Incyte Corporation (NASDAQ:INCY) Q1 2024 Earnings Call Transcript

Derek Archila: Hi, good morning. Thanks for taking the questions. Just two quick ones from us. I guess, first, just on Jakafi. As you noted, the Jakafi growth coming from GBHD and PV. So I guess, what does this mean for future assumptions around myelofibrosis? I know you said stable but how should we be thinking about that for the rest of this year? And then in terms of CDK2, I guess, where do you think the bar is right now, I guess, from a PPP? And I guess what do you intend to show this year for proof-of-concept? Thanks.

Barry Flannelly: I’ll take the first part of your question, it’s Barry. So for Jakafi, we continue to see myelofibrosis — the way I look at the myelofibrosis patient population, there is about 18,000 patients, prevalent patients with myelofibrosis. And because we are the market leader because of the overall survival and symptom benefit that Jakafi provides, we will continue to think of patients as either being on Jakafi, which is most of the myelofibrosis patients or they have been on Jakafi or they will be on Jakafi. When they progress on Jakafi, then there is other options, fortunately, that are available to them. But going forward for 2024 and beyond, we continue to expect to be the market leader in first-line myelofibrosis. And I’ll turn the call over to Pablo.

Pablo Cagnoni: Yes. Thank you for the question. So in our CDK2 inhibitor program, we continue to be encouraged by the data that we have seen. And regarding the part of your question about what data we’re going to review later this year, we are in the final stages of optimizing the dose for the CDK2 inhibitor program. Our idea will be later this year to provide a substantial clinical data set, including the dose selection for patients. Initially, the focus will be ovarian cancer, but not necessarily only over the longer-term, as well as we are starting combination trials in ovarian cancer, and we are continuing to enroll patients with breast cancer. So later this year, you will see the dose selection, as well as the data for ovarian cancer, as well as the development plan in ovarian cancer.

When it comes to the bar for efficacy, if you look at the CDK2 inhibitor landscape today, most of our competitors have decided to focus on breast cancer or other areas. We continue to believe that ovarian cancer is an important opportunity. Other competitors in the space like ADCs are coming into play. We are tracking those closely to figure it out what is the overlap between the different patient populations in different — with different molecular markers. But basically, in the second part of the year, later this year we’ll provide clarity on dose, schedule and the development plan in ovarian cancer patients.

Operator: Thank you. Next question today is coming from Jessica Fye from JPMorgan. Your line is now live.

Jessica Fye: Hi, guys. Good morning. Thanks for taking my questions. First, on Opzelura, is it possible to quantify the impact of the changed healthcare issue for that product? And what about for Jakafi, was that impacted at all by the Change Healthcare issue in the quarter? And then on povorcitinib, the Phase III studies in vitiligo. I noticed on clinicaltrials.gov, it looks like there is a single primary endpoint of F-VASI 75 for the Phase III trials, whereas Rinvoq, I think, has two primary endpoints of F-VASI 75 and T-VASI T50. So what’s the rationale for only having a single primary endpoint here relative to the competition? And how do you expect that to kind of play out based on the end points you are studying? Thank you.

Pablo Cagnoni: Hi, Jessica. I’ll take the Change Healthcare on Opzelura. What we see at the end of February that there was this cyber-attack reported pretty much caused the network interruption for a few weeks. So as a result, the Change Healthcare was unable to process the claim for a few weeks. When we looked at — when we deep dive in the data, we saw a softer March when you look at the entire atopic dermatitis market basket that we monitor, and that caused an estimate of $4 million to $5 million negative impact from Opzelura in Q1. The good news for us is that we are monitoring April, and we see demand, weekly demand back on track to the levels we saw pre-cyber attack and the more recently.

Barry Flannelly: And Jessica, just on Jakafi, we may have actually had an impact from Change Health, but we don’t know. We did have when it first happened some request from specialty pharmacies that wanted extended terms for payment. But we really can’t see a big impact because most of the specialty pharmacies were able to switch over to the other system that provides the service for the specialty pharmacies.

Steven Stein: And then just to address your question on povorcitinib in vitiligo, we have two identical Phase III studies ongoing STOP V1 and STOP V2 in patients 18 years or older with 5% or greater body surface area involvement of non-segmental vitiligo. It’s a little tricky on the endpoints. But just to tell you, our primary end point for the FDA in the United States is actually identical. It’s Facial VASI 75, and total VASI 50. For other parts of the world, there may be a different primary endpoint. For example, in Europe, they’re interested most in the total VASI 50. So that leads to some of the confusion. But for our study for the FDA, it’s both Facial-VASI 75 and total VASI 50, together measured at week 52. Thanks.

Operator: Thank you. Next question today is coming from Tazeen Ahmad from Bank of America. Your line is now live.

Tazeen Ahmad: Hi, good morning guys. Thanks for taking my question. On Opzelura, can you — and I’m sorry if I missed this in your prepared remarks, but can you talk about refill rates for patients maybe now that have been on therapy for a few quarters? Can you talk about how you are seeing their use of tubes with the average use of tubes is? I’m just curious that if patients are having good results with the claim, whether they are taking many drug holidays in between when they don’t have as much itch, for example? Thanks.