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.

Fortune 500

The 300 companies on this year’s list brought in over $12.5 trillion in revenue for the latest 12 months, with the median revenue figure at $24 billion.

America's Most Innovative Companies

Almost $20 trillion in revenue—and a record-breaking $1.87 trillion in profits. Introducing the 2025 Fortune 500, the definitive list of the biggest companies in America.

Industries included in the sector are insurance and managed care, medical products and facilities, pharmacy services, and pharmaceutical companies.

Fortune Sector Leaders: Health Care

The Fortune 500, in its 70th year in 2024, ranks the biggest U.S. companies by revenue.

The Fortune 500, in its 69th year in 2023, ranks the biggest U.S. companies by revenue.

The companies on this year's list stand out for celebrating innovation, promoting cooperation, and more.

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 .

Best Large Workplaces in New York

See which workplaces made this year's list.

Great-Places-to-Work-in-Biotechnology-Large-2022-Regeneron-Pharmaceuticals-Inc_1100602-4

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.”

Best Large Workplaces in Biotechnology and Pharmaceuticals

This year’s Fortune 500 marks the 68th running of the list.

This year’s group delivered stellar revenue and profit growth, but it underperformed the broader stock market.

100 Fastest-Growing Companies

Our 2021 list of the 100 best companies to work for, as ranked by their employees. See which companies made the list.

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.”

Fortune 100 Best Companies to Work For

This year’s Fortune 500 marks the 67th running of the list.

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

Our 2019 list of the 100 best companies as ranked by their employees. See which companies made the list.

This year's Fortune 500 marks the 65th running of the list.

Our 2018 list of the 100 best companies as ranked by their employees. See which companies made the list.

This year's Fortune 500 marks the 64th running of the list.

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;

100 Best Large Workplaces for Millennials

Everybody loves an up-and-comer: 2018's top three-year performers in revenues, profits, and stock returns.

Our 2017 list of the 100 best companies as ranked by their employees. See which companies made the list.

Welcome to the inaugural Fortune Future 50, our new ranking of companies best positioned for breakout growth.

The Future 50

This year's Fortune 500 marks the 63rd running of the list.

Everybody loves an up-and-comer: 2017's top three-year performers in revenues, profits, and stock returns.

Google/Alphabet is the No. 1 place to work for the seventh time in 10 years. Six newcomers include Veterans United at No. 30, Hilton Hotels at No. 56, and Slalom Consulting at No. 100. IKEA’s U.S. arm returns to the list, along with GoDaddy and Sheetz.

This year's Fortune 500 marks the 62nd running of the list.

This year’s list marks Fortune's 18th year of partnering with Great Place to Work. Google ranks No.1 for the sixth time, and 16 new companies make impressive debuts, including Acuity (No. 3), Twitter (No. 24), and Riot Games (No. 13).

This year's Fortune 500 marks the 61st running of the list. Wal-Mart claims the top spot again. See who made the list.

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. 

Best Companies

Rank last year

Years on list

U.S. employees

U.S. job openings

Year founded

Perks

100% health coverage

Unlimited sick days

Telecommuting

Job sharing

Subsidized childcare

Compressed work weeks

Fully-paid sabbaticals

On-site fitness/subsidized gym

On-site medical care facility

Non-discrimination policy includes sexual orientation

Sick days for part-timers

College tuition reimbursement

Student loan debt repayment

Hiring/staffing (past 12 Months)

# of job applicants

Avg. # of applicants per opening

# New graduates hired

Fastest-growing Companies

Revenue 3 Yr Growth Rank

Revenue 3 Yr Annual Growth Rate

EPS 3 Yr Growth Rank

EPS 3 Yr Annual Growth Rate

Total Return 3 Yr Rank

Total Return 3 Yr Annual Rate

Beat S&P 500 3 Yr Return

Current Streak

Years on List

Sector

Company Info

Founded

Industry Vertical

U.S. Employees

Sites

HQ Location

Web Address

Date info provided (companies may opt to keep some data confidential)

Future 50

Overall Score

Industry

Website

Employees

Revenues ($M) (Past 12 Months)

Profits ($M) (Past 12 Months)

Market Value as of Oct. 9, 2019 ($M)

Best Large Workplaces In New York

City

U.S. Revenue

Total Worldwide [including U.S.] Revenue in the Latest Fiscal Year

Strongest Dimension

Previous rank

State

Key Financials (last Fiscal Year)

Revenues ($M)

Profits ($M)

Assets ($M)

Total Stockholder Equity ($M)

Profit Ratios

Profit as % of Revenues

Profits as % of Assets

Profits as % of Stockholder Equity

Earnings Per Share (last Fiscal Year)

Earnings Per Share ($)

EPS % Change (from prior fiscal year)

EPS % Change (5 year annual rate)

EPS % Change (10 year annual rate)

Total Return

Total Return to Investors (last year)

Total Return to Investors (5 year, annualized)

Total Return to Investors (10 year, annualized)

Change The World

Impact Segment

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.

Q2 2026

Q1 2026

Q4 2025

Q3 2025

Q2 2025

Q1 2025

Q4 2024

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

legacy

Regeneron Pharmaceuticals

regeneron pharmaceuticals

Welcome to the Regeneron Pharmaceuticals first quarter 2026 earnings conference call. My name is Kevin, and I'll be your operator for today's call. At this time, all participants are on a listen only mode. Later, we will conduct a question and answer session. Please note 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, Kevin. Good morning, good afternoon, and good evening to everyone listening around the world. Thank you for your interest in Regeneron, welcome to our first quarter 2026 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, Commercial; and Christopher 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 forecast and guidance, development programs and related anticipated milestones, collaborations, finances, regulatory matters, payer coverage and reimbursement, changes to drug pricing, regulations and requirements, and our drug pricing strategy, 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-Q for the quarter ended March 31st, 2026, 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 on our quarterly results press release and corporate 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.

Thanks, Ryan. Thanks to everyone for joining today's call. We were pleased with Regeneron's performance to start 2026, highlighted by strong commercial execution across our key growth products, continued pipeline progress, a disciplined approach to capital allocation, and our agreement with the U.S. government to lower drug prices for American patients while preserving innovation. Starting with the financials, we delivered double-digit growth across both revenues and earnings. Total revenues increased 19% compared to the first quarter of 2025, and non-GAAP earnings per share increased 15%, demonstrating our ability to deliver strong operating performance while continuing to invest in our science and long-term growth opportunities. Global Dupixent net sales increased 31% on a constant currency basis to $4.9 billion in the quarter.

Growth was broad-based and driven by continued strong demand across multiple approved indications and geographies, reinforcing Dupixent's position as the foundation of our immunology franchise. We also continue to advance our efforts with next-generation therapeutic approaches to strengthen our leadership position in inflammation and immunology. EYLEA HD U.S. net product sales increased 52% year-over-year to $468 million. We continue to see encouraging physician adoption of EYLEA HD, reflecting confidence in its clinical profile and dosing flexibility. We resubmitted an application seeking FDA approval for filling of the EYLEA HD prefilled syringe at Catalent, Indiana, where the FDA has recently conducted a site re-inspection. In addition, the FDA did not act by the April 2026 PDUFA date for the company's regulatory application for a second contract manufacturer for the PFS. Therefore, this application remains pending.

Regeneron and both third-party filling manufacturers are working closely with the FDA to resolve all outstanding issues. We anticipate a regulatory decision on one or both applications during this quarter. In oncology, global Libtayo net product sales grew 54% to $438 million, driven by continued uptake in advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer, as well as early contributions from the adjuvant CSCC indication, which received FDA approval in the fourth quarter of 2025. Turning briefly to our pipeline before George provides more details in his remarks, we have continued to make meaningful progress across multiple therapeutic areas so far in 2026.

Last week, we received FDA approval of Otarmeni for genetic hearing loss, marking an important milestone for patients with this ultra-rare condition. We have committed to offering this product for free. While this may seem like an unconventional decision, we believe it's the right one for Regeneron. It reflects the ethos that we live by, pushing the boundaries of science to benefit humanity. Moving to other advances in our pipeline, we presented positive phase III data for cemdisiran, our investigational siRNA that targets C5 in generalized myasthenia gravis, which demonstrated a differentiated efficacy, safety, and convenience profile relative to approved myasthenia gravis therapies. We submitted a new application utilizing a priority review voucher and anticipate an FDA decision in the fourth quarter.

In metabolic disease, we in Hansoh announced positive phase III data in China for olatorepatide, our in-licensed GLP-1 receptor agonist, with full data expected to be presented by Hansoh later this year. Dupixent achieved multiple regulatory milestones, expanding the eligible patient population to younger age groups and to new diseases. The FDA accepted our biologics license application for garetosmab and granted priority review with a decision in August, representing another important step forward for our rare disease portfolio. Briefly on capital allocation, we continue to take an approach that balances internal investment, which we believe offers the greatest long-term return for shareholders, with direct return of capital through share repurchases and dividends, as well as business development. In support of that approach, our board authorized a new $3 billion share repurchase program reflecting confidence in our business and financial position.

We also recently entered into strategic collaborations with Telix and TriNetX. Last week, we entered into a Most-Favored-Nation pricing agreement with the U.S. government, achieving our shared goals of ensuring timely and affordable access to groundbreaking medical advancements for medical patients, maintaining the U.S. leadership in biotechnology, innovation, and manufacturing, and addressing the imbalance in the distribution of cost for medical innovation, which we have long argued has placed a disproportionate burden on American patients. In closing, the progress we've made so far in 2026 reflects the strength of our science and execution and sets a solid foundation for an exciting remainder of the year. I'll turn the call over to George to discuss our R&D progress in more detail.

Thanks, Len. I'll start with our differentiated approach to treating complement-mediated diseases, which was highlighted last week at our latest Regeneron Roundtable investor event. Our core strategy is to deploy customized approaches using an siRNA, an antibody, or a combination approach, depending on the level and durability of complement inhibition required for each disease. For example, it appears that in generalized myasthenia gravis, or gMG, that partial blockade with the C5 siRNA alone delivers optimal efficacy, safety, and convenience. While in PNH, complete blockade requiring combination of the siRNA with our C5 antibody is required to optimize efficacy. For myasthenia gravis, we presented results from the phase III NIMBLE trial at the American Academy of Neurology Conference, which were also simultaneously published in The Lancet.

Cemdisiran, our investigational C5 siRNA as monotherapy, met the primary and all key secondary endpoints with subcutaneous delivery every 12 weeks, delivering a 2.3 placebo-adjusted improvement in the MG-ADL endpoint at week 24. In registrational clinical trials for the leading approved C5 inhibitors, which are administered as large volume intravenous infusions dosed every two weeks or every eight weeks, placebo-adjusted improvements in the same MG-ADL endpoints have ranged from 1.6-1.9 points at similar time points. For Cemdisiran, clinically meaningful efficacy was demonstrated by week two. These improvements deepened over in time and were sustained through week 24 with no indication of waning efficacy between doses. The totality of the data, including mostly mild to moderate adverse events, support a compelling profile for Cemdisiran as a standalone quarterly therapy for this disease.

These data have been submitted to the FDA. We expect a regulatory decision in the fourth quarter of this year. In PNH, our phase III lead-in results reinforce the requirement for the combination of cemdisiran plus pozelimab, our C5 antibody, to deliver complete and sustained disease control. Lead-in results suggest that our combination will provide best-in-class control based on LDH measures that patients who are uncontrolled on ravulizumab can largely be controlled when switched to our combination. Enrollment in the registrational enabling cohort of the phase III study is now complete. Results are expected late in the fourth quarter of this year. Additionally, in PNH, as part of our ongoing complement strategy, we recently initiated a first-in-human study evaluating siRNA that targets complement factor B.

This approach is initially intended for the 20%-30% of patients who, despite optimal C5 therapy, remain anemic due to extravascular hemolysis, but also has the potential to expand to a broader PNH population. If successful, siRNA targeting of CFB could overcome the limitations associated with current CFB inhibitors, which require daily dosing and carry the risk of catastrophic hemolysis if doses are missed. In ophthalmology, our C5 approach in geographic atrophy is on track to deliver interim data from the exploratory cohort of our phase III study in the fourth quarter of this year, which will help inform our pivotal strategy. As a reminder, we are evaluating cemdisiran, with or without pozelimab, administered systemically with the goal of slowing the growth rate of GA lesions while avoiding ocular safety issues that have been observed with certain approved intravitreal therapies.

However, to ensure that we have optionality depending on what we learn clinically, we have also recently begun clinical development of an intravitreal formulation of pozelimab, and we will also follow up with a co-formulation of pozelimab with aflibercept, since some of the patients also develop wet AMD while being treated for their GA. Turning to immunology and inflammation, and starting with Dupixent. In the U.S., Dupixent was recently approved as the first and only medicine for allergic fungal rhinosinusitis, or AFRS, in adults and children six years and older. AFRS is a specific type of chronic rhinosinusitis with nasal polyps that more often requires surgery and is associated with higher rates of postoperative recurrence.

Dupixent was also approved in the United States and Europe as the first targeted medicine for children 2-11 years of age with chronic spontaneous urticaria, expanding the eligible patient population beyond adolescents and adults. This approval reinforces the expanding role of Dupixent across diseases driven in large part by type 2 inflammation and across a broad range of ages. Regarding our efforts to develop next-generation approaches to the Dupixent pathway, we have previously disclosed that we are developing innovative, VelocImmune-derived, fully human, long-acting antibodies and bispecifics that target the IL-4 receptor itself, as does Dupi, as well as the IL-13 and IL-4 cytokines that act through this receptor. We are on track to initiate a first-in-human trial for our IL-13 antibody by the middle of this year, both in healthy volunteers and in patients with atopic dermatitis, with plans to execute an expedited path to regulatory approvals.

Beyond Dupixent lifecycle opportunities, we continue to advance our next wave of immunology and inflammation programs. Our goal is to keep exploring genetically validated targets that have the potential to become future pipeline and product opportunities. We are initiating a first-in-human study of an antibody to a target identified by the Regeneron Genetics Center as being genetically linked to several diseases, such as lupus, Sjögren's, and primary biliary cholangitis. We're also continuing to evaluate the best path forward across respiratory and sinonasal diseases for itepekimab, our interleukin-33 antibody. In chronic rhinosinusitis with nasal polyp, our phase III studies are ongoing, with results expected in 2027. Regarding COPD, we, Sanofi, and global regulators continue to discuss a potential third phase III study, though no decision has been made on whether to move forward. Turning to oncology.

On fianlimab, our LAG-3 antibody in combination with Libtayo, our phase III study in metastatic melanoma remains on track, with results expected later in the second quarter of this year. The primary analysis of progression-free survival will now consider all patients enrolled in the study with a minimum follow-up of six months. In adjuvant melanoma, the study continues following the first interim analysis, with the second interim analysis, and if necessary, a final analysis, both expected in the second half of this year. We also continue to advance pivotal studies for linvoseltamab in multiple myeloma and pre-malignant conditions and expect to have results by early 2027 from our study in multiple myeloma patients that have received at least one prior line of therapy, as well as MRD negativity results in 2028 from our study in first-line myeloma patients who are ineligible for stem cell transplant.

Our first-line study for odronextamab in first-line follicular lymphoma is fully enrolled. This is the only study exploring a bispecific as monotherapy versus the current standard of care, which is R-CHOP, across this bispecific arena. Moving to anticoagulation. We initiated additional Factor XI registrational studies in stroke prevention in patients with atrial fibrillation who are not candidates for direct oral anticoagulants, as well as cancer-associated venous thromboembolism. Additional studies in peripheral arterial disease, peripherally inserted central catheter-associated thrombosis, secondary stroke prevention, as well as SPAF and DOAC-eligible patients are all expected to commence this year. Initial registrational studies from studies in venous thromboembolism prevention following knee replacement surgery are expected in the first quarter of 2027. Turning to obesity.

In March, Hansoh reported positive phase III results for olatorepatide, our in-licensed GLP-1/GIP agonist in Chinese patients with obesity, which compared favorably cross-trial to a previous Chinese study of tirzepatide for obesity. In this randomized, double-blind, placebo-controlled trial of 604 adults across 33 sites, olatorepatide met its co-primary endpoints and delivered up to 19% mean body weight loss at week 48. We are also encouraged by the safety results, in particular the gastrointestinal tolerability profile. Hansoh is planning on presenting these promising results at a medical meeting later this year. Building on this momentum, our olatorepatide phase II study in obesity is enrolling rapidly. Later this year, we expect to initiate two global phase III programs, one in patients with obesity and another patients with obesity and type two diabetes.

In parallel, our work on the olatorepatide Praluent combination continues, with our first clinical study of weekly Praluent initiating shortly. In rare diseases, Len already mentioned the FDA approval of Otarmeni, formerly known as DB-OTO. This was an incredibly meaningful moment for the company, as it is not only our first gene therapy approval, but one of the most striking successes with gene therapy in history, restoring for this first time a sensory function in humans. As published in The New England Journal of Medicine, nearly half the children who were born profoundly deaf were able to regain hearing at normal levels within one year of treatment. The mother of one of these children recently told the President of the United States a heartwarming story of how her son was now able to hear her say that she loved him.

We decided to make Otarmeni free in the United States because we believed it was the right thing to do for these families. We hope this highlights and reminds the world that it is the biopharma industry, which is frequently viewed so negatively, that is often responsible for delivering such medical miracles to humanity. Regeneron is a different type of company that attracts the best and the brightest to join our fight against disease because we have a heart and a soul, as well as a mission and a willingness to play the long game. Another rare disease that we have been studying for many years is fibrodysplasia ossificans progressiva, or FOP, a devastating condition in which muscle and soft tissues are progressively invaded and replaced by abnormal bone formation.

The FDA has accepted for priority review the BLA for garetosmab, our activin A blocking antibody, with a PDUFA date in August of 2026. If approved, garetosmab would become the first and only available treatment shown to prevent abnormal bone formation in FOP patients. In genetic medicines, our first-in-human trials testing siRNAs targeting superoxide dismutase, or SOD1, in amyotrophic lateral sclerosis, alpha-synuclein for Parkinson's disease, and MAPT for Alzheimer's disease are enrolling patients, and our initial MASH siRNA program readings targeting CIDEB, PNPLA3, and HSD17B13 are expected by the end of this year.

Concluding with recent early-stage research updates, the Regeneron Genetics Center recently announced a collaboration with TriNetX to access de-identified electronic health record data from a global network representing 300 million patients, creating an opportunity to connect large-scale genomic and proteomic cohorts to real-world clinical data in ways that can accelerate drug discovery, translation, development, as well as providing new ways of addressing digital health issues. Regeneron also announced a strategic collaboration with Telix to co-develop and co-commercialize next-generation radiopharmaceutical therapies, combining Regeneron's antibody discovery and oncology capabilities with Telix's radiopharmaceutical development and manufacturing expertise. In summary, we remain focused on advancing our late-stage, mid-stage, and early-stage programs, as well as innovative research, which we firmly believe has the potential to continue to change the practice of medicine. With that, let me turn it over to Marion.

Thanks, George. Our first quarter results represent a strong start to 2026. Our market-leading brands, EYLEA HD, Dupixent, and Libtayo, delivered ongoing growth based on their clinical profile and our ability to execute effectively in competitive markets. 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 EYLEA HD and EYLEA, which delivered combined U.S. net sales of $942 million in the first quarter, EYLEA HD net sales were $468 million, representing 52% year-over-year growth. During the quarter, physician demand for EYLEA HD increased sequentially by 10% despite typical first quarter seasonality. Additionally, in the first quarter, wholesaler inventory levels were reduced to the normal range.

EYLEA HD now has the broadest label and greatest dosing flexibility of any anti-VEGF medicine following recent label enhancements to include retinal vein occlusion and additional dosing options that range from every four weeks through every 20 weeks. We are encouraged by physician adoption following these label enhancements. Importantly, we also look forward to the upcoming FDA decision for the EYLEA HD prefilled syringe, which, if approved, would bring what we believe is a best-in-class device to retina specialists and help drive continued uptake for EYLEA HD. In the first quarter, EYLEA's U.S. net sales were $473 million, representing a 36% year-over-year decline. This reflects ongoing conversion to EYLEA HD, competitive pressures, and patient affordability issues.

Additionally, during the first quarter, there was only a modest reduction in EYLEA inventory and continued inventory absorption is expected to negatively impact net product sales in the second quarter by approximately $20 million. Looking ahead to the second quarter, we expect to achieve sequential unit demand growth for EYLEA HD that is consistent with the 10% sequential demand growth in the first quarter. Conversely, for EYLEA, we anticipate that demand will decline in the mid-to-high teens in the second quarter ahead of the potential launch of additional biosimilars in the second half of the year, coupled with the factors that I highlighted earlier. Together, EYLEA HD and EYLEA lead the innovative branded anti-VEGF category with more than 100 million injections of EYLEA HD and EYLEA administered worldwide since launch. Additionally, in the U.S., EYLEA HD now contributes half of net sales for our retina franchise.

Turning to DUPIXENT, which continues to transform the lives of more than 1.4 million patients worldwide with type 2 inflammatory diseases that are currently on treatment. In the first quarter, DUPIXENT net sales were $4.9 billion, representing 31% year-over-year growth on a constant currency basis. U.S. net sales grew 35% year-over-year to $5.6 billion. We continue to see growth across all nine indications, including recent launches, making DUPIXENT the Number 1 biologic medicine prescribed by dermatologists, pulmonologists, allergists, and ENTs. Across the blockbuster indications of atopic dermatitis, asthma, nasal polyps, and eosinophilic esophagitis, DUPIXENT continues to drive strong growth based on its differentiated clinical efficacy, safety profile, and physicians' strong preference for this brand. Uptake is also strong across more recent launches, including chronic obstructive pulmonary disease, chronic spontaneous urticaria, bullous pemphigoid, and allergic fungal rhinosinusitis.

These launches across a growing range of age groups provide a runway for even more patients to benefit from DUPIXENT. With annualized global net sales of nearly $20 billion and significant room for further market penetration across indications, DUPIXENT is well-positioned for sustained growth over the near and long-term. Turning to LIBTAYO, which delivered $438 million in global net sales in the first quarter. In the U.S., net sales were $286 million as LIBTAYO continues its strong trajectory as the leading immunotherapy for advanced non-melanoma skin cancers. The recent launch of LIBTAYO in adjuvant CSCC is also an emerging growth driver with encouraging uptake and positive feedback on this paradigm-changing treatment. LIBTAYO is the only NCCN Category One preferred immunotherapy option for eligible adjuvant CSCC patients.

In non-small cell lung cancer, Libtayo is established as the 2nd most prescribed first-line immunotherapy treatment in the U.S. We expect continued growth through 2026 as we gain incremental share in lung cancer and drive uptake in adjuvant CSCC. Onto linvoseltamab, which is in its 2nd full quarter on the market, early launch momentum has been driven by positive physician experience, a differentiated clinical profile, lower hospitalization requirements, and convenient dosing schedule. We expect continued gradual uptake as we work to advance our clinical program in earlier lines of therapy. I also wanted to spend a moment highlighting our expanding rare disease portfolio. Evkeeza is now in its 5th year on market in the U.S. and delivered net sales of $46 million for the quarter, representing 48% growth year-over-year.

Evkeeza is well established as a leading treatment for homozygous familial hypercholesterolemia, with more than half of all diagnosed U.S. patients currently on Evkeeza or in the process of starting Evkeeza. As highlighted by Len, we are also launching Otarmeni, which is the first and only gene therapy for children born with genetic hearing loss. In addition, we look forward to the anticipated FDA decision on garetosmab in August. Garetosmab is our potential treatment for FOP and has been shown to prevent 99% of abnormal bone formation. In closing, our strong first quarter results demonstrate growth potential across our portfolio. We continue to advance our in-line brands while also preparing for multiple potential indication and new product launches, including for cemdisiran for generalized myasthenia gravis, where there is significant commercial opportunity in this large and growing market.

We remain well-positioned to deliver meaningful benefits to patients worldwide across a growing number of diseases. With that, I'll turn the call over 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. Regeneron performed well in the first quarter, highlighted by double-digit growth on both the top and bottom line. First quarter 2026 total revenues grew 19% from the prior year to $3.6 billion, driven by higher Sanofi collaboration revenue as well as strong growth in net sales of EYLEA HD in the U.S. and Libtayo globally. First quarter diluted net income per share grew 15% to $9.47 on net income of $1 billion. Beginning with the Sanofi collaboration, first quarter total Sanofi collaboration revenues were $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, driven by Dupixent sales growth and improving collaboration margins. We now expect the Sanofi development balance to be fully repaid by the end of the second quarter. As a result, we expect Sanofi collaboration revenue to step up to reflect our full share of collaboration profits starting in the third quarter. Moving to Bayer, first quarter net sales of EYLEA and EYLEA 8 mg outside the U.S. were $729 million, inclusive of $333 million of EYLEA 8 mg sales. Total Bayer collaboration revenue was $287 million, of which $240 million related to our share of net profits outside the U.S. Other revenue grew 109% in the first quarter to $171 million.

This included $101 million related to our share of profits from ARCALYST and royalty income from Ilaris. To our operating expenses. R&D expense was $1.4 billion in the first quarter, reflecting continued investments to support Regeneron's innovative pipeline, including pivotal programs across late-stage opportunities in hematology oncology, complement mediated diseases, and anticoagulation. First quarter SG&A was $560 million, reflecting investments to support the launch of Libtayo and adjuvant CSCC and to drive continued growth of EYLEA HD. First quarter matching contribution to Good Days, an independent nonprofit patient assistance foundation, were de minimis. We remain committed to matching up to $200 million in 2026 to support patient access and affordability. Non-GAAP gross margin on net product sales was 86% in the first quarter.

Our GAAP gross margin was 76%, which was negatively impacted by costs incurred due to a temporary interruption in bulk manufacturing at our Limerick, Ireland site. We have now resumed initial production in the facility and expect to resume full production by the end of the second quarter. As a result, we anticipate our GAAP gross margin will continue to be negatively impacted in the second quarter as production returns to normal levels. This interruption has not impacted and is not expected to impact the availability of any products. Regeneron generated $848 million of free cash flow in the first quarter of 2026 and ended the quarter with cash and marketable securities less debt of $15.8 billion.

We repurchased $800 million of our shares in the first quarter and announced this morning that the board of directors has authorized a new $3 billion share repurchase program. With this new authorization, we have approximately $3.4 billion available for share repurchases as of today, and we remain opportunistic buyers of our shares. We have made some minor changes to our 2026 financial guidance, including updating our GAAP gross margin guidance to be in the range of 77%-78%. This reflects actual and expected costs incurred as a result of the aforementioned temporary manufacturing interruption. A full summary of our guidance can be found in our earnings press release published earlier this morning.

In conclusion, Regeneron is off to a strong start in 2026 with financial results that position us well to continue investing in our pipeline, delivering breakthroughs for patients, and driving 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. Kevin, can we go to the first question, please?

Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star one, on your telephone.If your question has been answered or you receive yourself from the queue, please press star one. One moment for our first question. Our first question comes from Tyler Van Buren with TD Cowen. Your line is open.

Hey, guys. Good morning. Thanks for the question. Dupixent continues to be a monster, delivering strong performances quarter-after-quarter, and it now looks like it will well exceed $30 billion of global sales. Given that, we get a lot of questions from investors, not just on life cycle expansion, but the Sanofi collaboration. Can you discuss your willingness to work on life cycle expansion efforts within the Sanofi collaboration or come to an agreement on commercializing these assets together in order to take advantage of the Dupixent rebate wall and the status of that, as opposed to moving life cycle expansion candidates forward yourself and potentially further building out the commercial infrastructure?

Oh, Tyler, it's Len. Thanks for that very poignant question. Maybe it'll give me an opportunity to publicly thank Paul Hudson for all the work he did on Dupixent since 2019. Thank you, Paul. We wish you good luck in your next chapter. As of today, Sanofi's new CEO, Belén Garijo, is officially, I think, the CEO today. We want to welcome Belén and wish her luck, and we look forward to working with her and the rest of her team. Tyler, you're right. Dupixent is a remarkable product. As Marion detailed and George outlined, it's helping so many different people with millions of people with different diseases and is a financial juggernaut for the company. We are always open-minded to transactions.

Certainly leveraging what we've built in terms of both development capabilities, as well as commercial capabilities, has merit to it. We can do these things ourselves. We've had interest from many different places, to take on some of the next opportunities with us. We're open-minded, and I look forward to talking with Belén and her team, in the coming weeks and months, etc.

Thanks, Len. Let's move to the next question please, Kevin.

One moment for our next question. Our next question comes from Terence Flynn with Morgan Stanley. Your line is open.

Great. Thanks. This is Chris on for Terence. We have a question about fianlimab in metastatic melanoma. Is the PFS differentiation enough to capture majority share, or do you think you need OS as well? Thank you.

Well, it obviously depends on the results. It depends on exactly what the PFS results are. The study is also designed so that.

Substantial OS benefit, we will see that as well. The hope, of course, is that the study will show both a PFS and an OS benefit. You know, the results remain to be seen.

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

One moment. Our next question comes from Chris Raymond with Raymond James. Your line is open.

Hey, this is Stanley Chon for Chris Raymond. Just one on the EYLEA pre-filled syringe. Any commentary on why FDA missed the April PDUFA? Was that a request for more information or a backlog issue? You noted there was a re-inspection at Catalent Indiana, and you've resubmitted. Can we re-read in between the lines and assume that means the site inspection was positive? What's your overall guidance on timing for either of these applications? Thank you.

Yeah. Thanks for the question. I think we've told you what we know. If the inspection turns out to be positive, I think they will approve the drug, so we await. Both applications are pending. The only thing I can say is that based on our conversations and how hard everybody's working at this and the FDA, I think, desire to, you know, get these sites up to the standards they want, as well as get the products out there that are waiting, that we anticipate action on one or both of these during this quarter.

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

Regeneron Pharmaceuticals (REGN) Q1 2026 Earnings Call Transcript

Company Participants