Gilead Sciences, Inc.

Ladies and gentlemen, thank you for standing by, and welcome to the Gilead Sciences' second quarter 2019 earnings conference call. My name is Liz, and I will be your conference 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 Sung Lee, Senior Vice President of 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 the second quarter of 2019. The press release and detailed slides are available on the investor relations section of the Gilead website. The speakers on today's call will be Daniel O'Day, Chairman and Chief Executive Officer, Johanna Mercier, Chief Commercial Officer, and Robin Washington, Executive Vice President and Chief Financial Officer. Also in the room are Diana Brainard, senior vice president and head of our HIV and emerging viruses therapeutic area, and John Sundy, senior vice president and head of our inflammation 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 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 our latest SEC disclosure documents and recent press releases. In addition, Gilead does not undertake any obligation to update any forward-looking statements made during this call. Non-GAAP financial measures will be used to help you understand the company's underlying business performance. The gap to non-gap reconciliations are provided in the earnings press release as well as on the Gilead website. I will now turn the call over to Dan.

Well, thank you, Sung, and good afternoon, everyone. It's now month five, and I'm really pleased that I've had the chance now to talk with you the second time in the second quarter after the first quarter call with some very good results. I'd like to share a few opening comments. and then I'm going to turn the call over to Johanna Mercier who joined us at the beginning of the month as our new Chief Commercial Officer. Very happy to have Johanna with us as well. Robin will then take over and walk you through some of the highlights of the strong quarter. So let me just start by saying I'm really pleased with the progress we're making across all the fronts. As one example, as the leader in HIV, we're very focused on continuous innovation, as you may have seen from some of the recent data we presented. Big Darby is the number one regimen in the United States now. Momentum continues to build, and we expect that momentum to continue in the future. I mentioned on the last quarter that I would focus on three key priorities as I came into this organization. The first one was the pipeline. The second one was optimal commercial delivery. That's both for our current products, but also as we prepare for some new and important and exciting launches. And then thirdly, really people, the organization bringing the right team together at the right time for Gilead. And as you can see, we've had a very busy quarter. We've announced key changes this quarter that helped to address really all three of these priorities. And importantly, we made these changes against a backdrop of strong financials and really promising pipeline progress. So let me say a few words about the major steps we've taken to, first of all, strengthen the pipeline with the Galapagos collaboration. Secondly, I want to dive a little bit into the highlights from our current pipeline. And three, talk a little bit about the organizational changes as well. So first, on Galapagos, it's fresh news. Earlier this month we announced an exciting new collaboration with Galapagos. As you know, Galapagos is a highly productive R&D engine. They have seven medicines now in clinical development, including filgotinib, which has a very comprehensive lifecycle program. And they have more than 20 medicines now in preclinical, and their model has been very productive at producing new candidates for the clinic every year. And, of course, with our increased investment, we would expect that to even increase in the future. Gilead and Galapagos They can invest and innovate to accelerate the progress based upon our investment. And in return, we have an exclusive access right to their proven drug discovery platform. All of this, I believe, will help patients, science, and our business in a very significant way. So I was really pleased this was the first collaboration that I could announce under my tenure, and yet this is still a beginning. We'll continue to explore other ways to strengthen our pipeline and our Innovation Network in the future. Secondly, on the pipeline side, this has been an important time for our existing pipeline. Let me touch on a couple of things that speak to our growth potential before handing it over to Johanna. And there's two things I want to just highlight here. Some recent promising HIV data that we presented recently. And secondly, since the last quarter, our plans to file Fogotna for approval. So first of all, we had a terrific week last week at the International AIDS Society Conference on HIV Science. We were able to present clinical data for our first-in-class HIV capsid inhibitor, the GS6207. And as you saw, the early results support further development as a long-acting therapy that we think will really meet the needs of the community that we serve. And then we also presented further data on DSCOVI for PrEP, additional data that reinforces the profile of DSCOVI in the PrEP setting. And as you know, this is currently under regulatory review in the United States, and we also have plans to file DSCOVI for PrEP in the EU in the first half of 2020. We are looking forward to the FDA Advisory Committee that will be held next week. And overall, we're encouraged by the government's engagement around HIV prevention in many forms. The Advisory Committee will be an important opportunity and provide a forum for Gilead to talk about the benefits of the SCOBY in the prevention setting for a broad population of individuals at risk for HIV. So secondly, on filgotinib, as you know now, based upon a meeting with the agency, we intend to file for U.S. approval for filgotinib later this year in rheumatoid arthritis based upon our discussions with the FDA. We will also be filing in the EU really imminently at this stage. So overall, very good news on the path forward for Fulgotinib. I had the chance actually recently to attend the ULAR meeting, the Annual European Congress of Rheumatology in Madrid, so I could get a firsthand view of the enthusiasm among physicians and thought leaders about the profile of Fulgotinib and the potential it has to be a best-in-class among the JAK1 inhibitors. Finally, then, a few comments about the work we've been doing to build the right team for the future. I'm very pleased to welcome Johanna, who you'll hear from next, and Christy Shaw, who joins us from Eli Lilly. She will start as CEO of KITE on August 1st. And as you know, with Christy's arrival at KITE, KITE will become its own business unit, and we remain committed to accelerating the pipeline and maintaining our leadership position in cell therapy. I'd also like to very much extend a thanks to three leaders who will be leaving Gilead, John McCutcheson, Greg Alton, and Katie Watson. John, Greg, and Katie have all made tremendous contributions that help to shape today's results that you're seeing and really Gilead's progress over the past many years, decades in fact. So I'd like to thank them as we transition the team forward for Gilead. So in closing, from my side, I just wanted to emphasize how increasingly optimistic I am about the future of Gilead and the potential that it has. This is a unique company. It's a company that cured hepatitis C and transformed HIV. I'm getting an up-close view of the unique strengths that made that possible. I'm looking forward to working with all the talented people at Gilead as we apply those strengths to the next wave of transformational advances in various diseases. We're making great progress and there's much more to come. And I look forward to continuing to share more about my vision for the future later this year as I've communicated. But as you can tell, I'm not waiting for that. We're implementing along the course of that strategy with many of the things that you've seen in this past quarter. So I'd like to thank all of our employees and partners around the world for their dedication and hard work that led to a successful quarter and whose commitment will continue to make it successful in the future. With that, I'd like to turn the call over to Johanna.