Gilead Sciences, Inc.

Hello everyone and welcome to the first quarter 2023 Gilead Sciences Earnings Conference call. My name is Nadia and I'll be coordinating the call today. If you would like to ask a question at the end of the presentation, please press star followed by one on your telephone keypad. I will now hand over to your host, Jackie Ross, Vice President, Investor Relations to begin. Jackie, please go ahead.

Thank you, Operator, and good afternoon, everyone. Just after market closed today, we issued a press release with earnings results for the first quarter of 2023. 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 Officer, Joanna Mercier, our Chief Medical Officer, Murdad Parsi, and our Chief Financial Officer, Andrew Dickinson. Before we get started, let me remind you that we will be making forward-looking statements, including those related to Gilead's business, financial condition and results of operations, plans and expectations with respect to products, product candidates, corporate strategy, business and operations, financial projections and the use of capital, and 2023 financial guidance, all of which involve certain assumptions, risks and uncertainties that are beyond our control and could cause actual results to differ materially from these statements. A description of these risks can be found in the earnings press release and our latest SEC disclosure documents. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements. Non-GAAP financial measures will be used to help you understand the company's underlying business performance. The gap to non-gap reconciliation is provided in the earnings press release in our supplementary data sheet, as well as on the Gilead website. With that, I'll turn the call over to Dan.

Thank you, Jackie, and good afternoon, everyone. The Gilead team continued its track record of strong commercial and clinical execution in the first quarter of 2023. Our base business grew at 15%, excluding Vicluri, with total product sales of $6.3 billion reflecting outperformance across the portfolio. On a year-over-year basis, roughly two-thirds of the $735 million increase in our base business sales were driven by HIV, and the other third was driven by oncology. Once again, we're seeing the tangible impact of our transformation and the successful diversification of our business. We saw year-over-year growth in HIV up 13%. Liver disease, which includes therapies for HCV, HBV, and HDV, up 6%, cell therapy up 64%, and Trodelvi up 52%. As expected, Vicluri revenues continue to track lower rates of COVID-19 hospitalizations. As a result, revenue of $573 million was down 63% from the first quarter of last year. On the clinical side, we received another FDA approval for Tredelvi in early February. This latest approval was for a third indication, pretreated HR-positive HER2-negative metastatic breast cancer. It's early days, but this has been a very strong commercial launch for Tredelvi in the U.S. so far. This further highlights the critical patient need that Tredelvi is addressing in this late-stage population, as well as the effectiveness of our commercial oncology team. We continue to prepare for Tredelvi's approval in pretreated HR-positive HER2-negative metastatic breast cancer in Europe in the second half of this year. Another key milestone for the quarter was the announcement of the primary overall survival data from the landmark Phase III Zuma 7 study. Yescarta is now the first and only treatment in nearly 30 years to show a statistically significant improvement in overall survival for initial treatment of relapsed or refractory large B-cell lymphoma patients versus historical standard of care in a curative setting. Full results will be presented at this year's ASCO. Turning to clinical progress in virology, we continue to add to the body of evidence for lenacapivir's effectiveness as part of a six-month subcutaneous therapy. At this year's CROI, the team shared positive Phase 1b data on the investigational lenacapivir and BNAB combination. The BNOD combination is, of course, just one of the eight long-acting combination options that we're exploring for lenacapivir, and we are pleased with our progress so far. In the meantime, following our first approval of lenacapivir as Sunlenca for heavily treatment-experienced people living with HIV, we are seeing strong engagement from KOLs and physicians who are interested in the full potential of lenacapivir for prevention and treatment. As you know, this first approval addresses a significant unmet need for a small number of people living with HIV who have very limited options available to them. And we look forward to making Lenacapavir available to many more people, beginning with the potential approval and prevention in the 2025 timeframe. We see Lenacapavir as having the most promising potential yet in the ongoing efforts to end the HIV epidemic. And we're looking forward to working with others to make it broadly available as soon as possible. With that, I'll hand over to Joanna for a review of our first quarter commercial performance. Joanna?