Exelixis, Inc.

Good day, ladies and gentlemen, and welcome to Exelix's second quarter 2021 financial results conference call. My name is Frenzy, 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, Francie, and thank you all for joining us for the Exalexis Second Quarter 2021 Financial Results Conference Call. Joining me on today's call are Mike Morrissey, our President and CEO, Chris Benner, our Chief Financial Officer, and PJ Haley, our Executive Vice President of Commercials, who will together review our progress for the second quarter 2021 ended June 30th, 2021. Peter Lam, 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. Exalexus had a strong second quarter across all segments of our business as we grew the Cabo Medics franchise and advanced our pipeline of promising early-stage programs. The company posted record Cabo's Antenna franchise net product revenue and total revenue in Q2, based on strong demand for the Cabo Medics Nivolumab combination across all segments of the first-line RCC market. Syndicated market research highlights that the Cabo NEVO doublet plays a leading role in first-line RCC and reflects the strength of the efficacy, tolerability, and quality of life data from the Checkmate 9ER trial. We maintain significant momentum with a 59% year-over-year growth in Cabo net product revenue in the second quarter of 2021 compared to the same period in 2020. Our goal remains to exit 2022 with a $1.5 billion annualized run rate for RCC in the U.S. ExoLux has also advanced key 2021 discovery, development, and regulatory activities in the second quarter. We reported top-line results for the Cabo Atezo doublet in first-line HCC from COSMIC 312 and in metastatic CRPC from COSMIC 021 Cohort 6. and we'll update you on regulatory feedback and details for upcoming presentations for these two trials in due course. We plan to file new SNDAs for CABO in these indications, pending positive regulatory feedback, along with the submission of COSMIC 311 and DTC, which was accepted for priority review with a PDUFA date of December 4th, 2021. The full portfolio of late-stage COSMIC and contact trials with cabozantinib-ICI combinations, continues to move forward according to plan. Our early clinical pipeline is advancing with significant progress in the XL092 program, the XL102 Phase 1 trial, and the initiation of clinical work with XB002, our first biologic to enter the clinic. The Exalexis discovery and preclinical teams continue to optimize and characterize 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. Finally, we've used success by the number of patients that derive benefit from the drugs that we discover, develop, and ultimately get approval to market. We currently estimate that more than 20,000 patients are treated quarterly with cabozantinib on a global basis. While we're proud to have achieved this magnitude of impact on people with cancer, We strive to excel at an even greater level every single day with CAVO across existing and new indications and our emerging pipeline of drug candidates in clinical and preclinical evaluation. With that, please see our press release issued an hour ago for our full second quarter financial results and an extensive list of key corporate highlights detailing our accomplishments in the quarter. I'll now turn the call over to Chris, who will review our second quarter 2021 financial results and provide an update to our full year 2021 financial guidance.