Exelixis, Inc.

Good day, ladies and gentlemen, and welcome to the Exelixis second quarter 2025 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. Please proceed.

Thank you, Tawanda, and thank you all for joining us for the Exalexis Second Quarter 2025 Financial Results Conference Call. Joining me on today's call are Mike Morrissey, our President and CEO, Chris Senner, our Chief Financial Officer, PJ 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 second quarter 2025 and in June 30th, 2025. 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, potential growth opportunities, and government drug pricing policies and initiatives. 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 can cause actual results to differ materially from those expressed by the company verbally and in writing today, including without limitations, 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. 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. XLS has had a strong second quarter, accelerating our progress and building momentum across all components of our business. Thriving growth of the Cobbler's Antidote franchise, now catalyzed by the early stage of a successful net launch, is our top priority while we execute on our R&D strategy to build a multi-compound, multi-franchise oncology business. All corporate activities are aligned on a single focus to improve the standard of care for patients with cancer. The magnitude of our future success will be determined by increasing the number of cancer patients we seek to serve and ultimately the impact we have on their disease with current and future Exalexis medicines. By driving for success across all components of our business, we hope to solidify our leadership in oncology drug discovery, development, and commercialization through intensity, innovation, and collaboration. Key highlights for the second quarter include, first, the robust performance of the Cabo Zantitib U.S. business, the strong growth in demand and revenue from our commercial activities. Cabo Zantitib continues to build on its leadership position as the leading TKI for RCC. Second quarter 2025, U.S. CAVO franchise net product revenues grew 19% year-over-year to $520 million compared to $438 million in the second quarter of 2024. CAVO's second quarter growth is noteworthy because it relates solely to commercial demand with negligible benefit from clinical trial sales and significant gross-to-net headwinds. Importantly, We saw brisk full quarter sales for the recently approved net indications and already built a leading share in the oral second line plus net segment, which contributed to approximately 4% of our second quarter 2025 net product revenue. PJ will provide more information and commentary about our second quarter franchise performance and encouraging dynamics of the net launch in his prepared remarks. And just last Thursday, our partner Ipsen received approval for NET from the European Commission, and revenues from this important new indication, as it rolls out across Europe, will add to our royalty stream. We will continue to evaluate further updates to our 2025 financial guidance as we build momentum on the NET launch and gain further clarity on additional revenue opportunities for the second half of 2025. Second, as outlined previously, vanzalitinib is rapidly advancing as our next oncology franchise opportunity and the subject of numerous ongoing and soon-to-start pivotal trials. We're pleased with the positive top-line results from Stellar 303 and CRC and look forward to engaging with regulators with the intent of filing for approval in this indication as quickly as possible. Stellar 304 and non-clear cell RCC is fully enrolled and continues to progress with top-line results expected in the first half of 2026, pending event rates. Based on evaluation of the data from CELTA-305 in head and neck cancer and the competition in this indication, we made the decision to not advance this trial into phase three. This decision was further supported by our assessment of the commercial opportunity of new ZANSA indications on the horizon that we believe have a higher probability of success little to no competition, and potentially an approximate threefold greater commercial value than the Stellar 305 opportunity. As we've highlighted previously, we stand ready to make tough, decisive capital allocation decisions based on clinical and competitive data and in-depth financial analysis. We're doing it now for Stellar 305, and you can expect the same level of rigor from us and all in the future across all components of the business. we continue to prioritize existing and new ZANZA indications as the most promising path to a second ExoLexus oncology franchise that we believe can eclipse the size, scope, and impact of our Cabo Zantative franchise. Third, the ExoLexus early stage pipeline is advancing quickly with a range of new and potentially differentiated biologics and small molecules heading into and through early clinical evaluation. As I highlighted last quarter, We're not looking to just build a big pipeline, but carefully and quickly identify the winners for advancement into full development as top investment priorities. Early evaluation of XL309 and XB010 continue to advance quickly, and we're pleased to have the bispecific XB628 and our second-generation tissue factor-targeting ADC, XB371, moving into the clinic. Finally, we remain committed to carefully managing capital allocation while we advance our R&D and commercial priorities. Our balance sheet and expected free cash flow provide us with the opportunity to advance our pipeline priorities, access new high conviction assets, and continue to repurchase shares when we believe they are undervalued. Business development activities continue in earnest, and we're focused on doing the right deals for the right assets at the right valuation. So with that, please see our press release issued an hour ago for our second quarter 2025 financial results and an extensive list of key corporate milestones achieved in the quarter. And I'll now turn the call over to Chris.