Great. Good morning, everyone. Thanks so much for joining us. We're really pleased to have Hervé Hoppenot, Chairman, President and CEO of Incyte with us. In the audience, we do have Christiana Stamoulis, CFO as well. Thank you both. Hervé, just to start here, you know, a high-level outlook, product diversification for Incyte has been a focus. As you stand today with Jakafi and Pemazyre and Monjuvi, Opzelura and the current pipeline, what is your outlook for the business at this point and growth in the medium and long term?
Again, thank you for inviting me. It's a pleasure to start the year here and speak about Incyte. Incyte is obviously about innovation and growth. I mean, that's really what the agenda is for us and has been for the past five years. Even if you look back at what happened over the past few years, it has been really happening at a fairly good pace. I mean, last reported quarter, we were growing at 20%. Now the sort of size of the organization in term of revenue is around $3 billion for this year. It's from- and it was $1 billion just five years ago. It has been a very good dynamic in term of growth. The growth came from new indication.
A lot of work has been done in the field of MPN and GVHD, new products in oncology and hematology, which is a second bucket. Recently, one year ago, emerging into dermatology with new products that are fulfilling a need that was really not well addressed in the past. That's the three buckets that we are working on. What you saw recently at ASH and what you saw through some of our communication is that for each of the three now, we are really making a lot of progress, and we have drivers that are adding to our current portfolio. What's also very interesting is that in our current portfolio, we have a lot of products that have been launched very recently, so we are still in a curve that is very early.
If you think of it from the diversification standpoint, obviously it's going to contribute in the year 2025, 2026, very much more than it does than it does today. The picture in the short term or medium term, if you look at 25 years, let's say 27, is obviously very, very favorable because we are anticipating Jakafi to continue to grow. In the U.S., we are anticipating the launches of Pemazyre and Monjuvi in Europe to contribute additional revenue to the corporation. We are also looking at Opzelura becoming a very meaningful part of our portfolio in the U.S., and we can speak about the launch of Opzelura. It's really an interesting subject, we're also going to launch Opzelura in Europe. It will be happening this year in 2023. That picture is excellent.
You look at how we are going to manage the longer term, and that's where at ASH, just a few weeks ago, I think, most people realize that there is in fact a very good chance that we would be able to bring new product in this window that will be changing the dynamic of the portfolio in MPN and GVHD, so myelofibrosis and GVHD, including products coming from our own pipeline that we just announced very recently. The whole picture of the medium term and the long term, in fact, being on this growth trajectory is now looking very much better than it was maybe two years ago.
Perhaps we can talk here about your strategy on business development. We've seen you step in here and do collaborations to M&A. What is the overall approach that you're taking as you look to 2023 and beyond? Are you prioritizing certain disease areas? You know, are there clear opportunities just given the current market conditions? On another note, I guess, do you view yourselves as a target?
What we view ourselves as a target, frankly, it doesn't matter. I mean, it's a sort of a, in terms of acquiring and complementing our so we have cash. We have like $3 billion in cash. We have no debt, so we have the ability to do a transaction. What we have done over the past five years is looking at different opportunities, always as either a licensing type of deal or partnership type of deal or an acquisition. The two of them having, obviously, different financial consequences in the short term and long-term margin consequences, and basically trying to balance the two in a way where if we believe the science is good enough and based on our expertise, and our expertise is in the intersection of cancer, immunology, inflammation. That's where we came from, in fact.
When you think of the JAK story, it was an inflammatory kind of, science that was used at the beginning when the JAK mutation was discovered in myelofibrosis and PV, that's where it sort of went into hematology. From there, we ended up in the middle of this immuno-oncology world a little bit because we came from the immunology side more than the oncology side. That's where we are looking. We now have a franchise in dermatology, so it's adding another opportunity to add to the portfolio. What we have done, over the past year is a good indicator of where we are going, is be very careful with over-evaluating assets.
We have been sometimes I've been described as being too careful because I don't like to spend too much money if we are not too sure what we are buying. That's a bias we are trying to work with. The board is sort of aligned with that, of saying there were evaluations specifically in cancer that frankly didn't make a lot of sense. We were basically, even if the assets were scientifically interesting and we ended up, you know, always being short of what other people would be paying for the same asset. Trying to find assets that will be complementary to our portfolio in dermatology. What we have seen, what you have seen recently, we did an acquisition of Villaris. It's an IL-15 beta receptor for dermatology, vitiligo, and maybe some other indication.
Early asset, not, you know, smaller investment in some way. We did partnership with Syndax, which was in fact axitinib. We have the rights worldwide, we are developing it very actively in the GVHD, so complementary to what we have with ruxolitinib. That kind of deal you will certainly see continuing, potentially, if we were to find an acquisition of a bigger size, we would be open to doing it, assuming the price is the right one.
Let's move to the product portfolio here, Opzelura and the launch here. Can you share with us the latest update on the launch, both in atopic dermatitis and vitiligo? Does physician and patient demand remain strong here? How do you think about the split between, you know, scripts and demand for vitiligo versus AD?
First, I mean, the launch of Opzelura in the U.S. has been, now is one year old. I must say it has been extremely successful from the patient standpoint and from the physician standpoint who are prescribing for either eczema or vitiligo. The two indications are very different. Eczema is sort of acute. We are speaking of patients who have been treated with other topicals. They are patients who are going to a dermatologist because steroids don't do very much or because Elidel or the other products that are used topically are not really successful. Here, what we realized at the beginning when we introduced Opzelura is that dermatologists are facing a very interesting situation where they would either go to a systemic treatment, which at the time was Dupixent.
It could be Rinvoq or, you know, any of the systemic products for eczema. They have to go back to what that same patient had received already, in many cases, given by a, by a GP. It was really a vacuum. There was a real vacuum in the middle of that range of treatment from the topical to the biologics or the systemic drugs. That's where Opzelura ended up filling that void in a way where patients could see very quickly the itch effect of using Opzelura. It is a characteristic of JAK inhibitors is that it has a very fast effect on cytokine and on the topical form, it is literally a soothing effect that is almost immediate.
80% of patients in our study were able to never go to any systemic treatment and basically stay and be fully controlled in term of inflammation, not just itch, in term of inflammation with Opzelura. What we put in place was a system where physicians and patients could try the product, and we had a way to buy back in some way, you know, the prescription when it was not covered by the insurance company. That ended up being extremely successful because the feedback from patients to their physician was really the driver of the adoption.
Because in many cases, it was like, "After years of trying all of these products, now, I really feel very differently from anything I've tried before." During that year, we were managing access through contract with the PBM, through a number of systems we had in place with the pharmacies that are delivering the product. Now we are at the stage one year after, which is relatively quick when you look at the timeline for many of these products in dermatology, where we have a very, very broad coverage. We have a good, you know, gross to net situation as we were expecting and we communicated from the beginning. Obviously, you know, the two with the volume growth and the gross to net improvement is leading what we are observing.
We believe that in that indication of eczema, before we go to vitiligo, we think Opzelura has a unique positioning today, and there is a very large potential for patients to benefit from it now that we are in that sort of more stable coverage situation. In vitiligo, it's not such an acute disease where, you know, scratching in eczema, you need to do something very quickly. In that case, many of these patients have had vitiligo for. We had patients in the study for 35 years, who in fact ended up repigmenting when they were treating with Opzelura. It's a situation where a lot of patients have been treated with something in the past, have not been seeing a dermatologist for a long time because frankly nothing works. We have a number of patients who are under active treatment.
We think it's around 200,000, 150,000-200,000 patients who are seeking treatment for vitiligo today out of 2 million patients or 1.5 million patients who are suffering from vitiligo. There, the prescription is leading to a treatment that has a duration with refills every month that can go to, I mean, we have seen in the study up to 52 weeks. I must say, I mean, the launch in vitiligo has been in large part driven by enthusiasm from patients. I was joking earlier, but if you go to TikTok or Reddit or many of these places, you will see a lot of Opzelura patients who are basically taking picture and showing the progress of their repigmentation relatively quickly after initiation. Selected group, obviously.
I think it's a product that can change the life of many of these patients suffering from vitiligo in a very meaningful way. We tend to underestimate how deeply impacting vitiligo can be. There are patients who don't care. We all hear that. There are a vast majority of patients who go through a number of trying different strategies, using makeup, doing many things to manage the vitiligo situation. Frankly, when they see what's happening when you use Opzelura, it's a large market. Think about it. I mean, we are speaking of 1 million+ patients who potentially could benefit with a treatment that takes between 6 months and 1 year, or maybe for some patients, a little longer.
It's a very large potential for Opzelura, and we are in this space now where it's growing. How many prescription are for eczema versus vitiligo today? I don't trust the sources that we have. I really don't, because when I look at how they are calculated, I'm feeling like it's not really certain. We don't speak about it, but you can imagine that you have double-digit growth of Opzelura patient number. That's what we spoke about at the Q3. On top of that, we have the growth coming from the new vitiligo patients. Vitiligo patients are obviously a very different number of tubes per patient per year than we have in eczema.
That's the sort of the dynamic of Opzelura, which I believe is going to be a very large contributor to Incyte revenue over the next many years. It's a great, it's a great situation. We are launching in Europe this year. The CHMP EMA process is ongoing, and we are expecting like midyear type of launch for Opzelura in Europe.
Should we-
In vitiligo.
In vitiligo.
Where we reverse the sequence in Europe.
Should we expect different trajectories for growth for both these indications?
You have a cumulative effect in vitiligo that is less there in eczema, so there is a chronic-ness, a chronic, aspect to the vitiligo curve that is less present in eczema. Yes, you could potentially assume that vitiligo will have a cumulative effect that will be slower, maybe at the early stage of the curve, but will lead to a bigger curve, where every patient will be using... We use the number of 10 tubes per year per patient. In fact, we don't know yet, so we'll see on the commercial side, in the commercial setting, how it's doing. Yeah, we think there will be an accumulation of new patients with existing patients in vitiligo that will be stronger than what we observe in eczema.
Turning to the reimbursement side, could you comment on the progress you've made here on percentage of covered claims? Have you reached that 40%-50% gross to net number you were targeting by year-end?
We'll see. When we speak about Q4, we'll see about that. What we said on Q3 is that we were making progress. We did something that frankly, after the fact, I was thinking, I don't know if it was very wise. We basically gave everybody a curve of what we were expecting to see for in term of gross to net, which is always dangerous, because predicting the future is something that you can never be sure about. What happened is very much in line with that curve. It was driven by our early ability to have PBM contracts. Think of it from the payer standpoint.
If the choice is to go to a systemic treatment like Dupixent or Rinvoq, or to have patients controlled with Opzelura, in fact, it's a very good deal for them in term of cost for the insurance company. That part was done very early. The distribution itself went through a little bit of an adjustment because many of these pharmacies specialized in dermatology were not used to something like Opzelura, in fact. That took a few weeks, months to get done. What we see now and what we are seeing in the past few months is very much a stabilization aligned with our prediction that we will be entering 2023 with a very good amount of claims being covered. At the end of Q3, it was north of 70%.
It gives you an idea of where it's going. Then shooting the growth from the volume standpoint will become easier because all the systems are in place and people are getting used to the paperwork. I mean, it's a product that requires prior authorization. There is a little bit of paperwork that needs to be done. Now people are used to it, and it's working really well.
Are there any hurdles or outstanding issues that need to be dealt with in 2023 on the payer front? Maybe help us understand on the gross to net side if there's a difference between the two indications?
There is no difference. You know, the gross to net is basically a number of discounts, copays that are impacting the way we are booking the net sales versus the gross sales. It's very simple. In there, you have the distribution part, so that's the same. It was the same. It's the same for both. We have the PBM discount. It's the same for vitiligo and atopic derm, so there is no difference there. Then you have a few small things, then you have the copays. The copay that you see is the one that is swinging, you know, with the evolution of the coverage and the listing in the plans. That copay has been obviously evolving very much favorably and Same for both AD and vitiligo. There will be no difference.
In fact, if we were calculating a net price, we would have different access situation, where sometimes there is a prerequisite for some prior treatment in atopic derm, like steroids or Elidel, et cetera, where in vitiligo, it's the first line for many of the plans. In term of gross to net, it will be the same calculation for both indication.
You reported a really nice, Opzelura sales number in 3Q. Help us understand what drove that number apart from demand. Were you seeing finally, you know, the reimbursement issues maybe mitigating here? Was there any aspect of bolus coming from vitiligo?
In Q3, we had some vitiligo patients, but it was not the main driver of what happened in Q3. What's happening in Q3 is the buy-down program, what I described as the sort of the way we wanted people to use the product to benefit from it and to learn how good it is. The buy-down has been removed from the gross to net calculation as over time. In Q3, there was a clear improvement of that gross to net calculation that was coupled with the volume growth that we have been observing both in atopic derm and the beginning of the vitiligo number. It's not a bolus of vitiligo. It's literally the stabilization of our gross to net situation that we were predicting would happen and did happen in Q3.
how do you think about the outlook from Q3 on?
What I think is over time, this product will become standard of care in the treatment of eczema for patients who are not fully controlled with other topicals. That's where it's positioned. As I said, there is not a lot of competition there because the only thing you can do is to go to a systemic. Some patients would need a systemic because of the size or the extent of their disease, but many of them, if most of them, will be able to be controlled fully by Opzelura. That's why we have this long-term guidance on Opzelura in atopic derm of $1.5 billion in the U.S. that we gave at the beginning to give an idea of what we think is what is feasible.
We believe today even more that it's a good, it's a good way to think of where it could go for atopic dermatitis. Then you have vitiligo that will be building on that. Frankly, we are not really sure how big it could be in vitiligo. That's part of us not giving long-term guidance yet. We want to see how the curve is building up. What we see from patients who have been using Opzelura today in vitiligo, seeing repigmentation happening already after a few months of treatment is giving us a lot of optimism about vitiligo being also a very important indication for Opzelura. I mean, if you think of Incyte, if you step back of saying, okay, diversification, innovation, Opzelura is clearly there. It's the first ever product to be approved for vitiligo.
It's totally unique in its profile in atopic dermatitis. It will have a size that will be very meaningful for the corporation at a time where we will need that diversification out of our original, Jakafi business, where we started. It's fitting really well with what we are trying to do, and it has been very successful.
Transitioning to Jakafi, which you just commented on, this is on track to be at least a $3 billion drug here in the U.S. Then you've obviously got the royalty from ex-U.S. How are you thinking overall about life cycle management, given the upcoming, you know, patent situation or IP situation at the end of the 2020 timeframe, 2028, to be specific?
Yep.
Could you just help us understand with firstly the QD formulation, which should get approved in March.
Mm-hmm.
what that does to, both, you know, I guess what that does in terms of your strategy in new and existing patients and to kind of aiding in that long-term curve.
The QD, obviously what we are doing is, and you saw at ASH a lot of data from some of our products in the so-called LIMBER program, which is our life cycle management for Jakafi, is, improve on safety and efficacy versus Jakafi. It's not just like trying to do a better formulation. It's really trying to move the needle in term of the clinical benefit because that's what we believe will give us what we need, which is a life for the entire franchise that goes way beyond 2029. As part of this, there is a QD. The QD, obviously, by itself, going from twice a day to once a day, is very beneficial for some patients, but it's not going to be the solution to all the Jakafi life cycle issues.
We believe when you combine in cancer patients, when you combine a once a day product with a twice a day product, there are a number of issues that can arise from errors and people taking the wrong product, twice a day versus once a day. There will be a benefit as we are seeing the field in myelofibrosis now moving very quickly to combinations, that having a once a day will be very beneficial because most of the other products, not most, all of them, in fact, are once a day. In our own portfolio and in the competitor's portfolio. That's one aspect. You can assume QD will be approved. What we will see slowly over a period of six years we have is, you know, use of QD instead of twice a day.
If that was the end of the story, it would have an effect, but not like the massive effect that we are expecting from some of our other approaches. The other approaches are in MF and PV and ET to bring new mechanisms that are changing the clinical profile of the treatment. The first one that we discussed at ASH just a few weeks ago is parsaclisib, and it's a new mechanism. It's very synergistic with Jakafi, and we have phase III studies ongoing. This year, 2023, we will see the phase III result at the end of the year, probably. We are finishing a core now. There is a 24-week follow-up. By the end of the year, we should be able to see the result.
It's important because it can improve on efficacy in a very specific population that is suboptimal responder to Jakafi in MF. As you know, in myelofibrosis, Jakafi works very well. I mean, everybody sees that. Most patients, if not all patients, at some point are going to go through progression of disease, new symptoms, spleen enlargement, et cetera. There is a real opportunity there to help these patients by doing a combination with parsaclisib. That one will be coming first. The next one in the same category is a BET inhibitor that we have. We showed some of the first data. We are doing also combination with Jakafi in myelofibrosis. It will probably go in the same population of suboptimal responders. Then we have an ALK2 inhibitor, which is working on a completely different mechanism.
It's basically managing hepcidin level in a way where we believe we can reduce anemia. Anemia in myelofibrosis is connected with the disease itself, so the bone marrow issues, but it's also connected to ruxolitinib. What we will be doing there is combining ALK2 with rux and what we expect, and we have started to see that at ASH. We have shown patients where hemoglobin is going up when they are treated with ALK2 plus rux and where we will be combining the two. We could do a fixed-dose combination, obviously, and that would be like a super Jakafi that has a very different profile because by managing anemia, you can increase the dose intensity of Jakafi.
We know from studies we have done with Novartis, et cetera, that a higher dose intensity has in fact a better outcome. That's sort of the play that we are doing on the Jakafi combination, improving on Jakafi. I think for each of these three, ALK2 and parsaclisib and BET, there is a good chance that, you know, it could basically replace Jakafi in some of these patients who are not fully controlled or patients who have anemia or patients where you don't want anemia to become a dose-limiting toxicity. On top of it, we have been looking at completely new mechanism, and we disclosed the first of this product coming from our own research. It's a CALR antibody, anti-mutant CALR antibody. It's very unique. It's a very interesting target. It's like 30% of MF and 30% of ET.
That would be 25%-35% of patients have that mutation. We know the mutation is a driver of the disease. We are starting the clinical work now this year on what will be the first of its kind monoclonal antibody blocking signaling for mutant CALR. By blocking signaling, in fact, it's leading to cell death. It's a case of a potentially disease-modifying product that would be changing completely the approach to treatment of MF and ET, where you could basically identify the mutation, which people are already testing for. It would not be a big issue there. Choose to have what would be a very much different type of approach than using a product like Jakafi. We have all of these programs now moving in parallel.
We've made a lot of progress. We are starting to disclose some of this data as it's coming. Obviously, the vision is that in the next five years, these products will be introduced. They will be replacing the use of Jakafi twice a day alone. You know, slowly or not, I don't know, quickly or slowly, it's going to basically make the entire franchise or give it a very different shape because it will be made of product and combination and fixed-dose combinations that have a life way beyond the 2029.
under the Inflation Reduction Act with Jakafi-
Mm-hmm.
It's carved out as a small biotech. Maybe help us understand the potential impact of the IRA?
IRA.
On Incyte and also what you're looking to understand in 2023.
IRA is, I must say, I mean, overall I see it as a positive for Incyte. I know I must be the outlier in the world of biopharma, mostly because of the reduction of the out-of-pocket for patients. I've been very vocal and known all over Washington as totally horrified by the system we have in this country, where cancer patients have to contribute up to $6,000 with a donut hole to their oral treatment for cancer. I mean, it's totally immoral. It's antisocial. It makes no sense. The good thing here with IRA is that there will be a cap starting next year. The cap is at $2,000 per year. I think it's too much, by the way.
I don't think there should be any out-of-pocket payments for cancer patients. Nobody's going to abuse their chemotherapy. I mean, totally it makes no sense, but it's better to have $2,000 as a cap and on top of it, that the months it can be paid monthly, so $178 per month. I think it will have an impact for Jakafi. In fact, I think it's a good thing for patients with PV because we know some patients going to the pharmacy and saying, "Come on, I cannot pay that kind of money." That could have a good impact for, I think for the entire industry and for Jakafi. On the negotiation and the contribution to catastrophic coverage, which are the two financial impact from IRA.
In fact, Incyte is exempted as a small biotech, so we don't see the negotiation issue impacting Jakafi at all. We will see the ramp-up of the contribution to catastrophic coverage to be very much slower that it would have been without the Small Biotech Exception. There will be some impact, but in some ways maybe the impact because of the lower co-pay will be compensating whatever additional contribution we do on. For us, as a corporation, I think it's it's it has no impact that we can we can quantify. In the long term, there are some issues in there. I mean, the nine versus 13 between small molecule and biologic makes absolutely no sense. I don't even know how it happened.
I mean, it's a bizarre situation. Certainly that would be something that should be looked at again because it's creating a huge bias in the way people will be looking at value of new assets or busy deals or whatever. That is not, I don't, I can't think of any justification for it. Yes, that would be the key point. In fact, I think the small molecule versus biologic is something that needs to be fixed.
Very quickly on Pemazyre and Monjuvi, how are these launches progressing here and where do you think the levers of growth could come from in 2023?
Pemazyre is the only product available for patients with FGFR mutated cholangiocarcinoma. We are at a stage where in the US we have more or less, most patients are being treated today. We've made a lot of very quick progress to get the testing being done, to get all of the. I would say the next step for Pemazyre in the US will be when we are getting the first line indication in cholangiocarcinoma, or we are doing two studies, one in lung cancer, one in GBM, glioblastoma. If we get positive results there, that will give a new growth potential for Pemazyre. I mean, there are still some progress to do in term of testing some patients with adenocarcinoma of unknown origin, because many of them are cholangiocarcinoma.
That's something we are doing, but you should not expect the curve of, in the U.S., the Pemazyre business to go through the roof now. I think it will depend on the data in first line, where we are very confident it will work and potentially in other indication. In Europe, we are still launching, so there is reimbursement taking place, and it's on a good growth. You can see Europe will catch up with the U.S. over the next year more or less, year and a half. Monjuvi. Monjuvi in the U.S. is managed by our partner, MorphoSys. In Europe, we are launching. We have already launched in Austria and Germany, and it has been doing very well, in fact, in term of growth and volume. That's a good thing.
Recently we got reimbursement in Italy, so that is taking place. Now we are waiting for France and NICE to go through their process. You can expect that to take a few more months. I would say Monjuvi in Europe will be Germany, Italy very much in 2023. We expect obviously France and UK to come or England to come after that. They are not like multi-billion type of products, Pemazyre or Monjuvi in their current indication. They have the potential to grow with new lines of therapy that we are developing and new indications that we are going after. It is contributing to this growth and diversification that we spoke about at the beginning.
Finally here, touch on your pipeline and what you're most excited about and specifically this oral, you know, PDL1 and why that could really change the dynamic of combinations on the forward.
Not just combination. You heard the previous speaker explain how valuable it would be to not have to go through an infusion, an one-hour infusion, for PD-1 antibody. I can just rebound on what was said and saying you can do a sub-q, that's great, but if you can do an oral, it's even better, obviously. That's what we are doing. We have an oral PDL1 inhibitor. It is active, it is safe. That was the big news at SITC. I know it was not like a top front page of the newspaper, but for us it was a big step.
You know, we had another product, 550, where we completely out of nowhere ended up facing a situation where there were some peripheral neuropathy, which we still to this day do not explain. We don't know why, we have looked at it with all kind of specialists in the field. Our second product, 280, is now going through all of these steps, and we know we don't have that peripheral neuropathy issue because we have treated 85 patients for a long period of time. We had a lot of responses. It's a different mechanism of action. The vision is saying, can you do as good as Keytruda or Opdivo with a pill that will be giving you the same outcome? The question is like, why is it good?
You heard some of it, in term of avoiding infusion by itself is a very good thing. There is more than that because the half-life of our product is so short, you take it twice a day, that if you are facing any kind of side effect, and you know, when you combine CTLA-4 plus PD-1, a lot of patients are facing immune-related on-target side effect. These patients who are treated with an antibody, the antibody will be there for 35 days or whatever it is after the day of the injection or the day the side effect is discovered. In our case, and we saw that with the peripheral neuropathy with INCB50465, you stop and it goes away. It's basically an anti-PD-1 with a switch off. Now, where does it apply? Where is it useful?
It can be in every situation where combination is leading to a side effect profile that sometimes is problematic, and that's why we are doing a number of studies in combination. The other place, and Rob spoke about it, is adjuvant treatment, where you want to be able to prescribe a product in the adjuvant treatment, where patients don't have to receive an injection. That would be a place where we would be going. It's also interesting to see that in many countries, having an oral product is making the reimbursement system completely different from what you get with an infusion, which has an impact on the hospital budget. You can imagine today in the cancer centers, the budget for injectable antibodies, PD-1 is fairly large. That could be another driver that could be helping in the adoption.
At the end of the day, we are doing now two things. We are developing the single agent. We are doing what we call benchmarking studies, where we are comparing our efficacy and safety to what you would expect from a Keytruda type of product. That would be obviously necessary to have the same level of efficacy. In parallel, we are combining with a number of products that are used in combination with Keytruda, like a kidney cancer, axitinib, like we have an agreement with Mirati to do a KRAS plus 280, our product, in lung cancer for KRAS mutated patients. We are doing studies with CTLA-4.
The idea is to show that you can combine, that you get the benefit, and that you have the switch, so that when you are facing an issue with safety, you don't have to leave the patients with long-term effect of the PD-1 treatment. I personally believe it's, you know, this product would not be replacing all of the injectable. I mean, it will be great. It's a $40+ billion kind of business. I think if you look at the slices of a patient group where it would be really beneficial to have an oral product versus an injectable, that will be a very meaningful contributor to Incyte. You know, we are in the phase where we will be moving to pivotal study over the next 18 months or so.
It will be in terms of timing, contributing at the right time.
Great. Well, with that, Hervé, thank you very much.
Thank you. Thank you for inviting me.
Thank you.