Incyte Corporation

Hello, and welcome to the Insight Third Quarter 2021 Earnings Calling Webcast. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. We ask that you please ask one question and one follow-up, then return to the queue. 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 Christine Cho, Head of Investor Relations. Please go ahead.

Thank you, Kevin. Good morning and welcome to Insight's third quarter 2021 earnings conference call and webcast. The slides presented today are available for download on the investor section of our website. Joining me on the call today are Irvay, Barry, Steven, and Christiana, who will deliver our prepared remarks, and Dash, who will join us for the Q&A. 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 period ended June 30, 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. I'm happy to report today on an important quarter for Insight, but before we do that, I would like to take a moment to speak about the significant transformation our company has undergone over the past two years. From the third quarter of 2019 to today, Insight has more than doubled its number of approved products from 3 to 7 and has increased the number of approved indications from 5 to 12, a significant achievement for patients around the world. Within the same time period, quarterly product and royalty revenues have grown nearly 50% from $534 million to $778 million in the most recent quarter. This $778 million in product and royalty revenue for Q3 2021 does not yet reflect revenue contributions from our two most recent U.S. approvals, Obzelura in atopic dermatitis and Jakafi in steroid refractory chronic GVHD. In addition, we expect further growth from the recent approvals of Pemazir in Europe and Japan and Minjuvi in Europe, where the launch is ongoing in Germany and will expand to other countries as reimbursement is secure. As you see on slide 5, we have provided long-term guidance for some of these products, and there is significant upside to the current sales number. Within hematology oncology, our MPN GVHD franchise, which includes JAKA-PHY and other innovations, is expected to surpass 3 billion in peak sales. Additionally, MONGIVI, approved for the treatment of relapsed or refractory DLBCL, has the potential to reach 500 million in this indication in the U.S. While we have not provided guidance in Minjuvi, Pemazir, and iKluzik, these products represent additional growth potential and generate further value to our business. Turning to dermatology, over the past year, we have successfully established our dermatology commercial franchise in the U.S. Given the product profile of Opsera and the talented commercial team we have in place, We are confident in the potential for Obzelura, and we expect pixels to reach at least 1.5 billion in the United States in atopic dermatitis. While still very early in the launch of Obzelura, the initial uptake has been strong, and Barry will be providing details in his prepared remarks. Looking ahead to other areas of our portfolio, we are anticipating multiple regulatory decisions in 2022, including Roxolitinib cream in vitiligo in both the U.S. and Europe, Parsaclisib in three non-Hodgkin's lymphoma indication in the U.S., as well as once daily Roxolitinib late in 2022 or early 2023. This 2022 regulatory decision, which closely follows multiple product approvals in 2021, positions us well for further growth and diversification of our product revenues in the coming years. Our partners are also making headway. With Novartis, roxalitinib is currently under review in Europe and Japan for acute and chronic GVHD, and capmatinib is under review in Europe for non-small cell lung cancer. In addition, Lilly is planning to submit an SNDA to the FDA for baracitinib in alopecia areata by the end of this year, if approved. These opportunities will provide valuable growth to our royalty revenues, which have already surpassed $400 million during the first nine months of this year. As you have seen, 2021 has been an important year of commercial, clinical, and regulatory success for Insight. With that, I will hand over to Barry to cover the individual product performance.