Gilead Sciences, Inc.

Hello, everyone. Thank you for attending Gilead Sciences' second quarter 2023 earnings conference call. My name is Sierra, and I'll be your moderator today. Call 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, press star 1 on your telephone keypad. I would now like to pass the conference over to our host, Jackie Ross, VP of Investor Relations. Please proceed.

Thank you, Operator, and good afternoon, everyone. Just after market closed today, we issued a press release with earnings results for the second quarter of 2023. 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, 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. With that, I'll turn the call over to Dan.

Thank you, Jackie, and good afternoon, everyone. As always, we appreciate you taking the time to catch up with Gilead in the midst of a busy earnings period. This was another very strong quarter for Gilead in terms of both business performance and clinical execution. Thank you to the Gilead teams that drove this progress with their dedication to improving the health of individuals and communities worldwide. Total product sales excluding Vicklery grew 11% year over year and closed a very strong first half performance in the base business. As we look to the full year, we are increasing guidance for total product sales. We now expect even stronger growth in our base business of 6.5% to 8%, which is expected to more than offset our revised expectations for Vigleri. As a result, our guidance for base business product sales has increased $550 million at the midpoint. In the second quarter, HIV contributed about two-thirds of the 615 million growth in our core business, growing 9% year-over-year. Oncology grew 38% year-over-year, and with product sales of 728 million in the second quarter, now has an annual run rate of approximately $3 billion. Moving to clinical progress, the second quarter was very active on the regulatory front, with approvals, positive opinions, or recommendations for six of our therapies, Tredelvi, Yaskarta, Takardas, Sunlenka, Hapkludex, and Vicluri. This regulatory progress highlights the strength of our increasingly diverse portfolio. It also reflects the ability of our teams to successfully navigate regulatory processes across the therapeutic areas and key geographies with speed and efficiency. In addition to this progress, we shared positive pipeline updates at ASCO, which included overall survival data for Yaskarta, the only large B-cell lymphoma cell therapy to demonstrate significant overall survival benefit versus standard of care in the second line setting, promising TRODELVI data in endometrial cancer, reinforcing our belief in TRODELVI as a cornerstone asset with pan tumor potential, and updated TIDGET data from the full study population of ARK7, establishing donvonilamab's proof of concept in lung cancer. We have also shared long-term data for hepcludex for hepatitis delta virus, showing improved response rates at week 96 compared to week 48. These data support new guidelines recommending hepcludex for people living with chronic HDV in the EU. With a broad portfolio of novel mechanisms and a commitment to pursuing areas of high unmet need, we know that some pipeline setbacks are to be expected. As we announced last month, we have discontinued the phase three enhanced study in higher risk MDS due to futility and a second interim analysis. As you know, MDS is one of the most intractable forms of blood cancer, and we are disappointed that the study was not able to deliver new hope for patients with the disease. We will take a thorough data-driven approach regarding next steps as we carry out the ongoing analysis of Megrolimab. Overall, we were executing well on our clinical commitments, and our current performance speaks to the strength of our combined oncology portfolio. We have a rich pipeline of activity in the second half, including an initial look at a subset of EVOKO2 data on Tredelvi plus Pembro in first-line metastatic non-small cell lung cancer. Before I hand over to Joanna, I'd like to welcome Cindy Peretti, our head of cell therapy, to our first Gilead Earnings Conference call. Cindy has now been with Gilead for two months and brings a wealth of oncology and leadership experience from Roche Foundation Medicine and the Sarah Cannon Research Institute. We're delighted to have Cindy join our Gilead leadership team, and it's great to have her with us on the call today. With that, I'll hand the call over to Joanna for a discussion of our commercial results. Joanna?