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 Second Quarter 2026 Earnings Conference Call. My name is Michelle and I'll 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, Investor Relations. You may begin.

Thank you, Michelle. Good morning, good afternoon, and good evening to everyone listening around the world. Thank you for your interest in Regeneron, welcome to our second 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, co-founder, board co-chair, President, and Chief Executive Officer. Dr. George Yancopoulos, co-founder, board co-chair, President, and Chief Scientific Officer. Marion McCourt, Executive Vice President, Commercial, Chris Fenimore, Executive Vice President, Finance, and Chief Financial Officer. For our call today, Len will briefly review key second quarter performance drivers, highlight important upcoming pipeline catalysts, provide a few comments on capital allocation.

George will then detail our recent pipeline progress, followed by Marion, who will review our commercial portfolio, finally, Chris will discuss our financial results and outlook. 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, changes to drug pricing regulations and requirements, our drug pricing strategy, intellectual property, pending litigation and other proceedings, 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 June 30th, 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. 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 our corporate presentation, both of which can be found on the Regeneron Investors 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, and thanks to everyone for joining today's call. Before we begin, I would like to acknowledge with deep sadness the passing earlier this week of financial industry luminary and longtime Regeneron Director, Arthur "Art" Ryan. Art served on our board for more than two decades and was a trusted advisor whose judgment, integrity, and business insight helped guide the company through many important milestones. Prior to joining Regeneron's board, he built a distinguished career in financial services, including serving as Chairman and CEO of Prudential Financial, and previously as President and COO of Chase Manhattan Bank. In addition, Art left an enduring legacy of civic engagement and philanthropy throughout Newark and Essex County, New Jersey. On behalf of everyone at Regeneron, I want to express our gratitude for Art's many contributions and years of service.

We join his family and all who knew him in celebrating his life and legacy. We will miss his wisdom and unparalleled support of Regeneron's mission. Turning now to our business. Regeneron delivered another strong quarter, with total revenues up 17% and non-GAAP earnings per share up 11% compared to the second quarter of 2025, making our second consecutive quarter of double-digit growth on both the top and bottom lines. Dupixent, EYLEA HD, and Libtayo all set new all-time highs for quarterly net sales and are carrying strong momentum into the second half of the year. Dupixent global net product sales, as reported by Sanofi, were $6 billion, up 38% compared to the second quarter of last year on a constant currency basis. Demand trends across all approved indications remained robust and accounted for the majority of the year-over-year growth.

We and Sanofi continue to see a long runway for Dupixent growth, driven by further penetration of existing indications, expansion into additional age groups, and international growth opportunities. Beyond Dupixent, we are rapidly advancing a broad portfolio of next-generation programs that we believe can build on the foundation we've established with Dupixent. George will discuss some of our recent progress in this area, including encouraging early clinical data from our long-acting interleukin 13 antibody. Our collaboration with Sanofi spans nearly two decades and has been one of the most successful in the biopharmaceutical industry. Together, we have built a highly productive development and commercialization engine, and the continued success of Dupixent in nine FDA-approved indications across specialties ranging from dermatology, pulmonology, gastroenterology, ENT, and allergy, highlights the value that this model can create.

Given that success, I can report that we have had productive early discussions with Sanofi to identify potential opportunities for further collaboration, including for several of Regeneron's DUPIXENT follow-on programs. EYLEA HD in the U.S. continued to gain momentum with net product sales in the second quarter of nearly $600 million, up 52% compared to the prior year. Importantly, this quarter marked the first time EYLEA HD net sales exceeded EYLEA, highlighting the continued strength of the conversion to our next-generation product. Physician unit demand for EYLEA HD in the second quarter increased 24% sequentially, reflecting continued strong uptake following recent FDA label expansions and growing prescriber appreciation for EYLEA HD's differentiated profile and dosing flexibility. We continue to work towards obtaining approval for yet another product enhancement for EYLEA HD, the EYLEA HD pre-filled syringe.

We expect launch of this enhancement to drive even further adoption of EYLEA HD. We are continuing to work closely with the FDA and multiple contract manufacturers with a goal of approval before the end of the year. All in all, EYLEA HD has performed extremely well. We look forward to continuing to grow this product. LIBTAYO maintained its strong growth trajectory in the second quarter. Global net product sales reached nearly $500 million, up 29% compared to last year on a constant currency basis. Growth was driven by continued strong adoption in its approved non-melanoma skin cancer indications and further penetration in non-small cell lung cancer, where LIBTAYO now captures 20% of new-to-brand prescriptions in the U.S. Beyond its growing patient impact and commercial contribution, LIBTAYO remains the strategic backbone of our ongoing efforts to expand and strengthen our oncology portfolio.

Turning to the rest of the pipeline. I firmly believe that one of Regeneron's core strengths is that we do not rely on any single program or platform. Our pipeline is broad, diversified, and highly productive. While not every program will succeed, we are confident that it will create many substantial value for patients and shareholders. With approximately 50 active clinical programs and many rapidly advancing pre-clinical candidates, we have one of the largest R&D portfolios in the entire industry. George will have more details on our pipeline progress in his remarks. I want to highlight a few important programs where we expect near-term regulatory and clinical milestones.

We anticipate multiple milestones for our C5 complement programs, including an FDA decision in November for our new drug application for cemdisiran, an siRNA that targets C5 and generalized myasthenia gravis, which we believe has the potential to offer a differentiated profile for patients living with this serious autoimmune disease. We also continue to make meaningful progress across several longer-term value drivers, including Factor XI for coagulation disorders, linvoseltamab for multiple myeloma and pre-malignant conditions, and our obesity portfolio, where we expect multiple phase III study initiations later this year. Now to a few comments on capital allocation, where our framework remains consistent. First and foremost, we believe the highest return opportunities to continue from investing in our own science. At the same time, we remain active in evaluating external opportunities.

We're casting a wide net across the universe of business development options with particular interest in areas where we can leverage Regeneron's differentiated expertise in genetics, antibody engineering, clinical development, manufacturing, and product commercialization. While we remain disciplined on valuation and strategic fit, we believe our financial strength, scientific capabilities, operational infrastructure, and long-term perspective position us well to capitalize on compelling opportunities as they emerge. In closing, our ability to repeatedly discover, develop, and deliver important medicines has been a defining strength of Regeneron for decades. This quarter's performance, together with the important milestones ahead, reinforces our confidence in the company's long-term outlook. We have a thriving commercial business, a deep and diverse pipeline, and a talented team committed to improving patients' lives through science. Together, these trends position us well to continue delivering meaningful innovation for patients and sustainable value for our shareholders.

With that, let me turn the call over to George.

Thanks, Len. Today, I'll focus on the key updates from our development pipeline. For a comprehensive summary of our mid- and late-stage pipeline, please refer to the Programs & Clinical Development section of our 10-Q. I'll start with our complement-mediated disease franchise, beginning with cemdisiran, our C5 siRNA. Regulatory submissions for cemdisiran monotherapy in generalized myasthenia gravis, or gMG, have been accepted for review by both the FDA and the EMA. The FDA target action date is in November of this year, while a European Commission decision is anticipated in the second half of 2027. If approved, cemdisiran would represent a highly differentiated treatment option in gMG and be the first siRNA approved for this disease. We believe cemdisiran's efficacy, safety, and convenient 4x per year subcutaneous dosing profile highly differentiated from C5 antibodies and other modalities approved for gMG.

For cemdisiran in combination with pozelimab, our C5 antibody, we continue to expect registrational data in paroxysmal nocturnal hemoglobinuria, or PNH, in the fourth quarter of this year. Our phase II leading cohort that compared this combination with eculizumab, an FDA-approved antibody to C5 for the treatment of PNH, suggested that our combination could provide a more convenient monthly subcutaneous regimen that could also improve disease control based on LDL measures and support our hypothesis that complete complement blockade in this disease is required for sustained disease control. As a reminder, the registrational study is evaluating non-inferiority of our C5 combination versus eculizumab, the other C5 antibody that is FDA-approved for the treatment of PNH, using co-primary endpoints of intravascular hemolysis control, as well as transfusion avoidance.

In ophthalmology, our C5 approach in geographic atrophy, or GA, remains on track to read out 26-week data from our exploratory cohort in the fourth quarter of 2026, which will help inform our pivotal strategy. As a reminder, we are evaluating systemic administration of cemdisiran with or without pozelimab with the goal of slowing the rate of GA lesion growth and associated declines in visual acuity while avoiding the ocular safety issues that have been observed with certain FDA-approved therapies. We are also evaluating intravitreal pozelimab in GA to provide optionality and are actively developing co-formulations of this with other agents, such as eflorafib, to address comorbid retinal disease settings. In immunology and inflammation, to follow on DUPIXENT's success, we continue to advance a series of next-generation, fully human antibodies and bispecifics designed to build on DUPIXENT by extending duration, enhancing target coverage, and potentially improving efficacy.

We have enrolled the initial healthy subjects in our first-in-human trial for a long-acting IL-13 antibody and expect to begin dosing patients with atopic dermatitis later this quarter, with plans to execute an expedited path to starting registration-enabling studies, potentially by the end of next year or early 2028. Our initial clinical data indicate that this antibody has a prolonged half-life that has the potential to extend the dosing interval well beyond those achieved with currently approved products in this category. First-in-human studies of our other next-generation long-acting antibodies are planned, with next generation DUPIXENT or Super-Dupy expected to be clinic ready by early 2027 and additional candidates, including our IL-4/IL-13 bispecific, next year. Briefly onto oncology.

ubamatamab, our MUC16xCD3 bispecific, continues to demonstrate promising monotherapy activity in low-grade serous ovarian cancer, a subset of advanced ovarian cancers, and we plan to present detailed data in this setting at a medical meeting this fall. We also continue to advance pivotal studies for linvoseltamab, our BCMAxCD3 bispecific in multiple myeloma and pre-malignant conditions, including a newly initiated pivotal study in high-risk smoldering multiple myeloma. We expect results next year from the LINKER-MM3 study, our confirmatory trial of linvoseltamab monotherapy versus standard of care in patients who have received at least one but no more than four lines of therapy. In 2028, we expect minimal residual disease or MRD negativity results from our first-line study in transplant-ineligible myeloma patients, as well as our linvoseltamab carfilzomib combination study in myeloma patients who have received one or more prior lines of therapy.

At the American Society of Clinical Oncology, or the ASCO meeting, we presented first results from the phase I/II LINKER-AL2 trial of linvoseltamab monotherapy in patients with second-line plus systemic light chain or AL amyloidosis. Normalization of free light chain occurred by day 15 across all doses, and 100% of patients achieved a hematologic complete response at the highest dose tested. The majority of patients with renal or cardiac involvement demonstrated improvement in organ function despite short follow-up. The phase II portion of the study, which has registrational intent, is now ongoing. A phase III study in first-line light chain amyloidosis is planned to start early next year. Moving to anticoagulation. We are on track to initiate the remaining phase III studies from our comprehensive Factor XI program this year, featuring cenvacibart, our catalytic antibody formerly known as REGN7508, and amrecibart, our A2 antibody formerly known as REGN9933.

Pivotal results from our studies in venous thromboembolism or VTE prevention following total knee replacement surgery are expected in the first half of 2027. In 2027, we anticipate results from the phase II Roxy Atlas study, which evaluates both Factor XI antibodies against apixaban in stroke prevention in patients with atrial fibrillation or SPA, which is expected to provide us with important insights into bleeding risks after three months of observation. We have also begun enrolling patients in our phase III SPA trial, Roxy Incline, that will evaluate both of our antibodies against placebo in patients who are not candidates for conventional anticoagulant therapy. We remain excited about our program in favor of antibodies as opposed to a small molecule approach, as we believe antibodies enable greater and more specific inhibition of Factor XI, leading to improved antithrombotic activity without increased bleeding risk or other off-target safety issues.

Turning to obesity. Olatorepatide, our dual GLP-1 receptor agonist in license from Hansoh, continues to advance. Data from Hansoh's phase III study of olatorepatide in Chinese patients with obesity, which top-lined in March, will be presented as a late breaker at the European Association for the Study of Diabetes Conference or EASD in October. Acknowledging the inherent limitations of cross-trial comparisons, olatorepatide generated weight loss that was comparable to the weight loss observed in a similar study of tirzepatide in China while demonstrating a favorable gastrointestinal tolerability profile, including meaningfully lower rates of diarrhea, nausea, and vomiting. We remain on track to commence phase III studies later this year in patients with obesity as well as patients with obesity and type 2 diabetes.

In addition to the olatorepatide monotherapy program, we also continue to advance our combination of ola and PRALUENT, our PCSK9 antibody, to address patients with obesity or type 2 diabetes that have comorbid hypercholesterolemia. At EASD, we will present 52-week results from the COURAGE study, including accompanying MRI findings in a subset of patients. Adding trevogrumab to semaglutide did not drive additional weight loss, but did show encouraging skeletal muscle mass preservation versus semaglutide alone. These findings reinforce our belief that preventing muscle mass loss may become increasingly important as obesity treatment evolves, particularly in older patients with sarcopenic obesity. In rare disease, we expect an FDA decision in August for garetosmab, our activin A blocking antibody in fibrodysplasia ossificans progressiva or FOP.

If approved, garetosmab would be the first treatment shown to reduce the number of new abnormal bone formation lesions, as well as clinician-assessed flare-ups in FOP patients. From our earlier-stage pipeline, we're planning to present at medical meetings this fall some promising clinical data from our pipeline of siRNAs for metabolic dysfunction-associated steatohepatitis or MASH, and for our NPR1 antagonist antibody, baloncibart, for the treatment of postural orthostatic tachycardia syndrome or POTS. We continue to work with the U.S. government and international health organizations to deliver potential new treatments for the devastating recent Ebola virus epidemic that is driving the current outbreak in the Democratic Republic of the Congo. Regeneron-developed antibodies are now being tested in non-human primates with early data showing they can prevent mortality when it's administered even after clinical symptoms have already appeared.

We are talking with the international health organizations to see whether we will be able to once again help with the current Ebola outbreak as we have in previous outbreaks. In summary, we remain focused on rapidly advancing our broad, diverse pipeline, which we firmly believe has the potential to change the practice of medicine across many diseases with high unmet need. With that, I'll turn it over to Marion.

Thanks, George. Our second quarter results reflect strong commercial execution across our portfolio, delivering meaningful growth from our market-leading brands in multiple therapeutic categories. Starting with our retinal franchise in the second quarter, Eylea HD and Eylea delivered just over $1 billion in combined U.S. net sales, up 7% quarter-over-quarter. We also achieved an important milestone in the second quarter, with more than 100 million doses of Eylea HD and Eylea administered to patients since Eylea's launch in 2011. Second quarter Eylea HD net sales in the U.S. were $596 million, representing a 52% year-over-year increase and 27% growth quarter-over-quarter. These results reflect strong physician demand, which grew 24% from the prior quarter.

Eylea HD has the broadest label and greatest dosing flexibility of any anti-VEGF medicine following last year's label enhancements to include retinal vein occlusion and additional dosing options that range from every four weeks through to every 20 weeks. Eylea HD now comprises approximately 60% of U.S. franchise net sales compared to 34% in the second quarter of last year. Within the innovative branded category, Eylea HD and Eylea captured 57% share in the second quarter and Eylea HD was the only innovative brand that achieved quarter-over-quarter share growth. Physicians increasingly recognize Eylea HD for its efficacy, safety, and durability profile. Initial uptake of Eylea HD in RVO has been strong, driven by its differentiated label and clinical data.

Eylea HD is the only product that offers every eight-week dosing in this indication and was the only product to demonstrate numerical improvement in visual acuity in clinical studies compared to Eylea, the prior gold standard in RVO. Eylea U.S. net sales in the second quarter were $412 million, representing a 45% year-over-year decline and a 13% decline quarter-over-quarter, primarily driven by ongoing conversion to Eylea HD and competitive dynamics. Looking to the second half of 2026 for Eylea, we expect sequential quarterly demand declines in the low to mid-teens due to the factors mentioned, as well as additional competition, primarily from multiple aflibercept 2mg biosimilar launches. With an Eylea HD label that now includes wet AMD, DME, DR, and RVO, as well as the broadest dosing interval in the category, retina specialists increasingly recognize Eylea HD as the next standard of care in the anti-VEGF category.

We expect this will drive sequential demand for EYLEA HD in the low-to-mid teens in the third and fourth quarters of 2026. Turning to DUPIXENT, which continues to deliver significant benefit to patients globally. With more than 1.5 million patients actively treated worldwide, DUPIXENT has had a tremendous impact across its nine approved indications and is the number one biologic medicine prescribed by dermatologists, pulmonologists, allergists, and ENTs. Second quarter net sales were $6 billion, reflecting 38% growth on a constant currency basis. U.S. sales grew 42% year-over-year to $4.6 billion, primarily driven by continued growth across our blockbuster indications and uptake in recent launches. In addition, as reported by Sanofi this morning, a favorable gross-to-net adjustment also boosted U.S. net sales in the quarter.

DUPIXENT continues to drive strong growth across blockbuster indications, including atopic dermatitis, asthma, nasal polyps, and eosinophilic esophagitis, supported by its clinical efficacy and safety profile. Uptake is also growing on our new indications of COPD, chronic spontaneous urticaria, bullous pemphigoid, and allergic fungal sinusitis. With significant opportunity to improve the lives of even more patients, DUPIXENT is well positioned for sustained growth over the near and long term across approved indications. In the second half of the year, we expect year-over-year global net sales growth to remain strong, but to moderate relative to the first half of 2026 as we annualize recent indication launches and face stronger prior year comparisons.

Turning to LIBTAYO, which delivered worldwide net sales of $489 million, up 29% year-over-year on a constant currency basis. In the U.S., sales grew 38% year-over-year to $343 million, with growth across both non-melanoma skin cancers and non-small cell lung cancer. The recent launch in adjuvant cutaneous squamous cell carcinoma has generated positive feedback on this paradigm-changing treatment and has been accompanied by increasing use across all approved CSCC settings. In first-line non-small cell lung cancer, LIBTAYO is now firmly established as the second most prescribed immunotherapy treatment in the U.S., where LIBTAYO's share of new patient starts has doubled since early 2025 to 20% as physicians increasingly recognize its strong clinical profile. We expect continued growth for LIBTAYO in the second half of 2026 as we strive to gain incremental share in lung cancer and drive uptake across all approved stages of CSCC.

Onto LYNOZYFIC, which is now in its third full quarter on the market. Physician feedback in this late-line treatment setting is positive based on LYNOZYFIC's differentiated efficacy and safety profile, lower hospitalization requirements, and convenient dosing. Despite its strong profile, we expect LYNOZYFIC growth to remain modest in this small late-line setting as we work to advance into earlier lines of therapy. Turning to rare disease, where Regeneron is expanding our portfolio of life-changing medicines for patients with significant unmet medical need. Our homozygous familial hypercholesterolemia medicine, EVKEEZA, delivered net sales of $53 million in the second quarter, representing 29% year-over-year growth. I am also delighted to inform you that first patients have been dosed with Otarmeni, the first and only gene therapy for children born with genetic hearing loss, and our early launch efforts continue.

We are looking forward to adding garetosmab to our rare disease portfolio with a potential FDA approval in August for FOP. FOP is a serious, life-threatening disease where garetosmab would be the first treatment shown to reduce the number of new abnormal bone formation lesions, as well as clinician-assessed flare-ups in FOP patients. We are also excited about the potential FDA approval of cemdisiran in generalized myasthenia gravis later this year. We see significant opportunity in a large and growing category based on cemdisiran's clinical profile demonstrated in this pivotal study, including rapid, deep, and sustained clinical benefit, favorable safety profile, and convenient quarterly subcutaneous dosing. In closing, our second quarter results reflect focused commercial execution across therapeutic areas. We continue to drive growth for our in-line brands and are preparing for upcoming launches. We remain well-positioned to deliver meaningful benefit to patients worldwide across many different diseases.

Thank you, Marion. My comments today for Regeneron's financial results and outlook will be on a non-GAAP basis unless otherwise noted. Regeneron delivered a strong second quarter, highlighted by continued momentum across our key growth drivers and disciplined execution across the business. Second quarter total revenue increased 17% from the prior year to $4.3 billion, driven by higher Sanofi collaboration revenue, reflecting the continued strength of DUPIXENT, as well as strong growth for EYLEA HD in the U.S. and LIBTAYO globally. Second quarter diluted net income per share grew 11% to $14.29 on net income of $1.5 billion. This included a $0.99 negative impact from acquired in-process research and development expense, reflecting upfront and opt-in payments associated with collaboration and licensing agreements.

Beginning with the Sanofi collaboration, second quarter total Sanofi collaboration revenue reached an all-time high of $2.2 billion, of which $2 billion related to our share of collaboration profits. Regeneron share of profits grew 59% versus the prior year, driven by DUPIXENT growth and improving collaboration margins. We've now fully repaid the Sanofi development balance, which was approximately $3.1 billion when the Sanofi antibody collaboration agreement was amended as part of the 2022 LIBTAYO transaction. That amendment accelerated repayment of the balance, which further reduced our share of collaboration profits as it was paid down. The repayment lowered our reported Sanofi collaboration revenue by approximately $930 million in 2025 and $530 million in the first half of this year. Given full repayment of the Sanofi development balance, starting in the third quarter, we expect Sanofi collaboration revenue to step up as we record our full share of collaboration profits.

Moving to Bayer. Second quarter net sales of EYLEA 8mg and EYLEA outside the U.S. were $667 million, inclusive of $366 million of EYLEA 8mg sales. Total Bayer collaboration revenue was $276 million, of which $227 million related to our share of net profits outside the U.S. Other revenue in the second quarter increased 5% to $193 million, of which royalty income from Aclaris combined with our share of profits from Arkylas totaled $157 million, an increase of 44% versus the prior year. Now to our operating expenses. R&D expense was $1.5 billion in the second quarter, reflecting continued investment to support Regeneron's innovative pipeline, which has approximately 50 product candidates, including mid and late-stage programs across heme-onc, anticoagulation, and complement-mediated diseases.

Second quarter SG&A was $574 million, reflecting investments to support our commercial portfolio, including continued growth of EYLEA HD and LIBTAYO, as well as ongoing launch activities across our broader product portfolio. Non-GAAP gross margin on net product sales was 87% in the second quarter. Our GAAP gross margin was 78%, which, similar to the first quarter, was negatively impacted by unabsorbed manufacturing costs related to the temporary interruption in bulk manufacturing production at our Limerick, Ireland, facility. Production at this facility resumed to normal levels as of the end of the second quarter. Regeneron generated $1.4 billion of free cash flow through the first half of 2026 and ended the second quarter with $15.1 billion of cash and marketable securities net of debt. During the first half of the year, we deployed approximately $2.5 billion to share repurchases, business development, and dividends.

Within that, we repurchased $1.2 billion of our shares in the second quarter alone, bringing total repurchases to approximately $2 billion for the first half, resulting in a net reduction of 2.4 million shares outstanding since the end of 2025. As of June 30th, we had $2.5 billion of share repurchase authorization remaining, and we continue to be opportunistic buyers of our stock. Finally, we made modest refinements to our 2026 financial guidance as we enter the second half of the year. A full summary of our guidance can be found in our earnings press release published earlier this morning. In conclusion, Regeneron's strong second quarter results position us well to continue investing in our differentiated pipeline, delivering important medicines to patients, and prudently deploying capital to 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. Michelle, can we go to our first question, please?

Our first question comes from Chris Raymond with Raymond James. Your line is open.

Hey, thanks for taking my question. Just on cash management. You guys have about $18 billion on hand now with the Sanofi obligations sort of rolling off. I guess it seems that will be accelerating pretty meaningfully. Hearing what you guys have said about R&D and share repurchases and other uses of cash, even with pretty robust investment, that outlook's pretty sizable. Len, I'm wondering if you could maybe square that dynamic with some of the aversion to M&A that you've expressed in the past as a primary use of cash. Thanks.

Thanks for the question. I don't think I expressed an aversion to M&A. I think I expressed an aversion to overpaying in M&A settings. We have been involved in many of these interested transactions. We have seen people pay far more than we think the value would justify. We deploy a lot of our R&D money, and I think we'll talk more about that later in the year when Chris gives some guidelines. If you look at what we spend on R&D, both internally and externally, we're really kind of in line with what other people spend, but we tilt more towards the internal R&D

We are not allergic to any external opportunity. We look at them all. We are pretty disciplined in trying to create value with these transactions. No aversion whatsoever. We can do small, we can do large. We want them to make sense and make money for our shareholders over the long term.

Thanks, Len. Michelle, let's go to the next question, please.

Thank you. Our next question comes from Chris Scott with JPMorgan. Your line is open.

Hey, this is Taylor Henley on for Chris Scott from JPMorgan. Thanks for taking our question. We were just wondering, given some of the recent updates in the broader I & I space, can you talk a bit more about your latest thoughts on expanding the Sanofi collaboration to include additional assets? Also what steps you could take to accelerate the development of those assets? Thank you.

Right. Thanks for the question. I think as you heard from Sanofi today, they talked about the productivity of our alliance. We agree with that this has been perhaps one of the, if not the most productive alliance in the history of our industry, with DUPIXENT driving remarkable returns for both Sanofi and Regeneron. We do have some follow-on opportunities to DUPIXENT, as George mentioned in his talk, including our IL-13 long-acting antibody, which we now confirmed with some very early PK data, dupilumab, and we have several others that are related to the DUPIXENT portfolio. We have had productive early discussions. BaiLYn, the new CEO, and I have talked multiple times.

We are looking to see what might make sense and what kind of transaction might make sense for the two companies to get together on further assets, where some of those assets might be best owned in a DUPIXENT portfolio. We'll keep you posted on those discussions as they progress.

When you asked about development and expediting it, we should just remind you that we have led the most innovative development program, probably in the history of the industry, in terms of with DUPIXENT, getting it approved for nine different indications, including many of them, the first approved biologic in many of these indications. Obviously, we know this field, we created this field better than anyone else, and just as we've been very innovative with the first-in-class DUPIXENT, you can imagine that we'll be just as, if not more innovative going forward.

Thanks, Len and George. Michelle, next question, please.

Our next question comes from Tyler Van Buren with TD Cowen. Your line is open.

Great. Good morning. Congratulations on the tremendous quarterly performance. Can you provide additional details on the ongoing EYLEA HD prefilled syringe review with hopeful approval by year-end now? When you say working with multiple contract manufacturers, does that mean there is now a third CMO in the mix? If so, why did you feel the need to add another? Or is it still just the two? Is the second one most likely to receive approval by the end of the year? Thank you.

Yeah, thanks, Tyler. A lot of things have been changing at the FDA. People have been changing. Leadership has changed. We had thought that we would get some action, perhaps an approval by the end of the second quarter. That obviously didn't happen. We have now had renewed discussions. We are looking at leaving no stone unturned, multiple, and that means more than two are in the mix. We could always use backups if we succeed on one, on three, one and two and three, or three and so forth. We're doing everything we can. We've had some good conversations recently. We know what the path is. We could see this ending by the end of the year or sooner.

Regeneron Pharmaceuticals (REGN) Q2 2026 Earnings Call Transcript

Company Participants