Incyte Corporation

Hello, and welcome to the Insight second quarter 2021 earnings 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 Christine Cho, Investor Relations. Please go ahead.

Thank you, Kevin. Good morning and welcome to Insight's second quarter 2021 earnings conference call and webcast. The slides used today are available for download on our website. Joining me on the call today are Herve, Barry, Stephen, and Christiana, who will deliver our prepared remarks, and by Dash, who will join us for the Q&A session. Before we begin, I'd like to remind you that some of the statements made during the call today are forward-looking statements and 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 year ended March 31st, 2021, and from time to time in our other SEC documents. We will now begin the call with Hervé.

Thank you, Christine, and good morning, everyone. So at the beginning of the year, we laid out several key business objectives for 2021, and we executed on a number of our commercial and clinical goals in the first half, representing a continuation of the momentum we saw throughout 2020. We believe these achievements, including the success of the TrueV and TrueAD program in vitiligo and atopic dermatitis, will significantly contribute to our long-term strategy for growth and diversification. In the second quarter, our product and royalty revenues grew 17% to reach nearly $700 million. Jackify net product sales were up 12%, with growth driven by the return of new patient starts to pre-COVID levels. Both Pemazir and Monjuvi revenues increased quarter over quarter, up 33% and 16%, as both new product launches continued to gain traction, and royalties grew 30% to 121 million for the quarter, with Jackify up 24% and Aluminium up 40%. Our performance in the second quarter shows the strength of our business and our new product launches are progressing well. We are looking forward to the second half as we await two important FDA decisions in September and the potential approval of Staphacitamab in Europe following the positive CHMP opinion received in June. While we are disappointed by the PEDUFA extension for roxalitinib prim in atopic dermatitis and for roxalitinib in steroid refractory chronic GVHD, We remain confident in the value these medicines can bring to patients based on the robust data from pivotal programs, TRU-AD and REACH-3, respectively. We will continue to work with the FDA on retifanlimab, which recently received a complete response letter for the BLA submission for SCSE. Retifanlimab remains under review with the European Medicines Agency. Moving on to our clinical development progress, in addition to the positive top-line results in vitiligo and long-term data in atopic dermatitis for roxalitinib cream, we also announced positive phase II data for parsaclizib in patients with autoimmune hemolytic anemia and the achievement of bioequivalence with QD roxalitinib, which is on track for an NDA submission in early 2022. Looking outside of the U.S., we have multiple growth opportunities across several markets. In the first half of the year, Pemazir was approved in Europe and Japan, and we have seen encouraging uptake with ex-U.S. sales reaching 3 million. Further, supporting the importance of Pemazir as a treatment for patients with cholangiocarcinoma, NICE provided a positive recommendation for Pemazir in the U.K. Turning to tafacitamab in the EU, if approved, Insight will be commercializing tafacitamab under the brand name Minjuvi, bringing the therapy to many patients in need. In Europe, 16,000 patients are diagnosed with relapse or refractory DLBCL each year, of which approximately 14,000 would be eligible for tafacitamab. Our hematology team in Europe, which was already deployed for ICLUSIG, are launch-ready and and we will be leveraging resources to support the launch of Taresitamab on a country-by-country basis. So slide six shows the key business objectives that we set for the year. So first, to continue driving growth in our current product portfolio. Second, to continue to expand and diversify our revenue base through new products and new indication launches. And third, to continue to progress our late-stage pipeline as well as our early... earlier stage program. So with that, I will hand it over to Barry to cover the individual product performance.