8/7/2025

speaker
Rebecca
Conference Call Host

and welcome to Gilead's second 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. 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.

speaker
Jackie Ross
Senior Vice President, Treasury and Investor Relations

Thank you, Rebecca. Just after market closed today, we issued a press release with earnings results for the second 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.

speaker
Daniel O'Day
Chairman and Chief Executive Officer

Thank you, Jackie, and good afternoon, everyone. The team and I are pleased to be here with you today to share the results of a very successful second quarter. This quarter had special significance, of course, with the FDA approval of Lenincapivir, or yes, Tugo, for twice-yearly HIV prevention. I want to take this opportunity to thank the many people who contributed to this remarkable achievement, from the Gilead teams who discovered and developed Lenincapivir, to the participants in the PURPOSE studies, as well as the KOLs, advocates, community partners, and others who have been part of the Lenincapivir journey. This is truly a milestone moment in the history of HIV, with the launch of a groundbreaking innovation that could bend the arc of the epidemic. Moving to the quarterly results, we had another very strong quarter of clinical, commercial, and operational execution. Excluding VicLurie, base business sales of $6.9 billion grew 4% year over year, driven by robust growth across Biktarvy, Dyskovy, Levdelsi, and Tridelvi. Product sales of $7.1 billion grew 2% year over year. The strong base business performance was partially offset by lower VicLurie sales due to fewer -19-related hospitalizations. HIV had a very strong second quarter, with demand-driven growth of 7% year over year, more than offsetting the anticipated headwinds from the Medicare Part D redesign. Biktarvy grew 9% year over year to $3.5 billion, and Dyskovy grew 35% year over year to $653 million. This was Dyskovy's strongest quarter ever, highlighting the growth of the HIV prevention market, into which we are now launching Yes2Go. It is now seven weeks since FDA approval of Yes2Go, and we are very pleased with what we're seeing so far. Joanna and Andy will take you through our results in more detail, but overall, the strong commercial execution and operating expense discipline year to date support higher expectations for the second half of 2025. As a result, we are increasing our revenue and EPS guidance for the full year. From a clinical perspective, the second quarter was one of the strongest in Gilead's history. In addition to the FDA approval of Yes2Go, we received a positive CHMP opinion from the European Medicines Agency. With more than one million new HIV infections globally each year, and over 600,000 HIV-related deaths, we believe Lenincapivir is one of the most important scientific breakthroughs of our time, which brings a sense of urgency and responsibility to reach the communities most in need as quickly as possible. At the same time, we continue to fully evaluate Lenincapivir's potential in the clinic. For example, we have just initiated Purpose 365, a phase three trial evaluating once yearly Lenincapivir for PrEP. Additionally, we continue to develop seven combination regimens that utilize Lenincapivir-based molecules for HIV treatment. In the second half of this year, we plan to share updates from Artistry I and Artistry II. These phase three trials are evaluating a potential new single tablet regimen, combining Bictegravir plus Lenincapivir, that could further extend the reach of Gilead's current HIV treatment business. Moving to oncology, we announced -to-back positive phase three results for Tridelvi with the top line data from Ascento III and the detailed data from Ascento IV. We now have data that show highly statistically significant and clinically meaningful benefit for Tridelvi across first line metastatic triple negative breast cancer. Tridelvi is already the leading therapy for second line metastatic TMBC, and with these data, we look forward to potentially advancing Tridelvi to the first line setting where it could benefit twice as many patients. In cell therapy, we expect to provide a pivotal update from the phase two Imagine I trial, evaluating a NIDA cell for multiple myeloma later this year. Given the compelling efficacy and safety data seen to date, combined with Kite's industry-leading manufacturing capabilities, we believe a NIDA cell is well positioned as a potential -in-class therapy for multiple myeloma. In summary, this is a very special time for Gilead that's underscored with our second quarter results. This highlights the strength of our R&D engine and the level of excellence in our commercial and operational execution. Having built this positive momentum, we're excited by what's to come with continued innovation that will benefit patients and drive growth across our therapeutic areas. With that, I'll hand over to Joanna.

Disclaimer

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