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: Marc Frahm - TD Cowen - Analyst
: Maybe just to start off with, Christiana, you want to get the high level earnings was a week or two ago, just kind of takeaways from the last quarter
and some of the guidance that you gave, and then we'll dive into some of the specific questions that I have, but also anybody from the audience,
we'd love to have your participation if there's burning questions as well.
Question: Marc Frahm - TD Cowen - Analyst
: And I think the next readout of those is in the next maybe a month or two is povorcitinib data in HS. So Steven to start out with, what are your
takeaways from the Phase 2 data that has been shown in terms of how povo kind of stacks up against some of the most recent entrants to that
space?
Question: Marc Frahm - TD Cowen - Analyst
: And you mentioned kind of the Phase 2 that you think that represents a best-in-class profile from -- especially when you look at the longer term
data, high score, 100. Do you think you need to replicate that in Phase 3 that this needs to be better than themselves to be a compelling option?
Does it need to be equal to or could it even be a bit worse and be pretty compelling still?
Question: Marc Frahm - TD Cowen - Analyst
: And so you mentioned maybe this is going to end up as 40% or a little bit more biologic-naive. Where do you think that IL-17 experience will be
because I think that will be very different than pretty much any trial that's ever going to run?
Question: Marc Frahm - TD Cowen - Analyst
: Maybe walk through the disclosure plan. I mean obviously, you'll talk to the high score 50 in the overall population at week 12 since that's the
primary endpoint, but what else should we expect in that initial release?
You mentioned the importance of biologic experience for global reimbursement. Is that a likely subgroup? Any further data cuts than 12 weeks
that we should also see?
Question: Marc Frahm - TD Cowen - Analyst
: And so I guess then especially, if you're only reporting the primary endpoint, then we should expect a medical meeting relatively quickly because
--
Question: Marc Frahm - TD Cowen - Analyst
: And then once stopped, HS does read out, what else do you need to gather before you can actually submit the NDA since this is going to be the
first approval?
Question: Marc Frahm - TD Cowen - Analyst
:
Question: Marc Frahm - TD Cowen - Analyst
: And maybe back to some of the efficacy analysis as we get the secondary analyses reading out. Is high score the right scale to show differentiation
for this asset or do you think it is pain or something else that's really the key? What will be commercially the most relevant differentiator?
Question: Marc Frahm - TD Cowen - Analyst
: I mean obviously, yeah, as you said, you'd expect to get that black box. In terms of if events are actually seen in this trial, where do you think that
line is within HS as to what's acceptable and where that risk could just get to be too much?
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MARCH 03, 2025 / 4:10PM, INCY.OQ - Incyte Corp at TD Cowen Healthcare Conference
Question: Marc Frahm - TD Cowen - Analyst
: This trial is going to read out shortly, but there's a number of other Phase 2s and 3s running for povorcitinib. Do you view this as the -- is this the
biggest commercial opportunity for povorcitinib? Is it some of these other -- and if so, what's the second biggest?
Question: Marc Frahm - TD Cowen - Analyst
: You mentioned that CSU trial. I think ClinicalTrials.gov indicates the primary completion date is on Friday. Just how quickly do you think you can
turn that around to some sort of update of what next steps may or may not be from that program?
Question: Marc Frahm - TD Cowen - Analyst
: And that's -- in terms of updating the street as to what that there is a next step or unfortunately not would happen within the year, not just internally?
Question: Marc Frahm - TD Cowen - Analyst
: Maybe we'll move to MPNs. Staying -- maybe starting with commercial. It just historically, Incyte has talked about the Part D redesign being
potentially a tailwind this year. What are you seeing in the -- we're a couple of months in, are patients able to access the smoothing of the out of
pocket costs? Is that helping in some of your conversion rates?
Question: Marc Frahm - TD Cowen - Analyst
: And then maybe going to the opposite end of the development scale, we're expecting Phase 1 data from the mCALR program this year. Starting
from enrollment, what are the types of patients that you've been seeing coming in because this trial does I believe allow MF and ET patients, but
also what level of like Jakafi experiences happened or other JAKs beyond Jakafi?
Question: Marc Frahm - TD Cowen - Analyst
: And kind of what's triggering showing, obviously some of that POC, but would you expect to have, if POC is being established that you have your
dose for the CALR antibody or --
Question: Marc Frahm - TD Cowen - Analyst
: You said data is -- the presentation is likely in the second half?
Question: Marc Frahm - TD Cowen - Analyst
: Maybe just on ET. I think people are maybe not familiar with that disease. Do you want to speak to what the unmet need is there and you started
to touch on what POC looks like, but is it just --
Question: Marc Frahm - TD Cowen - Analyst
: Yeah. So you mentioned in ET, part of the POC is normalizing the platelet count. Is that something that if you're really disease modifying an MF,
we should also be going the opposite way, right? Many of these patients do have suppressed platelets or red blood -- and/or red blood cells at
baseline. Should we see those recovering?
Question: Marc Frahm - TD Cowen - Analyst
: And I think we kind of work through the maturity of that data in the CALR side that's likely to get presented later this year. Just given that the JAK
is started a bit behind, should we expect that to be much less mature data, or is there kind of nuances of the trials and dosing that makes it maybe
get to --
Question: Marc Frahm - TD Cowen - Analyst
: Maybe also just on LIMBER, investors are generally pretty dismissive of the BET inhibitor program, in part because of the experience with MorphoSys
and Novartis. But you guys are pushing forward the Phase 3. What are -- what do you think people are missing?
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MARCH 03, 2025 / 4:10PM, INCY.OQ - Incyte Corp at TD Cowen Healthcare Conference
Question: Marc Frahm - TD Cowen - Analyst
: This is more a Christiana question. Just turning to Opzelura. You issued guidance $630 million to $670 million for the year, which I think some
investors saw as relatively conservative given the strength that you had in the back half of the year in '24.
Just what are the major kind of pushes and pulls there that factored into that guidance? What would need to happen to kind of exceed it or?
Question: Marc Frahm - TD Cowen - Analyst
: You mentioned the importance of patient activation in vitiligo. Just how have -- you've been on the market for almost two years now, right, in
vitiligo. Just what is -- how have patient volumes changed in that period? How successful have you been in patient activation over that period now
that there is a commercial therapy for vitiligo?
Question: Marc Frahm - TD Cowen - Analyst
: You also have some data already in prurigo nodularis as well as HS. Just when you take the, this is the mild to moderate populations obviously,
we're very topical, you take the unmet need in those patients, the patient numbers, the efficacy data you've shown so far, which of those do you
view as the bigger opportunity?
Question: Marc Frahm - TD Cowen - Analyst
: And how should we think about duration of therapy since that's a big factor potentially vitiligo versus AD, but how should we think about duration
of therapy in those two in the indications?
Question: Marc Frahm - TD Cowen - Analyst
: I know we're running up on time. Squeeze in one last question just on CDK2. On your call the other day, you did note that you'd likely update the
Phase 1 data set this year. Just how should we think about that upside in terms of size and scope?
And will it just be a variant, or should we expect endometrial latter --
Question: Marc Frahm - TD Cowen - Analyst
: Should we expect any data from those (multiple speakers)
Question: Marc Frahm - TD Cowen - Analyst
: That's unfortunately all the time we have. So we're going to have to cut off there.
Thanks everyone for joining as well as the team from Incyte.
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