Gilead Sciences, Inc.

Hello everyone and welcome to the third 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, please press star followed by one on your telephone keypad. I will now hand over to your host, Jackie Ross, Vice President of Investor Relations to begin. Jackie, please go ahead.

Thank you and good afternoon everyone. Just after market closed today, we issued a press release with earnings results for the third 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. I'm pleased to share that Gilead teams have delivered another strong quarter that rounds out two years of continuous growth for our base business. Our track record of commercial execution continued in the third quarter with our base business up 5% compared to the third quarter of 2022, and up 10% year over year for the first nine months of 2023. In the third quarter, our growth was driven by our leading therapies across virology and oncology. Victarbi had another very strong quarter, up 12% from the same quarter in 2022, and contributing to 9% growth overall in HIV in the first nine months of 2023. Oncology is also driving growth, and it was up 33% in the third quarter compared to last year. Revenue is now annualizing at more than $3 billion with growing adoption of Tredelvi, the only approved TROP2-directed ADC, and our industry-leading cell therapies. This was also another very good quarter for clinical execution as we continued to advance our 60 clinical programs across virology, oncology, and inflammation. Some of the highlights for the quarter included the European Commission approval of Tordelvi for pretreated hormone receptor positive HER2 negative metastatic breast cancer, allowing us to extend Tordelvi's reach to many more patients globally. The first data for Tordelvi in combination with PEMBRO for first-line metastatic non-small-cell lung cancer presented at World Lung. Our Phase II EVOC-02 trial showed a strong objective response rate in the PD-L1 high cohort, which supports proof of concept for our ongoing Phase III EVOC-03 trial. Important new data at ESMO for Tredelvi's Phase II Tropix-03 basket trial in our small-cell lung cancer and head and neck squamous cell carcinoma cohort. All of these milestones reinforce our conviction in Tordelby as our cornerstone oncology asset with pan-tumor potential. Staying with oncology, today we presented positive data from our Phase II EDGE gastric trial in partnership with Arcus, which further establishes proof of concept for the ongoing Phase III STAR-221 trial in first-line metastatic upper GI cancer. Additionally, we're encouraged by the continued strong data emerging from the ongoing phase one study of CAR-T, DBBCMA, and multiple myeloma. Together with our partner, Arcelix, we look forward to providing even more data during next month's ASH conference. The clinical momentum continues in virology. In HIV treatment, we reviewed promising data from the phase one study of GS1720 or once-weekly long-acting oral integration inhibitor to be combined with lenacapivir, and Phase II Artistry I trial evaluating a once-daily oral lenacapivir and bactegravir combination. We expect to share the data with you at a medical conference in early 2024. In HIV prevention, we completed enrollment ahead of schedule in our Phase III Purpose I trial investigating once every six months lenacapivir subcutaneous injection, and announced plans to initiate the Phase II Purpose V trial in 2024 to support access in Europe. In COVID-19, we completed enrollment in our Phase III Oak Tree trial, evaluating obaldesivir in standard-risk, non-hospitalized COVID-19 patients. We look forward to providing an update early next year. Vicluri remains an important therapeutic option for hospitalized patients with COVID-19. We recently received approvals from both the FDA and the European Commission to extend use of Vicluri in patients with mild to severe hepatic impairment. Looking at our pipeline overall, our aggregate progress in 2023 is such that we have already completed most of the milestone events as shown on slide 6. Our clinical pipeline now includes 27 programs in Phase 2 and 19 in Phase 3. We are looking forward to a busy period of updates from many of these studies in 2024, including those evaluating lenacapivir, Tredelvi, and obaldesivir. In summary, it's been another strong quarter of commercial and clinical execution, resulting in important progress for Gilead and the people and communities we aim to serve. With that, I'll hand the call over to Joanna to cover our commercial results. Joanna?