Incyte Corporation (NASDAQ:INCY) Q3 2023 Earnings Call Transcript

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Steven Stein: So thanks for the question. Absolutely, that’s the case. So I’ll be a little repetitive. The XR program, we’re busy in terms of response to the FDA now, and the idea is to get the XR approval prior to the loss of the LOE for RUX. Both BET and ALK programs, we want to declare where we go in if we go into registration studies end of this year, early part of next year, and it will give us enough time to execute a Phase III program and get across the finish line there. So that’s absolutely intent. The mutant CALR and V617F, as Pablo said, are early but great promise of disease-modifying agents. And so it’s a little unclear the regulatory part there, and it will depend on demonstrating safety and efficacy. But we’ll see if that keeps going well, you could potentially execute a rapid Phase III program, but it’s really too early to say.

Herve Hoppenot: But maybe I can add. I mean, on this view about the Jakafi patent expiration and the way we are sort of allocating resources. That’s basically the eight program. You saw one of the slides is speaking about the eight programs that we are prioritizing in R&D, and that’s where you have the list of the programs that will be impacting our revenue in the years that are coming relatively soon with CALR being maybe the one that is a little bit of a stretch. But for everything else, it could come before that time. And the povorcitinib program, which is increasing. Today, we have the news of an additional indication in prurigo nodularis is in Phase III now for one indication, it has Phase III is being planned for prurigo nodularis and vitiligo. So all of that should be coming in the years that are – that preceded the patent expiration for Jakafi.

Operator: Thank you. Our final question today is coming from Evan Seigerman from BMO Capital Markets. Your line is now live.

Unidentified Analyst: [Indiscernible] on for Evan. Just wanted to ask with the pre-submission meeting with FDA planned for RUX cream in pediatric patients. Are there any nuances with that submission in the pediatric population versus adults that you think will require a special consideration for the FDA and inside? And has there been any indication on when that meeting may take place? Thank you.

Steven Stein: It’s Steven. So we don’t guide to you when we have the actual meetings, but the only nuance in peds is some safety requirements to demonstrate under maximum use conditions that there’s no increased levels or untoward side effects. We’ve completed that work. We’re satisfied with the results and we’re discussing with the FDA. So that will put our submission sometime hopefully, in the first half of next year in terms of having that complete data set and submitting it then, and we’re very comfortable with the data. Thanks.

Operator: Thank you. We reach the end of our question-and-answer session. I’d like to turn the floor back over for any further or closing comments.

Ben Strain: Thank you all for participating on today’s call and for your questions. The IR team will be available for the rest of the day. Please don’t hesitate to reach out. Thank you.

Operator: Thank you. That does conclude today’s teleconference and webcast. You may disconnect your line at this time, and have a wonderful day. We thank you for your participation today.

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