Exelixis, Inc.

Good day, ladies and gentlemen, and welcome to the Exalexis third quarter 2020 financial results conference call. My name is Holly, 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 go ahead.

Thank you, Holly, and thank you all for joining us for the XLX's third quarter 2020 financial results conference call. Joining me on today's call are Mike Morrissey, our president and CEO, Chris Senner, our chief financial officer, Isla Schwab, our chief medical officer, Peter Lam, our chief scientific officer, and PJ Haley, our executive vice president of commercial, who will together review our corporate, financial, commercial, and development progress for the third quarter 2020 and September 30, 2020. 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 Costs 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. ExoLexis continued to advance all components of our business in the third quarter. as we built the foundation to accelerate revenue growth for Cabo Zantanib in 2021 with potential new commercial opportunities and a variety of mission-critical development and regulatory milestones. Please see our press release that was issued an hour ago for our third quarter 2020 financial results and an extensive list of key corporate accomplishments. The highlight of the quarter was the ESMO presentation of the positive results from Checkmate 9ER, the Phase III pivotal trial evaluating the Cabo-Nevo combination and first-line RCC. We're excited to highlight the compelling activity of the Cabo-Nevo doublet, notably the significant improvement in overall survival with a doubling of both progression-free survival and objective response rate and extended duration of response. The FDA has accepted our application and granted a priority review with the PDUFA date of February 20, 2021. The X-Luxus commercial organization is launch ready and the United States should approval come sooner. Our urgency and focus are driven by the consistent feedback from ESMO that NIEER represents best-in-class IOTKI data and reinforced by recent market research, which indicates that a large number of previously untreated RCC patients could benefit from the combination of these two market-leading single agents. When the size of the first-line RCC patient population and long duration of PFS observed with the CABO and EVO doublet are viewed together, We project a potential doubling of Cabo RCC revenues and expect to exit 2022 with a $1.5 billion annualized run rate in the U.S. if our assumptions and modeling are accurate. While first-line RCC remains our top priority as the next commercial growth opportunity for Cabo Santanib, we continue to make important progress with key discovery and development activities, while advancing CODLOS potential utility in additional oncology indications. Notable progress has been made in Q3 and throughout 2020 in enrolling the four COSMIC trials, including O21, 311, 312, and 313, as well as initiating three new global phase three pivotal trials of CODLOS antinative in combination with a titalizumab as part of the contact clinical trial program. The success of Checkmate 9-ER, coupled with data presented this year at various ASCO meetings for CABO-IO combinations in liver, prostate, lung, and bladder cancers, highlights the important role cabozantinib can play as a unique and differentiated TKI backbone. These early signals of compelling efficacy and tolerability may provide potential encouraging read-through for current pivotal trials and new indications. Finally, X-Luxus continues to make significant progress in our growing early stage pipeline. We are excited to advance XL092 into ICI combination cohorts and share the initial detail of its discovery and early clinical pharmacokinetic characterization, which validates our overall efforts to build an improved next-gen multi-targeted TKI that phenocopies CAVO's target inhibition profile with a more user-friendly clinical half-life. We aim to apply our 15 plus years of clinical experience with CAVO to a broad and accelerated development plan that has the potential to demonstrate a substantially improved risk profile compared to more typical early stage programs. We anticipate XL092 will move into full development in 2021. Beyond XL092, our early stage pipeline continues to advance nicely with internal discovery efforts and a number of important new collaborations to reinforce our growing presence in ADCs. We expect to file up to four new INDs over the next six months as a result of our internal efforts and the work of our discovery partners. I'm incredibly proud of the commitment and focus displayed by the entire Exalexis team as we continue to 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 Q3 financial results.