Gilead Sciences, Inc.

Ladies and gentlemen, thank you for standing by, and welcome to the first 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 will 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. It is now my pleasure to introduce Senior Director of Investor Relations, Doug Buffet.

Thank you, Andrew, and good afternoon, everyone. Just after market closed today, we issued a press release with earnings results for the first quarter 2020. The press release and detailed slides are available on the Investor Relations section of the Gilead website. The speakers on today's call will be Daniel O'Day, Chairman and Chief Executive Officer, and Andrew Dickinson, Chief Financial Officer. Also on the call will be Johanna Mercier, Chief Commercial Officer, Murdad Parsi, Chief Medical Officer, Christy Shaw, Chief Executive Officer of KITE and Diana Brainard, SVP and Head of HIV and Emerging Viruses Therapeutic Area. Before we begin with our prepared comments, 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 and results of operations. Plans and expectations with regards to products, product candidates, 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 these statements. Thank you for joining us. I will now turn the call over to Dan.

Thank you very much, Doug, and good afternoon, everyone. Well, as you can imagine, it's been an extraordinary week for Gilead, given the terrific news on our investigational antiviral drug remdesivir. The news shared yesterday that the data show the potential of remdesivir to help ease some of the burden of the pandemic is the outcome that we had all hoped would be possible. We're incredibly humbled to think about what this news could mean for patients and communities. I'd like to start by sharing my thanks to everyone who has helped to bring Remdesivir to this point, including all those involved in the collaborative clinical trials, the trial investigators, governments, hospitals, and above all, the patients who participated. I want to acknowledge our internal teams that have been working day and night on Remdesivir for the past three months. following many years of research long before the outbreak began. Because of their remdesivir news, the original focus for today's call has somewhat shifted. I'm sure you have a lot of questions on the results and the next steps. We'll provide an overview of what was a strong first quarter for Gilead, but with an abbreviated set of opening comments so we can leave more time for questions. I'll speak briefly about the quarter and Remdesivir before turning the call over to Andy to discuss financial details and the impact of COVID-19 on our business. As Doug noted in the opening, Christy, Johanna, Murdad, and Diana have joined us today to answer your questions at the end of the call. Gilead has been built to withstand significant challenges. There's a short-term uncertainty for all of us, but the solid foundations that Gilead has laid over the past 30 years and our focus on transformational therapeutics give us confidence in the long-term durability of the business. We'll do our best to provide you with a clear picture of where we are and what we expect as far as the near-term impact of COVID-19, while acknowledging that, as we all know, These are uncertain times with many unknowns, not least of which is how long the pandemic will last. So, turning to the quarter, I'll use the framework we introduced at the start of the year with the three pillars that will shape our future. A strong core business, our internal pipeline, and supplemental growth opportunities that are being enabled through our strategies. Our performance in the first quarter demonstrated the strength of our foundational business once again with double-digit growth in HIV. We reached and, in fact, exceeded all of our targets. Revenues for our HIV franchise were up 14% year over year. This was driven by both treatment and prevention, as Bictarvy remained the number one prescribed HIV regimen in the U.S. during the quarter, and approximately 38% of individuals on PrEP are now taking the SCOBY. What I would say in general about where we stand in HIV is this. We are very confident in the underlying competitiveness of our products and our position as a leader in HIV. Completing the picture in our core antiviral business, we saw sustained revenues from our HPV franchise in the last quarter. Since the introduction of authorized generics in the U.S., we've regained market share and now hold around 61% of share through ASEGRA and Gilead. So, moving from our core business to advancing our pipeline, I'll provide just a brief overview. More detailed information is available as part of our first quarter earnings materials in the investor relations sections of our website. Vilgotinib, as you are aware, is under regulatory review in the United States, Europe, and Japan as a potential treatment for rheumatoid arthritis. Our teams are preparing for a competitive launch and remain in close contact with regulators to understand the effects COVID-19 could have on review timelines. In HIV, we made progress across our pipeline, sharing important data at the virtual CROI conference with our innovative long-acting antiviral and HIV cure programs, reinforcing our long-term commitment to people living with HIV. In cell therapy, the FDA accepted type BLA for type X19 as a treatment for relapsed and refractory mantle cell lymphoma during the first quarter and granted a priority review designation. As you might recall, the European Medicines Agency validated our application in January. This represents really important progress. Patients with relapsed refractory mantle cell lymphoma, a rare form of non-Hodgkin's lymphoma, are in need of new therapies. If approved, Kite would be the first company with two cell therapies on the market. So I touched on our strong core business and advancing our pipeline. Now I want to say a few words about the work we are doing to expand our pipeline through business development, including, of course, the acquisition of 47 Acquiring 47 is a great early example of our strategy in action. We said we would build on our core area of expertise, which, as you know, are virology and immunomodulation, that we would keep a high bar and that our business development efforts were focused on clinical stage assets, such as megrolamine, which we gained as a part of this acquisition. We're working to integrate the teams and the programs, a joint effort which I'm leading with Mark McCamish, the CEO of 47, with the objectives of keeping things moving smoothly with Megrolimab and defining a working model that supports continued innovation. Next month, researchers will present data on our next-generation cancer therapies virtually at ASCO, including Megrolimab and a number of abstracts that highlight the Kite Cell Therapy portfolio. The presentations at ASCO underscore the strength of our scientific approach in immuno-oncology, and we look forward to sharing this latest research. Beyond 47, our business development team remains as active as ever. In the last month, we've announced three partnerships, a collaboration with Second Genome to identify biomarkers and potential new drug targets in inflammation, a licensing agreement between Kite and TeneoBio covering a dual targeting CAR-T therapies, and a three-year collaboration with OncoInnate to discover cancer immunotherapies. Overall, we continue to maintain our momentum, and I'm pleased with all the progress we've made this quarter. I'll now turn to remdesivir. The study results shared yesterday from the randomized, placebo-controlled Phase III NIAID study and from our own open-label Phase III simple study in patients with severe disease are important progress as we seek to understand the role that remdesivir might play in easing the burden of COVID-19 around the world. These trials are part of a suite of clinical trials investigating the effects of remdesivir. We designed a clinical research program to ask multiple questions in parallel, including which groups of patients are most likely to respond and when to treat and for how long. Various study designs were used from placebo-controlled to open-label to answer very specific questions in each case. We expected that the answers would emerge around the same time and that taken together, they would form a clear picture of how remdesivir might best be used for patients. Yesterday, we answered important questions with the initial results of the NIAID trial and simple trials. The NID data demonstrated that patients with COVID-19 who received remdesivir recovered faster than similar patients who received placebo. The results from the Gilead-sponsored simple study address a critical question about dosing. The data from the first of the simple studies showed similar clinical improvements in patients with severe symptoms of COVID-19, regardless of whether they received five or ten days of treatment. Thank you for joining us. The Gilead Simple Study suggests we may now be able to significantly increase the number of courses available with a five-day treatment duration for certain patients. As we announced previously, we are donating our entire existing supply, frankly, because this is the right thing to do at this time and the human health need in the pandemic. As you know, we've been ramping up production since January. We've significantly reduced lead times and expanded our global network of partners. As additional raw materials come available, we'll have an exponential increase in supplies towards the latter half of this year. We hope to have produced enough supplies to treat over a million patients by year end. We are also working to build a global consortium of pharmaceutical and chemical manufacturers to expand global capacity and production. It will be essential for countries to work together to create enough supply for people all over the world and we look forward to these collaborative efforts. For access and allocation, we'll work closely with governments and healthcare systems to provide access. We intend to allocate our available supply based on guiding principles that aims to direct global access for appropriate patients in urgent need of treatment. We recognize there's a lot of work left to be done and a long way to go in finding medical solutions to end the pandemic. and we'll continue to work with regulatory authorities on the best path forward for Remdesivir. At the same time, all of us at Gilead are relieved and grateful that our efforts on Remdesivir have led to this important progress at a time when we all need a beacon of hope. Before I turn the call over to Andy, I want to reiterate how grateful we are for the partnership with many groups outside Gilead to support the work on Remdesivir. The collaboration throughout this pandemic has been critical.