Gilead Sciences, Inc.

Thank you for standing by, and welcome to the Gilead Scientist First Quarter 2022 Earnings Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during this session, you'll need to press star 1 on your telephone. Please be advised that today's call is being recorded. If you require any further assistance, please press star 0. I would now like to hand the call over to your host for today's program, Jackie Ross, Vice President, Investor Relations. Please go ahead.

Thank you, Jonathan, and good afternoon, everyone. Just after market closed today, we issued a press release with earnings results for the first quarter of 2022. The press release, slides, and supplementary data are available on the Investors section of our website at gilead.com. The speakers on today's call will be our Chairman and Chief Executive Officer, Daniel O'Day, our Chief Commercial Officer, Joanna Mercier, our Chief Medical Officer, Murdad Farsi, and our Chief Financial Officer, Andrew Dickinson. After that, we'll open up the call to Q&A, where the team will be joined by Christy Shaw, the Chief Executive Officer of KITE. Before we get started, let me remind you that we will be making forward-looking statements, including those 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, business and operations, financial projections and the use of capital, and 2022 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 statement. 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, in our supplementary data sheet, as well as on the Gilead website. Now, I'll turn the call over to Dan.

Thank you, Jackie, and good afternoon, everybody. We appreciate you taking the time with Gilead today, and I also want to thank those of you who joined our virology and oncology deep dives over the last few months. These two events provided a more in-depth view of our portfolio, our strategy, and the teams behind them. We shared a much broader view of our growing clinical pipeline than we had in the past, highlighting its potential to deliver a number of new therapies to address unmet needs for patients across a diverse range of conditions. For those of you who joined, I hope you got a deeper sense of why we're confident of sustaining our leadership in virology and growing our oncology revenues so that it becomes more than one-third of our total revenue in 2030. I'll turn now to our performance this quarter, and I'm pleased to share that the year is off to a strong start in line with guidance as shown on slide four. Total product revenue is up 3% from last year to $6.5 billion U.S., with cell therapy, Bicluri, Tredelvi, and HIV driving growth. HIV grew 2% year-over-year, primarily driven by Bictarvi, which grew 18%, and reported more than 4% market share growth compared to the first quarter of 2021. This is notable given the impact of our Truvada LOE. Sequentially, HIV was down 18%, primarily as a result of first-quarter seasonality. Our growing oncology portfolio performed well, with Tredelvi revenue doubling compared to the first quarter of 2021, and cell therapy delivering another strong quarter of growth. We recently expanded our portfolio of marketed cancer therapies following the FDA approval of Yaskarta for second-line relapsed and refractory LBCL. I'm also pleased to highlight the FDA approval of our new cell therapy facility in Maryland, which is part of the expected 50% increase in our manufacturing capacity by the end of 2022. The new facility will support our cell therapy growth expectations over the next several years. Moving to the pipeline, we shared the Phase III top-line readout from Tropics II in March, showing that the study met its primary endpoint with a statistically significant improvement in progression-free survival versus physician's choice in chemotherapy. Additionally, the first interim analysis of the key secondary endpoint of overall survival demonstrated a trend in improvement. As you know, we are exploring potential pathways for approval with regulatory authorities to bring Tredelvi to these later stage patients. The details of the study results will be shared at ASCO in June. At the Oncology Deep Dive earlier this month, we highlighted the broad potential for Tredelvi across multiple tumor types and lines of therapy. with plans to initiate 13 more Tredelvi trials through 2023, including four more in 2022. Turning to slide five, as you know, the timing for Tropix-2 and the NDA decision for Capella are subject to change. In the case of Capella, this is due to the biocompatibility issue that we're working to resolve, and we're fully confident in Lenacapivir itself. Other than that, we are on track with the remaining targeted milestones we shared with you in January. We've added some of the newly-disclosed trials from our oncology deep dive as well on this slide. Additionally, we're pleased to note that the partial clinical holds for the pivotal migrolamib trials, including Enhance-3 for first-line unfit AMLs shown on this slide, have been lifted. I'm also pleased to share that despite the hold, there's no change to the timing of the first interim readout for Enhance for first-line high-risk MDS, which we expect in the first half of 2023. My dad will share more pipeline details later in the call. Before I pass it over to Joanna, I just want to take a moment to thank the Gilead and Kite teams who are putting the full weight of their expertise, passion, and commitment behind all of this work that you're seeing. It's thanks to our 14,000 employees across the world that we're delivering for patients with diverse conditions and diseases today and advancing a pipeline of innovative new therapies for the future. We have some bold ambitions for the coming years, and we're confident of achieving them given the level of innovation and capabilities that we have in place today. Now I'll invite Joanna to share an update on our first quarter commercial performance. Over to you, Joanna.