The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: David Lebowitz - Citi - Analyst
: Okay. That's a very good setup. I guess maybe just a few questions on Jakafi, just to level set and then we can move on to the list of very
interesting topics you outlined. So can you talk about the once-daily formulation and how that may help you and where that stands in terms
of readiness for launch?
Question: David Lebowitz - Citi - Analyst
: And beyond the convenience of the once-a-day, is there more to the pitch? Or is that the essence of it? Or is there some -- are there additional
benefits like, for example, less side effects or other aspects that are helpful?
Question: David Lebowitz - Citi - Analyst
: Okay. All right. Well, you mentioned 989 in your earlier comments. So maybe we could start there. Tell us a little bit about this target, this
mutant CALR antibody. What is the significance of that? And you mentioned the data is coming this weekend. I'm not sure the exact time,
but I'll be at ASH, so I'll check it out. So just tell us a little bit more about how you see that opportunity.
Question: David Lebowitz - Citi - Analyst
: Yeah, that was sort of getting to my next question. So yes, so you haven't specified what -- you mentioned both the post-Jakafi setting, you
mentioned the combo. You didn't specifically mention frontline in what you said, but I think that's got to be in the strategy somewhere?
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DECEMBER 02, 2025 / 4:15PM, INCY.OQ - Incyte Corp at Citi Global Healthcare Conference
Question: David Lebowitz - Citi - Analyst
: And the -- but then getting to sort of the bigger strategy as far as where you would initiate a Phase III, would it be sort of a multipronged
strategy where you go into some more -- one or more of these settings? Or of course, you've got the IRA considerations in terms of staggering.
So talk a little bit to the extent you can base it.
Question: David Lebowitz - Citi - Analyst
: And how are you competitively positioned with this particular target? Are you unique in having this construct? Or are there others that are
doing things with slight variations?
Question: David Lebowitz - Citi - Analyst
: Okay. All right. So we look forward to seeing that, and we'll check out the detail you mentioned on the Jakafi ineligible. So quickly on
ruxolitinib, the Opzelura, the cream, if we could ask a few questions there. Just talk about the growth of the product and how you see it
evolving? Where do you see the most uptake?
Question: David Lebowitz - Citi - Analyst
: And that submission is based on what set of data? Is it the US data that you -- or did you do additional studies to support the Europe work?
Question: David Lebowitz - Citi - Analyst
: Okay. So you would expect the typical pathway, the CHMP opinion in next -- sometime in the first half of next year or approximately?
Question: David Lebowitz - Citi - Analyst
: Okay. Okay. And do you speak about the split in terms of the revenues on those different indications on vitiligo versus AD?
Question: David Lebowitz - Citi - Analyst
: And I assume that kind of growth you talked about the 2x-ing by 2030, 10% CAGR, does that factor in some of the competitors? Because
there are some other products that are novel mechanisms that are topicals, I believe, like the PDE4 inhibitors, for example, do they -- you
factored that in clearly?
Question: David Lebowitz - Citi - Analyst
: Well, you're doing a very good job on the DTC because I see the ads on CNN. My phone probably is plugged into the TV. So it knows I'm
a biotech analyst.
Question: David Lebowitz - Citi - Analyst
: So then moving on to other topics. So to povo, there, you're preparing to submit very soon to the EU, yes. So can you just talk about the
steps there? And then what the pitch is as far as a strong statement on efficacy for HS.
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DECEMBER 02, 2025 / 4:15PM, INCY.OQ - Incyte Corp at Citi Global Healthcare Conference
Question: David Lebowitz - Citi - Analyst
: It's in. Okay.
Question: David Lebowitz - Citi - Analyst
: Okay. And if you could maybe just talk a little bit about the market and the untapped opportunity in HS. How big of a product do you think
povo could be if everything goes according to your projections?
Question: David Lebowitz - Citi - Analyst
: And -- but you'll have two important data sets, if I'm not mistaken, next year, Phase 3 data sets for vitiligo and for PN.
Question: David Lebowitz - Citi - Analyst
: And how do you see those? I mean the expectation is based on the Phase 2 data, based on the strength of the data in HS that those are
in good position to work? Or what do you need to see on those to be very confident in a strong profile?
Question: David Lebowitz - Citi - Analyst
: Okay. And just sorry for a basic question since we don't formally cover you at the moment. Povo, so that's not something that you could use
as a Jakafi replacement in those settings. Is that correct? It wouldn't -- there's a reason for that.
Question: David Lebowitz - Citi - Analyst
: Okay. So it just wouldn't work.
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DECEMBER 02, 2025 / 4:15PM, INCY.OQ - Incyte Corp at Citi Global Healthcare Conference
Question: David Lebowitz - Citi - Analyst
: Okay. I'm glad I asked for that clarification. All right. And now for one that we are very familiar with since we cover Syndax, Niktimvo, axatilimab.
So that launch has done exceptionally well. So maybe just tell us a little bit more about how you're investing in that asset and where you
see the growth. Obviously, there were royalty partners that were very interested in that asset and have made a big bet, just on the third-line
opportunity, let alone the other work you're doing in the earlier lines. So maybe you could kind of walk us through your strategy overall for
the program.
Question: David Lebowitz - Citi - Analyst
: Okay. And do you want to talk a bit about the studies that you're pursuing in the earlier lines. There's a few, the steroids and then with
Jakafi?
Question: David Lebowitz - Citi - Analyst
: Okay. And have you provided any time lines on readouts for those? Or those are just booting up now?
Question: David Lebowitz - Citi - Analyst
: And what are the data points or proof points that would support working in those frontline either combination? How much evidence is there?
I mean it's a good design that the study should be run. I'm just curious what -- where are you getting the confidence that it's likely to work?
Or is one more likely to work than the other?
Question: David Lebowitz - Citi - Analyst
: Okay. And then you mentioned briefly Rezurock. I mean that's a different mechanism, right? So like the read-through there, I assume the
answer is not much read-through, but anything else you want to say?
Question: David Lebowitz - Citi - Analyst
: Yeah. Okay. Ex-US, is there a plan? Or what is the thinking there?
Question: David Lebowitz - Citi - Analyst
: Okay. And then just like overall for this franchise, the profitability, can you talk about the profit margins? And you mentioned the BMT centers.
I'm also just curious, anecdotally, what are you hearing in the field as far as the experience given what you said before about the percent
that are staying on it for as long as they are?
Question: David Lebowitz - Citi - Analyst
: Okay. You mentioned at the top of the hour, the solid tumor work. So I want to make sure we have time to talk about both of those programs.
So let's start with KRAS. You just had some Phase 1 data, I think, at ESMO. So tell us more about the KRAS. Is it -- what's the exact mechanism?
It's -- this is a G12D, but is it -- the hitting the on state, hitting the off state, both. We'll talk about those details and how -- and there are quite
a few of these in development. And as you know, so how does yours fit in?
Question: David Lebowitz - Citi - Analyst
: And so this is one where both -- it must bind both. That's the point. Is that right?
Question: David Lebowitz - Citi - Analyst
: Okay. And then this -- the logical strategy question is, are these getting equal priority? Is one more of the favorite than the other? CDK2
sounds like you really like that one a lot, too. Well, you got already in Phase 3 there.
Question: David Lebowitz - Citi - Analyst
: Okay. And then just sort of last portfolio question. You've got a lot of things going on and a lot of interesting assets. Is there a BD pipeline
that you're looking at for other opportunities? Or do you feel you have enough on the plate at the moment? What else could we look forward
to?
Question: David Lebowitz - Citi - Analyst
: All right. Well, we'll be at ASH. We'll look forward to the data, and thank you both for joining.
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