Exelixis, Inc.

Good day, ladies and gentlemen, and welcome to the Exelixis fourth quarter and fiscal year 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, Mr. Andrew Peters, Senior Vice President of Strategy and Investor Relations. Please proceed.

Thank you, Tawanda, and thank you all for joining us for the XLUX's fourth quarter and fiscal year 2025 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 fourth quarter and fiscal year 2025, ended December 31st, 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 while 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, risk, 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. 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. 2025 was a transformational year for Exalexis with strong growth across all components of our business. We expect to build on this momentum in 2026 and have already made significant progress during a very busy January. Critically, and we'll emphasize this here and throughout the call, ExoLexus has a singular focus to build a multi-franchise business in solid tumor oncology based on the foundation of cabozantinib, the potential of zanzolintinib, and the depth of our early stage pipeline. As outlined at our December R&D Day, our strategy to build a pipeline of franchises in solid tumor oncology covers three critical dimensions, products, tumor indications, and modalities, and is based on current ExoLexus leadership in GU oncology and our aspirational goal to expand our leadership in the GI indications with equal intensity and potential upside. The ExoLexus strategy for product, tumor, and modality franchises provides the framework to drive both the growth of any overall market we choose to pursue and the potential to capture a greater share of the commercial opportunity with multiple entry points. Our operational model to establish, expand, and entrench any given franchise highlights the potential value for all our stakeholders. Importantly, the progress we have made over the last 12 months as well as our expectations for 2026 and beyond, are well aligned with this franchise-focused approach. With that context in place, we outlined important news and priorities to kick off 2026 at our corporate update in January at the J.P. Morgan Healthcare Conference. I won't reiterate everything here today, but just focus on the top highlights, including first, We saw continued strong performance of the Cabo's antigen business in the fourth quarter and full year 2025. Cabo Medics maintained its position as the leading TKI for RCC and the market leader for neuroendocrine tumors in the oral second line plus segment. Full year 2025, U.S. Cabo franchise net product revenues grew 17% to approximately $2.12 billion, compared to full year 2024. Fourth quarter 2025, U.S. Cabo franchise net product revenues grew 6% year over year to $547 million compared to the fourth quarter 2025. Continuing its role as a worldwide leading TKI, global Cabo franchise net product revenues generated by Exalexis and its partners were approximately $754 million in $2.89 billion in fourth quarter and full year 2025, respectively. Importantly, Cabo's U.S. net product revenues exceeded $100 million for the neuroendocrine tumor indication in 2025. Second, we're excited to accelerate Zanza as our next potential oncology franchise opportunity in 2026, with the recently announced acceptance of our NDA for the Zanza-Ateza combination in third line plus CRC, based upon the Stellar 303 data. The entire organization is rallying around this important 2026 milestone, and we've taken decisive steps to fortify our commercial footprints to maximize the impact of potentially launching two drugs in different indications in successive years. Notably, we've expedited the build-out of our GI sales team in January with the focus to accelerate the growth of the Cabo Medics neuroendocrine tumor opportunity before ZANSA could come online for CRC later in the year. We think this enhancement could be an important component of our growth narrative in the near term and speaks to the confidence we have in both Cabo and ZANSA as we move into 2026. Third, Zanzalitinib is rapidly advancing as our next franchise opportunity with seven ongoing and soon to start pivotal trials, along with a variety of important trial concepts under consideration as a potential next wave of pivotal trials. We continue to prioritize Zanza both as a monotherapy and in combinations for existing and new indications as an expeditious path to a second ExoLexus oncology franchise. Importantly, We're excited by the level of interest in new clinical collaborations for ZANSA from the JPM meeting that could expand the breadth and depth of our ZANSA pivotal trial efforts to potentially define new standards of care for patients with cancer. Fourth, as we highlighted at our R&D day in December, our ExoLexus IND pipeline is full for the next several years, with potential first-in-class and our best-in-class molecules demonstrating differentiating activity based on extensive preclinical testing. All our efforts are focused on identifying the next clinical asset we can move into full development as another potential ExoLexus franchise opportunity. Dana will summarize our status today at a high level, and I refer you back to the replay of our R&D day to dive into the details for Zanza and the rest of our pipeline. Finally, business development activities continue to focus on late-stage assets in the GU and GI space. We're pursuing back-end-loaded pay-for-success transactions that fit into our oncology franchise framework as a top priority. In terms of capital allocation, We're confident we have the balance sheet and expected free cash flows to advance our pipeline priorities, access new molecules from external sources when appropriate, and continue our share repurchase program when we believe our shares are undervalued. With that, please see our press release issued an hour ago for our fourth quarter and full year 2025 financial results and an extensive list of key corporate milestones achieved in order. I'll now turn the call over to Chris.