Exelixis, Inc.

ladies and gentlemen, and welcome to Exelix's first quarter 2024 financial results conference call. My name is Tawanda, and I'll be your operator 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, Mr. Varun Shravarnan, Director of Investor Relations. Please proceed.

Thank you, Tawanda. Thank you all for joining us for the XLX's first quarter 2024 financial results conference call. Joining me on today's call are Mike Morrissey, our president and CEO, Chris Senner, our chief financial officer, D.J. Haley, our executive vice president of commercial, Amy Peterson, our chief medical officer, and Dana Aftab, our chief scientific officer, who together will review our progress for the first quarter 2024 and in March 31st, 2024. 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 Securities and Exchange Commission, 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 costs associated with discovery, product development, business development, and commercialization activities. With that, I'll turn the call over to Mike. All right.

Thanks, Bharat, and thanks to everyone for joining us on the call today. Exalexis is off to a strong start in 2024 and had a productive first quarter across all components of our business. We're pleased to see both revenue and demand growth for the Cabo Zanza franchise in the U.S. and globally. Top priority is to move the needle for patients and shareholders by advancing Cabo Zanza and the rest of our exciting pipeline to improve the standard of care for patients with cancer. We have a lot to cover today, so let's jump right into it with the key highlights for the quarter, including first, We saw a strong performance of the Cabo Zantanib business in the first quarter of 2024 with continued growth in demand and revenue year over year compared to first quarter of 2023. Even with typical seasonal headwinds that were further magnified by the implementation of the IRA, Cabo Medics maintained its status as the leading TKI for RCC in both the first-line IO TKI market and the second-line monotherapy segment. First quarter, 2024, Cabo franchise net product revenues grew 4% year-over-year compared to first quarter 2023. Highlighting its role as a worldwide leading TKI, global Cabo's antediluted franchise net product revenues generated by Exalexis and its partners grew approximately 9% year-over-year in the first quarter of 2024 compared to first quarter 2023. As discussed previously, we're excited about the potential for additional Cabo growth with the new indications on the horizon that PJ and Amy will discuss shortly. Chris will review our full first quarter 2024 financial results in his prepared remarks. Second, we continue to advance our industry-leading pipeline across all stages of preclinical and clinical development. Our top priorities for 2024 are to advance potential new combo indications for NET and metastatic CRPC and expedite ZANSA clinical development with both existing and new pivotal trials, as well as potential new combination strategies. XB002 cohort expansion remains a clear focus for us, and XL309 continues to generate exciting momentum in the synthetic lethality space. Finally, we're thrilled with our progress in advancing new candidates in discovery and preclinical development, targeting a range of solid tumor indications that comprise an IND pipeline of both small molecules and biotherapeutics, which we expect to evolve quickly over the next several years. Third, final reply briefs for the second MSN and the trial were submitted in February, and we continue to expect a ruling in the first half of 2024. While we will not speak to any specifics today, this remains a critical milestone for the company and the Cabo Sanford franchise. ExoLexis will continue to vigorously protect our intellectual property rights with respect to Cabo and our other differentiated molecules we pursue on behalf of patients with cancer. Finally, fourth, we expect business development activities to ramp up significantly as we gain clarity on the outcome of the patent litigation. Importantly, we're exploring options to collaborate with other organizations in cost and compound sharing arrangements in a manner similar to our prior Cabos Antidote checkpoint combination endeavors. In addition, we are carefully reviewing the competitive landscape on an enterprise-wide level to identify additional later stage assets that we believe, through our unique Cabos Antidote lens, fit into our GU and GI oncology-focused drug development and commercialization platform. So with that, please see our press release issued an hour ago for our first quarter of 2024 financial results and an extensive list of key corporate milestones achieved in the quarter. I'll now turn the call over to Chris.