Arcutis Biotherapeutics, Inc. (ARQT)
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Goldman Sachs 45th Annual Global Healthcare Conference

Jun 12, 2024

Speaker 2

Sadly, we're not as much in your neighborhood, and thank you for trekking all the way across the country for the weather.

Frank Watanabe
President and CEO, Arcutis Biotherapeutics

Yeah, the weather.

Speaker 2

Yeah, no, it's been a little bit dicey, but you're making yourself here physically present very valuable and much appreciated. So let's catch up a little bit on Arcutis. It's been a story that's been going through a lot of the evolution. You were always trying to do important, but sometimes difficult things, including looking at markets that maybe don't get as well appreciated by the traditional big pharma companies, making sure that you're interrogating and approaching things in tactics that are slightly differentiated. Not everything has necessarily worked, but we're coming through a more challenging period here. So tell us a little bit about Arcutis and how you're feeling about where we're at with the company and the objective mid-2024.

Frank Watanabe
President and CEO, Arcutis Biotherapeutics

Yeah, I think you encapsulated sort of our approach well. I think we're a little bit of orthogonal thinkers. You know, we were created as a company to address what we saw as a gap in dermatology. You know, people weren't really innovating in some of these larger markets, you know, where biologics maybe aren't appropriate. And we saw an opportunity to really come up with innovative new therapies that address unmet needs. And I think it's always challenging launching drugs, right? But, you know, I think things continue to evolve and improve. You know, we launched our first product, the cream for plaque psoriasis. It's coming up on two years ago. It was approved in July of 2022. I think that product continues to gain momentum. And, you know, the clinician feedback has been very good.

Then we had the approval of our foam in seborrheic dermatitis in December, which I think is one of these neglected diseases that you mentioned. And that launch has been, I think, gone phenomenally well. And I think that's partially a reflection of prior experience with ZORYVE cream. The doctors knew the drug already, right? And they felt confident with it. But also it was a reflection of the lack of innovation and the high unmet need in seborrheic dermatitis. And so we've seen a really nice uptake in the foam as well. And then we're waiting eagerly for the final word from the FDA on the approval of our third product, which is another version of our cream for atopic dermatitis. That PDUFA is July the 7th. And, you know, so we'll be launching in atopic dermatitis sometime later this summer.

And then we have communicated that we plan on filing for our fourth approval in scalp psoriasis sometime during the Q3 of this year. So lots of exciting things happening. Product continues to perform clinically very well. And I think one of the other areas that, you know, we've tried to innovate is around access and reimbursement. That also continues to go very well for us. You know, we've had good success with the cream in commercial coverage. We are now starting to pick up Medicare and Medicaid coverage. Had a Florida win actually earlier this year. So we're on formulary for Florida Medicaid and expect to see more progress on that front as the year progresses. And the foam has done very well on coverage.

That's allowed us also to then, you know, really get our gross-to-net down rapidly to, you know, what we think is close to being steady state pretty quickly on both products.

Speaker 2

I think it's interesting, you know, you're a veteran in the industry. You come from a heritage where there's a lot of understanding of scientific and clinical development yourself personally. The company is based in Westlake Village, which obviously is the home to one of the large cap biotech and biopharma brethren. And so there's a lot of insight and capabilities and know-how within that ecosystem, within that community. I was always struck by the fact that there's this identification of opportunities for which there's typically initial skepticism in terms of like the usual playbook of just, you know, where do you go? And I think particularly for dermatology, you know, you always see moderate to severe, actively, you know, sort of progressive disease.

The real landscape of patients out there and the magnitude of clinical unmet need probably is a bunch of kind of silent people, except for the sound of a lot of scratching that's probably happening, who have more or less mild and moderately active disease. They're like, hey, what about us? What are we able to do to address our symptoms where we're not hospitalized, but we have significant needs? Boy, there is amongst clinicians and patients kind of almost a psychological gulf between going from, here's a Band-Aid. It's called topical steroids. It'll help you for a bit. Can't take it for long. Then, by the way, there's a pretty big gulf before we get to some wonderful, very sophisticated treatments, but involved typical injections and quite expensive.

And so that unmet need, which is just said commonly because there's a lot that perhaps overused, is something that you have very specifically targeted strategically. And you're doing it with topical treatments that make me think metaphorically of things that are like, it's not quite a drug device, but there's a drug presentation and formulation component to it. And I think that always actually translates to a certain extent to some element of competitive barrier to entry as well as durability. And the irony is, I think that separate from the molecule, your carrier is actually in some respects some of the special sauce.

Frank Watanabe
President and CEO, Arcutis Biotherapeutics

Absolutely. No question about it.

Speaker 2

That has made it possible. So maybe let's just talk a little bit about the product because it's one thing to track script trends and stuff like that. And maybe it's been a little while, and especially since the stock has reawoken, talk to us about the product, the presentations, because we have the cream, we have the foam, and the importance and the relevance of that when you're selling stuff to people who have a problem.

Frank Watanabe
President and CEO, Arcutis Biotherapeutics

Sure. Yeah. And so, you know, I think it really goes back to the foundation of Arcutis. You know, I was one of three guys at the beginning. I think you know the other two, right? So David Osborne was our Chief Technical Officer. He's retired now, but David is probably the best topical formulator in the whole industry. 36 FDA-approved drugs that he's invented. And then Howard Welgus was our first Chief Medical Officer. He's a dermatologist, 40 years in dermatology. And that gives us that deep understanding of what are the problems that derms and their patients are dealing with. And I'm very proud to say that we have eight dermatology clinicians at the company, eight, which is what gives us that understanding. But the formulation is absolutely critical. You know, a drug doesn't work if a patient doesn't take it, right?

And if it causes irritation at the site of application or if it's greasy or it stains their clothes, you know, those are all going to affect their compliance to the drug. And so we designed, intentionally designed formulations that were cosmetically elegant, you know, pleasing to the patient, but also were effective in delivering the drug. In addition to that, some of the diseases we're treating, you know, the formulations of many drugs can actually work against the efficacy of the drug, right? So every single topical anti-inflammatory drug except for ZORYVE has what's called penetration enhancers in them. It helps to deliver the drug. And these literally punch holes in the skin so that the drug can get in. We knew that was a bad thing to do, particularly in disease like atopic dermatitis. And so we don't use any penetration enhancers.

We formulated our drug so that it's matching the pH of the skin. So you're not changing the pH of the skin, which can also change the microbiome, which can affect disease. We use, when you mix oil and water, like when you're making salad dressing, you need what's called an emulsifier to get them to mix together. Most emulsifiers will strip oil moisturization out of the skin. We chose a moisturizer, a surfactant that doesn't strip moisture from the skin. So it's been very intentional about how we think about designing our formulation so that the formulation is working with the drug, not against it. And, you know, that was important in psoriasis. It's more important in seborrheic dermatitis. It will be very important in atopic dermatitis. And it aids both in the efficacy, we think, as well as in compliance to the medication.

Speaker 2

Right. No, the carrier itself, like a little bit of a secret sauce, but almost too good. I remember going to the American Academy of Dermatology meeting when it was in Boston, put the back of your hand out there. It was amazing. You held an analyst meeting. From that standpoint, recognizing the, you know, the patient experience very much about the immediacy of temporal relief. You said other drugs may cause irritation. I think you were kind. I think there's plenty of anecdote about it causing outright painful circumstances and sending you to a different clinician to distract you from your original itch problem because you had something more acute going on. So a product that really addresses a lot of unmet need here. Let's talk about the commercialization strategy here, perhaps in terms of the journey.

There's been a couple of opportunities to reset, but it started with a tactic that engaged sort of the complexities and the imperfections of the pricing environment. It's been able to work at a certain level, perhaps not, and therefore, like any approach, you've had to tweak it. Maybe talk about your comfort with where you are with your pricing strategy now and what you've learned since the launch and in particular how that's, you know, fitting in with any adaptations.

Frank Watanabe
President and CEO, Arcutis Biotherapeutics

So, you know, I would actually maintain that our pricing strategy has been right from the outset and it continues to be right. And I think the fact that, you know, we just won coverage for Florida Medicaid is a good example of that. And we, I can actually disclose here, I guess, because it's a public forum, we will get Texas Medicaid here very shortly as well.

Speaker 2

You heard it here first, folks.

Frank Watanabe
President and CEO, Arcutis Biotherapeutics

Yeah. So, you know, that's important, right? About half of the atopic dermatitis market and half of the seborrheic dermatitis market are Medicare and Medicaid patients. We didn't want to just ignore those patients like, unfortunately, many companies do. And so we priced our drug in such a way that we could get good Medicare and Medicaid coverage. We're starting to pick up Medicaid. We bid on Medicare business. We expect to start getting Medicare coverage later this year as well. And, you know, you think about the size of the opportunity, you know, half of all patients being government pay patients, not commercial patients. That's a big opportunity. And because of the way we priced it, our government book of business will be about as profitable as our commercial business as well. So we're not giving up a lot of margin and we have a big market expansion.

So we think it's the right strategy. It means that we're able to serve more patients, help more people with their disease, and create more shareholder value because it's going to drive growth in the sales volume.

Speaker 2

The gross-to-net has with new product launches. It's familiar with stuff that it's like starts at $15,000-$20,000 per year and you have all these patient assistance programs here. So you're kind of navigating probably a zone that certainly investors are less familiar with. And you have a couple of competitors who publicly talked about ambitions about what kind of gross-to-net they could achieve, found that that is a not easily attained objective here. Where we're at now, approaching the third anniversary, how should we think about what gross-to-net are currently across your business and where we could be maybe some reasonable objective? Let's pander a bit to our investor clients, say by the end of this year, end of 2025.

Frank Watanabe
President and CEO, Arcutis Biotherapeutics

So maybe I'll start with the end in mind, right? You know, the unfortunate reality of drug pricing in America today is for a retail product, right? You have to pay a rebate to the PBM or to the government. You have to pay the distributor. You have to pay the pharmacy. And the insurance companies continue to shift costs onto the patient. And you want the patient to have a reasonable copay so that they don't, that they fill their prescription. So you have to pay patient copay assistance as well, right? You add up those things. And for a retail product, that's going to probably eat up 50% of your list price. Sometimes more, right? If you're paying very large rebates, your gross to net's going to be really, really bad. But, you know, 50-ish% is sort of best in class.

We have continued to state that we thought we would get into the 50s with our gross-to-net. You know, I'm really pleased to say, you know, at the end of the Q1, we were already in the low 60s. That's with a new product launch in the quarter. So we're getting very close to what we expect to be steady state, which is, you know, in the 50s. You know, one of our competitors has also done that, right? They've shown that it can be done with the right programs in place. I feel confident we'll be able to get there. I think we'll probably get to steady state by the end of this year on ZORYVE Cream and psoriasis. ZORYVE foam and sebderm is rapidly catching up. You know, it will not be that far behind.

And then the atopic dermatitis launch, you know, as we pick up coverage, we'll rapidly get to that point as well. But I think we feel very confident. And I would say, you know, investors should look at our track record. We've been able to deliver every quarter, bringing that gross to net down. And, you know, low 60s already, I think is a good performance, but we think we can improve on it.

Speaker 2

sebderm, it's almost been a broken record with you talking. You guys don't appreciate the market opportunity. Analysts who you've known well for many years are like, yeah, Frank, okay. It's been quite an opportunity. Talk about the indication. Maybe, you know, share with us some of the aspects of the interface here because it's something we clearly didn't quite get. You've been able to execute.

Frank Watanabe
President and CEO, Arcutis Biotherapeutics

Well, you know, I think it's understandable, right? No one's worked in the space in years. So it's not like anyone's seen, looked at Sebderm very recently. But, you know, it's a big market, right? There are about 10 million Americans with seborrheic dermatitis. About 4 million of them are on drug treatment today. And, you know, the challenge is that the existing therapies weren't very good. They didn't work very well and they didn't fit patients' lifestyles, right? You know, shampoo, for example, that you're supposed to use today and leave in your hair for 10 minutes. Well, a lot of women don't wash their hair every day. That's not going to work for them. Or, you know, greasy steroids you're having to apply to your face. None of them worked very well and patients weren't very compliant to them.

And frankly, doctors were often reluctant to treat it because it was such a hassle and they knew it wasn't going to work. You know, we designed our foam and I actually have the foam in my pocket if you'd like to try it.

Speaker 2

Perfect. I live for show and tell.

Frank Watanabe
President and CEO, Arcutis Biotherapeutics

So I'll just give you a little squirt. That's actually a big squirt so you can use it in your hair. But, you know, you just take this very nice foam. You part your hair, you rub it on and that's it. It doesn't mess up your hair. It doesn't change your hair color. And then if you have any leftover or you have it on your skin, you just rub it in and it's gone.

Speaker 2

Wow. The blood-brain barrier thing is remarkable. I'm having complex thoughts now all of a sudden. We're solving the world's problems. No, very cool product.

Frank Watanabe
President and CEO, Arcutis Biotherapeutics

So great formulation. Fantastic efficacy, right? 80% of patients had IGA success at only week eight. One in two patients were completely clear at week eight. This is amazing efficacy. Far better, I think, than the other therapies. And we saw Sebderm is hallmarked by itch. That's probably the thing that bothers patients the most. We saw itch response in 48 hours with Sebderm. So, you know, what we're hearing from clinicians, I've been talking to a lot of clinicians lately, it performs so well in their clinic that they're actually starting to look for new patients to treat for Sebderm. So we're really excited. I think, you know, it's a major step forward in the standard of care. It's helping patients. It's making doctors' lives easier. And frankly, it makes our doctors look good, right? Because all of a sudden the patients, Sebderm is gone. They're not itchy anymore.

They're happy.

Speaker 2

Help us a little bit with the modeling here in the forecasting because the revenue has been strong from the get-go. Some commentary that you've had have meant parts of that equation. There was seemingly some element of pent-up demand that you were able to capture early on, right? Where are we in this? Because investors are often trying to like understand. It's almost like inventory stocking.

Frank Watanabe
President and CEO, Arcutis Biotherapeutics

No, that wasn't inventory stocking.

Speaker 2

That was a phenomenon for the net revenue print, and then we're trying to figure out where do I project from here to help us out.

Frank Watanabe
President and CEO, Arcutis Biotherapeutics

Q1, the uptake in Q1 was. It shocked even us, right? It was so rapid. I think that was a reflection of the fact that, you know, the unmet need was so high that a lot of dermatologists had pre-specified lists of patients that were going to start on ZORYVE. I even had doctors tell me that they'd already started writing prescriptions before the approval and just told the patient, "Hey, call me and I'll tell you when you can fill it," right? We had this big bolus of patients that hit us in Q1. I would have loved if that trend had continued, but we knew it wasn't going to last, right? We've seen moderating in the growth trend, which we told folks that would happen. But, you know, there are a lot of these patients out there, right?

You know, 4 million patients plus being drug treated. You know, we're running at a really nice clip of NRxs every week. The drug is performing. Doctors are able to get it. So I think we'll be able to sustain this growth trend that we're seeing right now, you know, since, say, the end of the quarter. We think that's a very sustainable, if not, you know, we could see some even some acceleration as time goes on.

Speaker 2

Your products translate very well in terms of communicating directly to the consumer, the end market, their patients. How do you think about, see, how should David be thinking about allocating budget towards marketing spend, in particular the direct-to-consumer angle?

Frank Watanabe
President and CEO, Arcutis Biotherapeutics

Yeah, so, you know, we have a direct-to-consumer effort ongoing. We've had since early on the psoriasis launch and Sebderm has a DTC component and AD will as well. You know, linear TV is really challenging with linear TV. You know, normal broadcast TV is very expensive, right? You're competing against, you know, Tesla and Starbucks and everyone else for that ad space.

Speaker 2

Pfizer.

Frank Watanabe
President and CEO, Arcutis Biotherapeutics

Pfizer.

Speaker 2

Super Bowl ad.

Frank Watanabe
President and CEO, Arcutis Biotherapeutics

Yeah. And you have a $75,000 a year drug, you can buy TV ads, right? It's hard to do, you know, a drug that might be $2,000 a year. So I don't see us doing linear TV, but certainly direct-to-consumer is part of our marketing mix and it's something that, as I said, we've been doing for quite a while.

Speaker 2

Returning to the foam aspect of the coverage, how do you see that mix and what do you need to do in order to improve coverage there? Is the price point that much different so that we're going to go live through because it is still ZORYVE the brand. There's cream and presentations. So what is the fine print in terms of, do you think you actually have some advantages of already at least a foot in the door, if not the name brand at the top of the list?

Frank Watanabe
President and CEO, Arcutis Biotherapeutics

We actually have more than that. So the PBMs, three big PBMs, viewed ZORYVE foam as a line extension to ZORYVE cream. And so we got coverage from the three PBMs at approval effectively, right? And that's one of the reasons why our gross-to-nets have improved so much is that we don't, we're not going back to reset again. You know, we still have to negotiate with the downstream plans to get coverage and we're in the process of doing that now, but even that has been substantially accelerated because we got the PBM so quickly. We expect something similar to happen with atopic dermatitis as well. We expect that to be considered a line extension so you're not going back to square one on coverage.

You know, we reported at the end of Q1, you know, we were what, 9 weeks into launch at the end of the quarter, that one in two foam scripts already were being reimbursed. That's unheard of in this day and age, right? To have half of your scripts covered at 9 weeks. And, you know, that's continued to improve and we'll provide an update at the end of Q2 as well where we stand. On the cream, you know, we're sitting at about 30 and 40 scripts being covered by insurance. And that gets back to the whole, you know, conversation on gross-to-net, right? We don't make any money for shareholders if it's a non-covered script. We actually were losing money until we, you know, changed the way that we handle non-covered scripts.

What investors should care about is how many of our prescriptions are we getting paid for and then how much are you getting paid, right? Which is the gross-to-net story. I think on both those fronts, coverage rates and our gross-to-nets, we've performed very well, which I think comes back again to our pricing and access strategy.

Speaker 2

Just strategically, it's always felt as if it's a category where when we talk to sort of the community dermatologists, they're always hungry for freebies and samples and stuff and using that as a strategy. Do you feel that that's going to be necessary as you continue to launch and particularly into AD? It's never really been at the front foot of what you've approached the market with.

Frank Watanabe
President and CEO, Arcutis Biotherapeutics

So sampling is certainly an important part of topical drug administration, although we don't sample the foam just because of the complexity of making really small cans of the foam. And the can's quite big, right? That's a 60-gram can. So we're not sampling the foam. The cream we continue to sample, I think that's an expectation in dermatology. We don't give away free drug. I think it's a little bit like crack. You know, you get people addicted to it and then you want to take it away. It doesn't go well. So we've never engaged in free drug. We didn't have a coupon program. We don't have a cash offer because the risk of abuse of cash offers is so high.

And I think that's one of the things that has hamstrung a number of the topical drugs in the past is that they got people addicted to all this free drug. And then when they asked them to start paying for it, they were like, "What?" So if you never start, you don't have to stop, right? And because we were frankly quite quick in getting insurance coverage, it was never really an issue for us.

Speaker 2

Right. I know for sure there's something very deep and philosophical in there as well, but it certainly also translates well to a business strategy for you guys. Data on atopic dermatitis, remind us about the profile. Here, the numbers are vast. The patients are not a monolith. You have all sorts of age groups. Talk about what the strategy is for positioning through even aging.

Frank Watanabe
President and CEO, Arcutis Biotherapeutics

Yeah. So in fact, you may have seen we released some new data on Monday from our long-term extension of the Revolution AD meeting in Chicago. You know, I think the product profile looks great. You know, we're seeing itch improvement in 24 hours instead of 48 hours in atopic dermatitis. At week 4, you know, around 40% of patients have an EASI-75. And what was interesting and what we released on Monday is that the longer patients are on the drug, the better they get. So, you know, by the end of 56 weeks of treatment, which was the end of this long-term study, two in three patients had an EASI-75 response. It's a very nice response, right?

You know, very interestingly, one of the other things that we released on Monday was once patients got to clear, you could switch them to an every week, twice a week maintenance dose. We were able to maintain most people at clear, almost clear on twice weekly dosing instead of daily dosing. That's the first time that someone's done that in a pivotal study showed that you could use maintenance dose to prevent the next flare instead of using drugs to chase that next flare, right? Waiting until the patient's flaring and then trying to treat it, we're actually preventing those flares. We think that profile looks really compelling. Safety and tolerability is excellent as it's been in every other indication.

You know, I think we have a profile that allows us to compete in first line against topical steroids and topical TCIs, which is where most patients are, right? DUPIXENT's a great drug, but, you know, we can't afford to have 90% of patients on DUPIXENT, right? Some patients will progress to Dupixent. Not a problem. Great drug, right? But for the majority of patients who are on steroids or TCIs, we think ZORYVE is a better option for the patient.

Speaker 2

Yeah. No, I mean, it's interesting because when you look at the actual data on DUPIXENT, less than 10%, I think it's 8% or 9% across several different studies of patients who theoretically would be eligible are taking the medicine. And very often there's all sorts of reasons, including cost and sort of like concerns about taking injectable therapeutic, but it is a very materially unmet need across the patient spectrum there. Talk about expanding the presence. There's elements of what you've said historically acknowledging that some of these derm markets are very much within the domain of primary care. And a smaller company would be able to benefit by somehow being positioned either through partnership with a sort of more deliberately expansive commercial organization.

Where are you in thinking that process, and maybe even just taunt us a little bit with some timelines because this is always a work in progress, but we're actually crescendoing with Sebderm and some of the data points here, so.

Frank Watanabe
President and CEO, Arcutis Biotherapeutics

Yeah. So, you know, about half of Sebderm patients are treated outside of dermatology and about half of atopic dermatitis patients are treated outside of dermatology. The majority of those patients are in primary care or pediatrics, right? And so I think we've been saying for quite some time that it was our objective to have a partner in primary care. We don't want to do it ourselves because that's a good way to waste a lot of shareholder money, right? Building our own primary care salesforce. But we've been saying for a while that that was a goal of ours. We are actively in discussions with potential partners. You know, I've said previously and continue to believe that it's very likely that we'll have an agreement by the end of the year for a partnership in primary care.

That's about the right timing for us with the atopic dermatitis approval coming up. We didn't need it right at launch because we've got to win with the dermatologists first, but there's obviously an immense opportunity to serve patients and to create shareholder value through a primary care partnership. I feel very confident about our ability to pull that off.

Speaker 2

What's that species? Is it someone who's a little bit more in sort of the consumer orientation? Is it one of the typical immunology big players that we think of?

Frank Watanabe
President and CEO, Arcutis Biotherapeutics

Well, I mean, the ideal profile is a company that has a pretty good-sized existing primary care salesforce and that has the capacity to promote our product in their salesforce, right? You know, what you don't want to do is partner with a company that has a GLP-1, right? Because that's going to be their priority all day long, right? You want someone who's going to really focus on your product and drive the success of your product. There are a number of companies that fit that profile.

Speaker 2

Yes. No, I can think of several. We can talk about it later. We can sort of blink one, blink twice, etc. But I think that there's certainly some, you know, sales bags out there that this could be very logical for. Help educate me on something. I know that we have an sNDA for scalp and body psoriasis. How does that differ? Sometimes you have label indications that it's like, well, this was approved. I'm already using it this way because there's always the practice of medicine. What's the impact that we should think about?

Frank Watanabe
President and CEO, Arcutis Biotherapeutics

Yeah. So, you know, big picture, about 40% of psoriasis patients have psoriasis on their scalp. Many of those patients have it also elsewhere on their body. Our cream is really designed for use on the body. It's not the ideal formulation for putting in your hair. So we formulated the foam originally actually for scalp psoriasis, and then we sort of stumbled into Sebderm based on talking with dermatologists. But it was originally designed for scalp psoriasis. And, you know, it works very well in scalp psoriasis. We've already done the phase 3 studies. We also, in the phase 3, we looked at efficacy in the scalp and separately efficacy on the body. And what we saw was that the foam performs identical to the cream on the body in treating psoriasis, and it actually outperforms on the scalp.

So we had a 70% IGA success rate on the scalp in our phase 3 trial. So really nice formulation. If a patient has scalp psoriasis, they just use the one foam everywhere. They don't need two prescriptions, right? Which is a big change. If they don't have scalp psoriasis, you know, they'll probably get the cream. I think some patients may prefer the foam and may use the foam even if they don't have scalp psoriasis. We're pretty agnostic to which one the patients use, right? We just want to treat patients and create shareholder value. But yeah, we'll file that in Q3, you know, expect approval probably middle of next year or something like that. And, you know, then we'll be going in with the tailwinds of the psoriasis launch and the Sebderm launch and the AD launch as we launch in scalp.

Speaker 2

Is Sebderm a seasonal phenomenon by any chance?

Frank Watanabe
President and CEO, Arcutis Biotherapeutics

All of these diseases are. Yeah. And, you know, Sebderm and atopic dermatitis both have skin barrier defects. And so dry and cold air tend to exacerbate it, and warm and wet air tend to mitigate it. Psoriasis responds to sunlight. That's why people use UV to treat it, right? So there is seasonality to all of these diseases. You see a lot of seasonality with biologics. I used to work on Enbrel. We could see it all the time, right? You don't see a lot of seasonality in general in topical prescriptions because the patients are only filling their prescriptions a couple of times a year, right? But where you do see seasonality is in patients coming into the office, right? As we go into spring and summer, there are less people flaring. They're not going to their doctor. As fall and winter come along, they're flaring.

They're going to their doctor. And so, you know, I think that may impact more on the NRX trend than the TRx trend. But there clearly is a seasonal component to all these diseases.

Speaker 2

Outside the U.S., any updated thoughts?

Frank Watanabe
President and CEO, Arcutis Biotherapeutics

So we've outlicensed in China and Greater Asia. We did a deal last year in China and Greater Asia. We did a deal with Japan earlier this year. You know, I think Europe, the challenge really is reimbursement. You know, it's an evolving landscape for topical reimbursement in Europe. So we're monitoring that situation. You know, I think we'll make a decision as that becomes clearer. I wouldn't say it's our top priority right now. And then, you know, we are on the market in Canada with the cream for psoriasis. We have our own operation in Canada, and we're awaiting approval for the foam hopefully later this year in Canada as well.

Speaker 2

Let's turn a little bit briefly to what else is next pipeline. You have two assets here, ARQ-255, JAK1 inhibitor, topical suspension. Talk about where you're aiming that for and where we're at.

Frank Watanabe
President and CEO, Arcutis Biotherapeutics

Yeah. So 255, yeah, is our topical JAK inhibitor formulated in what we call deep dermal drug delivery or 4D technology. This is a formulation that Osborne invented that actually allows us to deliver drug down the hair follicle to the base of the hair follicle, which is where the inflammation in the AA is occurring, right?

Speaker 2

Yes. Alopecia areata.

Frank Watanabe
President and CEO, Arcutis Biotherapeutics

Yeah. Traditionally, JAK, topical JAKs have not worked in alopecia areata because they're not penetrating enough. That was why we developed 255 was to get down to the inflammation. We're in a phase 1 trial right now, you know, mostly focused on safety and efficacy, but that will unlock our ability to go into phase 2 and really look at the efficacy of the drug. You know, clearly JAKs work in AA, right? You know, we've already got 1 approved, 2 approved. So we just need to get the drug where it needs to be, right? And it should work. So we're excited about that program. And, you know, we'll have hopefully data, you know, before too long, although again, mostly around safety and tolerability. And then our other pipeline program is ARQ-234. That's a fusion protein against an immune checkpoint target called CD200R.

Very excited about that program as well. CD200R is one of these targets like OX40 that you seem to be able to reset the immune system if you agonize these targets. And there's early evidence that like OX40, if you hit this target, you can get patients clear, but then you have this long period of efficacy off of drug. And so we think that, you know, this is probably the next frontier in the treatment of severe atopic dermatitis.

Speaker 2

Great. We will make sure to touch base upon some of the financial dimensions. Talk about how comfortable you are about prospects of ultimately becoming profitable as well as what the cash is right now.

Frank Watanabe
President and CEO, Arcutis Biotherapeutics

Yeah. So, you know, we're a biotech company. So I don't know that profitability is my top priority, but certainly self-sustaining is an important component. You know, we did a raise earlier this year in February. We feel like we're very well capitalized. And, you know, our new CFO, I think, has taken to saying, you know, on current plans, we may not need to do any more equity raises. You know, our burn is relatively stable right now, and we have, sorry, our OPEX spend is relatively stable. And our revenues are increasing, and so our cash burn is, you know, obviously going down. We ended last quarter with lower than $400 million on the balance sheet. So we feel good about where we are from a financial position.

Speaker 2

Yeah. No, it certainly seems to be a stable position, and those investors are quite happy from what I understand.

Frank Watanabe
President and CEO, Arcutis Biotherapeutics

I would hope so, but we got to keep keeping them happy.

Speaker 2

Excellent. Frank, thank you for taking the time. We appreciate it getting this update.

Frank Watanabe
President and CEO, Arcutis Biotherapeutics

Thanks.

Speaker 2

Thank you so much.

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