Exelixis, Inc.

Good day, ladies and gentlemen, and welcome to the xAlexis First Quarter 2025 Financial Results Conference Call. My name is Tawanda, 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, 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 xAlexis First 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 first quarter 2025 and in March 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, and government drug pricing policies and initiatives. Actual events or results could 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 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 cost associated with discovery, product development, business development, and commercialization activities. And with that, I'd like to turn the call over to Mike.

All right. Thank you, Susan, and thanks to everyone for joining us on the call today. Exalexa has had a strong first quarter, highlighted by significant progress and momentum across all components of our business. We continue to execute on our strategy to build a multi-compound, multi-franchise oncology enterprise. We expect 2025 to be a very busy and highly productive time for the company. I think it's safe to say that we have reached another critical inflection point in recent XOXO's history, and we're energized to take things to the next level as we move forward into the second quarter and beyond. As we've discussed previously, we have a singular focus on improving the standard of care for patients with cancer. Our future success in achieving this goal will enable Excelexis to help many more cancer patients and ultimately solidify our leadership position through innovation and execution. We're pleased to see accelerating growth of the U.S. Cabo franchise in the first quarter, both in terms of absolute revenue and relative growth compared to the competition, which reflects Cabo's status as the leading TKI for RCC. We anticipate seeing additional upside with new indications in neuroendocrine tumors, where we secured regulatory approval at the end of March. Key highlights for the first quarter include, first, we saw strong performance of the Cabo Zanta WS business with continued growth in demand, new starts, and revenues. First quarter 2025, U.S. Cabo franchise net product revenues grew 36% year-over-year to $513 million compared to $378 million in the first quarter 2024. Global Cabo franchise net product revenues generated by ExoLexus and its partners were approximately $680 million in the first quarter 2025 compared to $559 million in the first quarter 2024. Given the strong momentum of ComboMedics in the first quarter, we're increasing our 2025 full-year financial guidance for net product revenues and total revenues by $100 million. Second, on top of our strong financial and commercial performance, the highlight of the quarter was the U.S. regulatory approval of ComboMedics in both P-Net and E-P-Net ahead of our assigned PDUFA date of April 3rd, 2025. Our commercial team was ready to execute our detailed launch plan, and we were out in the field within hours of approval. PJ will provide more information and commentary about our first quarter commercial dynamics and the net launch in his prepared remarks. We plan 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 2025. Third, it's mission critical for us to advance new molecules from our pipeline into full development and ultimately onto the market to excel in our mission to help cancer patients recover stronger and live longer. We're excited to advance Zanza to the center stage in 2025 as our next oncology franchise opportunity. Important anticipated ZANZA data milestones from pivotal trials in the second half of 2025 include top-line results from STELLAR-303 in colorectal cancer and STELLAR-304 in non-clear cell RCC, and a decision to advance the Phase III portion of STELLAR-305 in head and neck cancer, all pending event rates for each trial. In addition, we expect to initiate the STELLAR-311 trial of ZANZA in NET in the first half of 2025, and anticipate Merck will initiate two RCC studies evaluating ZANSA plus Belsudafan this year. Fourth, as we highlighted recently, our ExoLexus IND pipeline is coming into focus with a range of new and potentially differentiated molecules heading into and through early clinical evaluation. The goal of these efforts isn't to build a big pipeline. It's to carefully and quickly evaluate new clinical assets and identify the winners for advancement into full development as top investment priorities. Early development of XL309 continues to be a main focus as both the monotherapy and in combination with PARP inhibitors to deepen and prolong responses. Ghost escalation with XP010 continues to advance quickly. We're making good progress on our goal to file up to three new INDs in 2025. XB628 recently entered the clinic, and we remain on track for IND submissions for XB064 and XB371 this year. Finally, in regard to capital allocation, we're excited about the trajectory of our business and have the balance sheet and expect a cash flow 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 are focused on late-stage assets in the GUGI space. Back-end loaded, pay-for-success transactions that tuck nicely into our existing and potential future oncology franchise remain a top priority. As always, we're focused on doing the right deals for the right assets at the right valuations. So with that, please see our press release issued an hour ago for our first quarter of 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.