Regeneron Pharmaceuticals, Inc.

Welcome to the Regeneron Pharmaceuticals Third 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 Crow, 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 Regenron and welcome to our third quarter 2023 earnings conference call. An archive and transcript 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 forecasting guidance, revenue diversification, 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 September 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, both of which can be accessed on our website. Once our call concludes, Bob Landry and the Investor Relations 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. Len?

Thanks Ryan, and thanks to everyone joining today's call. We generally delivered another strong quarter marked by continued execution across the company, which drove double digit top line growth and notable progress across our innovative R&D pipeline. Total revenues increased by 15% on a reported basis compared to the prior year quarter, primarily driven by Sanofi collaboration revenues and Liptayo global net product sales, which grew by 50 percent and 62 percent, respectively. Two picks in global net product sales were 3.1 billion, up 33 percent, reflecting strong growth across all approved indications. Non-GAAP net income per share, diluted share, increased by 4 percent, including an unfavorable 77-cent impact from acquired IP R&D. Today, I will briefly discuss the launch of ILEA-HD, the progress we continue to make across our pipeline, and our latest thinking on capital allocation. I will then hand the call over to George, Mary, and Bob, who will provide additional commentary on our pipeline developments, commercial execution, and our financial results for the quarter. Starting with ILEA-HD, which is off to a great start. We launched in late August, shortly following FDA approval and recorded $43 million of net product sales in the final six weeks of the quarter, which compares favorably to recent launches in the retinal disease category. Importantly, revenues were driven by strong initial demand with multiple reorders by distributors before the end of the quarter. In addition, Samples for ILEA-HD were made available shortly after the launch, enabling prescribers and patients to trial the product. Early ILEA-HD utilization has come from across the spectrum of wet age-related macular degeneration and diabetic macular edema patients, and momentum continues to build as positive real-world clinical experiences accumulate. We have also made significant progress establishing access and reimbursement, and we will continue to work on positioning ILEA-HD, the highest dose anti-VEGF therapy approved by the FDA, as the new standard of care in these retinal diseases. Moving on to the recent progress we have made advancing our pipeline, within hematology oncology and our CD3 bispecific platform, the BLA for odronextamab, are CD20 by CD3 bispecific in certain lymphomas was accepted by the FDA and granted priority review with a March 31st PDUFA date assigned. We also remain on track to submit a BLA next month for limvoseltamab, a BCMA by CD3 bispecific for multiple myeloma, with pivotal trials now underway for both programs to support potential accelerated approvals We are preparing for two commercial launches next year. Last week, we reported a potential breakthrough for patients with profound congenital hearing loss. The first patient enrolled in the Phase I-II Chord Clinical Trial of DB-OTO, an investigational cell-selective adenovirus-associated viral gene therapy designed to provide durable physiological hearing to individuals with profound congenital hearing loss caused by mutations in the otofuralin gene, experienced hearing improvement six weeks after treatment compared to baseline. We are looking forward to continued follow-up with this patient as well as enrollment of additional patients to further validate this gene therapy approach. While otofuralin gene deficiency is an ultra-rare condition, We are hopeful that we can expand our approach to gene therapy in the year to more common genetic causes of profound hearing loss. Finally, regarding capital allocation, while we continue to prioritize internal R&D investment, given the strength of our balance sheet and anticipated future cash flows, we believe we have the flexibility to take additional actions to drive shareholder value. Beyond our ongoing share repurchase program, we continue to actively pursue emerging science and innovative platforms that complement our core R&D strengths. In addition to the decibel acquisition, we announced last month an expanded research collaboration with Intelia, combining our proprietary antibody-targeted viral vector delivery technologies with Intelia's CRISPR platform to jointly explore in vivo programs outside of the liver for neurological and muscular diseases. We have always managed Regeneron with a focus on generating long-term returns, and we will continue to think carefully about how to strategically deploy our capital with the goal of delivering breakthroughs to patients and value to shareholders. In closing, we had a strong third quarter. The ILEA HD launch is progressing well. Our pipeline is delivering important innovations, and we continue to look at ways to efficiently allocate capital. With that, let me turn the call over to George.