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Gilead Sciences, Inc.
2/2/2023
Good afternoon. Thank you for attending today's fourth quarter and full year 2022 Gilead Sciences Earnings Conference Call. My name is Hannah, and I will be your moderator for today's call. All lines will be muted during the presentation portion of the call with an opportunity for questions and answers at the end. If you would like to ask a question, please press star 1 on your telephone keypad. I would now like to pass the conference over to our host, Jackie Ross. 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 fourth quarter and full year 2022. 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. After that, we'll open the call to Q&A, where the team will be joined by Christy Shaw, the Chief Executive Officer of KITE. 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 GAAP to non-GAAP reconciliations are provided in the earnings press release in our supplementary data sheet, as well as on the Gilead website. Now, I'll turn the call over to Dan.
Thank you, Jackie, and good afternoon, everyone. We had the opportunity to connect with many of you a few weeks ago in San Francisco, and I'm excited to be able to reconnect now to share our strong fourth quarter and full year results for 2022, in addition to our guidance for 2023. These show the tangible impact of our business transformation, notably the growth trajectory for our HIV portfolio and our fast-growing oncology business. The team will take you through our quarterly results in detail, but I'm very pleased to highlight on slide four the strongest full-year growth in our base business since 2015, when growth was driven by the peak of HCV sales. Full-year 2022 sales at Victarvy grew 20% year-over-year to $10.4 billion, exceeding $10 billion for the first time. Excluding Victory, our base business in 2022 grew 8% year-over-year And I'm pleased to share that our initial 2023 guidance points to base business growth between 4% and 6%. Andy will share our revenue guidance in detail, but I do want to take this opportunity to recognize the Gilead team for the progress we've made in returning to growth. Thanks to their commitment to improving the health of people and communities around the world, Gilead is now poised to extend its reach to more patients and more challenging diseases and conditions than ever before. Beyond our financial results, our clinical progress in 2022 reinforces how far we've come. At the end of the year, Sunlenka received its first approval in the U.S. for heavily treatment-experienced adults with multidrug-resistant HIV infection. This follows the European approval in the third quarter. Sunlenka is the first six-monthly subcutaneous medicine to be approved, and we believe it represents the most exciting innovation in HIV therapeutics in recent years, with significant potential across prevention and treatment. We look forward to partnering with the HIV community to increase awareness of Sunlenka and to advancing our portfolio of long-acting options. We are anticipating another potential approval any day now with the upcoming PDUPA date for Tordelvi in pre-treated HR positive HER2 negative metastatic breast cancer. We also expect to hear from European regulators later this year. In the meantime, Tordelvi's commercial momentum is building with full year 2022 sales growth of 79%. In cell therapy, we continue to reinforce our leadership and to execute on plans to broaden availability with Yaskarda most recently approved in Japan for second-line relapse through refractory large B-cell lymphoma. Murdad will talk you through our pipeline updates and key milestones in a few moments. For now, I'll simply note the significant expansion in our clinical programs, which have more than doubled in the last four years. We continue to add further programs, including our new preclinical candidates to partner with Lanacapavir for our long-acting HIV treatment programs, the new phase three oak tree study for a novel oral COVID-19 nucleoside, and the five phase three trials that we expect to initiate this year. Before I hand over to Joanna, I want to briefly review the clinical goals we shared with you a year ago. The Gilead and Kite teams have done a terrific job in both delivering as planned and acting with agility in response to changing circumstances. We had an impressive year of disciplined and determined execution in 2022, and fully expect to further strengthen our track record of execution in 2023 and beyond. With that, I'll hand over to Joanna for a review of our fourth quarter and full year commercial performance. Joanna?
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