Gilead Sciences, Inc.

Good afternoon, everyone, and welcome to Gilead's first quarter 2024 earnings conference call. My name is Rebecca, and I'll be your host for today. In a moment, we'll begin our prepared remarks. After that, we'll have a Q&A session. If you'd like to ask a question, please press star 1 on your telephone keypad. If you'd like to withdraw your question, please press star 2. I'll now hand the call over to Jackie Ross, VP, Investor Relations and Corporate Strategic Finance.

Thank you, Rebecca. Just after market closed today, we issued a press release with earnings results for the first quarter of 2024. 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 Parsi, and our Chief Financial Officer, Andrew Dickinson. After that, we'll open the call to Q&A where the team will be joined by Cindy Peretti, the Executive Vice President of KITE. Before we get started, let me remind you that we will be making forward-looking statements. Please refer to slide two regarding the risks and uncertainties relating to forward-looking statements that could cause actual results to differ materially. With that, I'll turn the call over to Dan.

Thank you, Jackie, and good afternoon, everyone. I want to start by thanking the Gilead teams for delivering a strong first quarter. which you see in our commercial performance and our clinical execution. Total product sales, excluding Vicluri, grew 6% year-over-year to $6.1 billion, driven by higher demand across HIV, oncology, and liver disease. Vicluri sales continued to track with the rates of hospitalization for COVID-19 and reached a total of 555 million. Once again, sales growth for the quarter reflected the diversity of our portfolio. HIV product sales grew 4% year over year. Oncology product sales were up 18%, driven by Tordelvi, which is well established as the number one regimen for second line metastatic triple negative breast cancer, and by our transformative cell therapies. As we outlined at the recent KITE Analyst event in Maryland, we have exciting plans to build on our clear market leadership in cell therapy. such as expand into community networks in the U.S., more than double our manufacturing capacity, and move into new indications and disease areas with next generation products. From an EPS perspective, first quarter results reflect the close of the SEMA Bay acquisition with an acquired IPR&D charge of $3.9 billion, or an expense of $3.14 per share. Excluding this charge, non-GAAP diluted EPS would have been $1.82 for the first quarter, which is above expectations, driven by higher product sales. The SEMA Bay acquisition brings us an important registrational medicine, Celadelpar, which has the potential to address significant unmet need in liver disease. We have filed for regulatory approval of Celadelpar as a treatment for primary biliary cholangitis, or PBC, with both FDA and EMA, and we expect an FDA regulatory decision in August. If approved, we will leverage our industry-leading commercial infrastructure and longstanding expertise in liver disease to bring Celadalpar, a potentially transformative therapy, to people with PBC who might benefit. Moving to clinical execution, we're very pleased with the momentum in our HIV pipeline, which was reflected in our 80 data abstracts at CROI. Based on the strength of the data, we've initiated phase three trials for Bactegravir and Lenacapavir, our novel once-daily oral regimen, and plan to advance once-weekly oral programs, including Lenacapavir plus Islatravir, into phase three. Later this year, we will host an HIV analyst event to share details of how we will further shape the HIV landscape with innovative options for prevention and treatment including the next wave of long-acting therapies. Before I pass it to Joanna, I will briefly recap our 2024 milestones on slide six. We have already achieved first patient in for the Phase III Artistry I and Artistry II trials, evaluating once-daily lenacapavir in combination with bactegravir, as well as Phase II first patient in for SWIFT, evaluating GS1427, our oral alpha-4-beta-7 inhibitor. We are also on track for our upcoming milestones, including updates from three phase three clinical trials for Tordelvi and Lenacapivir. Looking ahead to the rest of 2024, this is a time of focused execution for Gilead. We will stay disciplined and agile in our approach, and we will focus the organization on both near-term execution and longer-term plans. With 54 clinical programs in play, no major patent expiries to the end of the decade, and many opportunities for growth, we have a lot of potential and a lot to deliver. My thanks again to the Gilead teams for their great work this quarter and the ongoing progress across our diverse portfolio of therapies. With that, I'll hand it over to Joanna.