Eli Lilly and Company

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Ladies and gentlemen, thank you for standing by and welcome to the Lilly Q1 2025 earnings conference call. At this time, all participants are on a listen-only mode. Later, we will be conducting a question and answer session and instructions will be given at that time. Should you require assistance during the call, please press star, then zero, and an operator will assist you offline. I would now like to turn the conference over to your host, Mike Zappar, Senior Vice President of Investor Relations. Please go ahead.

Good morning. Good morning. Thank you for joining us for Eli Lilly and Company's Q1 2025 earnings call. I'm Mike Spahr, Senior Vice President of Investor Relations. Joining me on today's call are Dave Ricks, Lilly's Chair and CEO, Lucas Montarse, Chief Financial Officer, Dr. Dan Skowronski, Chief Scientific Officer and President of Lilly Immunology, Anne White, President of Lilly Neuroscience, David Hufa, President of Lilly International, Jake Van Narden, President of Lilly Oncology, and Patrick Johnson, President of Cardio Metabolic Health and Lilly USA. We're also joined by Mark Kuhman, Wes Tall, and Wai Wong of the Investor Relations Team. During this conference call, we anticipate making projections and forward-looking statements based on our current expectations. Our actual results could differ materially due to several factors, including those listed on slide four. Additional information concerning factors that could cause actual results to differ materially is contained in our latest form 10-K and subsequent filings with the SEC. The information we provide about our products and pipeline is for the benefit of the investment community. It is not intended to be promotional and is not sufficient for prescribing decisions. As we transition to our prepared remarks, please note that our commentary will focus on our non-GAAP financial measures. Now, I'll turn the call over to Dave. Thank you, Mike. Q1 was another exciting quarter. We increased our revenue, advanced our pipeline, invested to drive future growth, and shared the first Phase III clinical data from our oral GLP-1 or 4-glopron. Dan will share more details during the R&D update, but we're pleased with the results from the ACHIEVE-1 trial for 4-glopron in patients with type 2 diabetes. These data met our expectations and are the first step to delivering our overall goal for the program, which is to create a medicine that offers injectable GLP-1-like efficacy, safety, and tolerability with the convenience of a once-daily pill that can be manufactured at scale to meet global demand. This scientific breakthrough has the potential to eventually impact hundreds of millions of people around the world with chronic diseases. And we expect phase three data from seven global clinical trials to read out over the next 12 months across type two diabetes and obesity. We also expect potential regulatory submissions for obesity to begin worldwide by the end of 2025. On slide six, We list Q1 financial metrics and highlight progress related to our strategic deliverables. Revenue grew 45% compared to Q1 of 2024. Our key products, defined as Eblis, J. Perka, Kisanla, Wanjaro, Omvo, Resenio, and Zephound, grew by more than $4 billion and now account for $7.5 billion of revenue for the company. In addition to the Afogafron readout, We achieved several other key pipeline milestones this quarter. They include the approval of JPRCA in the EU for CLL, the approval of OMBO in the US, EU, and Japan for Crohn's disease, and the initiation of a phase three program for olomaracib in resected adjuvant non-small cell lung cancer. We also shared plans to more than double our manufacturing investment in the U.S. In total, we've announced over $50 billion of new U.S. manufacturing investments since 2020, including our most recent announcement to build four new facilities, of which three will be API or active pharmaceutical ingredient facilities. Lastly, we distributed $1.3 billion in dividends in the first quarter and executed a $1.2 billion share repurchase. We realize there's a lot of investor focus right now on tariffs and trade, so I'll make a few comments that reflect our current views on these complex and quite dynamic matters. We support the U.S. government's goals to increase domestic investment. However, we don't believe tariffs are the right mechanism. Enhanced tax incentives and or the extension of the Tax Cut and Job Act are better tools to achieve their goals. The announced tariffs currently, in effect, do not materially change Lilly's 2025 financial outlook. However, the expansion of tariffs in other geographies or increases in retaliatory tariffs would have a negative effect on Lilly and for our industry. As a company, Lilly has a large U.S. manufacturing footprint with 10 active projects ongoing to build and expand new sites. Upon completion of our manufacturing agenda, we will be able to supply medicines for the U.S. market entirely from U.S. facilities. as well as increase the volume of medicines we export. We will continue to execute our U.S. manufacturing agenda. However, we urge the administration to negotiate deals with key trading partners as soon as possible that level the playing field for American exporters like Lilly and remove harmful tariffs and non-tariff market access barriers in the developed economies. Now I'll turn the call over to Lucas to review our Q1 financial results.