: Investment Opportunities - Investing in beaten-down stocks with promising outlooks can yield above-average market returns over the long run [1] - Novo Nordisk and Regeneron Pharmaceuticals are highlighted as potential investment opportunities due to their promising prospects [2] Group 2: Novo Nordisk - Novo Nordisk has several catalysts that could improve its stock performance, including late-stage studies nearing regulatory submissions, particularly the CagriSema medicine, which is projected to generate $15.2 billion in annual sales by 2030 [4][5] - The potential launch of an oral semaglutide formulation for weight management could enhance Novo Nordisk's competitive position against Eli Lilly, as it is expected to be cheaper and increase access for cash-paying customers [6] - Recent label expansions for existing products are anticipated to positively impact Novo Nordisk's financial results, and its revenue and earnings growth remain stronger than most peers, making it an attractive investment opportunity at current valuations [7][8] Group 3: Regeneron Pharmaceuticals - Regeneron is effectively managing biosimilar competition while introducing new products to mitigate threats [9]

Investment Rating - The report maintains an "Outperform" rating for the industry [1] Core Insights - ASCVD (Atherosclerotic Cardiovascular Disease) is a leading cause of death globally, with significant mortality rates in both the US and China. In 2022, approximately 370,000 deaths from coronary heart disease and 160,000 from stroke were reported in the US, while China saw around 1.96 million deaths from ischemic heart disease and 2.3 million from stroke in 2021 [2][5][26] - The report highlights the increasing focus of multinational pharmaceutical companies (MNCs) on cardiovascular treatments, particularly targeting PCSK9 and Lp(a). The global market for PCSK9 is projected to reach between $11 billion and $19 billion, while the Lp(a) inhibitor market is expected to reach $3 billion to $7 billion [2][3] - Upcoming Phase 3 clinical trials for cardiovascular endpoints are anticipated to yield significant data in the coming years, with several studies scheduled for completion between 2025 and 2029 [2][3] Summary by Sections ASCVD Disease Burden - ASCVD encompasses a range of conditions including coronary artery disease, cerebrovascular disease, and peripheral artery disease. It is associated with significant mortality and morbidity, with controllable risk factors such as dyslipidemia, diabetes, hypertension, and smoking [5][6] LDL-C: Unmet Needs Post-Statin Therapy - Despite the widespread use of statins, a substantial proportion of patients do not achieve target LDL-C levels, indicating a significant unmet need in the market for additional therapies [26] Lp(a): An Independent Risk Factor - Lp(a) is identified as an emerging risk factor for ASCVD, independent of LDL-C levels. Its levels are primarily genetically determined and show a skewed distribution in the population, with a notable percentage of individuals having elevated levels that correlate with increased cardiovascular risk [35][40] Investment Recommendations - The report identifies key companies involved in the development of Lp(a) inhibitors, including Hengrui Medicine and CSPC Pharmaceutical Group, which have entered into licensing agreements with major pharmaceutical companies for their respective Lp(a) small molecule inhibitors [2][3]

Core Insights - Dupixent (dupilumab) has been awarded the "Best Biotechnology Product" of 2025 by the Galien Foundation, recognizing its significant scientific innovation and impact on various allergic and atopic conditions [1][2] - It is the first and only therapy specifically targeting the IL-4 and IL-13 signaling pathways, which are key drivers of type 2 inflammation [1][2] Company Overview - Regeneron Pharmaceuticals, Inc. is a leading biotechnology company focused on developing life-transforming medicines for serious diseases [23] - The company utilizes proprietary technologies, such as VelocImmune, to create optimized fully human antibodies [22][24] Product Details - Dupixent is approved for eight indications globally, including atopic dermatitis, asthma, eosinophilic esophagitis, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, bullous pemphigoid, prurigo nodularis, and chronic obstructive pulmonary disease (COPD) [3][6] - More than 1 million patients are currently being treated with Dupixent worldwide [2][6] Scientific Significance - Dupixent was developed based on a hypothesis that many allergic and atopic diseases are driven by excess IL-4 and IL-13, with Phase 3 trials demonstrating significant clinical benefits [2][5] - It is the first dual blocker of IL-4 and IL-13 approved by the U.S. FDA, highlighting its unique position in the market [2][5] Clinical Development - Dupixent has been studied in over 60 clinical trials involving more than 10,000 patients, focusing on chronic diseases associated with type 2 inflammation [8][9] - The product is jointly developed by Regeneron and Sanofi under a global collaboration agreement [7] Future Prospects - Regeneron and Sanofi are exploring additional indications for Dupixent in Phase 3 trials, including chronic pruritus of unknown origin and lichen simplex chronicus [9]