“we are on track to file before the end of this year.”

In context

“mmitment to disciplined expense management. Based on our financial results year-to-date, we are increasing our 2024 guidance across almost every metric, including revenue and non-GAAP gross margin, operating income, and EPS. We continue to make excellent progress in our Virology and Inflammation programs in the third quarter. The results from the PURPOSE 2 study, which build on the 100% efficacy shown in PURPOSE 1, demonstrate lenacapavir's unmatched clinical profile observed for HIV prevention. If approved, lenacapavir, as the first twice-yearly subcutaneous injection for HIV prevention, could make a major impact on global public health and significantly catalyze the prevention market. I'm pleased to share that the FDA recently granted breakthrough therapy designation to Lenacapavir, and we are on track to file before the end of this year. We look forward to sharing information on our plans for lenacapavir and the rest of our leading HIV portfolio at our HIV Analyst Event on December 10th. We are very encouraged by the launch of Livdelzi for primary biliary cholangitis or PBC, which was granted accelerated approval by the FDA in August. Livdelzi is a highly differentiated option for people with PBC who do not respond well to first-line therapy. Demand in the third quarter was ahead of our internal expectations, and we expect to see growing momentum into 2025 and beyond. Livdelzi brings the number of innovative therapies launched by Gilead since 2019 to six, representing another step towards our goal of delivering at least 10 transformative therapies by 2030. Moving to Oncology, we are excited to share preliminary data from”