Good morning, and welcome to the 2025 Annual Shareholder Meeting of Regeneron Pharmaceuticals. The meeting will begin after the following message.
At Regeneron, we've always pursued bold science to drive our purpose: transforming lives through groundbreaking innovation. That principle is just as strong today as it was when the company was founded.
We committed to not just treating disease, but to rethinking how medicines are discovered and developed, building technologies and scientific platforms capable of changing the course of serious conditions.
That investment paid off and has led to the approval of a dozen medicines, including four blockbuster treatments, helping people around the world with retinal diseases, type 2 inflammation, cancer, and more. Our scientific engine is more productive than ever. The breakthroughs we've made have created a pipeline with extraordinary potential.
We're already.
The meeting proceedings will now begin.
Good morning, ladies and gentlemen, and welcome. It is 10:30 , and time to call the Annual Meeting of Shareholders of Regeneron Pharmaceuticals to order. I'm Len Schleifer, Co-Chair of the Board and President and Chief Executive Officer of the company. As you have seen in our proxy materials, we are utilizing a virtual-only meeting format. This format has been designed to ensure that our shareholders are afforded similar rights and opportunities to participate as they would at an in-person meeting. Participating in today's meeting are Dr. George Yancopoulos, Co-Chair of the Board and President and Chief Scientific Officer of Regeneron, and Joe LaRosa, Executive Vice President, General Counsel, and Corporate Secretary and Secretary of this meeting. Also present, or connected by audio this morning, are other senior officers of Regeneron: Chris Fenimore, Executive Vice President of Finance and Chief Financial Officer; Marion McCourt, Executive Vice President Commercial; Dr.
Drew Murphy, Executive Vice President Research; Sally Paull, Executive Vice President Human Resources; Jay Petofsky, Vice President Controller; and Dr. Brian Zambrowicz, Executive Vice President Functional Genomics and Chief Velocigene Operations. On behalf of the Board of Directors and the management of Regeneron, I want to thank you for your attendance at our Annual Meeting of Shareholders and for the solid return of proxies. Before we proceed, I will ask Mr. LaRosa to review a few housekeeping items and to submit the required proof of mailing and advise us as to whether the necessary quorum is present.
Thank you, Mr. Chairman. The meeting is being recorded and will be made available on the investor relations portion of our company website. Returning now to the business of the meeting, the agenda for today's meeting, indicating the order in which we plan to deal with the business before us and the rules of conduct, are posted on the virtual meeting website. As in prior years, the company used the notice and access method of providing proxy materials to shareholders via the internet. Accordingly, the first order of business is the proof of the mailing of the notice of internet availability of proxy materials for the annual meeting. I have an affidavit signed by Ms. Joanne Vogel, an employee of Broadridge Financial Solutions, with respect to the mailing for the annual meeting, which commenced on April 29, 2025.
Copies of the proxy statement and our 2024 Form 10-K are posted on the virtual meeting website. An inspector of election has been appointed. The inspector is Ms. Tracy Oates, a representative of Broadridge Financial Solutions. The inspector of election has delivered a certificate to the effect that we have present, by proxy or in person, holders of record of Regeneron common stock and Class A stock, representing a majority of the votes of all shares entitled to vote at this meeting. Therefore, we have a quorum present.
Thank you, Mr. LaRosa. As noted, a short list of rules of conduct for the meeting have been made available. The business of this meeting is to allow shareholders of the company to vote on five matters set out in the agenda. After those matters have been voted, I will present a brief business overview of the company, and we will respond to questions from shareholders. In a moment, I will officially open the polls, which will allow you to vote electronically if you have logged into this meeting as a shareholder. Please note that if you have already submitted your proxy, there is no need to vote during the meeting unless you would like to change your vote. Voting during the meeting will revoke your prior proxy. I declare the polls now open. The polls will close today following the presentation of the items of business.
We are now ready to proceed to the items that you will vote on this morning. At this time, I would like to introduce the directors, all of whom are present or connected by audio this morning. In addition to Dr. Yancopoulos and me, we have Chris Poon, the board's lead independent director, Bonnie Bassler, Mike Brown, Tony Coles, Joe Goldstein, Kathryn Gaurini , Art Ryan, David Schenkein, George Scangos, Craig Thompson, and Huda Zoghbi. Mr. LaRosa, will you please outline the five items of business set out in the agenda?
Mr. Chairman, the first item of business is the election of four Class 1 directors for a three-year term and until a successor is duly elected. The nominees for Class 1 directors are Dr. Bonnie Bassler, Dr. Mike Brown, Dr. Len Schleifer, and Dr. George Yancopoulos.
Each of the nominees is currently a member of the board of directors and has been duly nominated. The board of directors has recommended a vote for each of the nominees. The second item of business is the ratification of the appointment of PricewaterhouseCoopers LLP as the company's independent registered public accounting firm for the fiscal year ending December 31, 2025. PricewaterhouseCoopers LLP now serves as the company's independent registered public accounting firm and has served in that role since 1988. The representative of that firm, who is with us by audio, is Sonia Luaces. Thank you for joining, Ms. Luaces. PricewaterhouseCoopers has been recommended and appointed by the audit committee of the board of directors to serve as the company's independent registered public accounting firm for the fiscal year ending December 31, 2025.
The board of directors has directed that this appointment be submitted for ratification by the shareholders at this annual meeting and has recommended a vote for such ratification. The third item of business is an advisory vote on the compensation of the company's named executive officers as disclosed in the proxy statement. The board of directors has recommended a vote on an advisory basis for approval of the compensation of our named executive officers. The fourth item of business is the approval of an amendment to the company's certificate of incorporation to declassify the board of directors. The board of directors has recommended a vote for this proposal. The fifth and final item of business is the approval of two amendments to the company's certificate of incorporation to eliminate supermajority voting requirements.
Because the votes required to amend the relevant provisions of the certificate of incorporation are different, this matter of business is set forth in two proposals, Proposals 5A and 5B. The board of directors has recommended a vote for Proposals 5A and 5B.
Thank you, Mr. LaRosa. If any shareholder has a question relating to any of the proposals, please submit it using the virtual meeting website and identify yourself. As a reminder, there will be ample opportunity for general questions about the company later in the proceedings. Any questions, Mr. LaRosa?
Yes, Mr. Chairman. We have a question from a shareholder.
Okay.
No questions for this section.
For this section?
Correct.
Sorry. That question will be dealt with after the company's status presentation.
If there are no further questions regarding the proposals, I will be closing the polls momentarily. Most of you have already voted by proxy and do not need to vote again at this time unless you wish to change your vote. However, anyone who would like to vote, please do so now. I declare the polls now closed. I would like to call on the inspector of election to provide a preliminary report on the results of the voting.
Mr. Chairman, the preliminary results of the voting are as follows. With respect to the first item of business, the election of four Class 1 directors for a three-year term, all nominees have been elected by the affirmative vote of a majority of the votes cast in person or by proxy at this meeting. With respect to the second item of business, ratification of the appointment of PricewaterhouseCoopers LLP as the company's independent registered public accounting firm for the fiscal year ending December 31, 2025, such appointment has been ratified by the affirmative vote of a majority of the votes cast in person or by proxy at this meeting.
With respect to the third item of business, approval on an advisory basis of compensation of the company's named executive officers as disclosed in the proxy statement, such compensation has been approved by the affirmative vote of a majority of the votes cast in person or by proxy at this meeting. With respect to the fourth item of business, approval of an amendment to the company's certificate of incorporation to declassify the board of directors, a majority of the votes eligible to be cast on this proposal voted in favor, thereby approving the amendment. With respect to the fifth and last item of business, approval of two amendments to the company's certificate of incorporation to eliminate supermajority vote requirements. The requisite votes, as described in the proxy statement, were not obtained, and therefore the amendments have not been approved.
My certificate as inspector of election will be executed and delivered to the secretary of the meeting. Mr. Chairman.
Thank you, Inspector. I will now provide an update on the company, after which my colleagues and I will be glad to answer your questions. I'll now be sharing a brief overview of Regeneron's recent progress, vision for the future, and industry-leading clinical pipeline. I would like to remind you that remarks made today may include forward-looking statements about Regeneron. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those projected in that statement. Please refer to Regeneron's SEC filings for additional information. Now let's begin. Let's start by grounding us in purpose. Regeneron is, most fundamentally, a company that uses science to help improve the health and lives of people in need. From day one, we had a simple yet profound directive: follow the science.
By doing so, we have grown from a small, ambitious startup to the leading biotechnology company we are today. We pioneer best-in-class technologies, creating innovative turnkey platforms that can repeatedly deliver practice-changing medicines. Through this work, we have built a robust homegrown pipeline of potential new treatments. Our focused strategy has enabled us to help millions of patients globally, establishing us as an undisputed leader in antibody therapies and positioning us at the forefront of numerous other cutting-edge therapeutic modalities, such as genetic medicines. We sustain this success through consistent investment in science, reinvesting over 30% of our revenues into R&D. This is well above the industry average, and it demonstrates our faith in our science, our research, and our tremendous team of innovators.
Our unwavering pursuit of scientific and technological innovation has not only grown our company but helped us flourish over nearly 40 years in one of the most competitive and challenging industries there is. Biotechnology, the business of discovering and developing new medicines, is indeed one of the most challenging fields. Nearly 90% of drugs that enter clinical trials fail to reach the market, and today, the average cost of developing a new drug exceeds $2 billion. Despite these challenges, the past decades have produced some of the most incredible scientific breakthroughs in history, including advances in gene therapy, immunotherapy, and targeted therapies. As an industry, we have cured diseases that were previously deemed incurable, made dramatic progress against deadly cancers, and have fought back novel pandemics. Most of these groundbreaking innovations originated in the U.S., making the biopharma industry a true crown jewel of America.
Regeneron is one of these remarkable American success stories, having overcome the formidable odds of this industry to make significant contributions to science, medicine, and above all, patients. In addition to the constant challenges of science and medicine, there are some very specific headwinds facing the industry today. These challenges are not insurmountable because we know that science is resilient and healthcare is critical. However, they will take carefully developed solutions and fierce advocacy. Addressing these issues is crucial to sustaining American innovation and fostering an environment where our industry can continue to thrive. Importantly, let me say that through nearly four decades of innovative work, we've considered ourselves a non-political company and have always put patients first. To achieve the goal of helping people through science and medicine, we work closely with officials from multiple administrations and both sides of the aisle.
We've survived and thrived in many challenging moments, and we will continue to do so. In the spirit of collaboration and continued greatness, there are a few areas that we believe should be addressed immediately. Incentivize fair pricing and enhance patient access. Most urgently, many patients, including our seniors, need help to cover their out-of-pocket costs today. Quick reforms, such as allowing pharmaceutical companies to provide Medicare patients with financial assistance to cover their copays, would allow patients to benefit from money in the system and get the medicines they truly need. Incentives for continued investment in innovation. Innovation must be fueled over time. In the private sector, companies should be encouraged to reinvest larger percentages of their revenues into research and development in order to protect public health. Incentives could come in the form of tax benefits or accelerated regulatory frameworks.
In the public sector, we must fuel the American scientific brain trust that has been built over decades and continue intramural and extramural investment in early science, such as through the important work of the National Institutes of Health. Once this innovation is produced, it should be protected for a reasonable amount of time. Just like Abraham Lincoln, we believe in the power of the patent to protect innovations for a defined period of time. This fosters an environment where innovation is encouraged and rewarded, and risk is tolerated. Finally, once innovation is delivered, developed nations should pay their fair share. Today, Americans pay for more innovative treatments than any other country. There is opportunity to create affordable access for all if every able country were to pitch in.
Unfortunately, some of the proposals we've heard to date serve to kneecap American innovators rather than discouraging the unfair disparities in pricing that exist today. We hope discussions will continue to identify better solutions. The U.S. biopharmaceuticals industry's productivity and innovation are second to none, but this unique value is not guaranteed and requires nurturing. Regeneron exemplifies the ability of America to make a difference in the world. With the right policies and support in place, we and many other companies will continue to build upon this legacy. As noted, Regeneron has demonstrated resilience, adaptability, and growth in the face of challenges. Challenge is, after all, a fundamental part of the scientific process. To date, we have secured regulatory approval for 14 homegrown medicines and developed a robust and diverse clinical pipeline of approximately 45 candidates and built a team of over 15,000 dedicated professionals globally.
Additionally, we have established the world's largest and rapidly expanding database of sequenced DNA and de-identified health information, a powerful resource that will accelerate our drug discovery and development initiatives. We are making several big bets on the future of genetic medicines. Our long-term commitment to science has resulted in four blockbuster commercial medicines, which place the company in a strong financial position. In the first quarter of 2025, our total revenues reached $3.03 billion, with non-GAAP diluted earnings per share at $8.22. Let's take a quick look at the core products driving our near-term financial performance. Dupixent continues to reach more patients and establish an additional type 2 diseases. First quarter 2025 net product sales grew 20% globally on a constant currency basis versus the first quarter of 2024, reflecting strong growth across all approved indications in all age groups and in all geographic regions.
In the U.S., where net product sales grew 19%, Dupixent now leads in both new-to-brand prescription share and total prescription share across all its approved indications, with the only exception being chronic spontaneous urticaria, which was only recently approved by the FDA. The chronic obstructive pulmonary disease, COPD, launch in the United States continues to gain momentum, with prescribers increasingly appreciating the role of type 2 inflammation in certain patients with COPD, coupled with greater urgency to identify and treat eligible patients. Moving to Eylea HD and Eylea, which for over a decade has led the anti-VEGF market, as discussed on our most recent earnings call, the overall size of the branded anti-VEGF category contracted in the first quarter of 2025. We have faced new branded and unbranded competition in the category, presenting additional challenges.
However, we believe certain product enhancements will strengthen EYLEA HD's position in the competitive anti-VEGF category. We remain focused on securing approvals for EYLEA prefilled syringe and expanding the FDA label to include the treatment of macular edema following retinal vein occlusion and monthly dosing in approved indications. Moving on to LIBTAYO, the platform of our large and diverse oncology pipeline. LIBTAYO in the U.S. 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 markets, LIBTAYO is now second in new brand prescription share, despite launching years after other competing therapies, reflecting its differentiated clinical profile and our commercial strategy.
In short, we expect Dupixent, EYLEA HD, and LIBTAYO to continue delivering growth for the foreseeable future through additional penetration in approved indications, new indications, combination with other pipeline candidates, and other potential product enhancements. While confident in the ongoing potential of our established medicines, we are even more excited about what the clinical pipeline holds. Out of approximately 45 candidates, I will highlight just a few. This slide covers programs that are currently in or soon to enter phase three or pivotal studies. A few callouts. In oncology, we have the first and only immunotherapy to work in the adjuvant CSCC setting. We have our LAG-3 antibody, fianlimab, in combination with LIBTAYO in advanced melanoma, where we expect pivotal data later this year. We have our myeloma and lymphoma programs, which have the potential to be best in class. We have a potentially best in class for complement-mediated diseases.
We think our anticoagulant approach has the potential to address a very large market opportunity. We're demonstrating early progress in our obesity studies and recently in-licensed our own GLP-1 GIP receptor agonist that has been studied in over 1,000 patients outside of the U.S. and can serve as yet another backbone for future combinations as we seek to improve the quality of weight loss. We also have several promising rare disease programs with novel and diverse mechanisms. For instance, DB-OTO, our AAV gene therapy, has improved hearing in 11 out of 12 treated children with congenital hearing deficiencies. We believe DB-OTO can be revolutionary for the children and families affected by otopharynx-related hearing loss. I want to share a brief video with you of one child who was born with profound deafness. She came into the study at 10 months of age.
We played sounds as loud as a vacuum cleaner next to her ear, and she could not hear anything. Now, fast forward, we are a year out from one-time treatment with DB-OTO. She is two years old, and you are being invited to share a beautiful moment with this child and her mother. I want you to pay attention to her speech and language abilities in this video. Also notice her ability to detect a faint warning signal in her environment towards the end of the video. Please play the video now. Wow. This is the type of program that reminds you why our work matters, why scientific innovation matters. The candidates on the previous slide represent only about a third of our clinical pipeline, and we are adding more and more programs every year.
I really believe the future of Regeneron lies in the incredible pipeline that comes from the differentiated technologies that our team has created and continues to enhance. Regeneron's strong financial position allows us to continue to invest in these differentiated R&D capabilities and pipeline to deliver new medicines to patients and long-term value to shareholders. We also take a disciplined approach to capital allocation in order to drive this long-term value. Among our R&D investments is the recently announced manufacturing and supply agreement with FUJIFILM Diosynth Biotechnologies to invest over $3 billion in North Carolina that will nearly double our U.S. large-scale manufacturing capacity. This agreement, along with our $3.6 billion expansion of our Tarrytown, New York R&D and preclinical manufacturing facilities, our fill-finish facility in Rensselaer, New York, and the acquisition of an additional property in Saratoga Springs, New York, represent planned investments of over $7 billion.
These investments will continue to grow in the U.S. and support our differentiated R&D engine while significantly increasing our ability to manufacture both clinical and commercial supply. In business development, we've always been selective where we invest externally, prioritizing our internal R&D engine while looking for ways to complement our own capabilities and programs. I already mentioned our strategic in-licensing of a GLP-1 GIP agonist, which we believe will add flexibility to our obesity efforts. Beyond these investments, we continue to return capital to shareholders through share repurchases and our recently initiated quarterly dividend program. We continue to see share repurchases as an efficient use of capital and remain opportunistic buyers of our shares.
Since our founding, Regeneron's mantra has been "Doing well by doing good." We do this through improving the lives of those with serious diseases, fostering a culture of integrity and excellence within Regeneron, and building sustainable communities. We recognize that acting responsibly is crucial to ensuring the long-term success of our company and fulfilling our mission to use the power of science to repeatedly bring new medicines to patients. We are proud of what we've accomplished over the past decades, delivering innovative medicines and technological breakthroughs that improve the lives of people around the globe. Our fundamentals are strong, our financials are strong, and our pipeline is one of the strongest in the industry. I feel confident that at Regeneron, the best is yet to come. This concludes my presentation, and the meeting is now open for questions.
If you'd like to ask a question, please follow the rules stated in the rules of conduct, submit your question using the virtual meeting website, and identify yourself. We intend to answer questions as time permits and in accordance with the rules of conduct. In the event that we are unable to address all pertinent questions in the time remaining, we will post such questions and our responses to the investor relations of our website.
Mr. Chairman, we have a question from shareholder [Davin Pokoy], and the question is as follows: What will happen with the drug last week that failed to meet its primary endpoint in the second study? Will you conduct a new drug trial?
Dr. Yancopoulos, our Chief Scientific Officer, please answer the question. Okay.
The question is in reference to our drug candidate, Dupicimab, which is an interleukin-33 blocker for chronic obstructive pulmonary disease or a subset of such patients. Let me remind everybody that Regeneron's Dupixent was the first biologic ever approved for this disease based on overwhelmingly positive data, not only reducing COPD exacerbations but improving significantly lung function. It really is a huge breakthrough, and it's been an incredible advance in literally practice-changing medicine for the many patients for whom the drug is appropriate. Our Dupicimab candidate that blocks a different set of interleukins than Dupixent, based on a lot of data, suggested that it could be a very valid and important addition for an overlapping subset of patients, importantly, a large number of COPD patients for whom Dupixent is not appropriate.
There was a lot of data supporting this possibility and opportunity, starting with human genetics data that was generated by our Regeneron Genetic Center, as well as compelling phase two data, which compelled us to go forward into these two largely identical phase three trials. Let me remind you that the first trial demonstrated overwhelming efficacy with a convincing dose response with the two doses tested, and the results were really very impressive, as good as anybody could have hoped for and suggested. Once again, this could be another major advance for a different subset of patients. Unfortunately, as the question refers to the second trial, though the data, as we've reported, looked very promising through the first half of the trial, something changed, and efficacy seemed to wane over the second part of the trial. We are really trying to understand it. We're looking deeply at the data.
We remind everybody that this study was undertaken during some very unusual times, during the time of COVID, which certainly changed many aspects of how the trial was conducted, and it's well known from real-world evidence. It affected exacerbation rates and so forth. We are doing our best to really understand what happened in the trial. Once we feel, we certainly feel that there's a great deal of potential for this therapeutic candidate, and once we feel that we can go forward, when and if we can go forward with sufficient confidence, at that time, we would decide to do so. We continue to believe that the pathway, there's a lot of evidence to suggest that it could really help a large number of patients, and we are continuing to look at it very carefully.
Thank you, Dr. Yancopoulos.
Of course, we are working closely both with our internal people, your team, Sanofi collaborator on this, and we are talking with the regulators. Are there any further questions, Mr. Secretary?
Mr. Chairman, there are no further questions presented by shareholders.
Thank you. If there are no further questions, the meeting stands adjourned. Thank you for attending today's meeting.
This now concludes the meeting. Thank you for joining, and have a pleasant day.
The host has ended this call. Goodbye.