Arcutis Biotherapeutics, Inc.

Good day, and welcome to Arcudis Biotherapeutics 2025 First Quarter Financial Results Conference Call. At this time, all participants are in the listen-only mode. After the speaker's presentation, there will be a question and answer session. Please be advised that today's conference is being recorded. I would now like to hand the call over to Amanda Sheldon. Please go ahead.

Thank you, Heidi. Good afternoon, everyone, and thank you for joining us today to review our first quarter 2025 financial results and business update. Slides for today's call are available on the investor section of the Arcutus website. On the call today are Frank Watanabe, President and CEO, Patrick Burnett, Chief Medical Officer, Todd Edwards, Chief Commercial Officer, and Latha Virovan, Chief Financial Officer. I'd like to 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 the company's 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.

Thank you, Amanda, and thank you to everyone for joining us today. Before I delve into the quarterly details, I want to take a moment to thank David Topper who will retire in a couple of weeks, for his many important contributions to Arcutis, both in his time as our CFO and during his many years as a consultant to our company. We wish him all the best in this next stage of life. And I'm very pleased to welcome Lata Verovan to our first earnings call as our CFO, a role she officially assumed this morning. Lata has been an integral part of our team for many years, and she is fully prepared to step up to this new role. I could not be more excited about her joining our senior leadership team. Turning to our results, if you take nothing else away from our call today, I want to highlight four key points. First, our team continues to execute exceptionally well, most notably our commercial and R&D teams, as evidenced by yet another strong quarter performance across our portfolio and our continued progress in advancing our pipeline. Second, with multiple upcoming catalysts and expanding markets, we are confident in our ability to sustain our growth throughout 2025 and beyond. Third, the most important of these market expansion opportunities is the conversion from the very large topical steroid market, and we are seeing tangible signs of growing momentum in that shift. And fourth, we are very pleased with our progress in Q1 in protecting our intellectual property. I am grateful to work with such a dedicated and stellar team who are building the leading topical franchise, one that is outperforming historical precedents in dermatology. Zoriv is endowed with a unique combination of attributes, including efficacy and safety, rapid onset, reliability, and the ease of use for both clinicians and patients that has allowed us to build a segment-leading franchise. Let's turn now to slide five of the deck. We had a robust start to 2025, and our first quarter performance was very much in line with our expectations. As our results indicate, commercial execution continues to be a key strength of our business and we expect sustained growth of the Zareed portfolio this year and beyond. In the first quarter, we reported revenues of 63.8 million, representing nearly a doubling of revenues year over year, excluding the non-recurring reduction in reserves for product returns of 4.1 million as reported in Q4 of 2024. As is typical for any retail pharmaceutical product, revenues were down compared to the fourth quarter due to the typical first quarter deductible resets and insurance changes. It's really quite remarkable that despite those typical headwinds, our sales were nearly flat, with only a 2% decline versus the prior quarter, which is very unusual compared to other branded top goals, or frankly, nearly every other product on the market, where substantial drops Q4 and Q1 are typical. Impressively, we delivered prescription demand growth of 10% compared to Q4, despite the typical pull forward of demand into Q4 as patients filled prescriptions early in anticipation of their copay resets. Blending growth to NETs have remained relatively steady as expected, with some minor anticipated quarterly fluctuations related to the reset of patient deductibles and plan changes. And as Q1 progressed, we saw our GTNs quickly trend back down towards steady state. The vast majority of patients with psoriasis, AD, and seb derm are currently treated with topical steroids, So there is an immense opportunity for future growth of Xareeb across our indications. And as Patrick and Todd will discuss more in just a few minutes, during Q1, we saw clear and growing momentum in that shift. We expect to further expand Xareeb's approved indications in 2025, beginning with the anticipated May 22nd approval of Xareeb foam for scalp and body psoriasis. We are also eagerly anticipating another approval for Xareeb cream, this time a 0.05% concentration, for atopic dermatitis in children ages two to five with an expected approval in October. Finally, we announced in April that at the request of Patagas, we had agreed to a joint stipulation to stay the ongoing patent litigation with them over their topical reform last ANDA. We agreed to this because it extends the 30-month stay we are entitled to under Hatch Waxman for as long as the Patagas requested stay in the case remains in place and it also allows us to delay or even avoid the cost of litigation and the distraction of litigation. Let me be clear, we are not and have not previously been in any settlement discussions with Patagas. We have not wavered in our confidence in the strength and breadth of our patent portfolio that reflects the innovations we have generated since our company's inception. We are confident in our legal position against Patagas. If and when the stay is lifted, we will continue to fight against Patagas's attempts to circumvent our legally issued patents on our psoriasis cream. Now turning to slide six, touching again on the immensity of our target market of 17 million patients. The size of this opportunity coupled with Zareve's unique and compelling value proposition provides us with strong conviction in our ability to continue to grow our product portfolio beyond what has historically been typical with other topical brands. Patrick, Todd, and I were out visiting clinicians all last week, and the feedback we heard from them on Zarif's performance is outstanding, only adding to our confidence in Zarif's future potential. As we've shared in the past, half of the treated patients and our targeted indications are treated in the DERM setting, and the other half are being treated outside of the dermatology office, primarily by primary care physicians and pediatricians. Our launches thus far, along with our upcoming launches if approved, continuously expanding coverage, and the COA commercial partnership enabled us to access the entire 17 million patient opportunity, another unique feature in the branded topical space. But as shown on the chart on the right, 94% of topical prescriptions written for our target patients are still for topical steroids, topical calcium neuron inhibitors, antifungals, and vitamin D analogs. Our long-term growth relies on shifting this use to Zareve as the go-to topical treatment. Encouragingly, we are seeing growing evidence that dermatology clinicians are starting to shift away from these products, and as the leading branded non-steroidal, Zareve is in the position to be the primary beneficiary of that shift. Todd and Patrick will delve deeper into the evidence we are seeing of this growing shift And Todd will go into further detail on how we view revenue and script growth trends evolving throughout 2025. Our QDIS as a company has had the good fortune to be presented with a rare opportunity, combining an immense market with a strong and well-recognized brand, which can create significant value for all of our stakeholders. Our team recognizes the uniqueness of our compelling position and remains highly focused on growing Zareef to its peak sales potential. With that, let me turn it over to Todd to provide some more color on where we are in our launch and how we will continue to execute on our vision.

Thank you, Frank. In Q1, once again, we delivered strong sales results, leveraging the strength of our product portfolio and are pleased by the continued positive response to Zuri from HCPs and patients and excited by the growth opportunities ahead of us. On slide 8, this quarter, we achieved $68.3 million in net product revenue for Zareeb, reflecting 196% growth year-over-year. Importantly, we saw strong sequential volume growth, and our blended gross-to-net remained in the 50% range, even with the typical temporary reversion in gross-to-net compared to Q4 2024. All commercial-stage companies faced challenges in the first quarter due to deductible receipts, changes in patient assurance plans, and prescription refills pulled forward into December. Zareef is not exempt from these challenges, and we did see some impact on Q1 revenue, but we are delighted that these had minimal impact on our Q1 performance, with only a slight decline in net sales compared to Q4. We are particularly pleased that, despite these customary headwinds, Zareef unit demand grew 10% quarter over quarter. Encouragingly, prescription trends in Q2 point to sustained growth continuing from Q1 and foretells solid performance for the remainder of the year, with expected volume and revenue growth throughout 2025. On slide 9, you can see that Zuri prescription volume has reached another record high at 17,000 weekly scripts on a rolling four-week average basis. In 2024, Growth inflections were driven by the launches of Xerif foam for seborrheic dermatitis and Xerif cream 0.15% for atopic dermatitis. Looking towards 2025, later this month, we anticipate the addition of a psoriasis body and scalp indication for the foam formulation pending approval. We expect this additional indication will reinforce our strong growth trend, although we would not anticipate the same magnitude of growth acceleration as with the Cevderm launch. Furthermore, we anticipate another label expansion in October, adding atopic dermatitis in ages two to five, which should be an additional catalyst for growth. As expected, prescription volume declined from December to January due to the expected pull forward of refills into December. However, Zuri quickly rebounded within weeks. recovering from the early dip and delivering growth across the entire portfolio. We expect this positive trend to continue as we gain share in the large topical steroid market. On slide 10, we highlighted our strong and robust insurance coverage. On the left, you'll see that we've achieved a remarkable position in terms of insurance reimbursement, with approximately 80% of total Zuri prescriptions being reimbursed. a steady state and optimal level across the portfolio. Since our last update, we've further broadened payer access for atopic dermatitis, which is now largely in line with psoriasis and seb derm coverage, and we expect to see further improvement in gross to net for this indication. In addition, we've secured expanded Medicaid coverage and established a strong presence. CEREV is now covered with a single step through a steroid or better, for 53% of state Medicaid lives, and we've seen strong quarter-over-quarter unit growth in this channel. The other point I want to highlight on this slide is that the profitability of our Zareve franchise continues to improve, driven by the high rate of reimbursed prescriptions across the portfolio. This positions us well for the future as we continue to grow prescription volume in 2025 and beyond. and we expect revenue to scale proportionately with that growth. Our commercial partner, COA, continues to make steady progress within the targeted primary care pediatric segments. As expected, the primary care selling cycle requires more frequent engagements to build familiarity, given that many providers have limited exposure to topical non-steroid treatments and historically default to steroid use. Physician feedback has been encouraging as education efforts increase, highlighting Zarif's unique profile as a safe, effective non-steroidal option that can be used anywhere on the body for any duration with exceptional tolerability. Importantly, with recent changes to the prescription process, the ease and reliability of prescription fulfillment will be a key differentiator with both physicians and staff. We remain confident in CODA's ability to expand adoption in primary care. And we're already seeing positive indicators from early prescriber uptake and encouraging signal for growth in this large and relatively untapped segment. On slide 12, I'd like to draw your attention to the left side of the slide. We are on a mission to convert steroid prescriptions to Zareed and to expand the overall branded topical market. As you can see, the immense topical steroid market has declined by 200 basis points over the past year, with that share being captured by branded topicals led by Zariv. This is an early but meaningful sign of our success, and Patrick will delve into the drivers behind this in a moment. Keep in mind, branded topicals still represent only a small portion of the overall market, which highlights the immense opportunity ahead for Zariv, as clinicians continue to transition from steroids to non-steroidal treatments, a trend we expect to accelerate. I'm excited to share tangible evidence of our momentum. Zareeb has continued to expand its leadership as a number one branded non-steroidal topical. In the most recent week, Zareeb captured a 41% share of that segment. On the right side of the slide, you'll see how Zareeb is consistently gaining share further validating our growth trajectory. On slide 13, as we've emphasized over the past several quarters, Zarif is uniquely positioned in the topical arena with multiple formulations to treat three major inflammatory skin conditions. And a fourth indication for phone scalp and body psoriasis is pending with a PDUFA date set for May 22nd. Zarif stands out for its rapid, reliable relief, its ability to be applied anywhere on the body, used for any duration, and its exceptional tolerability. It offers a simple, once-daily regimen with predictable patient access through consistent reimbursement and co-pay support. This growing portfolio effect allows dermatologists to take a personalized, multifaceted approach to managing complex skin conditions. making Zareeb their go-to treatment solution across indications. On slide 14, I'd like to delve into a recent analysis we conducted on prescribing behavior among clinicians. Unsurprisingly, we found that clinicians who prescribe Zareeb across multiple indications write significantly more prescriptions overall. But what is remarkable is the evidence of the portfolio effect that I've mentioned previously. As these healthcare providers recognize the values that we bring to patients, they're able to expand this use across a broader portion of their practice. For example, clinicians treating only one indication average three prescriptions per prescriber, while those prescribing for all three indications average 31 prescriptions per prescriber, a tenfold increase. We expect this amplification to increase further with the potential approval of our foam formulation for body and scalp psoriasis. With that, I'll now turn it over to Patrick for an R&D update.

Thank you, Todd. I'm on slide 16. We're now approaching several key milestones in 2025. And first, we have the FDA PDUFA target action date for Xareve foam for plaque psoriasis of the scalp and body down to the age of 12 on May 22, 2025. And we're highly optimistic about an on-time approval there. Second, we have an anticipated approval in October for Zarev cream 0.05%, a dose specifically developed for the treatment of mild to moderate AD in two to five-year-olds. We also continue to generate the necessary additional data that should ultimately support expanding the psoriasis indication down to the age of two as well. In our early stage pipeline, we look forward to the phase 1b readout for ARQ255, our topical JAK and alopecia areata, around the middle of 2025. We expect to file the IND for ARQ234, our biologic CD200 receptor agonist for atopic dermatitis, in the second half of 2025. Now, moving on to slide 17, we've been talking to you for several quarters about the growing momentum among clinicians for a shift away from steroids toward non-steroidal topical agents that are safer for long-term use for these chronic conditions. And in Q1, there were a number of notable events that really prove out and highlight that trend. For example, in January, a panel of some of the leading dermatology experts in the US published consensus guidelines on the use of topical steroids, as well as recommendations for the incorporation of advanced targeted topicals into the treatment regimen. I would call your attention to that group's conclusions shown on the lower left of the slide. Similarly, during Q1, A journal targeted to dermatology NPs and PAs published an extensive review on steroid safety concerns. And again, I would point you to the conclusions of that paper shown on the lower right. These are powerful calls to action from dermatology clinicians directed toward their dermatology colleagues. And these were only two of several recent research reports and publications highlighting the risk and cumulative effect of steroids. Last month, New Canadian consensus guidelines for the topical treatment of atopic dermatitis were published, recommending that steroids be reserved for short-term use due to greater risk of adverse events, including skin atrophy, hypopigmentation, and other systemic effects. And in March, the NIH published research that identified for the first time the pathophysiology of topical steroid withdrawal, also called TSW. This is a condition caused by long-term steroid use that leads to redness, itching, and scaling which can be difficult to distinguish from the underlying skin disease that was originally being treated by the steroid. As more evidence emerges for how the cessation of long-term topical steroid use can result in TSW, as well as criteria to help distinguish this condition from eczema, we expect more opportunities for the treatment of this condition will emerge as well. Now on slide 18, turning to our expected upcoming indication for scalp and body psoriasis, I wanted to share with you some impactful images of the benefits of our investigational xereve foam in treating psoriasis of the scalp and body from our erector clinical trial. In the top row, you can see a female patient with significant scalp and neck plaques that were initially rated a score of three or moderate on the investigator global assessment or IGA scale. These lesions were then significantly improved after only two weeks of treatment and the patient was subsequently rated as an IgA score of zero or clear by eight weeks. Similar efficacy can be seen in the bottom images of another patient with extensive body psoriasis with thick, brightly erythematous lesions on the back, who was likewise treated with Xarebe foam and dramatically improved from a baseline of moderate psoriasis to also be clear, an IgA of zero, by eight weeks. Now, this degree of improvement is quite remarkable. that highlights the strength of Zareve foam on both the scalp and the body, and when combined with its ease of use and broad patient access, makes Zareve highly compelling to healthcare providers. These results are highly representative of our phase three trial results, in which about two in three individuals achieved scalp IgA success, and nearly half achieved body IgA success. With that, I'll pass it over to Wata.

Thank you, Patrick. Before I begin, I want to thank David Topper for his guidance and mentorship over the past year, and especially during this transition. I am honored to step into the CFO seat during a very exciting period of our QDIS commercial growth. I'm on slide 20, showing financial results both year-over-year and quarter-over-quarter for the first quarter of 2025. We generated net product revenues in the quarter of approximately $63.8 million which is up 196% from Q1 of 2024. Recall that Q4 2024 number included a non-recurring $4.1 million adjustment for reduction in reserves for product returns. Last quarter, we noted that this number should be excluded from forward-looking calculations. Without this non-recurring revenue, net product revenues only declined by 2% quarter over quarter, reflecting the healthy state of our launches. I will remind you that in Q1, 2024, we executed an outlicensed deal in Japan with Sato, which brought in 25 million of non-dilutive capital, and we also received 3 million milestone payment from our Chinese partner, Wadong. This quarter, we received another milestone payment from Wadong of $2 million. Cost of sales in the first quarter were 8.8 million compared to 3.3 million in 2024. primarily due to catch-up amortization of the 10 million owed to AstraZeneca for reaching a sales milestone of 250 million of cumulative net sales. For the first quarter of 2025, our R&D expenses were 17.5 million, which is down 24% from 23.1 million in the first quarter of 24 due to decreases in the development cost of topical reflumilase programs and approximately 21% compared to the fourth quarter of 24. Recall that Q4 24 benefited from a one-time $3 million credit we received related to a closeout of our reflumilast study. SG&A expenses were 64 million for the first quarter of 2025 versus 54.8 million in the same period last year, up 17% as we invested in our commercial organization and our current and future launches. SG&A expenses We're also up approximately 11% as compared to the fourth quarter of 2024, primarily due to higher promotional spend for our current and upcoming Zuri launches. Our SG&A spend in Q2 will be higher than Q1, associated with the scalp and body psoriasis launch, and then normalized in the second half of the year. We expect a stable level to carry into 2026. This expense stabilization, combined with the tremendous growth potential of our Zuri portfolio, gives us continued confidence that we can reach cash breakeven in 2026. I want to take a moment to comment on the impact of tariffs on our business. We are a global operation with sales in the United States and Canada. All of our intellectual property for Zareeb is domiciled in the United States. We currently manufacture the majority of our product in the US and our API is sourced from Spain. We have also started manufacturing at a facility in Canada to mitigate any supply chain risks. As we have previously mentioned, our cost of sales is pharma-like, and if a tariff were applied to our entire unit cost, it would be immaterial, estimated to be less than a one percentage point impact on our cost of sales. The impact of tariffs on our QDIS will likely be no greater than on any other pharma company and substantially less than many, so we do not anticipate that it will be a significant issue for our QDIS. particularly compared to our peers with extensive non-U.S. manufacturing networks and or a significant portion of their intellectual property held overseas. I am now on slide 21. You can see we had cash and marketable securities of $198.7 million on our balance sheet as of March 31, 2025, which translates to a cash burn from operations in the quarter of approximately $30 million. Q4-24 had several one-time anomalies that benefited our cash burn for the quarter, but we were back to a more typical use of cash. Q1 burn was still lower than that of Q3-24, and we expect our quarterly cash burn to continue trending downward as our revenues grow and we approach cash flow break-even sometime in 2026. We have total debt of $107.6 million and have the option to redraw $100 million in whole or in part at our discretion through the middle of 26, providing us with significantly enhanced flexibility. The success of our Zuri portfolio and the economies of scale we're generating will permit us to invest in the business for continued growth and long-term durability. With that, I will hand it back to Frank for some closing comments.

Thanks, Lata. I will finish up where I began. Arcutus continues to execute exceptionally well driving growth of Zareve and advancing our pipeline. We are confident in our ability to sustain our growth throughout 2025 and beyond, considering all of the opportunities ahead of us. We are seeing tangible evidence of an accelerating shift from topical steroids to newer non-steroidals, and we are delighted with our progress in protecting our intellectual property. Our growing revenues, coupled with the strength of our balance sheet, puts us in a strong position to continue investing for the future And we remain optimistic about achieving cash break even in 2026. And with that, we'll open up the call for Q&A.

Thank you. If you wish to ask a question, you will need to press star 1, 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1, 1 again. We will take our first question. The first question comes from the line of Vikram Parahit from Morgan Stanley. Please go ahead. Your line is open.

Hi, good afternoon. Thanks for taking our questions. We have two. So first, thinking about the cadence of the re-performance throughout the rest of the year, is there anything you would point out on seasonality, cyclicality that we should keep in mind that could impact kind of quarter-by-quarter trends? And then secondly, for the alopecia areata readout expected in the middle of this year, what would you set in terms of expectations for what we can learn and what you hope to see for the product profile? Thank you.

Yeah, hi, Vikram. Good to hear from you. Yeah, Todd, can you maybe address the cadence quarter-by-quarter? And then, Patrick, if you could address the 255 readout.

Yes, as we experienced last year over the summer months, we do expect a modest seasonal impact to our performance. However, I think what's very important to point out here is that, as mentioned, we'll be launching foam for scup and body psoriasis. Not only that, we continue to see a positive impact about this portfolio effect that I mentioned earlier, which continues to provide us an opportunity to to convert, you know what I'm saying, the steroid market, which is a significant opportunity for us, which will continue to drive revenue growth in 2025. So, yes, we will see some seasonality, but we continue to be very positive relative to these that are value drivers that we're providing the market.

Okay. So, picking up on the question, Vikram, for ARQ-255. So, this is a Phase 1b trial that we conducted, and it's primarily focused on evaluating safety, tolerability, and then pharmacodynamics. We also looked at the PK and had some biomarker work in addition to some kind of early responses that we were looking for for clinical response for hair growth. So this is a three-month trial. The primary endpoint for most pivotal trials is six months. So what we're really focused on is just getting an early read on what might be able to be achieved with ARQ 255. So we're really looking forward to reading out the data from this in the middle of 2025. Got it.

Thank you.

Thank you. We will take our next question. Your next question comes from the line of Seamus Fernandez from Guggenheim Securities. Please go ahead. Your line is open.

Oh, great. Thanks for the questions. So, Todd, just when we get a sense for how the additional scalp psoriasis and body psoriasis opportunity can accelerate and expand the use of Xerupi foam. Obviously, that's kind of the standout product within the portfolio at this point and continues to be so, just trying to get a better understanding of how that can potentially expand utilization of the foam more broadly and And is it your view that it'll cannibalize cream or expand the market and the overall penetration? Then the second question is actually just, you know, help us understand where we are in the life cycle of Zareve as it relates to potential impacts of seasonality, you know, whether or not we would see anything like that given the mild to moderate, you know, treatment opportunity that you have in atopic dermatitis where, you know, Sometimes in the summer months, we could see some seasonality, but it seems pretty early in the life cycle of Zareve to see an impact there. But just wanted to get your thoughts. Thanks.

Yes, thank you for the question. So we don't anticipate any meaningful cannibalization of Zareve cream 0.3%. And let me be a little bit more specific about that, is that we expect a broader and increased utilization of Zareve for the psoriasis patient. And specifically what I mean is that Zareeb offers something that no other competitor can offer relative to the differentiation that I think that both patients and providers will value, and that is that we're going to offer optionality and choice, meaning that once a psoriasis patient is seen by the dermatologist, based upon where that psoriasis is located, as an example, if it's in a hair-bearing area, that that clinician will probably prefer to use the foam, given the unique formulation for hair-bearing areas, whether it be the scalp or for such as genital psoriasis. Hemp is on the body. They may select to use the 0.3 cream psoriasis. But nonetheless, we expect broader, more significant utilization of Xareeb across the two products, given that unique value proposition that we will offer. I will point out, though, with psoriasis patients, the data suggests that 50% of those patients do have scalp involvement. So we do anticipate increased utilization of the foam for those patients with either scalp or hair involvement. Moving to your second question relative to seasonality and atopic dermatitis, as mentioned earlier, we will expect some seasonality impact to the product. But nonetheless, you know, we continue to see strong growth of Xareve demand across atopic dermatitis and other aspects of the portfolio. But I think what's important to mention that I mentioned on my opening comments is this portfolio effect. We continue to see as more prescribers prescribe across the portfolio, they prescribe more . And what's important about that is the provider has more experience as they write this product, which creates more efficiencies in their writing, more predictability, not only for the provider, but all for the staff, where they can become more efficient and effective in processing those prescriptions. And I believe this portfolio of PEC that will be compounded by the Zerifoam launch for psoriasis will continue to drive strong demand growth over 2025.

Yeah, let me just maybe expound just a little bit more on the first point, because we get this question a lot, right? I think it's very unlikely that patients will get switched from the cream to the foam once the foam is approved, right? So that's cannibalization, right? I think going forward, what we probably will see is an increased use of the foam in new starts for psoriasis patients, keeping in mind that, as Todd mentioned, about half the patients with psoriasis have scalp involvement. But I think what's really more important is that none of the other non-steroidal options have a formulation that's suitable for treatment of the scalp, And it's quite challenging to treat scalp psoriasis even with steroids, A, because of safety concerns around, you know, proximity to the face and especially the eyes, and B, because there aren't a lot of good steroid formulations that are suitable for the scalp either. So, you know, if you're a clinician who's treating a large number of patients who have scalp involvement, Xerif foam now being approved or soon to be approved for scalp psoriasis gives you a great new option and a great new reason to choose Zoriv over the other non-steroidals and over the topical steroids that you've historically been using. So we really believe that this is going to be an important element of our continued ability to grow the franchise.

Thanks, guys.

Thank you. We will take our next question. Your next question comes from the line of Oyia from Mizuho. Please go ahead. Your line is open.

Thanks. Yeah, thanks, guys, for taking your questions. And congrats on the solid quarter. So maybe first question, just help us understand, you know, the cadence of the growth in that as we go through the year. Understandably, at the first half of the year, I think on the fourth quarter, you were expecting sort of maybe on the higher end of the 50s. Should we expect that to decline dramatically? towards the middle and then towards the low end as we approach the end of the year. So that's the first question. And the second question is, you know, in one of your slides, I think it's slide 12, where you showed a 4% growth in the topical branded product in first quarter 2024 and then 6% in this quarter. You know, given that, you know, like Ritama and Zareep Cream 0.3 and other products, Opsilor and stuff like that, been in the market at least for the last four years. What is it that drove this significant market share? Thanks, Cain.

Todd, you want to? Can you talk about the gross net trend?

Yeah, I'll talk about the gross net trend. As mentioned in the opening comments, we did see some impact on gross net early in the first quarter due to the deductible resets, but since that time have seen improvements and are in a steady state of the 50%. We anticipate to remain within the 50% gross net, although we will see improvements through the year as those deductible resets continue to decrease. as you roll through the second, third, and fourth quarter of the year, and are confident we will remain in the 50% range for gross to net.

And then, you know, with regard to your question about the trend and conversion, you know, I think, first of all, it's important to remember that, you know, Opsalura has been out for about four years. Zareve for psoriasis has only been out for three, and Vitamla has been out for about three. Zareev for Cebderm has only been out a year and AD has only been out for about six months, right? So we're still in very early stages of the process. I think also if you go back to 2021 when Opslura was approved, the branded non-steroid market, as I recall, was around 1%. So, you know, you've seen a really dramatic growth in that market over the last four years. with the addition of new products and as doctors adopt these products more. And I think a 50% increase in a 12-month period is really pretty remarkable and I think speaks to the acceleration of the trend that Patrick and Todd talked about. Clearly, we are working against a fairly ingrained habit, which is the use of topical steroids. But as Patrick mentioned, what we are increasingly hearing is clinicians telling each other that they really need to rethink their use of topical steroids and adopt these newer agents. And so we think that that trend will only continue as they have better options and new options like Serifoam for plaque psoriasis and the expansion of our AD label down to the age of two.

Is it just the addition of the new product that's accelerating this trend? trend or is it also something else? I guess I just wanted to get a better sense of why all of a sudden I guess we see this significant acceleration when other non-topicals have been on the market for quite a while as well.

I think you have to look at the clinical profile of those non-steroids. Remember back when the TCIs launched in 2020, sorry, in 2000, excuse me, Those two products rapidly ramped up to $600 million in annual sales in their fourth year on the market, and then they got the box warning, which has been and continues to be a major impediment to the use of TCIs, especially in children with atopic dermatitis. Those drugs also do have some local tolerability issues, and they're twice a day. And then, you know, you had Eucrisa come out in 2017, as I recall, clearly not an optimal non-steroidal that has never been very successful, particularly because of the local tolerability, but also fairly limited efficacy and an ointment, and it's twice a day. So that wasn't a great option either. So it really wasn't until the emergence of Opsalura and then Zareve and Depenirof that doctors had you know, really reasonable non-steroidal options that could compete with topical steroids. And I think that's why you've seen this growth from, as I said, about 1% prior to the emergence of the newer advanced topical therapies to 7% in, you know, about four years. So really, I think it's all being driven by the clinical profile. And, you know, prior to the emergence of these new advanced topical therapies, You know, the only option that doctors really had that were good drugs were topic steroids. Those are the only things that really worked. So. Okay. Thank you.

Thank you. We will take our next question. And the question comes from the line of Tyler Van Buren from TD Cohen. Please go ahead. Your line is open.

Great. Thanks for taking the questions. Can you guys please elaborate on the current split of patients patients being treated in the DERM office versus primary care. And I know you mentioned the 50-50 of the addressable patient population, but is that ultimately where you expect the split of patients to end up? And the second question is, as we think about the CAWA efforts, maybe you could elaborate on some of the barriers to PCP prescribing that are different from DERMs and what tactics CAWA is employing to knock them down in order to contribute to revenues meaningfully this year.

Yeah, thanks, Tyler. Good to hear from you, too. So, you know, in terms of the split, the patients split about 50-50 across derm and non-derm settings. And the non-derm settings are primarily primary care and pediatrics. You know, today, our business is overwhelmingly dermatology. Remember, our primary care and pediatric efforts are fairly nascent. And, you know, it's going to take a little time. Todd will mention that, go into more detail about that in just a minute. You know, I think it's hard to say where we ultimately land. I do think that primary care and pediatrics will, over time, become major contributors to growth for the franchise. But, you know, I don't know that we'll get to a 50-50 split, you know, because there are any number of other dynamics like paramix that also could factor into it. But I do think it'll be an important contributor to growth over the long term. And Todd, you want to talk a little bit about COA?

Yeah, absolutely. Relative to COA, I mean, COA does continue to make steady progress to what I'll call the dynamics of the PCP selling cycle. And we do expect them to have a positive impact to our revenue in 2025. But like all new sales forces or new product launches, especially within primary care, it takes a high level of engagement and frequency with that primary care physician to initiate a trial of the product. So we're confident that COA will continue to progress and have that type of impact. But you think about within the primary care repeat market, there's been no promotion of non-steroidals. COA was the first to do it within these two market segments. And so it does take a little bit of extra time in that selling cycle. to be able to educate not only the provider, but also to educate the staff relative to the process of fulfilling that prescription. But COA continues to engage there, create interest, and we are seeing positive signals as we move forward.

Thank you.

Thank you. We will take our next question. Your next question comes from the line of Kanbiz Yazdi from Jefferies. Please go ahead. Your line is open.

Hey, team, thanks so much for the questions. A few on my end. What are the next steps after litigation stay or you do a joint status update at some point? And then separately, maybe on ARQ 255, what are the key learnings from ARQ 252 and oral IVMAR-CIDNIP? And then as a third and last question, kind of what's the white space in alopecia areata for a new topical treatment? Thank you.

Sure. So let me address the IP question, and Patrick, maybe you could talk about 255 and alopecia areata. So with regard to the patent litigation, you know, the stay is an indefinite stay. You know, the... The reason that Patagas requested the stay is not something I could discuss. That's something that you would need to discuss with them. But, you know, I think that it is not unreasonable for one to conclude that they must have had some problem with their development or with the FDA, right? They filed in February of 2024 with the FDA their ANDA under the GDUFA guidelines, which are the same as PDUFA. they should have received a conditional approval in November of 24. To the best of our knowledge, they did not receive that. So, you know, I can't, I don't know what the issue is, but clearly they've had some issue. The quarterly updates that we provide jointly to the court really are just to update the court on the status of the dispute, let's say, between the two companies. They are also required to share with us their FDA correspondence so that we can see if that program is moving forward and when. And at such a time as we feel that it's necessary to move forward with litigation again, we have that option. We also will benefit from the remainder of our 30-month Hatch-Waxman stay should the litigation restart. But, you know, honestly, I don't know whether the litigation will ever progress, whether the program will ever progress. You really have to talk about that with Patagus. And then, Patrick, do you want to address the questions around 255 and alopecia areata? Yeah, absolutely.

So I think most importantly, it's important to note that ARQ-255 is a completely unrelated formulation to ARQ-252. So we have the challenge of being able to get sufficient drug with 252 into the skin. With 255, this is not a solution. The drug's not dissolved. It's actually a suspension of the JAK inhibitor, and it's designed to be able to deliver the drug down the hair follicles. and to overcome, I would say, what has been the biggest challenge for any topical approach for alopecia areata, which is just the depth of the hair follicle, which is where the relevant inflammation is, which is where the target is for this treatment. And so we took a unique approach with that. Now, with regard to the oral, we know that the oral actually works in alopecia areata. It's a very potent JAK inhibitor, so that's important. And the key issue is just to overcome getting the drug to where it needs to go. With regard to the second part of your question and the white space in alopecia areata, you know, we know that the, you know, oral systemic administration of JAK inhibitors for patients with extensive alopecia areata can be a treatment option. And many patients have benefited from that. I think the white space is really in several different places for that patient journey. One of them would be patients leading up to where they get to their 50% scalp involvement that would make them a candidate for systemic treatment. And many patients, even when they get there, aren't very keen on being long-term on the JAK inhibitor. Because many of these patients are younger and may not be, you know, wanting to go on to a systemic immune suppressant for a long period of time. And then the other one is once a patient may have had a good benefit from being on a JAK inhibitor, what's the long-term potential for managing that patient? You would at some point want to think about withdrawing that immune suppression and seeing if the disease is resolved kind of while the patient was on treatment. That would be another opportunity for being able to have a topical option. So I think there are many different places where a topical would be appropriate for use, even in an environment where we have systemic JAK inhibitors at work.

Thank you so much.

Thank you. We will take our next question. Your next question comes from the line of Serge Bellinger from Needham. Please go ahead. Your line is open.

Hi. Good afternoon. A couple for Frank and Todd. Going back to the 1Q performance, it looks like you were able to avoid the usual seasonality or not see the typical seasonality. Just curious if that was a function of strong growth that allowed you to avoid it, or there was something more specific in terms of a better reauthorization process that minimized the seasonality. And then secondly, I think on slide 10, you highlighted that 80% of Zorin franchise prescriptions are currently covered by insurance. I'm curious if we should expect some additional improvements on that number over time. Thanks. Yeah, Todd, do you want to take this?

Yeah, relative to Q1, let me just take a step back. Specifically, first let me address the revenue as mentioned in the opening comments. We did see some impact on our gross net early in the quarter, and of course that was due to the patients change in insurance, as well as the deductible resets that did reoccur during that time. But nonetheless, um, we were able to, uh, swiftly improve on our gross net in Q1 to where we, you know, make sure that we stayed within the steady state of the 50%, which is very encouraging and will, um, you know, be a positive signal as we roll forward into the year. Relative to demand, as mentioned earlier, we had 10% quarter over quarter growth, Q1 versus Q4. I think there's a direct correlation relative to the momentum that we have built with this franchise. When you think about, you know, Zareve's differentiation relative to other options within the market, being able to offer three unique Zareve products for three unique skin inflammatory diseases really makes Zareve a one-stop solution for both the provider and the patient. And I think that portfolio effect continues to resonate with both providers and patients. And we expect that only to be amplified once we get the foam scalp and body launch. And we'll continue that momentum as we roll through 2025.

You want to address the coverage rate?

Yes. Relative to the coverage rate, we mentioned that we're kind of in an optimal steady state relative to 80% covered or reimbursed prescriptions. We anticipate that we will, you know what I'm saying, relativity improvement will stay within that 80% range. We have very good coverage of Zareve across all three products now, which, you know, is leading to those reimbursed rates that we see, which I think was a contributor relative to maintaining a positive growth to net during Q1. So, we expect minimal change that will stay within that steady state of 80% covered reimbursed prescriptions.

And let me just touch a little bit on the demand point, too. You know, again, I think some investors maybe aren't used to this dynamic. But, you know, Q4 is typically very strong as patients pull forward demand before the deductible resets. We certainly saw that if you look at slide nine in our deck, there is a very clear demand spike in Q4. and many brands experience actually a decline in demand than in Q1 because the patients aren't filling scripts in January that they filled in December, right? So the fact that we were able to grow quarter over quarter in spite of that demand pull forward, I think it's really pretty notable. And if you look at many of the other brand of topicals, they have been largely flat in the quarter compared to Q4, whereas we've been able to to deliver yet another strong quarter of demand growth in Q1. And I think that bodes well for us going forward as well.

And if I could mention one other dynamic, if you think about what Frank mentioned relative to the pull forward of the refills into December, when you look at that demand increase that we had in Q1, those are MBRXs. That means they're new to brand RXs. And so we're driving new growth of new prescriptions in January which is going to lead to incremental refills, you know what I'm saying, in Q2, Q3, and Q4 this year. So once again, a very positive signal relative to the health of the business.

Thank you.

Thank you. We will take our final question. Your final question comes from the line of Douglas Tao from HCU Wainwright. Please go ahead. Your line is open.

Hi, good evening, and thanks for taking the questions. I'm just curious as we look ahead to the approval for the foam into scalp and body . I'm just curious because when we first saw the foam get approved to the market, we saw a very rapid adoption. We've obviously seen, as you've added, additional indications, some incremental growth, but perhaps less dramatically. You know, what is your expectation and how should we think about the trajectory from the addition of that indication, you know, fairly soon?

Yeah. So, Doug, that's really an important question. The launch of the foam and seborrheic dermatitis was a very, very unique event. unicorn kind of situation, one that I have never experienced in three decades in the business. I don't think Todd has either. You know, that was a disease that where there had been no innovation in over two decades, very large population, very high level of dissatisfaction with existing therapies. And I can tell you from I know for a fact that I spoke with a number of clinicians early last year who had literally hundreds of patients lined up waiting to go on the foam. So the minute we got approved, there was a vertiginous uptake of the foam, you know, the likes of which I have never seen before. And certainly we actually honestly hadn't expected when we launched it, not that pace. I don't think that scalp is of that same degree of unmet need. There are options. You know, you can use biologics, which are, you know, some of them are very, very good. You know, the scalp is one area that maybe doesn't respond as well, but it does respond. There are steroid options for use on the hair. So, you know, you don't have this complete absence of good options, I think, in scalp, although Zareve is a very, very competitive option. So I wouldn't expect to see that sort of almost vertical trajectory in scalp psoriasis And, you know, I think that there probably are some doctors who are using the foam already, although I don't think that's probably widespread, you know, because they need to code it as seb derm to get it reimbursed. So I think what we're likely to see is the scalp indication allowing us to continue our growth trajectory. You know, if you go again back to slide nine, right, how do we continue to grow that franchise at a fairly continuous rate? I think foam is going to be an important contributor to that, as will be AD in two to fives. But I wouldn't expect, you know, to see a sudden spike in our demand after the approval.

And if I can, which is to follow up, I mean, how much education and how much promotional sensitivity do you expect to see with the scalp and body indication with the foam?

Well, I mean, all of these diseases are highly promotionally sensitive. And, you know, I think that the scalp data is as Patrick showed you in the photographs and also the IGA success data, the data is very, very compelling. So it will be important for our reps to get out and educate clinicians on the effectiveness of Zareve and the safety and tolerability of Zareve in scalp psoriasis, which, you know, there has not been any promotion, no educational efforts to date. So I think that there will be, you know, some, you know, there will be incremental upside to from the scalp indication as we get out and start promoting this data, and also because it will help streamline the reimbursement process for using the foam in scalp psoriasis as well. Todd, I don't know if you have any other additional thoughts you want to add. No, you covered it very well.

Okay, great. Thank you very much. That's helpful.

Thank you. This concludes today's question and answer session. I'll now hand back for closing remarks.

Well, I'll just once again, thank everyone for calling in. I know this is a very, very busy time of the year with quarterly earnings. So we appreciate you guys making the time and appreciate all the great questions. And we look forward to talking to you all next quarter. Thanks.

This concludes today's conference call. Thank you for participating. You may