Good afternoon, everyone. Let's go ahead and get started. This is the fireside chat with Arcutis Therapeutics. Happy to have with me on the stage the team from Arcutis. Frank and Todd, thank you for joining us. Really appreciate it. Before we get started, let me just read a brief disclosure statement. For important disclosures, please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures, and if you have any questions, please reach out to your Morgan Stanley sales representative. My name is Vikram Purohit. I'm one of the Biotech Analysts with Morgan Stanley Research, and let's dive into it. Frank, maybe we'll start with you.
Before we get into any sort of specifics on reimbursement, pipeline, et cetera, just start off by discussing how ZORYVE has been trending in psoriasis, and now with the foam and seb derm, versus your initial expectations for these categories, call it two years ago.
Sure. So I think the psoriasis got off to a little bit of a slower start, quite frankly. You know, I think there were some growing pains and some learning experiences for us for our first launch. You know, we had a very experienced team, but I think every product, every new product has its own learning curve. You know, I think one of the strengths at Arcutis is that we're pretty nimble learning organization. We learned from that launch, and I think we applied all those lessons learned for the seb derm launch, and I think you saw a very different response with the seb derm launch. And then, you know, I think early days. Still early days with atopic dermatitis, but it's going very well as well.
And I think very clearly, you know, we've been able to incorporate those lessons in the atopic dermatitis launch as well. So, you know, each launch, we're getting the system down better and better and better. And in particular, with Todd and the new Commercial team in place, I feel like we've got the right people behind us. So all three products, I think, are performing very well. You know, we've got good underlying growth of demand. We continue to make improvements on our gross-to- nets. I feel very good about where we are from a coverage standpoint. We're starting to make headway now with the government payers, and in the meantime, we continue to progress the pipeline, as you mentioned before. So I'm happy with how things are going.
Great. You know, the topical derm segment was a bit of an unknown. The branded topical derm segment was a bit of an unknown to a lot of investors and analysts about two or so years ago. I guess, what do you think, from your perspective, have been some of the biggest lessons learned in the category? Now, again, with two presentations of ZORYVE on the market, and what have been some of the, I guess, surprises to the upside?
The lessons learned, you mean for us
For
As an organization?
Yeah, correct.
So I, I think, you know, all the complexities around fulfillment and pull-through with topical products is different than it is for the systemic agents, right? And I think that that was an important adjustment that we've made. And one of the things that really has helped us to get our coverage where it is, is figuring out all of that. And having Todd and his team and their background and experience in this space, I think, has helped us a lot. I think the other probably big takeaway has been, it's just the force of habit, right?
Mm-hmm.
You know, anyone who's ever tried to quit smoking or stop swearing or lose weight or anything knows how it is, how hard it is to change habits. Dermatologists are in the habit of writing topical steroids, right? And they don't really think about it that much. They, they've been doing it every day since they started their residency. They do it 30 x a day. It's just sort of, like, automatic. And getting them to change that habit, that behavior, is taking time. You know, I'm encouraged because, you know, if you look at. You know, I worked on, I used to work on Prozac, and it took a while to switch psychiatrists from TCAs to SSRIs, and it took a while to get them to switch from neuroleptics to atypical antipsychotics.
It took a while to get people to switch from warfarin to Factor Xas , and, you know, go through a whole series of drugs. It takes a while for those habits to change, but once they change, it's a profound shift, and I think that we are starting to see that in dermatology, a move away from topical steroids. We're also starting to see the specialty acknowledge that they need to start moving away from topical steroids. Topical steroids are great acute drugs, and these are chronic diseases.
Mm-hmm.
Right? And they're perfectly fine for a couple of weeks, but if you're on them for months, you're gonna run into problems. And dermatologists, I think, are starting to realize that now that they've got really good non-steroidal options, it's time for them to start rethinking about their treatment paradigms in the topical space.
Do you think, there's going to be kind of a tipping point, where we see a sudden change in behaviors over time for the category broadly?
Yeah. No,
Something you just chip away at slowly.
If you look at these other markets that have gone through this sort of transformation, it's a fairly linear process, over, you know, a number of years. But, you know, by year seven, year eight, the majority of the market has converted over to the new class of drugs.
Mm-hmm.
You know, if half of the steroid market converts over, this is going to be a gigantic category, right? Because there are so many topical steroid scripts out there, and you know, I think, and Todd and I both feel, and I think Patrick, our Chief Medical Officer, agrees, our product really has the kind of profile where we actually could replace topical steroids in a meaningful way.
Got it. Got it. Okay. Another big area of focus for the category has been reimbursement. So on gross-to-net, I guess start off with just kind of recapping your progress from the psoriasis launch to now for the cream, and then also for the foam, how that gross-to-net is trending, and your guidance on the best way to think about kind of implying and calculating gross-to-net as you report out quarters.
Sure, yeah. Todd, you wanna take that?
Yeah. On the gross-to-net, as reported during the Q2 earnings call, our blended gross-to-net is in the high fifties.
Mm-hmm.
When you break that out by product indication, we think of the ZORYVE 0.3, the psoriasis indication, gross-to-net to be at a steady state, which is in the mid-50s%. Thinking about, we've been fortunate to have ZORYVE foam treated as a line extension with the payers, which means we get rapid formulary coverage, which quickly transitions to covered scripts. If you think about it, we launched in January. 75% or slightly more of all the ZORYVE foam scripts are now covered, positive impact on gross-to-net. It's getting close to that of the psoriasis gross-to-net. We think by end of the year, we'll be at a steady state with the ZORYVE foam.
Atopic dermatitis, you can think of that, it'll take a similar ramp up and slope and gross-to-net as it did with ZORYVE foam, because it will be treated as a line extension likewise. So we believe that, you know, mid-next year will be at a steady state, with atopic dermatitis.
Do you think the steady state in atopic dermatitis versus psoriasis versus seb derm, do you think the level of competition in each respective category or the lack thereof, maybe impact the steady state that each indication-specific gross-to-net kind of gets?
Yeah, I don't necessarily think the competition will have an impact on the steady state of the gross-to-net. I think it's more how quickly can we garner covered scripts. So how quickly can we get the formulary coverage? How quickly can we translate that to a covered script is what's going to really help accelerate these gross-to-nets. We've seen that with the ZORYVE foam and seborrheic dermatitis, how quickly it ramped up, and how quickly, over time, the gross-to- net has improved, and I think we'll see a similar trajectory with atopic dermatitis.
I think one of the real advantages we have with the various indications and formulations of ZORYVE is that the process for getting reimbursement is exactly the same, right?
Mm-hmm.
The offices has already figured this out. They've already got the systems in place. They know how to get it done, and I think that's one of the contributors to the rapid ramp up in the foam and what we expect to see with the cream. You know, I think the other. It's worth pointing out, too, getting into the fifties in your gross-to-net is a pretty significant accomplishment in the current day and age across any therapeutic area, at least on the retail side, right? And I think historically, one of the things that has undermined a lot of brand and topicals was their inability to get down to a reasonable gross-to-net, down in the fifties. A lot of them were stuck in the seventies, even some of the products in the eighties.
You're just not making any money with a gross-to-net like that, right? So you're generating volume, but you're not generating revenue. So we've been very focused on getting our gross-to-nets down as quickly as we could, so that shareholders actually benefit from the volume that we're generating at the patient level.
Got it. Got it. Okay, that's helpful. So on volumes then, psoriasis has picked up recently, right? What do you think is driving that script growth? Are there specific patient subtypes, prescriber subtypes, geographies that are disproportionately driving some of the script growth we're seeing on a weekly basis?
Yeah, with the recent growth that we've seen in psoriasis, I think it's twofold. I think that first, it's broad-based relative to the patient type. I think one catalyst of that has been the halo effect of the seb derm launch. Meaning that the more dermatologists that are prescribing ZORYVE foam, that may have not prescribed psoriasis, are getting a positive experience with the foam, and more willing to prescribe ZORYVE foam, excuse me, ZORYVE cream for psoriasis now. The other is we expanded our field sales organization July first. I think that's having a positive impact. I think what's important about that, is we expanded it meaningfully by about forty reps.
The representatives that we hired all have dermatology experience, but more importantly, established relationships with those offices where they can have an immediate impact. I think the other is, the seasonality. We're coming out of the, what I'll call the, the seasonality timeframe during the year, where, you know, the weather's changing, dermatologists are seeing more patients, and, the dermatologists aren't on vacation. So I think that's likewise having a positive impact on this trend.
You know, I think beyond the vacation piece, too, these diseases do wax and wane during the year.
Mm-hmm.
And as it gets warmer and wetter, all three diseases tend to get better in general, and as it gets colder and drier, they tend to get worse. And so, you know, we probably had some effect of that as we went in spring and into the summer, and now as we head into the fall, we should see a ramp back up in frankly, patients flaring.
Got it. Okay. Helpful context. In terms of refill rates and the annual utilization, where does psoriasis currently stand, and where do you think seb derm is going to get to once that launch is a bit more mature?
Yeah, so in regard to the refill rates where we currently stand today on psoriasis, the total volume there, about 40% of it is refills for psoriasis.
Okay.
On seb derm, where we stand today, of the total volume, 33% of that is refills. We're very pleased to see where we are, both on refill rates for both products. If you think about this, take psoriasis for instance. You look at our clinical trials. Within eight weeks, 40% of patients were clear or almost clear. I mean, they're using less product.
Right.
And so if you think about these topicals, on average, it's two to three units per patient per year. So we're on track with our refill rates and where we should be for psoriasis, and we see early signals on seb derm that that will likely exceed what we projected before as, as far as an average of two cans per patient per year, would likely be three.
Okay, so it sounds like two to three tubes or cans per patient per year is kind of
Where both indications are trending. Do you anticipate something similar for atopic derm? I know it's early days for the launch.
Yes, yes, yes, very similar for atopic derm.
Got it. Got it. Okay. And any feedback from the field on how both the cream and the foam for psoriasis and seb derm are being used? Are patients using it kind of in conjunction with topical steroids on certain parts of the body, or are patients that are adopting it heavily, kind of using it as their mainstay treatment?
Yeah, it really varies from doctor to doctor, patient to patient. You know, I think there are some doctors who are still comfortable, particularly if a patient is flaring, with maybe starting them with a high-potency steroid. I know there are some doctors who are starting the high-potency steroid and ZORYVE at the exact same time.
Mm-hmm.
And then, you know, two to four weeks in, they're withdrawing the steroid and then just keeping the patient on ZORYVE. Other doctors are doing sequentially, steroid to ZORYVE. A lot of these patients are, you know, are just being managed chronically as well. And, you know, ZORYVE is a better maintenance option than the other options out there today. And so, you know, there are some patients who are switching over to that as well. But I really think it varies from clinician to clinician, sort of how they employ ZORYVE. But across the board, you know, we're getting very positive feedback on the clinical experience. You know, the two comments we hear consistently, well, three comments I would say, is it's a very reliable drug, right?
Mm-hmm.
If they give it to the patient, they know the patient's gonna get better, and our data bears that out with, you know, response rates, you know, in excess of 90%. They get no feedback in terms of side effects, you know, with the drug, and that it's relatively easy to get coverage for it. You know, those are the three dynamics I think that are contributing to the steady growth of the product over time.
Got it. Got it. Okay. You have a branded competitor in psoriasis currently, right, through Roivant's VTAMA. What are you hearing from the field in terms of how doctors are choosing one option versus the other?
I would say, you know, if you look at the data, too, I think, you know, a lot of doctors have tried both. It's not an unusual thing.
Sure
To give both products a try. I don't spend a lot of my time and energy focusing on what's going on with the Roivant product. We continue to see our primary competition as being branded top or being topical steroids, right? Because that's where all the patients are. You know, their drug works. I think it's associated with some tolerability issues, which I think has been a bit of a headwind for them. Based on what we've heard them report, I think they're having a little challenges with their gross-to-nets, which, you know, again, I think a lot of topicals have had problems with that. But you know, look, I think this is a big market. There's room for multiple branded competitors.
We have a branded competitor in the atopic dermatitis space as well, which is, you know, a very good drug. I think there's room for both of us. You know, again, the name of the game really is the conversion of that steroid business over to the newer non-steroidal agents.
Right. Right. Okay, fair enough. A similar question for seb derm as well. Obviously, a much earlier stage of the launch there than psoriasis, but what are you hearing in terms of the patient benefits that are being reported, the level of disease control patients are reporting?
Yeah.
How they're using the product versus, you know, antifungals, for example?
Yeah, in seb derm, the foam is really a paradigm-changing drug. I can't I don't think overstate that. You know, the existing therapies were both not terribly effective, and not very convenient for the patients.
Mm-hmm
And you know, it required a fairly complicated regimen. So having a single drug that can be used anywhere for any amount of time and really fits into a patient's lifestyle, is a game changer for doctors and patients. You know, I got an email a couple of weeks ago from a gentleman who you know, had been suffering from seb derm his whole life and had tried everything. Nothing could control his disease. He read about ZORYVE foam on the internet, asked his doctor, his doctor put it on him. He said within a week, he had cleared, and he emailed me and said, "You know, your drug has literally changed my life." It was a very inspiring email.
I just got a photograph the other day from a doctor of a before and after of a patient with seb derm on the face, and profound improvement in a very short period of time. So I think this is really revolutionizing the treatment of this disease, and what we're starting to hear as well from some doctors is that it's so easy for them to treat seb derm with ZORYVE foam, that they're willing to treat patients that they might not have treated in the past, right?
Because it was going to be a very complicated regimen, and they're like, "You know, is it really worth the trouble?" Now, they're like, "Hey, you know, you've got seb derm, I've got a solution for you." So, you know, I think it's still too early to say, but we potentially could see some growth in the market even, which we didn't expect, with the launch of ZORYVE, because it's performing so well.
Got it. Got it. Okay. Obviously, a pretty sharp uptake curve for seb derm in the first couple of weeks and months. Where do you think it kind of stables out - stabilizes out? Excuse me.
I suspect we're probably in the kind of steady state...
Yeah
Growth trend here.
I believe, yeah, we are. Yeah. So the weekly growth that we're seeing now, you think that's sustainable for the, for the near to midterm?
Yeah, I think so. I think, I mean, with the seb derm, it's a big market. There's no competition within the market. So I think you can see that the trajectory we're on will continue on that trajectory.
Got it. Okay. So like we discussed earlier, you launched in AD recently with the cream as well, the 0.15%. How's that tracking versus what you expected? And, what do you think is the best way for all of us to interpret that launch curve when we compare it to your branded competitor through Incyte and then also through, through even psoriasis, through even seb derm, how should we frame what that launch curve could or should look like?
Yeah, so I think I said at the last quarterly call, right? That I thought it was gonna fall somewhere in between-
Mm-hmm
The psoriasis launch and the seb derm launch. It's tracking a lot closer to seb derm than the psoriasis, which I'm very happy to see. I have to say, I've been pleasantly surprised at the early uptake. It's still early days. We're about six weeks into the launch, but the uptake, I think, has been very good, and clinician feedback has been very positive. We're also making rapid progress on the payer front. I don't think we had that sort of warehousing phenomenon we saw with seb derm, right? There was just-
Right
There were no options in seb derm. There are other options in the atopic dermatitis space. The flip side of that is the AD is a very, very large market. And this is an ideal product for atopic dermatitis. And, you know, I think it's really important, it's the very first topical that's once a day, which especially if you're treating a little kid, I mean, that's a big difference for a parent, not having to strip your kid naked twice a day and slather them in an ointment, right? So I think we will be very competitive in a very large market. I think we can see really nice growth in atopic dermatitis going forward from the starting point. And the most important thing is that the drug performs, right?
And that's the feedback we've been getting from doctors.
Do you think you're competing for a different subset of patients versus OPZELURA, or do you think it's the-
Probably.
It's head-to-head.
Yes. Probably a slightly different patient demographic. I mean, it... Look, OPZELURA is a very good drug.
Mm-hmm.
I mean, there's no question about that. You know, the label's a little scary. And there are a fair number of hoops to jump through in terms of access and reimbursement. You know, ZORYVE has a very clean label, no boxed warning, no limitations on age, on well, I'd say down to age six, no limitation on duration of treatment, on body surface area. So it's, I think, well suited to compete against steroids and topical calcineurin inhibitors as a first-line agent. Some patients are probably gonna progress to Dupixent or OPZELURA, and that's okay. It's a big market, and that's just kind of normal course of clinical treatment.
Got it. Got it. How much kind of cross-indication use are you seeing with the different presentations of, of the product? So for example, the foam being used for psoriasis, the cream being used for seb derm, the 0.15% being in use in place of the 0.3%. Are you seeing a significant amount of that?
We don't see any of it, no. Because, you know, the insurance companies want to see an AD diagnosis for this, a psoriasis diagnosis-
Sure.
for that, and a seb derm diagnosis for the, this. If the dermatologist decides, "Well, you know, I think that's seb derm," that's what we see, is that it's a seb derm, you know, foam-
Sure.
For the seb derm, right? Anecdotally, do we hear about doctors doing that? Yes. It's difficult to quantify because it doesn't show up in the data. You know, we obviously don't ever promote our drugs off-label.
Sure.
But, you know, dermatologists know it's the same drug, and they can, you know, pick and choose.
Got it. Got it. Okay. So now that you're out there in three dermatological indications, do you have the motivation to try to study ZORYVE in more conditions like vitiligo, others?
And we have a fourth, right, that we filed already.
Scalp psoriasis.
Scalp and body psoriasis, and we expect probably approval in the middle of next year. You know, I think whether we pursue an indication, additional indications or not, is still to be determined. There are probably other applications for ZORYVE. You know, I think you're already seeing a large number of case reports of ZORYVE working in other disease states, and there've been any number of them published, including some, you know, rare and very difficult diseases. There was a poster at EADV last year on the use of ZORYVE in a very rare genetic skin disorder. So dermatologists are experimenting with it. You know, whether we go down the long road of getting FDA approval or not, I think we'll have to see. We haven't made any decisions about that.
You know, if we do make a decision, we'll let the investment community know. We have, you know, other pipeline programs, obviously, and so we're constantly evaluating, you know, what's the best way for us to deploy the shareholder capital that we have in the company, and we don't want to pursue indications where we don't think that we can create shareholder value.
Got it. Okay. Makes sense. If maybe we could switch over now to your recently announced partnership with Kowa. The first question: how did you come upon Kowa as kind of the best fit for broadening out the reach for ZORYVE to the primary care segment?
Yeah. So, you know, we've been looking at the primary care space for quite some time now, and thinking about who might be the best partner, and we really were looking for three characteristics. One, we wanted someone with an existing primary care sales force. Two, we wanted someone who was willing to put ZORYVE in a high-priority position, you know, first or second-position detail. And three, we ideally wanted someone who had done co-promotes before and had experience with what made those work. And as we went through and looking at the various opportunities, potential partners, you know, Kowa was one of the very few companies that met all three of those criteria, right? There are plenty of other companies that have primary care sales forces. Many of them would not give us, you know, a first or second-position detail.
You can probably guess at some of those names. And then, you know, there are a number of companies that didn't have primary care experience, or sorry, co-promote experience, excuse me. And so Kowa really just fit all the key parameters, and we were able to negotiate, I think, a mutually beneficial deal between the two companies.
Got it. And remind us of timelines there. When could they be out in the field, and when could you start seeing kind of a script uplift and sales benefit from that?
Yeah. Kowa will launch into the market at the end of this month, so they'll be actively promoting in primary care and peds. But we don't expect a meaningful impact until 2025 from their promotional effort. It's a long selling cycle within primary care, giving time to, you know, orient the physicians to ZORYVE relative to the fulfillment process. It will take a bit of time, but so 2025, we expect an impact.
Any initial thoughts on kind of what the scale of that impact could be, just when you consider the opportunity in primary care versus where you are currently?
I mean, I think, you know, as you look across the various diseases, about half of atopic dermatitis patients are treated by non-dermatologists, mostly primary care patients and pediatricians. About half of seb derm patients are treated outside of dermatology, and about a third of psoriasis patients are treated outside of dermatology, right? So these are really large opportunities in, and they're not obviously all in primary care and pediatrics, but a lot of them are. So there's a ton of patients sitting out in this space, and, you know, we think that this product is very well suited to use by primary care doctors. It's not complicated, right? There aren't any major safety issues. There's nothing scary in the label. So I think eventually, it could be a very significant contributor to revenue.
As Todd said, you know, I think it'll take a little while. This is a brand-new drug for them. You know, they, this is not bread and butter for them treating AD and seb derm the way it is for psoriasis, or for a dermatologist, you know. Probably half the patients that a doctor or dermatologist sees has one of three diseases that we treat, right? So, I think it'll take a little bit more time, but eventually, I think it will be a very major contributor.
Got it. Got it. Okay, and the timeframe for that partnership, how long does that last?
It's a five-year deal.
Got it. Okay. Okay, I guess taking a step back, we'll put scalp psoriasis to the side right now, just because you're not commercialized there. But, psoriasis, seb derm, and AD, if you had to kind of benchmark what those commercial opportunities could mean or could look like, and where could they stack versus one another for ZORYVE, call it three to five years from now, how would you kind of rank them?
Yeah, so we haven't given revenue guidance, but we did share, I think, last year's R&D day, that we think that each one of these products at peak could be somewhere in the $700 million to $1.2 billion range, and all, you know, roughly of similar size. You know, I think what will be interesting is that once we get the scalp and body indication, I think that the foam across scalp and body and seb derm is probably going to be bigger than the 0.3% cream, the psoriasis cream, right? Because you've got two indications with one formulation, and two formulations that are very well suited to treating their diseases, and then I think AD, the 0.15% will be quite substantial just because of the size of the market.
And then, you know, of course, we are getting ready to file a sNDA for two to five-year-olds as well, for atopic dermatitis, and we hope to do that, you know, late this year, early next year.
Okay. Give us a sense of what portion of the AD population that represents, the two to five?
Two to five is a pretty sizable chunk of AD in general. In dermatology, it's only about 10%.
Okay.
The young kids, a lot of them are being treated by primary care doctors.
Okay. Got it.
By pediatricians, excuse me.
Yep, understood. Okay. I guess for scalp psoriasis then, how would you contextualize what that opportunity could mean on top of these three indications? And do you see a risk of potential cannibalization with the 0.3% that's currently out there?
Maybe I'll start with the second one, because that's the easier one. I absolutely, I think that the foam will cannibalize the cream when we get the scalp psoriasis indication, and I absolutely don't care. The cost basis is... The price is the same, and the cost of goods sold is about the same. So I, you know, as long as they're writing ZORYVE, I don't really care. In terms of the opportunity, you know, almost half of psoriasis patients have scalp involvement. And, like seb derm, there really aren't good options for treating scalp psoriasis, right? You're using shampoo or a solution. You're having to use it, you know, multiple times a week. You're probably using a different drug to treat your body psoriasis.
So to have a drug that is very effective, very safe and well-tolerated, and a single drug that can be used everywhere in the body, on the scalp, on the face, on the elbows, on the knees, in the groin, they've never had a drug like that, right? And it just simplifies the doctor's job, and it simplifies the patient's treatment regimen. So I think that scalp and body is going to be a really important driver of growth for this product long term. And I think it will look a lot more like seb derm because it's so highly differentiated versus all the other options. And so we expect that to do very well, performance-wise. And yeah, I do think it will end up replacing the cream for a lot of psoriasis patients.
Got it. Got it. Okay. So quite a few moving parts here, but do you think that that there's potential for ZORYVE sales guidance at some point, once you kind of have steady state with all these indications?
You're not the first person to ask me that. At some point, yes. You know, I think that the challenge for us has been, you know, we've been commercializing now for just about two years, and in those two years we've had three launches, and we have a fourth one coming.
Mm-hmm.
And then we have the primary care partnership on top of that, right? So there's a lot of catalysts going on that create uncertainty around the top line. We don't want to start issuing guidance until we can issue guidance with some degree of confidence. I think that given that we're in the midst of another launch right now, and we're looking at probably another launch middle of next year, I think it's unlikely that we would issue guidance in 2025. You know, David Topper may have a different view. We'll have to see. But I think until we feel like all the indications are in some kind of steady state where we can accurately project it, we probably won't issue guidance.
Got it. Okay, fair enough. When scalp psoriasis launches, assuming approval, do you expect another uptick in your sales team, sales force expansion, excuse me?
We just mentioned we expanded the field sales organization. I think we're very much right sized for the ZORYVE portfolio to include the psoriasis foam product. The intent of this most recent expansion was to make certain that we could have the appropriate frequency and share of voice on the high decile, high prescribing physicians, and I think that we're very much right sized for that, and we're prepared to add ZORYVE foam for psoriasis into the portfolio.
Got it. Okay, great. And then from a pipeline perspective, what's your current focus for the pipeline? What do you want the pipeline to look like, call it three to five years from now? The announcement you had recently on the alopecia drug, kind of what are your aspirations for that product? I'd just love to get some context there.
Yeah.
and kind of talk about it.
Yeah. So, as you know, as you mentioned, we just announced, I think, this morning, that we have completed enrollment in the phase I study for ARQ-255, which is our topical JAK for alopecia areata. You know, we'd expect to see a readout from that study. It's a three-month treatment period, so you know, the last patient visit won't be till the end of the year. So you know, sometime in the first half of 2025, we'd see the readout from that. And it is a phase I, so the most likely readout is, okay, yes, we can progress now to phase II. You know, with alopecia drugs, you typically need to treat for six months to see hair growth.
The hair growth cycle is fairly slow, so, you know, I don't think people should have too many expectations of efficacy signals from this phase I trial.
Okay.
But we're hoping to be able to progress that into phase II. And then, you know, the other major focus is ARQ-234, which is our biologic. It's a fusion protein against CD200R, which is, you know, one of the newer checkpoint agonist or checkpoints in the immune system, been discovered. It's a checkpoint agonist, and so by agonizing the checkpoints, unlike a checkpoint inhibitor, you do the opposite, right? You tamp down the immune system, you reset activated immune cells. And I think there's some very compelling data around the target. We think we have a very good asset.
Mm-hmm.
and we announced at the Q2 earnings call that we expect to open the IND for ARQ-234 during twenty twenty-five. And then, you know, would be looking to move into the clinic at some point with that program as well.
Got it.
You know, in terms of looking forward, you know, we've got a very strong development organization, both on the clinical side and on the manufacturing side. You know, we have our own internal programs. I mentioned the two most advanced ones. We are always looking at other opportunities. You know, right at the moment, I don't think that business development is imperative for our company. We've got a lot on our plate. You know, if a really good asset came along, we certainly would look at it seriously, but I don't think that acquiring additional assets is something that we need to do, certainly right now, in the here and now.
Got it. If the alopecia therapy, if that progresses to phase II, and let's say you get an encouraging signal, would you want to keep prosecuting that independently, or do you think there's an opportunity to partner that and basically just kind of be-
We certainly-
I mean, be a part of a bigger company that's-
We can develop it ourselves.
Okay.
No question about that, right? I mean, we've done it now for four different products, developed successfully ourselves, and, you know, in terms of commercialization, it would slot in very nicely into the dermatology sales organization. Alopecia areata is a drug or a disease, excuse me, is predominantly treated by dermatologists, so I don't think that there would be a compelling need to find a partner for that. ARQ-234 is a little bit different because, you know, I think, like many other of the immune-modulating targets, it probably has application well beyond atopic dermatitis and potentially well beyond dermatology.
Mm-hmm.
Right. So I think we'll have to see how the field evolves, but that might be one where it makes sense for us to partner with someone, maybe if they want to develop in rheumatology or gastroenterology or something like that.
Understood. Okay. We have about less than a minute left. Maybe a good point to close out on is kind of your financial position. Just remind us kind of your current cash balance and how you're thinking about future financing needs for the company.
Sure. So we ended last quarter, Todd's to keep me honest here, but $363 million in cash in the bank. And, you know, we feel we're in a very strong position financially. You know, David has said, I think, publicly, on a number of occasions, that with our current set of programs, we don't anticipate the need to raise additional capital from equity markets. You know, we're generating revenue, and we continue to grow that revenue, and we think that combination, along with what we have in the bank, should be sufficient for us to continue to operate the company. You know, if we were to do something business development-wise, that may change, but again, we don't have any plans to do that at the moment. So, we think we're in a very good position.
We also just renegotiated our debt agreement, which will save us quite a bit of money in interest expense, and that, of course, is contributing to our management of the burn as well.
Got it. Great. With that, we're actually out of time, so good time to close out. Thanks so much for joining us.
Thank you.
Frank, Todd, appreciate it. Thank you, everyone.
Great to talk to you.
All right. Thank you.
Thank you.