Gilead Sciences, Inc.

Good day, and thank you for standing by. Welcome to the third quarter 2021 Gilead Sciences Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 1 on your telephone. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Jackie Ross, Vice President of Investor Relations. Please go ahead.

Thank you, Catherine, and good afternoon, everyone. Just after market closed today, we issued a press release with earnings results for the third quarter of 2021. 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 up the call to Q&A, where the team will be joined by Christy Shaw, 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 the impact of the COVID-19 pandemic on Gilead's business, financial condition, and results of operations, plans and expectations with respect to products, product candidates, corporate strategy, financial projections, and the use of capital, and 2021 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 document. 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. I will now turn the call over to Dan.

Thank you, Jackie, and good afternoon, everyone. We appreciate you taking the time to join us here today. Starting on slide four, this was a very strong third quarter with significantly higher than expected demand for VicLurie. and positive HIV share gains as the market continues to recover. The high demand for VicLurie was associated with the latest surge in cases of COVID-19. The therapy has now been provided to more than 9 million people worldwide, including 6.5 million people in 127 middle and low-income countries through our voluntary licensing program. All of us at Gilead are proud of the important role that VicLurie continues to play. I wanted to acknowledge the way our teams have navigated the unpredictable path of the pandemic, flexing our own operations and supporting our partners' efforts to ensure VicLurie and Remdesivir are available to meet patient demand. At the same time, we're applying our three decades of expertise in virology to advance new options that can be taken outside the hospital and earlier in the disease. We recently filed an SNDA for IV outpatient use of VicLurie. This is based on data from our Phase III pine tree study that demonstrated a significant reduction in the risk of hospitalizations after a three-day IV treatment of Bechleri in the outpatient setting. In order to meet additional treatment needs, we also continue to advance our oral programs to develop a novel best-in-class therapy. Turning to HIV performance, we saw positive gains in the treatment market for the second quarter in a row and reported record revenue for Biktarvy. While treatment prescription volumes remained below pre-pandemic levels, we maintained total U.S. and EU treatment market share, and we grew Biktarvy share sequentially in both geographies. The PrEP market continues to recover, and our PrEP market share is holding steady despite generic entry. Overall, our third quarter results give us confidence that the HIV market is recovering from the pandemic, and our market share clearly highlights Gilead's strong market position. As a result of the strong quarter, we have increased our full-year revenue and earnings per share guidance. Beclery now looks set to deliver close to twice the revenue we expected at the start of the year. While our base business has clearly been affected by COVID, it has also shown resilience. At the guidance midpoint, we are now expecting full year total revenue to be $1.75 billion higher than we expected at the start of the year. Our confidence in the longevity of our HIV business is in part based on our progress in developing the next generation of HIV therapy and prevention. Lenacapavir is the cornerstone of that work, and we have four clinical trials evaluating Lenacapavir across treatment and prevention. highlighting our efforts to extend the options available to people living with or at risk of HIV. This quarter, Lenacapivir was granted FDA priority review for the heavily treatment-experienced population. As a reminder, Lenacapivir has breakthrough therapy designation, and if approved, would be the first long-acting treatment for people living with HIV who have multidrug-resistance as well as the first available six-month long-acting subcutaneous injection treatment for HIV. Separately, as you know, we signed an agreement with Merck earlier this year to explore combinations of lenacapivir and aslatravir in long-acting treatment. Earlier this week, we announced the start of a Phase II study with Merck evaluating a lenacapivir and aslatravir long-acting oral combination treatment. Our approach to long acting is very much shaped by people living with HIV. We've heard that they would welcome weekly oral or infrequent subcutaneous injections that could coincide with routine office visits or even be taken at home. The advantages of these options include greater convenience, the potential for stronger adherence, and privacy. Lenacapavir has shown promising potential in both oral and subcutaneous injections and and we'll continue to advance both options while updating you on our progress throughout. While extending our leadership in HIV, we are also executing on the significant potential in our broad and diverse oncology portfolio. This is potential that could bring transformational benefits for people with cancer and value for our stakeholders. Third quarter highlights include the initiation of two solid tumor trials for megrolimab, head and neck cancer, and a multi-tumor basket study. We plan to initiate an additional phase three study in first-line unfit acute myeloid leukemia, or AML, in early 2022. The FDA approval of Cercardus for adult relapse and refractory acute lymphoblastic leukemia, or ALL, is our fourth approved indication in cell therapy. Additionally, the KITE team has filed an SBLA for Yaskarta and second-line LBCL, which, if approved, would be the first CAR T therapy in an earlier-line setting. And a positive CHMP opinion for Tredelvi in second-line metastatic triple-negative breast cancer earlier this month. We expect an approval decision from the European Commission later this year, and this could potentially be our sixth approval for Tredelvi in triple-negative breast cancer in 2021. Additionally, we've just announced a new clinical trial collaboration and supply agreement with Merck to evaluate the combination of Gilead's TROP2 antibody drug conjugate Tordelvi with Merck's anti-PD-1 therapy, Catruda, for the treatment of first-line metastatic triple-negative breast cancer. When we acquired Immunomedics last year, we said that we would explore the use of Tordelvi across a wide range of tumor types and that we would pursue combinations with both internal and external molecules. you can see this start to play out now with this Merck partnership as an early example of our approach. Next, on slide five, I'm pleased to note that we delivered on three of our target milestones for the quarter. You will also note that the timelines for Tropic 2 and the Phase 1b McGraw-Lamont have shifted, as we now expect to have the PFS readout for Tropics 2 in late January or early February, and the top-line readout for the Phase 1b Megrolimab in the first quarter of 2022. Mirdad will also touch on this later in the call, but as you know, these modest timeline adjustments are quite normal in oncology, especially event-driven trials like Tropix-2. We look forward to sharing these updates in the first quarter of 2022. Taken as a whole, our oncology portfolio now spans some of the most promising targets in the field today. In addition to Tredelvi for TROP2, CD47, and cell therapy, these include TIGIT, adenosine, and many others. We are very encouraged by the momentum across these programs and look forward to sharing much more in the coming quarters. The positive momentum overall in the third quarter gives us great confidence in the direction we are taking and the pace of our progress. We are well on our way with the plans to sustain our leadership in HIV, and while there is much more to come in oncology, We've already begun to execute on the potential in our highly promising portfolio. But Gloria is making a significant impact as the pandemic continues to evolve, and we are well-placed for when the HIV market bounces back. I want to thank all the Gilead and Kite employees around the world who are making all this possible with their passion for scientific excellence and their commitment to global public health. With that, I'll hand over to Joanna, who will share an update on the commercial performance in the third quarter.