Incyte Corp Q3 2025 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Tazeen Ahmad - Bofa Merrill Lynch Asset Holdings Inc - Analyst : Thanks for taking my question. I wanted to focus on the upcoming mCALR data, you've given us a good preview of how many patients worth of data to expect. I think most people are going to be focused on the monotherapy arm. How important is that going to be for people to believe that you have convinced efficacy as it stands alone because there could potentially be the view that it could be synergistic with when added to Jakafi. So can you maybe level set for us what level of efficacy you're going to think is going to be convincing enough to move it forward even if it's in combination with Jakafi.

Question: Andrew Berens - Leerink Partners LLC - Analyst : Congratulations on the execution during the quarter. I was wondering if you could give some more color on the decision to terminate the Povo program in CSU following your announcement in April that Phase 2 is successful. Are we going to see the data at a medical meeting as you've previously guided?

Question: Andrew Berens - Leerink Partners LLC - Analyst : Okay. Thanks. And then if I could, just a question on the PD-1 TGF beta. I was at ESMO. I thought it was really encouraging and you guys are advancing into Phase 3. Are we going to see combination data before you make that decision to advance? Is there like -- I think there's like a run-in looks like on the clinicaltrials.gov?

Question: Jay Olson - Oppenheimer & Co Inc - Analyst : Congrats on the quarter, and thanks for taking the questions. Can you describe the rationale behind terminating the BET inhibitor program with that mostly related to your strategic focus on targeted therapies like mCALR and myelofibrosis. And as a follow up to that question, since the BET inhibitor was on track to begin registrational studies, how soon can you move mCALR into registrational studies?

Question: Salveen Richter - Goldman Sachs Group Inc - Analyst : Thanks for taking my questions. You've highlighted [VAF] as an important part of the mCALR story in terms of the MPN story in terms of the drug being functional cure. And just remind us what you want to see on VAF reduction and level set us on how well understood the ultimate correlation is between VAF and clinical outcomes. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. OCTOBER 28, 2025 / 12:00PM, INCY.OQ - Q3 2025 Incyte Corp Earnings Call And just a second question here, Bill, on your -- you've highlighted your focus on managing operating expenses and streamlining the company. How are you thinking about the evolution of the company's target margin profile over the next few years and also through the Jakafi LOE.

Question: Peter Lawson - Barclays Services Corp - Analyst : Thanks for taking the questions. Niktimvo, kind of how sustainable is the trajectory on that growth? It's pretty impressive this quarter, and I wonder if you could also talk around the profitability of that franchise.

Question: Peter Lawson - Barclays Services Corp - Analyst : Oh, yeah, sorry. On Niktimvo, if you could talk through the sustainability of the trajectory, it was really impressive this quarter, and if you could talk through the profitability as well.

Question: Evan Seigerman - Bank of Montreal - Analyst : Thanks for taking the question. Great to see a lot of you at ESMO. So I think we'd all agree that mCALR is a very critical juncture for Incyte, but I want to take it out of the picture for a second. So can you walk me through how the current pipeline needs to mature to drive growth through the Jakafi LOE? And then what type of business development, you're not going to be specific, but would you have to do to help also supplement that growth? Essentially, I want to understand what Incyte looks like with and without mCALR by the end of the decade.

Question: Derek Archila - Wells Fargo Securities LLC - Analyst : Thanks for taking the questions. Just curious for 989 pivotal trials in MF and ET expected next year. Will these be with IV with the on-body pump from Enfuse? And then just a quick follow up. In terms of a potential XR launch and kind of the commentary around the launch plans in the prepared remarks, I guess how do you plan to position with payers? And I guess what's your base case in terms of the amount of shares you can convert from Jakafi pre-generics.

Question: Reni Benjamin - Citizens JMP Securities LLC - Analyst : Thanks for taking the questions and congratulations on a great quarter. I guess just to follow up with Rux XR, there was a strategy way back when about combining it with a pipeline product to help kind of fight this LOE. Are you looking at any potential combinations to move this forward with either the pipeline or in-licensing a product and staving off this erosion curve for Rux? And as a follow up, you're starting this registrational program with TGF-beta. I'm kind of curious as you think about how large the study is, the delta that you need to show to have a positive study, how you come to the calculus given the kind of limited data that you have so far? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. OCTOBER 28, 2025 / 12:00PM, INCY.OQ - Q3 2025 Incyte Corp Earnings Call

Question: Jessica Fye - JPMorgan Chase & Co - Analyst : Thanks for taking my questions. I had a couple more on 989. So I guess for Pablo, recognizing that we won't have frontline data for 989 by year end, can you talk about what elements of these data in post-Jakafi patients and Jakafi suboptimal responders could make us come away confident that 989 could be successful in the frontline? And I guess specifically for that combo data set, I know it's smaller, but what are you going to be looking for as proof points that 989 is offering clear clinical benefit on top of Jakafi in the absence of a control arm? Is there like a certain magnitude of change from baseline on those key measures that you think would exclude any natural variability in the endpoints over time had the patients just remained on their Jakafi monotherapy? And I have a follow up.

Question: Jessica Fye - JPMorgan Chase & Co - Analyst : You mentioned looking at SVR25 in addition to SVR35. How do you incorporate SVR25 data into your decision-making?

Question: Kripa Devarakonda - Truist Securities - Analyst : Thank you so much for taking my question. Another one on 989. So when it comes to a Rux combo, is there a rationale to develop both in suboptimal responders as well as in Rux-naive patients, or do you see it as a better strategy to focus on one versus the other for the longer term? And secondly, what's the FDA guidance for the endpoints? Now, I know you said you need to show both SVR35 and TSS50, but would they be co-primary endpoints? And do you have to hit on both?