Regeneron Pharmaceuticals Q1 2025 Earnings Call Transcript

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April 29, 2025
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Operator

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.

Operator

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

Ryan Crowe
Ryan Crowe
Senior Vice President of Investor Relations & Strategic Analysis at Regeneron Pharmaceuticals

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.

Ryan Crowe
Ryan Crowe
Senior Vice President of Investor Relations & Strategic Analysis at Regeneron Pharmaceuticals

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.

Ryan Crowe
Ryan Crowe
Senior Vice President of Investor Relations & Strategic Analysis at Regeneron Pharmaceuticals

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.

Ryan Crowe
Ryan Crowe
Senior Vice President of Investor Relations & Strategic Analysis at Regeneron Pharmaceuticals

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?

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

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.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

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.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

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.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

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.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

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.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

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.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

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.

George Yancopoulos
George Yancopoulos
Board Co-Chair, Co-Founder, President and Chief Scientific Officer at Regeneron Pharmaceuticals

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.

George Yancopoulos
George Yancopoulos
Board Co-Chair, Co-Founder, President and Chief Scientific Officer at Regeneron Pharmaceuticals

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.

George Yancopoulos
George Yancopoulos
Board Co-Chair, Co-Founder, President and Chief Scientific Officer at Regeneron Pharmaceuticals

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.

George Yancopoulos
George Yancopoulos
Board Co-Chair, Co-Founder, President and Chief Scientific Officer at Regeneron Pharmaceuticals

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.

George Yancopoulos
George Yancopoulos
Board Co-Chair, Co-Founder, President and Chief Scientific Officer at Regeneron Pharmaceuticals

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.

George Yancopoulos
George Yancopoulos
Board Co-Chair, Co-Founder, President and Chief Scientific Officer at Regeneron Pharmaceuticals

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.

George Yancopoulos
George Yancopoulos
Board Co-Chair, Co-Founder, President and Chief Scientific Officer at Regeneron Pharmaceuticals

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.

George Yancopoulos
George Yancopoulos
Board Co-Chair, Co-Founder, President and Chief Scientific Officer at Regeneron Pharmaceuticals

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.

George Yancopoulos
George Yancopoulos
Board Co-Chair, Co-Founder, President and Chief Scientific Officer at Regeneron Pharmaceuticals

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.

George Yancopoulos
George Yancopoulos
Board Co-Chair, Co-Founder, President and Chief Scientific Officer at Regeneron Pharmaceuticals

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.

George Yancopoulos
George Yancopoulos
Board Co-Chair, Co-Founder, President and Chief Scientific Officer at Regeneron Pharmaceuticals

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.

Marion McCourt
Marion McCourt
Executive Vice President of Commercial at Regeneron Pharmaceuticals

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.

Marion McCourt
Marion McCourt
Executive Vice President of Commercial at Regeneron Pharmaceuticals

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.

Marion McCourt
Marion McCourt
Executive Vice President of Commercial at Regeneron Pharmaceuticals

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.

Marion McCourt
Marion McCourt
Executive Vice President of Commercial at Regeneron Pharmaceuticals

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.

Marion McCourt
Marion McCourt
Executive Vice President of Commercial at Regeneron Pharmaceuticals

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.

Marion McCourt
Marion McCourt
Executive Vice President of Commercial at Regeneron Pharmaceuticals

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.

Marion McCourt
Marion McCourt
Executive Vice President of Commercial at Regeneron Pharmaceuticals

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.

Marion McCourt
Marion McCourt
Executive Vice President of Commercial at Regeneron Pharmaceuticals

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.

Marion McCourt
Marion McCourt
Executive Vice President of Commercial at Regeneron Pharmaceuticals

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.

Marion McCourt
Marion McCourt
Executive Vice President of Commercial at Regeneron Pharmaceuticals

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.

Marion McCourt
Marion McCourt
Executive Vice President of Commercial at Regeneron Pharmaceuticals

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.

Marion McCourt
Marion McCourt
Executive Vice President of Commercial at Regeneron Pharmaceuticals

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.

Marion McCourt
Marion McCourt
Executive Vice President of Commercial at Regeneron Pharmaceuticals

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.

Chris Fenimore
Chris Fenimore
EVP, Finance and CFO at Regeneron Pharmaceuticals

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.

Chris Fenimore
Chris Fenimore
EVP, Finance and CFO at Regeneron Pharmaceuticals

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.

Chris Fenimore
Chris Fenimore
EVP, Finance and CFO at Regeneron Pharmaceuticals

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.

Chris Fenimore
Chris Fenimore
EVP, Finance and CFO at Regeneron Pharmaceuticals

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.

Chris Fenimore
Chris Fenimore
EVP, Finance and CFO at Regeneron Pharmaceuticals

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.

Chris Fenimore
Chris Fenimore
EVP, Finance and CFO at Regeneron Pharmaceuticals

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.

Chris Fenimore
Chris Fenimore
EVP, Finance and CFO at Regeneron Pharmaceuticals

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.

Chris Fenimore
Chris Fenimore
EVP, Finance and CFO at Regeneron Pharmaceuticals

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.

Ryan Crowe
Ryan Crowe
Senior Vice President of Investor Relations & Strategic Analysis at Regeneron Pharmaceuticals

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?

Operator

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

Tyler Van Buren
Managing Director, Senior Biotech Equity Research Analyst at TD Cowen

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.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

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.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

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?

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

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.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

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.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

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.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

That doesn't mean they'll approve it, but they will review quickly the data that's submitted and have a up and back because they recognize I think the importance in advance of the prefilled syringe being a better way of administering the product than out of a vial for patients getting intravitreal injections. So boil all that down, how long can this take? It could go quickly. As you said, the last time this happened, it took a few months. It could go longer.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

We don't think there's a reinspection involved. It's not an issue related to that. So we don't think there'll be these internal long timelines for that. But we'll know more in the coming weeks or months and we will hopefully get it across the finish line in a short while. But we'll try and keep you posted once we know what the FDA is really up to.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

I'm sorry that that's a little indefinite, Tyler, but that's the nature of the process.

Ryan Crowe
Ryan Crowe
Senior Vice President of Investor Relations & Strategic Analysis at Regeneron Pharmaceuticals

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

Operator

Thank you. Our next question comes from Alexandria Hammond with Wolfe Research. You may proceed.

Alexandria Hammond
Director, Head of Therapeutics at Wolfe Research LLC

Hey, thanks for taking the question. I want to pivot a little bit, and I'm curious on the pipeline. So on your Factor XI antibodies, how do you prioritize which indications to go after, and how should we think about the timing of launches? Can you provide any follow-up to on your discussions with regulatory authorities on aligning trial design? Thank you.

George Yancopoulos
George Yancopoulos
Board Co-Chair, Co-Founder, President and Chief Scientific Officer at Regeneron Pharmaceuticals

How do we prioritize? I couldn't hear you.

George Yancopoulos
George Yancopoulos
Board Co-Chair, Co-Founder, President and Chief Scientific Officer at Regeneron Pharmaceuticals

Back to 11 indications.

George Yancopoulos
George Yancopoulos
Board Co-Chair, Co-Founder, President and Chief Scientific Officer at Regeneron Pharmaceuticals

Indications. Well, we're doing a combination of indications that are maybe

Chris Fenimore
Chris Fenimore
EVP, Finance and CFO at Regeneron Pharmaceuticals

to

George Yancopoulos
George Yancopoulos
Board Co-Chair, Co-Founder, President and Chief Scientific Officer at Regeneron Pharmaceuticals

be expected and will take a little bit longer as well as some indications that we haven't disclosed that we think we might be able to get across the finish line sooner. In terms of our approaches, what we're trying to prioritize are indications and studies where we'll be able to show the benefit not only of the anticoagulation profile, but of the differentiated bleeding risk profile of both of these antibodies. And the hope is to actually show that one or both of these antibodies have very favorable anticoagulation as well as substantially lower bleeding risks than available options for patients. So we haven't disclosed all the indications, we haven't shown the timing of them, but there's a variety of them and some of them will be coming in sooner, some of them will be taking a little bit longer, and we hope that they will be emphasizing, as I said, the potential for really addressing what's holding back a lot of patients in this field from receiving anticoagulation therapy, which is minimizing the bleeding risk that these people invariably suffer from. As we've announced, we are beginning to enroll phase three studies this year.

Ryan Crowe
Ryan Crowe
Senior Vice President of Investor Relations & Strategic Analysis at Regeneron Pharmaceuticals

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

Operator

Thank you. Our next question comes from Chris Shaw with JPMorgan. You may proceed.

Chris Schott
Chris Schott
Managing Director at JP Morgan

Great, thanks so much for the question. I just had one on EYLEA and the foundation funding. I appreciate the color on the call. But just any updated thoughts on when we could think about the foundation reopening? And how quickly once it's reopened, we could think about some of these volumes moving from the generic Avastin back to branded agents?

Chris Schott
Chris Schott
Managing Director at JP Morgan

Thanks so much.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

Chris, thanks for the question. Just for the benefit of everybody, let me just remind everybody how all this works. When you're, under commercial insurance and you're younger than 65, if you have a copay in your, insurance program, sponsors that people like Regeneron can directly to a patient supply co pay assistance in the form of a coupon, etcetera, etcetera. When a patient turns 65, and if they go on Medicare, which most of our patients getting intravitreal injections are, those patients that are responsible for a copay, typically around twenty percent if they're in plain old Medicare, it varies somewhat if they're in Medicare Advantage. Some people, many people have insurance, supplemental gap insurance, AARP, whatever you wanna call it, which covers these co pays.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

But there are still others who don't have the insurance and can't afford the co pay associated with an injection of an anti VEGF agent, for example. The government has indicated that companies can be part of the safety net, if you will, to help patients who need financial assistance. And the way this works is that companies and others can support independent charitable foundations who then assist patients with retinal disease regardless of the drug they need. The foundations take in financially eligible patients and give out the assistance that they can afford to give out on a first come first serve basis. And so there is no direct relationship.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

If we give money to a foundation, it could go to support Bavismo, it could go to support Pavlue, it could go to support Eylea, it could go to support, in fact, in these funds as they're constructed today, it could go to support the drugs for geographic atrophy. There's no connection as there shouldn't be in what we give and then how the foundations dole out the resources. We would like to help as many patients as we can. It turns out we prime was the, if not the sole, the vast supporter of these foundations in the recent history. We're talking about having giving large sums of money in the neighborhood of over $400,000,000 last year to do this charitable work.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

As our commercial outlook in the field has changed, as our resources have changed, we looked at this and said, we'd like to continue doing this, but we can't do it all ourselves. We'd like to help as many people as possible. And so we're trying to come up with a way where others and Regeneron could make sure that people in need get the drug copay support without regard to what drug they actually choose or their doctors choose. And one of the things that we've come up with is sort of a standard thing that's done. We all have seen this in our charitable philanthropic efforts.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

We're considering a matching program where Regeneron would put up and say, we'll put up X dollars to some amount and that people, depending upon other people putting up, we would match their contributions. We would hope that this might stimulate others to be more philanthropic than they've been. We are working through the mechanics of this with the foundation, when this all can get launched. We hope in the not too distant future, whether or not others will step up to the plate. I'm not sure, but we certainly hope because patients do need this.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

I hope that answers your question. And since this is such an important issue, you, because if I haven't answered, it will give you another question to drill down on this a little further.

Ryan Crowe
Ryan Crowe
Senior Vice President of Investor Relations & Strategic Analysis at Regeneron Pharmaceuticals

Okay. We'll on for now. Chris, if you'd like to ask another question, please hop back in the queue. Josh, let's move to the next question, please.

Operator

Thank you. Our next question comes from Terence Flynn with Morgan Stanley. You may proceed.

Terence Flynn
Terence Flynn
Equity Research Analyst at Morgan Stanley

Hi, thanks for taking the question. Just wanted to ask an additional one on the prefilled syringe. Lynn, thanks for all the details. But can you confirm that this component is something that's used in your prefilled syringe that's already approved in Europe? Or is this a different component?

Terence Flynn
Terence Flynn
Equity Research Analyst at Morgan Stanley

Or is the component used in any other prefilled syringes? Just trying to understand the novelty here and why this might be a hang up. Thank you.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

Yes, this is the same device, same design and same components that was approved in Europe last year and has been safely used for months. So, we don't think there's any issue whatsoever with the approvability of this, but the FDA has their own set of questions. They want to know, did you do this or where's the data for that and that sort of thing. And they don't just automatically approve it just because Europe has approved it. But yes, your question is a good one, Terrence.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

It gives us all some confidence that these issues should be resolvable because they were resolved for European approval.

Ryan Crowe
Ryan Crowe
Senior Vice President of Investor Relations & Strategic Analysis at Regeneron Pharmaceuticals

Okay, thank you, Len. Let's move to the next question, please.

Operator

Thank you. Our next question comes from Akash Tewari with Jefferies. You may proceed.

Akash Tewari
Akash Tewari
Managing Director at Jefferies

Hey, thanks so much. So you mentioned $400,000,000 in patient assistance to Good Days. Can you comment on what percent of your U. S. Patient base received funding in 2024?

Akash Tewari
Akash Tewari
Managing Director at Jefferies

Is 25% a fair estimate? And just to kind of drill into the specifics, from what you've seen in Q1, what percentage of those patients are dual covered or have supplemental insurance so they would be able to get back onto EYLEA with help from Good Days. And then, Len, assuming that other Roche and some of these other players don't aren't receptive to this matching program, what is your team going to do? Is there a situation where funding to Good Days doesn't return at any point in 2025?

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

A lot of questions embedded in there, but the first series of questions we can't answer. We don't do any correlations about our contributions and the implications for EYLEA usage. That's not permitted. It's not appropriate. And the people who make the decisions that Regeneron are not the commercial people.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

This is not a conduit of any shape, matter or form, and that's not permissible under the rules. So we don't, we can't answer any of those questions about, EYLEA. In terms of what our game plan is, well, I think you've heard it. We want to stimulate a community of givers. You mentioned one, it doesn't have to be, it could be somebody else.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

If Elon Musk wants to give, that's good by us too. We're not targeting anybody in particular. We're just saying that we would like to stimulate others. And I should just leave it at that.

Ryan Crowe
Ryan Crowe
Senior Vice President of Investor Relations & Strategic Analysis at Regeneron Pharmaceuticals

Okay. Thanks so much. Let's move to the next question, please.

Operator

Thank you. Our next question comes from Carter Gold with Cantor. You may proceed.

Carter Gould
MD & Senior Analyst at Cantor Fitzgerald

All right, good morning. Thanks for taking the question. Sorry to come back to the regulatory operations and I appreciate all the color and nuance on the prefilled syringe. But Len, this is your fourth CRL and as well as a delay in the past sort of twelve months. Is there acknowledgment this performance is unsatisfactory across the regulatory group?

Carter Gould
MD & Senior Analyst at Cantor Fitzgerald

And maybe you could highlight any steps you've taken to improve regulatory performance. I recognize there idiosyncrasies. And if I'm being a fair, please correct me, but the rate of CRLs and delays really stands out versus peers. Thank you.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

Well, that's a tough one. Well, if anybody's gonna take responsibility, it's gonna be me. I'm not putting this on our regulatory group whatsoever, cause I think they've done a spectacular job as is our manufacturing group. We have a lot of activity at the FDA. I can't remember what we said, nine submissions.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

And so we're gonna have more than our share of regulatory interactions. I think our team is first rate. The kinds of issues that have come up are reflecting in my view, an increased scrutiny by the FDA post COVID on contract manufacturers performing a variety of functions. All of our CRLs, I should say not all, but for the vast majority of our CRLs, they relate to these issues, at, third party suppliers, which the FDA recognized, were woefully behind the times during COVID. There wasn't enough of them.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

They were flunking inspections. And so I think the FDA is trying to step up the game, if you will, of these contract manufacturers. And since we're so active, we see more. I don't think it's a, I'll acknowledge for sure that we're unhappy about this. And if there's a blame, I'm happy to take it personally, but it's certainly not the reflection on a regulatory group or manufacturing people who are working really hard to get this right.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

Now, in some cases, the rules have changed sort of mid game. We had a CRL where we hadn't quite enrolled enough people. And why did the FDA change that sort of approach? Was because other manufacturers weren't bothering to enroll anybody over a ten year period. And so they've said, we're not gonna do these accelerated approvals.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

So we got caught up in that, but we've rectified that and we're expecting that approval to come. There was another CRL related to a manufacturing thing originally with Eylea out of our control. We got that. I don't want this to sound like excuses. We own the issues because it's our product, but it is reflective, I think, more of what is going on at the level of the contract manufacturers.

Ryan Crowe
Ryan Crowe
Senior Vice President of Investor Relations & Strategic Analysis at Regeneron Pharmaceuticals

Okay, let's move to the next question, please.

Operator

Thank you. Our next question comes from Brian Abrahams with RBC. You may proceed.

Joe Johoon Kim
Joe Johoon Kim
AVP at RBC Capital Markets

Hi, this is Joe on for Brian. Thanks for taking our question. So for idepakimab, has there been any further evolution of our understanding in IL-thirty three as a therapeutic target since this Phase II COPD data and the mechanistic rationale behind idepecumab's more pronounced benefit in former smokers? And as you expand idipecumab development, how will the COPD results guide the further expansion? Thank you.

George Yancopoulos
George Yancopoulos
Board Co-Chair, Co-Founder, President and Chief Scientific Officer at Regeneron Pharmaceuticals

Well, a lot of our insights into IL-thirty three come from genetics in the pathway. As you know, from our Regeneron Genetics Center, we have a large number of human sequence. We can actually see variation in the IL-thirty three pathway. What we actually see is that patients who are genetically deficient in this pathway are protected from COPD, and those who have excess IL-thirty three activity are more prone to COPD, as well as a series of other diseases, some of which we've described, we're investigating with additional clinical trials. So that's where the whole rationale and the whole idea comes from, indications we go after.

George Yancopoulos
George Yancopoulos
Board Co-Chair, Co-Founder, President and Chief Scientific Officer at Regeneron Pharmaceuticals

As we've already said, our phase two study showed an overall reduction exacerbations that was driven by this former smoker population. We think we might be understanding a little bit about that mechanism, but nothing definitive and new up until this point. And I do remind you that these phase three studies did pass an interim analysis about halfway through the program, which gives us additional hope and confidence. So the genetics is strong here, the phase two data was strong here, and the fact that we passed an interim efficacy barrier gives us confidence here. But obviously we'll be getting the data in a short period of time and that will be definitive.

Ryan Crowe
Ryan Crowe
Senior Vice President of Investor Relations & Strategic Analysis at Regeneron Pharmaceuticals

Any thoughts on future indications based on the COPD results?

George Yancopoulos
George Yancopoulos
Board Co-Chair, Co-Founder, President and Chief Scientific Officer at Regeneron Pharmaceuticals

Well, we announced, as I just described in my comments, a few ongoing studies and a few studies that we're initiating. We're also very excited about the opportunity in asthma because the data is very strong there. And I think that depending on the COPD results, might be considering moving into that space as well, because the genetics there is also very, very strong.

Ryan Crowe
Ryan Crowe
Senior Vice President of Investor Relations & Strategic Analysis at Regeneron Pharmaceuticals

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

Operator

Thank you. Our next question comes from William Pickering with Bernstein. You may proceed.

William Pickering
Analyst at Bernstein

Hi, good morning. Thank you for taking the question. On the EYLEA HD monthly dosing submission, the ELARA safety trial just completed enrolling in March, and I believe that you submitted the filing before that. So what percent of the total enrollment was included in the submission? Did you have alignment with the FDA this would be sufficient?

William Pickering
Analyst at Bernstein

And what's your overall level of confidence in this submission at this point? Thank you.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

I don't think we're going to get into the details of all of that. Suffice it to say that they've accepted our submission, and therefore, there's no deficiency, say like we didn't have enough numbers or something like that. Now it's a review issue and we'll see, how that process goes. And we'll let you know when we know something. But in terms of whether or not, we've satisfied, the requirement for evaluation, We did pass that hurdle because it was accepted for review.

Ryan Crowe
Ryan Crowe
Senior Vice President of Investor Relations & Strategic Analysis at Regeneron Pharmaceuticals

Let's move to the next question.

Operator

Thank you. Our next question comes from Evan Seigelman with BMO Capital Markets. You may proceed.

Evan Seigerman
Evan Seigerman
MD & Senior Research Analyst at BMO Capital Markets

Hi, guys. Thank you so much for taking my question. I want to pose one for you, Len. Hypothetically speaking, if you could redesign a way to provide patient assistance without the use of charities and current legislation aside, how would you structure that program for Medicare? Would it be direct kind of co payments for patients who need it, or other kind of mechanisms?

Evan Seigerman
Evan Seigerman
MD & Senior Research Analyst at BMO Capital Markets

How do you think about that?

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

Yeah, that is a great question. And I addressed that, I think, recently on a CNBC interview that I gave, but let me revisit it. Just the level set everybody remember, the point being is that we cannot do direct patient assistance to people who are having their drugs paid for by government funding. I suggested with the stroke of a presidential pen, that they could choose to allow sponsors to provide copay assistance directly the way we do for commercial patients. The notion that somebody is going to take an expensive drug that requires treatment for cancer, let's say, or an injection in the eye or something like that, because they get copay assistance seems to me ill founded.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

And maybe it might increase utilization perhaps, but far more importantly, means patients will get the best drug that they and their doctors choose for them. There is lots of evidence and we just had it this quarter that we, most retinal specialists will tell you that Avastin is not the best drug to treat patients with variety of retinal diseases. Yet people who are poor, who can't afford copays wind up getting that in a disproportionate number as you saw when there was no copay assistance here. And that's really the wrong that needs to be righted. And were I designing this?

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

I would allow copay assistance directly from sponsors to patients. I think one could literally do this. If the president wanted to do this, he would get millions and millions of seniors, would be greatly appreciative that they weren't fussing and worrying and figuring out, am I getting the best treatment that's gonna make me not lose my vision? Or am I getting the right cancer treatment so that I can live to see the next year and so forth? I think that that would be a great thing for the president to do.

Ryan Crowe
Ryan Crowe
Senior Vice President of Investor Relations & Strategic Analysis at Regeneron Pharmaceuticals

All right. Let's move to one more. Next question, please.

Operator

Thank you. Our next question comes from Salveen Richter with Goldman Sachs. You may proceed.

Salveen Richter
Salveen Richter
Biotechnolgy Equity Research at Goldman Sachs

Good morning. Thank you. You tightened your capital expenditure guidance for this year. Can you help us understand this in the context of your recent manufacturing announcements and cadence here for forward spend, noting the current environment?

Chris Fenimore
Chris Fenimore
EVP, Finance and CFO at Regeneron Pharmaceuticals

Yeah, thanks, Salveen, for the question. We lowered the top end of the range by $25,000,000 There's nothing really to look through that other than just some timing of the way we see the expenditures going out, but we're committed to our capital plans and nothing has changed accordingly.

Ryan Crowe
Ryan Crowe
Senior Vice President of Investor Relations & Strategic Analysis at Regeneron Pharmaceuticals

Okay, I think we have time for one more question.

Operator

Thank you. Our next question comes from David Risinger with Leerink Partners. You may proceed.

David Risinger
Senior Managing Director, Biopharma at Leerink Partners

Yes, thanks very much. Len, I'm hoping you can address a big picture question. The industry is facing three major US government risks, specifically actions that are harming biopharma innovation, including FDA disruption, questioning of proven medical science, evisceration of the NIH, in addition, tariff threats, and then finally, the Trump administration's agenda to take down drug prices more than the Biden administration. So considering what appears to be a lack of appreciation in Washington of the benefits that the biopharmaceutical industry brings to Americans. Could you please comment on how you and your executive team and board are engaging differently today with Washington leadership to change the political agenda for the better?

David Risinger
Senior Managing Director, Biopharma at Leerink Partners

Thank you.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

Great question, David. Look, I think during this transition period, there is a lot of disruption in Washington. There is loss of personnel, reduction in force, new people in charge, new focuses and so forth. I told the president that, I thought that, RFK, junior, while he thinks outside the box, needed some assistance on the science front. I said that straight out, and offered to provide that.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

And I think that, there are others who feel similarly, as I do, that we can't lose the ability to do science. Does that mean that the way science has been done in this country, the way grants have been given out is done exactly right? No, there is room for improvement across all of what we do. We saw that during COVID when one of our antibodies didn't get the kind of indication it clearly should have based on the science. Why that happened?

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

Somebody wasn't following the science. So there's room for improvement, but of course there's risk, David, as you point out. If we take a path where we just stop following science and we give up on tried and true methodologies, I think we could be in trouble. If we take a fresh look at things, but still get guided by scientific principles, I think things could improve. Obviously, experience does matter.

Leonard Schleifer
Leonard Schleifer
Board Co-Chair, Co-Founder, President and Chief Executive Officer at Regeneron Pharmaceuticals

And I really hope that we do not lose really good people at the FDA in the rank and file, or even at the policy level. I think that would be deleterious. So I think we don't get to set the policy. We hopefully get to influence a little bit and we try and work through it. But the company spends a fair amount of effort trying to keep people on a path that will serve the health of our citizens as best it can.

Ryan Crowe
Ryan Crowe
Senior Vice President of Investor Relations & Strategic Analysis at Regeneron Pharmaceuticals

Okay. Thank you. And thanks to everyone who dialed in today for your interest in Regeneron. We apologize to those remaining in the Q and A queue who we did not have a chance to hear from today. As always, the investor relations team is available to answer any remaining questions you may have.

Ryan Crowe
Ryan Crowe
Senior Vice President of Investor Relations & Strategic Analysis at Regeneron Pharmaceuticals

Thank you once again, and have a great day.

Operator

Thank you. This concludes the conference. Thank you for your participation. You may now disconnect.

Executives
    • Ryan Crowe
      Ryan Crowe
      Senior Vice President of Investor Relations & Strategic Analysis
    • Leonard Schleifer
      Leonard Schleifer
      Board Co-Chair, Co-Founder, President and Chief Executive Officer
    • George Yancopoulos
      George Yancopoulos
      Board Co-Chair, Co-Founder, President and Chief Scientific Officer
    • Marion McCourt
      Marion McCourt
      Executive Vice President of Commercial
    • Chris Fenimore
      Chris Fenimore
      EVP, Finance and CFO
Analysts
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Key Takeaways

  • Regeneron reported a mixed first quarter with US EYLEA net sales down 39% year-over-year—driven by increased use of low-cost off-label Avastin amid a copay assistance funding gap—while EYLEA HD sales rose 54% YoY.
  • The FDA issued a complete response letter for the EYLEA HD prefilled syringe over a third-party component query, though safety and efficacy remain unaffected; separate SBLA submissions for RVO and monthly dosing have received Priority Review.
  • DUPIXENT achieved 20% global sales growth (19% in the US), leading prescription share across its approved type-2 indications (excluding CSU), with accelerating COPD adoption and a new FDA approval in chronic spontaneous urticaria.
  • Regeneron’s ~45-candidate pipeline is poised for multiple 2025 US approvals—including limboseltimab (relapsed/refractory multiple myeloma), odronextumab (follicular lymphoma), Libtayo in adjuvant CSCC, and Dupixent in bullous pemphigoid—as well as key pivotal data readouts.
  • The company maintains strong financial health with $17.6 billion in cash, $3 billion Q1 revenues, over $7 billion in planned US R&D and manufacturing investments, $1.1 billion in share repurchases, and a growing quarterly dividend.
A.I. generated. May contain errors.
Earnings Conference Call
Regeneron Pharmaceuticals Q1 2025
00:00 / 00:00

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