Incyte Corporation (INCY) Earnings Call Transcript & Summary
December 1, 2020
Earnings Call Speaker Segments
Maneka Mirchandaney
analystGreat. Good morning, everyone. This is Maneka Mirchandaney from the Evercore ISI biotech team. I'm really pleased to be here with Incyte. We've got Hervé, Christiana, Mike and Christine from the team. Thank you all for being here.
Maneka Mirchandaney
analystAnd maybe to start, can you just give us a quick sense for where Incyte is now? And what the key areas of focus for the company are going to be over the next couple of years?
Herve Hoppenot
executiveOkay. Well, good morning. Happy to be here to speak about that. I mean the way we look at -- I mean, it has been a fairly busy year. It was a little bit of a paradox because we were dealing with the COVID situation. And then at the same time, we had like 3 new approvals during the year. We have been in a fairly busy phase of the -- in the life of the corporation. And the way we look at it is really in like 4 pillars or 4 quadrants for the way the business will look like in 2025, some sort of a few years ahead of us. So the first one is obviously our MS, PV, GVHD franchise and how that is going to be evolving over the years and where we have a number of new projects that will be replacing Jakafi twice-a-day with new options for patients, and we can speak about it, but that's one of the quadrants. The second one is really our onco-hematology portfolio, and that's where we had pemigatinib approved recently in the U.S. We have Monjuvi that was approved recently in the U.S. So it's all of the hematology-oncology group that will be having a number of new products. You saw maybe the ASH data with parsaclisib, and it's an interesting -- very interesting new product that is emerging from that portfolio. We have retifanlimab, our PD-1 antibodies, so nothing very differentiated, but it's moving forward. And then in the pipeline, we have a number of exciting things in hematology-oncology, like 550, the oral PD-1 that was published recently at SITC, et cetera. So there is an MPN GVHD franchise. There is an onco-hematology portfolio that is growing and emerging very quickly. And then we have -- as the third quadrant, we have the dermatology franchise that emerged from our own biology research or finding indication where JAK inhibition or some other mechanism could be useful. And we saw vitiligo, atopic dermatitis as the first 2 indications where topical RUX can be used. We believe it's a fairly large potential. We have now a team being built in the U.S. We are anticipating priority review that will lead to potentially an approval by midyear 2021 in eczema, followed by a submission of an sNDA for vitiligo. So a fairly fast-growing franchise. And I think it will be the third pillar of that Incyte 2025. And the fourth one, which is not always looked at that way, is more financial, but I think it's a big contributor to our equilibrium or the balance of the corporation, is also royalties we are getting from Olumiant. And you saw the new indication for Olumiant coming in Europe recently. You saw the emergency use approval in the U.S. for COVID with Olumiant. You have Jakavi, Jakafi for ex-U.S. with Novartis, we have the new approval of Tabrecta that just happened a few months ago, which is an important product. And we are working on other type of partnership outside of U.S., Europe, Japan for the rest of the portfolio. So the picture we have is this sort of 4 different components of what Incyte will look like in 2025 and beyond. And what we see is that each of them have been actively changing over the past few months. So it's a fairly exciting picture.
Maneka Mirchandaney
analystGot it. No, that's super helpful. And maybe first, just starting with Jakafi and some of the moving parts there. I think it's annualizing about $1.9 billion in the U.S., consensus reaches about $3.2 billion in 2026. As you think about where we are now with that franchise, what do you think are the key growth sources going to be over the next few years to get Jakafi to kind of reach those numbers? What do you think the risks are to those estimates? And then what do you think could be the potential upside theoretically on to those numbers as well?
Herve Hoppenot
executiveYes. The difficulty is that the numbers are sort of peak sales of Jakafi. And the way we are looking at this franchise now is very different because what we believe is going to happen and we have -- are working very actively on that is that, the current Jakafi twice-a-day, as it is, is going to be replaced by better options for patients. So there is a little bit of a question of, do you predict what Jakafi will look like? Or do you look at the franchise in MPN and GVHD? And that's what we are speaking about. So in terms of the growth of ruxolitinib, as it is today, you have seen the number we had in Q3. So it has been growing fairly dynamically. We had an impact of COVID. I must say, after February, at the beginning of the year, pre-COVID, it was a different world. I must say, we were looking at something that would be exceeding the numbers we have today. We saw a dip in the new patient flow like every other cancer drug. And we saw a rebound in the summer, and we are on this basically trying to go back to baseline in some way. And in spite of that, the growth was still in the 17%, 19% ramp. So it was okay, but it was not maybe as high as it would have been without COVID. So there is a real question of coming out of COVID, how much of this existing indication are going to grow? And I think there is a good chance to have some form of rebound and where patients who are symptomatic are going to see their physician for MF and PV. The number of bone marrow transplants went down during COVID, so the number of GVHD went down. And we think the same thing could happen in the future, maybe is that we will see some form of a rebound. But we don't know. I mean that's something that all of us in the cancer field are looking at. It's a sad story because we know patients have not been diagnosed that should have been diagnosed during that period and it's a problem. Now -- so that's the existing indication. On top of it, we have chronic GVHD. So at ASH, in a few days, you will see the Phase III study that is very much the first of its kind to show a benefit of that magnitude. It has been picked up by ASH as one of the abstract of the full conference that they will be highlighting. So it shows the importance of it. And obviously, it will give us a new indication for -- if it's approved, for launching in the U.S., and that should help continue the growth that we have based on the portfolio that we have today, 4 indication: chronic, acute and GVHD plus PV, plus MF. And then what we are doing, as I was saying, is transforming this entire franchise by improving on Jakafi twice-a-day, is the one we have today. So the first step in there is the so-called XR formulation, which is in development. It should be submitted at the end of '21 for approval in '22. It's a different PK profile for ruxolitinib. It's a very important -- it could be a very important aspect. It's a once-a-day product. And we should be able to have it commercially available starting in '22. So you can imagine that there will be a substitution in some way of the new product to the existing Jakafi twice-a-day for new patients and potentially for existing patients. In parallel to that, we are developing a number of combinations that could be used to improve on efficacy and safety of Jakafi in MF, and it's delta, PI3 kinase delta. It's a BET inhibitor, and it's ALK2. Delta and BET are basically shooting at the same effect, which would be to improve the efficacy of Jakafi alone, both in sub-optimal responders to Jakafi and in the first-line setting. So the Phase IIIs are ongoing with delta. We are still in the feasibility phase with the BET inhibitor. We are basically testing it at a dose that is different from the one we used in the past. And then we will be combining it with Jakafi. And then if everything goes well going into Phase III. And that will basically expand the population of patients treated with that combination versus Jakafi today because today, we have a number of patients who are not responding well enough to Jakafi. And the last part in the combination for what we have now in the clinic is ALK2 with a very different approach, which is to look at how we can avoid those reductions due to anemia. There are a number of patients on Jakafi today who have to decrease the dose because of the risk of anemia. And in some cases, they have to stop treatment. And what we believe is that combining with an ALK2 inhibitor, we would have an opportunity to maintain the dose that has been shown to have a better efficacy and, therefore, to keep patients on treatment for a longer period of time. So that one is also in patients being tested as a single agent, then it will be combined with Jakafi next year. And we could potentially go into pivotal studies next year. So the last part of that franchise management is itacitinib for chronic GVHD. So we are doing a Phase II randomized study to test which dose of itacitinib would be best in the first-line treatment, and that would be available, again, probably in the next few months. I don't know if we gave any date on that. And then we could go into Phase III there. So you could see a portfolio of Jakafi, what is Jakafi today, moving into very different type of treatment depending on the patient profile and the needs that they have in terms of safety and efficacy.
Maneka Mirchandaney
analystGot it. No, super helpful. And a bunch of things to dive in to move with some of that commentary. I guess, starting first on the GVHD side. On your last earnings call, you kind of gave us the split of Jakafi sales by indication. And the GVHD portion has really been steadily growing over time. How much do you think there is room to grow, like, to your point, we've seen the REACH3 ASH abstract data, which could add another approved indication in GVHD, but the feedback we've gotten as well is that Jakafi is already being used to some extent in steroid-refractory chronic GVHD. So how incremental do you think that data and label expansion is compared to what's already being used for Jakafi and GVHD?
Herve Hoppenot
executiveNo, I think you're right. I mean there is some use in chronic. And frankly, we don't even track it very well because the coding are not always very precise. And there is another lap between acute and chronic. 30% of the -- or 70% of the chronic patients having acute before they have chronic. So it tells you the problem of how do you differentiate the type of disease that you are treating. What we also know is that there are a number of patients today in the U.S. who are not treated with Jakafi with GVHD. So what we think is that when we get the official approval and the ability to communicate and to explain how to use the product and do the right education of people who are treating these patients, sometimes, they are not in the hospital anymore because it maybe is months and years after they have received their bone marrow transplant. I think it will have a positive impact on the use of Jakafi in GVHD. So it should be -- it is the first randomized study ever to show a benefit in that setting. I mean it's a very important milestone for the community. And I think it will have obviously a positive effect when we get approval there. Now how much, I cannot quantify it for you. Maybe you are expecting me to give you like 100, 200, 500, I mean, kind of. I cannot do that because there is -- we were -- I must say, we were surprised by the size of the GVHD indication. If you compare what I was saying about it, like, 1.5 years ago, and what we have seen, it has been better than expectation. And not -- it's not just because of chronic and acute. I think it's because the definition of steroid-refractory depends on the availability of the treatment after service. So what we see is that after a few days of steroid, basically, physicians may choose to switch to something else if they don't see what they are expecting.
Maneka Mirchandaney
analystGot it. So to the COVID point, I think that's been an area of focus as well. You kind of talked about it on your last earnings call. Some impact in 2Q and 3Q, but rebound as well in 3Q. I guess with cases continuing to rise, how are you kind of thinking about that trend for 4Q and 2021 until we kind of get a vaccine more broadly available?
Herve Hoppenot
executiveI would say, first, it's not easy to predict. I think what we are observing is that physicians are living in a new routine now. So there is less of this sort of what happened in April in New York, where, frankly, from 1 day to the next, I mean, people were not seeing the physician anymore. It's not the case. We see hospitals working and physicians working in a different way. So the issue are what's happening to patients when they have symptoms, and they are on hydroxyurea and maybe they should be switched to Jakafi. And now are they going to see their physician or not? And that's where we have seen that there is a recovery of that, and it has to do with physicians maybe being now more organized with telemedicine to speak to their patients. And so my expectation is that as we are waiting for sort of the disappearance of this whole thing with a vaccine, there is a good chance that we will continue to see not as much as we would have seen without COVID, but a good level that -- of diagnosis and treatment as we have seen over the past few months. I don't have the data from last week and the week before. So -- but if you look at the trend, we were coming back to a certain level that was not normal, but was like 10% below normal, maybe in terms of flow of new patients in MF and PV.
Christiana Stamoulis
executiveAnd as we have shared in the past, the new patient starts we [Audio Gap] Revenues. And therefore, even with the slowdown, we haven't seen that much of an impact on revenues on it.
Maneka Mirchandaney
analystYes. Makes sense. I wanted to spend just a little time on the LIMBER program. I think this is obviously a very important part of the strategy for extending the license for Jakafi franchise. And so maybe for each one of the combo purchase, whether it's the PI3 kinase delta and ALK2 or BET, kind of walk through what you're hoping to show what would be a win in terms of either efficacy improvement for the PI3 kinase or the BET add-on or on the safety side with an ALK2?
Herve Hoppenot
executiveSo on the efficacy side, we are doing 2 studies with delta. One is sub-optimal responder to Jakafi. So it's a very important study because it is looking at patients who are not fully controlled by a dose of Jakafi that has been stable for a long period of time. And then what we do is that we keep them on that same dose, and we add PI3K delta, parsaclisib. And what you have seen in the data that was published on that is that we are able to, for that group of patients, shrink the spleen further than where it was with Jakafi alone and improve in terms of symptoms. So that would be, assuming the Phase III, we are starting now, it's a 212-patient study. Assuming it shows the same thing, it would be a very important new opportunity for patients because after starting with Jakafi, which is a standard of care now, you would have, depending on the level of response that you get, an opportunity to add PI3 kinase delta. And then we are doing a study, different goal in first line, where we are looking from the get-go at Jakafi versus Jakafi-plus delta. And the goal there will be to see that you have less patients who are basically suffering from sub-optimal response or even lack of response. So that's the 2 studies that have been initiated with delta. So assuming it's successful, it has a fairly important effect for us because then we would have the opportunity to do fixed-dose combination with Jakafi. And that would be a new way of approaching the initial treatment or the sub-optimal line of treatment for these patients. We are doing the same. We are following the same track with BET. So the BET inhibitor and the delta inhibitor, the goals are more or less the same. It's improving efficacy in terms of spleen response and symptoms. And you have seen with the BET inhibitor, some of the data from another company, and that's what we are looking at of saying, is that really something we can duplicate with our own product. And if you see -- if you look at the way the franchise would evolve, assuming that one of these 2 is positive, is that then we would be able to have a new FDC, a fixed-dose combination of RUX plus this delta or the BET in a way, obviously, that would be very different from what any competitors could do because nobody can do a fixed-dose combination with RUX till 2028 or end of '27. So that's the sort of the reason there. With the ALK2, we are looking at something very different is that by reducing anemia. And if you remember, there was a drug called momelotinib that was developed a few years ago that was multi targeted in some way. And one of the theory is that the ALK2 inhibition was helping reduce the rate of anemia. So we looked at that very carefully. And what we did is a very specific ALK2 that can be used in combination with Jakafi with the goal of improving the anemia profile, which would allow people to stay at the right dose of Jakafi, which we know is better than the low dose. And therefore, be on treatment longer and have a better outcome. And we think there are probably 20%, 30% of patients with MF and Jakafi who are in that situation where managing anemia would be a good thing. So I mean, if you look at the overall MF group of patients today, 20% to 30% of them would be addressed with something that is managing anemia and probably 30% to 40% more would be addressed with a better efficacy. So it could be a very powerful effect on the duration of treatment and on the number of patients who are treated, if we are able to be successful, both with ALK2 and the delta or BET.
Maneka Mirchandaney
analystAnd so then for the first-line setting, what do you think the incremental benefit kind of needs to be compared to Jakafi monotherapy to really get people to use a combo upfront instead of things, I'll try Jakafi first and see if it's working. And if not, maybe I add on a PI3 kinase delta or a BET inhibitor.
Herve Hoppenot
executiveNo, it's a good question. I think probably both viewpoints will be coexisting for a long time. I think we have a situation where there are a number of patients who are doing very well on Jakafi alone, and we have had patients with MF who have been on drug for like 7 years now. I mean, it's -- it can be, by itself, very -- enough to have a very good outcome. The problem is that we don't know exactly how to identify this patient from the get-go. So depending on what we get from the Phase III study, assuming we have superiority in spleen shrinkage and symptoms with the combination, I think physicians will choose which patient maybe should be younger patients. It reminds me a little bit of the CML story with Gleevec where we had the sub-optimal population and then we had the first line and what you found is that physicians were making their own decisions. And over time, the more effective product ended up being used as a standard of care. I mean that's what this story tells us.
Maneka Mirchandaney
analystYes. Got it. So we've heard a lot about MF and strategies to kind of improve on the Jakafi profile as well as extend the life of the franchise. We haven't heard so much on PV and what strategies there might be similar to MF where you could show an incremental benefit and improve outcomes as well as extend the life of the franchise. Why is that? And where do you think the unmet needs in PV are in a similar kind of vein?
Herve Hoppenot
executiveWith respect to MF, I mean, it's important to realize that it's not just like expanding the life over time, it's also expanding the size of the opportunity between now and 2027. So it will have an impact on the proportion of the franchise due -- that will be MF versus other indications. In GVHD, we spoke about itacitinib. I think if we can establish a first-line treatment in chronic, it will have also a good impact there. In PV, you have XR that will be available. So the once-a-day will be available. I think it will have potentially an impact on how much of the franchise is on the twice-a-day Jakafi, as we know it today. And we are looking at a number of new targets. We don't have -- we have not disclosed them yet, where the goal would be to have a different type of mechanisms that will be helping patients with PV. You can imagine, there are a number of biomarker-driven kind of thinking going on there. We have not yet disclosed the project themselves. So that's a place where, when I think about it, we have a number of things in MF that are going to expand that overall pool of patients. We have an approach in GVHD with itacitinib in chronic that could be making Jakafi twice-a-day obsolete in that setting. And in PV, XR is really what's going to happen in the short term. And then if we are successful in some of the projects that we are working on, being able to add new mechanisms that will be helping patients with PV.
Maneka Mirchandaney
analystGot it. I wanted to switch gears to topical RUX, obviously, a big focus heading into next year. Maybe just give us a quick snapshot of where you are right now in atopic derm and vitiligo for this program? What time lines are for submitting the atopic derm NDA as well as data readout for vitiligo?
Herve Hoppenot
executiveSo yes, you saw the data in atopic dermatitis. It was, I would not say surprising, but it was certainly as good as we could hope. So what we are doing now is putting the file together. The submission of the FDA will take place before the end of the year. So we are in December already. So it's fairly soon. And with the priority review voucher, it should be approved. If everything goes to the best possible scenario, it should be approved -- it could be approved by mid-year. So that would be like June '21, launch of eczema, the atopic derm indication for the cream. In parallel, the study in vitiligo is being finalized. We should have the results in the first half. So during the review of atopic derm, and we should be able to submit it to FDA after we receive approval in atopic dermatitis. So the sequence is: December, filing atopic derm; June, approval atopic derm; summer, submission of vitiligo. And hopefully, with a quick review, it could be approved in the months following that. So we are very excited about the potential for both indications. And we came a little bit with the vitiligo bias where we were looking at it as a place where there is no existing medical treatment with a disease-modifying effect. We are first of its kind to go there. There is a large medical need, not a cosmetic need, it's a real life-altering disease. And that's where we started. When the atopic derm data started to emerge, in fact, what became very visible is that in this treatment of atopic dermatitis, you have a Dupixent [indiscernible] on one side for the severe patients. You have steroids used as a first line for almost everybody with a smaller type of lesion. And then in the middle, there is this question that dermatologists are asking themselves is what to do because when there is a recurring disease, their itching is not going away as fast as they wish. And that is where RUX cream will be operating. So it's not going to really compete with Dupixent, but it has a level of efficacy that is not dissimilar to what we see with systemic drugs, and it has a safety profile that is obviously very good because of the lack of major systemic exposure. So it's a very promising product for both indications, and we are building the team to make the launch in the U.S. successful in 2021.
Maneka Mirchandaney
analystGot it. So just looking at consensus, it reaches about $1.4 billion in 2030, which, it doesn't seem too aggressive for a differentiated product and 2 large opportunities. I know you haven't given specific guidance here. But maybe just talk about your general comfort with where consensus estimates are. And also, how quickly you think these patients will kind of adopt topical RUX once it's approved?
Herve Hoppenot
executiveYou want me to predict the future around that. It's an exercise with risk. I mean the way we look at it is that it's a very asymmetric situation. So -- and frankly, it has been driving what we -- what the decision process of going alone and in the U.S. and building the team because what we see is that there are maybe 10 million patients diagnosed and treated with moderate -- mild and moderate atopic dermatitis in the U.S. So the number is so large that if you assume you give like 3 tubes or 3 months of treatment per year to this patient, which is what we have been observing, then you can multiply. And what you end up with is a number that is so high that the question is really, how is it going to be used in the practice of a dermatologist. And what we have done is work with the dermatologists based on their own patients. So we do chart reviews with them going through every patient and discussing, what would you do if that was available? Is that the patient you will treat, et cetera? And what it tells us is that in that indication of atopic derm by itself, there is a very large number of patients who are not Dupixent-eligible, who are not well-managed with steroids and where having a product like RUX cream would be appropriate. So from that point, we don't have yet set the pricing and, obviously, we are doing a lot of research about access and pricing and reimbursement. But what you see there is that there is potentially a very large number of patients. And then you look at the 1.5 million patients suffering from vitiligo, where today, only a few of them are receiving treatment because there is not a lot of available treatment. Many of them are receiving light therapy, which is expensive, it's reimbursed by many of the insurance companies. And it's very bothersome to the patient because they have to get it like many times a week for 1 hour. It's not very easy to receive. So when we do the same exercise of going through the charts from a dermatologist with a vitiligo patient and discuss who would be eligible for a drug like the one we have, again, we have a number that is fairly large. So the way we look at it is saying, it is unknown how big it could be. But we think there is a real potential that it could be very meaningful. It could add to the growth and diversification of Incyte. The fixed cost attached to building the team is around 200 people in the U.S., and that's what we are putting in place today. So it's like a $50 million kind of cost base, fixed cost base. There is a variable cost attached to the launch of the product, like marketing, advertising. And there, we want to make sure we do the right thing to be successful. And that, overall, is a very good business plan, I think, for the company, and that's what we are going for. I didn't answer your question about big sales, but what I'm saying is that it's a number that is -- that could be fairly meaningful, yes.
Maneka Mirchandaney
analystYes. Got it. Sticking on the JAK side for just 1 more minute. The hidradenitis program, I think, doesn't get quite as much focus in the pipeline, but you are moving into Phase IIb. So it's relatively late stage. How meaningful do you think this program could be? And what do you think the bar is for the Phase IIb readout as we kind of think about that data?
Herve Hoppenot
executiveYes. What we -- I mean -- so HS is obviously a very devastating disease. It is -- what we have shown with 707 -- 54707 is JAK1 selective product. And what we have shown in that setting is that you could have a benefit when you look at an endpoint, which is the number of -- how would I define?
Michael Booth
executiveIt's the AN count.
Herve Hoppenot
executiveOkay. And so what we are seeing is that there is proof-of-concept. We are doing the Phase IIb with different doses now. And that would be ongoing in 2021, and then we'll go to a Phase III. For a disease where today, Humira is the main product that is used, and where we'll need to see how it compares to Humira or how it can be used after or in combination, I mean we have not yet decided that. So we are in the phase where we are looking on how well the product is working in terms of what could be a primary endpoint for the FDA and the symptomatic effect of the product. And then we'll go from there. That program is a program that goes through a fairly phase-wise kind of approach, and we are now starting the Phase IIb. It's around 200 patients in Phase II.
Maneka Mirchandaney
analystGot it. Switching gears to Monjuvi. Obviously, another area of focus, particularly in the near term. Just give us a sense for how the launch dynamics are going in second-line DLBCL? How the initial talk and patient feedback has been since you launched? And also, how to think about growth in 4Q and 2021, if there's a group of people that have been waiting for this kind of therapy, particularly just given the lack of options in, like, a line setting?
Herve Hoppenot
executiveSo the treatment of DLBCL is fairly organized. I mean -- and so I'll drop the first line. And basically, the question is what do you do after that. And what we find is that most of the physicians in the U.S. are using Rituxan, again, in combination with some form of chemotherapy, and they are all kind of different regimens. So that's where Monjuvi belongs. It's basically saying after patients have been relapsing, following a Rituxan CD20 type of regimen, it is exactly where you should move to a CD19-targeted agent because there is a lot of biology around the mechanism of resistance to CD20. And so it's not like there is a pool of patients. You have to catch literally the patient when they are coming back to see the physicians. It is the only second line in a funny way -- not funny, but it's a little strange. It is the only second-line approved regimen in the U.S. and there are a number of third-line products. So that's what we are doing. It's basically working with physicians to educate them about the product and to help them identify the right patient for Monjuvi. It's doing well. I think the launch has been successful. It was one of these launches in the time of COVID. So it's a little exotic, frankly, from the -- how much you can meet with your customer and discuss with them directly. But it has been doing well. You saw the Q3, which were just the first few weeks on the market. We see the number of accounts that is growing, the number of people using it that is growing, and there is, in terms of feedback, a very, very strong positive feedback on the rate of complete response and the duration of complete response that you can see with the study that has been used for registration. So I think it's a project that is doing well. We are looking at going to first line, and you will see at ASH some of the data in the first-line regimen where we would be adding a CD19 inhibition to the CD20 inhibition in combination with chemotherapy. And that could be very interesting. It's a high bar. It's a difficult study to do, but we are moving forward with that study. And then we are looking at a number of other type of B-cell malignancies where it could be used. And frankly, there is one aspect of it that we think is very attractive is a combination with PI3 kinase delta where we are initiating a number of studies in different types of lymphoma that could be very important and interesting for us. So yes, it's a launch that was -- we got FDA approval a little bit ahead of the PDUFA date. So that was a good thing. And we have the teams working together between MorphoSys and Incyte to educate and to launch it in a successful way. And I think we are on a very good track.
Maneka Mirchandaney
analystCan you talk a little about Europe and ex-U.S. for Monjuvi and the extent to which you think the current data set should be able to support approval in some of those other territories as well?
Herve Hoppenot
executiveSo it has been submitted in Europe to EMA. We are in the process of the review. We said that the expected outcome will be in the second half of '21. And I would say, as you know, in Europe, single-arm studies tend to have a less favorable look than they have maybe by the U.S. FDA. It's not a good thing, it's just a fact of life. There is a lot of questions when you submit with a single-arm study. In that case, the rate of complete response and the duration of the complete response is a very strong argument. So we are fairly optimistic that it will go all the way and be successful, but it's not 100%. I mean, it's a situation where we have a number of investigators, who are based in Europe and doing this study who are supporting us. And the goal is, yes, to get to convince the EMA that the benefit risk is very positive. As you know, MorphoSys did an interesting design where there was a scientific control arm that was developed to look at what would be the effect of single-agent REVLIMID versus REVLIMID plus Monjuvi to show that it could not be due to the treatment with lenalidomide that, in fact, the effect of Monjuvi is visible. So that is part of a package that is being discussed with the European authorities. And we are planning for the answer in the second half of the year.
Maneka Mirchandaney
analystGot it. Looking ahead to ASH, which is coming up in a few days, the PI3 kinase delta space is getting more interest recently. Maybe just give us a sense for what differentiates parsaclisib? And what we should look for in the CITADEL program at ASH as well?
Herve Hoppenot
executiveYes. So ASH is a little bit of like the coming out of parsaclisib in lymphoma, where we have data showing that we can have a very high response rate in 3 types of lymphoma and at the same time, avoid mostly, not completely, but mostly some of the limiting toxicities of PI3 kinase delta that we have seen in the past. I think it's a class that has been not very well served by the first launches that we've done because the molecule had liver issues, and then there was this sort of immune long-term cumulative effect of PI3 kinase delta inhibition. What we have done is create a regimen when we have an induction followed by consolidation. We have removed the liver toxicity from the profile with better chemistry. So our molecule doesn't see the type of liver effects that you had with the first-generation molecule. And what we see now is what we were hoping, is basically maintaining a very high level of efficacy and at the same time, make the regimen something that can be given for a long period of time. So we are looking at this. And frankly, what it tells us is that there could be a new submission next year for parsaclisib in these types of lymphoma, and I think it's a good addition to our portfolio as a single agent for this type of disease, but as we said, parsaclisib is also developed in myelofibrosis in combination with Jakafi, is developed with Monjuvi in B-cell malignancies and even in some other indications. So it's a product that will become a franchise over time for Incyte.
Maneka Mirchandaney
analystGot it. In the last minute or so, I think investors are looking to see some more activity on the bids outside from Incyte. What's your latest thinking on the strategy for this Monjuvi-type partnerships, more bolt-on type transactions? Or do you think you might put all of your eggs in a smaller number of baskets?
Christiana Stamoulis
executiveSo in terms of business development, our priorities and the way that we're looking at opportunities have not really changed since we did the collaboration with MorphoSys. So we are continuing to be interested in bolt-on assets that we can bring in either through a licensing deal or through an acquisition, so we are agnostic in terms of the structure. But we are continuing to look for assets that could add to revenue diversification and growth, especially that mid-'20s time frame. And in terms of areas of interest, if you go back to the quadrant that Hervé described at the beginning, we are interested in opportunities in any of the 3 strategic quadrants. So MPNs and adding to deliver efforts there, heme-onc and also dermatology. But in all cases, we are looking for science-based programs. So we were doing some dermatology that is more challenging to find such problems. But definitely, there is an interest in all of those 3 broader areas where we can leverage our expertise, we can leverage our commercial presence and capabilities.
Maneka Mirchandaney
analystGot it. Awesome. I think that's all we've got time for. But thanks so much Hervé and Christiana for a really interesting discussion, and definitely looking forward to following up soon.
Herve Hoppenot
executiveGreat. Thank you.
Christiana Stamoulis
executiveThank you.
Maneka Mirchandaney
analystThanks.
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