Gilead Sciences, Inc.

Ladies and gentlemen, thank you for standing by, and welcome to the fourth quarter 2020 Gilead Sciences Earnings Conference Call. At this time, all participants are in 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 today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your first speaker today, to Andrew Ang, Senior Director of Investor Relations. Thank you. Please go ahead.

Thank you, Dulem, and good afternoon, everyone. Just after the market closed today, we issued a press release with earnings results for the fourth quarter and full year 2020. The press release and detailed slides are available on the investor section of the Gilead website. The speakers on today's call will be Daniel O'Day, Chairman and Chief Executive Officer. Joanna Mercier, Chief Commercial Officer, Murdad Parsi, Chief Medical Officer, and Andrew Dickinson, Chief Financial Officer. Also on the call and available for Q&A will be Christy Shaw, Chief Executive Officer of Kite. 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 condition and results of operations, plans and expectations with respect to products, product candidates, corporate strategy, financial projections and the use of capital, and 2021 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 these 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 GAAP to non-GAAP 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, Andrew, and good afternoon, everyone. Thank you for joining us today. We're pleased to have this opportunity to provide an update on our progress and answer your questions. I'll begin by offering brief remarks and then hand off to the team to go into more detail. Before I begin, I want to thank all those who contributed to the progress we will highlight today, both our teams across the company and our many partners and collaborators worldwide. Let me start by looking back at the fourth quarter. Our work continued across three main areas, as it has throughout 2020, responding to the pandemic with our antiviral therapy, VicLurie, delivering on our commitment to people with HIV, cancer, viral hepatitis, and other conditions, and thirdly, executing on our strategy. As a result of our efforts to expand and strengthen our portfolio, we're going into 2021 in a very different position to how we began 2020. Last month, we provided updated guidance for the fourth quarter and full year 2020 to ensure that you had a clear picture coming into today's earnings announcements. This updated guidance was largely based on the significant increase in the uptake of Vicluri. In the United States alone, hospitalizations quadrupled between October and January, and approximately one out of every two patients hospitalized in the U.S. are being treated with Vicluri today. We're grateful that Vicluri is able to play such an important role in getting patients out of the hospital faster. five days on average based on the NIAID Act I trial, especially as many parts of the world struggle with hospital capacity. The higher uptake of Vicluri, along with the continued growth of our leading treatment for HIV, Victarvy, helped to offset the ongoing impact of the pandemic on some parts of our business. Vicluri and Victarvy also helped to mitigate the expected impact of loss of exclusivity for Atripla and Truvada in October. Our efforts to build out our portfolio of medicines continued in the fourth quarter with our agreement to acquire Mir. The acquisition, which is on track to close in the first quarter of this year, subject to regulatory clearances and other closing conditions, will bring us a first-in-class medicine called Hepcludix for the treatment of hepatitis D, or HDV. This is the most severe form of viral hepatitis and affects some patients who are already infected with hepatitis B. Hepcludix is conditionally approved in Europe and has FDA breakthrough therapy designation as an investigational agent in the United States. The acquisition of Immunomedix closed in the fourth quarter, bringing the most significant recent addition to our pipeline, Tredelvi. Tredelvi is a foundational medicine in our cancer portfolio with significant potential across multiple tumor types. We're very pleased with how the integration with Immunomedics is going and look forward to updating you on our progress with TRODELVI. Andy, Joanna, and Murdad will share more detail on the quarter. I'd like to turn now to the year ahead. The first thing I would say is that we're moving forward with a clear path to growth. We have multiple opportunities in new therapeutic areas, especially oncology. We're very pleased with the strong and diverse oncology portfolio we have today. This portfolio consists of both marketed therapies, such as Tredelvi and Tocardis and Yesgarda from KITE, and programs across various stages of the pipeline. There are currently 27 internal ongoing clinical stage programs for hematologic malignancies and solid tumors. We also have many promising opt-in opportunities. One of those options is for the anti-TIGID program through our collaboration with Arcus Biosciences. Earlier this week, it was announced that we are increasing our investment in Arcus to help fund the continued progress of the promising Arcus pipeline. The foundation for our near and long-term growth is our continued leadership in antivirals. We are confident in the longevity of our HIV business. We expect Biktarvy to continue to be a mainstay of HIV treatment long into the future, and our investigational capsid inhibitor, lenacapivir, could be a best-in-class long-acting option for both treatment and prevention. Lenacapivir is a highly potent and, importantly, its flexible dosing profile gives us the potential to develop multiple long-acting treatment and prevention options. In 2021, we expect a number of important milestones in the areas I've just mentioned. Murdad will provide more detail on the regulatory milestones, and I will highlight a few for now within the broader context of what you can expect from us. Starting with our leadership in antivirals, we will, of course, be focused on the continued growth of Biktarvi and maintaining its leadership as the number one prescribed treatment for HIV in major markets. We plan to file an NDA in the U.S. for lenacapavir in a heavily treatment-experienced population. This should be in the second half of the year. We will also continue to explore the right options for combinations. In viral hepatitis, we look forward to expanding our business in HBV and HDV by growing sales of venlitie in the U.S. and Asia, and pending completion of the MIR acquisition, the anticipated filing of a BLA in the second half of the year. For Vicluri, we look to realize the full potential of the therapy as the pandemic evolves. As you know, we are studying new formulations and routes of administration for Vicluri as a treatment for COVID-19. With the strong antiviral business as our foundation, we are looking forward to the continued expansion of oncology as a new pillar of growth. Tredelvi, which will have its first full year on the market following approval, will be a significant contributor to our growth this year. We expect to hear about conversion from accelerated to full approval in the coming weeks based on the FDA review of the assent data. At the same time, we'll be pursuing the many pipeline opportunities for TRODELVI. It is currently being studied in 10 different tumor types. We expect to hear from the FDA on accelerated approval for TRODELVI in metastatic urothelial cancer in the first half of the year. And we're also anticipating a readout of the phase III tropics II study in hormone receptor-positive HER2-negative breast cancer in the second half. Data from the phase III ZUMA-7 study is expected in the first half of the year for Yaskarta's potential expansion into second-line DLBCL. And we should see phase Ib data from agrolimab in MDS in the second half of the year with the possibility of a regulatory submission based on these results. In addition, we'll assess opt-in opportunities throughout the year as data becomes available and continue to advance our internal programs. I want to add that we are focused on prioritizing in order to deliver on these opportunities. We now have a portfolio that allows us to be much more selective in terms of what we take forward. This means being very disciplined about investing where there is highest potential value. You've seen some of that with our decisions around Filgotinib and our investment in Trodelphi. Just briefly on the enterprise level activities, we will continue to expand our talent base and deepen our expertise outside antivirals as we did in 2020. We will also maintain our strong focus on inclusion and diversity. As part of this, we are strengthening our efforts to promote racial equity. Today, we announced that Gilead has become a founding member of a coalition called 110. This is a group of U.S. companies that is committed to hiring and promoting 1 million black Americans into family-sustaining jobs over the next 10 years. In addition, we'll continue to advance our ESG program and targets in line with our strategy. We will update you on our progress in these areas each quarter. There's a lot of important work ahead of us in 2021, and we're very much looking forward to turning our opportunities into tangible progress that will benefit patients, communities, and our shareholders. With that, I'll now pass over the call to Andy.