Incyte at Goldman Sachs Conference: Growth Beyond Jakafi

On Monday, 09 June 2025, Incyte Corporation (NASDAQ:INCY) presented at the Goldman Sachs 46th Annual Global Healthcare Conference, outlining its strategic vision beyond 2029. The company addressed the impending loss of exclusivity for Jakafi, its flagship product, while emphasizing its expanding pipeline and anticipated revenue growth from new product launches. Despite challenges, Incyte remains focused on diversifying its portfolio and capitalizing on emerging opportunities.

Key Takeaways

• Incyte plans to launch four new products or indications in 2024, aiming for an additional $1 billion in revenue by 2029.
• Jakafi’s Q1 2024 performance showed a 24% year-over-year growth, with future growth expected to be demand-driven.
• Opselura is projected to generate $650 million in 2024, with potential approval for pediatric atopic dermatitis.
• The mutant CALAR program, particularly INCB989, shows promise in treating myeloproliferative neoplasms.
• Incyte’s capital allocation prioritizes its pipeline, with potential for strategic acquisitions.

Financial Results

Jakafi:

• Experienced 24% year-over-year growth in Q1 2024.
• Growth driven by demand (10%), net price (7%), and reduced destocking (7%).
• 2025 guidance projects a 7% year-over-year growth at the midpoint.

Opselura:

• 2024 revenue guidance set at $650 million, reflecting a 28% increase.
• Pediatric atopic dermatitis (AD) could represent 10-15% of the overall AD market.

Other Products:

• Oncology assets expected to contribute over $400 million in 2024.
• New products anticipated to add $1 billion by 2029.

Operational Updates

Commercial Portfolio:

• Incyte is expanding its portfolio beyond Jakafi with four product launches planned for 2024.

Pipeline Progress:

• Four programs are advancing with Phase III data, and seven with proof-of-concept readouts.

Mutant CALAR Program:

• Initial Phase I data for INCB989 is promising, with full data expected.
• Combination with Jakafi is key for myelofibrosis (MF) treatment.

V617F Program:

• Data anticipated later this year, targeting a specific JAK2 inhibitor.

Opselura:

• Potential U.S. approval for pediatric AD in the second half of the year.

POVO:

• Phase III data in hidradenitis suppurativa (HS); FDA application expected in early 2026.

CDK2 Program:

• Shows a 30% response rate in ovarian cancer, with plans for accelerated approval.

KRAS G12D Program:

• Data expected later this year.

Future Outlook

Revenue Growth:

• Growth in 2024 driven by Jakafi demand.
• New products expected to compensate for Jakafi’s loss of exclusivity.

New Product Launches:

• Four launches in 2024 to contribute significantly by 2029.
• More than ten high-impact launches expected between 2026 and 2030.

Capital Allocation:

• Focus on internal pipeline, with opportunistic acquisitions of early-stage technologies.

Q&A Highlights

Mutant CALAR Program:

• Aims to address 35,000-40,000 patients in essential thrombocythemia (ET) across the U.S. and Europe.

Opselura:

• Pediatric AD offers significant potential, with 2 million children in the U.S. as potential beneficiaries.

POVO:

• Estimated 30,000 candidates in the moderate to severe HS population.

Jakafi:

• Benefits from Part D redesign reflected in Q1 results.

Incyte’s strategic focus on pipeline advancement and diversification positions the company for growth despite the challenges of Jakafi’s exclusivity loss. For further details, refer to the full transcript below.

Full transcript - Goldman Sachs 46th Annual Global Healthcare Conference:

Cristiana S, Incyte: The time of the LOE to fill in the gap and continue to drive growth beyond 2020 time. So when you look starting with our commercial portfolio, we have been expanding the commercial portfolio. Already you see we have a significant base that we have been building beyond Jakafi. So ObsElura, for example, it’s set at midpoint of the guidance that we have provided to contribute €650,000,000 in revenues this year. And with significant growth left in the program, We have a portfolio of their oncology assets that are set to contribute over €400,000,000 this year, again with significant growth.

So you see just between those two components, we have over $1,000,000,000 in revenue this year coming from products outside Jakafi and with significant growth, as I said, left in those programs. We have four expected product launches, new product or indication launches this year to already are happening to come. And we’ve said that we expect from those another $1,000,000,000 in contribution by 2029. So you can see the base that we are building without any further risk associated development risk associated, which will be playing out between now and 2019. And then we have the pipeline, which is expected to contribute as we have indicated 10 plus high impact launches between ’twenty six and 2030 that is going to play the role that we have that I’ve said of filling the gap and continuing to drive the growth beyond 2019.

This is a very important year for Insight because we are going to be turning the cart and have already started doing so on a number of programs. We have four programs with Phase III data, already three of those readouts have happened with the fourth to come and seven programs and by the way among those is POVO for HS. And POVO is expected to be a very significant program for INSIGHT and a program that we are developing across a number of indications. So we are already very pleased to see the HS data and additional readouts from Phase III studies to come next year. And then we have seven proof of concept readouts for programs that have significant potential as well.

Newton Keller is one of them that we’re very excited about. We will be presenting data in ET on Sunday. And that’s another program with significant revenue potential we are also developing in MS. So we are making great progress towards that goal and we believe that we are well positioned to address the LOE.

Unidentified speaker: Great. Maybe starting here with mutant KALAR. So we saw initial Phase I data in the abstracts, but the full data is going to be presented coming up. Maybe walk us through what the high level takeaway is from this update and how it informs your developmental strategy in both ET and MS.

Pablo, Incyte: So we think the data set that we put together, the abstract, are a really, really important piece of data for the program for Incyte and for patients with MPN overall. Because I think it confirms three things that are really critical that we talked about for the past year and a half in hypothetical terms and all three have turned out to be true. The first one was that a mutant caller antibody because of the specificity of this specific antibody that targets a neoepitope would fundamentally be well tolerated by patients. And I think that’s clearly demonstrated by the abstract. Forty one patients were enrolled at a range of doses, median exposure is about twenty weeks and only one of the forty patients had to discontinue treatment.

So that in a phase one study that tells you a lot about the tolerability of intervention. The second point was that we predicted that by shutting down the malignant clone and sparing the benign cells, the wild type cells, this would lead to a correction in the manifestations of the disease. And what we showed in the abstract is the platelet counts come down but importantly they normalize which is different from reduction. You can reduce platelets with a number of interventions. You have to constantly adjust the dose so you don’t go too low.

What we saw here in the curve is that platelets come down to the normal level and then without those adjustments they stay there through the follow-up that we’ve shown in the answer. That’s a really important principle. And the third was that we expected that there would be a certain level, and early evidence is beyond my expectations at least, there would be a certain level of reduction of the allele burden By targeting the malignant clones specifically the mutant cholera positive TPO receptor positive cells there will be a reduction in the variable fraction of the AF which we showed as well in the abstract. So in a way we have established a very, very important principle that a mutant cholera antibody, nine eighty nine as we call it, is well tolerated at the doses and for the length of duration given. Number two, that it can improve or normalize some of the manifestations of the disease in ET.

And number three, that reduces the presence of the malignant clone. So that’s ET data which is what we’re focused on now and we’re going to talk about more next Sunday. But whatever your preconception is about MF, I think your view of MF as an opportunity should be improved after the ET data that we put out. And the reason is it’s the same molecular mechanism. It’s the fact that the mutant color protein by complexing with the T4 receptor basically is an oncogenic signal that leads to proliferation of abnormal clonal cells, which is a different lineage in AT than in MF but it’s the same principle.

We’ll have MF data later this year. What we’ve said several times was that we want to have the combination with Jakafi before we talk about MF because we believe that is a key element of the development plan. As we all know Jakafi and first line MF improves survival and so to develop a new intervention in MF without having that combination data for us is premature. Once we have that data later this year we’ll talk about MF.

Unidentified speaker: And is the combination approach versus a monotherapy approach primarily driven by positioning? Or is there the titration aspect or some other aspect that you need to manage with regard to

Pablo, Incyte: No, honestly, look, there’s a development path in MF that is single agent as well potentially, which is in patients that either are intolerant or fail Jakafi. We’re not ruling that out. But before we have the whole picture and we talk about this externally, we want to have more data with the combination. And as in any phase one trial, first you escalate a single agent and then you incorporate the combinations of the combination data is lagging a little bit behind which is why we’ll have it later this year.

Unidentified speaker: Can you also speak to your confidence on the V617F program where we’ll see data later this year? And then you know what’s the opportunity here?

Pablo, Incyte: Doctor. Correct. So they look I remain confident in that program. The principle which we established preclinically and we’ve showed a couple of times including ASH twenty twenty three is once again the other big driver mutation in MPMs as you know, right? It’s almost all the patients with PV and a good percentage of patients with MFNET.

So but the principle there is that by binding everybody knows that Jakafi is a dual JAK1, JAK2 inhibitor, so less selective there but it’s also less selective or very low selective between wild type and mutated JAK2. By developing a six seventeen inhibitor which is a specific JH2 inhibitor we think we can deal with that lack of selectivity and potentially lead to similar effects in terms of reducing the malignant clone. The window that we’ve shown is a little bit tighter and we’ve shown that preclinically. But we think that with the right formulation we can hit that window and lead to the same type of effects. And we’ll have data later this year.

That study, if you all remember, the first part of the phase one study was in healthy volunteers in order to understand the formulation that we needed to advance. So that’s why that is behind the CALLAR program in terms of generating data in patients.

Unidentified speaker: Fast forward, say, your positive data in hand for M. CALAR and six seventeen F. How much of Jakafi have you offset through these two programs?

Pablo, Incyte: I mean, can Christiana can talk about revenue potential. I can tell you when you just look at let’s start with CALAR because we put data out. Okay? And so I think that’s a little bit easier to talk about already. So it’s about one hundred thousand patients with ET in The U.

S. Twenty Five Percent of them are called are positive. Of those, probably about a third to a quarter are indolent enough that they can be managed with either observation or maybe aspirin. About two thirds to three quarters require an intervention. Currently those interventions are suboptimal.

And we’ll talk about this with KOLs next weekend. But clearly a lot of patients become intolerant to refractory to hydroxyurea, which is a first line cytoreductive therapy and other therapies after that. So it’s about eighteen thousand patients that potentially are the target population in The U. S, the same number give or take in Europe. So Europe between thirty five thousand and forty thousand patients are at least in principle are the addressable population for the color antibody in ET.

It’s an important metric to know that at Jakafi in The U. S. Today there are about twenty eight thousand patients on treatment in PV, MF and GVHD. So in a way that gives you an idea that just KALAR and obviously a different price point for biologic that launches in the next few years. So I think the opportunity in ET alone is huge.

I don’t know if Cristina you want to go beyond that in MF and

Cristiana S, Incyte: Well everything then becomes additive. You have MF and then you have six seventeen F that would address MF and PV. So you can see how as we have said in the past, we expect that we will be able not only if successful to replace Jakafi, but grow significantly beyond. We will be addressing MSSPV and then we will expanding into ET that as described, it’s a very big opportunity, bigger than what we have in Jakafi alone today.

Unidentified speaker: Touching on Jakafi, so you reported a really nice first quarter and you raised 2025 guidance to about 7% year over year growth at the midpoint. Just walk us through the key underlying dynamics for the remainder of 2025, including how we should think about Part D redesign in the second half?

Cristiana S, Incyte: Yes. So Q1 was a very strong quarter. Jakafi grew 24% year over year. There were three components to this growth. It was demand 10%, seven % was coming from net price where the Part D redesign drove that effect and then another 7% came from less destocking that we saw this year versus in Q1 of twenty four.

Going forward, we expect the growth for the remaining of the year to be driven exclusively by demand. You won’t expect to see that jump that you saw between Q1 and Q2 in prior quarters coming from net price impact. And the reason is partly redesigned. Partly redesigned, if you recall in the prior years, Q1 was always affected by the fact that for Medicare Part D we were covering the doughnut hole and that impact was reflected primarily in Q1. This year under the Part D redesign, there is no longer the donut hole, but there is participation in the initial and catastrophic phases at 10% for the year for this first year.

However, Jakafi has qualified for the small biotech exception and as part of this, we are participating only at 1% of the initial and catastrophic phases this year. So this provided a big benefit relative to the donut hole coverage that we’ve had in the prior years. And that’s the benefit that you saw reflected in the net price in the Q1 of this year. Again, this benefit is really reflected in Q1 versus Q1 of the prior quarters. So when you look at subsequent quarters, you should expect net price to be pretty stable.

There would be still some benefit from the impact of commercial deductibles reset, which impacts Q1 that you won’t see in the subsequent quarters, but that benefit would be outweighed by the 340B growth that we expect. So expect the net price to be pretty stable with really the growth to be driven by demand.

Unidentified speaker: Sticking with the commercial business here, what are your expectations for Opsalura through the rest of the year and as we look longer term in terms of the sales trajectory?

Cristiana S, Incyte: So we provided guidance for Opsalura for this year. At the midpoint of the guidance, it’s $650,000,000 reflecting around 28% growth year over year. We see growth coming both from The U. S. And Europe.

In The U. S, we continue to see growth in both AD and vitiligo. And in Europe, growth driven by the continuing gap take in the countries where we have already commercialized OPSELURA for Vitiligo and the additional contribution coming from the new markets like Italy and Spain that are contributing in a more significant way this year. And we expect this to continue going forward. In addition, in the second half of the year, we expect in The U.

S. The potential approval of Opsilura for pediatric AD. That would be another contributor to revenue. We see pediatric AD as a significant opportunity as you have two million children with mild to moderate AD that are still on corticosteroids. So there is an opportunity there for Opsalura and especially given that itch is a very big problem and itch reduction is a big characteristic and differentiator for Opselura.

So that’s another opportunity to expand the use of Opselura. And then beyond AD and vitiligo, we see opportunity for Opselura to play a big role in other diseases where each is an important characteristic. Again, the rapid ish reduction is very important here. So diseases like HSN PN, where we are developing currently OPSELURA could add to the overall opportunity. NHS, when you look at mild to moderate, it’s at around one hundred and fifty thousand patients in The U.

S. PN, perigonodularis is another two hundred thousand patients. So there are significant opportunities to continue to grow OPSELURA.

Unidentified speaker: And maybe touch on the expansion into the pediatric population and how big an opportunity that represents.

Cristiana S, Incyte: So it’s at around two million children between the age of two and 11 in The US. As I said, a big share of those children still use corticosteroids, TCIs, so there would be a need for a product like OPSELURA, especially given the each reduction. We expect over time in the long run pediatric AD to represent at around ten percent to fifteen percent of the overall opportunity for OXELURA in atopic dermatitis. And that’s very much in line with other products in those indications.

Unidentified speaker: And how is compliance playing out in vitiligo?

Cristiana S, Incyte: So vitiligo compliance has been an area where we have been working on because patients need first of all to stay on therapy for a longer period of time in order to see the results that we were able to demonstrate in the clinical studies. And they need to use the cream appropriately, apply twice a day and for that longer period of time. And we’ve seen that patients don’t necessarily comply with the appropriate use and a big part has to do with lack of information, education. And so there are a number of initiatives that we are currently pursuing to educate both the prescribers and the patients around the importance of staying on therapy and using the cream as they are supposed to use it. We are already seeing some benefits.

The benefits translate into metrics. The one has to do with how many patients go beyond the first script. So we’ve seen that forty percent plus patients were only getting one script and then weren’t refilling their prescriptions. So we are seeing now this number coming down, which means they are using it more and they have the need to go back and get another script, another refill. And the second is what is the average number of refills a patient makes in one year on therapy.

And that’s a number that is still all over the place. You have patients with a couple of tubes a year and you have patients with 10 tubes a year. So what we are trying to do again through the various initiatives and increase education is get patients on using ObsEleura appropriately and see the number of tubes per patient start on average coming up.

Unidentified speaker: Pivoting over to POVO here, so the base three POVO data in HS fell short of expectations but the efficacy looked better in the biologics experience patients. Maybe walk us through how you’re thinking about the commercial strategy in light of this data and what the ultimate opportunity is.

Pablo, Incyte: Yeah, would challenge that fell short of expectations. Let’s just set things let’s agree where we are here. First of all, we had two positive Phase III trials. Both hit the primary endpoint for both those levels. And that’s important.

It was twelve week data as opposed to some of the other data that is being compared against, which tends to be week 16 data. So that needs to be kept in mind. There was an artificial threshold set out there. We don’t know where that came from. But from our perspective we have a new medicine for HS with two positive phase three trials.

And importantly aside from primary endpoint there was a very important we replicated the impact on pain improvement that we had from phase two, which we think is very important. Pain is the number one symptom in patients with HS. Obviously the lesions are very bothersome for this patient for a long list of reasons. But pain is a very important symptom. And pain improvement on povo we believe remains at least for orals best in class.

So that’s where we are. In addition to that we showed eighteen week data which all the caveats and the fact that it’s open label data. When you look at the placebo patients that crossover we doubled the number of responders, not the percentage because the denominator changes, but the number of responders doubles in six weeks only when they switch from placebo to PUBLON. So overall we’re very happy with the data. And as you point out Salveen, the data in biologic exposed patients looks even better with a 15 to 20 percentage point placebo adjusted rates of high score.

So as we see BOVO eventually coming to the market either late twenty six, early ’20 ’7, as we submit the application of FDA later this year, probably early twenty six, We believe there’s a couple of different groups of patients, pools of patients available at the time of launch. And that’s an important thing. A new patient is ready at the time of launch. And there’s a group of patients that probably prefer strongly an oral over an injectable. In our discussions with KOLs and others that percentage is about ten to fifteen percent of patients and probably presents about 3,000 patients ready to go when pov is launched that are waiting for an oral option.

Then you have a group of patients that are already biologic experienced at the time of launch. And those patients that have received an anti TNF and or an anti IL-seventeen are ready for a new mechanism. We think that pool of patients is ready for POVO. In addition to a group of patients for which perhaps POVO because of pain improvement or others is competitive as well. When you put all that group of patients together, it’s about 30,000 patients that are good candidates for Pogo, which we think is a very substantial commercial opportunity.

I think it’s important to remember that HS, the treatment flow here, patients won’t disappear, This is a chronic disease, unfortunately not curable. Patients were cycled through different mechanisms. And our prediction is that they will cycle different mechanisms. They will not repeat the same mechanism over and over. So you’ll have biologics anti TNF, biologics anti IL-seventeen and then we’ll have an oral JAK1 inhibitor.

We think that based on phase two to phase two data we have so far in HS the best in class JAK1 inhibitor. Obviously the RINVOQ data will come next year and we’ll see what it looks like. But at least particularly when you look at pain, phase two to phase two data, our pain data are significant, far superior to our competitors. So in summary, we think we have potentially a best in class oral JAK1 inhibitor for HS. We think we have important segments of the HS moderate to severe population where POVO will compete very well if not be better than biologics.

And we think that creates a very significant commercial opportunity in HS alone. And then all the other indications that we’ve talked about PN, vitiligo, We have proof of concept now in CSU as well. And we’ll have asthma proof of concept later this year.

Unidentified speaker: Pablo, when you look across your pipeline right now, what are you most excited about?

Pablo, Incyte: Look, I’m excited about the overall pipeline in the sense that we have a very well diversified by mechanism, by therapeutic carrier, by modality pipeline across the board. We have some bispecifics. We have some traditional biologics. We have T cell engagers. We have obviously small molecules.

And we have topicals still developing rux cream in other indications. And I think that provides a really important de risking across a range of potential therapeutic areas and indications. Honestly, think it’s hard not to be excited about the COLOR data. I mean we put it out just a few days ago. We’re going to talk more about on Sunday.

I think it’s the type of data that really it’s not just that I believe it’s positive data at this stage of development. It’s the type of data that potentially redefines how you treat a group of malignancies. And I think that is rare in drug development. We designed a drug to do specifically this, to suppress the malignant clone in myeloproliferative neoplasms. And it turns out based on the early data that does exactly that.

That doesn’t exist today for these patients. We think this will continue to change the goal of therapy in patients with MPNs from simply correcting the counts and improving the symptoms to doing that but also to potentially have a path to a potential cure in these patients. And I think that is honestly a rare privilege in drug development. So it’s hard not to be excited about that.

Unidentified speaker: And when could we get next updates across your CDK2 and KRAS G12D as well as Essient programs?

Pablo, Incyte: Yeah, look we’re going to have additional updates later this year. So the CDK2 program we updated it at ASCO. We are staying at about a thirty percent response rate with good durability and those responses are over between four and five months. So we’re happy with the data. We’re pushing as fast as possible to an accelerated approval in platinum resistant ovarian cancer.

In parallel with that we’re launching randomized trials in platinum resistant and we’re finishing the work in combination with bevacizumab for platinum sensitive disease. We think this is going to be an important new medicine for patients with ovarian cancer. We realize our competitive platinum resistant setting is but we think that’s why we need to establish this new medicine over time in platinum sensitive disease. It’s oral, it’s well tolerated, minimal dose adjustments in the phase one study. We think that it could play a very important role in platinum sensitive disease.

KRAS E2L disease is a very competitive space as you all know. Based on our preclinical profile we think we have a competitor. We’ll have data later this year. We should talk about it with that data out. We think there’s still a path to compete in pancreatic cancer.

We obviously need to see what that data looks like, how it stacks with RevMed and others. But we think potentially if we have the right single agent activity together with combinability with chemotherapy, we think there is a path to compete in pancreatic cancer still.

Unidentified speaker: Great. Maybe a last question here on capital allocation. So you’ve noted that you continue to monitor opportunities but are unlikely to do any major deals given the catalyst passed this year. How should we think about scenarios here and could this change on the forward?

Cristiana S, Incyte: So the priority continues to be the pipeline. You see how much we have going on with seven proof of concept readouts this year. You could see at least a subset of those programs moving into pivotal trials. So we have a lot already going on in the pipeline and that’s the priority. Over time, we will be looking at the pipeline, the drivers, our financial profile and decide whether we want to supplement our internal activities.

But right now the priority is the internal portfolio. We have the financial flexibility opportunistically to look at bringing in assets from the outside. But given how much we have going on at the later stage, the focus is more on the early stage technologies, capabilities that would help with the discovery efforts in the early part of the pipeline or if we were to find commercial near commercial assets that would add to revenues without significantly adding to revenue at least to R and D burn at least for a long period of time is something that we’ll consider as well. But again, the priority is the internal pipeline.

Unidentified speaker: Great. Well, with that Cristiano and Pablo, thank you so much.

Pablo, Incyte: Thank you. Thanks everyone.

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