Eli Lilly and Company

Ladies and gentlemen, thank you for standing by and welcome to the Lilly Q2 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 request 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 Zapar, Senior Vice President of Investor Relations. Please go ahead.

Good morning. Thank you for joining us for E9 Lilly and Company's Q2 2025 earnings call. I'm Mike Zapar, Senior Vice President of Investor Relations. Joining me on today's call are Dave Ricks, Lilly's Chair and CEO, Lucas Mondarse, Chief Financial Officer, Dr. Dan Skowronski, Chief Scientific Officer and President of Lilly Immunology, Anne White, President of Lilly Neuroscience, Ilya Yufa, President of Lilly USA and Global Customer Capabilities, Jake Van Arden, President of Lilly Oncology, Patrick Janssen, President of Lilly International and Ken Custer, newly appointed President of Lilly Cardiometabolic Health. We're also joined by Mark Heumann, Susan Hedgeland and Wai Wong of the Investor Relations team. During this call, we anticipate making projections and forward-looking statements based on our current expectations. Our actual results may 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 10K 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 our commentary will focus on our non-GAP financial measures. Now, I'll turn the call over to Dave.

Thanks, Mike. Q2 is a strong quarter. We delivered robust revenue growth, shared top-line clinical data from multiple phase three programs and invested in several initiatives that will support our future growth. Today, we shared positive top-line data from the ATTAIN-1 or Forgopron trial in people with obesity. In ATTAIN-1, patients taking the highest dose of Orforgopron lost more than 27 pounds or .4% of their body weight. In addition, the safety and tolerability in ATTAIN-1 was consistent with the injectable GOP-1 class. Orforgopron also met all secondary endpoints in this study, improving key markers of metabolic health, such as blood pressure, cholesterol, and inflammation. This is the second positive phase three trial for Orforgopron we reported this year, and we're encouraged by these results. Our goal from the beginning was to create a medicine that has a clinical profile consistent with approved GOP-1s while offering the convenience of a once daily pill and the production flexibility of small molecule chemistry to meet global demand. We believe this medicine has the potential to make a significant impact on human health, and we will now work with urgency to submit Orforgopron around the world to meet the global challenge of obesity. On slide six, we list key Q2 financial metrics and highlight progress related to our strategic deliverables. Revenue grew 38% compared to Q2 2024, driven by our key products. These include EBLIS, Jeperka, Kisanla, Monjaro, Omvo, Verzenio, and Zephound. In the US, we continue the robust uptake of Zephound and Monjaro, and Lilly gained market share in the Anchortin analog class for the fourth quarter in a row. Monjaro also recently became the market leader in the US in total prescriptions within the Type 2 diabetes Anchortin market. Outside the US, we continue to launch Monjaro in new countries. These include Mexico and Brazil most recently. We have now launched Monjaro in most major markets. Q2 is also a quarter of continued investment for Lilly. In addition to increasing commercial activities to support our newest medicines, we started multiple new clinical programs. While the company is experiencing rapid revenue growth, we're also increasing our R&D investment as early phase program data continues to impress us and to support our future growth of the company. Our financial performance in the first half of 2025 was strong, and as a result, we raised our revenue and earnings for share guidance. Lucas will cover this in more detail during the financial update. In addition to the results from AttainOne, we achieved several key milestones since our last earnings call. These include the US FDA approval of a new dosing schedule for Cassandra, the positive European CHMP opinion for Cassandra, announced positive results in the surpassed CDOT phase three trial for trisepatitis in people with Type 2 diabetes and heart disease. We announced positive results in the Bruin CLL 314 phase three trial of perturbutinib in CLL and SLL. And we launched the two highest doses of Zepbond and Vials in the United States. We announced and closed the acquisition of SiteOne Therapeutics, which expands Lily's pain portfolio and adds a clinical stage non-opioid pain program to our mix. And VIRB Therapeutics, which adds new genetic medicines for cardiovascular disease with potential to only be administered once in a person's lifetime. We made progress in Q2 and throughout the first half of 2025 to bring new manufacturing capacity online. We produced more than 1.6 times the amount of saleable increments doses during the first half of 2025 when compared to the first half of 2024. This includes a significant step up in capacity from our recently constructed facility in Research Triangle Park, North Carolina. We will continue to bring more capacity online in the second half of 2025 and expect our production capabilities to increase further. We also plan to announce the location of two of our new US manufacturing facilities later this quarter. During the quarter, we distributed $1.3 billion in dividends and executed approximately $700 million in share repurchases. Before I turn to the caller, Lucas, I'd like to offer some perspective on the drug pricing reform discussion that's going on. While we support the administration's position that medical research costs need to be shared more equitably across developed countries, it's also true that the US pharmaceutical market has significant defects, which shift costs to consumers and increase red tape. These problems also require urgent reform and make apples to apples comparisons of X-factory pricing inaccurate and misleading. At Lilly, we've already implemented several initiatives which directly lower patient costs for our most commonly used medicines. We operate a direct to consumer model at scale through Lilly Direct, which provides more affordable access to Lilly medicines. This includes our leading weight loss medications that found at a discount of more than 50% off the list price. We also led in resolving insulin pricing issues in our country by reducing list prices by 70% and ensuring broad access to $35 monthly patient costs, including for Medicare. Negotiated prices in Europe come with broad access, low patient co-pays, and without administrative hurdles like prior authorizations. There are also no intermediaries that distort prices and hospitals do not seek profit by selling medicines and marking them up. If we import foreign price controls and insert them into a US system that isn't built to function for patients, we risk embracing the worst of two worlds, the low productivity and output of Europe's biopharma sector with the high out of pocket and distorted prices of the US insurance market. Both today's patients and the future of new cures and treatments will suffer, along with the United States competitiveness. Of course, we will engage and are committed to working instructively with the administration to find solutions that both benefit patients while preserving the hope for tomorrow's cures and the scientific base that has made America the envy of all in global pharmaceutical innovation. Now I'll turn the call over to Lucas to review our Q2 results.