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Gilead Sciences, Inc.
2/1/2022
Good day, and thank you for standing by. Welcome to the Gilead fourth quarter and full year 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 Roth, VP of Investor Relations. Please go ahead.
Thank you, Gigi, and good afternoon, everyone. Just after market closed today, we issued a press release with earnings results for the fourth quarter and full year 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 TITE. 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, business and operations, financial projections, and the use of capital, and 2022 financial guidance. All of these 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 available on the Gilead website. With that, I'll turn the call over to Dan.
Thank you, Jackie, and good afternoon, everybody. As we head into 2022, Gilead's coming off a year of positive clinical momentum and strong financial performance, mitigating the impact of the pandemic on some parts of our business. Higher sales of VicGlory more than offset the impact of COVID-19 on HIV and HCV. VicGlory continues to play a critical role in helping to treat people with COVID-19 with continued activity against the Omicron variant. The FDA recently expanded its use beyond the hospital for patients at high risk of disease progression. In addition, we just initiated a phase one trial of GS5245, a novel oral COVID-19 nucleoside that once metabolized works in the same way as remdesivir. Our full year revenue for 2021 was 11% higher than the midpoint of our initial guidance in February of 2021. It was also an important year for our transformation to becoming a business that is based on diverse, sustainable growth. In 2021, we received seven approvals, or accelerated approvals, in the U.S. and Europe, and submitted an additional six filings. Our approvals included three for Tredelvi, with the FDA and MA approval in second-line triple negative breast cancer, as well as an accelerated approval from FDA for metastatic bladder cancer, two for self-therapy, with Yaskarta receiving accelerated approval in relapsed or refractory follicular lymphoma and Ticardis receiving full approval in adult acute lymphoblastic leukemia, and two expanded labels in virology, one for a pediatric label for Bictarvia in the U.S., and an expanded label for Bicluria in the EU for adults not requiring supplemental oxygen. Our 2022 plans include a significant increase in clinical development studies across our novel oncology portfolios. We are planning at least 20 additional trials, including seven phase three trials for Tredelvi. And these include the ASCENT-3 trial, which is evaluating Tredelvi in the frontline AAA breast cancer in the PD-L1 negative population. The ASCENT-4 trial, in collaboration with Merck, to evaluate Tredelvi and Keytruda in the frontline AAA breast cancer population in the PD-L1 positive population. and the EVOKE-3 trial, which will be led by Merck to evaluate Trodelvian, Contruda, and non-small-cell lung cancer. You will also see ongoing momentum in our virology portfolio as we continue to expand our leadership in antiviral therapies. We are advancing our longer-acting HIV options with lanacapavir as the foundation and look forward to potential regulatory decisions in 2022. If approved, Lenacapivir would be the only HIV treatment option administered twice yearly. In addition, we'll continue to drive progress across our broader virology portfolio, including hepatitis, COVID-19, and other emerging viruses. This is a really important time in Gilead's transformation journey. After the consistent work to execute on our strategy and expand our portfolio over the last two years, you will increasingly start to see this play out in tangible results. We're confident that Gilead has all the elements in place for a strong year and a strong decade. Joanna, Murdad, and Andy will now take you through the details of our progress and our plans. And let me hand first over to Joanna to talk about our commercial performance in the fourth quarter and the full year, and I'll be back to you in the Q&A. Joanna?
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