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

Regeneron studies the root causes of a broad range of diseases and identifies new therapies, including for rare and ultra-rare conditions, at its genetics center. Its research includes fibrodysplasia ossificans progressiva (FOP), a disabling disease that transforms soft tissue into bone, for which its treatment Pasatru received FDA approval in August 2026. Regeneron is also investigating treatments for lipodystrophy, a rare metabolic disorder. The company developed Inmazeb, an Ebola treatment provided at no cost to outbreak-affected countries since 2018, and donated 500 doses to the World Health Organization in response to the 2025 outbreak in the Democratic Republic of Congo.

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

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GPTW New York Large 2022-Regeneron Pharmaceuticals Inc

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

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

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

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

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

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

08.CTW20.Regeneron

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

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

Fastest Growing Companies 2020 90. Regeneron

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F500 2018-Regeneron Pharmaceuticals

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

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

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

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

legacy

Regeneron Pharmaceuticals

regeneron pharmaceuticals

Welcome to the Regeneron Pharmaceuticals First Quarter twenty twenty five Earnings Conference Call. My name is Josh, and I will be your operator for today's call. At this time, all participants are in a listen only mode. Later, we will conduct a question and answer session. Please note that this conference call is being recorded.

I will now turn the call over to Ryan Crow, Senior Vice President, Investor Relations. You may begin.

Thank you, Josh. Good morning, good afternoon and good evening to everyone listening around the world. Thank you for your interest in Regeneron and welcome to our first quarter twenty twenty five earnings conference call. An archive and transcript of this call will be available on Regeneron's Investor Relations website shortly after the call ends. Joining me on today's call are Doctor.

Leonard Schleifer, Board Co Chair, Co Founder, President and Chief Executive Officer Doctor. George Yankopoulos, Board Co Chair, Co Founder, President and Chief Scientific Officer Marion McCourt, Executive Vice President of Commercial and Chris Fenimore, Executive Vice President and Chief Financial Officer. After our prepared remarks, the remaining time will be available for Q and 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, 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 03/31/2025, which was filed with the SEC this morning. Regeneron does not undertake any obligation to update any forward looking statements, whether as a result of new information, future events or otherwise. In addition, please note that GAAP and non GAAP financial measures will be discussed on today's call. Information regarding our use of non GAAP financial measures and a reconciliation of those measures to GAAP is available in our quarterly results press release and our corporate presentation, both of which can be found on the 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, Doctor. Leonard Schleifer. Len?

Thanks, Ryan, and thanks to everyone joining today's call. For my remarks, I will review some of our key performance drivers, then briefly discuss some pipeline advances we have made this year. I will then hand the call over to George, who will provide additional insights on our pipeline. From there, Marion will review our first quarter twenty twenty five commercial performance. And finally, Chris will detail our financial results and provide an update on our 2025 financial outlook.

Let's get to it. Regeneron's performance in the first quarter was mixed with some difficult news related to our retinal franchise offset by encouraging news relating to the rest of our commercial portfolio as well as advances in our robust pipeline of differentiated clinical candidates. Beginning with EYLEA and EYLEA HD. On a macro basis, in the first quarter of twenty twenty five, the overall size of the branded anti VEGF category contracted due to an increase in the usage of low cost off label repackaged Avastin, likely driven by patient affordability issues because of a funding gap at CoPay assistance foundations. With respect to EYLEA, first quarter twenty twenty five US net sales were $736,000,000, down 39% compared to the first quarter of last year and down 38% compared to the fourth quarter of twenty twenty four.

However, physician unit demand decreased by 14% sequentially with the balance of the decline primarily attributable to lower wholesale inventory levels, which ended the quarter in the normal range. With respect to EYLEA HD in The United States, First Quarter Twenty Twenty Five sales were $3.00 $7,000,000 up 54% compared to the first quarter of last year and were essentially flat on a sequential basis. Compared to the fourth quarter of twenty twenty four, EYLEA HD physician unit demand grew by 5%, which was offset primarily by a modest wholesaler inventory drawdown. On the regulatory front, last Wednesday, we were disappointed with the FDA's decision to issue a complete response letter for our submission seeking approval for the EYLEA HD prefilled syringe. Since receiving the CRL, we have held several teleconferences with the FDA to better understand the contents of the CRL and believe the key outstanding issue relates to a question posed by the FDA to a third party component supplier.

This component supplier has expeditiously responded to FDA requests for information. The COL did not identify any issues with respect to the safety or efficacy of EYLEA HD, the usability of the device, proposed labeling, or pre approval inspection findings. We also recently announced that the FDA had accepted for Priority Review an SBLA for EYLEA HD to treat macular edema following retinal vein occlusion or RVO and for monthly dosing in approved indications following the use of a priority review voucher. We believe these product enhancements will strengthen EYLEA HD's position in the competitive anti VEGF category if approved. Moving to DUPIXENT, first quarter twenty twenty five net product sales grew 20% globally on a constant currency basis versus the first quarter of twenty twenty four, reflecting strong growth across all approved indications in all groups in all age groups I should say, and in all geographic regions.

In The US where net product sales grew 19%, Dupixent now leads in both new to brand prescription share and total prescription share across all of its approved indications, with the only exception being chronic spontaneous urticaria or CSU, which was approved by the FDA only eleven days ago. The COPD launch in The US continues to gain momentum with prescribers increasingly appreciating the role of type two inflammation in certain patients with COPD coupled with greater urgency to identify and treat eligible patients. Payers are increasingly recognizing the value that Dupixent offers and have implemented broad and favorable coverage decisions for commercial and Medicare patients. With those pieces in place, we now look to drive patient awareness of Dupixent as a new treatment option for COPD through a recently launched direct to consumer campaign. Libtayo in The US grew 21% compared to the first quarter of last year and has established itself as a cornerstone therapy for advanced non melanoma skin cancer while its share of the lung cancer market continues to increase.

In the highly competitive first line advanced non small cell lung cancer market Libtayo is now second in new to brand prescription share despite launching years after other competing therapies reflecting its differentiated clinical profile and our commercial strategy. We expect Dupixent, EYLEA HD and Libtayo to continue delivering significant growth for the foreseeable future to additional penetration in approved indications, potential future indications, potential combinations with other pipeline candidates, as well as other potential product enhancements. Now briefly moving to our pipeline, which now includes approximately 45 product candidates in clinical development. We continue to make significant investments in R and D, which have yielded notable progress across several key programs so far this year, including four regulatory approvals and nine regulatory submissions. For the remainder of 2025, we anticipate US regulatory approvals for limbuseltimab in relapsedrefractory multiple myeloma, odranextumab in late line follicular lymphoma, Lymptayo in adjuvant CSCC, Dupixent in bullous pemphigoid, as well as differentiated enhancements to the EYLEA HD US label.

We also now expect to read out pivotal or proof of concept data across programs in immunology, oncology, hematology, internal medicine, and rare diseases, programs that George will discuss in a minute. In closing, Regeneron remains in a very strong position scientifically, commercially and financially, enabling us to invest heavily in R and D and deliver scientific breakthroughs, maximize growth opportunities from our in line brands, successfully launch new products and indications, and return capital directly to shareholders through dividends and share repurchases. We look forward to providing updates on these efforts as we move through the remainder of 2025. With that, I'll turn the call over to George.

Thanks, Len. Twenty twenty five is shaping up to be an exciting year for advancing our broad and differentiated pipeline. We look forward to reporting several pivotal or proof of concept data sets from multiple programs. I'd like to briefly highlight these significant opportunities and discuss additional pipeline advancements. Starting with DUPIXENT, which continues to set a high bar across multiple type two allergic diseases.

Earlier this month, DUPIXENT was approved for the treatment of adults and adolescents with chronic spontaneous urticaria who remain uncontrolled despite antihistamine treatment. This approval marks the seventh type two allergic disease for which Dupixent has been approved by the FDA and is the first new treatment option for CSU patients in over a decade. Dupixent was also accepted for priority review for the treatment of bullous pemphigoid with a PDUFA date of June 20. Bullous pemphigoid represents yet another first in class opportunity for DUPIXENT, which is the only biologic to achieve significant improvements in disease remission and symptoms in this setting. And finally, DUPIXENT became the first ever biologic medicine to be approved for COPD in Japan, marking the forty fifth country in which the COPD indication has been approved.

We are eagerly awaiting the pivotal readout for dupicumab, our interleukin 33 antibody for COPD in former smokers regardless of eosinophil levels with data expected in the middle of twenty twenty five. In addition to COPD, we recently initiated a phase three program for adipicimab in chronic rhinosinusitis with nasal polyps, an indication with strong genetic validation. As well as a phase two study in chronic rhinosinusitis without nasal polyps. In addition, next year we are expecting proof of concept data for ipicimab in non cystic fibrosis bronchiectasis. Turning now to oncology efforts.

We recently submitted US and EU regulatory filings for Libtayo in adjuvant CSCC, where Libtayo became the first immunotherapy to show a benefit in a high risk population. In early June, these data will be presented in an oral presentation at the American Society of Clinical Oncology or ASCO annual meeting, highlighting a sixty eight percent reduction in the risk of disease recurrence or death compared to placebo with no new safety signals identified. This dataset underscores our belief that Libtayo provides a best in class foundation for combinations with our other oncology assets. And in this regard, Libtayo is being tested in combination with the enalumab, our LAG-three antibody in several solid tumor settings. In melanoma, early clinical data have suggested that this combination can provide substantial additive benefit compared to PD-one monotherapy without exacerbating safety.

An ongoing Phase three trial in first line metastatic melanoma evaluating this combination compared to KEYTRUDA monotherapy is expected to read out in the second half of this year. We reiterate that these data confirm best in class activity in melanoma, it will increase our confidence for this combination in other cancer settings. In first line advanced non small cell lung cancer, a pre planned interim analysis was conducted this month on two ongoing Phase two studies evaluating this combination. Due to limited follow-up, the Phase two portion of the studies will continue unchanged until additional data are available. The next analysis for these studies are expected in the first quarter of twenty twenty six in which a decision whether to advance to phase three will be made.

No new safety signals were observed in either study. Turning to our CD three bispecifics. The European Commission recently granted conditional marketing authorization for Linosifix or Limboselumab, our BCMA by C3 bispecific for the treatment of adult patients with relapsed refractory multiple myeloma who have received at least three prior therapies, marking Linosifix first global regulatory approval. In The US, our resubmission of the lenvosetamab BLA for relapsedrefractory multiple myeloma was accepted by the FDA with a PDUFA date of July 10. We believe lenvosetamab has the potential to be the best in class BCMA by CD3 bispecific due to its differentiated clinical profile, dosing, administration.

Our broad clinical program in earlier lines emphasizes monotherapy and limited combinations and continues to advance with the confirmatory phase three linker MM3 study in relapsed refractory multiple myeloma now fully enrolled. At ASCO, also in oral presentations, we will present initial results from the Phase onetwo LINQR MM2 trial, evaluating liboseltimab in combinations with Carfilzomab and with Bortezomab in patients with relapsed refractory multiple myeloma. Both combinations demonstrated a high rate of deep and durable responses with a safety profile consistent with the individual drugs supporting further development. For ozroniximab, our CD20xCD3 bispecific, The FDA has accepted the BLA resubmission for relapsed refractory follicular lymphoma with a PDUFA date of July 30. Ojonexumab has demonstrated potentially best in class efficacy in this late line setting and our differentiated clinical development focuses on monotherapy and limited novel combinations in earlier line and continues to advance.

Turning to hematology. We are rapidly advancing our factor 11 program, where we are investigating two different antibodies that target different factor 11 domains to create a tailored approach to anticoagulation, offering the potential for improved blood clot prevention and lower bleeding risk. We remain on track to enroll patients in pivotal studies this year, both in settings with large patient populations and longer follow-up, as well in settings with small populations and shorter follow-up that may provide a quicker path to market. Moving to our obesity efforts. Regeneron has decades of experience in muscle biology, growth factor signaling pathways, and genetics.

We are capitalizing on this expertise to position ourselves as a key player in the rapidly expanding obesity market by investigating agents that enhance GLP-one weight loss by maintaining muscle mass. Our muscle sparing phase two COURAGE study is investigating the addition of Tirvagrutinib, our GDF8 antibody to semaglutide with and without gartosumab are active in A antibody with the goal of improving the quality of weight loss. We expect to report data for the twenty six week primary endpoints including percentage of weight loss and percentage of fat loss compared to baseline in the second half of this year. At the upcoming American Diabetes Association meeting in June, we anticipate that Lilly will present phase two data from a very related program evaluating semaglutide combined with an antibody that binds to actin type two receptors, which blocks myostatin and actin signaling. The weight loss, lean mass preservation, overall metabolic profile, along with safety and tolerability will help inform next steps for our programs as well.

And finally, moving to our Regeneron genetic medicines pipeline. Our novel c5sRNA and antibody combination has demonstrated rapid, complete and uninterrupted inhibition of c5 as seen in our ongoing pivotal program in patients with paroxysmal nocturnal hemoglobinuria. These profound findings increase our confidence in seeing robust improvement in generalized myasthenia gravis, where pivotal results from an ongoing Phase three program are expected in the second half of this year. Our unique mechanism of action provides more complete c five inhibition than observed with other c five approaches that are approved in this indication, as well as the potential for more convenient subcutaneous regimens. In summary, Regeneron continues to deliver scientific firsts and drive innovation.

Our unique R and D capabilities have allowed us to build one of the most prolific pipelines in our industry, and we look forward to reporting multiple impactful readouts later this year. With that, let me turn it over to Maryann.

Thank you, George. Despite a challenging environment in the first quarter, our commercial teams are positioned to capitalize on multiple near term opportunities across the portfolio, including product enhancements and launches of both new medicines and new indications for previously approved medicines. Looking to the future, as George highlighted, our pipeline is poised to deliver the next wave of significant commercial opportunities that may provide innovative medicines to even more patients. Beginning with our first quarter results for EYLEA HD and EYLEA, combined U. S.

Net sales were 1,040,000,000.00 down 30% sequentially, primarily reflecting lower wholesaler inventory levels for both products, which declined during the quarter to the normal range, as well as continued competitive pressures. In aggregate, sequential physician unit demand for EYLEA HD and EYLEA declined by 11%. We believe there was a significant negative impact in the branded anti VEGF category due to an ongoing funding gap at not for profit patient assistance foundations that provide copay support for eligible patients with retinal diseases. Consequently, low cost, off label repackaged Avastin increased its anti VEGF category share by approximately six percentage points to 32%. Despite these challenges, EYLEA HD and EYLEA captured 41% of the anti VEGF category, maintaining market leadership.

For the first quarter, EYLEA U. S. Net sales were $736,000,000 primarily due to lower wholesaler inventory levels, lower physician demand, as well as increased competition. While we expect competitive pressures for EYLEA to persist, our focus remains on promoting the ongoing adoption of EYLEA HD, which has the potential to become the new standard of care. EYLEA HD was the only branded medicine in the anti VEGF category to maintain U.

S. Net sales quarter over quarter, achieving $3.00 $7,000,000 and growing 54% year over year. In August, we anticipate potential FDA approvals of EYLEA HD in retinal vein occlusion and for every four week dosing across all approved indications. If approved in RVO, EYLEA HD would be the first and only treatment that can be dosed up to every eight weeks, which is twice as long as any other product in the category. In addition, with the potential approval of every four week dosing, Eylea HD would offer physicians the most flexible dosing options in the category.

With these label enhancements and anticipated approval of the prefilled syringe, we expect to see an acceleration in EYLEA HD demand. And now to DUPIXENT. In the first quarter, DUPIXENT achieved global net sales of $3,700,000,000 representing a 20% year over year increase on a constant currency basis. In The U. S, net sales grew 19% to $2,600,000,000 based on robust demand across all approved indications.

In the first quarter, U. S. Net price was unfavorably impacted by the annual reset of commercial insurance deductibles and the implementation of Medicare Part D redesign. DUPIXENT continues to live up to its potential to dramatically improve patients' lives with approvals in seven indications, four of which have achieved blockbuster status globally. DUPIXENT's unique mechanism of action makes it the only medicine that addresses the underlying drivers of disease and treats multiple comorbid type two conditions.

Despite increasing competition in established indications, DUPIXENT remains the market leader. In atopic dermatitis, increased promotional spend from competitors has accelerated market growth, with DUPIXENT continuing to capture the vast majority of new patients. In asthma, DUPIXENT continues to lead all biologics, new to brand share, and is now the category leader in total prescriptions. Momentum in new indications continues to build and COPD uptake is accelerating. Most pulmonologists have extensive experience in prescribing DUPIXENT for asthma and are increasingly prescribing it for COPD.

Many have remarked on DUPIXENT's ability to reduce exacerbations, rapidly and meaningfully improve lung function, and reduce the need for oxygen therapy. With physician and patient awareness building and strong reimbursement established, the COPD launch has outperformed all other DUPIXENT indication launches in cumulative new to brand prescriptions with the exception of atopic dermatitis. Earlier this month, DUPIXENT was approved to treat patients with chronic spontaneous urticaria or CSU, where we estimate there are more than three hundred thousand patients in The U. S. With disease inadequately controlled by antihistamines.

DUPIXENT is the first new targeted treatment for CSU in over ten years, providing a new treatment for patients that previously had limited options. The launch is underway and early feedback has been favorable. Our DUPIXENT team is also preparing for potential approval in bolus pemphigoid, which would represent the fourth approval in a chronic and debilitating skin disease driven by type two inflammation. Nearly thirty thousand adults in The U. S.

Suffer from this difficult to treat condition where current care is limited to corticosteroids and immunosuppressants. These treatments have poor clinical efficacy as well as safety concerns, particularly in older patients. If approved, DUPIXENT would be the first and only targeted medicine to treat this disease. In summary, DUPIXENT is now firmly established as the standard of care across a range of Type II conditions and has substantial growth opportunities in both existing and new indications. Turning now to Libtayo.

First quarter global net sales grew 8% year over year on a constant currency basis to $285,000,000 with U. S. Net sales reaching $193,000,000 up 21%. First quarter results reflect typical seasonality dynamics and the timing of shipments and lower inventory levels. In The U.

S, demand continues to increase across both non melanoma skin cancer indications and lung cancer, and we are seeing growth in approved indications internationally. We look forward to the potential FDA approval of Libtayo for adjuvant treatment of high risk cutaneous squamous cell carcinoma, where we estimate there are approximately ten thousand patients in The U. S. Who may benefit from this treatment. Our oncology teams are excited about the potential to launch two new hematology products later this year, lembasalteumab in relapsedrefractory multiple myeloma and odronextumab in relapsedrefractory follicular lymphoma.

Both have demonstrated best in class clinical profiles in these later line settings. In summary, our commercial portfolio is well positioned to capitalize on many near term growth opportunities, enabling us to deliver more treatments to more patients. With that, I'll turn the call 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. First quarter twenty twenty five total revenues were $3,000,000,000 inclusive of higher Sanofi collaboration revenue, driven by Dupixent growth and higher U. S. Net sales of EYLEA HD compared to the prior year.

First quarter diluted net income per share was $8.22 on net income of $928,000,000 Beginning with collaboration revenue, revenues from the Sanofi collaboration were approximately $1,200,000,000 of which $1,000,000,000 related to our share of collaboration profits. Regeneron's share of profits grew 27% versus the prior year, driven by volume growth for DUPIXENT and higher collaboration margins. The Sanofi development balance was approximately $1,500,000,000 at the end of the first quarter, reflecting a reduction of approximately $180,000,000 from the end of twenty twenty four. Moving to buyer, first quarter net sales of EYLEA and EYLEA 8Mig outside The US were $858,000,000 up 5% versus the prior year on a constant currency basis and inclusive of 146,000,000 of EYLEA 8Mig sales. Total buyer collaboration revenue was $344,000,000 of which $317,000,000 related to our share of net profits outside The U.

S. Net or operating expenses. R and D expense was $1,200,000,000 in the first quarter. Modest growth versus the prior year was driven by continued investments to support Regeneron's innovative pipeline, including higher personnel expenses and clinical manufacturing costs. First quarter SG and A was $537,000,000 down 8% from the prior year.

The decline was driven by lower general and administrative expenses, while selling expenses were flat year over year. First quarter twenty twenty five gross margin on net product sales was 85%. The lower gross margin versus the prior year reflects higher inventory write offs in the first quarter of twenty twenty five and a change in product mix. Our effective tax rate increased versus the prior year, primarily driven by a lower benefit from stock based compensation deductions. Regeneron generated $816,000,000 in free cash flow in the first quarter and ended the quarter with cash and marketable securities of $17,600,000,000 and debt of approximately $2,700,000,000 We continue to monitor developments regarding pharmaceutical sector tariffs.

While we do not expect previously enacted tariffs to have a material impact on our business, any potential impact from sector specific tariffs is not quantifiable at this time due to uncertainty around the details of implementation. Regardless of any potential tariffs, Regeneron has always been committed to making significant investments in The United States to expand our R and D and manufacturing capabilities. We recently announced a new agreement with Fujifilm Diosynth Biotechnologies in North Carolina to invest over $3,000,000,000 to nearly double our U. S. Large scale manufacturing capacity.

This agreement, along with our $3,600,000,000 expansion of our Tarrytown, New York R and D and preclinical manufacturing facilities, our fillfinish facility in Rensselaer, New York, and the acquisition of an additional property in Saratoga Springs, New York, represent planned U. S. Investments of over $7,000,000,000 These investments will enable us to continue to grow in The U. S. And support a differentiated R and D engine while significantly increasing our ability to manufacture both clinical and commercial supply.

Beyond these investments, we continue to return capital to shareholders in the first quarter, both through share repurchases and the payment of our recently initiated quarterly dividend. We repurchased approximately $1,100,000,000 worth of our shares in the first quarter, with approximately $3,900,000,000 remaining available for share repurchases as of March 31. We continue to see share repurchases as an efficient use of capital and remain opportunistic buyers of our shares. In addition to share repurchases, our newly initiated dividend program allows us increased flexibility return capital to shareholders. We paid our first quarterly dividend last month, and the Board of Directors has declared the next dividend of $0.88 per share, which will be paid in June.

Finally, we have updated our 2025 gross margin guidance to be in the range of 86% to 87%. This change is primarily driven by higher than expected inventory write offs in the first quarter. A full summary of our latest guidance can be found in our press release issued earlier this morning. In conclusion, Regeneron's strong financial position will allow us to continue to invest in our differentiated R and D capabilities and pipeline to deliver new medicines to patients and long term value to 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 and 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. Josh, can we go to the first question, please?

Thank you. Our first question comes from Tyler Van Buren with TD Cowen. You may proceed.

Hey, guys. Good morning. Thanks very much for the question. Regarding the EYLEA HDCRL for the prefilled syringe, can you elaborate further on the question posed by the FDA and perhaps more importantly, the situation to the original EYLEA HDCRL as that speed to resolution was very quick, about two and half months, if I'm not mistaken, which would still be ahead of the RVO and every four week dosing PDUFA in August.

Right. Tyler, thanks for the call. It's Jaime speaking. I think you have to understand a little bit of detail on the processes and what happens in that when you reviewing, when the FDA is reviewing your submission for an approval of a new device, we don't necessarily make all the components. And in this case, we don't make all the components.

You might be buying a stopper from somebody, some glass from somebody else, a needle from somebody else and so forth. And we have the design and then we have an assembly. When the FDA has questions about one of the components, that's what's referred to as a drug master file. They go to the holder of that drug master file. Let's say it's somebody who makes one of the components, the FDA has a question, well, do you guys do this?

And then the hold of the master file responds to the FDA. By rule, we are not party to that up and back between the FDA and the third party component supplier. The reason we're not parties because most of the time these questions relate to general practices where in which the supplier is not only supplying Regeneron, they might be supplying 20 other pharmaceutical companies, which is in fact the case in some of these DMFs we're dealing with here. So that's the general tone of things. The questions get asked in this particular case, based on our phone calls after we received the CRL last Wednesday, we realized that nobody had gotten these questions until the day of the CRL or a day before, after the CRL.

In any case, on our conversations with the FDA, we believe that there's one key issue that is left to resolve. There are a few other minor ones, which I think were just clarifications, but the one key issue relates to a supplier and the supplier has told us that the FDA asked for some data. They have all the data, they expeditiously supplied it. Now, of course, we don't know the data because we can't be involved by rule in that process. We take it, not word that they think that they have satisfied the agency.

Of course, the FDA has to review this. That could be up and back. You said this, well, we really wanted that, maybe have more of this and so forth. So that leads to a little bit of uncertainty on how fast this could all get resolved. We do have commitments from the FDA that they will move expeditiously as well.

Regeneron Pharmaceuticals (REGN) Q1 2025 Earnings Call Transcript

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