Incyte Corporation (INCY) Earnings Call Transcript & Summary

January 12, 2026

US Health Care Biotechnology Company Conference Presentations 40 min

Earnings Call Speaker Segments

Jessica Fye

Analysts
#1

Great. Good morning. Welcome, everyone. My name is Jess Fye, biotech analyst at JPMorgan, and I'm delighted to be continuing conference this morning with Incyte. First, you're going to hear a presentation from the company's CEO, Bill Meury, then we're going to open it up for Q&A. If you have a question, you're sitting in the room, someone will bring you a mic. [ Audio gap ] If you want to ask it, over the portal, internet to me on the iPad, you can do that too. But with that, let me pass it over to Incyte's CEO, Bill Meury.

William Meury

Executives
#2

All right. Good morning, everyone. Thanks for being here. What I want to try to do with our time this morning is give you a clear and balanced picture of Incyte and talk about how we're thinking about building the company. As I was walking in the room, someone asked me what makes Incyte unique? The way I think about it is we're not a diversified giant or a small start-up. We have the innovation and growth potential of a biotech company and the capabilities and resources of a large pharma company. I would say the sweet spot of scale. What we're trying to solve for right now is top-tier revenue growth and durable revenue earnings and cash flow. Now in order to navigate the transition of Incyte from a Jakafi company to a hem/onc and IAI company, we have to do these three things right. You see them on the slide. First, scientific innovation. As you know, return on R&D investment in biopharma has been stubbornly challenging and persistently difficult to unlock. And Incyte is not necessarily immune to that reality. But what I would say is that our pipeline is stronger, deeper and more strategically aligned than ever before. It's not consumed by moonshots or safe low return bets. It has the right balance in terms of risk and reward. We focus on compounds where our science gives us an edge in areas where we can lead that specialized high-value markets. In terms of operational execution, there's plenty of biologic risk in the industry, and so we have to control execution risk. Operationally, department heads at Incyte, R&D, manufacturing, commercial are expected to run their business at a detailed level. And in terms of execution, we're focused on doing three things well: first, setting priorities. We focus on the vital few things that can create value. So for example, our R&D investment in 2026 will be just north of $2 billion. 80% of that investment is in seven priority compounds. So there's no diffuse spending. We're not scattershot, and we've gotten rid of what I call limbo projects. Second, set deadlines and commit to meet those deadlines. Deadlines inspire productivity in the company probably more than compensation, and they create urgency. And then finally, we make sure that long-term strategic growth initiatives are fully funded and resourced. Last point here is value creation. We're not the National Cancer Institute. We're not the National Institute of Health, and we have to convert science into FDA approvals and cash flows. We think about our business across three dimensions or therapeutic areas: hematology, oncology and IAI. We're not looking to configure a loose unrelated group of products. We're trying to build franchises because franchises give strategic, operational and financial advantages. This informs what we do, what we don't do, what we invest in, what we don't invest in, gives employees clarity and should give investors some predictability. Hematology is a central identity of the company, and we have a window of opportunity to transition the treatment of MPNs from non-specific symptomatic therapies to mutation-specific disease modifying therapies. In oncology, I think we've quietly and systematically built what could be a high-impact oncology portfolio. And of course, in IAI, we have a jacket franchise with topical to oral and mild-to-severe solutions. There are two achievements in 2025 on this list that stand out to me. The first one is our core business is exceeding expectations on three levels. Total sales, Jakafi sales, which is important because Jakafi is a funding vehicle for our pipeline and for new product launches. And then in terms of the core business, ex Jakafi, we expect is going to be up over 40% in '25 over 2024. Second, we fundamentally changed the shape and maturity of our pipeline in 2025. We moved multiple assets from early-stage development to late-stage development. So to put this in context, when we started 2025, we had no proof-of-concept data on 989. No proof-of-concept data on G12D, TGF-beta by PD-1, no Phase III data on POVO. No safety data of Niktimvo in combination with Jakafi. And we had no frontline DLBCL data on Monjuvi. We have all of those things right now. The point here is that we have much greater visibility into the potential growth profile of the company and our ability to set a new high more mark for Incyte. Three simple but important points for 2026, and I'll break each one of these down. First, our core business ex Jakafi has the potential to be as big as Jakafi is currently by 2030. Key part of that growth story will be product launches for Jakafi XR, Opzelura, POVO and Monjuvi. Second, our pipeline has the breadth and depth to support top-tier growth and potentially 2 to 3x our top line. We have seven assets being supported by 14 pivotal trials in 2026. And then finally, in terms of business development, we see it as a multiplier to extend or strengthen the core. We're not looking to chase deals, fill a revenue gap or buy unbounded downside risk. We want high fit opportunities that have the potential to create durable revenue earnings and cash flow into the next decade. Now this is a road map essentially for what I would call [ Act 2, ] and I'll start at the end and work our way backwards. If you see the top right. What we want to do is configure a company that can achieve top-tier revenue growth, call that a 15% to 20% 5-year CAGR is diversified in terms of number of products, indications and markets has minimal LOE exposure, has healthy operating margins on a balance sheet that could approach $7 billion to $8 billion by 2030. Now if we start at the beginning on the far left of this chart, we have a core business that will fund the pipeline and reduce the depth of the trough. We have product launches and a pipeline that will become the core business, reduce the duration of the trough and build a glide path post-2029. Let's take a look at the core business. You can read this from bottom to top. Dark blue is Jakafi, light blue is the core business. You can see in 2024, we had sales of $3.62 billion. We expect to finish 2025 at or a tick above the upper end of our guidance of $4.32 billion. In terms of Jakafi, it had a very strong fourth quarter and a good year, and we're very focused on the health of that business given the fact, as I mentioned earlier, it is a funding vehicle. Now here, I'm zooming in on the core business. And the core business is defined in the right, the list of products Opzelura, Niktimvo, Monjuvi, Zynyz, Pemazyre and Iclusig. And you read this from left to right. If you take a look at 2024, sales were approximately $827 million. We expect to finish '25 million at $1.26 billion, which is the midpoint of our range, up 45%. Two comments about this. If you look at the products on the right, every single one of them were up in 2025 over '24. That's number one. Number two, Opzelura, Niktimvo and Monjuvi with the largest absolute growth contributors to our core business ex Jakafi. We can read this slide right here from left to right. On the left, you have Opzelura, Niktimvo, Monjuvi, Zynyz. And then 2025 sales, what I want to focus on is the third column from the left, which is the growth drivers. Our estimation is Opzelura has the potential of 2x over the next five years. Growth from Opzelura is going to come from three sources: first, increased penetration of the AD and vitiligo markets in the United States. 2025, Opzelura in AD was up between 20% and 25%, and vitiligo was up between 15% and 20%, that's number one. Number two, we'll be launching Opzelura for AD in Europe in second half of 2026. Most of the benefit of that launch will be in 2027. In Europe with Opzelura in vitiligo today, we finished '25 just south of $150 million. The AD market in Europe is 5x the size of the vitiligo market, that's going to be an important growth driver. We're also pursuing indications for prurigo nodularis and hidradenitis, that's number one. As it relates to Niktimvo, had an excellent first year. It's annualizing at over $200 million. We penetrated roughly 20% of the third-line plus population. So there's still a lot of headroom. I think one of the most important facts about the launch is that the persistency rate with Niktimvo is between 60% and 70%. That is patients who started at the beginning of the launch for the year and are still on therapy at the end of the year, and what that equates to is compounding revenue. We're pursuing combinations of Niktimvo with steroids and ruxolitinib, which could 2x the addressable population for Niktimvo, important product. We have an excellent partnership with Syndax. As it relates to Monjuvi, we released data in frontline DLBCL last week and presented it. We just released it last week. This is a very positive large Phase III trial in DLBCL. There were clear improvements in PFS, EFS in a high-risk population defined by IPI 3 to 5, and in patients with complex biology. Not a winner-take-all market. It's not a battle between Monjuvi and Polivy in my opinion. 50% of the market is still in R-CHOP. So Monjuvi plus lenalidomide represents an intensification strategy versus a substitution strategy with Polivy. The point is that this will sustain the growth of Monjuvi. Over the next five years, we now have not just a: two-indication drug, relapsed and refractory and follicular, but also frontline DLBCL. And we'll be sharing more information about Monjuvi including activity in various subgroups. Now this is a snapshot of our pipeline. And there are five points I'll make here. The first one is, these seven assets form three franchises: hematology, oncology and immunology, number one. Second, what you see here are novel and/or first-in-class agents. That is there are no me-toos or late entrants. Third, six of the seven programs are in Phase III, and the majority of these programs were homegrown. Fourth, this pipeline has the potential to achieve top-tier growth, net peak sales opportunity of north of $10 billion. Naturally, that is not a hard target. It's indicative of the substrate in the pipeline. Well, of course, refine our view of the potential of this pipeline as more information is collected on each asset as we derisk it, it becomes less opaque and more transparent. And then lastly, each one of these assets has strong IP and an exclusivity period that extends to the end of the next decade or the beginning of the following one. This is our MPN portfolio. We're developing three targeted therapies you can read from left to right that shut down the driver mutation and don't just manage the disease, but modify the disease. So if you think about MF, PV and ET, standard of care treatments, Jakafi, hydroxyurea and interferon. They block pathways. They manage symptoms, they're blunt instruments, very different in what you see other areas of oncology. In other areas of oncology, immunotherapy, precision medicine and targeted therapies are the standard of care, not the case here with MPNs. We have an opportunity to trigger a changing of the guard in the treatment of these blood cancers. In 2027, we'll provide an update on 784, which is our T cell engager. In the second half of '26, we'll provide more information about our 617F small molecule. Right now, I want to focus on 989 and give you an update of what's happened since the ASH meeting about 30 days ago. To remind you, this is an all-comer strategy, type 1, non-type 1, front line, second line, mono and cabo, at least as it relates to myelofibrosis. I'll move from left to right on this slide, you have important updates. First, we'll have a meeting with the FDA this quarter, and we expect to gain alignment on our program in terms of endpoints, dose and design. By the middle of 2026, we'll start a second-line study in ET, and we'll provide updated data from the ongoing Phase I program. So that's ET. In MF, in the middle of 2026, we expect to have alignment with the regulators on a second line study in MF, and we'll share updated data from our ongoing Phase I second-line MF cohort. Then in the second half of 2026, we expect to start second-line MF study as well as provide data from the Phase I cohort examining 989 and 989 ruxolitinib frontline MF. And then finally, we gained agreement about a week ago with the FDA on a subcu development program for 989. A couple of comments about ET. The practice-changing thesis or the blockbuster thesis on 989, I think is predicated on two things. First, on the left, high clinical and molecular response rates, relative to the standard of care, which is HU. and then on the right, a large chronic underserved market. And I think the best way to think about the ET market is to stratify it. So we have 20,000 patients in the United States with a CALR mutation ET. That excludes the watch and wait group. 50% of them achieve only a suboptimal response, not because hydroxyurea is not an effective cytoreductive agent, it is. But most patients can't reach a therapeutic dose due to side effects. Ask any hematologist, and there is a therapeutic squeeze with hydroxyurea. Now our partial response means residual symptoms, residual thrombotic risk and the potential risk of transformation, although it is low. That is one sort of segment. 25% of patients with hydroxyurea or with ET a resistant hydroxyurea. An HU resistance is an independent negative prognostic indicator for survival. 989 has the potential to reshape the use even with second-line data of the use of hydroxyurea and becoming standard of care. MF shares the same biology as ET, but it's more complex, more aggressive and linked with shorter survival. We shared data at the ASH meeting this year, second-line MF, what I would describe on the left is first-line efficacy in a second-line study. If you look at the right, there are roughly 10,000 patients in the United States with a CALR mutation and MF. As remarkable and as important as Jakafi is, it's essentially a quality of life drug, but only 30%, 40% of people achieved an SVR35. At diagnosis, about 1/3 of people are anemic and after treatment, that number almost doubles. And probably the most important point on this chart is that 20% of people are at risk for transformation to AML. So the potential for 989 in both ET and MF is significant. Our strategy in oncology right now is threefold. First, we focus on novel biologic targets and pathways. So think TGF-beta by PD-1, G12D, CDK2. High-incidence cancers that miss the IO revolution, colorectal cancer, pancreatic cancer and ovarian cancer. And we're developing treatments that can be used frontline in combination with standard of care chemo, which can have the most immediate medical impact and commercial impact for Incyte. We're running four Phase III trials across these compounds. I'm going to focus on G12D and provide you with an update there. This was long considered as many people in this room know the Everest of oncology, considered an undruggable target. Today, it's probably one of the most scientifically compelling targets in oncology, and Incyte has a credible path having the first selective G12D inhibitor for pancreatic cancer. Standard of care has been chemo for decades. There are no targeted therapies, as you know. The 5-year survival rate is quite low. 734 is a highly selective G12D inhibitor. We ran a large Phase I trial of approximately 300 patients, including 200 in PDAC. This weekend, we presented data at ASCO GI, and there is an update on our monotherapy arm, 1,200 milligrams daily. The objective response rate was 37%. The disease control rate was 78%. There are very few discontinuations or dose reductions due to side effects. And the swimmer plot in terms of durability of benefit is very, very encouraging. We also shared data on 734 in combination with both standard of care chemo regimens, GEMNab and FOLFIRINOX. We have a manageable safety profile without compromising dose intensity. We are starting a Phase III program in frontline PDAC in first quarter, very encouraged by what's happened with this compound over the past year. Turning to povorcitinib. We're developing it for hidradenitis, vitiligo and prurigo nodularis. It could be the first oral JAK inhibitor for HS. It will open up a large market in vitiligo that is patients with a BSA involvement of greater than 5%, which is a market we can't get to with Opzelura, practically speaking. And it could be the first and only JAK inhibitor in prurigo nodularis. The NDA for povorcitinib is expected to go in the first quarter of 2026, we expect to launch at the end of '26 early 2027. We'll have data from our vitiligo and prurigo nodularis programs in the second half of 2026. A couple of comments about povorcitinib. I think the HS market is primed, not only for povorcitinib, but for an oral anti-inflammatory that has biologic efficacy. And there are other JAK inhibitors out there. I don't think it's a fight to the death, winner take-all market either. Hydradenitis is one of the most challenging dermatological conditions that you can have. Pain is the defining symptom. Today, if you think about what is available to dermatologists and patients, you have an antibiotic on one side, which does very little for inflammation, and you have an IL-17 on the other side, which is effective, but works about half the time. JAK inhibitor like povorcitinib is a multi-cytokine inhibitor. And in HS, that matters. This is very different than IL-23-mediated psoriasis or IL-4/13-mediated atopic dermatitis advantage. We achieved clearance rates in the 50% to 60% range by week 24. That's as good as a biologic. Pain relief in 60% to 70% of people by week 2024, most of that relief comes in the first three weeks. We have an opportunity to capture patients at two inflection points, after antibiotic were prebiologic and post biologics. We have a path to replace Jakafi and set a new high watermark. And these are three strategic priorities that we're focused on in running the company, build the core business, advance the pipeline and use business development to strengthen and extend the core. Thank you very much.

Jessica Fye

Analysts
#3

Great. Thanks for the presentation. And as a reminder, if you've got questions in the audience, you can internet me over the iPad or just raise your hand, someone will bring you the mic. So you spent a lot of time kind of outlining the plan to address the Jakafi LOE. Can you double-click a little bit on how you're going to balance managing expenses during that kind of LOE period called the trough period, how you balance that with kind of investing to support growth as you come out the other side?

William Meury

Executives
#4

Yes, it's a good question. We will get leverage out of this business over time. Right now, we're solving for -- what we're solving for is the steepest possible growth curve post 2029 that we can create. We approach budgeting and allocating operating expenses in a very sort of bottoms-up way. And our first call on capital right now is that core business. So that business is as big as Jakafi when we hit 2029. And then the second call on capital are the R&D programs. And we're not -- as I mentioned, we're not spreading our bets everywhere. We're focused on seven compounds that some of them are calculated risks, but that we think can create outsized returns. And we will manage our margins between now and then, but what we want to solve for is not the next three years, we may trade a little bit of margin, a little bit of R&D burn, so that we can create a glide path to growth. But I will tell you, the company will be disciplined in terms of how we're managing OpEx. Our G&A in 2026 will be down 5% to 10%. Sales and marketing, growth, operating expense growth will be managed. Of course, in R&D, our operating expenses there will be up north of 10%.

Jessica Fye

Analysts
#5

A question in the audience?

Unknown Analyst

Analysts
#6

Yes. I'm Martin [ Versace, ] I'm a biotech entrepreneur, but I'm here because I'm also patient in PV taking Jakafi. And I just wanted to share that I had to get Jakafi prescribed in Europe because at MSK in New York and Cornell in New York, they wouldn't prescribe it to me, because they said I didn't meet all the criteria of PV, and they said -- like I saw them very resistant to prescribing a medication that for the last two years has been the best thing that ever happened to me. I mean it's -- compared to all the other alternatives is -- I mean, I'm better than I ever was. I don't know what it does, but not only controlling the hematocrit, but it seems to be very good for the immune system and anything else. Why are doctors resistant, and I can give you names, Dr. Rampal, [ Robos, ] reluctant to prescribe it, saying that I didn't fill all the criteria of PV. When in Europe, they just gave it to me.

William Meury

Executives
#7

Well, first of all, if you give me the name of the physician, I will go visit that physician. Pablo, do you want to take that?

Pablo Cagnoni

Executives
#8

Look, I think that when you look at the trajectory of Jakafi and PV over the past 10 years since initial approval, I mean, it's been the fastest-growing segment of the market. So it's unfortunate to hear that some physicians is still resistant. And I don't know the specifics of the case. But the adoption of Jakafi in PV in the U.S. has been excellent across the board. Sometimes, I think the same physicians are more conservative about when they initiate Jakafi versus other interventions like phlebotomy and other things. But I think in general, we're quite happy the way the community -- and 2 years ago, 2.5 years ago, we presented the magic PV data that basically show that there's an improvement in thrombosis free survival in patients with polycythemia vera that take Jakafi. I think that has really led to an inflection point in adoption. So maybe your experience precedes the availability of that data and maybe that explains why those particular physicians were too conservative.

Jessica Fye

Analysts
#9

So turning to the pipeline, 989 got a lot of focus last year. Thinking about frontline MS, what would you need to see in the data to justify moving into frontline?

William Meury

Executives
#10

In our frontline Phase I results?

Jessica Fye

Analysts
#11

Yes.

William Meury

Executives
#12

You're going to want to -- well, in a monotherapy scenario, you're going to want to see the SVR35 at a clinically meaningful level, nice improvements in TSS50. We expect to see continued anemia response. So if you can replicate what we've observed in that Phase II, or excuse me, in that Phase I trial, second-line patients, we'll have to talk to the FDA about a path for generating a frontline indication, but I think all the information is there. Obviously, in combination, you're going to have to see additive benefit in terms of 35 -- SVR35 symptoms, and we'll see how the anemia response looks. And we'll learn more when we get the Phase I data in the second half of '26. Pablo?

Pablo Cagnoni

Executives
#13

I think Bill made the comment during his remarks that what we've seen so far, just to remind everyone, is basically first-line efficacy in second line patients. When you look at the results we presented at ASH in terms of SVR35, TSS50, they're comparable with historical benchmarks for Jakafi in first-line patients with MF. So that's really a really good start. The additional thing we've seen, there are two additional things are: number one is anemia improvement. 56% of the patients have improvement in hemoglobin, which is very, very meaningful in this population. And the final piece is that the safety profile is a lot more benign than Jakafi. As good as Jakafi is, and we just heard a testimony, it's -- CALR has been -- 989 has been extremely well tolerated. So other question in first line is, is it going to be a single agent, or is it going to be a combination. We're doing both. As you know, we're randomizing patients through 989 versus 989 plus Jakafi in previous untreated MF. Once we have that data, we'll make that decision. It could very well be a three-arm study, with Jakafi as a control and two other arms running combination with one single agent. And the endpoint is something we'll need to discuss with FDA. I think I'm particularly excited about the data in terms of anemia improvement and maybe bringing the FDA forward to say that maybe that is a more relevant endpoint for patients with MF, perhaps in symptoms. So we'll see how we balance those things once we have more data.

William Meury

Executives
#14

We're committed to developing this front line, but we need data. An important point, 60% to 70% of patients on Jakafi ultimately end up on the second line of progress. So even the second-line data, whether it's in ET or in MF and this is not meant to lower expectations, is going to have an immediate impact, one in the hematology community and then in terms of what 989 can mean to Incyte when we launch it.

Unknown Analyst

Analysts
#15

I have a question. As you think about core business pipeline, capital allocation strategically on a high level, how do you think about China as a competitor and partner?

William Meury

Executives
#16

It's, one, a source of innovation for sure, and it can also be a partner. I think it's exactly what you said. Today, obviously, we're 90% U.S. We have an emerging business in Europe. I would expect over the next couple of years, not only our presence, but our work in China is going to continue to expand.

Jessica Fye

Analysts
#17

So coming back to 989, how should we think about the time lines for second-line development in MF and also ET?

Pablo Cagnoni

Executives
#18

So the -- we presented the updated data in ET at ASH, and I think it was a very compelling data set in terms of complete hematologic response and the molecular impact of 989 in terms of reducing the size of the malignant clone in patient. So we're really, really excited about that data. And as Bill mentioned in his remarks, we are in the process of -- we're going to meet with FDA this quarter to finalize -- fully aligned on the regulatory path in second-line ET, and we expect in the first half of the year to initiate the Phase III in second-line ET. So that's already moving forward in a way. In second-line MF, we're finalizing some of the data that we need for optimizing the dose in patients with second-line MF. We obviously present the data as well at ASH, which we thought was very impressive in terms of SVR35, TSS50 anemia and molecular responses, particularly when you think about the reduction of the size of malignant clone in the bone marrow and in peripheral blood. So with that data, as it continues to evolve, we will accelerate that in the second half of the year, and we expect to start a pivotal trial in second-line MF patients in the second half of 2026. So those two studies will start this year.

Jessica Fye

Analysts
#19

And when do they end?

Pablo Cagnoni

Executives
#20

Let's get them started, and then we'll give you more clarity on when. But -- and the reason -- I'm not -- regarding your question, but the reason -- one of the key questions for that is particularly in ET is whether we align with the FDA on the timing for the primary endpoint, which traditionally has been 52 weeks. We think we have a good argument based on the responses we've seen on normalization of platelets, which happened very fast with 989 to have an endpoint at 24 weeks, which we believe is more meaningful in terms of accelerating time to market. Once we have the full alignment with FDA, we'll talk a little bit more about the timelines for approval.

William Meury

Executives
#21

Jess, one thing I would add, and we're pretty modest about the accuracy of our future predictions. But if you look at the pipeline, G12D, CDK2, the additional indications for Niktimvo, which I think are important and 989, I'll just focus on those four, all have the potential to launch between 2027 and around [ 2023. ] Time is of the essence here. And obviously, 989 is one of the more appealing pipeline assets that we have. This is a giant execution test, but all of these Phase III studies are going to start in the next 6 to 9 months.

Jessica Fye

Analysts
#22

And what about your JAK2V617F inhibitor. You talked about like a new solid dispersion formulation to address previous exposure issues. So what's the status there?

Pablo Cagnoni

Executives
#23

So we have the formulation. It's been testing on healthy volunteers, and that's going to enter the clinic this quarter. So that's why our guidance at second half of this year, we'll have data -- clinical data from the small molecule V617F inhibitor. I think it's important to remind everyone where that program is at, we escalated the dose over the course of 2025. We realized that we would not hit the exposures that we needed, we would not hit [ IC-35, ] which is what we predicted we needed to have a clinical impact in these patients. So to be clear, the hypothesis that inhibit and cytokines of V617F, we believe it's intact that if you inhibit that target, you will have clinical efficacy in patients with MPN. So we expect to have that data to confirm the hypothesis in the second half of '26.

Jessica Fye

Analysts
#24

And assuming the kind of exposure challenge has been addressed, what's the kind of target product profile you're seeking for that product?

Pablo Cagnoni

Executives
#25

I think it's pretty traditional what we've done in other -- with other medicines in MF and PV in this case. This is an important component of potentially for patients with polycythemia vera, which is improvement in the classic end points. That's what we need to see. We need to see improvement in SVR35, TSS50, hematocrit increases in PV, was basically the same thing. By blocking this target, we expect we're going to have, not only the impact on the clinical symptoms, but also impact the molecular endpoints like we saw with 989.

William Meury

Executives
#26

And Pablo just comment on the mutation frequency for 617 relative to CALR.

Pablo Cagnoni

Executives
#27

So the really important part there is, thank you for reminder, is in PV, 90% of the patients have V617 mutated. So that is a really, really large segment of the population. In MF, that segment is about 60% or so of the patients. So it's the majority of the patients have V617 mutations. Just to remind everyone, between 617F and CALR, you basically cover with one or the other, and they're mutually exclusive about 90% of all the patients with ET and MF and PV.

William Meury

Executives
#28

There is potentially a Gleevec moment with 989. Now we have a lot more work to do, and we have to convert Phase I information to Phase III. But if you think it took a decade for there to be appreciation in the hematology community that Gleevec was disease modifying. It was originally thought to be a glorified hydroxyurea that debt with blood counts. That's changed a lot. Now that's a fairly high bar, you got half to that concept, this is going to be a very meaningful product.

Jessica Fye

Analysts
#29

Okay. And then you talked about for Opzelura, the AD opportunity in Europe from like a volume perspective. What about price? How confident are you in the kind of being able to preserve price as you move into that space?

William Meury

Executives
#30

Yes, it's a good question. In -- most of our business for Opzelura in vitiligo is in France, Germany and Italy. And the prices there are 50% of what they are in the United States. In Germany, however, the price is much closer to the U.S. market, a big part of the growth of Opzelura in AD in Europe will come from Germany. And the way to think about is Opzelura becomes essentially a step ahead of Dupixent. There's -- that is a stopping point before going to an IL-13. I think the best benchmark is at current pricing with vitiligo, which is small. As a market in terms of prevalence, this business was $150 million just under. And so even it's 5x at a lower price, the ex U.S. business for Opzelura could be a $300 million incremental sales opportunity for Opzelura we think about the next five years.

Jessica Fye

Analysts
#31

So I guess when you talk about the core business, which are these kind of like approved non-Jakafi products, but not the kind of development stage products. Where do you think the -- there's the biggest disconnect between like where you see street numbers, and where you think those products are going?

William Meury

Executives
#32

Well, I think if you look at the historical rates on Opzelura, I mean, that business is growing at a 20%, 25% clip. I mean this year will be up over 30%. Niktimvo, obviously is in its first year, and new product launches are unpredictable. It had a very good first year, and there's still a lot of headroom there given the penetration of the third line plus market and as I mentioned, persistency. I think as we continue to progress into 2026. I think you probably see those numbers continue to be refined. And then Monjuvi, that's $200 million, $250 million product right now, I think that frontline DLBCL study, it's not about how it compares to Polivy. DLBCL is a heterogeneous cancer. R-CHOP is still standard of care, and we have solid data in terms of PFS and EFS, like I said, we'll go into the subgroup activity in the second half of the year. That's clearly not incorporated in any estimates for on Monjuvi. And you have a three-indication lymphoma treatment. There's value there.

Jessica Fye

Analysts
#33

Great. All right. So we're out of time. So thank you.

Pablo Cagnoni

Executives
#34

Thank you.

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