Incyte Corporation (INCY) Earnings Call Transcript & Summary

January 6, 2022

NASDAQ US Health Care Biotechnology conference_presentation 41 min

Earnings Call Speaker Segments

Salveen Richter

analyst
#1

Good afternoon, everyone, and thank you for joining us for the Goldman Sachs CEO Unscripted Conference. We're really pleased to have Herve Hoppenot, Chairman, President and CEO of Incyte. Thank you, Herve, for joining us. Happy New Year.

Herve Hoppenot

executive
#2

Thank you for inviting me.

Salveen Richter

analyst
#3

Thank you. And as we start or stand today -- as you stand today, sorry, with Jakafi, Pemazyre and Monjuvi and recently approved Opzelura and the current pipeline, what is your outlook on the overall business and where you must focus in 2022?

Herve Hoppenot

executive
#4

Salveen, thanks for the invitation. So 2022 is very simple. In fact, in many ways, it's about growth of revenue, and we have obviously Jakafi that is growing in its old indication, but we have a new indication for Jakafi. We just got it in the chronic GVHD. We have the launch of Opzelura, RUX cream in the U.S., and it's a big event for the corporation, because it's a new division. [indiscernible] that we are launching, and it's doing very well. And then in Europe, we are launching Monjuvi, and we are launching Pemazyre. So there is still in the U.S. also growth from many of these products. So it's really from the revenue standpoint, about the launches that we have ongoing and making them very successful. On the pipeline, it's obviously on the short-term new indication, it's all about vitiligo and Opzelura getting approval for vitiligo, the PDUFA date is in April. So that -- it will come relatively soon. And then on the pipeline, it's about progressing the key projects. So LIMBER is obviously very important. And then oral PD-L1, adenosine and we have a program with parsaclisib in autoimmune hemolytic anemia that is important. Now starting -- Phase III is ongoing and the number of dermatology projects in HS and also vitiligo with the systemic JAK 707. So that's the key thing for us. Growing the revenue, getting the launch in vitiligo, the approval obviously first on the launch in vitiligo and the few projects that are really the highlight of the pipeline moving quickly in 2022.

Salveen Richter

analyst
#5

And so what key event should be -- should we be watching these apart from the derm launches here?

Herve Hoppenot

executive
#6

So the derm launches are the key. I mean, that's something you have to keep an eye on it. And it's the first phase with atopic derm, the second one with vitiligo in the second half of the year. So that's a big thing, because there is so much upside that it's really something important for the company. And then we will have new data with our oral PD-L1 project. So that should be something very valuable. We have in the LIMBER program, the ALK2, which is a way to manage anemia potentially, if it does what it's supposed to do and that we will get information also during this year to tell us if it is happening as we hope or not. So that should be very important, in fact, for LIMBER, for Jakafi and the whole franchise. And as I said, we have 707 in HS and vitiligo, more extended type of disease compared to what we are doing with the cream and all of that should be also coming during the year.

Salveen Richter

analyst
#7

And what is your view right now on business development? Can you just talk about the considerations and the overall approach as well as current partnership that you have?

Herve Hoppenot

executive
#8

So the current partnerships are frankly helping a lot, because as you can see, I mean, we have a number of projects that are coming from some of the partnerships. The last one is axatilimab with Syndax for GVHD. It's a unique mechanism of action, interesting drug in third line. And obviously, for us, it's a very important product to combine with a JAK inhibitor in first line, so that where we are not with Jakafi today. We have the launch of Monjuvi, is doing well in Germany, where it's happening now in Europe. As we described it, in the U.S., it was a little bit of a slow curve in the middle of the dark days of COVID. I mean we had a number of explanation, but that's something we need to fix. We have a number of projects with Merus, our bispecific partner. So the partnerships are doing really well. We have a very positive cash flow as you know. We are accumulating cash. So the question is how do we use that cash in a way that we'll be adding to the growth curve and the diversification before 2028. It's sort of fairly simple. The problem is, as you know, in oncology, sometimes acquiring assets is disproportionately expensive compared to the value. Let's put it this way. So we have sort of -- we have been looking at opportunities that we decided not to pay at the same price that some others are paying. We are also interested in other type of hematology, noncancer type of hematology or now that the dermatology franchise is being established, we could certainly add assets in dermatology on the sort of the high science type of dermatology that would fit well with Opzelura. So that's what we are looking at. It's still the same spirit of trying to get growth and diversification in the therapeutic areas where we have a good infrastructure and capabilities today.

Salveen Richter

analyst
#9

And what do you think investors are underappreciating about the Incyte story right now?

Herve Hoppenot

executive
#10

I think the wait-and-see approach is clear about Opzelura. If you compare our internal plans, what we are trying to do to the way it is sort of looked at from the outside, it's clearly something. And then on the pipeline, and again, it's understandable, because it's a question of data. People want to see what it looks like. The oral PD-L1 is unique. It's first -- only in class. I don't know of any other of its kind being developed today, and it has a very large potential if it does what we hope it does, and we can speak about the data, but it seems to be going in the right direction. I think the ALK2 is misunderstood in the LIMBER program, because when you're able to avoid or reduce anemia significantly, anemia from MF, but it's also anemia from Jakafi. You can increase dose intensity of Jakafi, and it will have an efficacy impact, because we know that higher dose of Jakafi is more efficacious. So that's something that is not fully understood when we speak about it. And frankly, the adenosine program is something that's very exciting, because it has very broad application. We have a unique thing, which with the CD73 and the most potent A2A/A2B inhibitor small molecule and that is something that is fairly unique. It is in the clinic. We will have combination data by the end of this year. So it's something that could also be -- maybe more than what most people are expecting.

Salveen Richter

analyst
#11

So starting with Opzelura here. Could you just give us the latest update on the launch? The script trends look good here. How is uptick playing out in with physicians? What are you hearing from patients?

Herve Hoppenot

executive
#12

No, I think it's public knowledge, because everybody has access to the prescription. We have like -- if you take the first 10 weeks since the launch, there were more than 15,500 new patients treated with Opzelura, which is very much aligned or better than what we were planning for. So that's very, very good. It's also showing that the curve is really leading to our guidance. If you remember, we explained that we believe Opzelura could be around $1.5 billion in the U.S. alone. And when you sort of look at the way the curve is starting, we are very much aligned with that. So that's great. And frankly, the feedback is what's fueling the adoption is that we know from physicians that they see the Opzelura as being a safe way to use a JAK inhibitor. They see the effect of JAK inhibition on atopic dermatitis is very fast in term of itch, in terms of inflammation. And as we have seen in some of our data, there is a long-term effect that is literally disease control over -- for a very large number of patients, it was 80% in our study at -- looking at it at 1 year. Patients are also giving feedback to their physician, because many of them have been rotated between steroids and Eucrisa and the other things, Elidel, et cetera. And there is a feedback from the patients saying this is not the same game. I mean, this is doing something different. So all of that is contributing to what is now a very successful launch.

Salveen Richter

analyst
#13

And there was a product quality issue that you talked about that led to a suspension of a sample program. Has that been resolved? And has there been any impact here to commercial supply?

Herve Hoppenot

executive
#14

So yes, it was a texture issue from some crystallization of APIs that was seen in some isolated batches that we had included including the sample batches. So now we have implemented some process improvements already to prevent this crystal formation. We are manufacturing the batches, the commercial batches on a regular basis. So there is no supply for commercial issue. And we are planning to rerun the batch for the samples in the next few weeks and months, more or less. So that's the next -- that will be the next step. So as of today, it's something that has not been stopping the adoption of the drug and the availability of commercial product.

Salveen Richter

analyst
#15

And on the payor side, are you still expecting broad coverage in 1Q this year?

Herve Hoppenot

executive
#16

Yes, the discussions are ongoing. We have made a lot of progress. We have some smaller plans or regional plans where it has been already finalized. But for the 3 big plans, it's ongoing, literally as we speak. We are expecting -- so what we are expecting -- well, what you should be expecting in Q4 is that we have been distributing a lot of products that has been prescribed. And we have covered the cost of it, because it was blocked automatically. So the gross to net for Q4 will be a very large discount, because we wanted to do that. I think it's really helping the launch. In Q1, we expect to have the blocks removed. So that's where we will start seeing the actual gross to net that should be then the sort of standout happening in Q2. And then we will see the contribution at full speed in Q3 and Q4. I mean, if you think of how the next few quarters are going to be taking place, we are expecting the blocks to be removed and the formulary status to be stabilized before the end of Q1.

Salveen Richter

analyst
#17

And Herve, have you guided to what long-term gross to net should look like here?

Herve Hoppenot

executive
#18

Yes, what we have said is that we will be anticipating on the overall gross to net, which includes the different discounts that we are giving plus the copay cards, et cetera, that it will be somewhere -- and obviously, we cannot be very precise, but it will be somewhere between 25% and 50% from the gross price.

Salveen Richter

analyst
#19

And you talked about the acceptance of the sNDA for vitiligo with regulatory decisions in Europe and the U.S. this year. Could you walk us through -- clearly, the population is large, but can you remind us which patients you're targeting here and what the opportunity is in rest of world?

Herve Hoppenot

executive
#20

Okay. So let's speak about the U.S. first. I mean, we have benefited in April. We have done a study where it's basically patients who are 12 and older and have BSA, which is the extent of the disease, less than 10%. So that's the population. That population, we think is north of 1 million. There is 1.5 million patients suffering from vitiligo, maybe more, in fact. And out of these 1.5 million, 150,000 to 200,000 are seeking treatment. And the treatments they receive can be things like light therapy. Some of them are receiving topical creams of all kinds that have not very proven efficacy, but -- and some of them are using bleaching like discoloration or other ways to try to deal with vitiligo. So that's 150,000 to 200,000. Frankly, when we ask -- when we do reviews of -- chart reviews with dermatologists, the potential of -- I mean Opzelura will be the first ever product to have proven repigmentation ability. It's something that now has been established over a long period of time. It's like 1.5 years of treatment that can be necessary, but a lot of patients are willing to do that. So it's difficult to give you what the upside could look like. What we know is that if you take the number of tubes that we are using and the number of patients we are speaking about, every 10,000 patients would translate into north of $100 million of business, and we are speaking of hundreds of thousands in some way. So that's why there is a lot of -- when you think about upside that cannot be very well quantified. It's a case where it's -- we know the clinical data is very positive. We know the FDA is very interested, because they did meeting about the patient needs with vitiligo very recently. And the testimonies at that meeting were absolutely clear about how vitiligo can be destroying the life of some of these patients. Some people don't care literally, but for some people, it's a very serious issue. So that's the way we look at it. There's a lot of upside, very good overlap with our prescribing base for atopic derm. And so for the U.S., it's fairly simple. Outside of the U.S., in Europe, we will be launching ourselves or maybe with partners, but we'll be booking the revenues. And the submission is done and should be leading to a CHMP recommendation at the end of the year, let's say very December or very late in the year. And outside of U.S. and Europe, we'll be partnering, and we have a number of discussions ongoing.

Salveen Richter

analyst
#21

Can you just talk about what type of partners you're looking for ex U.S.?

Herve Hoppenot

executive
#22

Ex-Europe and ex-U.S., it will be in Asia. So you can imagine they are sort of established dermatology companies, medical dermatology companies that are very interested, because of the uniqueness of this. And in some countries, the vitiligo stigma is even more pronounced than what we have in Europe and U.S. So there is a lot of interest.

Salveen Richter

analyst
#23

And could you just talk about the next-generation approaches here that you're developing the -- you have a JAK1, I believe, in trials for vitiligo?

Herve Hoppenot

executive
#24

Yes, 707 is a systemic product. It's a pill. It's JAK1 selective inhibitor, and it will be studied in extended vitiligo for patients who have BSA that is, I think, in the protocol, it says more than 8%. So it's basically the other type of -- the other group of patients who -- for whom a cream is not appropriate, because you cannot use it on such a large area.

Salveen Richter

analyst
#25

And then moving over to Jakafi here. Do -- I guess, do new patient starts remain at pre-COVID levels? Are you seeing or anticipating any impact here from the Omicron wave?

Herve Hoppenot

executive
#26

So yes, we -- I mean, we went back in the last quarter of the year, so it was before Omicron. We went back to where we were in 2019. Now it's far less than where we would have been without all of this, because we still have a number of patients who are not visiting their physicians. I mean, I don't know if you hear that from other cancer companies, but there is a real situation where it's probably 10% to 20% depending on the disease of patients, who have not been seeing their doctor. So that's something we are also seeing. Omicron, I don't know. I mean it's sort of depressing because we have the feeling of going back 1 year. And so I -- hopefully, it's a short wave and -- But in general, what we have seen is the normalization back -- of normalization back to where we were in 2019. And the new patient flow for us is sort of difficult, because we have the chronic GVHD indications that came late in the year. So we have seen an uptick of new patient starts after the chronic GVHD approval. So it's sort of -- now it's difficult to compare to what it was in 2019. But in general, there is still an effect of the COVID situation, we believe it's real in terms of number of patients. And we are palliating that with new indications. So in some way, we are now crossing the level we had before the pandemic.

Salveen Richter

analyst
#27

And you talked about life cycle management being a key focus here, so the LIMBER program. Can you talk about these different approaches and where you see the greatest potential to extend the Jakafi franchise?

Herve Hoppenot

executive
#28

Yes. So if you put GVHD on the side for a minute because that's a separate program where we have a number of things ongoing with axatilimab. In MF, which is the largest indication for Jakafi, we are -- today, we are clearly looking at both improving efficacy and improving safety and by improving safety, as I said, it's a way to have also better efficacy. So what's happening today in MF is that there is a large proportion of patients, who are suboptimal responders, there are patients who are not progressing very well, but they are not responding very well. They still have a spleen that is enlarged, they still have symptoms. And that's a place where we have two approaches. One is PI3-kinase delta. So we have 2 Phase III studies with parsaclisib ongoing. One is first line. So that's basically saying, can you beat Jakafi in the first line. It's a very high bar, by the way. It's not an easy thing to do. And we have one that is far easier in terms of what we are trying to do, which is in suboptimal responders to Jakafi, can you do better than continuing Jakafi, which is obviously making the efficacy that you need from your additive product or addition of parsaclisib far less challenging than it is in the first line. So the Phase IIIs are ongoing. They are accruing. It's a difficult place to get the right patient, but it's now doing very well across the world, and that's the parsaclisib. And then we have a BET inhibitor. And as you know, there is company that has been developing a BET inhibitor earlier than us that -- but we are looking at the same type of mechanism and the same hypothesis. The beauty of what we do is that when we will have the once-a-day Jakafi, we will be able to do fixed dose combination with either parsaclisib or the BET inhibitor. And therefore, we'll have a fixed dose combination that obviously commercially will be very competitive, because nobody else can do it until 2028. So that's the efficacy. And then as I was speaking about it a little bit earlier, the ALK2 hypotheses is very interesting, because it's a hepcidin pathway. It is something that has been not proven, but looked at very carefully for momelotinib, which is another JAK inhibitor that had in fact, an impact on that same pathway and had a rate of anemia that was lower than maybe would be expected. And that's what we are trying to reconstruct with a separate, very potent specific ALK2 inhibitor combined with Jakafi. And we are now at a stage where we'll be starting combination in somewhere during 2022. We have done the dose escalation. The preclinical data is beautiful. And as I said, we need to demonstrate that we can change hemoglobin level while treated on Jakafi. And that, again, has a fixed dose combination with ruxolitinib would be a very interesting way to improve not only safety, but also efficacy. And that's what we are looking at is basically separate mechanisms that will add to Jakafi that we can put in a fixed dose combination in the next few years with the once-a-day formulation that we have already developed.

Salveen Richter

analyst
#29

And when could we get that? Just remind me, when do you think the extended formulation could get on to the market?

Herve Hoppenot

executive
#30

So the once-a-day submission should lead with -- to an approval beginning of next year, beginning of next year.

Salveen Richter

analyst
#31

And then just with the...

Herve Hoppenot

executive
#32

But the value of that is to have a once a day is better. I mean it's -- we all know it's sort of weak, but it's still good. And -- but the key thing is to be able to do fixed dose combinations that would be changing completely the entire perspective for the franchise.

Salveen Richter

analyst
#33

Got it. And then with some of the recent launches here with Pemazyre, could you just walk us through how that's progressing and how physician interest and adoption are playing out in terms of the metrics that you're monitoring?

Herve Hoppenot

executive
#34

So Pemazyre is approved in a small indication. We are speaking of hundreds of patients in some way. So we are in a small number. It has been doing very well. The sales in fact, were higher than we were expecting in that very small indication. And it's all coming from the best possible scenario is that the duration of treatment is far longer than we were expecting. So in fact, patients respond very well. Maybe the patients we had in the clinical trial were more refractory or something or physicians are using it earlier, but what we see is the longer duration of treatment. So it shows also the tolerability is very good. So that's for cholangiocarcinoma. We have a very small indication we will be submitting, which is a sort of a hematology of FGFR1, 8p11 type of MPN, but that does not matter very much. We are speaking about tens of patients here. And then we have now two programs: one in GBM and one in lung cancer where we are looking at the same hypothesis is that patient with a certain type of FGFR mutation and translocation would be benefiting from the treatment. We saw that from our agnostic studies that we did over the past 2 years. And now we have decided to zoom in GBM and the lung cancer. So it's a program that is clearly a very orphan disease, excellent for patients. I mean, we get more thank you notes about developing this for cholangiocarcinoma, than I have got for many of the other things. But at the same time, we think it can become something meaningful if we are able to add new indications beyond cholangiocarcinoma, and that's what we are working on. And even in cholangio alone, we -- I think I used the number $200 million as a sort of what it could be. And it is what it is, but it's contributing to, again, diversification and growth in a small way, but it's still contributing to it.

Salveen Richter

analyst
#35

Will we get any data from all these other indications this year?

Herve Hoppenot

executive
#36

I don't think so, because that studies that we're initiating. So it's always a question like, do you speak about responses in the first 5 patients in your study or not? We will probably wait to have a good number of patients, I guess.

Salveen Richter

analyst
#37

And then on Monjuvi, how is that progressing? I know it was off to a difficult start just because of COVID, but where does that stay in all that?

Herve Hoppenot

executive
#38

I mean in the second-line setting in DLBCL, it has this unique positioning. It's a non-chemo type of regimen. So the tolerability when you take lenalidomide and Monjuvi is excellent compared to what you would be able to do with alternative treatments. It has a great efficacy profile. You saw the long-term follow-up. The CR rate is like 40%. It's almost [indiscernible] like in somewhere. And so there is -- it's an excellent product. And the feedback we get is very consistent with that. What happened at the beginning is that a lot of the patients, who were treated were fourth and fifth line, which is not -- it's often the case when you launch a new product. And the duration of treatment was very short. So we have been seeing progress quarter after quarter where now the patients, who are initiated, are receiving the product for longer. And I think it would be the key. Our competition, if you want, is really a Rituxan chemo where a lot of physicians are using R-CHOP, obviously, and maybe they will be changing that in the future. But today, it's R-CHOP. And then they are using Rituxan chemo with a different type of chemo, and that's where we need to be able to demonstrate to physicians that using a non-chemo non-Rituxan based combination can work better for patients, in fact. So that's where we are. The COVID did not help. The fact that there was a number of injection to be given early in the first weeks of treatment was not helping either, because people didn't want to take public transportation to go to the hospital, et cetera. So it was weaker than we were expecting, but frankly, we have a lot of expectation now to succeed in Europe, where it's a different dynamic. So it's already doing very well in Germany as we speak, where it has been launched and then develop Monjuvi in new indication, earlier line. We have a first-line study with R-CHOP and potentially in other type of B-cell malignancies. We have studies in combination with parsaclisib that we want to do. And so there will be expansion beyond the current indication coming over the next few years. So overall, I think it will be a good contributor to our growth over the next 10 years.

Salveen Richter

analyst
#39

And how are you thinking about its utilization compared to CAR-T therapies? Is there a rationale to use these sequentially?

Herve Hoppenot

executive
#40

So the sequential aspect has been more or less addressed now, because there is data showing that you can use CAR-T after using Monjuvi, because that would be the sequence, if you want. I think they are very different from two standpoints. One is the setting. If you want to treat patients in the outpatient setting, then obviously, CAR-T is not the option. So that could be -- if you are not in a big academic center, if you are treated in a private practice, it makes a lot of sense to use Monjuvi, lenalidomide before you send the patient to another city to be treated with CAR-T. And then there are patients who, frankly, cannot receive CAR-T because of their physical status and we're using a non-chemo type of treatment like Monjuvi, lenalidomide, is very reasonable. So I think both of them are sort of making the two options not really competitive, literally. I think it's more like two different type of patients, two different types of setting.

Salveen Richter

analyst
#41

And on the pipeline just separately, you have a number of PDUFAs coming up for parsaclisib in NHL. What represents the most significant opportunity for you here?

Herve Hoppenot

executive
#42

No. So the most significant opportunity for parsaclisib is MF, myelofibrosis, that's what we spoke about and hemolytic anemia, autoimmune hemolytic anemia, where we are starting a Phase III. In that program, obviously, we are always looking at ways to get accelerated approval. So that's what we did with the lymphoma program. So we have the studies at the FDA being reviewed as we speak. You know and I know the FDA is not -- is looking at the class with a critical eye. We see some other companies going to ODAC and there are a number of questions about the class. So I would say, when I think about parsaclisib, there is this opportunity to go quick, if we get approval in one of this lymphoma, but the substance of it is really MF and the hemolytic anemia. Now we'll see, we are in discussion with the FDA, and we'll update everybody as we go and we get more information on the review that they are doing. But frankly, it's a class that has been now under a lot of scrutiny for everybody in a way that is not helpful. Let's put it that way.

Salveen Richter

analyst
#43

And you have a number of early to mid-stage pipeline assets that are advancing. What are you most excited about here?

Herve Hoppenot

executive
#44

As I said, I mean, so that is the entire derm franchises, so we can put that in one bucket. And then you have the oral PD-L1. We have 3 products in the clinic. We spoke a little bit about 550, which is the most advanced, because it has -- it demonstrated efficacy, multiple patients having responses. And we had higher rates than expected compared to antibodies of some form of neuro side effect. And so that was not -- that was -- it's something that we are working on changing the schedule, changing different aspects of the treatment to see if there is a relationship between this type of side effect and the way the drug is administered. We have 2 other products in the clinic, 280 is the most advanced. We have, in fact, not seen any of these same type of neurotox side effects. So that's a good sign. And we are seeing signs of tumor shrinkage, efficacy. So that's a franchise that I think could be very important, because being able to give a PD-L1 or the same type of efficacy that what you get with an antibody with an oral product, would be extremely valuable in terms of safety. Because it's like having a switch off. You can stop taking the drug. The half-life is very short, which is not the case for the antibodies. You can combine with oral product. You can give it in the adjuvant setting where patients don't like very much getting injections. So there is a number of opportunity in the big field of PD-1, PD-L1. We're having -- being the only one or the first company with an oral product could be very valuable. So that's one. I spoke about the adenosine program, because, again, very broad, very unique products, both of them developed in-house. ALK2, as we discussed for LIMBER. And so that makes a number of products that will be coming over the next few years. I think it's an exciting time, both on the small molecule where we have all of this history of getting drugs through the finish line, but we have also some biologics with Merus antibodies that we are developing ourselves now that are getting into the clinical stage. So the early pipeline is very vibrant, a lot of activity there.

Salveen Richter

analyst
#45

And on the adenosine assets, I guess, how do you see them differentiate from some of the other companies that are working or have been working on adenosine compounds, be it A2A/A2Bs or CD73?

Herve Hoppenot

executive
#46

So it's basically -- so it's the most potent A2A/A2B that is in the clinic today, the one that we have developed. I think the idea is not only to antagonize at that level, but also by using the CD73 in combination to be able to reduce the adenosine level very meaningfully. And that's something that we believe can be done uniquely by using these 2 components. And then we are combining that, and we will be getting that very quickly in combination with a PD-1 antibody. And that's something that we can see from our biology model is also very powerful. So I don't think there are a lot of the same type of approach where people are taking a small molecule against A2A/A2B, an antibody against CD73 for a lot of reasons that we could discuss, but that we believe is the best way to do it. And then combining that with a PD-1 could have a very unique profile. And that's what we are trying to look at. This year, we'll be working on dose escalation of both 73 and the A2A/A2Bs, the combination of the 2 and then we'll be adding the PD-1 to that a little bit later.

Salveen Richter

analyst
#47

And then there have been companies bringing in AI machine learning to go after drug development, right, where we've seen companies like Relay going after FGFR or today, we saw Amgen just do a partnership. How are you thinking about these tools and drug development at large?

Herve Hoppenot

executive
#48

No. We think there is obviously an enormous amount of value of additional information. That -- there is no question about that. We have our own systems, if you want. I don't know where the limit is to become an AI versus being sort of a software. In some ways, there is a lot of gray zone between the 2, and that's where probably where we are. As a company, we also have -- I think there is something about interaction between biology and chemistry, which I know for the past 10, 15 years at Incyte has been a key of being able to develop many of these. I mean, we have -- we are one of the few companies with 4 internally developed discovered molecule on the market today, capmatinib, baricitinib, pemigatinib and ruxolitinib. And all of them are more or less very unique in many ways, and that comes from this work together between the teams in a way that is daily. I mean, it's a daily level of interaction and having systems, AI that help in selecting the structure that will be more appropriate for certain targets. It's certainly something we do on a regular basis. So maybe not as much as yet, but what you are describing. But I think there is this human, machine kind of interaction that is absolutely key to get to success here because not all of it is just coming from brute force. We saw that in chemistry. There was this idea of if you hire 1,000 chemists, they will do more than if you have like 50. And in fact, if you look at it now, you will find that it's not the case. So there is -- the size of the sort of brute force approach to some of that is not always the only way to be successful. But yes, we are looking at many different partnerships that we could do in the sense of being able to identify the right scaffold that would be working on certain types of targets we are interested in. So we do some of that. We have not been publicly making a big partnership, but there is a number of activities already taking place.

Salveen Richter

analyst
#49

Great. And then just going back to derm here, you do have other assets going after different autoimmune and inflammation diseases here. Maybe just walk us through those programs and also how you're thinking about this as a vertical evolving over time?

Herve Hoppenot

executive
#50

So I spoke about -- so we have obviously RUX cream, where we have AD approved in the U.S. Vitiligo submitted in both U.S. and Europe, and we have a number of additional indications that we think we can very uniquely address with ruxolitinib cream. We have already spoken about the pediatric indication in AD, which is ongoing. And there is a long -- in fact, a fairly interesting list of a new indication we are looking at. Then we are looking at JAK1 707. It's a systemic treatment with all the caveat of the JAK systemic situation, which is what it is, but where we think it can be very beneficial for system, a more extended vitiligo and for HS. So HS study is already ongoing. And we should have the result this year, in fact, in 2022. So that could be a very big milestone for that program. And obviously, we are also looking at prurigo nodularis, which is another indication where we know the JAK mechanism could be working. So that's what we have been speaking about. We have a number of preclinical projects we are pursuing today that are around the same interaction between immunity, inflammation and dermatology. And I think it's a place where there is a lot of diseases, in fact, that's where we could find innovative, interesting first-in-class or unique in there, products that will have a large application. Now that we have made the decision to go into the commercial side, we are -- it makes everything easier. So it's a subject of a lot of activity. So I guess it was a little surprising to see a cancer company going into derm. But frankly, it's one of these cases where the science was leading us into vitiligo originally and unmet medical needs, unique, so we loved it when we started to look at it. And that's where this whole idea of, in fact, immunity and dermatology are more or less the same thing, inflammation and immunology, yes.

Salveen Richter

analyst
#51

Maybe a last question here then. Is there another area that science is leading you to? Or do you see yourself as kind of these 2 disease-focused company for now?

Herve Hoppenot

executive
#52

I think for now, we are trying to consolidate in both, which is already a lot of work. We have a very good pipeline, both in oncology and dermatology. So there is no like strategic thinking of saying let's go into CNS. I mean that's not the case. We want to -- now if somewhere in our development, we end up with indication like I was describing, which would be non-cancer hematology, that would be something we can handle, because a lot of it is overlapping with what we are doing or if it's some immune disease that is not dermatology, but somewhere adjacent, it's something that we could also do. So that's the way we are sort of looking at it today.

Salveen Richter

analyst
#53

Perfect. So with that, Herve, thank you so much. Really appreciate your time today.

Herve Hoppenot

executive
#54

Well, thank you for inviting me. Thank you for the time.

Salveen Richter

analyst
#55

Thank you. Take care.

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