Gilead Sciences, Inc.

Good afternoon, everyone, and welcome to Gilead's first quarter 2025 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, and to withdraw your question, press star two. I'll now 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 first quarter of 2025. 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, 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 our first quarter results, which reflect strong commercial and clinical execution across the business. Our base business, excluding Victory, grew 4% from the first quarter of 2024, primarily driven by growth in our HIV business. HIV sales were up 6% year-over-year, with Victarvy up 7%, highlighting our demand-led volume growth that was offset in part by the expected headwinds associated with the Part D redesign. LevDelvi continues its strong launch momentum with $40 million in sales in its second full quarter since launch. Year-over-year growth in our HIV and liver disease businesses was partially offset by softer-than-expected Trodelvi sales due to inventory dynamics that masked increase in demand, as well as headwinds in cell therapy. Total product sales, including Vicklery, were down by 1% from last year, reflecting fewer COVID-19 related hospitalizations. Beyond our commercial results, we also saw impressive operational execution with strong operating margin and earnings per share results that highlight our continued focus on expense management and leverage in our business model. Our diverse pipeline continues to deliver across HIV, oncology, and inflammation. In HIV, we are now only weeks away from the anticipated FDA decision on twice-yearly lenacapivir for PrEP. We remain on track for the June 19th PDUFA date and the potential launch in the U.S. immediately following. As a reminder, this is one of up to nine potential HIV product launches we are targeting before the end of 2033, building on Gilead's decades of leadership in HIV innovation. In oncology, earlier this week, we announced the positive results from the Phase III Ascent 04 study of Chordelvi in combination with Pembrolizumab for first-line PD-L1 positive metastatic triple negative breast cancer. The results showed a clinically meaningful and statistically significant improvement in progression-free survival over the standard of care. This news represents an important potential benefit for patients. metastatic TNBC is one of the most aggressive forms of breast cancer and has historically been very difficult to treat. We expect to share the ASCENT-04 data at a medical congress in the near future and to file with global regulatory authorities as quickly as possible. We continue to expect an update later this quarter on the Phase 3 ASCENT-03 study evaluating Trodelvi monotherapy in first-line metastatic triple negative breast cancer patients who are not candidates for PD-1 inhibitors. Moving to cell therapy, we plan to provide an update on our registrational Phase II IMAGINE 1 trial later this year and remain on track to potentially launch a NITO cell and late-line relapsed or refractory multiple myeloma in 2026. We believe that a NITO cell's clinical profile, combined with KITE's exceptional manufacturing capabilities and industry-leading turnaround time, puts us in a strong position to address the unmet need for patients with multiple myeloma. In inflammation, we are launching Livdelzy in additional markets following approval from the European Commission in February. We look forward to continued momentum as we bring Livdelzy to more people seeking to manage their primary biliary cholangitis with a differentiated option. As we wrap up a strong first quarter performance, we can look forward to continuing positive momentum We have multiple potential launches ahead, including lenacapivir, a needle cell, and now Tredelvi. As a reminder, we have no major LOEs until the end of 2033 and expect to drive top line growth over time across all three of our therapeutic focus areas of virology, oncology, and inflammation. The overall strength of our business means we are well positioned to adapt to a range of potential policy outcomes in the United States. It is worth noting that Gilead's average corporate tax rate of approximately 20% reflects the fact that the substantial majority of our intellectual property is already registered in the United States. The 2017 tax reform was instrumental in us bolstering our U.S. investment, and Gilead is differentiated in that almost 100% of our R&D capital infrastructure is in the U.S. In addition, we have been increasing our investment in U.S. manufacturing over the last several years with two large-scale cell therapy sites, and we have additional investment projects underway that are expected to run through 2028. Our focus is on delivering on our multiple upcoming launches and advancing our diverse pipeline. And in the meantime, we continue to engage with the administration to encourage a balanced policy agenda that prioritizes innovation and the needs of patients. With that, I'll hand it over to Joanna.