Gilead Sciences, Inc.

Good afternoon, everyone, and welcome to Gilead's fourth quarter and full year 2024 earnings conference call. My name is Rebecca, and I'll be today's host. In a moment, we'll begin our prepared remarks, followed by our Q&A session. To ask a question, please press star one. To withdraw your question, press star two. Now, I'll hand the call over to Jackie Ross, Senior Vice President of Treasury and Investor Relations.

Thank you, Rebecca. Just after market closed today, we issued a press release with earnings results for the fourth quarter and full year 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, Dietmar Berger, 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. 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'm pleased to share Gilead's very strong fourth quarter and full year results, which highlight growing revenues and exceptional bottom line growth. Starting with our full year performance, total product sales, excluding VicLurie, increased 8% year-over-year to $26.8 billion, and fourth quarter 2024 total product sales, excluding VicLurie, increased 13% year-over-year to $7.2 billion. Full-year HIV sales grew 8% in 2024 to $19.6 billion, significantly ahead of our expectation to grow HIV 5% in 2024. Full-year sales for Bictarvy, the standard of care for HIV treatment, grew 13%. In recent years, our HIV business has established a track record of consistently strong growth, with 5% growth in 2022, 6% in 2023, and now 8% in 2024. This is driven by the strength of our innovation and by the consistently strong execution of our team. In 2025, while volume and demand growth will continue, we can expect to see a temporary masking of the trend with the anticipated impact of Medicare Part D reform on revenue growth. This will effectively reset the base from which our HIV business will continue to grow from 2025. We fully expect to see our leadership in HIV continue and extend beyond the 2030s based on our long-acting portfolio of which Lenacapivir is the foundation. In December, we filed for approval of Lenacapivir for twice-yearly HIV prevention in the U.S., where it has breakthrough therapy designation, and we continue to make progress on our global filings. At the end of January, we filed for approval with the European Medicines Agency and our submission will be assessed under an accelerated review timeline. Given the unprecedented efficacy in the Phase 3 Purpose 1 and Purpose 2 trials and the significant potential that exists in HIV prevention, we are looking forward to delivering on this global opportunity in 2025 and beyond. As we shared at our HIV Analyst Day in December, We have a broad and unmatched clinical program for both HIV treatment and prevention that builds on what we currently offer with Bictarvy and Descovy. We expect to deliver up to seven potential new HIV treatment options and two prevention options before the end of 2033, including new daily, weekly, and monthly orals, as well as quarterly and twice yearly injectables. We look forward to sharing a number of HIV clinical updates this year, including updates from Artistry 1 in people with HIV on complex regimens, and the Phase 2 portion of our Wonders 1 trial, evaluating a potential once-weekly HIV treatment option. Moving to inflammation, the fourth quarter of 2024 was the first full quarter since commercial launch for Livdelzy in the United States, and we are extremely pleased with the results. The strong sales of approximately $30 million for the quarter underscore the important differentiation that Levdelzi brings to people with primary biliary cholangitis, and we expect a European Commission decision later this month following the CHMP recommendation for Levdelzi in December. Our liver portfolio, which amounts to a $3 billion business today, is a steady contributor for Gilead, and we look forward to seeing it evolve with the new impetus of Levdelzi. We also continue to make progress across our early and promising inflammation pipeline. This includes the recent addition of our STAT6 program from Leo Pharma and the advancement of our bisistronic CAR-T targeting CD19 and CD20 for autoimmune diseases. In oncology, we continue to make progress on expanding the reach of our cell therapies to the many additional patients who could benefit from a one-time therapy in these challenging hematological malignancies. And at the same time, our collaboration with Arcelix on a needle cell continues to yield promising results. Data from the Registrational Phase 2 IMAGINE 1 trial were shared at the ASH meeting in December, where a needle cell demonstrated its potential to be a best-in-class BCMA CAR T therapy. We continue to target commercial launch in 2026 and have separately dosed our first patient in the Phase 3 IMAGINE 3 trial in the second to fourth line setting. Trodelvi, meanwhile, remains the only approved TROP2 ADC to demonstrate overall survival benefit in pretreated HR-positive HER2-negative metastatic breast cancer and in second-line metastatic triple-negative breast cancer. Additionally, Trodelvi has six ongoing Phase III trials with updates from the ASCENT-03 and ASCENT-04 trials in first-line metastatic triple-negative breast cancer expected this year. We also anticipate initiating another phase three trial for Tredelvi in extensive stage small cell lung cancer patients later this year. Our many near-term opportunities across HIV, oncology, and inflammation will help to drive the next wave of growth for Gilead. We have no major loss of exclusivity until late 2033, and we have significant potential across the entire portfolio. With that in mind, I'm delighted to introduce our new Chief Medical Officer, Dietmar Berger, who joined us in early January. Dietmar's exceptional leadership in global drug development, his track record in delivering transformational therapies, and the breadth and depth of his experience make him an ideal leader for taking us through the next chapter for Gilead, and I know you will all enjoy getting to know him in the months ahead. I would also like to thank Murdad Parsi for his contributions to Gilead over the last five years and wish him the very best for his retirement. Among his many achievements, Murdad developed a world-class team that has helped to build the most robust and diversified pipeline in Gilead's history, now with 54 ongoing clinical programs, up from just 32 clinical programs in 2019. With that, I'll hand it over to Joanna.