Regeneron Pharmaceuticals, Inc.

Joining me on today's call are Dr. Leonard Schleifer, Board Co-Chair, Co-Founder, President and Chief Executive Officer, Dr. George Yancopoulos, Board Co-Chair, Co-Founder, President and Chief Scientific Officer, Marion McCourt, Executive Vice President of Commercial, and Chris Fethmore, Executive Vice President and Chief Financial Officer. After our prepared remarks, the remaining time will be available for your Q&A. I would like to remind you the remarks made on today's call may include forward-looking statements about Regeneron. Such statements may include but are not limited to those related to Regeneron and its products and business, financial forecasting guidance, development programs and related anticipated milestones, collaborations, finances, regulatory matters, payer coverage and reimbursement, intellectual property, pending litigation and other proceedings, and competition. Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities Exchange Commission, including its Form 10-K for the year ended December 31, 2025, which we plan to file with the SEC next week. Regeneron does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise. In addition, please note that GAAP and non-GAAP financial measures will be discussed on today's call. Information regarding our use of non-GAAP financial measures and a reconciliation of those measures to GAAP is available in our quarterly results press release and our poker presentation, both of which can be found on the Regeneron Investor Relations website. Once our call concludes, the IR team will be available to answer any further questions. With that, let me turn the call over to our President and Chief Executive Officer, Dr. Leonard Schleifer.

Glenn, take it away. Thanks, Ryan, and thanks to everyone for joining today's call. Virginia uncapped 2025 with another solid quarter of commercial execution, with fourth quarter total revenue of 3% year over year, driven by double-digit net sales growth for three of our leading products. Compared to the fourth quarter of last year, global net product sales for Dupixent, as reported by Sanofi, increased by 32%, and Libtyo by 13% at constant exchange rates, while ILEA-HD in the United States grew by 66%. Global Dupixent net sales were $4.9 billion in the fourth quarter and $17.8 billion for the full year 2025. Dupixent is currently the most widely used innovative branded antibody medicine with more than 1.4 million patients on therapy globally. now approved in eight indications, most of which remain significantly underpenetrated, Dupixent is well-positioned for future growth. Global Libtyo net product sales were $425 billion in the fourth quarter and $1.45 billion for the full year 2025. In the U.S., Libtyo continues to be the market-leading immunotherapy for advanced non-melanoma skin cancer. Following FDA and EC approvals of Liptio for adjuvant CSCC in the fourth quarter, we are making great progress launching this potential blockbuster opportunity, with this indication expected to be a significant growth driver for Liptio in 2026 and beyond. Liptio also continues to build, share, and advance non-small cell lung cancer, where in the U.S. it is now the second most prescribed immunotherapy in the first-line setting, with new patient market share in this setting greater than Optivo, Tecentric, and Infinsi combined. ILEA HD net product sales in the United States were $506 million in the fourth quarter, up 66%, and $1.6 billion for the full year 2025, up 36%. Despite continued patient co-pay, affordability issues that have dampened branded anti-VEGF category growth. In November, the FDA approved ILEA-HD for macular edema following retrovane occlusion, or RVO, and monthly dosing across all approved indications, further strengthening the ILEA-HD compelling profile. Our FDA submission seeking approval of the ILEA-HD pre-filled syringe Using a new manufacturer has been accepted for review. A standard pre-licensing inspection has been scheduled, and a decision on our filing is expected in late April. In addition, as a backup, Catalan Indiana continues to work with the FDA to resolve findings from a previous inspection. We continue to believe that all three of these product enhancements are key to fully unlocking ILEA's HD commercial potential. While we anticipate continued growth in ilea HD this year, ilea 2 mg will continue to be under competitive pressure, which is expected to intensify the second half of 2026 as multiple biosimilar products are launched in the United States. Regarding patient affordability, we are pleased that we matched a $60 million donation to the Good Days Retinal Vascular and Neovascular Disease Fund in the fourth quarter. Today, we reiterated our commitment to helping patients afford their medicines by extending our matching program through the end of this year up to $200 million. Turning now to our negotiations with the United States government regarding efforts to reduce drug costs for American patients. We are actively engaging in constructive discussions with the Center for Medicare and Medicaid Services and other federal agencies and we anticipate reaching an agreement that aligns with the frameworks previously established by other companies. We remain optimistic about striking a deal with the administration to achieve our shared goals, ensuring timely and affordable access to groundbreaking medical advancements for American patients, maintaining the United States' leadership in biotechnology, innovation, and manufacturing, and addressing the longstanding imbalance in the distribution of costs for medical innovation, which has historically placed a disproportionate burden on American patients. Finally, looking ahead to the next 12 months, Regeneron has several key objectives that I'd like to share. First, we anticipate at least four FDA approvals, including three for new molecular entities across three distinct modalities, plus approval for the Atelier HD pre-filled syringe. as well as several additional regulatory submissions. We expect registration-enabling data from multiple programs, including pheanilamab, RLAC3 antibody, in combination with Liptio in advanced melanoma, as well as a combination of Cervicerine and Pizelumab in PNH. In addition to the ongoing treatment studies in key areas, such as myeloma, anticoagulation, and complement-mediated diseases, 2026 will be an important clinical development execution year, as we anticipate initiating 18 additional Phase III studies with cumulative target enrollment of approximately 35,000 patients over multiple years, setting the foundation for Regeneron's next wave of potential blockbuster products. We also plan to begin clinical development of at least three first-in-class antibodies that address novel targets, of which two were discovered and validated by the General Genetic Center, as well as our long-acting IL-13 antibody in atopic dermatitis. We expect strong commercial execution to continue, maximizing the potential of our leading brands across key therapeutic areas. And finally, we plan to continue prudently deploying capital through share repurchases, and complementary business development, all with the goal of driving long-term shareholder value. Obviously, a busy and ambitious year ahead, one that I'm particularly energized and excited to embark upon. We look forward to reporting our programs on these goals as we move through the year. With that, I'll turn the call over to George.

Thanks, Len. Earlier this month at the J.P. Morgan Conference, we highlighted the breadth and depth of our pipeline, which is expected to generate clinical data over the next few years spanning oncology, hematology, complement-mediated diseases, anticoagulation, and obesity, as well as in other areas. In 2026, we plan to build on our established leadership in ophthalmology as well as immunology and inflammation while advancing key late-stage programs. Starting with ophthalmology, ILEA-HD was recently approved by the FDA for monthly dosing and for the treatment of RVO, further strengthening its clinical profile. Data supporting these approvals will be presented at the upcoming antigenesis meeting, further highlighting the efficacy, safety, and durability of ILEA-HD, along with dosing flexibility designed to support more personalized patient care. In terms of our ophthalmology pipeline, for our C5 program, For geographic accuracy, we expect interim data from our Phase III study in the second half of 2026. We are currently evaluating our C5 SRNA simdicerine as monotherapy and also with pososalimab, our potentially best-in-class C5 antibody, with the goal of providing a systemic treatment that avoids safety issues from repeated intravitreal injections associated with currently approved GA therapies. In case intravitreal delivery is required to adequately treat this disease, we've also begun clinical development of an intravitreal formulation of FogelMav to evaluate local C5 inhibition for appropriate patients. Beyond GA and ophthalmology, we have initiated a study of a novel intravitrally delivered two-cell receptor blocking antibody for non-infectious uveitis, a disease generally driven by autoimmune T cells. This advance was made possible by our unique antibody capabilities as we are not aware of any other company that's been able to generate such an antibody. This year, we also plan to initiate clinical development for a long-acting antibody targeting a novel genetically validated target for glaucoma, along with a long-acting antibody that aims to treat thyroid eye disease and Graves' disease. Moving to immunology and inflammation, we are committed to strengthening our leadership by advancing several next-generation therapeutic approaches. As we first revealed at the J.P. Morgan Conference, In addition to exploring longer dosing intervals for 2-Pixen, we are progressing velocity-derived, fully human, long-acting antibodies with enhanced binding properties that target the IL-4 receptor alpha, the same target as 2-Pixen, as well as antibodies targeting IL-13, IL-4, and a bispecific antibody targeting both IL-4 and IL-13. All of these approaches are designed to enable extended dosing on long-acting IL-13 antibodies is expected to enter the clinic in the coming months, embarking on an expedited development plan in atopic dermatitis that we believe will enable us to remain competitive to other industry players that are pursuing related approaches. Our other long-acting antibodies are expected to enter the clinic by 2027, each with a custom development plan. At the same time, our Regeneron Genetic Center has utilized its large-scale genetics approaches to identify several exciting new immunology and inflammation targets. Similar to the picture, we believe these may represent future pipeline and product opportunities. The first of these antibodies is expected to enter clinical development in the first half of this year. After initially evaluating healthy volunteers, we plan to rapidly advance this candidate to establish proven concepts in several genetically linked diseases, such as lupus, Sjogren's, and primary biliary cholangitis. Turning now to Allison. Our initial cat and birch phase three study demonstrated that allergen-specific monoclonal antibody cocktails can meaningfully address ocular endpoints, adding to earlier data that showed significant reductions in nasal, respiratory, and skin endpoints. These phase three data from the cat and birch programs will be presented at the upcoming Quad AI conference. We anticipate initiating the confirmatory phase three study for cat allergy in the first half of the year, while the confirmatory phase three study for birch allergy already underway. We are also advancing an innovative strategy with the goal of eliminating all IgE-mediated allergies. Our initial clinical effort is in patients suffering from severe food allergies involving transient lithocytic treatment followed by long-term dupixent maintenance. This approach demonstrated proof of principles with the first four treated patients all achieving over 90% sustained IgE reduction. These results validate our approach of first removing IgE-producing plasma cells and then preventing their return. Building on this, we are developing next-generation agents specifically targeting IgE-producing cells with the first expected to enter clinical development over the next year for potentially more rapid and broader allergy applications. On to oncology as the analyte. Our lag-free antibody combination with the child. Our pivotal study in first-line metastatic melanoma remains on track to read out in the first half of this year. Early clinical data from our first acute study across multiple advanced melanoma cohorts suggested a potentially differentiated and best-in-class profile. Also in the first half of this year, we're expecting an interim analysis for our study in adjuvant melanoma, as well as phase 2 data in advanced non-small cell lung cancer, a more speculative setting in which clinical validation has not yet been established for LAG3 and PD-1 combinations. Moving to hemo, linazific, or BCMA by C3 bispecific, is establishing a new benchmark in multiple myeloma. In late lung disease, and with the caveat of cross-trial comparisons, linazific has demonstrated nearly double the complete response rate compared to other BCMA by C3 bispecifics at similar follow-up times, with lower rates of cytokine release syndrome, shorter hospitalization requirements, and more convenient dosing intervals. Building on its remarkable monotherapy activity across multiple lines of therapy, we are undertaking an ambitious development plan to simplify the existing myeloma treatment paradigm, which currently relies on highly complex, intense, and burdensome triple and quad drug combinations by exploring lithotropic monotherapy as well as in simple combinations in early night settings. In our phase two study in newly diagnosed multiple myeloma, All nine invaluable patients treated with linozivic monotherapy at the planned phase 3 dose achieved MRT negativity, an endpoint the FDA recently endorsed as a registrational enabling for this malignant disease. Even more compelling are the early signals in myeloma precursor and related settings. For example, in invaluable patients with high-risk smoldering myeloma, linozivic once again achieved 100% MRT negative in all 12 invaluable patients. whereas the standard of care, daratumumab, achieved less than 10% in complete response. Similarly, in second-line patients with light chain amyloidosis, linovibic monotherapy normalized abnormal light chain levels in approximately two weeks, whereas in a separate study, a daratumumab containing quad combo regimen took approximately five months to approach these levels in first-line patients. Both of these promising results could herald market advances to existing standard of care, which can involve complex and toxic multi-drug combinations. With four pivotal studies underway and four more initiating by the middle of this year, we are rapidly advancing our relativistic development program with the hopes of transforming the myeloma treatment paradigm and ultimately preventing progression to malignant disease. On to complement-mediated diseases. Our C5 program consists of customized approaches to treat different diseases, which require different levels of targeted inhibition to maximize efficacy for each condition. I previously summarized above our C5 efforts in geographic attributes. You know, our pivotal study for generalized myosinographic tests, we showed that condition alone achieved differentiated efficacy and convenience with every three-month subcutaneous dosing delivering a potentially best-in-class profile. with a placebo-adjusted improvement in the myasthenia grafts activities of daily living score of 2.3 endpoints at 24 weeks, the primary endpoints of the study, and the best results among C5 inhibitors to date based on cross-trial comparisons. We remain on track to submit our U.S. regulatory application in the first quarter with potential approval anticipated later this year or early next year. In paroxysmal nocturnal hemoglobinuria, or PNH, where our phase three lead-in data showed the combination of cindycin and rizomab was necessary to achieve potentially best-in-class disease control, with 96% of patients controlled in the pivotal trial lead-in cohort, and with the ability to rapidly rescue patients previously treated with rizomab who had not been well-controlled. These results once again have the potential to deliver a best-in-class profile with pivotal data expected late this year or early next year, positioning this combination of C5 complement inhibitors as a new standard of care for PNH. Moving to anticoagulation, clot prevention remains a critical unmet need since less than half of eligible patients receive anticoagulant therapy, primarily due to concerns about their bleeding risk. To address this, we are developing two complementary Factor XI antibodies, one optimized for maximal antibiotic activity and the other designed to further reduce bleeding risk, enabling a tailored approach based on individual patients' benefit-risk profile. Initial clinical data support this strategy, showing impressive efficacy and a favorable bleeding profile compared to current standards of care. Pivotal studies are already underway in prevention of post-surgical venous thromboembolism, or VTE, with pivotal studies in cancer-associated VTE prevention, catheter-associated thrombosis, drug prevention in patients with atrial fibrillation, and peripheral artery disease, all expected to initiate this year. Moving to obesity, we continue to pursue a differentiated strategy that includes oligorepotide, our in-licensed GLP-GIP agonist entering pivotal monotherapy studies in 2021, as well as a co-formulation of oligorepotide with praluin, our antibody to PCSK9. Since current GLP agonists do not meaningfully lower LDL cholesterol, this co-formulated combination is designed to treat the large population of people living with obesity who also suffer from hyperlipidemia with a single, convenient, and similarly affordable once-weekly subcutaneous injection analogous to the currently approved GLPs. Moreover, imagine if someone had invented a new GLP that, in addition to delivering profound weight loss, could also lower bad cholesterol by 50% to 60%. It would create an important and differentiated opportunity for the many obese patients simultaneously suffering from hyperlipidemia with elevated cardiovascular risk. Our clinical program for this novel combination that we believe can deliver these same dual benefits is expected to begin later this year. Before I turn the call over to Mary, I would like to quickly address a couple of additional developments in our pipeline. In rare diseases, our DVO gene therapy continues to produce transformative outcomes with meaningful hearing gain in 11 of the 12 treated children born with profound genetic deficits. This program was selected as the first new molecular entity to receive the FDA Commissioner's National Priority Voucher designation. and we are awaiting a regulatory decision in the first half of this year. In fibrodysplasia osseous cancer progresiva, or FOP, a debilitating disease in which the soft tissues of the body are progressively replaced with abnormal bone, our Gartosumab program demonstrated a more than 99% reduction in abnormal bone formation at 56 weeks, an unprecedented result, and we are awaiting a regulatory decision from the U.S. and EU in the second half of this year. Our commitment and dedication to these types of rare diseases, particularly those that affect children, not only speak to the heart and solar regenerative, but have also proven to pave the way for broader opportunities in the future, as we would hope would be the case here. In summary, our scientific and clinical momentum continues to accelerate across the R&D enterprise with multiple pivotal readouts regulatory milestones, and first-in-class programs advancing in 2026. I have never been more excited about the breadth, depth, and potential impact of our pipeline. With that, let me turn it over to Mia.