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: Andy Berens - Leerink Partners - Analyst
: <_ALACRA_META_ABSTRACT>For those not familiar with company, can you just give a general overview of where you've been and the focus going forward?
Question: Andy Berens - Leerink Partners - Analyst
: Great. Well, thank you, HervT. We'll certainly talk about Jakafi. But I think that the company's definitely entered a period where there's
pipeline assets people are very excited about. I want to hear about those.
Why don't we start, I guess, with Jakafi since that's really been the backbone of the company? What are you seeing in the core
indications? There have been a number of new drugs that have been approved, but Jakafi seems to be continuing to be very strong.
So what's the commercial dynamic there from competition?
Question: Andy Berens - Leerink Partners - Analyst
: Great. A concern of investors has been -- Jakafi has been very successful. But all successful drugs, they eventually lose exclusivity.
Maybe we could talk a little bit about your efforts to extend the IP through the LIMBER trial. You just had some positive top-line
results from the bioequivalence trial with Jakafi XR. So maybe we could talk about the strategy there.
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MARCH 11, 2025 / 1:20PM, INCY.OQ - Incyte Corp at Leerink Partners Global Healthcare Conference
Question: Andy Berens - Leerink Partners - Analyst
: Okay. And the other part is potentially co-formulation.
Question: Andy Berens - Leerink Partners - Analyst
: Okay. And part of the issue, I think, with other BET inhibitors has been Jakafi does improve symptoms very dramatically and improving
on that is a high hurdle. Do you think that there's any potential to convince the FDA to not require TSS scores? Or is that something
that they just are not convinced that splenic reduction is enough to --
Question: Andy Berens - Leerink Partners - Analyst
: How important -- I mean, one of the differences you have from the other BET inhibitor is your dose daily. You don't have a drug
holiday. We had talked to MorphoSys about this. And I know that they measure the symptom scores, I think, on an iPad every day,
but they never disclose, like, was there any change -- right.
Question: Andy Berens - Leerink Partners - Analyst
: Right. And I think they actually measured -- the measurement was taken during the drug holiday, too, to complicate it even further.
Question: Andy Berens - Leerink Partners - Analyst
: That's my belief. I don't know the way -- yeah. Okay. Well -- before we move on to some of the pipeline and OPZELURA, maybe the
CALR program and some of the other efforts you're making to change the disease. I guess it'd be good to frame that in the context
of how much of the Jakafi population do you think that these drugs could eventually capture and what's going to be the role in the
treatment paradigm?
Question: Andy Berens - Leerink Partners - Analyst
: Okay. And what would the development path -- I know you guys are probably still figuring out the FDA, what -- how to get it approved.
But what do you think the trial design would be?
Question: Andy Berens - Leerink Partners - Analyst
: Okay. Do you think that the FDA might be open to looking at the genetic information, ctDNA showing suppression? Is there enough
of a link between that surrogate and the clinical outcome of these patients or is that still kind of an evolving area?
Question: Andy Berens - Leerink Partners - Analyst
: Okay, yeah. No, I mean, the history of the company has been -- you got Jakafi approved very quickly by creating an end point that
--
Question: Andy Berens - Leerink Partners - Analyst
: Okay. Why don't we shift to --
Question: Andy Berens - Leerink Partners - Analyst
: Right. I know that was the analogy I was thinking of in CML -- why don't we switch gears to OPZELURA? You've had launched in
several indications. You had some data recently reported in PN. I guess, why don't we talk about the commercial launch and then
the data and the implications of that?
Question: Andy Berens - Leerink Partners - Analyst
: And the data in PN, you had one trial that was successful and the other had a high placebo response. Why do you think that occurred
and what are the implications potentially?
Question: Andy Berens - Leerink Partners - Analyst
: Okay. And I guess we'll get an update when you have visibility on that? Well, it's the unpredictability of drug development, a lot of
factors. One of the probably the most promising assets that I get questions from is povo. And you got a number of readouts coming.
The first one is in HS. Why don't we talk a little bit about that?
I think there was some people reading the tea leaves on some of your comments, Pablo, on the earnings call that you didn't seem
so confident maybe. How confident are you in this read out? Because I think it is a very -- even aside from the Jakafi patent cliff, I do
feel like it's one of the things that could make people less concerned with the revenue stream for the company because this could
Question: Andy Berens - Leerink Partners - Analyst
: Right. And I think, looking at the other agents -- injectable agents, there's no topical available, no oral available. The range has been
from a low of concentrix in the, I guess, low double digits to high HUMIRA. You guys showed around what was 17%, I think.
And I think your comment was you hope to replicate that. But there was also -- at 12 weeks, there was a 28% delta. So I guess the
question is, which part of it do you want to replicate, the 17% or the 28%?
Question: Andy Berens - Leerink Partners - Analyst
: Okay. And from our diligence, there really is the doctors do want an oral option for these patients. So I think that is a big value
proposition.
Question: Andy Berens - Leerink Partners - Analyst
: Right, okay. And you did make some changes to the trial design to lessen the placebo response, right? You moved it to 12 weeks
and then you also add more severe patients --
Question: Andy Berens - Leerink Partners - Analyst
: And those data are coming soon.
Question: Andy Berens - Leerink Partners - Analyst
: All right. In terms of the rest of the pipeline, I mean, I know the --
Question: Andy Berens - Leerink Partners - Analyst
: Right. And I guess -- asthma is obviously one of the largest ones, but also probably the riskiest just in --
Question: Andy Berens - Leerink Partners - Analyst
: Okay. And the rest of the pipeline, I know you highlighted a number at the JPMorgan conference. Which -- the last minute left, which
of the other programs would you like to file a CDK?
Question: Andy Berens - Leerink Partners - Analyst
: When will be the next update for the CDK2?
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