Gilead Sciences, Inc.

And welcome to Gilead's third quarter 2024 earnings conference call. My name is Rebecca, and I'll be your host for today. In a moment, we'll begin with our prepared remarks, followed by our Q&A session. At that time, if you'd like to ask a question, please press star one on your telephone keypad. If you'd like to withdraw your question, please press star two. I'll now hand the call over to Jackie Ross, Vice President of Investor Relations and Corporate Strategic Finance.

Thank you, Rebecca. Just after market closed today, we issued a press release with earnings results for the third quarter of 2024. 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 Officer Joanna Mercier, our Chief Medical Officer Murdad Parsi, 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. Before we get started, 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. The team and I are pleased to share Gilead's third quarter results. highlighting another very strong quarter of commercial and operational execution with robust year-over-year revenue performance across HIV, oncology, and liver disease, including 9% growth in HIV. We also delivered strong bottom-line results that highlight the leverage in our business model and reflect our ongoing commitment to disciplined expense management. Based on our financial results here 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 initial launch of Livdelzy for primary biliary cholangitis, or PBC, which was granted accelerated approval by the FDA in August. Livdelzy 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. LIVDELSI 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 the registrational phase two IMAGINE ONE study of ANITA cell for the treatment of relapsed or refractory multiple myeloma at ASH next month, in addition to updated data from the Phase I study, together with our partner, Arcelix. We're also pleased to have begun the Phase III IMAGINE III study in earlier-line patients. The combination of ANITA cells' potential best-in-class clinical profile with Kite's leading cell therapy manufacturing has the ability to transform care for a large number of multiple myeloma patients. We continue to evolve our oncology program in response to clinical data, regulatory feedback, and the competitive environment. We are carefully prioritizing our resources for the most promising programs. For example, we are advancing TRODELVI in first-line PD-L1 high metastatic non-small cell lung cancer, where we have seen supportive data in combination with PEMBRO while discontinuing development in Second Line Plus. We are also starting a new program for small cell lung cancer based on promising efficacy data from the phase two tropics O3 basket trial. Touching briefly on slide six, we have completed all of the clinical milestones and updates we targeted for 2024 and look forward to a strong end to the year with key presentations coming up at ASH and our HIV analyst events in December. Those are the main points I wanted to share for now in what has been a very strong third quarter, thanks to the tremendous efforts of the Gilead teams. I look forward to our Q&A session at the end, and now I will pass it on to Joanna.