INCYTE CORP Q4 FY2024 earnings call

• 2024 total revenues grew 15% to $4.2 billion, with Jakafi net sales at $2.8 billion (+8% Y/Y) and Opzelura net revenue at $508 million (+50% Y/Y). - Completed a $2 billion share repurchase in 2024. - Niktimvo launched in the US for chronic GVHD. - Submitted sNDA for ruxolitinib cream in pediatric atopic dermatitis, with potential approval in H2 2025. - Submitted pivotal study results for tafasitamab in follicular lymphoma and ratifamlimab in squamous cell anal carcinoma, expected to be approved in H2 2025. - Povorcitinib in Phase 3 studies for hidradenitis suppurativa, vitiligo, etc., with Phase 3 data expected in H1 2025. - Leadership change in commercial organization: Mohamed Issa assumed role of Executive Vice President, Head of U.S. Oncology.

Incyte's 2024 total revenues grew 15% to $4.2 billion. Jakafi net sales in 2024 were $2.8 billion, growing 8% year-over-year. In the fourth quarter, Jakafi net product revenue grew 11% Y/Y to $773 million. Opzelura saw strong growth in 2024, with net revenue reaching $508 million, up 50% Y/Y. In the fourth quarter, Opzelura net product revenue was $162 million, up 48% Y/Y. Jakafi's net product revenue for 2025 is expected to be in the range of $2.925 to $2.975 billion. Opzelura's 2025 net product revenue is expected to be between $630 million and $670 million.

• Jakafi net product revenue expected to be $2.925 to $2.975 billion in 2025. - Opzelura net product revenue expected to be $630 to $670 million in 2025. - Other oncology products net product revenues expected to be $415 to $455 million in 2025. - COGS expected to range from 8.5% to 9% of net product revenues. - R&D expenses expected to be $1.93 billion to $1.96 billion. - SG&A expenses expected to be $1.28 billion to $1.31 billion.

• Potential differences in clinical trial results from expected outcomes. - Impact of IRA-imposed price increase caps on net pricing. - Competition in pipeline programs, including for KRASG12D and other indications. - Uncertainties in the commercialization and adoption of new products and indications.

Q: Good morning. Thanks for taking our question. This is Paul on for Michael. We have two on the pipeline. First, on Opzelura. Can you set some expectations for the upcoming Phase 3 in prurigo nodularis? What's the clinical bar here given there's no topical therapies available? And then secondly, just on the CDK2 program, are there any plans to provide another clinical update on the Phase 1 ovarian cancer study perhaps with longer follow-up at the expansion dose levels? And what are the gating factors to formalizing a pivotal study dose selection?

A: Good morning. Thank you for the questions. Let me take the second one real quick. For the CDK2 program, as we discussed earlier this year, we plan to initiate pivotal trials this year. And as we discussed, that will be in platinum-resistant ovarian cancer. We've taken a dual approach there with a single-arm study for what we hope will be accelerated approval in the US, as well as a randomized trial that we will provide more details over the course of the year. So that program is advancing rapidly and we will provide an update later this year as you -- as you asked. And I think what -- in terms of setting the bar for Opzelura Phase 3 in prurigo nodularis, when you look at the Phase 2 data and the improvement both on the global assessment of itching, as well as the [WNRS] (ph) endpoint, we think that if we are anywhere in the [indiscernible] Phase 2 trial showed, this is going to be a very important addition to [indiscernible] for patients with prurigo nodularis. The availability of a topical for patients that have perhaps less severe disease than those that may require systemic medicine such as Povorcitinib, we think it's going to be very important. So we want to be somewhere -- and as we all know from the extensive safety track-record of rux cream, it's a very, very well-tolerated medicine. So if we are anywhere near what the Phase 2 results showed, I think we're going to be -- it's going to be very important contribution for patients.