Regeneron Pharmaceuticals, Inc.

to the Regeneron Pharmaceuticals Second Quarter 2022 Earnings Conference Call. My name is Bella, 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 today's conference is being recorded. I will now turn the call over to Ryan Crow, Vice President, Ambassador Relations. You may begin.

Thank you, Bella. Good morning, good afternoon, and good evening to everyone listening around the globe. Thank you for your interest in Regeneron, and welcome to our second 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, 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 open the call for Q&A. I would also like to remind you that remarks made on this call today 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 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 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 quarterly period ended June 30, 2022, 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 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, 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. With that, let me turn the call over to our President and Chief Executive Officer, Dr. Len Schleifer. Len?

Thank you, Ryan, and thank you to everyone joining today's call. Regeneron had a strong second quarter with notable execution, across R&D, commercial, and business development functions. Total revenues increased by 20% when excluding contributions from our COVID antibody cocktail, with net sales for ILEA, Dupixent, and Libtio each reaching new all-time quarterly highs and growing by double digits year over year on a constant currency basis. In addition to exceptional commercial execution, we made significant pipeline progress with three regulatory approvals, two accepted regulatory filings, and one positive Phase III readout. We also completed the acquisition of Checkmate Pharmaceuticals and the third quarter purchase of Worldwide Rights to Libtyo from Sanofi, both of which we believe will strengthen our oncology franchise in the near, medium, and long term. We also reported today preliminary but promising anti-tumor activity and safety data for Regen5678, our PSMA by CD28 co-stimulatory bispecific in combination with Libtyo in patients with advanced metastatic castrate-resistant prostate cancer. George will have more to say on this shortly, but we believe this represents an important step towards validating our co-stimulatory approach to fighting cancer and potentially advancing the science of immuno-oncology. Turning to our commercial performance, in the second quarter, ILEA global net sales grew 13% at constant exchange rates to 2.5 billion. In the U.S., ILEA net sales were 1.6 billion, up 14% year-over-year, and outperforming anti-VEGF category growth of approximately 8%. Despite new competition, Aaliyah's share was approximately half of the anti-VEGF category and 75% among branded agents, affirming its status as the gold standard anti-VEGF therapy. We believe a flipper set represents a significant potential growth opportunity going forward, given favorable demographic trends as well as the potential for Aflibicept 8 mg to augment the category and complement our retinal franchise. Regarding our investigational Aflibicept 8 mg, the goal of our clinical program is to evaluate whether visual acuity among wet AMD and DME patients can be maintained or improved compared to ILEA while extending the interval between doses. Equally important is maintaining the high bar for safety that has been set by ILEA over the past 10 years, 55 million injections worldwide, and 8 million patient years of experience. We anticipate pivotal results in late quarter three or early quarter four, and with supportive data, a BLA submission completed by early 2023. Dupixent continued to grow at a remarkable pace after five years and more than 450,000 patients treated since launch. In quarter two, global net product sales were 2.1 billion, an increase of 43% at constant exchange rates compared to last year, reflecting Dupixin's differentiated clinical profile and ability to effectively treat more and more patients with the type 2 inflammatory diseases where Dupixin is approved. In the U.S., we saw growth across all indications, including initial contributions from atopic dermatitis in patients as young as six months to five years of age, and from eosinophilic esophagitis, both of which are indications approved by the FDA during the second quarter and represent the first approved systemic treatment options for these patients. We hope to add a third first-in-class indication for Dupixent later this year, in patients with prurigo nodularis, which is currently under priority review with the FDA. In oncology, Liptyo net product sales grew 25% globally at a constant currency to $141 million in the second quarter of 2022, including 17% growth in the U.S., driven by non-melanoma skin cancer indications and monotherapy non-small cell lung cancer. We have long believed that the key to fully unlocking the opportunity in oncology is through differentiated combinations, with Liptio possibly serving as our foundation for many of them. That belief was the basis for acquisition of the global rights to Liptio. We plan to invest further in Liptio-based combinations, pairing it with promising candidates in our oncology pipeline, such as LAG3 antibody Frianulamab, and our many investigational bispecifics, as well as with candidates from external collaborations. We continue to make progress with these libtile combinations and intend to share initial data in the second half of this year from our emerging oncology pipeline, which George will discuss in more detail. Regarding the FDA's review of our libtile chemo combo supplemental BLA for the treatment of non-small cell lung cancer, We are pleased with the progress that we have made as the FDA continues its review. However, we recently were informed that an FDA travel complication relating to scheduling a routine clinical trial site inspection in Eastern Europe will likely delay their decision until after our September 19th PDUFA date. While any delay is disappointing, a new site inspection date has been scheduled. Therefore, we do not expect a lengthy extension of the review period, and we do not expect it to meaningfully impact our launch plans, assuming FDA approval. We continue to actively work with the FDA, believing the ongoing review is otherwise progressing well, and all other elements of the review remain on track. Regarding our COVID-19 response, Regeneron remains committed to combating the virus by developing additional novel antibodies. We continue to work with the FDA to establish a regulatory pathway for these antibodies, which could potentially serve an important role in protecting immunocompromised individuals who do not respond adequately to COVID-19 vaccines, as well as treating infected patients for whom all antiviral therapy is not appropriate. In closing, as I reflect on our performance during the first half of the year, I am very proud of our numerous achievements. which were only made possible by the dedicated Regeneron employees around the world. Together, we have continued to serve patients in need while strengthening the foundation of the company and leveraging our financial strength to better position Regeneron to achieve sustainable growth over time. We are excited about the increasing commercial momentum for our core products and the important progress we have made in advancing our pipeline. Our strategy continues to focus on investing in our internal R&D capabilities while exploring potential collaborations that will enable us to fully realize the power of our science. We remain confident in the strategy and in our growth prospects, as well as in our ability to deliver breakthroughs to patients and value to shareholders. Now, I'll turn the call over to George.