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Gilead Sciences, Inc.
5/7/2026
Good afternoon, everyone, and welcome to Gilead's first quarter 2026 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. Please note that the process for queuing questions has changed this quarter. To ask a question, press star 1, and to withdraw your question, press star 1 again. Now, I'll hand the call over to Jackie Ross, Senior Vice President, Treasurer, and Head of Investor Relations.
Thank you, Rebecca. Just after market closed today, we issued a press release with earnings results for the first quarter of 2026. 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 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.
Thank you, Jackie, and good afternoon, everyone. I'm pleased to share highlights from Gilead's first quarter, which has extended our consistent track record of commercial, clinical, and financial execution. Our strong financial performance and increase in sales guidance reflects the depth and quality of our portfolio, the numerous launches underway, and our continued focus on financial discipline. As we execute on the strongest pipeline in our history, Gilead is also taking steps to further strengthen the company's position for the future. We are looking forward to sharing much more on our Celex, Oro, and Tubulus in the coming quarters. Our HIV business grew 10% year-over-year, reflecting 7% growth for Biktarvy and an impressive 87% growth for our U.S. PrEP business. The ongoing success of the S2GO launch is a key driver of this growth in HIV prevention, with first quarter sales growing 72% sequentially. Looking forward, with no major LOEs until 2036, Gilead's HIV business is poised for strong, durable growth, supported by up to seven potential new HIV product launches by 2033. The first of these potential launches is Bictegravir plus Lenacapavir, an investigational once-daily oral regimen for virally suppressed people with HIV. This is now under priority review, and we expect an FDA decision in August. Other upcoming HIV milestones include Phase III updates later this quarter from the Island 1 and 2 studies, evaluating a potential first once-weekly oral for virally suppressed people with HIV. We shared encouraging Phase I data at CROI in February for a long-acting integration inhibitor, GS3242. Later this year, we plan to share additional data that could support the combination of GS3242 with lenacapivir as a potential twice-yearly injectable treatment regimen. The timeframe for potential launch is between 2031 and 2033. In oncology, first-quarter Tredelvi sales were up 37% year-over-year, reflecting growing demand for Tredelvi. We anticipate regulatory decisions on extending into first-line metastatic triple-negative breast cancer in the second half of this year. Ahead of these decisions, Cordelvi has already received NCCN Category 1 recommendations across the first line and is the leading ADC and second-line metastatic TMBC treatment. We are also expecting Phase III updates, from the EVOCO3 trial in first-line metastatic non-small cell lung cancer and the ASCENT-GYN trial in second-line plus metastatic endometrial cancer in the second half of this year. The pending acquisition of Tubulus is another significant milestone in building Gilead's oncology franchise. The company brings a clinical stage candidate, TUB40, which we believe has the potential to be a leading ADC in ovarian cancer and a next-generation ADC platform with a promising early pipeline. At the upcoming ASCO meeting, we look forward to additional Phase I data on TUB40 and platinum-resistant ovarian cancer. Additionally, we are expecting a regulatory decision on InitoCell, our potential best-in-disease BCMA CAR-T in December of this year. Our acquisition of Arcelix, which closed on April 28th, reflects our conviction in the potential of a needle cell as a differentiated option for patients with multiple myeloma. Given the significant opportunity in fourth line, as well as earlier lines of therapy, we believe a needle cell could become a foundational therapy for multiple myeloma, driving growth in our cell therapy business in 2027 and beyond. The ArcelX platform will leverage KITE's industry-leading manufacturing capabilities and could further strengthen our future in oncology and inflammation. In liver disease, Levdelzi revenue for second-line primary biliary cholangitis more than tripled year over year. We are expecting an update from our Phase III ideal study for Levdelzi in the second half of this year. If positive, the ideal study could support a label update and expand the second-line PBC addressable population. Additionally, we expect a regulatory decision and potential U.S. launch of Hapcludex for chronic hepatitis delta virus infection later this quarter. In inflammation, the potential acquisition of oral medicines will add to our portfolio with Gamgertamig, a BCMA-CD3 T-cell engager in multiple B-cell-driven autoimmune diseases. We will also share phase two updates for our oral ARAC4 inhibitor and oral alpha-4 beta-7 small molecule this year. These commercial and clinical updates demonstrate the strength of our execution today, underpinned by our continued commitment to financial discipline. As we look to the remainder of 2026, we see many exciting opportunities to further expand our impact on the patients and communities we aim to serve. With that, I'll hand it over to Joanna.
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