Incyte Corporation

Hello, and welcome to the InsightCorp third quarter 2020 financial results conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Mike Booth, Head of Investor Relations at Insight. Please go ahead, sir.

Thank you, Kevin. Good morning, and welcome to Insight's third quarter 2020 earnings conference call and webcast. The slides used today are available for download on the investor section of insight.com. I am joined on the call today by Irve, Barry, Stephen, and Christiana, who will deliver our prepared remarks, and by Dash, who will join us for the Q&A session. During the question and answer session, I ask that you limit yourself to one question, and if needed, one follow-up, as this will enable as many of you to ask questions as time allows. Before we begin, I'd like to remind you that some of the statements made during the call today are forward-looking statements, including statements regarding our expectations for 2020 guidance, the commercialization of our products and our development plans and expectations for the compounds in our pipeline, as well as the development plans of our collaboration partners. These forward-looking statements are subject to a number of risks and uncertainties that may cause our actual results to differ materially. including those described in our 10Q for the quarter ended June 30, 2020, and from time to time in our other SEC documents. In addition, I would like to caution everyone that the COVID-19 pandemic is an evolving situation, and we may therefore be unable to assess the full effects of governmental, business and social actions and policies, and overall economic conditions on our business. Accordingly, it is important to keep in mind that our statements on this webcast speak as of today. We'll now begin the call with Avi.

Thank you, Mike, and good morning, everyone. In the short quarter, we saw continued strong growth within our commercial business, and we progressed our clinical portfolio on both development and regulatory fronts. Commercial performance across the business was strong. Our product and royalty revenue grew 16% to $621 million. driven by Jackify, as well as an increasing contribution from new product launches and from royalties. Jackify sales grew 13% year-over-year to reach $488 million, with growth seen across all three indications. Jackify and Illumiant royalties grew 17% and 32% respectively, totaling nearly $100 million in revenues for the quarter. There is significant momentum in the first weeks of launch of Monjuvi in the U.S., and I am pleased to say that Pemezir, which was launched at the end of April, has outperformed our initial expectation. The application seeking approval of Staphacitamab in relapsed or refractory DLBCL is under review in Europe, and applications seeking approval for Pemigatinib in cholangiocarcinoma are under review in both Europe and Japan. It has been a busy quarter for baracitinib development updates. Exciting data were recently presented from the ongoing evaluation of baracitinib in patients with severe alopecia areata, and Lilly's development program in this indication includes two phase three trials. If approved, baracitinib may be the first JAK inhibitor to be approved for alopecia areata. And in October, baracitinib became the first oral JAK inhibitor indicated for the treatment of moderate to severe atopic dermatitis, following its approval by the European Commission. This represents a new potential source of revenue for Insight. And with Lilly, we also announced positive data from the ACTT2 trial of baracitinib in COVID-19. From our IO portfolio, positive results were presented from Our trial evaluated retifendimab in squamous cell enol carcinoma, and from our dermatology portfolio, we share positive preliminary efficacy and safety results for our oral JAK1 inhibitor, 54707, in hydradenitis superativa, HS. HS is a chronic skin condition caused by inflammation and infection of the sweat glands. We also presented pooled results from the Phase III through AD program of Roxalytinib cream in atopic dermatitis. These results are indicative of why we are so excited by the potential of our dermatology portfolio and why we are establishing a new dermatology franchise for Insight. Insight has deep expertise in immunology within our drug discovery team, And we have leveraged our cross-program knowledge of the JAK-STAT pathway to develop innovative medicines to treat autoimmune disorders. We are now developing science-based therapeutics for the medical dermatology community and have multiple first-in-class candidates that we believe can deliver important benefits to patients. Our dedicated dermatology development group. continues to execute with precision and speed, as evidenced by the rapid advancement of RockScream in recent years, including the successful Phase III program in atopic dermatitis and the recent completion of recruitment into the pivotal VT LIGO program. We are also building our U.S. commercial organization. The expected acceleration of regulatory timelines through the use of the priority review voucher gives us added momentum here, and I'm very pleased to say that we have been able to recruit some exceptional talent as we continue to build our dermatology team. I will end my introduction by reminding you of the tremendous progress we have made so far in 2020. We have announced multiple positive pipeline developments since the beginning of this year, as shown by the check marks on slide 6. And looking forward, we have five important updates to come over the next two months. We expect to submit the NDEA for Roxalutinib cream at end of year and to initiate the first phase three trial in the Limber program. Important translational data from 86550, our oral PD-L1 inhibitor, is going to be presented at CITC next week. And we are also expecting a busy ASH conference in early December. At ASH, our presentation will include an oral presentation of the rich free data from Roxalutinib in chronic GVHD, as well as a series of updates from the Parsaclizib-Citadel program in several different non-Hodgkin lymphomas. And we also intend to host an investor call on Monday, 7th of December, to provide our highlights from the conference. I will now pass the call over to Barry for the commercial overview.