“We are preparing for potential launch as early as late 2025.”

In context

“12% in the second quarter of 2024 compared to the same period last year. With that in mind, we are thrilled with the unprecedented results seen in our pivotal Phase 3 PURPOSE 1 trial, achieving 100% efficacy with zero cases of HIV infections in a broad population of cisgender women, including those who are pregnant or lactating. This is just the beginning of our larger, landmark PURPOSE program which includes multiple populations and communities where PrEP is underutilized or more difficult to access today, such as cisgender women, transgender men and women, Black and Latino individuals, and young adults. Overall, we expect lenacapavir will emerge as the regimen-of-choice for those who want or need prevention as the first and only long-acting option with twice-yearly subcutaneous dosing. We are preparing for potential launch as early as late 2025. Moving to the Liver Disease portfolio on slide 11, sales were up 17% year-over-year and 13% sequentially, driven by higher demand and higher average realized price due to channel mix in the U.S. Our Liver Disease franchise continues to differentiate itself, with leading share in HCV despite fewer HCV starts year-over-year together with growing demand in HBV and HDV. As you know, our PDUFA date for seladelpar is next week, and we stand ready to launch commercially in the U.S. We are able to leverage our existing commercial footprint in liver diseases, and continue building upon these relationships to quickly bring seladelpar to many of the 130,000 people impacted by PBC in the U.S. who progress after initial treatment. Outside the U.S., commercial preparations are well underway, and we loo”