Exelixis, Inc.

Good day, ladies and gentlemen, and welcome to the Exalexis 3rd Quarter 2021 Financial Results Conference Call. My name is Jeff, 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, Jeff, and thank you all for joining us for the XLX's third quarter 2021 financial results conference call. Joining me on today's call are Mike Morrissey, our president and CEO, Chris Senner, our chief financial officer, PJ Haley, our executive vice president of commercial, and Peter Lamb, our chief scientific officer, who will together review our progress for the third quarter 2021 and its September 30th, 2021. 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 the future events and future performance of the company. This includes statements about possible developments regarding discovery, product development, regulatory, commercial, financials, 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 limitations, 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. Now, 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 third quarter across all components of our business as CaboMedic's demand and market share grew in the face of increased competition. At the same time, we advanced our pipeline of promising early-stage programs with a new IND and an additional collaboration for an exciting target in the RNA sensing pathway. On the commercial front, ComboMedix maintained its status as the leading TKI for RCC and Q3. We saw strong demand for the ComboMedix-Nivolumab combination across all segments of the first-line RCC market, including continued NRX and TRX growth. Despite some quarter-to-quarter choppiness, we are pleased to see CaboMedic's net product revenue in the third quarter of 2021 maintains significant momentum with 63% year-over-year growth compared to the same period in 2020. To expand on this further, three factors converged to impact the second quarter of 2021 CaboMedic's revenues. First, a significant growth in demand following the success of the nine-year launch. Second, an increase in inventory, reflecting the growing demand seen throughout the first half of 2021. And third, clinical trial comparator sales. While third quarter Cobb-O-Medics demand continued to grow in the face of increased competition, the latter two factors did not occur to a significant extent in Q3. Looking ahead, we expect Cabo to achieve well in excess of $1 billion in U.S. revenue in full year 2021, and our goal remains to exit 2022 with a $1.5 billion annualized run rate for RCC in the U.S. We view our progress in 2021 as putting us in a good position to achieve this goal. XOX has also advanced key 2021 regulatory development and discovery activities in Q3. We were thrilled with the early approval of Cabo Medics and Second Line DTC and excited to bring this new treatment option to prescribing physicians and patients to treat this indication for which no standard of care previously existed. The abstract for the Cabo Atezo Doublet and First Line HCC from Cosmic 312 was accepted for presentation at the ESMO Asia Virtual Oncology Week Congress during the virtual plenary session on Saturday, November 20th. Based on recent feedback from the FDA, we plan to file the COSMIC 312 SMDA in early 2022 once the final OS data are available. In regard to late-stage development, the full portfolio of COSMIC and CONTACT trials with cabozantinib ICI combinations continues to advance. In particular, the CONTACT-01 and CONTACT-03 studies in forms of non-small cell lung cancer and renal cell carcinoma, respectively, are nearing full enrollment. Top-line results for COSMIC 313, which is evaluating the Cabo-Nevo epitriplet in previously untreated intermediate or poor-risk RCC, are now expected in the first half of 2022 based on current event rates. Our early clinical pipeline is advancing as well, with significant progress for XL092, XL102, and XB002, and we expect to share initial clinical updates for each program over the course of 2022. Since reinitiating the buildup of our early-stage pipeline in 2017, the XLX's discovery, business development, and non-clinical teams have seamlessly integrated their work streams to pursue compelling opportunities across small molecules and biologics with the aim of growing our clinical pipeline, most recently exemplified by our new IND filing for XL114 and the collaboration with Storm Therapeutics. So with that, please see our press release issued an hour ago for a full overview Q3 financial results, and an extensive list of our corporate milestones achieved in the quarter. I'll now turn the call over to Chris, who will review our third quarter 2021 financial results.