Exelixis, Inc.

Good day, ladies and gentlemen, and welcome to the XLXS fourth quarter and full year 2022 financial results conference call. My name is Vaishnavi, 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, Vaishnavi, and thank you all for joining us for the Exalexa's fourth quarter and full year 2022 financial results conference call. Joining me on today's call are Mike Morrissey, our president and CEO, and Chris Fenner, our chief financial officer, who will review our progress for the fourth quarter and full year 2022, ended December 31st, 2022. PJ Haley, our executive vice president of commercials, Vicki Goodman, our chief medical officer, and And Peter Lamb, our Chief Scientific Officer, are also on the call today and will participate in our question and answer portion of the call. 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 results 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 now turn the call over to Mike.

All right, thank you, Susan, and thanks to everyone for joining us on the call today. ExoLexus had a strong fourth quarter and full year 2022 across all components of our business. We're pleased to see continued growth of the Cabo Zantan franchise in the U.S. and globally in the fourth quarter and full year 2022, while advancing our discovery and development priorities to build the ExoLexus product portfolio of the future. As we had a complete corporate update a few weeks ago at the JP Morgan Healthcare Conference, Chris and I will provide a summary of top corporate and financial highlights for the fourth quarter and key 2023 priorities before moving into Q&A with the full team. First, we saw a strong performance of the Cabo's antediluted business with continued growth in demand and revenue in the U.S. Cabo Medics maintained its status as the leading TKI for RCC, in both the first-line IOTKI market and the second-line monotherapy segment. Fourth quarter CABA franchise net product revenues grew 25% year-over-year compared to fourth quarter 2021. CABA franchise net product revenues grew 30% for the full year 2022 compared to full year 2021 and have approximately doubled since 2020. Importantly, global CABA's antigen franchise net product revenues generated by ExoLexus and its partners were approximately $520 million and $1.9 billion in the fourth quarter and full year 2022, respectively. Chris will review our 2023 financial guidance in his prepared remarks. Second, our top priority for 2023 is to advance the ExoLexus development pipeline with new potential CAVO indications, expedite exams of lintinib, development with new pivotal trials, pursuing XB002 myelotherapy and combination expansion cohorts with the goal of moving this agent into full development by year-end. Our discovery organization is advancing XB010, XB014, and XB628 in developmental development towards potential INDs with a range of additional projects vectoring towards development candidates for both biologics and small molecule platforms. Third, business development activities will continue to be a critical focus for XOXs throughout 2023. The two option deals with Cybrexa and Seropa are off to a great start, and we're working closely with those teams to advance their efforts to get to an option decision as quickly as possible. Our strategy to access clinical and or near clinical stage assets that have the potential to provide differentiated benefits to patients with cancer will continue to be our primary focus in 2023. The option deal framework is a capital and resource-efficient way to generate clinical proof-of-concept data and only pay for success if that data is supported. And finally, on January 19th, the Federal District Court in Delaware issued its ruling in the first XOXs versus MSN case, what we refer to as MSN-1. MSN's validity challenge to the cabozantinib compound patent was rejected and and MSN's proposed generic product was ruled to not infringe the ex-flexus N2 polymorph patent. MSN did not dispute the validity of the N2 polymorph patent, so it also remains valid and in force, and no intellectual property in the ex-flexus cobalt antidepressant patent estate has been invalidated. Our attention and resources have now shifted to MSN2, which goes to trial in October, and we will continue to vigorously protect our intellectual property rights. So with that, see our press release issued an hour ago for our fourth quarter and full year 2022 financial results and an extensive list of key corporate milestones achieved in the quarter. I'll now turn the call over to Chris.