Regeneron Pharmaceuticals, Inc.

Welcome to the Regeneron Pharmaceuticals' fourth quarter 2022 earnings conference call. My name is Shannon, 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 is being recorded. I will now turn the call over to Ryan Crowe, Vice President, Investment Relations. You may begin.

Thank you, Shannon. Good morning, good afternoon, and good evening to everyone listening around the globe. Thank you for your interest in Regeneron, and welcome to our fourth quarter 2022 earnings conference call. An archive of this webcast will be available on our investor relations website shortly after the call ends. Joining me today are Dr. Leonard Schleifer, co-founder, president, and chief executive officer, Dr. George Yancopoulos, co-founder, president, and chief scientific officer, Marion McCourt, executive vice president and head of commercial, and Bob Landry, executive vice president and chief financial officer. After our prepared remarks, we will then open the call up 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 businesses, financial forecasts and guidance, development programs and related anticipated milestones, collaborations, finances, regulatory matters, payer coverage and reimbursement issues, intellectual property, pending litigation and other proceedings, and competition. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those projected in that statement. A more complete description for these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2022, which we expect to file with the SEC on Monday, February 6th. 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 measures will be discussed in today's call. Information regarding our use of non-GAAP financial measures and a reconciliation of those measures to GAAP is available in our financial results press release and our corporate presentation, which can be accessed on our website. Once our call concludes, Bob Landry and the IR team will be available to answer any further questions you may have. With that, let me turn the call over to our President and Chief Financial Officer, Len Schleifer. Len? Happy Chief Executive.

Sorry, Chief Executive Officer, but it's okay. Good morning to everybody, and for those of you experiencing the Arctic freeze, I hope you're staying warm. Our strong fourth quarter performance kept a remarkable year at Regeneron, highlighted by significant achievements, that better positioned the company to deliver sustainable growth and shareholder value. Fourth quarter 2022 revenue increased 14% compared to the prior year, when excluding the impact of contributions from Regenco and Rona Preve, underscoring the commercial strength and increasing diversity of our business. We also made several important advances across our pipeline during the quarter. notably the submission of a biologic license application for a flipper set 8 milligrams in neovascular age-related macular degeneration, or wet A&D, as well as diabetic macular edema, or DME, positioning us for a potential U.S. launch in late August of this year. Additionally, we received FDA approval for Liptio in combination with chemotherapy as a first-line treatment for advanced non-small-cell lung cancer. making Libtyo only the second PD-1 or PD-L1 antibody approved in this setting, regardless of a patient's histology or PD-L1 expression level. We also presented data from a rapidly advancing oncology pipeline, including for Fianlumab, our LAG-3 antibody, in combination with Libtyo, an advanced non-small cell lung cancer, Ogenexamab, our CD20 by CD3 bispecific, in B-cell lymphomas, and limvosteltamab, our BCMA by CD3 bispecific in multiple myeloma. Finally, Dupixit was approved for prurigo nodularis in Europe. Briefly reflecting on 2022, we entered the year with three strategic imperatives that we felt we had to accomplish in order to position the company for long-term growth. First, we had to fortify the medium and long-term outlook for our retinal franchise. Based on the positive results that we reported in September 2022, we believe Aflibicept 8mg has the potential to change the treatment paradigm for patients with wet AMD and DME by becoming the new standard of care for these patients, positioning Regeneron for prolonged leadership in this category. we needed to maintain and grow Dupixent leadership across a variety of type two allergic diseases. 2022 turned out to be a phenomenal year with Dupixent global net product sales approaching 8.7 billion and growing 44% at constant currency. Despite new competition, Dupixent maintained a leading market position in atopic dermatitis, asthma, and nasal polyps, and was also approved in new indications, geographies, and younger populations, which George will detail shortly. Collectively, these 2022 approvals meaningfully expanded the Dupixent commercial opportunity, allowing the addressable population to increase by approximately 225,000 patients, bringing the total addressable population to over 7 million patients globally. Third, we wanted to make significant progress towards becoming a leader in immuno-oncology, and 2022 turned out to be a crucial year. Key to this long-term goal was requiring Sanofi's share of global rights to Libtyl, an antibody discovered by Regeneron, which was a necessary step towards realizing the full clinical and commercial potential of this foundational therapy. It also enables us to unlock combination opportunities from promising candidates in our oncology pipeline, including with our LAG-3 antibody, our co-stimulatory bispecifics, and our CD3 bispecifics. Looking ahead, we expect 2023 to be another notable year, with significant incremental progress across these imperatives as well as in other areas of our business. We are preparing for a potential U.S. launch for Aflibicept 8 mg in late August, given prescribers' decade-plus experience with ILEA, and now with the 48-week data for Aflibicept 8 mg, which demonstrated comparable efficacy and safety to ILEA, but with longer treatment intervals, we believe that over time there is an opportunity for Aflibicept 8 milligrams to become the new standard of care for wet AMD and DME. We expect Epixin to continue to strengthen its leadership position across approved type 2 allergic diseases based on its differentiated mechanism of blocking both interleukin 4 and interleukin 13. In 2023, we have an opportunity to reach even more patients with potential regulatory approvals in new diseases, geographies, and younger populations that could add another approximately 500,000 patients globally to the biological eligible population. Additionally, we look forward to the upcoming readout of our first phase three study of Dupixin in COPD in the first half of this year. In oncology, we expect to continue rapidly advancing our pipeline for our LAG3 combination with Liptio We are moving forward with expansion beyond melanoma to include lung cancer and potentially other solid tumors. For our co-stimulatory bispecifics in combination with Liptio, we are continuing dose expansion in our Phase I-II PSMA by CD28 program in advanced prostate cancer. We also expect to report additional Phase I data from our EGFR by CD28 program in solid tumors and to present initial clinical data for our MUC16 by CD28 program in recurrent ovarian cancer. And within HEMUNC, we anticipate second half regulatory submissions for ogenetsimab and follicular lymphoma and diffuse large B-cell lymphoma, as well as limvoseltamab and refractory multiple myeloma. In 2023, we also plan to rapidly move forward with clinical development of our next generation COVID-19 antibody, which we believe could help protect the millions of vulnerable patients who are unable to mount a sufficient immune response from vaccination and treat those who require other alternatives. Activities enabling clinical manufacturing have commenced, and we expect to enter clinical development later this year. In closing, 2022 was a pivotal year at Regeneron, and we expect to continue making significant progress in 2023. Our strategy remains focused on investing in our internal R&D capabilities, which has historically generated a high rate of return. We remain confident in our near and long-term growth prospects, with approximately 35 pipeline candidates currently progressing through clinical trials. We will also continue looking for opportunities to complement these internal efforts by exploring potential collaborations. With our commercial capabilities continue to drive revenue growth and our strong financial position, Regeneron is extremely well positioned to continue delivering breakthroughs for patients and value to shareholders. Now, I will turn the call over to George.