Gilead Sciences, Inc.

Ladies and gentlemen, thank you for standing by, and welcome to the Gilead Sciences fourth quarter 2019 earnings conference call. My name is Liz, and I will be your operator today. At this time, all participants are in a listen-only mode, and as a reminder, this conference call is being recorded. I would now like to turn the call over to Douglas Maffei from Investor Relations. Please go ahead.

Thank you, Liz, and good afternoon, everyone. Just after market closed today, we issued a press release with earnings results for fourth quarter and fall year 2019. The press release and detailed slides are available on the Investor Relations website. Speakers on today's call will be Daniel O'Day, Chairman and Chief Executive Officer, Andrew Dickinson, Chief Financial Officer, Johanna Mercier, Chief Commercial Officer, and Murdad Parsi, Chief Medical Officer. Also in the room are Christy Shaw, Chief Executive Officer of KITE, and Diana Brainard, Senior Vice President and Head of our HIV and Emerging Viruses Therapeutic Area. Before we begin with our prepared comments, let me remind you that we will be making forward-looking statements, including plans and expectations with respect to products, product candidates, financial projections, and the use of capital, and 2020 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. In addition, Gilead does not undertake any obligation to update any forward-looking statements made during the call. Non-GAAP financial measures will be used to help you understand the company's underlying business performance. Starting in 2020, Gilead will no longer regularly exclude stock-based compensation expense from its non-GAAP financial information. The GAAP to non-GAAP reconciliations are provided in the earnings press release as well as on our website. I will now turn the call over to Dan.

Thank you, Doug, and good afternoon, everyone. I'll share a few opening comments before I turn the call over to Andy, and then Johanna will take you through the commercial highlights of the quarter, and Murdad Parsi, whom, as you know, joined us as Chief Medical Officer in November, will offer a few remarks before we open up the call to questions. We had a very strong quarter, capping a solid year for Gilead. Our financial results in 2019 were driven in large part by the outstanding performance of our HIV franchise. It's now been almost a year since I arrived at Gilead. We've made key decisions and changes that have positioned us for success. Over the past decade, the company has set a high bar, and we hope to raise that high bar over the decades to come. Today, I'm going to focus my comments on three areas. One, our strong base business. Two, the existing pipeline opportunities. And three, our new strategy to drive innovation and growth. So I'll begin by saying a few words about the strengths of our core business, starting with HIV, where we again achieved record revenue for both the quarter and the year. Today, approximately 80% of people living with HIV who are on therapy in the U.S. are on a Gilead-based regimen. Across the franchise, we've seen durability and sustainability of the business, which we expect to continue in 2020 and beyond. Much of this strength is being driven by Victarvy. Today in the U.S., approximately one in two patients who are new to therapy and patients who are switching therapy are initiating on Victarvy. We're also very pleased with the early progress with Discovery for PrEP, the strength of the launch and the positive response we are seeing from patients and providers. Johanna will share more details shortly on that. Looking to the future, we're focused on the potential of our capsid inhibitor as the anchor molecule for multiple long-acting HIV options. We may be able to dose as infrequently as twice a year, and we're working rapidly to progress this medicine for both HIV prevention and treatment. Rounding out the antiviral picture, we continue to see sustained revenue from our HCV business. Since the introduction of authorized generics in the U.S., we've regained market share and now hold around 60% share through Asegwa and Gilead, up 18 points from the beginning of last year. Finally, as we look across our core business, I'd like to highlight the geographic expansion, and in particular China. During the fourth quarter, we had four medicines, Spamlidi, Occlusa, Harvoni, and Genvoia, included in China's national reimbursement drug list. This is a significant accomplishment that will enable much broader access to these medicines in the region. So beyond our core business, our current pipeline concludes several important opportunities that I'd like to cover. We have 14 late-stage studies underway, four of which have received breakthrough therapy designation from the FDA. During the fourth quarter, we submitted a regulatory filing for filgotinib to the FDA, and it's now under priority review for rheumatoid arthritis. Filgotinib is also under review in Japan and the EU. We're actively preparing for competitive launches globally, which Johanna will talk more about later. I'm encouraged about the potential of filgotinib to be best in class among the JAK inhibitors and the strength of the team we have in place to market the medicine following approval. Beyond Fulgotinib, we are pleased with what we see in the Galapagos pipeline and believe that the partnership has the potential to drive significant future growth. We are looking forward to the ulcerative colitis data this year, and we remain very optimistic about both our partnership with Galapagos as well as the promising inflammation pipeline we have in hand. In cell therapy, we have a pioneering platform that is enabling us to advance new therapies. With the goal of driving long-term innovation and growth. To that end, our second cell therapy treatment, KITE-X19, is now under review in the U.S. and Europe as a treatment for relapsed refractory mantle cell lymphoma. This follows the presentation of positive data at the American Society of Hematology meeting in the fourth quarter of this year. We also presented data at ASH showing the approximately half of patients treated with Yaskarta for relapsed refractory large B-cell lymphoma were still alive after three years of treatment in the ZUMA-1 study, confirming Yaskarta's benefit-risk profile in the real-world setting. These long-term data speak to the durability of Yaskarta's treatment. Finally, in cell therapy, we look forward to sharing results from our Yaskarta Phase III second line DLBCL trial in the second half of this year. MRDAD will offer some more color on our pipeline in just a few minutes. In addition to the programs I've described that we have in hand, I introduced our new corporate strategy last month. This strategy will guide our work as we seek to drive innovation and growth over the next decade. Over the next 10 years, we aim to introduce 10 new transformative therapies. To help us achieve that ambition, Thank you for joining us. including transformative partnerships such as Galapagos and small to medium-sized bolt-on acquisitions. Andy will talk more in a few minutes about our capital allocation priorities including today's announcement of a further increase in our dividend and an additional share repurchase authorization and our strong financial position which gives us the opportunity to look externally as we strengthen our pipeline. Before I hand off to Andy, who will delve into a more detailed financial review, I'd like to say just a few words about the broadening outbreak of coronavirus. As an organization, Gilead is committed to collaborating with global health organizations to support pandemic responses, including this one. Our investigational compound, remdesivir, has demonstrated in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS, which are structurally similar to the current strain of the coronavirus. However, there are no antiviral data that show activity against this strain. We're working with the government and non-government organizations and regulatory authorities to develop a strategy to provide remdesivir to patients with coronavirus for emergency treatment in the absence of any approved treatment options and to support clinical trials to determine whether it can safely and effectively be used to treat the current strain of the coronavirus. As a reminder, remdesivir is an investigational agent. It is not approved anywhere globally, and has not been demonstrated to be safe or effective for any use. I'm proud of our teams and the work we've done to offer expertise and resources to help patients and communities fighting coronavirus. In closing, I'm very optimistic about where we are today and the future. Our base business is strong, durable and growing, as demonstrated by our fourth quarter numbers and year-end results. The near-term pipeline provides several important opportunities with readouts expected later this year with Fulgotinib and Yaskarta. And over the long term, we've introduced a new strategy to drive growth by growing our pipeline internally and, importantly, also externally through our ongoing BD activities. On behalf of the leadership team, I'd like to thank all of our employees and partners around the world for the dedication and hard work that led to the success of 2019 and whose commitment is driving our success in 2020 and beyond. I remain excited about the potential of Gilead as we enter the next chapter. With that, I'll turn the call over to Andy.