Gilead Sciences, Inc.

Victoria, Good afternoon, thank you for attending the fourth quarter and full year 2023 Gilead sciences earning conference call my name is Victoria and i'll be your moderator today. Victoria, All lines will be muted during the presentation portion of the call with opportunity for questions and answers at the end, I would now like to pass the conference over to your host Jackie Ross Thank you, you may proceed Jackie.

Jackie Ross 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 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. 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, 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 2024 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. With that, I'll turn the call over to Dan.

Thank you, Jackie, and good afternoon, everyone. The team and I are pleased you could join us today as we share the details of our full year and fourth quarter performance and the latest on our clinical portfolio. Starting with our full year performance, 2023 was a strong year for Gilead, with 7% growth in product sales, excluding Vicluri, driven by HIV and oncology. HIV grew by almost $1 billion, with Victarbi sales growing 14% to almost $12 billion and increasing its market share in the US to 48%. Oncology grew 37% to almost $3 billion, an increase of almost $800 million in just one year. This growth was split evenly between our Kite Cell Therapies and Tredelvi. Vicluri for COVID-19 contributed $2.2 billion in 2023, ahead of our expectations, but down year over year as expected, given the evolution of the pandemic. In the last two years combined, Gilead's base business has grown approximately $3.3 billion, or more than 7% annually, largely offsetting the decline in Vicluri revenues over the same period. The consistent growth in our base business gives us a strong foundation as we continue into 2024 and look to deliver on our broad clinical portfolio. This is a catalyst-rich phase for Gilead with more than 20 updates this year and many more to come beyond 2024. Starting with oncology, we expect at least 12 further updates by the end of 2024. These include phase three updates for Tredelvi in bladder and triple negative breast cancer. and results from the pivotal Phase II IMAGINE I study for a needle cell and multiple myeloma, for which we saw encouraging Phase I data at the American Society of Hematology meeting in December. Also in cell therapy, we are very pleased to have shortened our manufacturing time for Yaskarta by another two days in the U.S., reinforcing our industry-leading median turnaround time, which is now at an anticipated 14 days. As you know, we did not reach the primary endpoint for EVOKE-01, our phase three trial for second line plus metastatic non-small cell lung cancer. Murdad will go into detail on this later, but while we did not see the outcome we hoped for, the data are encouraging on a number of levels. Namely, a numerical improvement in overall survival favoring Tredelvi, including in both squamous and non-squamous tumors. A safety profile consistent with our product label that could continue to differentiate TRODELVI versus other TROP2 ADCs. And while not statistically powered, a potential benefit for a pre-specified subpopulation that saw more than three months median overall improvement. The team is evaluating next steps given the data and the significant unmet need, and we look forward to discussing the data with regulators. Based on the totality of the results in both Evoque 02 and Evoque 01, We are confident in Tredelvi's potential in patients with metastatic non-small cell lung cancer, including in earlier lines of therapy. In virology, we are looking forward to a very important year for our HIV portfolio. Among the multiple updates we are expecting are the phase three data for lenacapavir in HIV prevention, and at least eight updates from our HIV treatment program. These are milestones that could bring us closer to our goal of helping to end the HIV epidemic. building on Gilead's decades of leadership in HIV. In COVID-19, today we are announcing that our phase three trial, Oak Tree, evaluating opaldesivir did not meet its primary endpoint. We conducted the study to explore whether opaldesivir could address the public health need that existed with COVID-19 for standard risk patients. Again, Merdad will share details later, but essentially because of the way things have evolved, the standard-risk population is now better able to fight COVID-19 without antiviral therapy. This made it more difficult for obaldesivir to show a benefit compared to placebo. We know that the world needs to be equipped for other viruses, and the broad antiviral activity of obaldesivir shown preclinically means it has potential for other viral infections. The updates we are expecting in 2024 have the potential to unlock multiple opportunities across virology and oncology. With a broad portfolio where the risk is balanced, we look forward to following the science and continuing to make a positive impact for patients and communities. Gilead has set an ambitious goal of delivering at least 10 transformative therapies by 2030, and we are driving confidently to that goal. Before I hand over to the team for their updates, I'll move to slide six and recap that we executed well in 2023 and achieved all the remaining targeted goals that we expected to in the fourth quarter. We'll share our 2024 milestones later in the presentation, but it's clear that it's going to be a very busy year for Gilead. I'd like to thank the teams for their work in bringing us to this important catalyst-rich phase for the company and for the strong commercial performance that gives us a firm foundation on which to build. With that, I'll hand it over to Joanna.