Exelixis, Inc.

Good day, ladies and gentlemen, and welcome to the Exelixis fourth quarter and fiscal year 2023 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 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 XLX's fourth quarter and fiscal year 2023 financial results conference call. Joining me on today's call are Mike Morrissey, our president and CEO, and Chris Fenner, our chief financial officer, who will review our progress for the fourth quarter and full year 2023, ended December 29th, 2023. PJ Haley, our executive vice president of commercial, Amy Peterson, our chief medical officer, and Dana Aftab, our chief scientific officer, are also on the call today and will participate in the question and answer portion of the call. 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. Actual events or results could, of course, differ materially. We refer you to the documents we file from time to time with the FPC, 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 the 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. XOX has had a strong year in 2023, and we're already sprinting into 2024. after a busy January where we provided important updates across literally all components of our business. We're pleased to see continued growth of the Cabo Zantanit franchise in the U.S. and globally in 2023, which provides the foundation for our efforts to advance our drug discovery and development priorities that we outlined at our R&D day in December. We reviewed important news to jumpstart 2024 at our corporate update in January at the JPM Healthcare Conference. I won't reiterate everything here today, but just focus on the top highlights, including first, we saw a strong performance of the Cabo San Antonio business in the fourth quarter and full year 2023, with continued growth in demand and revenue. Cabo Medics maintained its status as the leading TKI for RCC, in both the first-line IOTKI market and second-line monotherapy segment. Fourth quarter, CAVO, franchise net product revenues grew 14% year-over-year compared to fourth quarter 2022. CAVO franchise net product revenues grew 16% for full year 2023 compared to full year 2022. Highlighting its role as a worldwide leading TKI, global CAVO's antenna franchise net product revenues generated by Exalexis and his partners were approximately $600 million and $2.3 billion in the fourth quarter and full year 2023, respectively. Chris will review our 2024 financial guidance in his prepared remarks. Second, final reply briefs should be submitted in the next few weeks for the second MSN and the trial that took place in October, and we expect a ruling in the first half of 2024. Obviously, this is the critical milestone for the company and the Cabo's antigen franchise. While we will not speak to any specifics today, I'm proud of the work that our team did preparing and presenting this case. Exalexis has and will continue to vigorously protect our intellectual property rights with respect to Cabo and our other differentiated molecules that we pursue on behalf of patients with cancer. Third, we made significant progress in advancing the pipeline in 2023 that was highlighted at our R&D Day presentation in December. Our top priority for 2024 is to advance potential new CAVO indications for NET and metastatic CRPC. The recent CONTACT02 presentation at ASCO-GU generated a lot of buzz at the meeting that Amy is sure to address in the Q&A session shortly. Zans and development continues to be a key priority for us in terms of both existing and new pivotal trials, and enrolling XB002 expansion cohorts is at a critical stage with a global network of sites now contributing to this effort. And as you heard from Dana in December, our IND pipeline is full for the next few years with exciting new compounds that could address a range of solid tumor indications with potentially differentiating profiles based on extensive preclinical testing. With that, please see our press release issued an hour ago for our fourth quarter and full year 2023 financial results and an extensive list of key corporate milestones achieved in the quarter. I'll now turn the call over to Chris.