Gilead Sciences, Inc.

Ladies and gentlemen, thank you for your patience and thank you for attending today's third quarter 2022 Gilead Sciences earnings conference call. My name is Amber and I will be your operator 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 one on your telephone keypad at any time. It is now my pleasure to hand the conference over to our host, Jackie Ross, VP of Investor Relations. Jackie, please proceed.

Thank you, operator, and good afternoon, everyone. Just after market closed today, we issued a press release with earnings results for the third quarter of 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 up 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 2022 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, everybody. We're pleased to connect with all of you today to share the details of another very strong quarter. Thanks to strong commercial and clinical execution by our teams, The positive momentum continues to build. Total product sales excluding Vicklery were $6.1 billion, growing 6% sequentially and 11% year over year. The total including Vicklery was $7 billion. If we exclude the impact of foreign currency fluctuations and the tail end of the loss of exclusivity for Truvada and Atripla and HIV, total product sales excluding Vicklery grew 15% from the third quarter of last year. The majority of this growth was driven by HIV, and over 40% of the $620 million increase in sales came from oncology. The team will share more details, but this has been a great quarter for commercial execution, including continued share gains for Victarvie, growing momentum for Tredelvi, another impressive quarter for Cell Therapy, and a strong quarter for VicLurie. We also saw continued clinical momentum this quarter. Some of the highlights include the FDA priority review granted to Tordelby for late-line HR-positive HER2-negative metastatic breast cancer, the EU approvals for Yaskarta for second-line relapsed and refractory large B-cell lymphoma, and Ticardis in adult acute lymphoblastic lymphoma. And in virology, Lenacapivir received its first regulatory approval in Europe. Marketed as Sunlenka, It is approved for heavily treatment-experienced people living with multidrug-resistant HIV, making it the first approved capsid inhibitor and the first therapy with a six-month dosing schedule for HIV treatment. We are taking multiple important steps to advance our ambitious clinical pipeline, including in oncology, we are expanding our lung program with eight trials now active and three more planned to start in the coming months. We plan to resume our phase two trial investigating a once-weekly oral combination of Merck's Slatravir and Arlenicapivir. This will be one of many ongoing combination studies we have for long-acting HIV treatment, in addition to our extensive program for prevention. And we continue to further strengthen our early-stage portfolio, adding a BTLA agonist for inflammation from Mirovial and an option for a bispecific antibody for oncology from Macrogenics. Moving to our clinical goals for 2022 on slide five, we're on track to start the two remaining phase three trials, namely EVOK3 for first-line non-small cell lung cancer and ZUMA23 for first-line high-risk LBCL. We continue to expect another interim readout for the phase two R7 study in first-line non-small cell lung cancer before the end of the year. Overall, this has been another very strong quarter and a very strong year for Gilead. We're seeing impressive growth of our base business with continued shared gains for Victarbi and excellent performance for cell therapy and growing demand for Tredelvi. On the clinical side, we've had the first approval for Lenacapivir, a foundational asset for the future of our HIV franchise. Tredelvi is now under priority review for HR-positive HER2-negative breast cancer in the U.S., and we're executing on an extensive development program across virology, oncology, and inflammation. Finally, the recent task settlement is expected to significantly extend the exclusivity of key components of our HIV franchise in the U.S. I'd like to take this opportunity to thank the Gilead and Kite teams for their outstanding clinical and commercial execution. This consistent execution of our strategy, along with a very robust portfolio, has led to some terrific progress in 2022, and we look forward to building on that momentum through the rest of the year and beyond. With that, I'll invite Joanna to share an update on our third quarter commercial performance.