2/10/2021

speaker
Lateef
Call Operator

Good day, ladies and gentlemen, and welcome to the Exelixis fourth quarter and full year 2020 financial results conference call. My name is Lateef, 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.

speaker
Susan Hubbard
Executive Vice President of Public Affairs and Investor Relations

Thank you, Lateef, and thank you all for joining us for the Exalexa's fourth quarter and full year 2020 Financial Results Conference Call. Joining me on today's call are Mike Morsey, our President and CEO, Chris Senner, our Chief Financial Officer, Gisela Schwab, our Chief Medical Officer, and PJ Haley, our Executive Vice President of Commercial, who will together review our corporate, financial, development, and commercial progress for the fourth quarter 2020 and December 31, 2020. 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, 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 completion, regulatory review and approval processes, conducting clinical trials, compliance with applicable regulatory requirements, our dependence on collaboration partners, and the level of costs associated with discovery, product development, business development, and commercialization activities. Now with that, I will turn the call over to Mike.

speaker
Mike Morsey
President and CEO

All right. Thank you, Susan, and thanks to everyone for joining us on the call today. Exalexis ended 2020 with a strong fourth quarter, hit the ground running in January as we strive to accelerate revenue growth in 2021 and beyond with the Cabo Nevo launch and first-line RCC and a variety of mission-critical development and regulatory milestones. Please see our press release that was issued an hour ago for our fourth quarter and full-year 2020 financial results and an extensive list of key corporate accomplishments. We'll keep our prepared remarks short today as we had a full update recently at the J.P. Morgan Healthcare Conference, including providing 2021 financial guidance. Obviously, we're thrilled with the recent approval for the Cabo Nevo combination and first-line RCC based on the positive results from the Checkmate 9ER pivotal trial. We believe we have significant momentum heading into the launch 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 assumptions and modeling are correct. This week will be busy for us as we share a number of important clinical updates for Cabo Xanthinib at ASCO GU, both as a single agent and ICI combination partner. In addition, over the course of 2021, we foresee a broad slate of important discovery, clinical, and regulatory milestones, including first, three potential SMDA submissions, second, up to two additional INDs, third, advancing the cabozantinib cosmic and contact clinical trials, fourth, building the XL092 full development program, fifth, the early evaluation of our new clinical stage molecules XL102 and XB002, and finally, sixth, advancing a deep bench of exciting discovery programs toward development candidate status. It goes without saying that 2021 will be an action-packed year for the ExFlexus team, and we're working as one to maximize our chance of success across the range of milestones ahead of us. I'm incredibly proud of the commitment and focus displayed by the entire team in 2020, and excited for the future as we drive our business forward during these challenging times. So with that, I'll turn the call over to Chris, who will provide an update on our fourth quarter and full year 2020 financial results.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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