Exelixis, Inc.

Good day, ladies and gentlemen, and welcome to the Exelixis Third Quarter 2025 Financial Results Conference Call. My name is Cherie, 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, Cherie, and thank you all for joining us for the Exalexis Third Quarter 2025 Financial Results Conference Call. Joining me on today's call are Mike Morrissey, our President and CEO, Chris Center, 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 third quarter 2025 and at October 3rd, 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 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 product commercial success, market competition, regulatory review, and approval processes, conducting clinical trials, compliance with applicable regulatory requirements, our dependence on collaborative partners, and the level of costs associated with discovery, product development, business development, and commercialization activities. And with that, I'll turn the call over to Mike.

All right. Thank you, Susan, and thanks to everyone for joining us on the call today. X-Alexis had a strong third quarter, building on our progress from the first half of 2025. Accelerating R&D momentum coupled with flawless commercial execution has the potential to transform our business as we bring new treatment options to patients and build value for shareholders. The entire Excelexis team is committed to building a best-in-class, multi-franchise oncology business, and all corporate activities are aligned on a single focus to improve the standard of care for patients with cancer. Our future success will be accelerated by increasing the number of cancer patients served with current and future ExoLess medicines and the impact we have on their disease. The Cabozantinib business has never been stronger, and we're pleased to see Zanzalintinib move to center stage with our first big clinical success in CRC. Key highlights for the third quarter include, first, continued robust performance of the Cabozantinib U.S. business, with strong growth in demand and revenue from our commercial activities. Cabo Zantib maintained its leadership position as the top TKI for RCC, and importantly, shows consistent growth in the first-line segment. U.S. Cabo franchise net product revenues grew approximately 14 percent year-over-year to $543 million in the third quarter of 2025, compared to $478 million in the third quarter of 2024. Global Cabo franchise and their product revenues generated by Exalexis and their partners were approximately $739 million in the third quarter 2025 compared with $653 million in the third quarter 2024. We're excited by the broad adoption of Cabo for the recently approved net indications and have already built a leading position in the oral second line plus net segment with a greater than 40% new patient share based on market research. CABA demand in neuroendocrine tumors grew about 50% and contributed approximately 6% of our third quarter business. With a strong foundation, we expect to exceed $100 million in revenue for the net indication in 2025. Based on our early success in the net launch, And with other GI opportunities on the horizon, we're expediting the full build out of our GI sales team starting in fourth quarter 2025 to accelerate the growth of the CABO net indication before ZANSA comes to the forefront. We think this enhancement could be an important component of our growth narrative in 2026 and speaks to the confidence we have in both CABO and ZANSA as we close out 2025. TJ will provide more information and commentary about our third quarter franchise performance and encouraging dynamics of the net launch in his prepared remarks. Second, zanzalitinib is rapidly advancing as our next oncology franchise opportunity and the focus of seven ongoing and soon-to-start pivotal trials. We've continued to prioritize ZANSA with existing and new indications and combinations as potentially the most promising and expeditious path to a second ExoLexus oncology franchise, and one that we believe can eclipse the size, scope, and impact of our cabozantinib business. Importantly, we're engaged in numerous clinical trial discussions for ZANSA that could expand the scope and reach of our ZANSA pivotal trial efforts. We're thrilled with the positive results for Stellar 303 and CRC and intend to file in this indication with regulators as quickly as possible. We understand the nuances of the CRC market in the U.S. and believe we can effectively navigate the intricacies of this complicated disease and the current competitive dynamics pending approval. I'll remind everyone of the important messages from the full dataset presented at ESMO and published simultaneously in Lancet. ZANSA, in combination with Atezo, led to the first clinical success in a non-MSI-high, third-line-plus CRC population when compared against a contemporary standard of care. I want to reiterate that four other checkpoint-containing regimens failed to achieve this goal. Market research underscores that late-line CRC patients are interested in utilizing immune checkpoint inhibition to attack their disease head-on, so the ZANZA-ATEZO combo could represent a meaningful advance. The absolute magnitude of the overall survival benefit in the ITT population with the ZANZA-ATEZO combination is notable, especially in the context of the offering the potential of a non-chemo-containing regimen. We're especially pleased with the magnitude of benefit in patients with prior Bevacizumab treatment since the vast majority of CRC patients in the U.S. receive Bevacizumab as part of their first and or second-line treatment regimens. Tolerability and safety of the Zanzu and Tezo combination is consistent with other TKI checkpoint combinations. The 303 trial continues to accrue survival events in the non-liverment subgroup, and we expect to trigger the final analysis for non-liverment patients in mid-year 2026. And again, as you'll hear from Dana, seven ongoing and new Xanadu-pivotal trials are in the queue to address important unmet medical needs for known and new indications across multiple lines of therapy. The XOX's early stage pipeline continues to progress quickly with a range of new and potentially differentiated biologics and small molecules heading into and through early clinical evaluation. Dana will highlight these activities today at a high level, and you can expect additional details on these efforts along with our ZANZA pivotal trial update at our upcoming R&D day on December 10th. Finally, we continue to carefully manage capital allocation while advancing our R&D and commercial priorities. Our balance sheet and expected free cash flows remain strong and provide us with the opportunity to advance our pipeline priorities while we return cash to shareholders. We plan to repurchase shares when we believe they are undervalued, and we're pleased that we have been authorized to repurchase an additional $750 million of our shares. So with that, please see our press release issued an hour ago for our third 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.