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.

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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.” 
 
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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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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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F500-2021-354-Regeneron Pharmaceuticals

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.

This year's Fortune 500 marks the 66th running of the list.

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 third 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 is being recorded. I will now turn the call over to Ryan Crowe, Senior Vice President, 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 third 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 Chris Fenimore, Executive Vice President and Chief Financial Officer. After our prepared remarks, the remaining time will be available for Q&A. I would like to remind you that 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 of different materiality 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 U.S. Securities and Exchange Commission, including its Form 10-Q for the quarter ended September 30, 2025, which was filed with the SEC this morning. 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 corporate presentation, both of which can be found on the 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.

Thanks, Ryan. Thanks to everyone for joining today's call. For my remarks today, I will summarize our third quarter top-line performance, provide an update on EYLEA HD regulatory matters, briefly discuss our recent pipeline progress, and close with some comments regarding our discussions with the U.S. government to lower drug costs for American patients while preserving innovation. I'll then hand the call over to George, who will provide more details on our pipeline progress. From there, Marion will review our commercial performance, and finally, Chris will detail our financial results and guidance. Regeneron delivered a solid third quarter, driven by double-digit net sales growth for three of our leading products. Compared to the third quarter of last year, worldwide net product sales for Dupixent increased by 26% and LIBTAYO by 24% at constant exchange rates, while EYLEA HD in the U.S. grew by 10%.

Regeneron had Dupixent global net sales for the third quarter of 2024 with $4.9 billion, as recorded by Sanofi, with strong growth continuing across approved indications in geographic regions. In the U.S., Dupixent net product sales grew 28% compared to the third quarter of last year, while maintaining its leadership position in both new-to-brand prescription share and total prescription share across all indications approved prior to this year. Dupixent has now proved the U.S. to treat eight distinct diseases driven by underlying type 2 inflammation, including diseases of the skin, gut, and respiratory system, spanning age groups from infants to the elderly, and with more than 1.3 million patients globally being actively treated. Dupixent is one of the most widely used biologic medicines. Dupixent's approved indications could potentially address more than 4 million patients in the U.S.

alone, positioning it to remain a strong growth driver over the near, medium, and long term. Global LIBTAYO net product sales were $365 million, up 24% on a constant currency basis compared to the third quarter of last year. In the U.S., net product sales grew 12%, where LIBTAYO continues to be the market-leading immunotherapy for advanced non-melanoma skin cancers, while building share in lung cancer. Earlier this month, the FDA approved LIBTAYO in high-risk adjuvant cutaneous squamous cell carcinoma, making LIBTAYO the first and only PD-1 antibody indicated for this setting. While it only has been a few weeks since approval, our launch is already off to a great start, and we look forward to treating the up to 10,000 addressable patients in the U.S. who could benefit from this medicine. Moving to EYLEA and EYLEA HD, affordability issues continue to dampen branded anti-VEGF category growth.

As announced in June, we initiated a matching program for up to $200 million in contributions to the Good Days Retinal Vascular and Neovascular Disease Fund, but I am disappointed to report that the match in the third quarter was under $1 million due to lack of donations from other potential contributors. We remain committed to matching future donations to this fund through the end of the year. Despite affordability headwinds, EYLEA HD had a strong performance in the third quarter, with U.S. net product sales reaching $431 million, an all-time high, driven by robust physician unit demand growth, partially offset by a lower net price. We continue to believe that future product enhancements, such as a four-week dosing interval, the inclusion of macular edema-filing retinal vein occlusion, or RVO, and a prefilled syringe administration are needed to fully unlock EYLEA HD's commercial potential.

Earlier this month, we were notified by Catalent Indiana LLC, an affiliate of Novo Nordisk, that the FDA classified their facility as Official Action Indicated, or OAI, and to date, the issues identified during the July, 2025 inspection have not been completely resolved. On that basis, the FDA issued a complete response letter yesterday for the prefilled syringe supplemental BLA, with the sole approvability issue relating to unresolved inspection findings at Catalent. We continue to execute on our previously announced plan to submit an application to add an alternate prefilled syringe filler by January 2026, which would trigger a four-month FDA review. We have also been diligently working with an alternate vial filler and have already submitted an application to include them in the EYLEA HD BLA with a PDUFA date in late December.

This would provide an additional opportunity for the FDA to approve the sBLA for every four-week dosing and RVO, given we believe there are no other outstanding review issues for this application. Moving briefly to our pipeline, which George will soon discuss in more detail, we continue to make significant investments in R&D that have yielded notable progress across several key programs. In just the past three months, we have announced positive Phase III, or registration-enabling data, for six distinct programs spanning immunology, neurology, allergy, and rare diseases. Over the next several months, we look forward to rapidly expanding pivotal programs in hematology-oncology, thrombosis, obesity, and other metabolic diseases, as well as allergies, all of which we believe represent an impressive next wave of innovative medicines discovered or developed by Regeneron. Finally, I'd like to take a moment to address our ongoing progress toward reaching an agreement with the U.S.

government to help lower the cost of medicines for American patients. We are having constructive discussions with the administration, and I'm pleased to share that our priorities are closely aligned. Both Regeneron and the administration are deeply committed to ensuring that American patients have timely and affordable access to groundbreaking medical breakthroughs. We likewise share the goal of preserving the United States' position as a global leader in biotech innovation and manufacturing. For more than a decade, George and I have argued that foreign governments have benefited from American innovation without sharing the burden of its cost. We are hopeful the efforts of this administration can level the playing field and convince high-GDP nations to contribute their fair share rather than relying on the United States to shoulder the vast majority of this responsibility.

By addressing this imbalance, we can ensure a more equitable global system that supports continued advancements in medicine while improving affordability for U.S. patients. Furthermore, we agree that investing in U.S. manufacturing is not only vital for creating jobs and strengthening our economy, but for safeguarding national security. In fact, in testimony before Congress in 2014, Regeneron highlighted the importance of prioritizing biotech manufacturing and innovation in the United States. Regeneron has already made significant commitments in this area, including our plans to invest over $7 billion in infrastructure and manufacturing facilities in New York and North Carolina over the coming years. We remain optimistic about finding common ground with the administration that strikes the right balance between achieving our shared priorities while advancing Regeneron's mission of harnessing the power of science to deliver life-changing medicine to patients.

In closing, Regenerons' business continues to perform well with impressive commercial execution, driving strong financial results in the third quarter. Our pipeline is poised to deliver scientific breakthroughs that can potentially help treat millions of patients and translate into meaningful commercial opportunities. The commercial team remains focused on maximizing growth drivers from our inline brands while successfully launching new products and indications. Finally, we continue to prudently deploy capital with the goal of delivering long-term value to shareholders. With that, I'll now turn the call over to George.

Thank you, Len. Over the last few months, as Len just mentioned, we have delivered multiple important data readouts showcasing the strength of our robust pipeline and the potential to drive future growth. We have positive pivotal data for Dupixent, for our C5 program, our cat and birch allergy programs, as well as in our rare disease programs. I will also update progress in oncology, anticoagulation, and other programs. Starting with immunology and inflammation, Dupixent continues to deliver remarkable outcomes in addressing indications driven by type 2 inflammation, potentially adding to its existing approvals for eight diseases in the U.S. We are anticipating the FDA's acceptance of our submission for allergic fungal rhinosinusitis, or AFRS, in patients aged six years and older, based on positive data that we plan to present shortly. This represents yet another potential opportunity for expanding Dupixent's label.

Moving to our IL-33 antibody, itepekimab, which was studied in COPD, for which it met its primary endpoint in one of two replicate Phase III trials. We and Sanofi are contemplating another Phase III trial for itepekimab in COPD, pending feedback from regulators. Itepekimab development is also advancing in other respiratory diseases, most notably our ongoing Phase III studies in chronic rhinosinusitis with nasal polyps, where our genetic evidence is compelling. Moving to our innovative and multi-pronged allergy programs. As previously announced, our Phase III studies of our antibodies for cat allergy and for birch allergy have yielded statistically significant and clinically meaningful outcomes on primary and key secondary endpoints. These results represent the first proof of principle that targeting allergens with highly specific monoclonal antibody cocktails can achieve improvements in both ocular itch and redness.

Importantly, in prior clinical trials, our cat and birch allergy approaches have delivered impressive and durable therapeutic benefits across nasal, respiratory, and skin allergy symptoms. In the coming months, we plan to present these results at an upcoming medical meeting and initiate confirmatory Phase III studies for these programs. In the U.S. alone, these therapies could help approximately 1.6 million people suffering from severe cat allergies and approximately 1.4 million people suffering from severe birch allergies. Regarding our innovative severe food allergy program, enrollment and dosing are progressing well in our small proof of concept trial combining linvoseltamab and Dupixent. The first three patients have responded remarkably, with greater than 90% rapid reductions in the allergy-causing immunoglobulin E levels following a short course of linvoseltamab treatment, which are then maintained and continue to decrease with ongoing Dupixent maintenance.

Full enrollment of this small initial study is still expected over the next few months. Based on insights gained from the program so far, we are advancing the development of next-generation agents designed to specifically and safely deplete allergy-causing plasma cells, the first of which is expected to enter a clinical trial next year, alongside several other promising novel candidates in immunology and inflammation. Moving on to oncology and starting with LIBTAYO, which was recently FDA approved as the first and only immunotherapy for adjuvant treatment of high-risk cutaneous squamous cell carcinoma following surgery and radiation, based on the only successful clinical trial in this setting. The post-trial data showed a notable 68% reduction in risk of disease recurrence or death. This approval expands and extends LIBTAYO's leading position in non-melanoma skin cancers.

Moving to fianlimab, our LAG-3 antibody study in combination with LIBTAYO, our pivotal trial in metastatic melanoma is ongoing, with enrollment for our progression-free survival cohort completing last January, and results are now anticipated in the first half of the coming year due to slower rates of event accrual. Lynozyfic, our BCMAxCD3 bispecific, has been approved in the United States and the EU for relapsed-refractory multiple myeloma. Lynozyfic has the potential for best-in-class efficacy in the late-line setting compared to the other approved BCMAxCD3 bispecifics, with almost double the rates of complete responses as reported in the respective label. This is the basis for our enthusiasm for studying Lynozyfic in earlier lines of myeloma and even in precursor settings as a monotherapy or in limited combinations.

Consistent with this, we've recently presented promising phase two results in high-risk smoldering myeloma patients with Lynozyfic monotherapy, demonstrating a 100% objective response rate in 19 evaluable patients, with all six patients who have been followed for at least one year achieving a molecular complete response. A Phase III head-to-head study against Darzalex is planned to start in the coming months, with Darzalex having demonstrated a 9% complete response rate in this setting. In addition, we have observed rapid normalization with Lynozyfic monotherapy in previously treated light chain amyloidosis patients, including patients who had previously received and failed a Darzalex-containing combination chemotherapy. Finally, I would like to highlight that Lynozyfic has demonstrated an 83% overall response rate as a monotherapy in newly diagnosed multiple myeloma patients, with responses deepening over time. Updated results will be reported at a medical meeting later this year.

Altogether, these data give us confidence in terms of pursuing Lynozyfic as a monotherapy or in simplified combination in early lines and precursor settings of myeloma. Though I won't go into detail on undronextimab today, I want to highlight that our Phase III study evaluating undronextimab as first-line monotherapy against the standard of care in follicular lymphoma patients is fully enrolled. Similarly to Lynozyfic, undronextimab demonstrated potentially best-in-class efficacy in late-line patients, driving our enthusiasm for this approach in the earlier line settings. I'd also like to remind you that in the leading cohort for this Phase III study in first-line follicular lymphoma, undronextimab monotherapy demonstrated a 100% complete response rate, further reinforcing the potential of undronextimab in this setting. Moving on to our C5 and complement inhibitor programs.

Let me remind you that in paroxysmal nocturnal hemoglobinuria, or PNH, where de-blockade of C5 seems critical to prevent breakthrough hemolysis and potentially catastrophic events, the leading cohort for our Phase III study demonstrated that our once-monthly subcutaneous regimen, combining a C5 antibody with a C5 siRNA, may provide the best-in-class disease control with the best-in-class convenience. For PNH patients, we have also just initiated our first in human study of our siRNA targeting complement Factor B, primarily intended for the 20%-30% of patients who remain anemic despite optimal C5 therapy due to so-called extravascular hemolysis. Moving on to our C5 program in generalized myasthenia gravis, in the third quarter, we announced positive Phase III results for our C5 siRNA, cemdisiran.

This siRNA, conveniently dosed subcutaneously every three months, shows statistically significant results for the primary endpoint, improvement in the MGADL score compared to placebo, and numerically better results compared to other C5-inhibitor therapies in cross-trial comparisons. The convenience advantage for patients currently being treated with regular intravenous infusions, together with its efficacy and safety profile, positions cemdisiran as a potential best-in-class treatment option for this debilitating neuromuscular disorder. We are planning on submitting a U.S. regulatory application for cemdisiran monotherapy in the first quarter of 2026, pending FDA discussions with global submissions to follow. Finally, for our C5 program, in terms of our efforts in ophthalmology, we are hoping to complete enrollment in the first quarter of 2026 for the leading cohort of our first Phase III study in geographic atrophy, with initial results expected by the end of 2026.

Additionally, in ophthalmology, I'd like to note that we are initiating a clinical trial in active non-infectious uveitis of an intravitreally delivered CD3 monoclonal antibody, which is designed to locally block autoimmune T cell activity in the eye, marking the first in a new series of novel ophthalmology targets that we will be progressing to the clinic over the next year. Turning to our anticoagulation efforts, and in particular to our Factor XI program involving two different antibodies designed to tailor anticoagulation therapy for each individual patient's needs, pivotal studies in postoperative venous thromboembolism following total knee replacement surgery are in progress, with data anticipated in 2027. Pivotal studies in other anticoagulation indications are set to launch in the coming months.

On November 10th, we will kick off a new investor event series called the Regeneron Roundtable, which will spotlight our various innovative pipeline programs, starting with our Factor XI story, in which we will provide, for the first time, exciting new clinical data in trials exploring the Factor XI antibodies in catheter-associated thrombosis in a provoked subclinical GI bleeding study. Upcoming Regeneron Roundtables will spotlight our opportunities in hematologic and solid tumor oncology, obesity, and other areas. Moving to our growing siRNA portfolio coming out of our research collaboration with Alnylam, I'd like to highlight our ongoing clinical studies, including our pNPLA3 and CIDEB siRNAs in MASH, our SOD and HTT siRNAs in amyotrophic lateral sclerosis and Huntington's disease. In addition, we plan to begin clinical trials for our alpha-synuclein siRNA for Parkinson's disease and our MAPTau siRNA for Alzheimer's in the coming months.

Finally, I'd like to highlight our commitment to developing innovative new approaches in the ultra-rare disease space. In the third quarter, we announced unprecedented clinical benefit using garetosmab in our Phase III OPTIMA trial in fibrodysplasia ossificans progressiva, or FOP. Individuals suffering from this tragic genetic disorder progressively replace their muscle and soft tissue with abnormal bone formation, encasing themselves in a horrific osseous cage. Remarkably, in the OPTIMA trial, we were able to demonstrate a greater than 99% reduction in abnormal bone formation at 56 weeks, offering great hope for this ultra-rare genetic disorder. Regeneron plans a U.S. regulatory submission by the end of 2025. We are also providing new hope for children suffering from another ultra-rare genetic disorder, in which the absence of the OTOF gene results in profound genetic hearing loss.

As we recently described in the New England Journal of Medicine, our novel gene therapy approach provided meaningful hearing gains in 11/12 treated children, with several achieving normal hearing levels. The FDA recently announced that this program was the first new molecular entity selected for a Commissioner's National Priority Voucher, and we are finalizing preparations for a U.S. regulatory submission this year. This program highlights Regeneron's commitment to advancing the leading edge of biotechnology. In summary, Regeneron has delivered a quarter filled with positive clinical readouts, advancing our pipeline and reinforcing our leadership in scientific innovation, from groundbreaking advances addressing some of the most common medical conditions to transformative innovations in the ultra-rare disease space. With that, let me turn it over to Marion.

Thanks, George. Our third quarter performance highlights the strength of Regeneron's commercial portfolio. Today's results demonstrate our ability to drive growth of inline brands and to accelerate launch opportunities, delivering our transformative medicines to even more patients. Beginning with EYLEA HD and EYLEA, total combined third quarter U.S. net sales were $1.11 billion, comparable on a sequential basis, as a decrease in EYLEA net sales was offset by an increase in EYLEA HD net sales. EYLEA HD net sales grew 10% quarter-over-quarter to $431 million, again growing faster than any other innovative medicine in the category. EYLEA HD unit demand grew 18% quarter-over-quarter, which was partially offset by ongoing competitive pricing pressures within the category. As EYLEA HD grew, EYLEA's third quarter U.S.

net sales decreased 10% quarter-over-quarter to $681 million, reflecting a commensurate decline in unit demand driven by the ongoing conversion to EYLEA HD, patient affordability issues, and competitive dynamics. We expect a similar demand decline in the fourth quarter for EYLEA, along with ongoing pricing pressure. Together, EYLEA HD and EYLEA lead the branded anti-VEGF category based on best-in-class efficacy, safety, and with EYLEA HD durability. EYLEA HD now represents approximately 40% of Regeneron's U.S. retina franchise. Looking ahead to the fourth quarter for EYLEA HD, we anticipate sequential demand growth to moderate to high single digits as we await label enhancements. Once approved, we believe these enhancements have the potential to generate a significant positive inflection in demand. Now to Dupixent. Third quarter worldwide net sales reached $4.9 billion, growing 26% on a constant currency basis compared to the prior year.

In the U.S., Dupixent's net sales reached $3.6 billion, reflecting 28% year-over-year growth. Dupixent leads the market across all established indications, including atopic dermatitis, asthma, nasal polyps, and eosinophilic esophagitis. In addition, Dupixent is the main beneficiary of competitive market growth efforts based on its proven efficacy, safety, ease of access, and ability to address unmet patient needs. Our recent launches in COPD, chronic spontaneous urticaria, and bullous pemphigoid are progressing very well. Across all launches, Dupixent's differentiated clinical profile and growing physician experience are driving strong uptake. In COPD, prescribers see Dupixent's benefits across a range of appropriate patient types, and recent market research found pulmonologists expected to substantially increase their prescribing of Dupixent over the next 12 months. Additionally, there has been rapid uptake among chronic spontaneous urticaria patients as both dermatologists and allergists embrace Dupixent.

In bullous pemphigoid, Dupixent is the first biologic medicine addressing a critical unmet need. Physicians are eager to transition elderly patients off steroid therapy, with Dupixent offering them a safer and more effective alternative. In summary, Dupixent continues to transform the lives of patients across indications, geographies, and age groups from as young as six months. There are currently more than 1.3 million patients worldwide benefiting from Dupixent for multiple type 2 diseases. Turning to oncology and hematology, in the third quarter, LIBTAYO delivered $365 million worldwide net sales, growing 24% on a constant currency basis compared with the prior year. In the U.S., LIBTAYO net sales grew 12% year-over-year to $219 million based on strong demand across all approved indications. In non-melanoma skin cancers, LIBTAYO's strong performance is based on established market leadership and ongoing category growth. We are making encouraging early progress with the U.S.

launch in adjuvant cutaneous squamous cell carcinoma, where physicians are already embracing LIBTAYO as a new treatment option. We estimate that up to 10,000 eligible patients may benefit from LIBTAYO in this setting. In lung cancer, LIBTAYO is now the second most commonly prescribed immunotherapy for newly diagnosed patients. Physicians increasingly recognize LIBTAYO as an important treatment option based on clinical experience, versatility as a monotherapy or in combination with chemotherapy, and an increasing body of clinical evidence, including recent five-year survival data. Outside the U.S., LIBTAYO sales reached $146 million, growing 47% year-over-year on a constant currency basis, supported by sustained demand and ongoing launches in international markets. Moving to our new hematology therapy, Lynozyfic, we've made strong early progress in commercializing this important bispecific for fifth-line multiple myeloma patients. Positive launch indicators include physician feedback, formulary listings, pathway inclusions, completion of REMS requirements, and payer coverage.

While we expect modest revenue contribution in this heavily pretreated population, Lynozyfic is an important therapeutic advance to the hematology community, and we look forward to additional clinical data supporting its potential use in earlier treatment settings. In summary, in the third quarter, Regeneron delivered ongoing growth across EYLEA HD, Dupixent, and LIBTAYO, and made important progress in several launches. Our commercial portfolio is well positioned to capitalize on many near-term growth opportunities, enabling us to deliver more treatments to more patients. With that, I'll 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. Third quarter 2025 total revenues of $3.8 billion grew 1% compared to the prior year, reflecting higher Sanofi collaboration revenue driven by strong Dupixent sales growth and continued growth in net sales of LIBTAYO globally and EYLEA HD in the U.S., partially offset by lower net sales of EYLEA in the U.S. and lower Bayer collaboration revenue. Third quarter diluted net income per share was $11.83 on net income of $1.3 billion. Beginning with the 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 34% versus the prior year, driven by volume growth for Dupixent and improving collaboration margins.

The Sanofi development balance was approximately $900 million at the end of the third quarter, reflecting a reduction of approximately $300 million since the end of the second quarter and approximately $730 million since the start of the year. Dupixent's continued strength has enabled a rapid reimbursement of the development balance in 2025, and we now expect this balance to be fully reimbursed by no later than the end of the third quarter of 2026. Moving to Bayer, third quarter net sales of EYLEA and EYLEA 8 mg outside the U.S. were $854 million, inclusive of $232 million of EYLEA 8 mg sales. Total Bayer collaboration revenue was $345 million, of which $312 million related to our share of net profits outside the U.S. Other revenue in the third quarter was $198 million, which included $165 million of profit share and royalties associated with license agreements.

The increase from the prior year was driven by higher royalty income from ALAS and growth in our share of profits from ARCALYST. Now to our operating expenses. R&D expense was $1.3 billion in the third quarter, reflecting continued investments to support Regeneron's innovative late-stage pipeline, including our pivotal programs for Lynozyfic and Ordspono, and earlier lines of myeloma and lymphoma, our Factor XI program in anticoagulation indications, and our ongoing efforts in other clinical programs. Third quarter SG&A was $541 million, down 12% from the prior year, primarily driven by lower charitable contributions to an independent nonprofit patient assistance foundation. Third quarter 2025 gross margin on net product sales was 86%. The lower gross margin versus the prior year reflects a changing product mix and higher ongoing investments to support our manufacturing operations.

Regeneron generated $3.2 billion in free cash flow through the first nine months of 2025 and ended the quarter with cash and marketable securities, less debt of approximately $16 billion. Through the first nine months of 2025, we have repurchased approximately $2.8 billion of our shares, the most ever allocated to open market repurchases in any full fiscal year in our history. We continue to be opportunistic buyers of our shares and anticipate returning approximately $4 billion to shareholders through dividends and repurchases in 2025. Moving to guidance for 2025, we have updated and narrowed the ranges across our financial guidance, which can be found in our press release issued earlier this morning.

Finally, as we turn to 2026, we continue to make significant progress across our innovative pipeline and anticipate advancing multiple large registrational programs in myeloma, lymphoma, anticoagulation, obesity, and other hematology and solid tumor oncology programs, as well as several new assets into the clinic. We believe investing in these programs can drive significant long-term value, and to support these efforts, we currently expect a mid-teens % increase in R&D expense in 2026 relative to 2025. We will provide details on 2026 guidance for other line items early next year. In conclusion, Regeneron's third quarter results demonstrate the ongoing strength of our business and enable us to continue investing in our differentiated pipeline to deliver significant advances for patients and drive long-term value for shareholders. With that, I'll pass the call back to Ryan.

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 to the next. Shannon, can we please go to the first question, please?

Thank you. As a reminder, 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 Akash Tewari with Jefferies. Your line is now open.

Hey, thanks so much. It seems like your team has retooled your commercial strategy on EYLEA, and it seems related to kind of price. What are you doing on a ground level when it comes to volume-based discounts that's allowing you to take share from Roche and Amgen? Are you seeing more price erosion on EYLEA, or are we also seeing that discounting on high dose? Maybe just lastly, should we continue to see volume gains and revenue gains ahead of the label enhancement potentially mid-year? Thanks so much.

I think you may have set the record for the number of questions we're not going to answer, and not because we don't want to. Marion would love to, but I think that there's so many competitive issues ongoing there in terms of our strategy on the ground, our rebates, and so forth. I'm not sure we're able to really help you out there. Marion, I don't know if you want to add anything.

I think I would just add that when we look at the EYLEA HD performance in the quarter, the favorability that we're seeing certainly is related to EYLEA HD, the product and the science. You know retina specialists see the clinical efficacy, the safety, and now durability with EYLEA HD, and that is making a big difference.

We do see that until we get these enhancements in place, we can't see a significant upswing.

Yeah. Len, if you like, I can highlight what I shared a moment ago, but just to answer the question a bit more completely, for EYLEA HD, I mentioned we anticipate sequential demand growth to moderate to high single digits as we await label enhancements. We also made a comment on EYLEA that we anticipate similar levels of demand reduction in the coming quarter. As I noted today, we saw a 10% reduction in EYLEA 2 mg, and that was in terms of the lower demand quarter-over-quarter. I hope that's helpful.

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

Our next question comes from the line of Jeffrey Meacham with Citi. Your line is now open.

Morning, guys. Thanks for the question. I guess for Chris or Len, you know I'm utilizing the balance sheet, and you guys haven't historically done larger scale BD. It seems like that's going to be the case going forward. In manufacturing, what's the appetite to further expand your plans that you've announced just so you own all elements of the, you know, of manufacturing? Obviously, that would be viewed pretty favorably by the Trump administration as well. Thank you.

Yeah, it's a great question, Jeff. Just on whether or not we would use a balance sheet for large deals, we certainly have no allergy to doing that if we saw the right opportunity. It's not a question of philosophy there. It's really a question of what would make sense where we think we could create additional value. In terms of investing further in manufacturing, as I said during our remarks, we've been talking about the need for domestic manufacturing since 2014, I think, in testimony before Congress. We mentioned the over $7 billion investment plan. I think you do highlight one piece of the whole puzzle that we do not have adequate positioning in, which is the filling. I'm pleased to say that we would expect our filling plant to come, which we've invested quite a bit in, Jeff.

It's now ready to go, and we expect it to come online during the coming year. That's a great question, and it should help us sort of control all aspects of this standard biologics manufacturing.

Okay, thanks, Len. Shannon, next question, please.

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

Thanks for taking the question. It's just maybe a question on EYLEA HD. Marion, I think I've heard you talk a lot about the importance of these label enhancements, and Len, I just heard your comment about share and how important they are. I think we've come to understand maybe the primary need here is, and the reason for these enhancements and why they're important, is for certain clinics to have dosing flexibility so they can center their inventory around one drug. Just maybe, Marion, as you've seen this market evolve, can you talk about how clinic inventory policies have evolved over time and especially how private equity in this space may be influencing this? Is this really more of a, as you're looking for share with clinics that don't necessarily have relatively aggressive inventory policies? Thanks.

Chris, my comment would be that the retina community and certainly retina KOLs look for the ability to select the right product for their patients. I'm not an expert in inventory, but I can share with you that EYLEA HD is a newer branded product in the category, two years in the market now. Certainly availability, not only inventory-wise, but payer coverage-wise. As I mentioned a moment ago, the most important characteristics of the product is this element of profound clinical efficacy, safety that people really can count on. Of course, with EYLEA HD, they're getting, for appropriate patients, the ability to have durability that is very, very important for the patients and their caretakers.

Regeneron Pharmaceuticals (REGN) Q3 2025 Earnings Call Transcript

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