Regeneron Pharmaceuticals, Inc.

Welcome to the Regina Rahn Pharmaceuticals Second Quarter 2023 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, Investor Relations. 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 second quarter 2023 earnings conference call. An archive of this webcast will be available on our investor relations website shortly after the call ends. Joining me on today's call are Dr. Leonard Schleifer, Board Co-Chair, Co-Founder, President, and Chief Executive Officer, Dr. George Yancopoulos, Board Co-Chair, 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 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 forecasts and guidance, revenue diversification, development programs and related anticipated milestones, including anticipated regulatory actions, 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, where the quarterly period ended June 30, 2023, 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 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 further questions. With that, let me turn the call over to our President and Chief Executive Officer, Dr. Len Schleifer. Len? Thanks, Ryan, and thanks to everyone joining today's call.

Regeneron delivered strong results across the organization in the second quarter of 2023, while continuing to make progress toward our long-term objective of growing the business while simultaneously diversifying its revenue and earnings streams. Total revenues increased by 11% compared to the prior year quarter, primarily driven by Sanofi collaboration revenues and Libtayo net product sales. which grew by 39% and 49%, respectively. Non-ILEA revenue contributions were 41% of total revenues, the highest proportion for any quarter in the last 10 years, excluding those with COVID antibody revenue contributions. Overall, we were pleased with the trajectory of the business and believe the company continues to be well-positioned to deliver long-term growth. In a few minutes, George, Marion, and Bob will provide commentary on pipeline developments, commercial execution, and financial results that we achieved during the second quarter. For the remainder of my remarks today, I will focus on Aflibricep 8 milligrams. We are very excited about the emerging clinical profile, including the compelling two-year data from the Pivotal Photon Study in patients with diabetic macular edema, which George will discuss in more detail. Now I will summarize the progress that has been made toward getting this important product candidate approved by the FDA. As we announced in late June, the complete response letter, or CRL, that we received from the FDA regarding our biological license application for a FlibroCept 8 milligrams for the treatment of patients with wet age-related macular degeneration, DME, and diabetic retinopathy, did not identify any issues related to a flibrocept 8 milligrams clinical efficacy, safety profile, trial design, labeling, or drug substance manufacturing, nor has the FDA requested any additional clinical data. The CRL was entirely based on unresolved observations resulting from the May 2023 FDA pre-approval inspection of a third-party contract manufacturing organization, Catalan, that Regeneron engaged to complete vial filling for Aflibizep 8 milligrams. The inspection observations were noted in a Form 483 and were related to a manufacturing line in Catalin's facility that is used to fill vials with Aflibizep 8 milligrams, as well as our C5 antibody, Cozelumab, for the ultra-rare Chappell disease, which has a PDUFA date of August 20th. The inspection was conducted as part of the FDA review process for both the Aflibicept 8-mg BLA and the Pazelamab BLA. Broadly speaking, the observations cited production and process control procedures, equipment validation, and facility maintenance. We, Catalan, and the FDA have had multiple discussions since the Aflibicept 8-mg CRL. There is a clear understanding of the remediation work that is required to allow the FDA to resume approving BLAs that involve manufacturing on this line. Catalan has already provided data and information to the FDA that could satisfy some of these requirements and expects to be able to provide the remaining required data and information by mid-August. The FDA said they will strive to complete their review expeditiously prior to the August 20th PDUFA date for Pozellamab. However, if they are unable to complete their review before this date, the FDA said that they may need to extend their review by up to three months. If they do extend the review, FDA has stated that they will continue to prioritize the review and complete it as early as possible. Importantly, the FDA has also stated that their review of the Catalan manufacturing data in the context of the Pizellamab BLA will support actions for both the Pizellamab BLA and the Aflibrocept 8 milligram BLA resubmission, which has already been submitted. In summary, We in Catalan expect to submit by mid-August all of the Catalan manufacturing data and information required to address the observations resulting from the pre-improval inspection. The FDA has stated that they will strive to complete their review expeditiously prior to August 20th. If not, we anticipate the FDA will act on a Pizellamab and a Flibicep 8-milligram BLAs before the end of the third quarter. In closing, we remain confident in our strategy of focusing investment on our internal R&D capabilities while exploring potential external collaborations, as well as in our ability to deliver breakthroughs to patients and value to shareholders. With that, let me turn the call over to George.