Gilead Sciences, Inc.

Good day and thank you for standing by. Welcome to the Gilead Sciences second quarter 2021 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 will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Jackie Ross, VP, Investor Relations. Please go ahead.

Thank you, Joelle, and good afternoon, everyone. Just after market closed today, we issued a press release with earnings results for the second 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, 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 the impact of the COVID-19 pandemic on Gilead's business, financial condition and results of operation, 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. Thanks for taking the time to join us here today. We're pleased to provide you with an update on our second quarter, where we delivered solid financial performance and significant progress in our increasingly diverse pipeline. 2021 is an important year for our pipeline, and we're very encouraged by the milestones we've achieved for therapies that are potentially transformative for Gilead and for patients. All of this reinforces our confidence in our strategic direction. I want to take this opportunity to thank our global community of Gilead and Kite employees who consistently go above and beyond to drive progress, with resilience and dedication. Different parts of the world are riding the ebb and flow of COVID-19 cases at various times. And while the vaccines give us hope and optimism, we are still very much living with the pandemic. Remdesivir continues to play an important role in fighting the virus and has now been used to treat an estimated 7 million hospitalized patients worldwide. Turning to the main highlights of the quarter on slide four, The second quarter was a solid quarter overall, but Clary's sales of $829 million were once again higher than anticipated, offsetting the lingering impact of the pandemic, particularly on HIV treatment. In light of this pandemic impact, Victavi's performance is quite encouraging. Revenue for the quarter was $2 billion up 24%, or $390 million from the same quarter last year. This more than offset the $322 million headwind associated with the impact of the Truvada and Atripla LOEs. Much of that headwind is now, of course, behind us. Overall, our share of the HIV treatment market held steady quarter over quarter, and our PrEP share remained steady even with generic entries. These dynamics give us confidence that the underlying demand for our HIV products remains strong. and positions us well for growth as the overall HIV market recovery gains momentum. Moving to our clinical pipeline, 2021 is a catalyst every year for Gilead, and we've delivered all of our key first half pipeline commitments. Among other milestones, We shared top-line data from the highly anticipated ZUMA-7 trial, where Yaskarta improved event-free survival for second-line large B-cell lymphoma, or LBCL, patients by 60% compared to the standard of care. This is truly a landmark trial, the first and largest reported Phase III trial readout, that demonstrates the efficacy and safety of cell therapy, and we are excited by the opportunity to bring the potential benefits of cell therapy to patients in earlier lines. We shared positive Phase III data from MIR-301, which will help support our anticipated BLA filing for hepcludix for HDV in the U.S. later this year, and we submitted our NDA for use of lenacapavir in the heavily treatment-experienced population with multi-drug resistance. This filing was based on data from the Phase 2-3 Capella study presented earlier this month. We also shared strong lenacapivir data from the Phase 2 Calibrate study in HIV treatment, which will be used to inform our broader lenacapivir efforts. Our partner, ARCIS, provided an interim update from ARC-7 that supports the continuation of both ARC-7 and ARC-10 trials for their antithetic candidate, domvanilamab. Lastly, on slide four, we're beginning to see the positive impact of our strategy, which we introduced early last year. The business is diversifying across indications and therapies. In particular, we are seeing cell therapy and Tredelvi contribute to growth and expect they will be key growth drivers for Gilead. While we build out the oncology business, we remain focused and committed on ensuring the long-term competitive positioning of our virology portfolio. Next, on slide five, we highlighted our pipeline execution so far this year, and I'd like to thank all those who helped us to deliver on this ambitious agenda, including our employees, the people who participated in the studies, our partners, and the study investigators. As we look ahead to the rest of the year, our target milestones include A progression-free survival or PFS readout in our event-driven Phase III Tropics II study evaluating TRODELVI in hormone receptor HER2-positive negative metastatic breast cancer. A Phase Ib readout for megrolumab in myelodysplastic syndrome or MDS. Depending on the data, timing, and results, this could result in a BLA submission for accelerated approval. and initiation of the potential phase III lenacapivir and aslatrevir long-acting oral combination. As you know, this is in collaboration with Merck, and the development and formulation work remains on track. We look forward to updating you next quarter about the additional milestone progress. We understand the continued strong and consistent pipeline execution is critical to extending the virology business and expanding further into oncology. We believe our current and pipeline therapies can address significant unmet medical needs. We are very encouraged by the progress Gilead and Kite are making. We are well on our way in our journey to expand and diversify into new therapeutic areas, and we are already seeing the evolution of both our pipeline and commercial portfolio. With that, I'll hand over to Joanna, who will share an update on our commercial performance for the second quarter.