Exelixis, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Exalysis First Quarter 2020 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. If you should require assistance during the conference, please press star then the zero on your touchtone telephone. As a reminder, this conference is being recorded I would now like to turn the conference over to your host, Ms. Susan Hubbard, EVP of Public Affairs and Investor Relations. Please proceed.

Thank you, Nita, and thank you all for joining us for the Exelixis First 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, PJ Haley, our Executive Vice President of Commercials, and Gisa Schwab, our Chief Medical Officer. who together will review our corporate, financial, commercial, and development progress for the first quarter 2020 and in March 31, 2020. Peter Lamb, our Chief Scientific Officer, is also with us and will be joining for the Q&A session following our prepared remarks. During the call today, we will refer to financial measures not calculated according to general 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, as well as the impact of the COVID-19 pandemic on Exalexis's business operations. 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 now with that, I will turn it over to Mike.

All right. Thank you, Susan, and thanks to everyone for joining us on the call today. XLX has had a strong first quarter across all components of our business. Our entire team, working remotely as a cohesive unit, continues to navigate the challenges of the COVID-19 pandemic with a singular focus of ensuring that we do everything in our power to maximize access to carbamazantinib for cancer patients through either commercial channels or clinical trials. We recognize that cancer patients need to take their treatments as directed, and we've gone to great lengths to ensure patient access to our medicines in these challenging times. We'll keep our prepared remarks short and address your questions as the main part of today's update. Please see our press release that was issued an hour ago for our first quarter 2020 financial results and an extensive list of corporate highlights. Before we review the performance of our business in the quarter, I want to provide a brief update on how Exalexis has responded to COVID-19 at an organizational level. Our top priority is the health and safety of the Exalexis workforce. So we implemented our work from home policy ahead of the California shelter in place order and quickly pivoted our sales force to move to virtual touch points with prescribers. At the same time, the 600 plus members of our XLXs team have engaged in the fight against COVID-19 on the community level by donating to charitable organizations supporting cancer patients during the pandemic, which XLXs has matched at the corporate level and through the donation of personal protective equipment We like to think that tough times brings out the best in people, and I'm proud to say that's certainly the case at XLXs. The COVID-19 pandemic continues to evolve quickly and has had a relatively modest impact on our business to date. We remain optimistic that the 2020-2021 timeframe can be a period of focused execution and achievement for XLXs. The pandemic is imposing challenges on our day-to-day operations and gives rise to a level of uncertainty. We remain on track to have 12 label-enabling trials for COBOxantinib enrolling by year-end and achieve six top-line data readouts over the course of the year, which could lead to four new potential indications for COBO in 2021. We also expect to advance XTEL092 into immune checkpoint inhibitor or ICI combination cohorts and file up to three new INDs for compounds from internal or collaborative efforts. Obviously, everything is fluid at this stage and we'll continue to update you as we progress throughout the year. The recent success of Checkmate 9ER with the Cabo-Nego combination and Firstline RCC highlights the important role CaboSensitive can play as a TKI backbone in driving both compelling efficacy and tolerability in ICI combination strategies and provides potential encouraging read-through for ongoing and planned pivotal trials for other ICI combinations and new indications. Finally, as you know, we have an ongoing and a litigation against MSN. Earlier today, we received notice that MSN has filed additional paragraph four certifications challenging the Cabo's Antony of the composition of matter patent and a method of use patent. Two orange book listed patents not asserted in their original paragraph four letter. We are not surprised by this development, as such challenges are standard in the ordinary course of pharmaceutical business. We are well prepared to respond and vigorously defend what I believe to be a very strong intellectual property estate that protects Cabozantinib, an innovative drug of growing medical importance. So with that, I'll turn the call over to Gisela, who will provide an update on Checkmate 9-ER and other 2020 development activities. Isla?