Incyte Corporation

Hello, and welcome to the Insight Second Quarter 2020 Financial Results Conference Call and Webcast. At this time, all participants are in a listen-only mode. If anyone should require operator assistance, please press star zero on your telephone keypad. A question and answer session will follow the formal presentation. 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.

Thank you, Kevin. Good morning, and welcome to Insight's second 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 the 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 March 31st, 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 it is still relatively early to be able 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 Herve.

Thank you, Mike, and good morning, everyone. In the second quarter, we continued to execute well across the various facets of our business, driving strong revenue growth, achieving success in regulatory actions and in key clinical programs, while further improving our sound financial position. Jackify grew 16% year-over-year to reach $474 million in the second quarter. Jacavi and aluminum royalties also grew nicely, up 16% and 35% respectively. And I'm also pleased to be able to report six sources of product and royalty revenues for the first time with the approvals of Pemazir and Tabreta. Total product and royalty revenues were $593 million for the quarter, up 16% year over year. We announced two product approvals since we reported Q1, including Tabreta, which is licensed to Novartis, and just recently we received our first approval for Monjuvi in collaboration with Morphosis. Monjuvi is the first FDA-approved therapy for the second-line treatment of adults with DLBCL, and we believe it has the potential to transform the treatment of patients with relapsed or refractory disease. We also announced the positive results of REACH-3, which is the largest randomized clinical trial ever conducted in steroid refractory chronic GVHD patients. At EHA, we presented encouraging proof-of-concept data from our Roxolitinib plus Parsaclizib trial, as well as updated two-year data from the L-MIND trial, which confirms the durability of responses to tafacitamab. Our financial position is also very strong, with $1.6 billion in cash and equivalents at the end of the quarter. Slide 5 shows our ongoing revenue momentum over the last several years, and we expect recent new approval to add further to our top line. During the remainder of this year, we expect to maintain the momentum of Jackify in MPN and look to drive additional growth in GVHD. Furthermore, we are focusing on executing successful launches of both Monjuvi and Pemazir, and we expect Abresta royalties to increase following the approvals and subsequent launches by Novartis in both the U.S. and Japan. Before the end of 2020, we plan to submit the NDA for roxalutinib cream seeking approval in atopic dermatitis, and we also expect to initiate the pivotal program of roxalutinib plus partaclizib in patients with myelofibrosis. Before I hand off to Barry, I felt it important to provide an overview of COVID-19 impact on our business. On the revenue and supply side, we have not seen any material impact on key timelines. With regards to clinical development, there has been no change to key late-stage programs since we reported Q1. While the regional shutdowns due to COVID-19 affected certain studies, the impact has been largely transient, and we remain on track with key timelines. For example, while new patient recruitment in our study had experienced a slowdown early in the quarter, recruitment has since rebounded to pre-pandemic levels. Therefore, we continue to expect results in 2021. In summary, since the beginning of 2020, We have announced three products approval and announced positive results from two separate pivotal programs, with free and true AD. These achievements, on top of strong commercial performance and excellent progress in clinical development, are important parts of this transformational year for Insight. I will now pass the call over to Barry.