Good morning, and welcome to day two of the Bank of America London Healthcare Conference. I'm Dan Lundquist, the US Healthcare Specialist. I'm very pleased today to have the management of Incyte with me here on stage to kick us off. We have Hervé Hoppenot, chairman and CEO, as well as Christiana Stamoulis, the Chief Financial Officer. I will join them over here on the far side. Just to kick us off, Hervé, maybe just kind of give us an update on, you know, this year, how things have gone, and maybe anything you'd like to give an update on.
Okay. Yeah. Thank you. So this year, I mean, it's obviously a year where we continue on two things. I mean, it's growth and diversification on the commercial side and obviously with the pipeline. So on the growth side, I mean, the Q2 results were, in fact, very strong in terms of top-line growth, both on Jakafi and on the rest of the portfolio. The Jakafi number is showing that that franchise in each of the three indications continues to grow very well. The other products are mostly oncology products that are launching in Europe now with Pemazyre and Monjuvi, and doing well. I mean, it's a slow process because you go through the reimbursement cycle, but it's progressing very well.
More importantly, obviously, Opzelura in the US, where we are now a few months into the launch in vitiligo, and we see that the potential there is very large, and the adoption is doing well. So it's a big step for Incyte in the fact that we are now establishing this dermatology franchise commercially, very successfully. So that's great. And then you have obviously a number of pipeline products that are progressing. I cannot go through the whole list, but in Q2, we spoke specifically about two pivotal study now being positive, leading to a new indication for Opzelura in pediatric eczema, and that's very important in term of commercial potential.
A new product, axatilimab, for chronic GVHD, where we showed for the first time results that are certainly leading to understanding that it's very efficacious and very well tolerated, and it has a very unique mechanism of action, and we believe it will be a good, very good addition to ruxolitinib in chronic GVHD. So it's time where now things are clicking, very well, both on commercial and pipeline. And obviously, I mean, there are a lot of moving parts, so we can go through some of them, but it's a very good, very positive time for Incyte.
Excellent. Thank you. And we definitely will drill down on a number of those pipeline updates. But let's first start with Jakafi. You know, you raised the bottom end of guidance during Q2 earnings, so signaling confidence in the overall numbers. Just kind of walk us through, you know, what the big drivers of that have been, what underpins a lot of the confidence, in terms of, you know, how you've thought about 2023.
Yeah, absolutely. So the growth in Jakafi and the reason why we updated the guidance, we raised the bottom end of the guidance, is because of the growth that we've seen in we've seen in the first two quarters of the year, which are is driven primarily by patient demand. So when you look at the guidance that we have now, the... It implies a 7%-9% year-over-year growth or $170 million-$220 million in incremental revenue compared to 2022. And this is the level of incremental revenue that we've been seeing in the last few years. So very much in line with the work that. It is driven primarily, as I said, by patient demand, and we see demand growth across all indications, MF, PV, and GVHD.
So we feel very good about the guidance and what we're seeing in the Jakafi franchise.
And can you walk us through current market share in myelofibrosis and PV, and where you think the growth will come from for the next 2-3 years?
So the growth will come from all three indication. In fact, it's GVHD, PV, and MF. So current share of patient is around 40%-45% for MF. It's around 35%, maybe for PV, and 17%-20% for GVHD. So growth is coming. The fastest growing has been in the past two years, GVHD, because of the launch in chronic, and is now, I think, PV, that we are seeing growing at a faster rate than the other indications. So you can imagine the ratios are going to evolve, and we think PV will become the main indication in the next few years. You know, our long-term guidance is north of $3 billion. We are $2.6 billion ± for this year. So we are very much on a track to get there, to exceed it, in fact.
And we think it will come from each of the three indications. An important aspect of the US reimbursement system and the IRA and the way it's going to impact us is that it will be positive for Jakafi, in the sense that reducing the copay has, in fact, a disproportionate impact on a product like Jakafi for Medicare patients, which are most of the patients, obviously, with myelofibrosis and many of the patients with PV. So we see that as a positive, you know, in the next few years. And it's a brand that is very established and is the standard of care for each of the indication where it's approved. So it's progressing with the market.
... So there's an upcoming PDUFA for a competitive product in myelofibrosis. How do you think the market will evolve over the coming years with momelotinib, if it gets approved, and what sort of impact do you see to Jakafi?
So the impact on Jakafi overall, you can imagine, is going to be very impossible to see in so many ways, because we are speaking of a share of what's 40% of the total in the, in the MF, in the MF, franchise. The new patients is a small part of the total, so the, the pool is higher than the flow, obviously, very much. And, so I don't think, I mean, from the, the Jakafi growth over the next year, it's not, it's not something that will be very, very visible. I mean, the product, it's not the first. I mean, we have a number of other drugs that have been approved, in, in MF. Jakafi is very strongly established as a standard of care.
It has a survival benefit, so patients, you know, denying Jakafi to them is a big step, and it has shown to have this survival benefit in all subgroups of patients, including anemic patients, which is one of the subject with momelotinib. So momelotinib was studied after Jakafi in patients who would not benefit anymore from Jakafi, and I think that would be very useful, in fact, to the growth of the overall franchise. Because we still see today that there are a number of patients who are on the, or in a wait-and-see kind of mode in MF because of the lack of good second-line treatment. So having a new second-line treatment would be very beneficial somewhere.
Great. Maybe shifting to one of the, you know, newer indications, where we've had a lot of success, GVHD. Can you help frame the overall GVHD market opportunity, where you think ultimately that 17%-20% market share could get to?
It's not a market share. 17-20 is the share of Jakafi used in GVHD.
Right. Okay.
So the market share is more or less 28,000 patients. Fourteen thousand of them are eligible for Jakafi, and out of this, probably half of them would be on ruxolitinib. So patient share that is currently, it's an estimate with all the caveats in the world, but we think it's around that number. So we have growth there that is possible. There is also growth coming from the duration of treatment, so that's the two components. And obviously, now we have axatilimab that's going to be hopefully available in the next few years, and that will be adding what is, in fact, a very unique mechanism of action. It's macrophage-directed, which is obviously more of a disease-modifying effect that you can expect.
We think between RUX and axatilimab, there is a lot of optionalities we can play with, not only with the sequence, but also obviously potentially using them in combination in earlier stage of the disease. So we see GVHD first as a great story, a great success story for Incyte. It's an indication that nobody had ever pursued before us, and where we have created this entire new standard of care, new practice of medicine, and now we are coming with additional new mechanisms that will be very helpful for these patients.
Great. Maybe shifting for potential next steps for ruxolitinib XR following the CRL, maybe kind of walk us through what your thought process is there.
So that's a disappointing story, to say the least. It was... You know, the way you show bioequivalence for twice a day versus a once a day versus a twice a day is something that is well established. And in this case, FDA is worried that difference in Cmin is in fact potentially, or the impact it could have on the overall profile of the product. So that came to us, not... It's not the usual way to look at it, but it is what we have to deal with. So we are doing two things.
One is basically data-driven, so it's really submitting new data that will be showing that, in fact, in the range of Cmin that we are seeing, the chance that it will have an impact on the efficacy profile of ruxolitinib is not there. So that's sort of trying to show that the current formulation is, in fact, doing what we think it should do. I would give it a low probability of success, frankly, but we think it's important to see if we can go through that route.
The other way, which is longer term, it will take more than two years, is to resubmit with a new, new formulation that will have, in fact, a slightly different dose of ruxolitinib in it, so that the Cmin bioequivalence can be established, as well as maintaining the AUC bioequivalence that we have with the formulation. So that's where we are on this. Two potential outcome. One would be relatively quick, but low probability. One would be very high probability, because we know we can do it, but it will take time because you need the stability and all the other aspect of getting it resubmitted to FDA.
Okay. Thank you very much. Let's shift a little bit to the BET and the ALK2 programs. Maybe kind of talk about what we should be expecting in terms of additional updates in the second half, and then how we think about further development of Rux combos with, you know, those assets, and what the potential opportunity in each of those, for each of those combinations could be.
Okay. No, I mean, the studies are ongoing. There are studies that are establishing the dose and the profile of RUX in combination with BET, RUX in combination with ALK2, and you should expect to see an update on these studies with more patients, higher dose. We are still in dose escalation on ALK2, and we are more on dose optimization with BET. So, that's what you can expect. Next year will be the year where we will be initiating the studies that potentially would be the pivotal studies. So that's an important step, and obviously we are taking our time to get the dose right. I mean, it's an important, very important moment in the life of this type of project. So the two of them are very different.
So BET is obviously a simple story of saying you can add to efficacy of Jakafi, and by doing that, you add to the side effect in some way, and is a balance of the two, some things that you can that can benefit patients with myelofibrosis. You know, there is a BET inhibitor that is ahead of us, that is going to show some data by the end of the year, from a MorphoSys and in the first line setting. And we are looking at different options. Obviously, we'll be learning a lot from what we see there. There are two aspects to this increase in efficacy.
One is the spleen size, which I think is relatively straightforward, and the other one is more complex with the symptom scale, where it is in fact tricky to improve it by adding new mechanisms that have potentially new side effects. So that's where we are with the BET project. You can imagine, you know, pivotal study starting next year would lead us to a new product that could be available two to three years after that. So ALK2 is completely different. It's really a mechanism that is helping maintain the dose intensity of Jakafi, and that's something that we believe can be very important in terms of outcome for patients. So there we are in the mode of, like, preventing anemia that would be dose-limiting for ruxolitinib.
We are, as I said, still in dose escalation because we have a lot of very, very clean safety profile, and we don't want to give up any kind of efficacy in the process. So we continue to dose escalate, and the goal would be to combine it with Jakafi in certain types of patient or line of therapies that have not yet been established. But that's what we are working on now.
Great. Maybe shifting from Jakafi over to Opzelura. Gross-to-net has been a big focus for investors. It was 60% in 1Q, 55% in 2Q. Are you still, still expecting that to be 50% on average for the year? And how should we think about those dynamics moving forward, both more near term and long term?
Gross-to-net, as you indicated, came down to 55% in the second quarter from 60% in Q1. What we saw in both quarters was Medicaid as a percent of total revenues or scripts increase. That increase is baked into the gross-to-net number that I indicated. But it does play a role as to how gross-to-net may evolve going forward. We see a path to getting lower than 55%, but that would very much depend on how Medicaid will continue to evolve through the rest of the year. Part of the impact has come from basically two states, California and New York. There have been specific events in each of those states that have driven that demand.
In the case of California, it was a change in the legislation that allowed for undocumented residents to get under Medicaid, and that created a big increase in Medicaid utilization across the board, not just for Opzelura. And in the case of New York, it was more specific to Opzelura. Opzelura was added to the preferred drug list. So going forward, it depends on how Medicaid rules may change, whether they are now going through a reevaluation of patients to see whether they are still eligible for Medicaid. Other states may put Opzelura on the preferred drug list. So all this could play a role in impacting the share of Medicaid as percent of total and as a result of gross-to-net.
We are comfortable with the 55%, and then the rest, if there is further improvement, will depend on the Medicaid side.
Understood. That helps answer one of my next questions.
But it's important to remember that the access part of Opzelura over the past two years has been extremely successful. And because I know everybody has been, like, looking at this number, like 51, 52. So no, it's, it's all, you know, happening depending on many things that are well beyond our own control. But we are in a zone, which is the one that we indicated from the beginning of saying: "You know, you have to see it will be somewhere around 50% in terms of gross-to-net," and the access to Opzelura is, in fact, excellent. And the feedback we get now from doctors is that it is easy to prescribe because they know that most of the insurance companies, 80+% now of the insurance company are listing Opzelura on their, on their formularies.
So it's a, it's a... which is not the case of all products in the field. I mean, as you know, it's a field where there are a lot of access issues, and I think we have been very, very successful in getting Opzelura in there.
Maybe kind of looking across the two indications. So how would you phrase and characterize, you know, how the launch is progressing in atopic dermatitis and vitiligo relative to your internal expectations? And then kind of any thoughts about, you know, how you expect that to trend, you know, over, say, the next couple of years?
... So, I mean, they are two very different indication. Eczema is a place where patients have been treated with multiple things, sometimes for decades, and where the and their eczema is still not controlled. And when they are prescribed Opzelura, it is frankly, and we have that feedback from across many, many patients. It is a completely new era for them because suddenly they have a topical treatment they can use, and 80%+ of them will never go to any other treatment. I mean, it is full control of eczema for many of the patients and very quick onset on the itch in minutes. We are not speaking about hours or days anymore and, and that's something that is very unique, and what we think is that it will continue to grow. We are accumulating patients, obviously, who have now experience with Opzelura.
Some days they may have a flare or recurrence of their eczema, and they know how to deal with it. So that's sort of accumulating these patients with a disease that has an acute need. You need to treat when you have an event. Vitiligo is completely different. Vitiligo, there has never been any product approved for vitiligo patients. It's a disease where, again, many of these patients have suffered from for years and years without having any possibility to really repigment the skin in a way that would be visible and, and quick, and we are now providing that to them. So patients are going through the motion of going back to their dermatologist, which is not always easy, in fact, so that's one of the aspect.
And then deciding to get on Opzelura, and that's a process that takes some time. But where we see the uptake, when you look at the curve of Opzelura prescription over the past few months, I mean, since the vitiligo has been adding to atopic dermatitis, it has accelerated. So we see that process starting, not only starting, but now taking a lot of momentum. And that's a different momentum because obviously, the number of tubes and refills that you get for vitiligo is very different from what you get in the case of atopic dermatitis. So there are two trends in the curve. One is AD growing steadily, and then you have vitiligo adding to that and accelerating with the refills starting to kick in in the past few months.
So that ended up being a little bit of a leading question to what I was going to ask now, in terms of just what the biggest growth drivers of, of Opzelura growth are in 2023, and kind of how the momentum of that sets you up well for clearly 2024, but years in the-
No, the momentum is fantastic. I mean, it's really growing very well on in both indications with two different profiles. So it's like, it's almost like two different products in some ways that are being established, and in both feedback from physicians and patients are incredibly positive because in atopic derm, it's very acute. Immediately you can see the effect. In vitiligo, when patients are using the cream over a period of time, it takes weeks, but then you start seeing the repigmentation. And frankly, for patients with vitiligo, it's very motivating to see the repigmentation process being induced by Opzelura. It's a life-changing product for patients with vitiligo.
So, one of the things you'd mentioned previously is getting patients with vitiligo to get into the dermatologist and-
Mm-hmm
... you know, start to seek treatment. You said in the past, only 10% of those patients actually do seek treatment.
Mm-hmm.
Are you seeing an uptick? I mean, you, you mentioned it, but what do you think is driving that uptick in patients seeking treatment? What is your plan to reach out to the remaining portion of the patients, really building that market, given you are the first and only approved drug in that setting?
Oh, it's a big, it's a big story. In the community of patients with vitiligo, it's a big story. And you can go to any website, any place where patients are seeking information about potential treatment for vitiligo, and the number one—by far, the number one thing that the people have is Opzelura is a new option, FDA-approved only for the first time, et cetera. I mean, it is, it is something that is very noisy in the field of a vitiligo patient, so that's one of the key driver. We know now. I mean, it was a few months ago, but at the time already, we had, like, one in five patients going to see their dermatologist asking for Opzelura. So they just go there to get an Opzelura prescription.
So on top of it, you have obviously the medical community is very motivated because it's sort of a new era for them. After having to tell patients, "You know, it's a, an autoimmune problem, we really don't have anything that can, has been proven to work." Now they have an option, and we... You know, it's a dialogue that has changed completely because the question becomes like, "Why not?" Instead of, "There is nothing we can do," and it's a, it's a big, it's a big step. Now, the speed at which it's happening is sometimes I mean, we are like everybody is sort of wishing it would go faster. It's very much in line with the expectation because we know the flow of new patients to a dermatologist is something that is slow by nature, just because the making an appointment is not easy.
It takes time. I know it sounds weird, but it takes a lot of time to get an appointment to a dermatologist, so.
Yeah, you see that across all physicians these days. I think about trying to make appointments for my kids and taking months and months. Can you maybe discuss your plans related to DTC marketing to help expand that patient pool? I think, you know, broader awareness of the disease certainly will help identify and expand that patient pool.
I think vitiligo as a disease, the awareness of vitiligo has exploded in the past years. Interestingly, I'm not saying we were the source of all of that noise, but we did. In fact, we were. But the fact that there is a new treatment, and it's something we have seen many, many times, when a new treatment become available, there is obviously a noise, a share of noise that is increasing. And vitiligo has been in the news in many countries all around the world in the past few months because of Opzelura becoming the first approved product. So it's, it's an... There is beyond the DTC advertising we do in the U.S. In fact, in Europe, if you look at the TV coverage of vitiligo stories recently, it has been very, very high.
And all of them end up with a discussion about Opzelura and the approval of Opzelura. So it's, it is there. The DTC itself we have in the U.S. is working very well. I don't know if you have seen it, but it's, it's really establishing this idea that now you can. I mean, it's something that is a choice for patients to decide to repigment, and go into this journey, which takes time. I mean, so it's not a short one, but over a period of a year, most of the patients will end up with a very deep and, visible repigmentation of the skin, and that's something that they need to, to decide to do. And what we see is that it is the case for most of the patients.
So you've touched on compliance in a couple of the comments earlier. You mentioned, you know, 80% of patients on AD drugs will stay on that drug. Maybe just kind of talk about, you know, how you're thinking about compliance for each indication, estimated average annual tubes per patient use for each indication. Just-
Mm.
Any numbers around, you know, what I'm assuming is fairly high compliance rates.
It is so completely different for the two indications. The clinical trial experience we have is not very good at predicting what the commercial compliance will be, because in the study, patients are asked to do certain things, like, you know, eight weeks to go to the endpoint twice a day, and you sort of tend to have a better compliance in clinical trials. We are learning on the commercial side, how it's evolving. We said, like two to three tubes per patient per year in eczema. We are in fact crossing the two, so we are in two to three, now, closer to two tube. We are two point, you know, zero something. That's where, that's where we think it's going to stabilize, and part of it is the speed of relief.
So there is a tendency for patients to take less cream after a few days because they already have a reduction of inflammation and complete reduction of itch for many of them. So we see that. So two is probably a good way to calibrate what will be happening in eczema. Maybe a little more, but not very much. In vitiligo, we spoke in the U.S. about 10 tubes per year, so a little bit less than a tube per month, depending on the size of the areas that you are treating. We are not there yet, but we are... It has been progressing very much, so we need a little bit more time. But we stick with that number because we think it's probably feasible.
Just kind of thinking about patient and physician experience, have you had any pushback on usage given the label, black box warning, anything along those lines?
I think, I mean, dermatologists are using a lot of products that have a black box. The case of Opzelura having a black box is a subject of a lot of debate in the dermatology community of saying, "Why?
Why?
The systemic absorption is very low, and so the understanding from the dermatologist community is very clear of saying, "There is no reason to be worried about side effect of Opzelura when we know that the systemic exposure is very low." In Europe, there is no black box at all. In fact, it's the safety of Opzelura in the European label is, there is one line: It's an acne-like irritation of the skin. So that's where we are. On the patient, it could have an impact, and people are reading the label, obviously, are asking questions. Physicians are willing to respond, and we don't think it has been, you know, having a huge impact, but it could have some level of impact.
Okay, fair enough. Mentioned Europe. How are you thinking about the opportunity in Europe following the recent EC approval? How is this market different? And what are your expectations for the launch?
So the launch is taking place in Germany. It's always the same sequence in Europe, where you have to go through the reimbursement system, and it takes years. So that makes it a big difference with the U.S. So we are in Germany. We are now submitting dossier in many countries. It's an indicator. We started with vitiligo in Europe, so the. We don't have the same sequence. And it is a disease where nothing has ever been approved. So we have to build the value dossier, as we call it, and we expect to have good interaction with the healthcare provider. Our view is that the suffering of patients in vitiligo, the impact it has on the life of patients with vitiligo, and that's something we have been learning about over the past year, is in fact incredible.
We are speaking of people who have a social life, which, in not all cases, but in many cases, is very seriously impacted by their vitiligo. There are a number of ways we are trying to quantify that to, you know, explain that. In fact, treating these patients, repigmenting the skin, is something that has a lot of value for, for society, so.
Maybe on the other side of the indications you're in the US, can you maybe talk us through plans for Opzelura and atopic dermatitis in Europe?
... So the atopic dermatitis plan is being developed. We intend to get it approved in Europe. We need to prove that we can use it in a subpopulation, so that it will not be for all patients with eczema, because we know the pricing impact on the size of the target population will be, in fact, not favorable to the brand. So we are in that process of identifying the right patients that will be, in fact, where it's going to work very well, but it's also going to be restricted to a subpopulation. So that's what you can expect to see.
Okay. Thank you. Maybe moving on to the pipeline. We touched on it a little bit earlier, with AXA and GVHD, but you recently reported positive top-line data from the AGAVE-201 trial. Can you maybe discuss or build upon the earlier comments on just the overall market opportunity for AXA and where you stand in terms of BLA submission timelines?
So the BLA submission timeline is the end of the year, so that's should be happening. The data, as you have seen it, is very excellent in terms of efficacy. It's like 70%+ response rate. It has a very good safety profile, and it has a mechanism that is truly differentiated from all the other products. And the study we did was done in patients with a very advanced stage of the disease, way more than other products that have been developed in the same type of indication of third line. In our case, it was fourth and fifth line in most of the patients. So it is a very, very good results. Establishing the brand in third line or after Jakafi, let's say, is certainly what we'll be looking for in the short term.
It has a good potential, as you have seen. I mean, I don't know if you have followed the growth of Rezurock, for example, in that indication, but it is a meaningful number of patients that could benefit there. And then obviously going to earlier stage of treatment, and as I said, we are not completely set yet on how to do it in combination with drugs or some other combination, but we are looking at both, and that's what you can expect. So submission in December, so approval next year, let's say. And then we have the new earlier line of therapies that we will be implementing also sometime next year.
Great. How are you thinking about positioning for povo in indications like HS compared to other assets in your pipeline?
So in HS, we have two studies that are ongoing. One is with povo, so it's basically the severe, you know, moderate and severe patients. Its positioning is very high level of efficacy. I don't know if you saw the phase II data that we have published, but it is certainly at the top of the response that you can expect or that you see in this disease. And it's an oral product. It has a mechanism that is, in fact, very well suited for HS. And HS, we think, is underdiagnosed today and certainly underreported. So the whole incidence of HS question, you know, there are a number of companies that... It's funny, I mean, nobody was working in HS two years ago, and now we have a number of companies going there.
A lot of biologics, and that's one field, you know, where there is a question of injectable and biologics and how they will compete with each other. We will be on the oral side with a broader mechanism, by definition, because JAK inhibition is a, you know, multiple cytokine impacted, and we think it has a good, it has a very good profile. We need to see the phase III. In parallel, we are doing a study with RUX cream, so in phase II now, where we are looking at the less severe patients, so mild patients, and that could be a franchise for us, where we have basically a topical for mild to moderate and systemic for moderate to severe.
Great. Maybe, just quickly, a couple more in here, as I survey the room. What updates can we expect from the oral PD-L1 program, in solid tumors in 2023? And maybe kind of just, thoughts on just oncology in your pipeline there.
So oncology is, I mean, obviously, we spoke a little bit about some of the project we have in myelofibrosis, so ALK2 and BET and QD for RUX. We have CALR, which is a totally new target in the MF and ET. It's a very interesting target. It was a plenary session at ASH when we did based on the preclinical profile of the product. So we are now doing the clinical studies, and we will see. I mean, that one could be potentially very quick in some way because if it works as we expect from the preclinical profile, it will be, you know, disease-modifying and very visible very quickly. So that's a CALR project. We have the oral PD-1 that is well advanced, so we are doing two things.
One is single agent development, where we are basically benchmarking in indication where Keytruda or Opdivo or other of the systemic, of the antibodies are used. So that is called the benchmarking program, where we go to this indication and try to demonstrate that using an oral PD-1, like 280, in our portfolio. We have two of them in development, 318 and 280. So we are basically trying to show you get the same efficacy as what you would see with an IV antibody. And we are also in parallel, developing 280 in combination with a number of product. I mean, the beauty of our oral PD-L1 program is the switch off.
That, in fact, it has a short half-life, and the mechanism is such. It's dimerization, internalization of the receptor. It is such that if you stop taking the product, the effect of the product goes away very quickly, which you cannot do with an antibody, obviously. And in combination with CTLA-4, in combination with KRAS, in combination with axitinib for VEGF inhibitor for kidney cancer, we think this ability to, you know, change the side effect profile of the combination could be, in fact, very beneficial. So we are doing the study with CTLA-4, axitinib, and, and KRAS from Mirati, and we are doing some other, some other combination on top of that. So you should see some of this data, I guess, next year. Maybe not before the end of the year, but somewhere in the next year.
That will be important because it could lead to the next step, which will be the pivotal study.
Great.
It's a very exciting project, by the way. It's, something that I know is difficult to just quantify in some way, but it is, it is a fascinating, potential for an oral PD-L1 with a short half-life.
Excellent. Maybe we'll go to Sandeep with a question.
Hi. Can you talk about how the vitiligo market will evolve? How you think it's gonna evolve over the next few years? Do you think... Do you see other mechanisms of action coming in? Do you see potentially other players, or do you have other mechanisms that you think might work? Or is it enough for the topical JAK, the way the current formulation is to kind of meet the needs, and you're getting enough of a response in that population? Or do you see other mechanisms that may be needed for the non- either non-responders, or are there, you know, breakthroughs? Thank you.
So the cream is the topical form of JAK, is for patients who have a smallish, smaller type of size of vitiligo. You cannot use the cream if you have a vitiligo that is extended to your entire body. So we are doing a study. In fact, this data will be available soon, or is it available already?
Phase III. It's phase III.
So phase III is starting now. So we have the phase II data, that is, there for a systemic JAK. So you can imagine on the JAK. So JAK mechanism is very powerful in vitiligo. And so the question is the administration. Systemic, you could use an oral drug. On more localized type of vitiligo, like we approved today, you do it with a topical. So I think that will, that will stay like the two types of vitiligo. And you can imagine that the earlier it is diagnosed, the less extended it is, and therefore, using a topical form could become the main way to do it. If you assume that everybody gets treatment very quickly, which may be the case in the future. We are speaking of millions of people, right? It's not a small number of patients.
And then you have the speed of repigmentation, which is something that you can improve on, obviously, and there is a question on how you can do that. We are looking, obviously, at new mechanism. We are now in the clinic with an IL-15 beta receptor antibodies. That is, in fact, we hope going to be a very good complement to using a JAK inhibitor, systemic or cream for the JAK, where you could use it maybe with an IL-15 beta receptor antagonist, which is targeting the type of T cells that we believe are the source of the disease. They are basically resident T cells that are, you know, leading to this depigmentation at the local level, under the skin, literally. And so we are working on many different ways to approach vitiligo.
Our view is that it is a very problematic disease for patients. For many patients. You know, it's never for everybody, but most of the patients are, in fact, suffering deeply from their vitiligo, the you know, the appearance, et cetera. In many communities around the world, it’s a very serious problem for—in terms of social life, and we think ultimately we want to be—obviously, we are the leader, we are the first, we are the only one today, but we want to continue on this to become the company that has made vitiligo very treatable in a practical way in the future. So yeah, we anticipate new mechanism to be developed. We have already now three programs in vitiligo, RUX cream, Povo, and our IL-15 beta receptor antagonist.
So it's an important program for us, and it's a large number of patients, and it's a large medical need.
Excellent. Well, Hervé, Christiana, thank you very much. And we will be following your progress closely. Thank you.
Thank you.
Thank you.