Gilead Sciences, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the third quarter 2020 Gilead Sciences Earnings Conference call. At this time, all participants are on a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you would need to press star 1 on your telephone. Please be advised that the recording is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, to Douglas Maffei, Senior Director of Investor Relations. Thank you. Please go ahead, sir.

Thank you, Zulem, and good afternoon, everyone. Just after market closed today, we issued a press release of the earnings results for the third quarter of 2020. The press release and detailed slides are available on the investor section of our website. The speakers on today's call will be Daniel O'Day, Chairman and Chief Executive Officer of Joanna Mercier, Chief Commercial Officer, Murdad Parsi, Chief Medical Officer, and Andrew Dickinson, Chief Financial Officer. Also on the call and available for question and answer will be Christy Shaw, Chief Executive Officer of KITE, and Diana Brainard, SDP and Head of our Virology Therapeutic Area. Before we begin with our prepared remarks, let me remind you that we will be making forward-looking statements, including risks and uncertainties, related to the impact of the COVID-19 pandemic on Gilead's business, financial conditions, and results of operations. Plans and expectations with regards to products, product candidates, corporate strategy, financial projections, and the use of capital. And 2020 financial guidance, all of which involve certain assumptions, risks, and uncertainties that are beyond our control. and could cause actual results to differ materially from those statements. A description of these risks can be found in the earnings press release and our latest SEC disclosure documents. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements. Non-GAAP financial measures will be used to help you understand the company's underlying business performance, The gaps and non-gap reconciliations are provided in the earnings press release as well as on the Gilead website. I will now turn the call over to Dan.

Thank you, Doug, and good afternoon, everyone. This has really been a pivotal quarter for Gilead. With last week's closing of the immunomedics acquisition, we've effectively transformed our near and long-term growth story. Trodelby, an improved medicine for third-line metastatic triple-negative breast cancer, has tremendous potential for patients today and significant pan-tumor potential for the future. We are all excited to deliver on that potential, along with the teams from Immunomatics, who became a part of the Gilead family last week. I want to take this opportunity to thank everyone at Immunomatics for the extraordinary work that you've done on Trodelby to date. It's an honor to work with you. with all of you now to build on those efforts for the benefit of patients with cancer around the world. The acquisition is undoubtedly an inflection point in terms of our growth and adds to the growing pipeline of transformational medicines that we've been strengthening over the course of the year. All of this is building on the strong foundation of our core business. We've seen the strength and durability of our HIV business once again in the past quarter, and we're confident in our long-term leadership. I'd like to briefly talk about the changing nature of our growth prospects, driven primarily by the acquisition of Immunomedics. I'll also touch on our core business, and I'll say a few words about Procurity, or Remdesivir, which just gained FDA approval, and then Joanne and her dad will pick up with more details. I'll start with Immunomedics and Tredelby. The acquisition of Immunomedics is the largest transaction in Gillian's history and undoubtedly marks a turning point for the company. As you know, Tordelvi is already approved in the U.S. for third-line metastatic triple-negative breast cancer. The recent data at ESMO underscored its transformative potential for this particularly challenging form of cancer, as well as the potential for treating bladder cancer. We will explore expansion into earlier lines of therapy in the short term, and overall we see Tordelvi as a pipeline and a product. The prevalence of TROP2 in multiple cancer types means TRODELVI has hand tumor potential. Secondly, in addition to its extensive potential as a monotherapy, TRODELVI stands out because of the way it lends itself to combinations. The early data are promising, and we look forward to exploring combinations with various types of agents going forward. The acquisition gives us an immediate presence in the field of solid tumors and brings us the significant expertise of the teams from Immunomedics. We're complementing our existing strengths in hematologic cancers through our combined TITE and Gilead pipeline and building on the important progress we've already made this year in building our oncology pipeline. Including Immunomedics, we have completed a total of 10 transactions in oncology so far this year. I'll just mention two of the significant opportunities that are the results of those transactions. is now in phase three for MDS and offers a potential first-in-class option utilizing the CD47 pathway to activate the innate immune system. Our partnership with is progressing well. We are particularly excited by the potential of the compound as well as other work that's coming out of that collaboration. In cell therapy, we're now the only company with two FDA-approved therapies, Yaskarta and Tercardus and Kite. Earlier this month, we received a positive opinion for Kite X-19 from the European Medicines Agency, the Committee for Medicinal Products for Human Use. I'm also pleased to announce that the FDA has accepted the Yaskarta SDLA for relapsed or refractory follicular lymphoma and marginal cell lymphoma after two or more lines of systemic therapy. The agency also granted priority review for this application. Zuma 7, the industry's first ever randomized trial in cell therapy and the only cell therapy in second line with overall survival as an endpoint, will be delayed slightly due to the slowdown in the rates of events. However, we expect the data in the first half of 2021, and based upon that data, we're ready to submit quickly after. In summary, we've made great progress in building out and advancing our pipeline to drive growth this year, and Chardelby represents a true growth inflection point, changing our outlook significantly and positioning Gilead as an important contributor in the field of oncology. The foundation for all this additional growth is our durable core business. In HIV, we saw a solid rebound in the third quarter with 14% quarterly sequential growth in the global franchise. While COVID-19 continues to impact our business, there were clear signs of recovery in the third quarter. Moreover, the underlying demand is strong as Victardi continues to be the treatment of choice for patients and providers. On the prevention side, we exceeded the goal we set at the beginning of the year of switching 40% to 45% of clinically appropriate at-risk individuals on PrEP to Dyscovy. As of October 1st, we were at 46%. Joanna will share more perspectives on our third quarter sales in a few moments. Finally, I'd like to briefly comment on Remdesivir, which we now refer to by its brand name of Bechlery. Bechlery received full FDA approval this month for treating hospitalized patients with COVID-19. It's the only FDA-approved therapy for COVID-19, in addition to being authorized or approved for use in more than 50 countries worldwide. We are also now in a position to meet global demand because of the work we've done since January to ramp up our supply. It's worth stepping back for just a moment to recognize how remarkable it is that we are in this position today. At the start of the year, most of the world had not even heard of COVID-19. The scientific community knew very little about the virus or its devastating potential. Today, less than 10 months later, we have an FDA-approved therapy that is helping patients around the world to recover faster, and for some groups of patients, Vickleria is lowering the risk of death. All of this comes at a time when the rates of hospitalization, sadly, in many places are increasing. We have repeatedly seen the clinical benefits of Veclaria across multiple clinical trials. In the past quarter, these benefits have been unequivocally demonstrated by the gold standard of global clinical trials. The definitive results from the fully-powered, double-blind, placebo-controlled, and randomized NIAD Act I trial showed an average reduction in recovery time of five days. I sometimes imagine how I would feel if a family member was hospitalized for COVID-19, and I'm sure many of you think of this as well. I'm extremely grateful that a therapy exists that has been validated with all of the rigor required for an FDA approval and whose benefits have been demonstrated in peer-reviewed data from a trial that is without question the pinnacle of clinical studies today. Magad will talk about all the recent data on BigQuery, including what we've seen from the WHO study and the ongoing development program shortly. Joanna will talk about the recent move to a commercial distribution model in the U.S., which is going very well. I'd just like to close on Victoria by expressing my gratitude once again to all the Gilead employees who have put their hearts and souls into this work since January, along with our many partners. On behalf of all of us, I want to say how privileged we feel to play a role in helping with the pandemic and be able to put our antiviral expertise to work for patients with COVID-19. I also want to emphasize that we will continue to do all it takes to fulfill our responsibility with Victoria. To wrap up my prepared remarks, I want to emphasize that our portfolio and pipeline are much stronger going into the fourth quarter in 2021. By executing on our strategy in a disciplined way throughout the past 12 months, we have significantly changed the nature of our growth process, especially following the acquisition of Immunomatics, and we have maintained the long-term durability of our core HIV franchise. We're not done, of course, but we've made significant progress, and for that I want to thank all the teams at Gilead and Kite and our many partners worldwide. With this, I'll hand the call now over to Joanna.