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On Monday, 10 November 2025, Incyte Corporation (NASDAQ:INCY) presented at the Guggenheim Securities 2nd Annual Healthcare Innovation Conference. The company outlined its strategic priorities, focusing on innovation in myeloproliferative neoplasms (MPNs) and promising oncology programs. While Incyte emphasized disciplined capital allocation and R&D efficiency, it also acknowledged the challenges of converting scientific advancements into revenue and growth.
Key Takeaways
- Incyte is prioritizing mutation-specific therapies for MPNs, aiming to replace nonspecific treatments.
- The company plans to initiate a Phase 3 program for its potential Jakafi replacement, 989, in mid-2026.
- Povorcitinib is positioned to capture the immune-mediated skin conditions market, offering rapid relief.
- Nectimbo, for chronic graft-versus-host disease, is seeing strong commercial success with plans for expansion.
- Incyte maintains a disciplined approach to capital allocation, focusing on high-quality R&D investments.
Strategic Priorities and Capital Allocation
Incyte is committed to advancing its expertise in myeloproliferative neoplasms, focusing on mutation-specific targeted therapies. The company is also building a solid tumor oncology portfolio with promising candidates like G12D and TGF-β by PD-1 programs. Incyte is optimizing R&D spending by concentrating on fewer, high-quality investments and streamlining its cost base. Disciplined capital allocation remains a priority, with a focus on strategic business development rather than acquisitions.
MPN Portfolio and 989 Development
The development of 989, a potential replacement for Jakafi in essential thrombocythemia (ET) and myelofibrosis (MF), is a key focus. The ET market presents a $5 billion opportunity, targeting patients resistant to hydroxyurea. In MF, the market is valued at $2.5 billion. Incyte plans to start a Phase 3 program for 989 in mid-2026. The company is also working on a subcutaneous formulation with Enable Injections and exploring V617F inhibitors to enhance its offerings for MPN patients.
Inflammatory Portfolio and Povorcitinib
Incyte is expanding its presence in immune-mediated skin conditions with Povorcitinib, which offers a broad anti-inflammatory profile. This product aims to capture patients with hidradenitis suppurativa before biologics or after other treatments fail. Incyte plans to leverage commercial synergies with Opzelura, which has reported significant growth and is expected to continue expanding.
Nectimbo (GVHD)
Nectimbo is experiencing a strong commercial launch, with annualized sales approaching $200 million. The drug shows good persistency among patients and is positioned to grow further. Incyte aims to achieve a steroid-free regimen in combination with Jakafi, aligning with market demands for chronic graft-versus-host disease management.
Future Outlook
Incyte’s future outlook remains optimistic, with a focus on growth and innovation. The company aims to have solutions for every myeloproliferative neoplasm patient by the end of the decade, as highlighted by Pablo Cagnoni, Head of R&D. Strategic business development will continue to support internal R&D efforts, ensuring a robust pipeline and market presence.
Readers are encouraged to refer to the full transcript for a detailed account of Incyte’s presentation and insights.
Full transcript - Guggenheim Securities 2nd Annual Healthcare Innovation Conference:
Michael, Interviewer: Welcome to this Fireside Chat with Incyte. It is my great pleasure to welcome Bill Moore, President and CEO, as well as Pablo Cagnoni, the Head of R&D. Welcome. Thanks for joining us.
Bill Moore, President and CEO, Incyte: Nice to be here.
Pablo Cagnoni, Head of R&D, Incyte: Good to be here. Thank you, Michael.
Michael, Interviewer: Bill, perhaps just starting out with a bigger picture question. To what degree have your initial expectations been met since you joined the company earlier this summer, and have your strategic priorities changed in any way?
Bill Moore, President and CEO, Incyte: Good question. Thanks, Michael. I would say three things as it relates to my expectations. I have a much greater appreciation today about the depth of our MPN portfolio. I mean, Incyte’s central identity is a hematology company, namely MPNs. We have three targeted therapies entering mid to late stages of development: 989, 617, bispecific. We have some undisclosed discovery programs. I think we have a window of opportunity here to transition that market from today, which is essentially nonspecific symptomatic therapies, to mutation-specific targeted therapies. I think it is going to be an important part of the growth story. That is number one. Number two, I think the company strategically, systematically, and quietly has developed what could be a high-potential solid tumor oncology portfolio. Our G12D and TGF-β by PD-1 programs have not fully declared themselves, but at ESMO this year, we really de-risked both programs.
We’re planning to initiate phase three pending more data and regulatory interactions. It’s much more than I expected when I came in. The last point relates to capabilities. I think the R&D organization really punches above its weight. I think we have a top-ten quality R&D organization without some of the complexity and process associated with a top-ten company. I guess the last comment I would make, I think the core business, excluding Jakafi, that business that will exist well past 2029, fundamentally is in a very strong position. As it relates to strategic priorities, we’re going to press on our advantage in MPNs. That’s number one. We’re going to get our R&D spending exactly where we want to be. I think what we’re focused on right now is fewer, higher-quality investments. We’re not going to be scattershot. We’re not going to suffer from diffuse spending.
Next, we’re going to get our cost base right and separate the good costs from the bad costs. We’ll streamline in areas where it makes sense, but we will make sure that we don’t underfund critical initiatives or compromise future growth. After roughly 130-140 days, I think we’re in a very good place. We got to convert all these phase one studies into phase three programs and FDA approvals. We don’t expect people to take our word for it. We have to turn science into revenue, earnings, and cash flow, and that’s what the focus is right now.
Michael, Interviewer: Great. Just another high-level question, Bill. What is your approach to balancing capital allocation to either fund potential larger acquisitions, perhaps beyond some of the tokens we’ve seen recently, with internal R&D investments and potentially even share buybacks at some point?
Bill Moore, President and CEO, Incyte: Yeah, it’s a good question. A couple of basic principles. We don’t think we can buy our way through 2029. I don’t think that’s the way we think about BD. BD is going to supplement what we’re doing internally, namely in hematology, oncology, and I&I. As you know, there are very few positive asymmetrical opportunities out there. What I can promise you is that we will have a great deal of throughput, and we will have a framework so that we know exactly what our criteria are for doing a deal, and we know what the opportunity costs are. We have a strong balance sheet that’s continuing to grow. Internal investments and external investments are looked at the same way. They’re put through a framework, a scorecard, and they’re ranked in terms of strategic value and, importantly, IRR.
If we see things that are going to build a high-support, high-growth, durable business well into the next decade, that’s the type of deal we’re going to do. It’s not to solve sort of a revenue gap in the short term.
Michael, Interviewer: Right. Then maybe shifting over to discussing some of the pipeline opportunities. MPNs are clearly a core competency of Incyte, with Jakafi being the leading JAK inhibitor on the market for some time now. As we think about the mutant CALR opportunity and 989, your antibody product candidate here, which could really emerge as a differentiated product in the space. First of all, how do you think about the overall commercial opportunity for 989 in MF and ET?
Bill Moore, President and CEO, Incyte: Yeah, thanks for the question. I’d start at the end. If you look at the data we produce in ET and MF, phase one data, and so we have more work to do, it has the potential to replace Jakafi. It’s a superior alternative to HU in ET. Whether it’s first line or second line or monotherapy in combination for patients with MF, it is also a superior treatment. We are going to design a phase three program, which we expect to start in the middle of 2026, give or take, that is going to be—and I’ll let Pablo comment on this—that is designed to demonstrate the clinical utility of 989 in both of those conditions and in various clinical situations. That’s what our focus is right now.
You’ll see more data at ASH, but we have what I think is a clear path to a phase three program and ultimately an FDA approval. Just one more comment on the commercial opportunity on the ET side of the house, very, very big market. 20,000 patients with a CalR mutation with ET. You got to bifurcate that market. You have low risk, high risk. You have a large group of partial responders and a large group of patients who are resistant to hydroxyurea, which is a negative prognostic indicator for survival. That’s a $5 billion market when you think about it commercially. And we’re going to get a significant portion of that. On the MF side of the house, very different situation, of course. Smaller number of people, about 10,000 with a CalR mutation. Much more aggressive cancer. The risk of transformation is much higher.
That’s about a $2.5 billion market. In patients with a CalR mutation in MF, I expect us to get a very, very high share. When you put the two pieces together, you could certainly pencil out, without heroic assumptions, a replacement for Jakafi as a base case. Pablo could, of course, speak about how we’re thinking about development and the data that we just shared in the abstracts.
Pablo Cagnoni, Head of R&D, Incyte: There are a range of options, as Bill mentioned. Before the end of the year, we’re going to provide an update on the ET data that we presented at EHA, which showed clear evidence of normalization of platelet counts, a well-tolerated profile with only one of the patients having discontinued due to an adverse event at that point, and clear evidence of disease modification based on the molecular endpoints, not just VAF, but reduction of malignant megakaryocytes in the bone marrow and reduction of immature progenitors in peripheral blood. 989 in ET patients we showed at EHA, and we’re going to update that at ASH. Clearly does what it was meant to do. We put up the abstract for the MF data for the first time last week. We’re going to have more data on that at the ASH meeting as well.
What you’ve seen in MF is, in a way, similar to ET. Clear impact on clinical endpoints: spleen shrinkage, improvement in symptoms, improvement in anemia in more than half the patients, which we’re very pleased to see, and molecular endpoints as well: megakaryocytes, peripheral blood reduction in progenitors, and VAF improvement. All that, once again, with a well-tolerated profile, patients are staying on drug, which ultimately tells you they are tolerating it well. The question is, what do we do next? We have a number of steps to take in the next few months, and we’re going as fast as we can to initiate a second line study in ET, which we mentioned back at EHA. The goal is to start that sometime in the first half of 2026. We think it’s a pretty straightforward design.
In ET, really, the term second line is a little bit of a misnomer because a lot of the patients just do not want to be on hydroxyurea because of tolerance or because of constant dose adjustments to prevent reduction in white cell count. So patients that have previously been exposed to hydroxyurea that need a better alternative, that is the population we think is the fastest way to get 989 approved in ET patients. We are not discounting a first-line trial, which is not the highest priority right now. In MF, the options are going in post-Jakafi patients. That is a population that desperately needs new therapies. There is a number of medicines approved in that setting over the past few years, none of which are very good at doing what these patients need, which is spleen shrinkage, symptom improvement, and anemia improvement. Not just less anemia, but anemia improvement.
We think 989 has the potential to do that. That’s, again, high priority in MF. The question is, first line MF. That’s something we’re already thinking about. We’re generating data in patients, in naive patients with MF. That work is ongoing. We will not present it this year, but it’s ongoing, both 989 as a single agent and 989 in combination with ruxolitinib, to understand how to design that trial. It’s our goal to make this available to patients with previously untreated MF, but we just need a little bit more data to design this study. That’s basically the path we’re going to follow. All this is going to be rolled out over the course of 2026.
Bill Moore, President and CEO, Incyte: Yeah, and just one comment on the anemia that Pablo talked about. Mayo Clinic did a study and looked at patients with MF who had no anemia versus patients with MF and anemia and the difference in survival. No anemia, it was 7.9 years. Anemia, it was between 2.3 and 3.4 years. Every day, hematologists are dealing with a trade-off decision. I can control symptoms and shrink the spleen, cause anemia, which could impact survival. Or I can avoid anemia and not control the condition. To a certain extent, 989 addresses sort of this Jakafi anemia paradox, and it could be a really important aspect of the profile. That is what we see in the phase one data.
Michael, Interviewer: Yeah, maybe just follow up, Pablo, the data in the ASH abstracts, especially in the MF study, was really surprisingly impressive, especially on the SVR rates. Maybe talk a bit more about how much more you’ll share at ASH as it relates to some of the other outcomes.
Pablo Cagnoni, Head of R&D, Incyte: We’ll have a few more patients. It’s a different data cut. A few more patients, about 15%-20% more patients in the presentation than are in the abstract. The follow-up gets extended. Now, the median doesn’t change a lot because you keep adding new patients, and so the median sort of moves a little bit around. Obviously, the patients at the lower doses will have much longer follow-up. There will be patients added that were treated at higher doses with short follow-up. I think it would be important incrementally to continue to reassure us and everyone else of the well-tolerated profile of 989 and the effects on spleen symptoms and anemia. In addition, we’ll have a very detailed presentation on the translational endpoints.
That is really important because for all the good things 989 seems to do for these patients on the clinical side, what is absolutely unique about it is its ability to reduce the burden of the disease without impacting benign hematopoiesis. That is measured in three ways. We will talk about VAF, which is really a lagging indicator of what is going on in the bone marrow, reduction of malignant megakaryocytes in the bone marrow, reduction of malignant progenitors in peripheral blood. As a result of that, when those go down, it is like shutting down the faucet. When those go down, VAF will go down over time. The effect in VAF that we report in the abstract in MF is clear. Our expectation is that over time, that effect will deepen as the impact of shutting down the disease comes into play.
Michael, Interviewer: You did recently announce a collaboration with a company called Enable Injections to develop a SubQ formulation in a way of 989. Perhaps talk about the collaboration a little bit more and how this fits in the overall development strategy.
Pablo Cagnoni, Head of R&D, Incyte: We think subQ is important. These are chronic diseases. Our goal here is to really induce disease modification, which we think will lead to very long duration of therapy in these patients. The current schedule for 989 is IV every other week. As soon as we had an understanding of what the recommended dose for future testing would be, we accelerated the testing of the subQ formulation. Now, because of the volume that will be required to infuse, somewhere between 1,500 and 2,500 milligrams every other week, we decided to put in place a collaboration with a company called Enable Injections. They have a device called Enable. To be clear, what this is not. This is not something a patient has to wear all the time. This is something that they simply put on their body when they need to be infused. They push a button.
It takes between 10 and 20 minutes depending on the dose. After that, they remove the device. In between doses, they do not wear anything. It is a device that has been used for marketed drugs already. We are really very happy with the collaboration. Our goal is to accelerate this development as much as possible. It probably will not be part of the initial trial in ET, but we will integrate it into the development plan as soon as we can.
Bill Moore, President and CEO, Incyte: Think about it as a fast follow-up. J&J was the gold standard for this when IV SubQ, and it was about six to nine months. That’s the same strategy that we’re going to apply here at Incyte.
Michael, Interviewer: Right, sounds good. Maybe just one more on MPNs. Just recently, you did announce acquisition of a JAK2 selective inhibitor. Maybe just talk about generally how a JAK2 selective molecule fits into your overall longer-term strategy in MPNs and specifically what made that program attractive.
Pablo Cagnoni, Head of R&D, Incyte: Our goal by the end of this decade, early next decade, is to have a medicine, a solution for every patient with a myeloproliferative neoplasm, across the board: ET, MF, PV, CALR, 617F mutations. Part of that strategy, obviously, CALR is the first data set in that targeted strategy. We have a V617F inhibitor program in the clinic. We introduced a new formulation. We need to escalate the dose to confirm the hypothesis that inhibiting that target leads to important clinical outcomes in patients with V617F mutated MPNs. Now, in that context, I think it’s important to know that not all the best ideas sometimes might or may not be inside Incyte. There is a group and a company called Prelude that developed what we think is an interesting suite of V617F inhibitors. And so we decided that needs to be part of the strategy.
We put in place a deal that was announced last week by which we have the option to acquire the V617F inhibitors. These are important for us to complete the range of options that we have internally. We also have internal backup programs. Basically here, the best molecule will win. That’s basically what we’re going to do. We’re going to run this through the logical steps. The lead is in the clinic. The others will be introduced in the clinic in the relatively near term. In the long run, the best molecule will win.
Michael, Interviewer: All right, thanks. Yeah, maybe switching over to your inflammatory portfolio. Povorcitinib is a really interesting drug, we think. Physicians that we spoke with more recently are very excited about the longer-term follow-up data, especially in HS. Maybe stepping back, Bill, talk about how you think about the Povorcitinib opportunity overall and then specifically in the HS market.
Bill Moore, President and CEO, Incyte: Good. I think first I’d start with we’re building a franchise in immune-mediated skin conditions. That is, we should be the only company with a topical to oral solution, Opzelura and Povorcitinib, cover mild to severe disease, Opzelura and Povorcitinib, and localized and extensive disease. As it relates, Michael, to Povorcitinib for HS, here’s how I would think about the profile. Mechanistically, it covers multiple cytokines, not a single cytokine, like an IL-17, for example. I think HS is very different than other single cytokine conditions like IL-4/13-mediated AD or IL-23-mediated psoriasis. A broad anti-inflammatory profile here, or effect rather, is important. Second, if you look at the data, not just the 12-week data, but out to 24 weeks on Povorcitinib, what you see is first, rapid pain relief.
What HS specialists want to do first is make people feel better, relieve pain, and then make them look better, that is, clear their skin. I do not think anyone is going to produce data on povorcitinib that is better than what we have for povorcitinib, rather. Next, you have skin clearance numbers that approach 50%-60% at later time points, solid and very, very competitive. We have an HS 90 and high score, 90 and high score, 100 rates that hover around 20%. If you look even more closely at the data, 75% of people in the povo arm did not have a flare, and flare is the primary cause of pain. I believe that we have an opportunity with povorcitinib to capture patients at two critical inflection points.
The first one is after an antibiotic, before they need a biologic, or after a biologic when an IL-17 or a TNF alpha is not enough. There will be two sources of utilization. It could be the first oral HS treatment approved by the FDA. It may not be the only, but I do not see HS right now, given that the current treatments work about 50% of the time, as a winner-take-all type of category. This will be an oligopoly. There will be multiple products available. I think we do have an advantage in terms of our franchise, in terms of the data that we have. A very meaningful opportunity, layer in an indication for PN, layer an indication for vitiligo, and this will become one of the larger products at Incyte over the next several years.
Michael, Interviewer: How do you think about the opportunity to leverage your existing footprint around Opzelura to create commercial synergies between the two products?
Bill Moore, President and CEO, Incyte: Yeah, it’s a good question. There’s no question there are strategic and operational and financial advantages to building franchises. We have infrastructure right now in place. We have both provider and payer capabilities. We’re, of course, wired into the dermatology community. We will be able to get synergies. There’s revenue synergies. Sometimes they’re a little hard to quantify. Of course, there’s cost synergies that you can create by having one product and two products in one therapeutic area. That is part of the overall strategy of the company. You see us doing that in hematology or in MPNs. We expect to have more than one product. The same is true in our solid tumor portfolio. If we’re successful with TGF-β and G12D, for example, we have a GI portfolio.
In INI, Michael, just like you mentioned, we’ll have a one-two punch, which financially creates some advantages.
Michael, Interviewer: Opzelura has now really become a quite meaningful revenue contributor to Incyte’s top line. I think historically, Incyte spoke about a $1.5 billion peak sales opportunity in AD alone. Perhaps talk a bit about how you’re tracking towards that revenue type opportunity and how some of the near-term lab expansion opportunities could drive near-term growth.
Bill Moore, President and CEO, Incyte: Yeah, it’s a good question. If you look at what we reported this quarter, third quarter, in terms of growth, both U.S. and internationally, we were a high double-digit grower. I think that we posted a 30% growth versus prior year, 20%, excuse me, 20% versus prior year. The business has the potential to grow on a five-year compounded annual basis of about 10%, which is essentially 2Xing your business. That growth will come from both the United States and from Europe, where we’re going to get an indication for moderate AD in the middle of 2026. That does not include indications for PN, which we could secure, or for HS. Michael, your number of about $1.5 billion, just based on what we see today and layering in additional indications, I think is a very reasonable and good assumption.
Michael, Interviewer: Great. Perhaps shifting over to Nectimbo, which is one of your newer products, which has been off to a very strong commercial launch in GVHD. Yeah, maybe provide a little bit more context on how the product has been used on the market in clinical practice since its launch, perhaps relative to other available therapies, and where do you see the approved indication to potentially peak in terms of sales.
Bill Moore, President and CEO, Incyte: Since I have a transplant specialist next to me, I’ll start off with a couple of points and then turn it over to Pablo. First, by the end of the year, this product will be annualizing at almost $200 million. It’s off to a very good start. That’s mostly third-line plus use, all right? We see some earlier line use, but mostly it’s being used third-line plus. One of the most important findings so far during the launch is that 70%-80% of people put on Nectimbo in roughly February of 2025 are still on Nectimbo. We’re seeing the persistency that you want to see, which speaks to the sustainability of the current growth trajectory, which, if you look at Sanofi’s Rezurock and Nectimbo, they look like they’re on very similar curves.
Now, it’s a new product launch, and things can be unpredictable and fluctuate from quarter to quarter. This is off to a solid start being used, like I said, third-line plus. The last comment I would make, and then I’ll ask Pablo to comment, is to turn this into a business that approaches, let’s say, $1 billion as sort of an aspirational target, it’ll be important for us to demonstrate the utility of Nectimbo on top of steroid or on top of Jakafi. I think the real goal of a transplanter is a steroid-free regimen, which is what you would get from taking Jakafi and Nectimbo. Those studies are ongoing. We’re releasing data on the safety of Nectimbo on top of Jakafi. Ultimately, the efficacy and safety data is what we’re going to need to secure those indications. I think that’s where we’re at.
Very pleased with the approach. In terms of where it’s being used, I would just comment.
Pablo Cagnoni, Head of R&D, Incyte: I mean, not a lot to add there other than to say, look, bone marrow transplant patients with chronic graft-versus-host disease are patients that are cured of their disease mostly, and they have this complication that needs to be managed. The management of that complication needs to happen with the fewest possible side effects. That is why we think Nectimbo, when it gets tried initially on label, which is third-line plus, is going to keep moving up a little bit in the management of these patients because transplanters and patients want a steroid-free way to manage manifestations of chronic graft-versus-host disease. That is key. I assume that as we release the data and combination with Jakafi, that combination is going to be used empirically by some transplanters as well.
It is probably going to be moved up a little bit in the management of disease over time.
Michael, Interviewer: Great. Thanks, Pablo and Bill. Unfortunately, we have to end here.
Pablo Cagnoni, Head of R&D, Incyte: Thank you.
Michael, Interviewer: I really appreciate the time. Thanks for the opportunity.
Bill Moore, President and CEO, Incyte: Great. Thanks, Michael.
Pablo Cagnoni, Head of R&D, Incyte: Thanks, Michael.
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