Exelixis, Inc.

Good day, ladies and gentlemen, and welcome to the Exalexis First Quarter 2021 Financial Results Conference Call. My name is Daphne, 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, Daphne, and thank you all for joining us for the Exelixis First Quarter 2021 Financial Results Conference Call. Joining me on today's call are Mike Morrissey, our President and CEO, Chris Center, our Chief Financial Officer, TJ Haley, our Executive Vice President of Commercial, and Gisa Schwab, our Chief Medical Officer, who together will review our corporate, financial, commercial, and development progress for the first quarter 2021, ended March 31, 2021. Peter Lamb, our Chief Scientific Officer, is also here and will join us for the question and answer session following our prepared remarks. 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 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 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 started 2021 with a strong first quarter, where we saw significant revenue growth from the Cabo Nevo first-line RCC launch and posted our highest quarterly net product revenue since the initial Cabo Medics approval in 2016. Please see our press release that was issued an hour ago, for our first quarter financial results and an extensive list of key corporate accomplishments. We'll keep today's prepared remarks short so we can get to your important questions. Obviously, we're thrilled with the early performance of the Cabo Nebo launch in Firstline RCC, which we believe reflects the strength and breadth of the efficacy, tolerability, and quality of life data from the Checkmate 9ER trial. We continue to build momentum with a combined 35% growth in revenue over the last two quarters, and anticipate a near doubling of CABO RCC revenues by the end of 2022 when we expect to exit with a $1.5 billion annualized run rate in the U.S. if our launch assumptions and trajectory continue on its current course. Also in the first quarter, we advanced key 2021 discovery, development, and regulatory activities. We remain on track to report top-line results for the CABO ATEZO double it in first-line HCC from COSMIC 312 and in metastatic CRPC from COSMIC 021 cohort 6, and expect to file up to three new SMDAs for CAVO across these indications, pending positive results, along with the filing for COSMIC 311. Our early clinical pipeline also advanced nicely in the quarter, with significant progress in the XL092 program, the initiation of the Phase I clinical trial of XL102, our novel CDK7 inhibitor, and the IND filing for XB002, which was accepted by the FDA in April. Our discovery and preclinical teams continue to make important progress towards the optimization and characterization of new development candidates for both small molecule and ADC programs, which we believe will provide the foundation for new clinical candidates in the near future. I'll close here by saying that the Exalexis team has hit the ground running in 2021 and is building on the urgency and focus from our recent progress to maximize our chance for success across the range of milestones ahead of us. I'm incredibly proud to say that we're coming out of COVID stronger than ever as we drive our business forward to help cancer patients live longer and recover stronger. So with that, I'll turn the call over to Chris, who will provide an update on our first quarter 2021 financial results. Chris?