Exelixis, Inc.

Good day, ladies and gentlemen, and welcome to the XELIX's second quarter 2023 financial results conference call. My name is Tawanda, 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. You may begin. Thank you.

Thank you, Tawanda, and thank you all for joining us for the Exalixis second quarter 2023 financial results conference call. Joining me on today's call are Mike Morrissey, our president and CEO, Chris Benner, our chief financial officer, PJ Haley, our executive vice president of commercial, Dana Aftab, our chief scientific officer, and Vicki Goodman, our chief medical officer, who will review our progress for the second quarter 2020-23 and the June 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 be making 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 those 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 SEC, 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. XOX has had a strong second quarter across all components of our business. We're pleased to see continued growth of the Cabo Xanthidib franchise, while at the same time, we expedite a range of discovery and development programs to build the ExoLexus pipeline of the future, with the goal of helping many more cancer patients. Key highlights for the second quarter include, first, strong performance of the Cabo Xanthidib business with continued growth in demand and revenue in the U.S. Cabo Medics maintained its status as the leading TKI for RCC, in both the first-line IOTKI market and the second-line monotherapy segment. Second quarter of 2023, Cabo franchise net product revenues in the U.S. were approximately $410 million and grew 18% year-over-year compared to second quarter of 2022. Global Cabo franchise net product revenues generated by Exalexis and its partners were approximately $577 million in second quarter of 2023, and also grew 18% year over year compared to second quarter 2022. 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 need. Our singular goal is to improve standard of care for patients with cancer. The more patients we help, the more value we create for patients, their families, healthcare providers, and their shareholders. We have an integrated R&D strategy spanning drug discovery, development, and commercialization activities, and are developing a pipeline of biologics and small molecules that have the potential to significantly move the needle for cancer patients. Dana and Vicki will highlight our second quarter progress later in the call. I'm pleased to announce that we'll present our R&D efforts at an investor event on December 2nd in New York City. Third, business development activities remain a priority as we continue to seek opportunities to access clinical assets with the potential to generate differentiating clinical data in solid tumor indications. We have several late-stage discussions ongoing, and while there's no guarantee of success in closing these transactions, we look to continue using this approach to fortify our product portfolio. Finally, fourth, ExoLexus entered into a settlement and license agreement with Teva to resolve patent litigation where ExoLexus will grant Teva a license to market its generic version of ComboMedix in the U.S. beginning on January 1, 2031, if approved by the FDA and subject to conditions and exceptions common to agreements of this type. Our attention and resources remain squarely focused on the second MSN case, which goes to trial in October. We will continue to vigorously protect our intellectual property rights. So with that, please see our press release issued an hour ago for our second quarter financial results and an extensive list of key corporate highlights achieved in the quarter. I'm now turning the call over to Chris.