Exelixis, Inc.

Good day, ladies and gentlemen, and welcome to the Exilexis Second Quarter 3026 Financial Results Conference Call. My name is Kathleen, and I will 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, Mr. Andrew Peters, Senior Vice President of Strategy and Investor Relations. Please proceed.

Thank you, Kathleen, and thank you all for joining us for the XLX's second quarter 2026 financial results conference call. Joining me on today's call are Mike Morrissey, our president and CEO, Chris Senner, our chief financial officer, Dana Aftab, our executive vice president of research and development, and PJ Haley, our executive vice president of commercial, who will review our progress for the second quarter 2026 and in June 30th, 2026. 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 Securities and Exchange Commission, 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 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 the discovery, Product Development, Business Development, and Commercialization Activities. With that, I'll turn the call over to Mike.

All right. Thank you, Andrew, and thanks to everyone for joining us on the call today. That's Alexis continues to execute across the key elements of our business, positioning the company to deliver on our strategic objectives for 2026 and beyond. We are in the early innings of our next phase of growth as we deliver on our strategy to evolve from a single compound company to one with a pipeline of potential oncology franchise opportunities. Zanzilintanib is poised to transform ExoLexis as our next franchise molecule, potentially first with the third-line plus CRC filing that's currently under review, followed by accelerating progress on the next six pivotal trials that we've highlighted recently. Importantly, a second wave of trials is lining up nicely to initiate potentially as early as 2027. Our confidence in Combo's long-term revenue growth trajectory remains unchanged. The updated financial guidance reflects modestly slower growth in 2026 due to a more gradual ramp for the net indication. which reflects the unique characteristics of the net patient population and histology. We remain confident in the long-term potential of the CABO net indication and view the net franchise as an important growth driver for CABO, ZANSA, and other molecules in our pipeline. We continue to see meaningful opportunities to expand our impact for patients, strengthen our commercial position, and create value for shareholders. Our strategy to build a multi-franchise oncology business contains five key elements, including first, execution. ANDA is leading the pack as our next potential franchise opportunity and our highest R&D priority. The Excel team continues to execute on key objectives across the program, including the stellar 303 regulatory review, pivotal trial data readouts, expediting clinical trial enrollments, and new study initiations. The second is expansion. We are building the foundation for the next wave of growth opportunities for Zanza. Beyond our current pivotal trials, we are actively evaluating new development opportunities that could further expand the scope, reach, and long-term value of Zanza in GU, GI, and other indications. Our goal is to build a durable franchise with stacking capabilities that could drive growth for years to come. Third key element is commercial performance. We continue to see substantial growth from the Cabo Xanthin franchise. Cabo remains the leading TKI for RCC, the market leader for the oral second line slash net segment, and a key player in the treatment of patients with liver and thyroid cancers. Second quarter of 2026, U.S. Cabo franchise net product revenues grew approximately 10% year-over-year to $573 million. Continuing its role as a worldwide leading TKI, global combo franchise, net product revenues generated by Exalexis and its partners grew approximately 13% year-over-year to $806 million in the second quarter of 2026. Fourth is preparation. We continue to prioritize our commercial readiness for the potential launch of Zanza and Thirdline Plus CRC, pending a positive regulatory review later this year. We believe the CRC opportunity represents an important first step towards establishing Zanza as our second oncology franchise and a significant driver of future growth. We see this element of our strategy as especially timely as we pursue new GU and GI indications, specifically in tandem, early and late stage opportunities in CRC with Stellar 303 and Stellar 316. Fifth and finally, discipline. We remain committed to rigorous expense management and capital allocation. This can be seen by trimming expense guidance while we invest in our mission-critical R&D priorities and keeping our projected free cash flow essentially unchanged. We believe this balanced approach remains an important differentiator and positions us to create long-term value while maintaining strategic flexibility. Taken together, these five strategic elements, working in tandem, underscore the strength of our strategy and the progress we are making across the business. We believe we are well-positioned to advance Zanza towards becoming a major oncology franchise, expand our development portfolio, drive continued growth to the Cabo Zantana franchise, and deploy capital in a disciplined manner to maximize shareholder value. So with that, we see our press release issued an hour ago for our quarterly financial results and a comprehensive summary of key corporate milestones achieved during the period. And with that, I'll turn the call over to Chris.