Great. Good morning, everyone. My name is Jessica Fye. I'm a large cap biotech analyst at J.P. Morgan, and we're delighted that you are all here in person for the healthcare conference this year. We're kicking off this morning with Incyte, and I'm joined by the company CEO, Hervé Hoppenot. I'll pass it over to him.
Thank you, Jess, and welcome to everybody in person here. What I will do, I think the format for this year will be a 20-minute presentation, and then we can have a Q&A for the following time. Let's move to the next slide. Obviously, I will be making forward-looking statements in my presentation, so refer to the SEC document we have on our website. To start, what I would like to do is a reminder of who is Incyte and where we are today. As you can see on the slide, I mean, it's really a fully integrated company from discovery to commercial. We have 3 different platforms we are working with in drug discovery.
We're obviously in small molecule, which is historically where we come from, and you can see the list of products that have been now put in the clinic, and some of them are commercially available. We have now a monoclonal antibody development team and a bispecific antibody development team with a partnership with Merus. On the clinical development side, there are three teams working in parallel. One for MPN, which is GVHD, which is basically the life cycle management of JAKAFI, one for cancer and hematology, and one for dermatology, which is one of the key points of the past few years, is our expansion into dermatology. On the commercial side, we have 6 products coming from our pipeline approved in the U.S. and in Europe, four commercialized by Incyte in the U.S., three in Europe, the other being partnered.
In Japan, we have four approved product and one commercialized by Incyte. That's sort of the picture we are starting from. On the revenue side, if you look at the past, five years, you can see that, we have been growing at a fairly high rate, you know, between 10% and 20% some percent per year. We are now in 2021 around $2.93 billion, in fact. For 2022, we will be, on the same type of growth rate, as you can see from the guidance. Today, I will be speaking about Q3 2021. I'm not going to speak about Q4.
A very dynamic growth of our revenue over the years, and at the same time, as we have been investing in R&D and continue to invest in R&D, investing in the commercial side of the business, we have been able to create leverage in the P&L with the growth of the top line year after year as we are growing expenses at a lower rate than we are growing our revenue. That's the sort of the picture we are starting from. What I would like to do is to zoom on 2022, which is a very important year in some way. It's a sort of a pivot of the entire portfolio, where, as I said, we had 16% growth of revenue after three quarters.
We had a number of regulatory approvals around the world, some of them for small indications, some of them for very important indication like JAKAVI, ruxolitinib in GVHD outside of the U.S. and Europe. Olumiant, our partner product with really for alopecia areata, where it is the first product to be approved for that indication. We'll speak about it, obviously, OPZELURA for vitiligo in the U.S. being the three most important. We have two files under review. One is our vitiligo submission in Europe, and the other one is a QD ruxolitinib in the U.S. That's sort of the picture for 2022 of what's important, and obviously, OPZELURA being one of the key comp...
new component of the portfolio and being very successful with around 150,000 patients treated after 3 quarters, which, as I will describe it, is a very good number and a very important perspective for the long-term future of our portfolio. On the pipeline in 2022, the important part are povorcitinib. It's a long half-life, very selective JAK1 inhibitor oral, where we have positive data in HS. The progress with our oral PD-L1 program, which as you can imagine, is very important, has large potential and has moved now to the next step. A number of presentations that were done at ASH on PI3Kδ, parsaclisib, our ALK2 inhibitor, and a new monoclonal antibody, CALR, going into the clinic this year, and it was part of the plenary session at ASH.
It was certainly an important step. Key highlight of 2022. Now looking forward, and that will be what I will be trying to describe quickly in the next few minutes, is how are we going to maintain the growth and at the same time, continue to diversify our portfolio. We have basically four components of revenue that are impacting the growth rate. It starts with MPN and GVHD, so JAKAFI today, and all the expansion of that portfolio that we call LIMBER. As you can see, we have a number of projects there. We have a hematology oncology portfolio that is made of different products, starting with MONJUVI.
We have a program in autoimmune hemolytic anemia, and our oral PD-L1 small molecule, and then two programs that are early coming from our own research with the A2A/A2B CD73 and the CDK2 inhibitor. The short component is dermatology, and you will see the list here, and I will go in some details on that, and then the royalties we are receiving through our partnership. Let's start with our MPN and the JAKAFI. I think, looking backwards, looking at the past history of JAKAFI, it's really important to realize that it's a great example of what we tend to do at Incyte.
In many ways, you can think of it as something that is a sort of a blueprint for some of the other products that we are developing today, including OPZELURA, where it's a sequence of indications, sometimes in relatively small indications, each of them taken individually. In all cases, in indications where there was no other FDA-approved product available at the time when JAKAFI was approved, and obviously growing a franchise to become, our guidance is north of $3 billion in the next, at peak. It's an example on how over a long period of time, we can create meaningful franchises with good science and good clinical development, and obviously the ability to commercialize in this type of indications that are relatively specific.
I must say on this slide also that in December we received approval in pediatric ALL for JAKAFI in the U.S., which is in fact the official trigger for the pediatric exclusivity for JAKAFI. Now we are officially speaking of the first possible loss of exclusivity for JAKAFI would be in end of December 2028, so it will be for 2029. When you look at MPN, MPNs are 3 disease that you see here, myelofibrosis, polycythemia, and ET, essential thrombocythemia. The current situation with JAKAFI is that we have around 55% of patients being treated with JAKAFI in MF and around 25% in PV. JAKAFI is not approved in ET. Obviously, it gives us a lot of potential to continue to expand.
The list of projects that you have at the bottom of the slide is basically trying to address how we can go beyond what is the current JAKAFI patient pool and also improve over JAKAFI in term of safety and efficacy over time. ruxolitinib XR is a simple project. It's basically a QD formulation of ruxolitinib. It's very important for combination and fixed dose combination. You have BET CALR, PI3Kδ , ALK2, and I will speak about that. CK0804 . CK0804 is a project we have with Cellenkos. It's an umbilical cord Treg that is used in MF, where the first patient are now being treated.
If you zoom to myelofibrosis, what you see is that 18,000 patients who are the available pool of patients for the U.S., we said 55% of them are on JAKAFI. You have different population of patients on JAKAFI, some of them being well controlled, and that's the best scenario. Now remember that in myelofibrosis, all patients at some point are going to have progressive disease. We are in a situation where some patients will be controlled for years. We have patients who have been like six years on JAKAFI and being fully controlled, but at some point it will become a problem again. You have a number of people who are sub-optimal responders to JAKAFI, but staying on JAKAFI because of the only option that they have.
You have patients who are on a subtherapeutic dose of JAKAFI, mostly because of anemia. I will speak about it because it's very important. You have a number of patients who have been previously on JAKAFI, so they are basically refractory in some way to the treatment, or they had to stop because of side effect, mostly anemia. There are around 25% of patients still today who are in a watch and wait and watch kind of mode, where basically, there will be physician would be waiting a little bit before they would start treatment.
What you see in our LIMBER program is that we are trying to address each of this population with very specific approaches, where ALK2 will be certainly helping all the patients where anemia from MF or anemia from JAKAFI could be a problem, where Delta and BET have exactly the same profile of improving efficacy for patients who are not fully controlled, and where CALR will be creating a completely new way to think about treatment of this disease, with identification of the patients who have the mutation and treatment with targeted products that can have a disease-modifying effect. 35% of patients are in that situation.
Speaking more specifically about ALK2, because I think it's a very important project in this portfolio, you can see here patients who have been treated with ruxolitinib plus a low dose, low-ish dose of ALK2, 100 mg QD. Basically what it shows is that from the mechanism that was expected, which is hepcidin reduction, you can see it happening in these patients. Now in the last data that we just presented at ASH, you can see that in fact hemoglobin in some patients, it's two patients out of the four patients that were treated at that dose, hemoglobin is moving up, which would not happen spontaneously.
We are in a mode now where we believe, in fact, the mechanism is what we were hoping and expecting, and we are moving to the next step of development, of continuing to increase the dose and potentially move to pivotal studies. In the case of CALR, it's a preclinical project. What makes it very interesting is it's a lethal approach to mutant cells, so it can have a disease-modifying effect, as you can see on the left. On the right, if you look at the model of mice where we are basically injecting mutant CALR cells, you can see that by using that product, you can have sort of normalized bone marrow for these mice, which is obviously what we expect, hope to see in a human.
Would have a very deep effect on the treatment of not only myelofibrosis, but also ET, essential thrombocythemia, where there is a large number of patients also with a CALR mutation. That's for LIMBER for 2023. As you can see, we have a number of expected event for the year. The approval of axatilimab is the PDUFA date is March 23rd. We will get what could be pivotal data for axatilimab in GVHD in third line around mid-2023. We have all the progress we are making with axatilimab ruxolitinib in earlier line of therapy, with CALR, with parsaclisib ruxolitinib and BET and ALK2 over the year. Very important year for the LIMBER program. Moving to the hematology oncology, other hematology oncology beyond the LIMBER program.
You can see the, some of the programs that we are running here with very interesting studies being done in warm autoimmune hemolytic anemia with parsaclisib, two large program with tafasitamab. Still in the proof of concept stage, I would point out the CDK2 program, which is coming from our own research and now in the clinic. The PD-L1, oral PD-L1 program that, as I said, is making a lot of progress. I would spend a minute on it, on trying to answer the question of why would anybody be interested in an oral PD-1, PD-L1 type of product, because that's, I guess, what a lot of people are asking. As you can see on the right, it's an active product, so we know it has activity.
We know the safety profile is very good for that molecule. If you remember, we had another one where there was an issue with peripheral neuropathy. We are now in the mode of looking at how we can apply that to where it is needed. The first and most important feature of that new product is the ability to switch off because of the short half-life. There are a number of patients who are suffering from immune-related AEs from treatment with, you know, checkpoint inhibitors, and having a short half-life with an oral product gives you the opportunity when you stop taking it to cease these side effects, having a very much shorter duration. It's very important. Sometime even, you know, helping patient recover from them. That's what we are looking at.
Obviously, it means in many cases that we will be doing studies in combination with other product in that field, like CTLA-4. The other thing is that we can do oral-oral combinations. We have studies ongoing with axitinib and with KRAS inhibitor from Mirati. That's an important feature. It can have the same benefit of being able to manage potential toxicities, and obviously the convenience and the dosing flexibilities, the lack of cost of infusions, the time saved in term of chair time, et cetera, et cetera. That project is now moving well, and we will have, I think a number of updates during the year 2023. Now, moving to the dermatology, which is obviously the new part of the organization. The launch of OPZELURA has been very successful.
I spoke about the 150,000 patients being prescribed in the U.S.. The launch in vitiligo took place in Q3, so it's still very fresh. We are seeing the growth in atopic dermatitis still growing at a good rate. Now we see the addition of vitiligo to that. As you can see on the right, the profile of OPZELURA is very unique there. It's all in atopic dermatitis about efficacy and the speed of each reduction. If you have eczema, if you know somebody with eczema, you can literally try it and you will see it does something very different from many of the other topicals or all of them. Then in vitiligo, it's obviously the first and only product with a repigmentation endpoint approved by the FDA.
You can see from a clinical study what the, how it can change, you know, the life of patients suffering from vitiligo. In that, in that field, if you want to, you know, to follow the launch of OPZELURA, I recommend going to the, on the Internet in many of the sites, you know, like Reddit and TikTok and others, where you start seeing, and these are taken from this site, you start seeing on social media, you start seeing the patients, basically the community working together and following their own progress while treated with OPZELURA. As you can see, it's fairly striking and relatively fast, in fact, even compared to what we had in our pivotal study.
In addition to the U.S., we are planning to launch vitiligo in Europe this year in 2023. We believe, in fact, OPZELURA in atopic dermatitis and vitiligo in the U.S., in vitiligo in Europe, has the potential to be one of the large product in our portfolio. We just recently were issued a method of use patent for OPZELURA in atopic dermatitis and vitiligo based on our unexpected high clinical success in the phase III s. That data is included in the label. What we are now expecting is that the generic, the first generics of OPZELURA could be available not before 2040, which is obviously giving us a very much longer life for this important product. The development of OPZELURA is not stopping now. We have these two indications.
As you can see from the slide, we are planning to get pediatric atopic dermatitis as the next indication, and the study should be completed this year. We have three indications we have disclosed where we are starting phase II in lichen sclerosus, lichen planus, and HS in a subpopulation of HS. It's a product, it's a franchise with a long life from the commercial standpoint, and we are very optimistic about how it's going to evolve. It's not the only thing we have in dermatology. As you can see, OPZELURA is a big part of our program, but we have two additional products. One is povorcitinib. It was called 707. It's a JAK1 inhibitor.
It is now in phase III for HS, the severe form of HS. We have two studies in vitiligo and prurigo nodularis, phase II , randomized phase II s that are ongoing, and a new product that maybe I will say a word about in the minute I have left, which is also an important part of vitiligo. This is povorcitinib, JAK1, with, which is a product, now that has been in the clinic for a number of years, so that if you are not familiar with HS, it's a very debilitating disease. It's a chronic disease. It's very painful. It has a lot of impact on the life of patients who are suffering from HS. There is no oral treatment available for treating HS. Now povorcitinib is in phase III .
We are speaking of around 150,000 HS patients with moderate or severe form. As you can see on the right, it's a phase II study in over 200 patients. There is a very clear efficacy coming from povorcitinib on the AN count in that study. You also see that there is maybe a plateauing of the efficacy for doses above 45 mg. The phase III we have ongoing is 45 versus 75 versus placebo, and it will be, it is starting, and it will be available in the next year. The last thing I would say about our dermatology portfolio is auremolimab. It's a new monoclonal antibody against IL-15Rβ, and it is now entering the clinic, and it has a very interesting mechanism.
You can see on the right the studies that have been done, where it will be addressing, you know, what is the cause for relapse in vitiligo, which is the memory T cells, and it will be shutting down this aspect of vitiligo. It will be very complementary to what we are doing with the JAKs, both as a cream and as a systemic treatment with povorcitinib. A new component of our vitiligo. We are very committed to vitiligo patients and frankly make this a disease of the past in many ways, and that will be one of the component of our portfolio. I will stop here. Just a reminder on the, you know, what's coming over the next few years. It's a long list. It's fairly exciting.
There are teams working on each of these project, I truly believe there is certainly a very bright future for Incyte in term of growth over the years in each of these categories. The JAKAFI, the lifecycle management, the new product in cancer, and the dermatology franchise. I will stop here with a slide of the news flows that you can expect from this project in 2023, I thank you for your attention. We are moving to the Q&A.
Great. There are gonna be mic runners in the room. If you want to ask a question, feel free, and I think we can have a couple other members of the management team come up here, Christiana, the CFO, and Steve, the Chief Medical Officer.
You want me to stay at?
Up to you.
It's up to you. I'll stick with them.
Great. Just as a reminder, there is a portal where you can ask questions too. That'll send them to me on an iPad, and I can ask them for you if you want. I guess maybe just to start off.
I'll take it back.
... you took a look back at JAKAFI's growth. It's obviously continued to grow year after year for quite some time. How should we think about the growth rate from here looking forward? Kind of the existing indications, where do you see the greatest growth opportunity?
What we see for JAKAFI twice a day, which is the JAKAFI that is available commercially today, we are seeing growth in MF, and it's entirely driven by the new patient flow, is that JAKAFI is the standard of care for patients newly diagnosed with MF. In fact, as you see, there is a reservoir of patients there that are in a wait and watch or, you know, kind of situation. Part of it is because there is no good second-line therapy. People will be waiting a little bit for patients who have symptoms that are fairly limited and say, "Maybe it's better to wait a little bit, and then we'll start treatment when it's necessary." Part of it could be because they don't want to face potentially some of the side effects.
I think there is, in the dynamic of the next 5-7 years, where we will be developing a number of option as a second-line treatment for suboptimal responders. We and other companies will do that. There will be an earlier treatment in MF, and that will continue to grow our JAKAFI business. In PV, there is a lot of room. Many patients are not being treated with JAKAFI for multiple reasons. It's a little bit of the same saying, does it justify, you know, the treatment and the potential side effect?
It's also, frankly, with the co-pay, and I believe Medicare, the new Medicare IRA capping of the co-pay for patients in the U.S. will be helping PV because that's a case where we know, we don't know how many, but there are patients who are not getting treatment because of that. GVHD, there is a lot of room to grow in GVHD, where we are still in the launch mode for chronic GVHD. As I was describing, we have a number of projects with axatilimab that will be helping in the third line. Frankly, we are expecting to grow in the first line with a combination of JAKAFI axatilimab. That will be a steroid-free first line for GVHD, which obviously will be very valuable. We see that, and then we have the entire expansion of what this portfolio will do.
You can imagine that if we are able to treat patients with a suboptimal response to JAKAFI with one of our new combination, it could be parsaclisib, it could be BET. The parsaclisib phase III will be available at the end of this year, so it's coming relatively soon. We will extend the duration of treatment, and that will have an effect on the overall revenue here. If you think of something like CALR, it's a disease-modifying type of approach. Now it's pre-clinical, so we need to be careful. It's, we need to do the study. If you assume that this is successful, it will expand the market if there is such a word.
The number of patients who can benefit from this treatment in a very meaningful way in MF and in ET, where today we don't have a lot of use from JAKAFI. The way we see it is a number of years of expansion and in many ways, transformation of the standard of care in a way that will give the entire franchise a long life.
You mentioned the QD ruxolitinib, I think at ASH there was an allusion to the possibility of maybe not launching that sort of like the day it's approved. How are you guys thinking about when it's optimal to launch that product and kind of how it fits into your portfolio?
No, yeah, it came a little bit as a surprise from the IRA in that, you know, from the new Medicare system. We had to sort of look back on how, what was the consequence of this new rule on something that is in the writing of the regulation part of the line extension. We have to make sure, some of it is not totally clear yet. I mean, the way we think about QDs, first, it's better to have a QD than twice a day, but frankly, it doesn't make a huge difference. There may be some effect of having a smoother PK curve that we need to establish, and it's not done yet, but that will be some work to do.
Obviously, the QD is extremely valuable because when you combine a once a day with a once a day in cancer, it is far safer than combining a once a day with a twice a day oral drug. Think of twice-a-day JAKAFI combined with parsaclisib or BET or any of these products. They're all once a day. In fact, all the new products are once a day. It can create a lot of issues. The ultimate goal of the whole program is to do fixed-dose combination, where we will have a pill that contains ruxolitinib once a day and parsaclisib, ALK2, BET.
Each of these products can be combined in a fixed-dose combination. That will obviously give a very clear commercial advantage like we have seen in HIV and, you know, in many different type of disease, where being able to do it when others cannot do it is going to be a big advantage. That's the three things, is make it available, do the combination work, and then do the fixed-dose combination. All of that is going to happen over the next five years. The exact date of the QD launch, I told you the PDUFA date is in March. We are looking at more specifically, and maybe we'll need clarification on what would be the impact on the catastrophic coverage discount that we have to give, because that's not yet fully clear.
Okay. maybe switching to OPZELURA, I think you guys have talked about pulling back on the full buy-down program, in order to kind of help gross-to-nets. Has there been any disruption to volume as you've kind of worked down that program?
It's not to help growth to net. It's basically the plan, the buy-down program was a program we put in place at launch with the idea in atopic dermatitis that if you use it, you will love it. That was literally because we knew from patients who have been treated in the studies, the feedback was, It has this product, has a soothing effect on eczema. It's removing the itch, the scratch, and it has an anti-inflammatory effect that has long-term maintenance. I mean, I showed the slide. You have 80% of patients will never need to go to any other treatment after 50 weeks of observation. What we did is telling physicians, "This is a new product. It's completely different from what you have had in the past.
You try it, and we will cover the cost if your insurance company is not covering it, which is most of them at the beginning. From the beginning, the plan was to do that, and then when coverage is increasing, to stop it, and that's exactly what's happening. The buy-down program is not happening anymore. We still have a patient support program that is basically when patients unfortunately are not covered by their insurance company, we will take care of them, but it goes through a different process with a free drug process. That's where we are, and it's, I think it has been a very important part of the perception of OPZELURA at launch was the feedback from patients to their physician was very in eczema. You know, in vitiligo it's different. You saw the picture.
The question is how fast can people see the repigmentation take place? In eczema, it's literally patients going back to the physician saying, "Wow, this is really different.
Mm-hmm. It, it looks like at least the data that we can see OPZELURA scripts are continuing to grow...
Yes
... nicely, but I know you said the data might not be as reliable.
We don't-
Christiana, how are they feeling?
We are tracking obviously very closely the IQVIA data and how the scripts in IQVIA track to actuals. In a few weeks, we have earnings, so we will be sharing with you an update of how they compare as well as what the IQVIA data includes in terms of scripts and how to interpret it going forward.
One of the other questions we kind of hear and kind of debate with investors is between AD and vitiligo, which should we think of as kind of the larger commercial opportunity? I'm curious if you guys have any updated thoughts on which will ultimately be the bigger driver.
It's like a Sophie's choice. I mean, I don't know. We know, you know, we gave some long-term guidance on atopic dermatitis, and we believe, and I know it sounded a little bit ambitious, I guess, but now we are showing... We are seeing the curve, and it becomes very realistic that, you know, the peak sales for OPZELURA in atopic dermatitis could be around $1.5 billion for the U.S. alone. When you divide by the number of tube and the cost, what you see is that it's like, you know, 400,000 or 500,000 patients in a pool of 5 million. It's not completely unrealistic. It will take time, but that's it. In vitiligo, we are dealing with, I was showing like 1.5 million patients suffering from vitiligo.
Many of them have given up on seeing a dermatologist. In fact, some of the picture you saw, we spoke to them, and they were in that case. The question will be. There is around 150,000 patients in the U.S. seeking treatment for vitiligo. There is no other approved product for vitiligo than OPZELURA today with a repigmentation endpoint. You have the sort of low-hanging, 150,000 patients, and then the question is how many of the 1.5 million will go back to their dermatologist saying, "Hey, I saw it on Reddit, and I want to, I want to try it for myself." That's the unknown of vitiligo, and that's why we didn't give guidance for vitiligo.
If you multiply and you look at the usage, the number of tube per patient for vitiligo, every 10,000 patient will be around $100 million of business. That gives you a scale of what it could be. We believe internally that there is a very, very large potential for vitiligo because it's a semi-chronic treatment. Many patient will use the cream over a period of 50 weeks. You saw the curve, it's improving over time, so.
Yeah, it seems like at least based on our physician calls that the physicians very much understand that for vitiligo you need to kind of keep patients on and kind of have them kind of wait it out a little bit before they see, you know, benefit. I think you just suggested that sometimes it's happening pretty quickly. Is it playing out any faster than you expected?
I think, you know, when you look at the curve we showed, which is the curve of the different percentage of repigmentation, what you see is that as early as 4-8 weeks you start seeing repigmentation. I think that's the key. Nobody is expecting a full repigmentation after one month or two, but when patients are seeing that in time, you could see the picture, I mean, they are speaking for themselves, that when you start seeing the repigmentation takes place, then patients are literally very compliant with the treatment and continuing it. Then we go to what could be described as full or quasi-full repigmentation. There the question will be, what do you do? Do you continue or do you stop?
That's a study that we have ongoing that will be probably in fact available next this year of what to do when you reach a level of repigmentation that is almost 90% +.
Mm-hmm.
We'll have data this year to give guidance on what to do at that point.
Like, what's the best-case scenario for you on how that data plays out?
I think both are good. If people are not relapsing, it would be beautiful because then patients will be very motivated to go through the treatment knowing that at the end it's done. If we see that some patients are relapsing and that continuing to use OPZELURA is the best way to prevent it from happening, then it would be very useful guidance for them. We are totally, you know, We don't have a preferred outcome. I think both of them are good for patients and therefore will be good for OPZELURA. I mean, the number of patients that could potentially be treated is so large, it's not a question of, you know, adding a few months of treatment for a patient.
Okay. Maybe I'll ask just one on the pipeline before we run out of time. On the LIMBER-304 trial, can you qualitatively talk about the type of spleen size reduction or the type of symptom score improvement you think would be clinically meaningful?
Yeah, sure. Just a reminder, the study's in what we call suboptimal ruxolitinib responders. They've been on therapy for at least three months and at a stable ruxolitinib dose of at for eight weeks before coming on study, but still having an inadequate response in terms of either spleen reduction or symptoms or both. And then we're measuring in the study, spleen volume reductions at 10%, 25% and 35%. We'll have it across the board as well as symptoms. In the phase II data, It improved over time. If you look at the 12-week endpoint and then the 24-week endpoint, there was an appreciable increase in spleen volume reduction and then an even better response in terms of symptoms.
Somewhat surprisingly actually, but the symptom responses were upwards of, you know, 30% at 12 weeks using an MPN-SAF and then upwards of 50% of them responded at 24 weeks. It's both. We think, you know, for approvals in this space to demonstrate clinical benefit to regulators, you'll always need both. The first line endpoints are well established. It's spleen volume reduction, 35% plus symptoms to get across the board. We think for a suboptimal study, you'll need to demonstrate both. If we replicate the phase II data in our phase III , we're pretty confident we'll have a positive study and be able to submit it for an approval.
Okay. Great. Well, we're about out of time, so we'll leave it there. Thank you very much.
Thank you.
Thank you.