Regeneron Pharmaceuticals Inc 2026 Q3 Earnings Call

You may begin. Thank you, Shannon.

Good morning, good afternoon, and good evening to everyone listening around the world. Thank you for your interest in Regeneron, and welcome to our Third Quarter 2026 Earnings Conference Call. An archive and transcript of this call will be available on the Regeneron Investor Relations website shortly after our call concludes. Joining me on today's call are Dr. Leonard Schleifer, Co-Founder, Board Co-Chair, President, and Chief Executive Officer, Dr. George Yancopoulos, Co-Founder, Board Co-Chair, President, and Chief Scientific Officer, Marion McCourt, Executive Vice President, Commercial, and Chris Fenimore, Executive Vice President, Finance, and Chief Financial Officer. For our call today, Len will briefly review key third quarter performance drivers and highlight a few emerging pipeline programs. George will then detail our recent pipeline progress, followed by Marion, who will review our commercial performance, and finally, Chris will discuss our financial results and outlook.

After our prepared remarks, the remaining time will be available for Q&A. I would like to remind you that remarks made on today's call may include forward-looking statements about Regeneron. Such statements may include, but are not limited to, those related to Regeneron and its products and business, financial forecasting guidance, development programs and related anticipated milestones, collaborations, finances, regulatory matters, payer coverage and reimbursement, changes to drug pricing regulations and requirements, 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 September 30, 2026, which was filed with the SEC this morning. Regeneron does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise. In addition, please note that GAAP and non-GAAP financial measures will be discussed on today's call. Information regarding our use of non-GAAP financial measures and a reconciliation of those measures to GAAP is available in our quarterly results press release and our corporate presentation, both of which can be found on the Regeneron Investor Relations website. Once our call concludes, the IR team will be available to answer any further questions.

With that, let me turn the call over to our President and Chief Executive Officer, Dr. Leonard Schleifer.

Thank you, Ryan, and welcome to everyone joining our call today. We are pleased to report another quarter of strong performance, driven by outstanding commercial execution and a large and diverse pipeline that is continuing to deliver on its promise. Total revenue grew 36%, and non-GAAP earnings per share grew 70% compared to the third quarter of 2025. This marks our third consecutive quarter of double-digit growth on both the top and bottom lines. Our commercial teams continue to execute at a very high level. Dupixent, EYLEA HD, and LIBTAYO each set new all-time highs for quarterly net sales for the second quarter in a row. Dupixent global net sales in the third quarter, as reported by Sanofi, reached a record $6.5 billion, up 35% year-over-year at constant currency, which is truly remarkable for a medicine approaching 10 years on the market.

In the U.S., where Dupixent is the leading biologic in eight of its nine FDA-approved indications, quarterly net sales grew 40% and exceeded $5 billion for the first time, primarily driven by robust demand across all indications, as well as gross-to-net favorability as disclosed by Sanofi. EYLEA HD quarterly net sales in the U.S. reached a new all-time high of approximately $700 million, up 62% from a year ago, and now represent nearly two-thirds of our U.S. retinal franchise. Physician unit demand grew 20% sequentially, reflecting the value retinal specialists and their patients see in extended dosing intervals, as well as last year's label enhancements, which added the retinal vein occlusion indication and greater dosing flexibility. We remain optimistic for approval of the prefilled syringe before the end of the year, and we expect it to drive even further adoption if approved.

LIBTAYO is making important differences for patients with skin and lung cancers, and it continues to build clinical and commercial momentum. In the U.S., it is the leading immunotherapy in non-melanoma skin cancers and the second most prescribed immunotherapy in non-small cell lung cancer. Global net sales reached a record $550 million, up 51% in constant currency, and U.S. net sales grew 81% to nearly $400 million. Last week at ESMO, we presented longer-term data from our phase III C-POST trial, showing an increasing overall survival benefit with adjuvant LIBTAYO in high-risk cutaneous squamous cell carcinoma, where it is the first and only approved immunotherapy. LIBTAYO is now on an annual run rate of approximately $2.2 billion and remains the foundation for our broader oncology strategy. Beyond our strong commercial execution, our pipeline is poised to deliver several potential blockbuster opportunities over the next several years.

Let me highlight new advances in four of our pipeline programs, while George will discuss in more detail, along with other late-stage clinical programs, including Factor XI, Lynozyfic, and olatorepatide. In neuromuscular disease, we expect an FDA decision in November for cemdisiran in generalized myasthenia gravis. If approved, cemdisiran would be the first siRNA therapy for generalized myasthenia gravis and the only treatment that can offer quarterly subcutaneous dosing. Early in my career as a neurologist, I cared for many patients with this difficult-to-treat condition, so it is particularly gratifying to see us bring forward a potential new treatment option for them. In metabolic disease, MASH affects millions of people, and treatment options are limited. Our CIDEB program is a great example of our genetics-driven scientific process.

Regeneron Genetics Center discovered that people with naturally occurring loss-of-function variants of the CIDEB gene have a markedly lower risk of fatty liver disease and cirrhosis, which led us to develop a first-in-class siRNA that targets CIDEB. We are encouraged by the initial clinical data, which suggests best-in-class, best-in-disease potential, and we are rapidly advancing this program into registration-enabling studies. I would also like to highlight our program for Postural Orthostatic Tachycardia Syndrome, or POTS. This is an increasingly recognized debilitating condition that affects many young people, often disrupting school, work, and daily life, with very few effective treatment options and no FDA-approved medicines. Recent estimates suggest that between 500,000 and several million people in the U.S. alone suffer from POTS.

We believe the initial clinical data that George will highlight supports our antibody's potential to become the first FDA-approved treatment for this disease, and we plan to initiate a potentially pivotal study next year, pending regulatory feedback. In oncology, we recently shared encouraging data for ubamatamab, our MUC16xCD3 bispecific antibody, in advanced low-grade serous ovarian carcinoma. This is a rare and difficult-to-treat form of ovarian cancer that often affects younger women who urgently need better treatment options. We saw durable responses in heavily pre-treated patients at rates well above those historically seen with available therapies. We are already enrolling a dedicated, potentially registrational cohort and plan to start a confirmatory phase III study next year. Each of these programs is supported by compelling clinical data, human genetic validation, or both.

It is no accident that they span four distinct therapeutic areas and that each has first-in-class or best-in-disease potential. That reflects our disease-agnostic enterprise approach to R&D. Rather than confining ourselves to a few therapeutic areas, we apply our core technologies wherever the science leads us. These technology platforms, including our VelocImmune antibody and bispecific engines, Regeneron Genetics Center, and siRNA and gene editing technologies that allow us to translate genetic discoveries like CIDEB into potential medicines. Today, that approach supports approximately 50 clinical programs spanning immunology, oncology, ophthalmology, hematology, cardiovascular and metabolic diseases, neurology, and rare diseases. Our commercial organization has been built the same way. Our teams already call on ophthalmologists, dermatologists, pulmonologists, allergists, gastroenterologists, ENT specialists, oncologists, cardiologists, and hematologists. If cemdisiran is approved, we will begin to call on neurologists as well.

That means many of our pipeline medicines, including several of the programs I just mentioned, can launch into specialties where we already have deep relationships and expertise, and can leverage our existing infrastructure and capabilities. Briefly on business development. Historically, we have been a net out-licensor of innovation, with the most recent example being the expansion of our alliance with Sanofi. We are contributing to the alliance for next-generation long-acting antibodies, all invented at Regeneron, that target the same pathways that made Dupixent so successful. Regeneron will lead research and development, and Sanofi will lead global commercialization, now with greater transparency and increased participation by Regeneron. If approved, these medicines can also benefit from Dupixent's commercial leadership and the strong market access position it has established, an advantage neither company could capture on its own.