Eli Lilly and Company

Ladies and gentlemen, thank you for standing by, and welcome to the Lilly Q3 2023 earnings 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. To 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, Joe Fletcher, Senior Vice President of Investor Relations. Please go ahead.

Good morning, and thank you, Paul. And thanks, everybody, for joining us for Eli Lilly and Company's Q3 2023 earnings call. I'm Joe Fletcher, Senior Vice President of Investor Relations. And joining me on today's call are Dave Ricks, Lilly's Chair and CEO, Anad Ashkenazi, Chief Financial Officer, Dr. Dan Skowronski, Chief Scientific and Medical Officer, Anne White, President of Lilly Neuroscience, Ilya Yufa, President of Lilly International, Jake Van Narden, President of Loxo at Lilly, Mike Mason, President of Lilly Diabetes and Obesity, and Patrick Johnson, President of Lilly Immunology and Lilly USA. We're also joined by Michaela Irons, Mike Springnether, and Lauren Zierke of the IR team. During this conference call, we anticipate making projections and forward-looking statements based on our current expectations. Actual results could differ materially due to several factors, including those listed on slide three. Additional information concerning factors that could cause actual results to differ materially is contained in our latest Form 10-K and subsequent Forms 10-Q and 8-K filed with the Securities and Exchange Commission. The information we provide about our products and pipeline is for the benefit of the investment community. It's 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 non-GAAP financial measures. Now I'll turn the call over to Dave. Thanks, Joe.

In Q3, Lilly continued the progress we made so far this year. We delivered strong financial results, continued to advance our R&D pipeline, and invested in our future through several business development transactions. As you can see on slide four, we continued to make progress against our strategic deliverables this quarter, excluding revenue from the olanzapine portfolio and COVID-19 antibodies. Revenue grew 24%. Our new products and growth products combined contributed approximately 17 percentage points toward volume growth, with over 12 percentage points coming from our growth products. Last week, we announced that the FDA approved OMVO for the treatment of moderately to severely active ulcerative colitis in adults. This marks Lilly's first approval in the US for a type of inflammatory bowel disease, and it's important for Lilly's growth in its immunology portfolio. In addition to the FDA approval for OMVO, we had several other important pipeline updates since our last earnings call. Specifically, Jardiance was approved by the FDA for the treatment of adults with chronic kidney disease at risk of progression. And we reported positive phase three results from the VIVID-1 trial, which evaluated the safety and efficacy of mirakizumab for the treatment of adults with moderately to severely active Crohn's disease. In Q3, we announced that the FDA issued a complete response letter for Leberkizumab based on inspection findings at a third-party manufacturer. The letter stated no concerns with the clinical data package, the safety, or the label. We will continue to work with the third-party manufacturer and the FDA to address the findings to make Leberkizumab available to patients as quickly as possible. In terms of business development, we once again had a very active quarter. In Q3, we completed the divestiture of the Olanzapine portfolio, which will further enable us to focus on our current and new product launches. The financial impact of this transaction is reflected in the Q3 results. Additionally, within the quarter, we completed the acquisition of two clinical stage companies, adding to our Phase II portfolio, Dice Therapeutics and Fursanus Bio, as well as the acquisition of Emergence Therapeutics and Siglon Therapeutics. We also announced that we reached an agreement to acquire Point Biopharma, which if approved, has the potential to expand our oncology capabilities into next generation radioligand therapies. And lastly, we distributed over a billion dollars in dividends this quarter. On slide five, you'll see a list of key events since our Q2 call, including several important regulatory, clinical, and other updates we are sharing today. Now let me turn the call over to Anat to review our Q3 results.