These companies use the creative forces of capitalism to solve big problems—and do well by doing good.

Regeneron studies the root causes of diseases and identifies new therapies for rare and ultrarare conditions at its genetics center. For example, the company has been studying conditions such as fibrodysplasia ossificans progressiva (FOP), a disabling disease that transforms muscles, ligaments, and other tissue into bone, and is conducting late-stage trials of a FOP treatment. Regeneron is also testing a novel approach to treating lipodystrophy, a rare disorder that leads to low levels of body fat and its abnormal distribution, plus reduced leptin levels, disrupting metabolism.

Change the World

With a combined revenue of $21 trillion and $2.1 trillion in profits, the 2026 Fortune 500 is the definitive list of America's largest companies.

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GPTW New York Large 2022-Regeneron Pharmaceuticals Inc

Employees say: 
 
“When I joined as a temp, I was made to feel a full member of the team, my suggestions and opinions were appreciated. I also love the willingness by the company to adapt and progress and to provide flexible working arrangements post-COVID. The extra freedom provided by flexible working arrangements has changed the way I view working a 9-5 and has made this company really stand out in a great way.” 
 
Read the Great Place to Work review .

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Employees say: 
 
“The culture and energy of the people in Regeneron make it a great place to work. I am proud of our science and ethics. Each employee makes a difference in patients' lives and that is what is truly important. It fuels me to be the best.”

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100-best-companies-2021-51-Regeneron

Regeneron’s anti-coronavirus cocktail REGEN-COV was provisionally approved in November 2020 to treat COVID-19 symptoms, and may also reduce its spread. But to develop the important therapy, the biotechnology and pharmaceuticals firm had to keep its own researchers and other staff safe as one of the first U.S. hotspots exploded just miles from its Tarrytown, N.Y., headquarters. The company sent nonessential workers home while implementing safety measures in its research labs. By spring of 2020 Regeneron was providing regular COVID testing for employees, and indefinite paid leave for those infected to recover and quarantine. The firm donated coronavirus-testing components to its home state, with hundreds of staff voluntarily working overtime and weekends to produce them. Regeneron also rolled out a new five-year responsibility strategy organized around stakeholders, including new diversity and inclusion measures after the summer’s wave of protests against anti-Black police brutality. Says one employee: “As an African American male, it’s nice to know that I work for a company that really puts its money where its mouth is regarding making changes in underserved communities.”

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The biotechnology company produces medicines and treatments for allergic and inflammatory diseases, eye diseases, cancers, and more. Regeneron became a household name in 2020 when the U.S. government granted it a $450 million federal contract to develop an antibody drug to treat COVID-19. Former U.S. President Donald Trump reportedly received the treatment while hospitalized with the illness in October 2020.

Our 2020 list of the 100 best companies as ranked by their employees. See which companies made the list.

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F500-2020-405-Regeneron

The biopharmaceutical company develops and manufactures medicines designed to treat a range of illnesses, including asthma, chronic pain, cancer, and infectious diseases. In the latter category, Regeneron is deeply involved in the pursuit of treatments for COVID-19.

As we face unprecedented collective challenges, cooperation has become a business superpower.

08.CTW20.Regeneron

The world has battled Ebola since 1976, but only late last year did it get therapies that should meaningfully reduce the virus’s death toll. In a randomized clinical trial conducted during an outbreak in Africa, one such drug—Regeneron’s antibody cocktail, EB3—proved so clearly effective in reducing mortality that the trial was ended early. Regeneron is now racing to develop a comparable cocktail for COVID-19.

Collectively, the ranked companies produced a three-year average shareholder return of 19%, vs. 11% for the S&P 500.

Fastest Growing Companies 2020 90. Regeneron

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We surveyed tens of thousands of young employees to create this list of millennials’ favorite workplaces.

F500 2018-Regeneron Pharmaceuticals

Employees say: 
 
&nbsp; 
 
"Regeneron is all about innovation. Whether it is in our scientific endeavors, employee recognition programs, or seasonal celebrations we are always finding new and exciting ways to do things." 
 
&nbsp; 
 
"The thing I love most about working at Regeneron is that when they say data is king, they mean it. Our work and projects are always changing based on what the data shows us. This allows us to work as equals with senior management. When you are presenting or discussing projects, it doesn't matter your role— if you have a good idea, and good data to support it, then you are taken seriously. This removes a lot of the bureaucracy and politicking that happens in other companies." 
 
&nbsp;

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Wal-Mart stayed on top as its sales crept closer to half-a-trillion dollars. Apple moved into the top five. And UnitedHealth Group continued its steady climb. 

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Regeneron Pharmaceuticals is a major pharmaceutical company that develops and sells drugs covering areas of immunology, oncology, ophthalmology, and rare diseases. During the COVID-19 outbreak it developed a widely used monoclonal antibody treatment. Other flagship products include Eylea, an injection to treat age-related macular degeneration and other eye conditions; Dupixent, a therapy for inflammatory diseases like atopic dermatitis, asthma, and chronic rhinosinusitis; and Libtayo, for certain types of cancer. The company was incorporated in 1988.

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Regeneron Pharmaceuticals (REGN): Company Profile, Stock Price, News, Rankings

legacy

Regeneron Pharmaceuticals

regeneron pharmaceuticals

Welcome to the Regeneron Pharmaceuticals fourth quarter 2025 earnings conference call. My name is Shannon, and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Please note that this conference call is being recorded. I will now turn the call over to Ryan Crowe, Senior Vice President of Investor Relations. You may begin.

Thank you, Shannon. Good morning, good afternoon, and good evening to everyone listening around the world. Thank you for your interest in Regeneron, and welcome to our fourth quarter 2025 earnings conference call. An archive and transcript of this call will be available on the Regeneron Investor Relations website shortly after our call concludes. 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 Christopher Fenimore, 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 forecast and 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 and 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 quarterly 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. Len, take it away.

Thanks, Ryan, and thanks to everyone for joining today's call. Regeneron capped 2025 with another solid quarter of commercial execution, with fourth quarter total revenue up 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 Libtayo by 13% at constant exchange rates, while EYLEA 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 8 indications, most of which remain significantly underpenetrated, Dupixent is well positioned for future growth.

Global net Libtayo net product sales were $425 billion in the fourth quarter and $1.45 billion for the full year 2025. In the U.S., Libtayo continues to be the market-leading immunotherapy for advanced non-melanoma skin cancers. Following FDA and EC approvals of Libtayo 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 Libtayo in 2026 and beyond. Libtayo also continues to build share in advanced 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 Opdivo, Tecentriq, and Imfinzi combined.

EYLEA next, EYLEA 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 copay affordability issues that have dampened branded anti-VEGF category growth. In November, the FDA approved EYLEA HD for macular edema following retinal vein occlusion, or RVO, and monthly dosing across all approved indications, further strengthening the EYLEA HD competitive profile. Our FDA submission, seeking approval of the EYLEA HD prefilled syringe using a new manufacturer, has been accepted for review. A standard pre-licensing inspection has been scheduled, and the decision on our filing is expected in late April. In addition, as a backup, Catalent in 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 EYLEA HD's commercial potential. While we anticipate continued growth in EYLEA HD this year, EYLEA 2 mg will continue to be under competitive pressure, which is expected to intensify in 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 Centers for Medicare & 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 long-standing 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 EYLEA HD prefilled syringe, as well as several additional regulatory submissions.

We expect registration-enabling data for multiple programs, including fianlimab, our LAG-3 antibody, in combination with Libtayo and advanced melanoma, as well as a combination of cemdisiran and pozelimab in PNH. In addition to the ongoing clinical 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 Regeneron Genetics 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.

Finally, we plan to continue prudently deploying capital to share repurchases, dividends, 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 and 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, EYLEA 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 Angiogenesis meeting, further highlighting the efficacy, safety, and durability of EYLEA HD, along with dosing flexibility designed to support more personalized patient care.

In terms of our ophthalmology pipeline, for our C5 program for geographic atrophy, we expect interim data from our phase III study in the second half of 2026. We are currently evaluating our C5 siRNA, cemdisiran, as monotherapy and also with pozelimab, our potentially best-in-class C5 antibody, with the goal of providing a systemic treatment that avoids the 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 pozelimab to evaluate local C5 inhibition for appropriate patients. Beyond GA and ophthalmology, we have initiated a study of a novel intravitreally delivered T-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 Dupixent, we are progressing VelocImmune-derived, fully human, long-acting antibodies with enhanced binding properties that target the IL-4 receptor alpha, the same target as Dupixent, 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.

Our long-acting IL-13 antibody 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 as other industry players 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 Genetics Center has utilized its large-scale genetics approaches to identify several exciting new immunology and inflammation targets. Similar to Dupixent, 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 proof of concept in several genetically linked diseases such as lupus, Sjögren's, and primary biliary cholangitis. Turning now to allergy.

Our initial cat and birch phase III 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 III data from the cat and birch programs will be presented at the upcoming AAAAI conference. We anticipate initiating the confirmatory phase III study for cat allergy in the first half of the year, while the confirmatory phase III study for birch allergy is 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 linvoseltamab treatment followed by long-term Dupixent maintenance. This approach demonstrated proof of principle, with the first four treated patients all achieving over 90% sustained IgE reductions.

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 and fianlimab, our LAG-3 antibody combination with Libtayo. 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 in-human study across multiple advanced melanoma cohorts suggested a potentially differentiated investment 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 II data in advanced non-small cell lung cancer, a more speculative setting in which clinical validation has not yet been established for LAG-3 and PD-1 combinations.

Moving to linvoseltamab, our BCMA x CD3 bispecific, is establishing a new benchmark in multiple myeloma. In late-line disease, and with the caveat of cross-trial comparisons, linvoseltamab has demonstrated nearly double the complete response rate compared to other BCMA x CD3 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 linvoseltamab monotherapy as well as in simple combinations in early-line settings.

In our phase II study in newly diagnosed multiple myeloma, all nine evaluable patients treated with linvoseltamab monotherapy at the planned phase III dose achieved MRD 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 evaluable patients with high-risk smoldering myeloma, linvoseltamab once again achieved 100% MRD negative in all 12 evaluated patients, whereas the standard of care, daratumumab, achieved less than 10% complete response. Similarly, in second-line patients with light chain amyloidosis, linvoseltamab 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 linvoseltamab 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 target inhibition to maximize efficacy for each condition. I previously summarized above our C5 efforts in geographic atrophy.

In our pivotal study for generalized myasthenia gravis, we showed that cemdisiran alone achieved differentiated efficacy and convenience with every 3-month subcutaneous dosing, delivering a potentially best-in-class profile with a placebo-adjusted improvement in the myasthenia gravis activities of daily living score of 2.3 points at 24 weeks, the primary endpoint of the study, and the best result 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 III lead-in data showed the combination of cemdisiran and eculizumab 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 ravulizumab 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 antithrombotic 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 of cancer-associated VTE prevention, catheter-associated thrombosis, stroke 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 olorelapide, our in-licensed GLP-GIP agonist, entering pivotal monotherapy studies in 2026, as well as a co-formulation of olorelapide with Praluent, 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%-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 DB-OTO gene therapy continues to produce transformative outcomes, with meaningful hearing gains in 11 of the 12 treated children born with profound genetic deafness. 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 ossificans progressiva, or FOP, a debilitating disease in which the soft tissues of the body are progressively replaced with abnormal bone, our garetosmab program demonstrated a more than 99% reduction in abnormal bone formation at 56 weeks, an unprecedented result, and we are awaiting on regulatory decisions in the US 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 soul of Regeneron, 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 Mary.

Thank you, George. The fourth quarter delivered a strong finish to 2025, completing a successful year across our commercial portfolio. Our market-leading brands, Eylea, Dupixent, and Libtayo, continued to deliver sustainable growth based on their clinical profiles, as well as our ability to execute effectively in competitive markets. In 2025, we expanded use of our existing brands and successfully launched new medicines and indications across multiple therapeutic areas and geographies. We begin 2026 well-positioned to advance our portfolio and are excited by upcoming opportunities to change the lives of even more patients. Starting with our retinal franchise of Eylea HD and Eylea, which delivered combined U.S. net sales of $1.1 billion in the fourth quarter. Eylea HD net sales reached $506 million, representing 18% sequential growth.

Performance was driven by a 10% increase in physician demand compared to the third quarter, highlighting Eylea HD's strong clinical profile and commercial momentum, despite a 7% sequential decline in the overall anti-VEGF category. This fourth quarter dynamic is typical for the anti-VEGF category. For full year 2025, the category maintained approximately 5% growth versus 2024, while the innovative branded segment, which excludes Avastin and biosimilars, declined by approximately 12%. Importantly, Eylea HD represents a growing proportion of Regeneron's total anti-VEGF franchise, now contributing nearly half of total net sales. Following recent label enhancements to include monthly dosing and retinal vein occlusion, Eylea HD now has the broadest label and greatest dosing flexibility of any anti-VEGF medicine. Physicians were eagerly awaiting both label enhancements, and we are seeing positive early launch signals in our efforts to get this important medicine to even more patients.

The combination of this new dosing flexibility with Eylea HD's demonstrated durability further strengthens its position in the anti-VEGF retinal category. New real-world market data shows that on average, patients with ongoing anti-VEGF therapy who switched to Eylea HD were able to extend their treatment duration by almost 4 weeks. This underscores Eylea HD's durability profile in addition to its well-established efficacy and safety. We look forward to the potential FDA approval of our prefilled syringe, which, if approved, will provide additional convenience for retina specialists and further enhance Eylea HD's profile. While Eylea HD grew, Eylea 2 mg fourth quarter U.S. net sales declined 15% sequentially to $577 million. Together, Eylea HD and Eylea continue to lead the innovative branded anti-VEGF category. Looking ahead, we remind you of 2 separate factors that will impact early 2026.

The first quarter is typically impacted by patient reauthorizations, and as we disclosed earlier this month, wholesaler inventory levels were elevated by approximately $30 million at the end of the fourth quarter for Eylea HD as well as Eylea. We expect first quarter net sales will be negatively impacted as the inventory is absorbed. For Eylea HD, we anticipate high single-digit sequential demand growth in the first quarter, while Eylea demand is expected to decline at a double-digit rate based on competition and, importantly, ongoing conversion to Eylea HD. Turning now to Dupixent, which delivered $4.9 billion in the fourth quarter global net sales, representing 32% year-over-year growth on a constant currency basis. U.S. net sales grew 36% year-over-year to $3.7 billion, based on broad demand growth and strong performance across several ongoing launches.

Dupixent is now approved in eight type 2 inflammatory diseases and is the number one prescribed biologic among dermatologists, pulmonologists, allergists, ear, nose, and throat specialists, based on the combination of its differentiated efficacy, safety, and treatment experience. Across Dupixent's established indications, including atopic dermatitis, asthma, nasal polyps, and eosinophilic esophagitis, Dupixent continues to deliver robust demand growth, supported by strong physician preference in each of these indications. We've also seen remarkable uptake in our more recent launches, including COPD, chronic spontaneous urticaria, as well as prurigo nodularis, and with physicians regularly sharing their experiences on how Dupixent has changed the lives of their patients, many of whom previously had no approved treatment options. With many indications still significantly underpenetrated, Dupixent  continues to be well positioned to deliver near, medium, and long-term growth.

Turning to oncology and hematology, Libtayo reported $425 million in global net sales in the fourth quarter, up 13% year-over-year on a constant currency basis. In the US, net sales grew 14% year-over-year to $285 million, based on strong demand growth across all approved indications. Libtayo is the leading immunotherapy for advanced non-melanoma skin cancers, and our recent launch in adjuvant CSCC is off to a great start, including the recent addition of Libtayo in the NCCN guidelines as the only Category One preferred immunotherapy in this setting. In advanced non-small cell lung cancer, Libtayo is now the second most commonly prescribed treatment for patients receiving their first immunotherapy.

Physicians increasingly recognize Libtayo as a preferred treatment option based on clinical experience, versatility as a monotherapy in combination with chemotherapy, supported by an increasing body of robust clinical data, including recently reported five-year survival results. Briefly turning to linvoseltamab, our new treatment for relapsed refractory multiple myeloma. We are encouraged by the launch progress to date, with physicians appreciating linvoseltamab's differentiated clinical profile, less burdensome hospitalization requirements, and convenient dosing regimen. We expect adoption to continue to steadily build over time in this late-line setting, with the larger commercial opportunities in earlier lines of therapy. In summary, in the fourth quarter, we delivered strong growth across Eylea HD, Dupixent, and Libtayo, and we continued to progress several launches, including linvoseltamab. In 2026, our commercial portfolio is well positioned to capitalize on many near-term growth opportunities, enabling us to deliver more treatments to patients.

With that, I will turn the call to Chris.

Thank you, Marion. My comments today on Regeneron's financial results and outlook will be on a non-GAAP basis, unless otherwise noted. Fourth quarter 2025 total revenues of $3.9 billion grew 3% compared to the prior year, reflecting higher collaboration revenue, driven by strong global Dupixent sales growth, continued growth in net sales of EYLEA HD and Libtayo, as well as higher other revenue, partially offset by lower net sales of EYLEA 2 mg. Fourth quarter diluted net income per share was $11.44 on net income of $1.2 billion. Beginning with the Sanofi collaboration, fourth quarter total Sanofi collaboration revenues were approximately $1.6 billion, of which $1.5 billion related to our share of collaboration profits. Regeneron's share of profits grew 42% versus the prior year, primarily driven by Dupixent and improving collaboration margins.

The Sanofi development balance was just below $600 million at the end of the year, reflecting a reduction of approximately $300 million since the end of the third quarter and over $1 billion in full year 2025. Dupixent's continued strength enabled a rapid reimbursement of the development balance in 2025, which we now expect to be fully reimbursed by mid-2026. Once fully reimbursed, Sanofi collaboration revenues will reflect our full share of global profits for Dupixent and Kevzara. Moving to Bayer. Fourth quarter net sales of EYLEA and EYLEA 8 mg outside the U.S. were $817 million, inclusive of $312 million of EYLEA 8 mg sales. Total Bayer collaboration revenue was $319 million, of which $270 million related to our share of net profits outside the United States.

Other revenue, which includes profit share and royalties associated with license agreements, as well as amounts earned for contract manufacturing, grew 33% in the fourth quarter to $239 million. This included $179 million related to royalty income from Ilaris, plus our share of profits from Arcalyst. Ilaris net sales exceeded $1.5 billion in 2025, achieving the top royalty tier of 15% for the first time. Per our agreement with Novartis, escalating royalty tiers, which range from 4%-15%, are applied to cumulative net sales from the start of each calendar year. This leads to step-ups in royalty income each quarter as higher royalty tiers are applied to cumulative net sales. Now to our operating expenses.

R&D expense was $1.3 billion in the fourth quarter, reflecting continued investments to support Regeneron's innovative pipeline, including multiple late-stage opportunities. Fourth quarter SG&A was $691 million, inclusive of a matching contribution to the Good Days Retinal Vascular and Neovascular Disease Fund of approximately $60 million. Our effective tax rate in the fourth quarter was 17%. The increase in our tax rate from the prior year primarily reflects a lower tax benefit from stock-based compensation. Regeneron generated $4.1 billion in free cash flow in 2025 and ended the quarter with cash and marketable securities, less debt of $16.2 billion. We returned $3.8 billion to shareholders in 2025, primarily through $3.4 billion in share repurchases.

We continue to be opportunistic buyers of our shares, with $1.5 billion remaining authorized for repurchases as of December thirty-first. We also initiated a quarterly dividend last year, providing us with additional flexibility to return capital to shareholders. In 2025, we paid nearly $400 million in cash dividends and announced this morning that our board of directors has authorized a quarterly dividend of $0.94 per share, payable in March, equivalent to $3.76 on an annual basis. We continue to view our dividend as a way to expand the pool of potential Regeneron shareholders to include funds with a dividend mandate, while share repurchases will remain the primary means of returning capital to our shareholders. I will conclude with our financial guidance for 2026.

Consistent with what was provided at the J.P. Morgan conference a few weeks ago, we expect 2026 R&D spend to be in the range of $5.9 billion-$6.1 billion. The increase versus 2025 is driven by costs to support our expanding late-stage pipeline, including new phase III studies in oncology and hemo, our Factor XI antibodies, and our obesity program. In addition, as you heard from George, we plan on advancing several new molecules into the clinic across a number of different therapeutic areas, including ophthalmology and immunology. We expect 2026 SG&A to be in the range of $2.5 billion-$2.65 billion, reflecting investments to support the ongoing launches of Libtayo and Adjuvant CSCC and linvoseltamab and late-line multiple myeloma, as well as other potential launches, including cemdisiran and gMG.

We expect our gross margin and net product sales to be in the range of 83%-84%. This guidance reflects a changing product mix as well as cost to support expanding our bulk manufacturing capacity and fill finish capabilities. We also expect 2026 capital expenditures to be in the range of $1.1 billion-$1.3 billion, primarily related to the ongoing expansion of the R&D facilities at our Tarrytown headquarters and investments in our manufacturing network to support our growing commercial portfolio and pipeline. Finally, we expect our 2026 effective tax rate to be in the range of 13%-15%. It is important to note that our 2025 effective tax rate benefited from a favorable tax audit settlement, which reduced our 2025 ETR by 1.2 percentage points.

A full summary of our guidance can be found in our earnings press release published earlier this morning. In conclusion, Regeneron's strong performance in 2025 positions us well to continue investing in our differentiated pipeline, to deliver significant advances for patients and deploying capital to drive long-term value for shareholders. With that, I'll pass the call back to Len.

Thank you, Chris. This concludes our prepared remarks. We will now open the call for Q&A. To ensure we are able to address as many questions as possible, we will answer one question from each caller before moving on to the next. Shannon, can we please move to the first question?

Thank you. To ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Our first question comes from the line of Alexandria Hammond of Wolfe Research. Your line is now open.

Thanks for taking the question. So clearly, there's a ton of interest in the upcoming readouts for Libtayo plus fianlimab. So in metastatic melanoma and adjuvant, any update on when we could receive this data beyond first half? Should we expect to get an adjuvant interim update with the metastatic? And I guess as a follow-up, we know there are several interims for the adjuvant. So if we don't get an update on the adjuvant with the metastatic readout, when could we expect that next interim? Thank you.

Thanks, Alex. We don't really have any additional clarity right now on the timing for the advanced melanoma readout. First half is the best estimate at this time. In terms of the adjuvant timing, that's also in the first half. They may coincide, they may not. Once we have the data, we will read it out shortly thereafter. Shannon, let's move to the next question.

Our next question comes from the line of Chris Raymond with Raymond James. Your line is now open.

Yep, thank you. Just a question on Dupixent IP. I'm sure you're aware of Sanofi's commentary yesterday about taking, you know, potential for, from taking the runway out, you know, well beyond, you know, the current thinking, and I think their commentary took things out maybe to the 2040 or beyond range. I know you don't wanna give too much detail here, Len, but maybe any commentary you can provide in light of those comments yesterday. Thank you.

No, no additional comments. I thought Sanofi did a good job laying out what the realm of possibilities are.

I think we should highlight the fact that we have also a lot of exciting follow-on opportunities in this space, particularly with our collection of what we hope will prove to be the best-in-class, long-acting IL-13, IL-4, and IL-4/13 bispecifics, as well as what we call a new souped-up Dupixent molecule that is a new version of Dupixent that was naturally selected that might have even more improved properties. I think it's worth just highlighting again, because a lot of people don't realize how special Dupixent is. In terms of not only its remarkable efficacy, how when it delivers, it doesn't just help a little, it really dramatically benefits patients across these eight now approved diseases. But the thing that I think is underappreciated is its incredible safety profile. And I think that, you know, we've all seen this.

So many people are trying all sorts of other approaches to go after some of the same diseases like atopic dermatitis. We've seen data, let's say, with OX-40 and OX-40 ligands, which I think most people now realize are somewhat disappointing, not only from the efficacy side, but perhaps even most importantly, from the safety side. What people, I think, don't appreciate and understand is when we discovered Dupixent and understood this whole pathway, we realized that this was a specific pathway that was driving only allergic disease, and it was a vestigial, largely a vestigial part of the immune system that was no longer required to fight most pathogens. That's why, unlike most other immunomodulators, it doesn't suppress overall immunity.

When you suppress overall immunity with things like JAK inhibitors or things like OX-40 ligand, you suppress everything, and then you raise concerns and fears, the possibility that the general immunosuppression will now subject the patients to more infections, which is generally actually what you see. And remarkably, you know, with Dupixent, you don't see these sorts of things. So you don't see generalized increases in infections. We don't have black box warnings about infections because we're not generally suppressing the immune system. We're only suppressing the part of the immune system, which is largely vestigial and is largely aberrant activated in our modern world, for reasons we have theories about, but won't get into now, that drive allergic inflammation. So it's a very special approach, and you don't have to worry about, for example, getting Kaposi sarcoma or things like that, with treatment with Dupixent.

Thanks, George and Len. Let's move to the next question, please, Shannon.

Regeneron Pharmaceuticals (REGN) Q4 2025 Earnings Call Transcript

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