Gilead Sciences, Inc.

Good day and thank you for standing by. Welcome to the Gilead Sciences first quarter 2021 earnings conference call. At this time, all participants are in listen-only mode. After the presentation, there will be a question and answer session. To ask a question during this session, you will need to press star then one on your telephone keypad. Please be advised that today's conference may be recorded. If you require any further assistance, please press star then zero to reach an operator. I'd now like to hand the conference over to your speaker today, Jackie Ross, Vice President, Investor Relations.

Please go ahead. Thank you, Liz, and good afternoon, everyone. Just after market closed today, we issued a press release with earnings results for the first quarter of 2021. The press release, slides, and supplementary data are available on the investor 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 Parsi, 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, our plans and expectations with respect to products, product candidates, corporate strategy, financial projections, and the use of capital, and our 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 statement. Non-GAAP financial measures will be used to help you understand the company's underlying business performance. The GAAP and non-GAAP reconciliations are provided in the earnings press release, in our supplementary data sheet, as well as on the Gilead website. I will now turn the call over to Dan.

Thank you, Jackie, and good afternoon, everyone. We appreciate you taking the time to join us today. Before I hand over to the team to go into the details of our commercial pipeline and financial results, I wanted to share our overall assessment of Gilead's first quarter. 2021 is a pivotal year for Gilead, and as you can see on slide four, we're off to a solid start. Our first quarter total product sales were in line with our internal expectations. While our core business was more impacted by COVID-19 than we anticipated, This was offset by higher VicGlory sales. In the United States, one in two hospitalized patients are receiving VicGlory, and worldwide, VicGlory continues to play a key role as a standard of care treatment for patients who are hospitalized with COVID-19. Given the desperate situation in India, Gilead has been working with the Indian government, health authorities, and our voluntary licensees to increase supply of remdesivir and provide donated medicines. As the trajectory of the pandemic evolves globally, we will continue to invest in multiple clinical studies of Vicluri, including alternative formulations. Earlier this month, we received two FDA approvals for Tredelvi. The full approval for metastatic triple negative breast cancer extended the label to second-line plus patients. This means Tredelvi could help many more patients. as there are more than double the number of patients in this category, as there are in the third-line setting. We also received accelerated approval in second-line plus metastatic urothelial cancer. In March, we announced a new partnership to combine investigational lenacapivir with Merck's investigational islatravir for long-acting HIV treatment, accelerating the path to the next wave of therapies. While many people living with HIV may prefer a daily regimen like Bictarvy, we believe that broadening their options to include weekly oral therapies and infrequent injections every three months or longer addresses a significant patient need and sets up strong, sustainable HIV leadership into the late 2030s. Long-acting formulations such as lenacapivir as monotherapy are also likely to unlock further PrEP usage and reach many more people at risk of HIV. We are also pleased with our progress in advancing lenacapivir in both treatment and prevention settings as part of our internal clinical development. This past quarter, we reported compelling long-acting efficacy data for lenacapivir in heavily treatment-experienced people with multidrug-resistant HIVs. We are fully confident that Lenacapivir will be the foundation for our long-acting HIV treatment and prevention portfolio. And while we advance Lenacapivir, Bigtarvy usage continues to grow, with one in two people living with HIV starting their treatment on Bigtarvy in the U.S. In addition, Bigtarvy is capturing one in two switches, and approximately half of those are switching from a regimen that includes a non-Gilead agent. In addition to securing regulatory approvals in oncology, we have already achieved several other pipeline milestones, including EMA validation of the Tredelby MAA for metastatic triple negative breast cancer and submission of the supplemental biologics license application to FDA for Tocardis in relapse or refractory ALL. Building on the work we did last year, we continue with the disciplined prioritization of our pipeline across Gilead. To share one example, Kite completed an optimization exercise this past quarter to ensure that resources are focused on the most promising opportunities to make a difference for patients. Finally, we're looking forward to a full year of clinical news flow for Gilead. Our pipeline list for 2021 includes over 20 milestones across therapeutic areas. While they are all important steps in Gilead's journey to serve more patients and diversify our business, slide five lists the most significant items so you can track our progress more clearly. These include the Phase III Tropics II PFS readout for Tredelvi in hormone receptor-positive HER2-negative metastatic breast cancer, Yaskarta's Phase III ZUMA-7 readout for second-line DLBCL, which could result in an S-BLA submission later this year. The Phase III readout for Hapcludix that could lead to BLA filing. Arcus' Domvanilamab Phase II ARC-7 interim readout in non-small cell lung cancer, which could inform an opt-in decision. McGrolamab's Phase 1b data readout in MDS, which could lead to a submission for accelerated approval later this year, and potential Phase 2 initiation of lenacapivir and islatravir as a long-acting oral HIV treatment in the second half of 2021. Our aspirations for patients are bold, and our pipeline offers diversity across indications and risk profiles. While execution will continue to be a focus, these milestones give us a great deal of optimism about the future and our ability to deliver therapies that make a meaningful difference for patients. Before I hand off, I want to take a moment to thank Dr. Bill Lee, who is retiring from his role as Executive Vice President of Research after 30 years at Gilead. On behalf of all of us, I want to offer my sincere gratitude to Bill for his outstanding contributions that have helped to benefit millions of patients around the world. I would also like to welcome Dr. Flavius Martin, who joined Gilead as the new EVP of Research on April 12th. Flavius has an impressive track record in overseeing industry-leading research and advancing new therapeutic candidates. With that, I'll invite Joanna to update you on our commercial operations in the first quarter.