2/10/2026

speaker
Rebecca
Conference Call Host

Good afternoon, everyone, and welcome to Gilead's fourth quarter and full year 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 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 2025. 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 and Corporate Affairs 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. I'm pleased to share another very strong set of results for Gilead, closing out a remarkable year for the company with clinical, commercial, and operational achievements that set the stage for a very promising 2026. Starting with our full year results, our HIV business grew 6% year over year, driven by 7% growth in Biktarby and 47% growth in our HIV prevention portfolio. This was despite an estimated $900 million headwind in 2025 associated with the Part D redesign. Absent this headwind, our HIV business growth was 10% in 2025. Yes2Go, our twice yearly HIV prevention injectable, has already exceeded our coverage goals and is rapidly gaining market share in addition to expanding the reach of HIV prevention to new users. With its unique potential to bend the curve of the HIV epidemic, Yes2Go is a transformative medicine that we expect to drive durable, steady, and long-term growth in our HIV prevention business in the coming quarters and years. Our liver business grew 6% in 2025 compared to 2024, largely driven by the rapid adoption of Levdelzi for primary biliary cholangitis. And in oncology, Tredelvi also grew 6% in 2025, driven by momentum in metastatic triple negative breast cancer following positive phase three updates. And cell therapy was down about 7% year over year, largely in line with our expectations and reflecting continuing competitive headwinds. Moving to clinical progress, following a very productive year in 2025, we have a catalyst-rich year ahead, including... Phase 3 updates from ILIN 1 and 2 trials evaluating Islatravir plus Lanacapavir, the potential first once-weekly oral treatment for people with virologically suppressed HIV. Two Phase 3 updates for Tredelvi, including the EVOKE-03 trial in metastatic non-small-cell lung cancer and the ASCENT-GYN-01 trial in advanced endometrial cancer. Lastly, we expect an update on the Phase III IDEAL study evaluating Levdelzi in second-line primary biliary cholangitis patients with only incomplete response to UDCA. The strength and the pace of progress in our clinical pipeline is driving a steady cadence of product launches, and on the heels of Levdelzi in 2024 and Yes2Go in 2025, we are targeting four commercial launches this year, including Trodelvi for first-line metastatic triple negative breast cancer, extending beyond second-line treatment for which Trodelvi is a standard of care, following positive results from the Phase 3 ASCENT-03 and ASCENT-04 studies. A new daily oral combination of Bictegravir and Lenacapavir for HIV treatment, following positive updates from the Phase 3 Artistry 1 and Artistry 2 trials. Anitocel, our potential best-in-disease BCMA CAR T for fourth-line or later relapsed or refractory multiple myeloma, and Bulabratide in the U.S. following approval in the EU for treatment of chronic hepatitis delta. These commercial and clinical milestones reflect the success of our diversification strategy that has been shaping Gilead over the last six years. We have up to 10 ongoing and potential new launches, through 2027, and the strongest pipeline in our almost 40-year history. At the same time, we remain committed to operating expense and M&A discipline, continued delivery of exceptional operating results, and growing returns to shareholders. With many of the policy-related uncertainties behind us and no major product LOEs until 2036, Gilead is entering 2026 in a position of strength. With that, I will hand it over to Joanna.

Disclaimer

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