Regeneron Pharmaceuticals Inc Collaboration

You may begin. Thank you, Michelle.

Good morning, good afternoon, and good evening to everyone listening around the world. Thank you for joining today's call to announce the expansion of the collaboration between Regeneron and Sanofi. We have members from the management teams from both Regeneron and Sanofi here today. Before we get started with introductions and our meeting agenda, both companies will note read their forward-looking statements. For Regeneron investors, I would like to remind you that remarks made on today's call may include forward-looking statements about Regeneron. Such statements may include, but are not limited to those related to Regeneron and its products and business, financial forecast and guidance, development programs, and related anticipated milestones, collaborations, finances, regulatory matters, payer coverage and reimbursement, changes to drug pricing regulations and requirements, and our drug pricing strategy, intellectual property, pending litigation and other proceedings, and competition.

Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-Q for the quarter ended June 30, 2026. Regeneron does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise. Regarding Sanofi's forward-looking statement, please refer to the language on the slide.

For Sanofi investors, we would like to remind you that information presented in this call contains forward-looking statements, which are subject to substantial risk and uncertainties that may cause actual results to differ materially. We encourage you to read the disclaimer in the presentation, and we also refer you to our Form 20-F on file with the U.S. SEC on our French universal registration documents. Let me turn the call over to Ryan.

Thank you, Francois. Now moving to today's speakers and our agenda. Joining me on today's call are Dr. Leonard Schleifer, Regeneron's Co-founder, Board Co-chair, President, and Chief Executive Officer. Dr. Belén Garijo, Sanofi's Chief Executive Officer. Dr. George Yancopoulos, Regeneron's Co-founder, Board Co-chair, President, Chief Scientific Officer, and perhaps most pertinent for this call, the visionary and principal inventor and developer of DUPIXENT, as well as for the technologies that have delivered not only DUPIXENT, but all of the new assets being added to the alliance today. Finally, we also have François-Xavier Roger, Executive Vice President, Chief Financial Officer at Sanofi.

For the presentation today, Len and Belén will begin with a high-level overview of the deal and strategic rationale, highlight the productivity of the Regeneron-Sanofi collaboration over the past two decades, as well as how the alliance intends to leverage the R&D engine and commercial platform the companies have jointly built over the years. George will discuss the antibodies that the companies will now jointly develop, as well as their development timelines. Finally, Francois will review the key financial and operational terms for the transaction. After prepared remarks conclude, the remaining time will be available for Q&A. Additional members of the management teams from both Regeneron and Sanofi will also be made available to answer questions at that time. With that, let me turn the call over to Len and Belén to begin today's discussion presentation.

Thank you, Ryan, and thanks to everyone for joining our call today. It's an exciting day for Regeneron and Sanofi as we extend our highly successful collaboration by adding differentiated assets that have the potential to address type 2 inflammatory diseases. For more than two decades, our alliance with Sanofi has been one of the most productive collaborations in the history of the biopharmaceutical industry. Together, we have developed and commercialized DUPIXENT, which redefined what was possible for the treatment of type 2 inflammatory diseases. Like any long-standing partnership, our journey has not been without challenges, but we have worked through them and are now focused on the renewed momentum of our alliance and the opportunities ahead. Today, we are opening a new chapter. Our agreement extends our shared leadership well beyond DUPIXENT. Regeneron is contributing four fully human next-generation long-acting antibodies.

The lead candidate targets IL-13 and is currently in the clinic for atopic dermatitis. Regeneron is also contributing three preclinical candidates, including an IL-4, IL-13 bispecific, as well as antibodies to the IL-4 receptor alpha and Interleukin-4. These are also long-acting. George will provide more details on these opportunities later in his presentation. Sanofi, in turn, is contributing an option for lunsekimig, their IL-13 TSLP Nanobody, to potentially be added to the alliance at Regeneron's discretion, pending phase II results in chronic obstructive pulmonary disease. Together, we are combining both companies' development capabilities to bring forward this next wave of innovation for type 2 inflammatory diseases. Assuming successful development and regulatory approval, we will launch these medicines by leveraging our jointly built global commercial platform that currently serves more than 1.5 million DUPIXENT patients worldwide.

The deal construct is also deliberately simple and aligns our shared motivations to advance the standard of care for type 2 inflammatory diseases. Regeneron and Sanofi will equally share development and commercialization costs while splitting any global profits 50-50. In addition, Regeneron will receive a $1 billion upfront payment from Sanofi, along with the opportunity to earn up to $7 billion in additional milestone payments upon the achievement of specified development, regulatory, and commercial milestones. Moving to Slide 7. Together, Regeneron and Sanofi have built something remarkable. What started nearly 20 years ago as a modest collaboration combining Regeneron's antibody platform with Sanofi's global development and commercial reach has become one of the most productive alliances in our industry. We now look forward to the next decade and beyond, building upon the success of DUPIXENT with the ambition to maintain our long-standing leadership within immunology.

Briefly to DUPIXENT, the standard of care for type 2 inflammatory diseases, which is now one of the most widely used antibody medicines in the world, invented at Regeneron by George Yancopoulos and developed by George and his team in collaboration with Sanofi. Based on second quarter 2026 global net sales of EUR 5.2 billion as recorded by Sanofi, DUPIXENT is now annualizing above EUR 20 billion across nine indications. In the U.S., DUPIXENT is the number one biologic prescribed by dermatologists, pulmonologists, allergists, and ENTs, and leads in total prescription share in eight of its nine approved indications. As we look to the next generation of type 2 medicines, extending the alliance beyond DUPIXENT is about more than simply adding new antibodies.

It is about pairing these next-generation assets with a proven global development platform and a sophisticated commercial engine that has already established leadership in type 2 inflammation and is well-positioned to sustain that leadership into the future. Let me turn the call over now to Belén to further discuss how we will build on our strong commercial position in immunology.

Thank you, Len, and hello, everyone. I am super excited with our announcement today since this is an important strategic step forward for both companies as we aim to sustain leadership in atopic dermatitis with a novel long-acting IL-13 antibody, as well as the next-generation pipeline candidates. Let me tell you why we are so excited with the journey ahead. First of all is the market potential. While advanced therapy penetration has significantly grown over the last few years, thanks in large part to DUPIXENT, only about 20% of eligible U.S. patients are being treated on advanced therapy today. There are many opportunities for growth, and we expect the market to nearly double over the next five years. Despite the very successful development and commercialization of DUPIXENT, there is still a need for meaningfully longer dosing intervals without compromising efficacy or safety.

And this is what we intend to address with our novel long-acting IL-13. We see an attractive opportunity here as we will leverage our established commercial footprint, the prescriber relationships that we have developed over many years, as well as the patient support infrastructure to accelerate our next generation of alliance products. Moving into slide 10, let's take a closer look at the atopic dermatitis market. AD is a large market with more than 2.5 million patients suffering from moderate to severe atopic dermatitis in the U.S. alone. We are projecting the U.S. market reaching approximately $20 billion in sales by 2032, and to continue to increase thereafter with advanced therapy penetration exceeding 50% by 2040, consistent with what we have seen in other mature immunological diseases such as rheumatoid arthritis or Crohn's disease. AD is not a saturated market.