Regeneron Pharmaceuticals, Inc.

Welcome to the Regeneron Pharmaceuticals first quarter 2023 earnings conference call. My name is Josh 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, Josh. Good morning, good afternoon, and good evening to everyone listening around the world. Thank you for your interest in Regeneron and welcome to our first 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 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 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 March 31, 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? Thank you, Ryan, and thank you to everyone joining today's call. Following our significant achievements in 2022, Regeneron is off to a good start in 2023, highlighted by important regulatory and pipeline advances, commercial execution, and prudent capital allocation, all of which position Regeneron better the company to deliver sustainable long-term growth and shareholder value over time. George, Marion, and Bob will cover details of our first quarter performance in a few moments. In the meantime, I would provide an update on our goal of continuing to grow our business while simultaneously diversifying our revenue and earnings streams, which is part of our long-term vision for Regeneron. We have made substantial progress toward achieving that goal. Over the past four years, while total revenues have nearly doubled, ILEA accounted for only 57% of total revenues in the first quarter of 2023 compared to 88% of total revenues for the year 2019. Driven primarily by the growth of Dupixent, our Sanofi collaboration accounted for 25% of our total revenues in the first quarter of 2023 compared to only 6% of our total revenues in 2019. We expect this trend of revenue growth along with diversification to continue. For example, assuming the approval and successful launch of a Flibberset 8 milligrams, which has a June 27th PDUFA date, ILEA 2 milligrams is expected to become its smallest share of our revenues, while a Flibberset 8 milligrams is expected to contribute to overall revenue growth. In addition, Dupixent remains in a high growth mode, with global net product sales up 40% on a constant currency basis compared to the prior year quarter, driven by growth across all five approved indications. We believe the positive phase three results for Dupixent in a subpopulation of COPD patients with evidence of type two inflammation, as well as the promising results for our IL-33 antibody, it's a Pecumab in former smokers represent additional significant opportunities to accelerate revenue growth as well as diversification. Our oncology portfolio is also starting to make a meaningful contribution to our top line with last year's acquisition of full global rights to Libtayo and the recent launch of Libtayo in combination with chemotherapy in advanced non-small cell lung cancer. Moreover, we believe that cianumab, our LAG3 antibody, in combination with Liptio, has the potential to become an important therapy in both melanoma and non-small cell lung cancer, where we have already advanced to pivotal studies. We are also quite excited about the emerging clinical profile for limvoceltamab, our BCMA by CV3 bispecific. Updated data for which will be presented at the upcoming ASCO annual meeting. We remain on track to submit a BLA seeking accelerated approval in late stage myeloma later this year. We continue to invest in our research and development engine and expect it will deliver new differentiated medicines that will drive organic growth over time. Our broad development pipeline of nearly three dozen programs, spans many different therapeutic areas and modalities. Notably, our co-stimulatory bispecifics in cancer, our early pipeline in cardiovascular and metabolic diseases, as well as our collaborations with our Nilem, Intelia, Decibel, and others are expected to drive medium and long-term revenue growth, profitability, and diversification. Before handing over to George, I'd like to take a moment to recognize the contributions that Dr. Roy Vagelos has made to Regeneron over the nearly three decades that he has served as our board chair. Over the years, he has provided invaluable guidance, and he continues to inspire us as we work to turn world-class science into medicines. Roy will retire from the board after his current term ends next month. At that time, in addition to our current roles at the company, George and I will be appointed by the board to serve as co-chairs And Christine Poon, a member of Regeneron's board since 2010, will be appointed as the board's lead independent director. With that, let me turn the call over to George. Thank you, Len.