Exelixis, Inc.

Good day, ladies and gentlemen, and welcome to the Exelixis third quarter 2023 financial results conference call. My name is Gigi, and I'll be your operator for today. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to your host for today, Ms. Susan Hubbard, Executive Vice President of Public Affairs and Investor Relations. Please proceed.

Thank you, Gigi, and thank you all for joining us for the XLS's third quarter 2023 financial results conference call. Joining me on today's call are Mike Morrissey, our president and CEO, Chris Center, our chief financial officer, TJ Haley, our executive vice president of commercial, Amy Peterson, our chief medical officer, and Dana Aftab, our chief scientific officer, who will review our progress for the third quarter 2023 and in September 30th, 2023. Peter Lamb, our EVP of Scientific Strategy, will join us for the Q&A portion of the call. During the call today, we will refer to financial measures not calculated according to generally accepted accounting principles. Please refer to today's press release, which is posted on our website, for an explanation of our reasons for using such non-GAAP measures, as well as tables deriving these measures from our GAAP results. During the course of this presentation, we will be making forward-looking statements regarding future events and the future performance of the company. This includes statements about possible developments regarding discovery, product development, regulatory, commercial, financial, and strategic matters. Actual events or results could, of course, differ materially. We refer you to the documents we file from time to time with the FTC, which under the heading Risk Factors, identify important factors that could cause actual results to differ materially from those expressed by the company verbally and in writing today, including without limitation, risks and uncertainties related to product commercial success, market competition, regulatory review and approval processes, conducting clinical trials, compliance with applicable regulatory requirements, our dependence on collaboration partners, and the level of cost associated with discovery, product development, business development, and commercialization activities. And with that, I will turn the call over to Mike.

All right. Thank you, Susan. And thanks to everyone for joining us on the call today. ExoLexus had a strong and very active third quarter across all components of our business. We're excited to see the Composantinib franchise continue to grow, both in size and potential scope, while we advance a range of discovery and development programs to build the ExoLexus pipeline of the future. Our singular goal is to improve the standard of care for patients with cancer. Key highlights for the third quarter include, first, strong performance of the Composantinib business with continued growth in demand and revenue in the U.S. Cabo Medics maintained its status as the leading TKI for RCC. Third quarter of 2023, Cabo franchise net product revenues were approximately $426 million and approximately $586 million in the U.S. and globally, respectively. Chris and PJ will update our progress in the quarter and provide additional commentary on our financial and commercial activities. Second, Excel's top priority in R&D is to deliver a pipeline of clinically and commercially differentiated medicines for large populations of cancer patients with high unmet medical needs. We'll highlight our integrated strategy spanning discovery, development, and commercialization activities that builds on past and recent composantative success at our upcoming R&D investor event on December 12th in New York City. Amy and Dana will highlight our third quarter progress at a high level today and I'm excited to have them join me and PJ as we dive into the details in December. Our upcoming R&D day is the first we've had in many years, and we look forward to the opportunity to elaborate more broadly on our strategy to propel the organization forward and serve more patients with cancer, all in our continued efforts to generate sustainable, long-term value for shareholders. Third, business development activities remain a priority as we continue to seek opportunities to access clinical assets, potential to generate differentiating clinical data, and solid tumor indications. In September, ExoLexis and Silico announced an exclusive license agreement granting ExoLexis global rights to develop and commercialize ExoL309, a potential best-in-class small molecule inhibitor of USP1, which has emerged as an important target for synthetic lethality in the context of BRCA mutated tumors. Fourth and finally, the second MSN trial took place last week at the U.S. District Court in Delaware. The case is now submitted, and we don't want to get ahead of the court by commenting or speculating on any components of the trial or the potential ruling, either today or in the future. We feel very confident in the case we presented last week and the overall strength of our Cabo Zanted patent estate. So with that, please see our press release issued an hour ago for our third quarter financial results and an extensive list of key corporate highlights achieved in the quarter. I'll now turn the call over to Chris.