Arcutis Biotherapeutics, Inc. (ARQT) Earnings Call Transcript & Summary

Good morning, and welcome to the ZORYVE launch call. [Operator Instructions] As a reminder, this call is being recorded, and a replay will be made available on the Arcutis website following the conclusion of the call. I would now like to turn the call over to your host, Latha Vairavan, Vice President, Finance and Investor Relations. Please go ahead, Latha.

Thank you, Sarah. Good morning, everyone, and thank you for joining us today to discuss the launch of ZORYVE cream for atopic dermatitis. Slides for today's call will be available on the Investors section of our website after the call. On the call today, we have Frank Watanabe, President and CEO; Patrick Burnett, Chief Medical Officer; Todd Edwards, Chief Commercial Officer; David Topper, Chief Financial Officer; and our special guest, Dr. Jonathan Silverberg. I'd remind everyone that we will be making forward-looking statements during this call. These statements are subject to certain risks and uncertainties, and our actual results may differ. We encourage you to review all of these filings with the Securities and Exchange Commission, including descriptions of our business and risk factors. With that, let me hand the call over to Frank.

Thanks, Latha. We're glad that join us today for this very exciting call. So let me get to our first slide here. Okay. After receiving FDA approval for ZORYVE cream for the treatment of mild-to-moderate atopic dermatitis in adults and children's ages 6 and older on July 9, we're thrilled to share that the launch is now underway. We're extremely pleased with the updates to our label, which expands the total addressable market for ZORYVE by an incremental 1.4 million patients who are topically treated by a dermatology clinician for their atopic dermatitis. We are also delighted to announce today that we have signed a co-promotion agreement with Kowa Pharmaceuticals, which further expands our total addressable market, allowing us to address millions of patients treated outside of dermatology office for their atopic dermatitis, seborrheic dermatitis or plaque psoriasis. Todd will share more details on this exciting opportunity in just a few minutes. 8 years ago, a handful of us started Arcutis with a vision to build a leading innovation-driven medical dermatology company, and I'm incredibly proud of the progress that we've made in making that dream a reality. With the approval of -- with AD approval, ZORYVE is now able to treat 3 major inflammatory skin diseases, making it the first steroid-free topical with this broad of a label. ZORYVE cream for atopic dermatitis is our third product approval in 24 months, a rare accomplishment for any biopharmaceutical company and a testament to our team's outstanding execution. Our AD launch bolsters our portfolio and complements our ongoing launches of ZORYVE cream for plaque psoriasis and ZORYVE foam for seborrheic dermatitis and builds on the growing momentum of both of those launches. And we're not done yet. I'm delighted that last week, we submitted another sNDA for ZORYVE foam 0.3 for the treatment of scalp and body psoriasis in adults and children down to the age of 12, which will be an important catalyst for continued growth in the future. And as I mentioned a minute ago, we're excited about our new agreement with Kowa Pharmaceuticals to promote ZORYVE to PCPs and pediatricians. We expect all of these factors will allow us to build a segment-leading franchise, will translate into sustained revenue growth and will increase operating leverage from the stacking of new indications, expansion of our prescribers and the continued expansion of payer coverage, all of which should translate into growing shareholder value. At the beginning of 2024, we spoke to you about the potential to expand our total addressable market tenfold by early 2025, and I'm delighted by the progress we've already made towards that goal. With the approval in 80 coming on top of the seb derm launch earlier this year, we now have more than tripled our total addressable market to 4.4 million patients who have commercial coverage and are treated by dermatology clinician. We are also making steady progress on expanding into the more than 3 million patients with Medicare and Medicaid who are treated by dermatology clinicians for our targeted diseases with recent Medicare formulary -- Medicaid formulary wins, in Florida, Texas and New York, and we hope to garner a few more large states by the end of the year. We also continue to make good progress on Medicare coverage and hope to see some early Part D wins later this year. And the Kowa partnership we announced today will allow us to begin to expand our access into a significant portion of the 7 million patients treated outside of the dermatology clinic. We believe that the differentiated features of ZORYVE cream position us well for success in the highly competitive AD market. ZORYVE Cream has demonstrated rapid and robust efficacy in treating AD and Patrick will take you through those details shortly. Bringing the first once-daily topical to the AD market is a major benefit for patients and parents and the ability to use ZORYVE on any area of the body and for any duration or other key benefits for clinicians and patients. As we have seen in other indications, ZORYVE's tolerability is highly favorable and supports chronic utilization of the drug without the tolerability concerns that plague many other topicals. Additionally, ZORYVE's formulation is patient-friendly offering numerous benefits that we believe will enhance compliance. Again, Patrick will discuss that in more detail in a few minutes. And as we saw with seborrheic dermatitis, we are rapidly gaining high-quality coverage for ZORYVE in AD, which will simplify clinicians' prescribing experience and allow us to rapidly drive down our gross to nets. Finally, dermatology clinicians already have positive experience with ZORYVE in psoriasis and seborrheic dermatitis, which will be a positive tailwind as we launch in AD. I would like -- now like to turn it over to Patrick, who will take you through the details of the ZORYVE data supporting, the unique position for the treatment of atopic dermatitis. Patrick?

Thanks, Frank. It really is a pleasure to speak to you today about our latest approval -- our latest approved indication, atopic dermatitis. We're also honored to have Dr. Jonathan Silverberg with us today to share a dermatologist perspective on treating these patients, insights into the patient experience and why there's such a strong need for a safe and effective nonsteroidal topical therapy. Let me start today by giving a little bit more context around atopic dermatitis. It's a very common chronic genetically predisposed inflammatory skin disease and frequently, first appears during childhood, although it can persist through a patient's life and sometimes it only appears in adulthood. AD is characterized by compromised skin barrier function coupled with neuroimmune dysregulation with itch being the most common and burdensome symptom. The itch is such a prominent feature sometimes preceding even lesion development. So that sometimes dermatologists refer to it as the itch that rashes. There's still significant unmet needs despite therapeutic progress in recent years and primarily in the need for safe and effective chronic topical treatment. ZORYVE's active ingredient is roflumilast, which is a potent and selective PDE4 inhibitor. The PDE4 mechanism is really well suited for addressing the key signaling pathways implicated in driving the science and symptoms of atopic dermatitis. By modulating cyclic AMP levels, PDE4 inhibitors decrease inflammatory response to a decrease in cytokines, which promote inflammation, specifically IL-4/13 in the AD context and increasing anti-inflammatory cytokines. PDE4 also plays a role in neuronal signaling, which may contribute to roflumilast impact on itch beyond just reducing inflammation. And I'll show you our itch data here in just a moment. So PDE4 inhibition helps to restore skin barrier balance and reduce itch through both direct and indirect pathways, ameliorating the key burdens that patients face. We're very pleased with the label in atopic dermatitis that the FDA is approved. The ZORYVE being indicated as a treatment for mild-to-moderate atopic dermatitis in patients down to the age of 6. The drug is labeled for once-daily use without any limitations on treatment areas, extensive body surface area treated or duration of use. As I'll show in a minute, we saw rapid and reliable symptom relief across multiple measures and lastly, we have no boxed warnings, unlike several other atopic dermatitis treatments. The anti-inflammatory benefits of roflumilast delivered through our unique cream formulation, which clinically is ideally suited to treat the skin of the AD patient. The formulation is a key differentiating feature of ZORYVE cream and is critical to allow the delivery of roflumilast without disrupting the skin barrier. ZORYVE is formulated with our proprietary hydro art technology, which is moisturizing and non-irritating and has a unique emulsifier that does not dry the skin because it doesn't strip at the dermal lipids. It's the only topical anti-inflammatory treatment that does not contain any penetration enhancers, which can exacerbate skin barrier disruption. It also does not contain common irritants like alcohol or fragrance and has a pH that matches out of the skin. These properties of ZORYVE cream, coupled with the favorable tolerability data demonstrated in our clinical trials, presents a unique profile that's well suited to fit into a patient's daily regimen, which can encourage treatment adherence. We've shared our AD Phase III data with you in the past, but I cannot reiterate enough the most important benefit of ZORYVE Cream is the ability to work quickly and to provide relief from atopic dermatitis symptoms. Our Phase III INTEGUMENT-1 and INTEGUMENT-2 studies included a broad population of patients, ages 6 and over with mild-to-moderate atopic dermatitis. The trials did not have a body surface area limit. And we enrolled patients with body surface areas ranging from 3% to 88%. In fact, our median BSA was nearly 10%, which means that half the patients had a body surface involvement that would have warranted the use of a biologic or a systemic agent. ZORYVE was applied once daily as a monotherapy for 4 weeks, and it rapidly cleared the signs and symptoms of AD including itch. The primary endpoint of the study was validated IGA, AD or vIGA-AD success which, as a reminder, is a score of clear or almost clear plus a 2 grade improvement from baseline. 31% of patients achieved IGA success with ZORYVE at 4 weeks and over 41% of patients achieved a vIGA-AD score of clear or almost clear at 4 weeks. As dermatologists and a practicing clinician, I would say that we are more used to looking at EASI-75. That's the eczema area and severity index, which is more clinically relevant measured -- which is a more clinically relevant measurement as it takes into consideration both the severity of disease signs and the body surface area involved. An EASI-75 responder has cleared 75% of their disease compared to baseline, and this is something that's more straightforward to communicate to HCPs and patients. Close to 43% of participants achieved EASI-75 with ZORYVE at week 4. I want to finish on the slide with itch response at week 4, which is the WI-NRS success, meaning that patients came into the study with a clinic meaningful itch of 4 or greater on the 10-point worst-itch numeric rating scale, and had a 4-point or greater improvement. Our response here was 32% at week 4 and well separated from vehicle. As I mentioned earlier, itch is the hallmark symptom of AD and it's also the symptom that patients report as the most bothersome to them. I think it's quite notable that as you can see on this slide, the impact on itch was very rapid with ZORYVE having demonstrated a statistically significant improvement over vehicle within 24 hours after the first application of the drug. As time progresses, we see that the robust and sustained improvement in itch when using ZORYVE. Rapid itch relief with ZORYVE has been shown across all our indications. But for the AD patients, itch is really the key symptom. So we're quite excited to see how ZORYVE can begin to alleviate it in as quickly as a day. Here you see some representative photographs from patients in the INTEGUMENT trials. We have the patient's baseline on the left and then moving to the right week 1 and then week 4. Along the top of baseline for the face, you can see that this patient who scored at an IGA of moderate at baseline, has erythemic patches across her forehead and a lot of erythema scaling and edema of the eyelids. The eyelids are also particularly sensitive to treat. And already at week 1, there's a substantial improvement, which continues to improve and achieves almost clear at week 4, which is IGA success for this patient. Along the bottom, looking at the second patient, a 54-year-old female who also came into the study as moderate and made it to almost clear, which is a treatment of success. Note that the confluent erythema scaling across the back at baseline with a lot of excoriations, which are scratch marks, which indicate the level of itching. These lesions are largely resolved at 4 weeks. These patients are a good example of the diverse body locations and extensive disease in our pivotal trials. And as a practicing clinician, I can say that both a physician and a patient would be quite pleased with these results in only 4 weeks, particularly with a nonsteroidal treatment. Back to our pivotal trials on Slide 18, so I can cover safety. Consistent with what we've shown in our previous studies across different indications, ZORYVE was remarkably well tolerated in our Phase III AD pivotal studies as summarized on this slide. As I've mentioned before, as a clinician, I can see discontinuation rates due to adverse events are a key metric of treatment tolerability. And here, you can see that our discontinuation rates due to an adverse event were very low at 1.6% and were very similar to those reported for vehicle. Moving on to our most common adverse reactions. This slide gives a bit more detail on these common adverse drug reactions that were reported in our pivotal studies. As I mentioned, these ADs are consistent with our earlier proofs and we continue to show very good tolerability. Even though AD patients have a sensitive skin that's notable -- that is notable that the application site pain was reported at only 1.6% of subjects with ZORYVE and was generally comparable to vehicle. This is particularly important given the pediatric population of kids 6 and older, who would be eligible to receive ZORYVE. Because AD is a chronic disease, long-term safety and efficacy are key considerations. So we also conducted a long-term open-label extension trial, which evaluated ZORYVE for an additional 24 or 52 weeks beyond the initial 4-week double-blind Phase III studies. In total, 658 patients rolled over from INTEGUMENT-1 and INTEGUMENT-2 trials, including 439 patients initially treated with ZORYVE and 219, who were initially treated with the matching vehicle. In the open-label extension, everyone receives ZORYVE treatment. Very importantly, no new safety signals were reported with sustained treatment. In addition, in this study, participants who achieved a vIGA-AD score of 0, which means that they were completely clear, were switched from their once-daily to twice-weekly application of ZORYVE. In total, 130 patients or nearly 20% transitioned to this twice-weekly regimen. On this slide, you can see the efficacy results with continued use of ZORYVE as demonstrated with the EASI-75 endpoint. Along the left in yellow, you can see the efficacy for patients in the INTEGUMENT-1 and 2 parent studies than rolling over where all patients were receiving active treatment. Patients on vehicle on the parent study are in black circles, and they quickly come up to join the patients in yellow, who started on active and are now continuing to improve over time with an impressive 65% of ZORYVE-treated patients attaining an EASI-75 response at week 56. Now gives me great pleasure to introduce Dr. Jonathan Silverberg, one of the world's leading experts in the treatment of atopic dermatitis. Dr. Silverberg is an Associate Professor of Dermatology at the Gorgon University School of Medicine, where he's the Director of Clinical Research and contact dermatitis. He's a renowned thought leader in dermatology and an expert inflammatory skin disease with a focus on atopic and contact dermatitis, hand eczema, chronic itch and many other chronic inflammatory skin disorders. Dr. Silverberg has been an author in several ZORYVE clinical study publications. We've asked him to share with you his perspectives as a dermatologist, who's dedicated to his career to caring for atopic dermatitis patients. Jonathan?

Thanks very much. Good morning, everyone. So just to start out, I think this is an important slide, really at a high level, just to understand a little bit about the disease state. And we're classically taught that there's a sort of age-related progression of the presentation of atopic dermatitis, where in infancy is much more involvement of the rash of the scalp to face certainly can affect any part of the body. And then as children get older, it will start to affect the more of those so-called classic areas, creases of elbows, knees, et cetera. And then in adults, you see much more of that. There's certain -- to a certain extent, there's truth to that. But it turns out it's far more complicated. We see lots of -- or just as much head and neck involvement in adults as we do in children. We see a lot of involvement pretty much of anywhere on the body. So it's not just the elbows or the crease, as really atopic dermatitis can affect any part of the body. I think there's often a misconception that atopic dermatitis is simply a pediatric disease. And part of that is because when you look at the epidemiology, the relative prevalence is much higher in kids than it is in adults. But the prevalence in adults is still quite high. And if you actually just do the math, just given the fact that there are a lot more adults in the U.S. population and there are children, there are far more adults with atopic dermatitis out there than there are children. So I think it's important just to understand, if anything, this is more of an adult disease than it is a pediatric disease by absolute numbers. And we understand that there's a differential burden across the different age groups or just in terms of how it impacts quality of life. An atopic dermatitis is a disorder that can affect really any and every aspect with respect to quality of life. It's actually more burdensome in studies that have looked comparing with psoriasis and many of our other chronic inflammatory skin diseases. And I think it's important to understand all this because recognizing that this is a chronic disease, recognizing this is something that for many patients can really impact them their entire life, it really highlights that we need treatments that can be used both that are effective and safe for long-term chronic use, right? We don't -- whenever I have this conversation with patients, I always emphasize to them I'm not looking for a quick fix. You've had this all your life. We need to have something that's really going to work for you in the long term. And so when you think about the sort of topical space, as it pertains across all of these different types of patients with atopic dermatitis, we acknowledge there's still a lot of unmet needs for topicals. And Obviously, topical steroids have been used for decades in the management of this disease personally. I look forward to a day when I never have to use topical steroids again. There's -- they are a workhorse, and we use them because of they're accessible or we're just familiar with them. But there's still a lot of challenges in terms, certainly of their chronic use and concerns about long-term safety concerns. And in truth, we actually have very little data with them actually being studied in atopic dermatitis. Most of the background for how they were approved was not actually being studied in humans, but using these vasoconstriction proxy assays that in the modern era, I don't think the FDA would have ever accepted other than they've sort of been sort of grandfathered in. So there's definitely a lot here to understand, but I think most importantly is that this is a chronic disease, and it's something that really affects all aspects of patients' lives and all ages of patients' lives. Now formulation is something I think that's certainly well recognized in dermatology, but I think we don't talk about it enough, particularly in atopic dermatitis. So we understand that in atopic dermatitis at the heart of the pathophysiology of the disease, there is an impacted skin barrier. And that may be secondary to the inflammation or sort of a genetic predisposition in terms of flagment mutations. But regardless of the underlying causes of that disregulated skin barrier, it's there. And that's something that's important because we know that, that impaired skin barrier is a potential driver for one, the -- as I always tell patients, the inside world, not staying in, the loss of moisture and drying out of the skin, but also the risk of the outside world getting in. And in terms of potential pathogens or irritants or allergens from the outside world, crossing that impaired skin barrier and then potentially triggering and flaring that underlying atopic dermatitis and also potentially triggering other secondary issues. So it really does matter what we put on our skin and what our formulations that we're using. And when we think about a lot of the -- just the different topicals that are out there, as Patrick mentioned earlier about ZORYVE, but penetration enhancers not being part of the formulation, it does matter. This is a conversation I have with patients a lot. I'm also a patch tester. I deal with contact dermatitis on a daily basis. And this is a big issue. We see contact dermatitis coming up to these different excipients used in topical formulations all the time. And in fact, the #1 reason why we see contact dermatitis in atopic dermatitis patients is exactly this. It's the ingredients in there over-the-counter prescription topicals being used. So they're using a medication to fix one problem and now they pick up a new problem. So this is not a trivial issue and so much of what I'm dealing with on a regular basis. We also understand that many of the different ingredients they're used in topicals can be irritating to the skin in terms of the surfactants that can just strip away some of the lipids on the skin. And this is something that is a very real issue. It's certainly driven major market trends when it comes to over-the-counter formulations for different products. And it's something that really needs to be paid attention to in our prescription space as well. When we think about the choice of a vehicle, this is always -- it's largely driven by patient preference but also balancing out the efficacy. We're classically taught that appointments are better than vehicles and better than motions and better than gels. And in general, that tends to be true. Although now we have amazing formulations of creams that are performing as well as ointments. But if you look at the patient preference, patients clearly prefer creams over ointments, like 9 out of 10 times or more because of the way they feel, because of their elegance, right? Nobody wants to walk around with a greasy thick ointment that's going to trash their clothing or it's going to be visible to the public, and everyone knows they're wearing medicine. And so an elegant formulation really does matter to patients. But thinking about a formulation also that doesn't have a lot of these different potential ingredients that could cause allergic contact dermatitis, irritant contact dermatitis really does matter. I think that's a major strength for the reformulation is that it doesn't have all these common irritants and allergens that we're dealing with on a daily basis in dermatology as being culprits. But certainly, understanding that elegance does matter to patients in the dermatologist a lot. I think just to note also about the tolerability. This is not a trivial point. Sometimes, I think we prescribe stuff because we're sometimes just out of route. But we also are very well aware without picking on any specific therapies that there are a number of the nonsteroidals out there that are poorly tolerated, that have a lot of stinging and burning too and for some, a lot. And this is a major issue and a major limitation for those therapies. So the fact that ZORYVE is so well tolerated is really an important feature for patients, but not just for patients, but for us as practicing dermatologists. We don't like headaches. We don't like prescribing things that we're going to get callbacks for. We don't like prescribing things where we have to spend an extra 5 minutes in the office explaining to how to navigate the side effects or else, we like simple therapies. And ZORYVE is a very simple therapy because it doesn't have all of these limitations that come up with so many of our other formulations. And I think the formulation is very much related to adherence, although adherence obviously, a much broader concept or issue that comes up in dermatology by and large. We know that there are a lot of things that can drive adherence, especially when you're thinking about -- well, in general, but we can apply all of this to the topical space as well. Certainly, we want something that works. Patients want a therapy that they feel is working and working pretty quickly. And that is inspiring or motivating for them to stick with that therapy. And so that's definitely an important feature. Fear of adverse events may be one of, if not the biggest issue, I think, that I encounter in my practice, and I think that we've seen from just patient-centric research in atopic dermatitis. There is so much fear out there around topical corticosteroids. I mean it's all over social media. Some of it may be completely overblown, but that's what we're dealing with. And patients are afraid that if they use topical steroids, they're going to look like Arnold Schwarzenegger, and it's just -- it's a thing, and it's hard to undo that. And so it's so important for us to have nonsteroidal therapies that really do the job well. But application, the tolerability and the elegance really, really matters. It's very hard for patients to use ointments and things that are not going to dry in well because it's going to destroy their clothing with daytime use, it's going to destroy their linens at night. It feels greasy and gross. It's hard to tolerate in the summertime. So a nice, elegant cream formulation is a real win for patients. And this is something that I've seen in the real world in the psoriasis space with ZORYVE cream and certainly outside of atopic dermatitis, even just thinking about the ZORYVE foam for seborrheic dermatitis how well received they are by patients because of how elegant they are. But with respect to the adherence issue, financial burden, we want things that have good access, don't have huge out-of-pocket cost for patients. And we always want to discuss and encourage adherence and think of strategies with patients that will allow them to build that into their routine. But I think also, as we think about the pediatric space, right? As I mentioned, atopic dermatitis affects more adults than it does kids. But it is a disorder that affects kids, and you have to have the therapies that are comfortable to the caregivers, right, to the parents. And it's so important to not have black box warnings. It's so important to not have scary-looking adverse events on a package insert that are going to sort of scare them away from using it. And so having such a clean label really is important and I think really does encourage adherence. When we think about topical steroid use in contrast, and when we think about the messaging how we, as dermatologists recommend their use, we say, use really sparingly for 2 weeks and stop. That's really an implicit message to say we're scared of this topical steroid therapy that we're prescribing, don't use it all that much. And in fact, that is sort of the running theme of how we use topical steroids. So it's so important for us to have nonsteroidals that really will encourage long-term adherence, don't have any of the limitations of the box warnings or anything else. And importantly, that we can use it essentially when you need it and not when you don't, right, a therapy that you can use to treat the flares. And if you're able to stop, great, if you want to continue using it, you can, you can use it on sensitive areas. We're not worried about the steroid side effects. We're not worried about limitations of use on body surface area. And so again, this really comes back to this message of simplicity, which is something that patients and dermatologists are all very much looking for. And so with that, I thank you for your attention. And now I'll be turning it over to Todd to discuss commercial considerations.

Great. Thank you, Dr. Silverberg. We appreciate your comments and insights. And as the prior speakers have indicated, this is a very exciting day for patients, their health care providers and our company. The anticipation we have seen for this launch in atopic dermatitis is very encouraging, and I'll talk about that in a moment. As you've already heard, atopic dermatitis is a very burdensome and chronic disease that presents across the body. Atopic dermatitis is highly prevalent and in fact, is the most common inflammatory skin disease seen in dermatology clinics. Skin lesions and flares are highly visible and create constant stress for patients. The most common and bothersome symptom in AD is itch, which mainly impact sleep and work productivity. There are flares and the social stigma that many patients experience can lead to significant negative mental and emotional burdens for patients. Because the disease can be diagnosed early in childhood, managing these symptoms can be extremely stressful for caregivers and families who cope with sleep disturbances, and that can affect school and compromise their everyday life. While there have been treatment advances for these patients, a significant opportunity remains in the AD market today. Steroids are starting point for AD therapy with 68% of patients still being treated with topical corticosteroids, which the American Academy Dermatology recognizes as ill-suited for long-term use. Even with the availability of nonsteroidal topicals, they only represent 19% of the total market opportunity. These are agents that have been on the market for several years. Now an uptake is slightly limited due to safety concerns. This market has also seen an increase in biologic and oral JAK treatments. These treatments only account for 13% of the total market since the benefit risk profile, combined with the high cost typically positions their use as later lines of therapy and for hard-to-treat patients or severe AD patients. Within the context of the current market, ZORYVE's profile in atopic dermatitis is highly differentiated, but no box warning, no limitations on body surface area treated or location of treatment, and it can be used for any duration, which is very important for chronic disease. So it was also well tolerated and does not contain any penetration enhancers, sensitizers or common skin irritants. And very importantly, for patients ZORYVE is the first topical atopic dermatitis treatment that only requires once-a-day application, positioning it well for use early and chronically in a treatment algorithm. Turning to the launch. I think it is notable that nearly all our dermatology targets for atopic dermatitis with the same as our targets for psoriasis and seborrheic dermatitis. Our field force already has established relationships with these clinicians and their office staff. We've already educated them on our co-pay card program and any required prior authorizations and importantly, we have already had favorable clinical experience with the efficacy and tolerability of ZORYVE cream in their psoriasis patients and ZORYVE foam in severe dermatitis patients. Our sales organization is extremely enthusiastic about bringing the familiar benefits of ZORYVE to the AD patients within these dermatology practices. Our sales force is fully trained and ready to begin promotion today. As I just mentioned, there are significant overlap with the large group of dermatology clinicians we have already been calling on for psoriasis and seborrheic dermatitis. Again, these physicians have already had a positive experience with the 2 approved products in the product portfolio. ZORYVE cream is 0.15% will be available in pharmacies this week and will be priced identically to the other 2 ZORYVE treatments. And like seborrheic dermatitis, 2 of the largest pharmacy benefit managers, or PBMs, are already covering the cream for atopic dermatitis. And we would expect a third to add ZORYVE for atopic dermatitis soon. Of course, we still have some work to do on coverage by downstream insurance plans. But like the phone, we expect that time line to be accelerated compared to what is typical. Combined, the early PBM coverage and expect to accelerate coverage by downstream plans should allow us to rapidly bring our gross to nets down for atopic dermatitis, and we don't anticipate a large impact on overall portfolio gross to net from the AD launch. ZORYVE really represents a portfolio and a product for Arcutis and is unique in dermatology with our multiple formulations and indications. In psoriasis, ZORYVE cream offers to 9 million U.S. psoriasis patients and effective and easy treatment that can be used everywhere on the body. In seborrheic dermatitis, ZORYVE foam offers a 10 million patients struggling with that condition with 1 product that can be used once a day to treat any affected area, including the scalp. In an atopic dermatitis, we can now offer the 26 million U.S. atopic dermatitis sufferers and effective to [Technical Difficulty]

Give us 30 seconds. I think we just lost our speaker.

Okay. Folks, sorry about that. Sometimes we get so dependent on this technology and then it falls flat for us. So we are back. Todd will try and join us here in just a moment. So Todd had just been going through the reprofile. Let me turn really quickly to the primary care partnership. We are really pleased to have entered into a co-promotion collaboration with Kowa that allows us to bring ZORYVE to primary care and pediatric physicians. We've been working on identifying a primary care partner for some time and we're thrilled that Kowa checks all of our boxes with respect to covering a broad PCP target audience having a proven track record of successful co-promotions and positioning the bandwidth to prioritize the promotion. We've worked with Kowa to identify the PCP and pediatric targets who have the highest potential to write ZORYVE. The Kowa sales force will have a dedicated focus on our product for at least the first 2 years. There are significant commercial synergies in this Kowa with our existing dermatology focused strategy. We will leverage the same branding and promotional messaging and materials and product and reimbursement training. Kowa's PCP and pediatric targets will have the same access to samples as our dermatology offices. They will also be able to access the dermatology experts for peer-to-peer programs to advance the understanding of ZORYVE in the primary care setting. The patients in primary care offices will benefit from our existing co-pay card favorable market access coverage. And our collaboration plan is built on transparency, teamwork and shared accountability to ensure a successful partnership. So let me just wrap up and say today's launch of ZORYVE cream for atopic dermatitis and our new premier care partnership are 2 more huge steps forward in our journey to build the leading innovation-driven medical dermatology company. I would be remiss if I didn't acknowledge and thank all of the dermatology clinicians who have partnered with us to run the clinical trials in atopic dermatitis and all of the patients who volunteered to participate in the studies. I'd also like to thank our incredible Arcutis team members for their sustained outstanding execution. They never cease to amaze me by their professionalism and dedication to dermatology. Having had a trial with atopic dermatitis myself, and a number of friends who suffer from AD or who have children who suffer from AD, I know all 2 will have badly people struggling with AD need new treatment options, and I'm very proud that Arcutis can now offer them ZORYVE. We are excited to show the investment community what we can do with our new indication. And with that, operator, we can open it up for Q&A.

Our first question comes from Kevin Strang at Goldman Sachs.

This is Kevin on for Chris. Just a quick question for Dr. Silverberg, you mentioned the importance of long-term chronic use for medications in atopic derm. So with this in mind, how would you communicate the value proposition for ZORYVE in atopic derm relative to the current treatment landscape, including topical steroids and biologics from an efficacy, safety and convenience standpoint, as well as from pricing? And then how do you envision using ZORYVE in your practice?

Sure. Thanks for the question. I think the messaging -- I don't know if there's a single message I have with patients in the way I'll converse with them directly, but it's really -- it's about the first and foremost that we don't have the limitations of being a topical steroid. We don't have this concern where we have to cut short the use and that most importantly, you can use on any part of the body, right? It's one of the big question, well, can I use it on the face, can I use it on the armpit area, can I use it on the genitals. The answer is yes, right? We don't have any of those limitations. We don't have any of those concerns and that it can be used for the long-term treatment without any safety concerns. And that's enormous, right? That's a broad statement that's rolling together a lot of data, right? The data is showing good, both short-term and long-term efficacy. The data is showing very assuring long-term safety, right? And that we don't have the black box concerns. We don't have any of the other stuff. We're not worried about cumulative exposure, systemic exposure, any of these things. So all of that is really important, but allows for a very simple message to patients use it, right? When you're going to find in the dermatology world is when they're prescribing they're not going to necessarily start explaining an entire package insert. In fact, they don't want to. They want something that is very simple. And so this is about as simple as you're going to get. Are there any concerns? No. Not really. And we're not sugarcoating that. They really aren't, right? And it works, use it, done. And do I have to worry about stopping? No, right? Just use it and you're fine in that respect. So it's a very simple message that can really address all of the different sort of locations and presentations of atopic dermatitis. With respect to the -- what was the second question was.

How would you potentially use it in your practice?

So I'm already using it now in terms of like for psoriasis and then the foam for seborrheic dermatitis. And so it's right now become a very important part of our practice. And I envision using it very much the same way that I'm doing now for with psoriasis doing it the same way for atopic dermatitis. And that it really is serving as a -- in a sense a jack of all trades, both as first-line potential use where for patients like why do I have to use topical steroids? If I can get a ZORYVE covered, and it's sort of the perfect solution to use instead of a topical steroid. I don't have the long-term limitations. And if I have patients who maybe are coming in now, they already have treatment experience already using topical steroids and maybe they're using it on certain parts of the body, but they need good nonsteroidal for sensitive sites, well I have the ability to use ZORYVE in that case as well. So it really allows me to either use it as the mainstay, the workhorse for treating patients as that primary therapy as well as for sort of plugging the gaps and the unmet needs for individual patients with their existing therapies.

The next question comes from Uy Ear at Mizuho.

So I guess the first question, maybe just to elaborate on the prior question for Dr. Silverberg. Like what proportion of patients currently in your practice if you don't mind sharing are on ZORYVE and those who are not, why are they not on? And maybe help us to also understand a bit about -- you indicated you view psoriasis and we spoke with other KOLs that kind of perplexed as well as why some of the physicians out there are not switching over to nonsteroidal -- topical nonsteroidal products? And I have a couple of follow-ups as well.

Okay. So percentage in the practice, I don't know, it's hard to say. I mean, focusing in on those on-label use in terms of psoriasis and for seb derm, I would say for my topical usage, I would say for new starts, topical usage, ZORYVE is definitely high up there. I don't know the exact number. When you ask, though, what is the -- and I answered the question in that way very specifically, as you asked the question, like of all psoriasis patients. I live in a little bit of a weird world or a less typical world because I -- as an academic and a referral center and supposed to be the grouper, the worst of the worst rashes, I'm getting some really severe scenarios that are sometimes on multiple biologics or oral plus biologics, plus topicals, right? So it's a little bit of a different scenario there, but I think for the by and large, for the average mild to moderate, whether it's psoriasis patient or mild-to-moderate atopic dermatitis patient, where topicals can do the trick by and large. I think ZORYVE has been making a real dent. Now to your question of why isn't there more? I actually -- I mean, from everyone I speak to, there's been very -- it's very well received. I don't really ever get negative comments from many of my dermatology colleagues about ZORYVE about, Oh, I don't use it because of XYZ, which is not the case necessarily for other therapies where folks can often point to a single 1 or 2 reasons, whatever that they're not using some therapies. I think part of it is about just why topical steroids are still being used so much is, I mean, a part of it is just the access issue and that we -- that their payers position them in certain ways in different diseases. But I think really a lot of it is just teaching old dogs new tricks. And as we see with the next generation of dermatologists and trainees out there who are getting also using it. It is very well received. I think with any new therapy, just in general, this has nothing to do with dermatology, but it certainly applies in dermatology. There's always that group of docs who when you do that market research, they'll say, I don't take a new therapy until it's approved for 6 months, 18 months, 24 months, whatever it is. So some of it is just there's a little bit of a slow roll in, in certain practices and some dermatologists may be a little bit more risk averse in that way. And so they may say, "Well, I want to wait a little longer until I see even more reassuring real-world evidence. But everything we've seen has been reassuring and has been reaffirming of the profile we've seen to date. So I think with continued use in the market, we're just going to see continued expansion and more dermatologists taking to it and using it over time.

Okay. And for the sort of Arcutis management team, Frank. Could you maybe help us understand a little bit more about the collaboration? I think recently, the products and the main one, at least went generic and just wondering whether the genericization of that particular product is beneficial or is not beneficial to the partnership, how that may help or not? And was the 200 sales reps, is that sort of the original -- is that the most reps that they have? Or do they have a lot more?

Yes. So I'll take the first question, and then I'll ask Todd to talk about sales force size, if he's back. He had a power outage apparently where he was. So with regard their prior products or their current product, they promote Laval, which is a branded generic that lost exclusivity. I believe it was late last year. No, absolutely, I see that as a benefit. Again, one of the challenges for us was finding a primary care sales force -- an existing primary care sales force that had the capacity to promote our product in a very high position in the old world, we would have talked about first position detail. I don't know the position matters so much anymore as a priority. But if you think about -- if we had done a partnership with Lilly or Novo, we wouldn't have gotten any attention, right? Because it's all Ozempic or Munzara all the time with everyone. And so the fact that they had lost exclusivity on their lead product really was what created the opportunity for us to slot ZORYVE in that top priority position into their sales force. And I can tell you, I was with their CEO last week, and they are very highly motivated, they are very excited about this agreement, and we're just delighted to work with them. I think it's a great team that's shown repeatedly that they can work in these kind of co-promote agreements. Do we have Todd back?

No, you should answer the question. Okay?

Okay. And you asked about the sales force. I believe that they had peaked at 300 is my recollection in sales force size when they had Laval still patented. That there's obviously down somewhat, and they do have some plans for some modest expansion of their team as part of this collaboration. But I don't think we'll get back up to 300. It's a decent-sized primary care sales force. And we are working with them right now to really identify who the right targets are, so that they're focusing on the highest potential primary care and pediatric doctors for treating all 3 diseases, but particularly atopic dermatitis and seborrheic dermatitis.