Arcutis Biotherapeutics, Inc. Price & Performance (ARQT)

With that, Thank you, Lasse, and thank you to everyone for joining us today. Before we get started, I want to highlight three key themes that we're going to focus on throughout call today First of all, we had very strong execution throughout 2024. Second, we believe we are nicely set up to continue growing Zarev in And third, the key to our success going forward is going to be driving the shift away from topical steroids. So with that, let me turn to Slide five of the deck. Closing out a very strong fourth quarter and full year for 2024, we are optimistic about the strong foundation we have established for the entire Zarebe portfolio and for continued growth of our franchise this coming year and beyond. I want to take this moment to thank the entire Arcutis team for their hard work exceptional execution in 2024. We are building a leading top goal brand one that we believe will outperform historical predicates based on its remarkable F and safety rapid onset, unique formulation and the ease of use for both clinicians and patients. This past year, we launched Zaree Foam for seborrheic dermatitis and 0.15% cream for atopic dermatitis and also broaden patient access across indications.

In 2025, we'll further expand Zarev's approved indications continue to expand our prescriber base beyond dermatology, further penetrate the government payer segment and focus on taking market share from topical steroids. We're especially excited about our May 22 PDUFA date for an expected indication in scalp and body psoriasis provide another opportunity for doctors to prescribe Zaree Foam to meet a substantial unmet medical need. Continued our strong sequential revenue growth. For the quarter, we had revenues of $71,000,000 was $69,000,000 of that coming from the Zarev franchise, This includes a non recurring adjustment of $4,000,000 that David will address in detail later. On an annual basis, we had total revenues of $197,000,000 with three product sales of $167,000,000 dollars four seventy one percent growth year over year and we are just scratching the surface of this very large and attractive market. We expect substantial continued momentum in 2025 and Todd will provide further detail on how we view revenue and script growth trends evolving threat Blended gross to nets have reached steady state in the 50s although we expect to see some quarterly fluctuations related to patient deductibles particularly in the first quarter as is typical for nearly every product.

Regardless, we expect gross to nets to remain in the 50s and Todd will provide some additional color on what we expect for gross to nets as the brand matures. Looking towards 2025, we believe we are well positioned to achieve future further strong growth strong revenue growth. Psoriasis and septum indications continue to grow We're still very much in new launch mode for atopic dermatitis. And we expect to add further indications and label expansions in the coming year providing us with significant growth opportunities ahead. Turning to Slide six, I want to emphasize the sizable growth opportunity we have in our target markets. We've shared this slide with you before, but we've now updated this slide to include the opportunity in eighty patients ages two to five based on our supplemental NDA with an anticipated PDUFA sometime in Q4 of twenty twenty five. Dermatologists treat well over eight million patients across our approved indications, And we've already secured broad access to the roughly 4,500,000 commercially insured patients treated by derms. We're now making great progress in gaining Medicare and Medicaid coverage which is expanding ZERIV usage into the almost 4,000,000 dermatologists treated patients with government insurance. Furthermore, our CoA commercial partnership permits us to simultaneously pursue the more than 8,500,000 patients being treated outside of the dermatology office for these indications.

This includes primary care physicians and pediatricians for whom Zarev represents an ideal easy to use topical anti inflammatory agent. Within each of these large segments outlined on the slide, the vast majority of patients are currently treated with topical steroids. But clinicians are starting to shift away from these products although we're only in the very early stages of this transition in medical practice. And Patrick is going to talk more about the shift away from steroids in just a few minutes. Moving to Slide seven, we are confident in our ability to sustain our growth because of four significant tailwinds that are going to propel Zaree forward in the years to come. Let's dig into those tailwinds a little bit further. First, we continue to educate physicians on our three approved indications while continuing to expand the XERIV product label. As mentioned, have an expected approval in scalp and body psoriasis in May, as well as anticipated expanded indications for pediatric patients both atopic dermatitis and eventually psoriasis. These expanded pediatric indications are especially important for our commercial partner COLA and reinforce ZARIB as a first line topical agent to a broad prescriber base that now encompasses primary care physicians and pediatricians.

Second, with our commercial coverage as established, we are now engaging with government payers across both Medicare and Medicaid which encompass approximately 3,700,000 incremental patients in dermatology offices and many more in primary care and pediatrics. We have been rapidly gaining wins in Medicaid with Zareve already available for one and two Medicaid patients and Todd will provide some more color on that front. Third, our partners at CoA are now promoting XERIV to high potential primary care doctors and pediatricians and we expect them to gain growing traction as 2025 progresses. We look forward to meaningful contribution from this co promote beginning this year and growing from there. And finally, with our broad product offerings, comprehensive patient access and differentiated product profile for both doctors and patients, Arcutis is now well positioned to take meaningful market share from the 16,000,000 topical steroid prescriptions written by dermatologists for our approved indication each year. There has been growing momentum in that direction and Todd and Patrick will delve into this further. Taken together, this immense market size coupled with the excellent efficacy and safety of XERIEP and its ease of use and access make us highly optimistic regarding our future prospects and committed to grow ZARIF to its peak sales potential.

With that, let me turn it over to Todd to provide some further commentary around our launch progress reimbursement and the outlook for 2025. Thank you, Frank. We're extremely enthusiastic about the growth and the expansion of our product portfolio the strong response from HCPs and patients the immense opportunities that lie ahead. This quarter, we achieved $69,400,000 $65,400,000 before the non recurring adjustment in net product revenue for Zaree. Reflecting 46% growth over the third quarter. Without our non recurring adjustment for product return reserves, and $166,500,000 in net product revenue for the full year. A growth of 471% over last year. This strong performance continued the robust quarter over quarter growth trend that we have seen throughout the year. This robust revenue growth was driven primarily by prescription growth across the portfolio of Zuri products. Along with a slight gross to net percentage improvement with the blended gross to net remaining in the low 50s for Q4. Looking forward to 2025, in the first quarter, we expect the typical gross to net impact driven by deductible resets, insurance plan changes for the New Year. As we know well, this phenomenon negatively impacts sales of many products across the pharmaceutical space.

But as is typical, we expect gross to net to quickly trend back to steady state in subsequent quarters. Turning to volume, we anticipate sustained growth and are encouraged by the trends so far this year. It is common to see a decline in prescription volume growth for products in January following the end of year demand pull forward. And we are seeing such a decline for many of the other branded topical non While the typical Q1 gross to net fluctuation will affect total net product revenue, we are encouraged we've been able to sustain and even to date in 2025 compared to Q4 'twenty four. Speaking of Q4 prescription volume, on Slide 10, you can see that Zare prescription volume has reached another record high 16,000 weekly scripts. Quarter over quarter prescription growth was 44% over Q3 and prescriptions grew 334% on a year over year basis. You can clearly see the inflections and growth during 2024 due to the launches of Zarefoam and CepDerm zero point one five percent cream for atopic dermatitis. However, in Q4, I want to emphasize we delivered growth across our entire product portfolio. Every indication has grown and we expect this key trend to persist.

As we continue to take share from the enormous topical steroid market. I will delve into the drivers of this phenomenal growth next. On Slide 11, I want to discuss the factors that led exceptional growth we achieved in Q4 and that we expect to drive continued growth and success in 2025. The first of these is our atopic dermatitis launch. Which is still generating an inflection in prescriptions as you saw on the prior slide. Quite simply, physicians are recognizing that our once daily non steroidal anti inflammatory can be used safely and effectively anywhere on the body affected by atopic dermatitis. For any duration and are appreciating the ease of reimbursement and prescription fulfillment established by our chain. The second growth factor is our sales force which has significantly enhanced our share of voice across derm clinicians. With the multiple indications and formulations we have created a unique portfolio versatility effect. Which allows dermatologists multiple approaches to treating complex skin conditions using one or more XERI products. This is the third growth driver and creates an amplification effect upon each of the individual strengths of the cream. As well as the foam formulation. By this, I mean that doctors now have a spectrum of options with respect to which Zarex strength and formulation is tailored to each specific indication.

This optionality and flexibility drive an overall increase in the use of the entire ZO RE portfolio. Which is rapidly becoming the go to solution for dermatologists. We expect this to be a sustainable advantage into 2025 and beyond and should be further amplified by the addition of a new foam indication for body and scalp psoriasis in the second half of twenty twenty five. And a subsequent pediatric label expansion [indiscernible] Lastly, I want to highlight the strong execution of our entire commercial organization which has been steadily picking up commercial and government coverage, delivering effective and targeted messages and beginning our drive to convert over a meaningful percentage of the topical Slide 12 is an important slide where I want to make two key points. One is that our commercial coverage is quite good and overall portfolio gross to net as we said last quarter, has reached steady state. We expect the portfolio gross to net to be in the 50s throughout 2025.

First, to the left, you can see we have a strong position with prescriptions covered by insurance. We are at a steady state and an optimal point for psoriasis and septerm at 80%. And we are continuing to improve cover prescriptions for atopic dermatitis currently at sixty five percent. I'm delighted to report that since our last update, we have secured Medicaid coverage in two additional states, Ohio and Illinois. We have now secured Medicaid coverage in states that represent approximately one in two Medicaid beneficiaries. And we expect to add further states through 2025. Importantly, the quality of Medicaid coverage is very strong. We are also making progress in our negotiations with Medicare Part D programs. Now moving to gross to net. In the chart on the right, we highlight the progressive improvement in our blended gross to net over time. Our blended gross to net across all three indications in Q4 similar to Q3 in the low 50s. Gross to net has reached a steady state and will be in the 50s throughout 2025. As Frank stated earlier, we do expect some variability in the first quarter due to a reset of patient deductibles and changes in insurance plans.

Which both occur early during each year across all covered drugs. As we have reiterated, we expect that Q1 gross to net will be at the higher end of the 50s range but will quickly return to steady state and remain in the 50s throughout the year. I am extremely excited to share some market research data with you on Slide 13. We recently conducted research to assess unaided awareness of Zarebe as well as the most affected XEREB messages that Doctor. Are hearing and remembering. We were extremely pleased both with the overall brand awareness of Zareeb as well as with the magnitude of improvement we have achieved over time. In psoriasis, unaided awareness grew from 55% in the second quarter to sixty three percent in the fourth quarter. Our foam formulation used in CepDerm is even more widely recognized. And unaided awareness grew from 75% in Q2 to 88% in Q4. This means that just about every dermatologist is aware of ZERIFOONG and could rapidly recall it when prescribing to an appropriate patient. For the atopic dermatitis, zero point five zero point one five percent Zuri Cream formulation, which launched in mid-twenty twenty four unenamed awareness grew from two percent in Q2 to forty four percent in Q4, This is an impressive gain since we are still early in the launch.

Torability and ease of use are really the standout messages for Zarev. Doctors remember that we are the only topical non SORROWA agent approved across three inflammatory skin indications. Additionally, the most motivating message for dermatologists focuses on SERI's [indiscernible] Which we view as a clear differentiator for our product. Earlier this month, we were delighted to announce a partnership with Odell Beckham Junior, or OBJ iconic professional football player who is affected by seborrheic dermatitis and who is a current XERIFOAM user. In the past twenty years, patients with subderm had no innovation available to them. As a result, many retreated from care resigning themselves to their condition. They were frustrated that nothing was available to help them. They lived with the embarrassing itchy, flakely, redness and on their scalp. Face and body, had to endure repeated shampoos and steroids causing more frustration. We believe that increasing patient awareness of sev derm and destigmatizing the disease were prompted return to treatment for many of these patients. This important next step in the Zarephoam promotion strategy aligns well with the high level of unaided awareness for Zarev and positive clinical experience for the dermatologists, as well as a strong coverage position OBJ will be key in the coming year executing our XERIFOAN patient awareness initiatives.

OBJ's personal story of stroke with sev derm his symptoms and all the treatments he tried will resonate with these patients. And as a Zarephoam patient himself, he will share the meaningful difference using Zarephoam has made on his life. We are ecstatic at the early reception from this new partnership. Not only does OBJ have a massive social media following of more than 17,000,000 followers, but in the first week alone, Interviews with him in mass media outlets like People, Prevention, Cosmopolitan and Forbes have generated well over 1,500,000,000 media impressions. I would be remiss if I didn't also point out that at this time, we do not anticipate launching broadcast TV DTC advertisements as part of the OBJ partnership. Rather, we will rely on his celebrity reach, social media presence, digital advertising, and publicity to generate public awareness. Thus, while there was some incremental SG and A spending associated with this partnership, are talking low double digit millions not tens or hundreds of millions in incremental spend. On Slide 15, I want to reiterate the majority of prescriptions across all three AZREVE indications are for topical steroids. Of the 24,000,000 topical prescriptions written by dermatology clinicians, there are three current indications during 2024 Roughly $16,000,000 were for topical steroids, In contrast, 1,400,000 prescriptions were for branded topical non steroidals and around 500,000 were for XERIV, highlighting the immense growth opportunity as clinicians transition away from steroids to newer topical agents, which we will expect them to do as Patrick will discuss shortly.

Our greatest opportunity is steroid conversions to Zareep, providing the entire branded topical marketplace. As we are already the leading branded topical in NRX's we believe that by focusing our energy on steroid conversion, we can impact more patients and continue to grow XERIV. Slide 16 highlights the strength of the XERIV differentiated offering. Which encompasses three formulations of XERIV, and the expected fourth indication of scalp and body psoriasis with the PDUFA upcoming in May 2025. Cerebral's differentiation is rapid relief on any part of the body for any duration high tolerability and quick onset of itch relief, Additionally, it is a simple to use once daily treatment. And is easily accessible to patients with the same predictable reimbursement process and copay card across our entire portfolio. With that, I would now like to turn it over to Patrick to provide a brief R and D update. Patrick?

After strong series of accomplishments, in 2024. First, we have an upcoming P FDA PDUFA action date for XERIFOAM in scalp and body psoriasis down to the age of 12 on 05/22/2025, and all aspects of this submission remain on track. Second, we have an anticipated approval in Q4 twenty twenty five for Xareve cream zero point zero five percent at the dose specifically developed for the treatment of mild to moderate AD in two to five year olds.

We expect to initiate an additional trial of XERIVINE at the zero point zero five percent dose in mild to moderate AD patients ages three to 24 during 2025.

Moreover, we continue to generate the necessary additional data should ultimately support expanding the psoriasis indication down to the age of two. In our early stage pipeline, look forward to the Phase Ib readout for ARQ which our topical Jack and alopecia areata in the first half of twenty twenty five. We expect to file the IND for ARQ-two thirty four our biologics CD200 receptor agonist for atopic dermatitis later in 2025 However, we do acknowledge that Lilly has deprioritized CD200R program and will continue to evaluate our own asset as we progress this program. Now on Slide 19, we can see that dermatology community is coalescing around increased awareness of the challenges of managing patients with chronic inflammatory skin diseases like psoriasis, AD and seborrheic dermatitis with topical steroids.

These include local tolerability issues, safety concerns and limitations on duration of dosing for more potent steroids. This view is being expressed more and more frequently both in published literature and at important medical conferences attended by dermatologists as evidence against steroid overutilization mouse. For example, the Journal of Clinical and Aesthetic Dermatology NPPA Journal, recently ran a lengthy article reviewing the concerns of managing inflammatory skin diseases with topical steroids. And recommending clinicians move toward greater use of nonsteroidal agents like ZARIV. [indiscernible] We're also now in the busiest season for DermMeeting. With several major meetings just wrapping up and the AAD a week away. I want to share some of what we're hearing. [indiscernible] such as those two that we've included at the bottom of Slide 19, Reflecting the stance from the podium at MauiDurm, about topical steroids going away as a mainstay of AD.

As well as the response from a derm provider after a recent presentation on steroid overuse and its impact on her practice, and her communication with patients. I've been in dermatology for over twenty years This is not a conversation I've heard before. It is reminiscent of what took place when Biologics came onto the scene and old school immunosuppressors were set aside in the long term management of psoriasis and AD.

Importantly, the profile of Zarev is perfectly positioned to step into this space this opening.

In our clinical trials, we study patients who previously used topical steroids and were able to demonstrate that XERIV is well positioned both as first line treatment as well as for those patients who've already tried and failed topical steroids. We did this across all of our development programs. Taking AD as an example and looking at the right side of Slide 19, in our INTEGUMENT studies, showed that Zareep cream zero point one five percent, has excellent clinical improvement for atopic dermatitis patients even in those who have previously failed topical steroids.

We believe that data like this combined with the changing consensus on steroid use should drive a prolonged shift away from steroids will benefit patients, and our brand. With that, I'll pass it over to David. Thanks, Patrick. I'm on Slide 21. Showing financial results both year over year and quarter over quarter for the fourth quarter. We generated net product revenues in the quarter of approximately $69,400,000 which is up 413% from Q4 of twenty twenty three and fifty five percent from Q3 of this year. For all the reasons outlined by Frank and Todd, we we believe we are still very much in the early stages of our growth with significant up In January, ahead of the JPM conference, we preannounced unaudited product sales of approximately $63,000,000 While we outpaced that estimate a bit in terms of actual sales in Q4, the amount by which we beat it was principally due to a reduction in reserves we were holding for product returns of 4,100,000.0 Excluding this non recurring adjustment, we had net product revenues of That non recurring amount should be excluded for forward looking calculation. For the fourth quarter, our R and D expenses were [indiscernible] of 2023 due to decreases in the development cost of topical refumulas programs down approximately 26% compared to the third quarter of twenty twenty four this year.

The reduction in R and D expenses was also due in part to a one time Q4 credit of $3,000,000 we received related to a closeout of our FumileF study. SG and A expenses were $57,600,000 for the fourth quarter of twenty twenty four versus $48,700,000 in the same period last year, up 18% as we invested in our commercial organization and our current and future launches.

SG and A expenses were essentially flat as compared to last quarter. Our continued strong revenue growth supports our belief that we are investing and we continue to believe that we will reach cash breakeven in 2026. [indiscernible] full year 2024, we generated net product revenues $166,500,000 which is up 471% year over year. Total revenues in 2024 were 196,500,000.0 up 230% year over year. Based on the Zarev revenue run rate we saw in Q4, we ended the year at an annual run rate of approximately $250,000,000 in product sales. Frank and Todd have highlighted the tailwinds for the full year 2025 and beyond that should allow us to build on this impressive growth including new indications, expansion into government payers, broadening of our prescriber base and our efforts to take meaningful share from topical steroids. For the full year 2024, our R and D expenses [indiscernible] which will not decline over time. In 2025, we expect a similar level in R and D as in 2024, year in which we will advance ARQ-two thirty four and two fifty five, which minimal spend for our topical refumilas programs and continued investment in our medical affairs activity. SG and A expenses $229,400,000 for the full year 2024, versus $185,100,000 in the same period last year, up 24% to support a significantly higher level of revenue growth.

In 2025, we do expect an increase in SG and A expenses considering our launch in scalp and body psoriasis, the annualized cost of the increased sales force and sustained marketing efforts to supporting all ZARED indications. On Slide 23, you can see we had cash and marketable securities $228,600,000 on our balance sheet as of 12/31/2024, we which translate to a cash burn from operations in the quarter of less than $1,000,000 We had great revenue growth in Q4 and lower expenses through the R and D credit I noted earlier and some of our expenses rolling over into 2025. This along with a few working capital items led to our low cash burn. Q4 was a bit of an anomaly, but moving forward, we expect higher SG and A and modestly higher cash burn in the first quarter And as Frank indicated previously, expect our quarterly cash burn to continue trending down in the long run as our revenues grow and we reach cash flow breakeven sometime in 2026. In October, we repaid $100,000,000 of our debt facility, which will significantly lower our interest expense in 2025. We have the option to redraw that $100,000,000 in whole or in part at our discretion the middle of twenty twenty six, providing us with significantly enhanced flexibility.

We believe our current capital together with the available $100,000,000 in debt our growing Zaree revenue stream and improving economies of scale allow the company to reach cash flow breakeven in 2026 even as we continue to invest in the business for continued growth and long term durability. To reiterate what we have said previously, we do not expect to return to the equity market to support our existing business. Thanks, David. So in closing, let me reiterate our three key messages.

Our business is strong as we wrap up a stellar 2024 We look forward to continued growth of the Zareep portfolio in 2025 and beyond, And the key to that continued growth is the growing shift from topical steroids to non steroidals in our large target market of 17,000,000 patients. After our significant efforts last year, Zarev is now the number one branded topical product But as you saw, this is just a drop in the bucket of the enormous topical steroid market. We're excited about the opportunity ahead of us and in 2025, we will continue to tackle it comprehensively using multiple levers like our new indications and label expansions, our primary care partner our consumer outreach with OBJ and our continuous continuously improving reimbursement coverage. Lastly, as David said, we have line of sight to breakeven in 2026 which will further improve the overall characteristics of our business and create optionality for even more growth. And with that, we'll conclude and open the call up to Q and A. Now first question coming from the line of Vikram Prahlad with Morgan Stanley. Your line is now open.

Hi, good afternoon. Thank you for taking our questions. So we had two just one on the quarterly release.

So you clarified a big chunk of the delta between [indiscernible] preannouncement and the actual 4Q results of roughly $69,000,000 But for the residual roughly $2,000,000 Was that related to inventory or another factor if you could clarify that?

That would be helpful. And then secondly, Just had a question for you on IP. There's been some investor interest and questions in the upcoming claim construction hearing. In your ongoing IP lawsuits. So just wanted to ask if you could speak to your kind of confidence in protecting the IP for Fiservie franchise going forward and how you feel about that that process? Okay. Sure, Vikram. Thanks for your question. So David, maybe can you go in a little more detail around the delta between what we had preannounced for Q4 and this final Q4 print and what was driving that.

Sure. Couple of things I say. First of all, as I mentioned, we did make an adjustment for the reserves we had accumulated for product returns.

That total adjustment was essentially a bit over $5,000,000 but a $1,000,000 change of that was due to the fourth quarter of twenty twenty four itself. So we can't refer to that as an adjustment. So that's a part of it. The other part I would chalk up to us being conservative when we pre announce revenue. Simple as that.

And then Vikram, with regard to your second question, I think it's a completely understandable question. It's one we get a lot What I can say at this point is, you made reference to the upcoming Markman hearing that's scheduled to occur in April 2025. You can review what's publicly available on the court docket, but we can't comment beyond that specifically vis a vis the Markman hearing. What I will say is that as we've said before, we are very confident in the strength of our IP portfolio our ability to maintain exclusivity of XERIV and we intend to vigorously defend our intellectual property rights as appropriate.

Fair enough. Thank you.

Thank you. Our next question coming from the line of Tyler Van Bruen with Citigroup. Your line is now open.

Hey guys, thanks and congratulations on the exceptional So I think many people were surprised by the growth in weekly prescriptions that we saw with Zoriv Cream heading into year end and quarter over quarter in Q4 relative to what we saw in Q3 versus Q2. So can you elaborate on the impact? I mean, you talked about multiple drivers, but can you elaborate on the impact of the sales force expansion had how much it was expanded by and whether you'll continue to expand it as sales increase moving forward?

Yes. So Tyler, just to clarify, are you asking specifically about the growth of the cream or the 0.3 or you're just asking generally about the growth that we're seeing across the board in prescriptions?

Generally about the growth I'd be curious to hear about the cream and psoriasis if you have any additional color there since there was really significant quarter over quarter growth for Q4 versus Q3 as opposed to Q3 versus Q2?

Sure. Sure. Yes. Todd, can you maybe go in a little more detail about our view specifically with regard to Q4 and the growth at both the portfolio level? And then maybe if you have any color around each of the individual SKUs?

Portfolio growth is mentioned. Portfolio growth is primarily driven by volume growth, the slight on net revenue, a slight increase with gross to net. But nonetheless, as mentioned, we did see growth across the entire product portfolio, which we're very encouraged by. More specific to Xirea cream for psoriasis, when you think about the what I'll call the versatility effect that I mentioned providers are now being able to get clinical experience with XERIEVE across three different products across one for sev derm, one for atopic dermatitis and now psoriasis and that's amplifying the increased utilization of these products across the portfolio to include increased utilization of XERITRAME for psoriasis So we're very encouraged by that. In reference to the sales force expansion that we had on June 1, increasing the share of voice, That was definitely a driver of the increased prescription growth that we saw in Q4. And we believe that we are currently rightsized for the dermatology market with the portfolio that we're managing today.

Thank you.

And our next question coming from the line of Seamus Fernandez with Guggenheim Mehl and is now open.

Thanks for the question.

So just wanted to circle up [indiscernible] the momentum in the business, it can you just give us a little bit of color on fourth quarter how the refills were sort of coming in Was there clear proof from your perspective that there was an increase in the resale rate? And just wondering how the sort of the estimate of the tubes per year is actually coming in relative to your expectations on a go forward basis as we think about the growth in the overall market? And then the second question is just very quickly, Consensus is kind of between $280,000,000 to $285,000,000 this year. Just wondering how you guys are thinking about the opportunity for sustained growth and the opportunities to see the scripts perhaps maintain this very strong linear trajectory that we saw through the balance of 2024. Sure. Okay. If the Arcutis team, if you guys could pause just a second before you start answering your question, I think that the very front end of your questions answers are getting clipped off.

So Todd, if you could comment maybe on the momentum in Q4 and particularly around what we're seeing with refills the indicators of the pull forward that we believe happen and then also maybe comment on our current thinking around tube per year consumption. And then also, if you could maybe touch on the opportunity for sustained growth again And then David, I think it'd be helpful if you can give maybe some color around our current thinking around consensus for 2025?

Yes, Frank. I'll start. Relative to the 2s per year as we've communicated before, we expect Suricream zero point three percent for psoriasis on the average tubes per patient per year to be around two tubes per year. And for Xirefoam, for Sevderm likely around two to three cans per year. For atopic dermatitis, it's still still early within the launch, but we expect on average two point two three year for an atopic dermatitis patient. And then in reference to Q4 and refills, we're very encouraged by the refill rates with XERIV cream for psoriasis, which was around forty percent of the total volume was refills. And then for XERIFO and for Seb Derm, it was around thirty eight percent refills and atopic dermatitis still early at the launch and for the refills. But nonetheless, once we mature that product, it will likely be similar to Zarek Premium Suritis around 40% within the refills. As Frank mentioned, we did see some pull forward in December from Q1 due to patients wanting to get their prescriptions refilled prior to their deductibles being reset. So we did see some pull forward into December. But nonetheless, we're very encouraged with the prescription trends and growth here in Q1.

Albeit that we still that we had that pull forward from January into December. We continue to see robust prescription growth despite some of the typical disruption that we see in the first quarter with patients switching insurances have to be recertified per product like XERIV and we fully expect to continue this momentum throughout 2025.

Hope I'm not being cut off. As for the estimates, that are out there, we are very comfortable with the consensus out there for the full year of 2025, definitely comfortable. I think it's important to think a lot about how those revenues will be distributed across quarters for the year. You've heard Todd say a couple of times now that first quarter for the products like many, many other products can be affected by a slight change in gross to net as deductibles get reset and so forth. So while obviously prescription growth is extremely robust there can be an impact of revenue. I'll just think about how to distribute that $280,000,000 to $285,000,000 across the fourth four quarters.

Thank you.

And our next question coming from the line of Serge Belanger with Needham. Your line is now open.

Hi, good afternoon.

Couple of questions. The first one I guess a follow-up to the guidance or [indiscernible] consensus number and how we should model twenty twenty five On Slide six, you highlighted about 4,000,000 patients are covered by Medicare and Medicaid.

Just curious how many of them had coverage at the start of the year and when you expect they will have coverage throughout the year. And then second question, more of a broader strategy question. David highlighted how well the company has capitalized in the near term breakeven point is on the horizon in 2026. So just curious, how much of a priority in the near to medium term is profitability for the company given that you do have a pipeline and you've discussed BD in the past Thanks.

Sure. So Todd, if you could maybe address And Serge, you're asking about the amount of Medicare and Medicaid patients had coverage at the beginning of twenty twenty five or the beginning of twenty twenty twenty five.

Okay. Yes. So Todd, if you could maybe talk a little bit more about where we stand with regard to Medicare and Medicaid as of the beginning of this year and how that will translate in the patient opportunity for 2025. And then, when you're done talking about that, I'll come back to the question around profitability and the pipeline.

Yes.

Thank you, Frank, for the question. And specifically, to Medicaid, we're very pleased with the Medicaid coverage that we've been able to secure up to the start of 2025 and that would be that one in two Medicaid beneficiaries now have access to Zareb. And one of the things very important to highlight is not only the approved access we've had relative to Medicaid, the quality of that access. And what I mean by that, if you as an example, if you look at the state of California with Medi Cal, There is no step edit for XERIV. So it's a first line therapy within the state of California. If we look at the state of Florida, you have to step through Azeri to be able to access the Tomah within psoriasis. So high quality Medicaid coverage in one in two Medicaid beneficiaries have access to XERE. Specifically to Medicare, to Medicare Part B, we can continue to have our discussions and negotiations with the Medicare Part B PBMs as they navigate them with implementation of the IRA, the Inflation Reduction Act. Implementation of the IRA has operate operationally slowed those discussions down and that process with the PBM. But nonetheless, we're very optimistic that we'll be able to accelerate these discussions and continue to improve on our Part D access as we navigate through twenty twenty five.

And then Serge, with regard to your question around profitability, this is obviously something that the leadership team thinks a lot about. At Arcutis. I think getting the cash breakeven is very important because it gives us a degree of operational flexibility as we think about running the business for the future. The first priority has to continue to be investing in the growth of Zarev And as I think Todd mentioned during the call, we feel like we have the right level of investment. It's something that we constantly evaluate whether there are incremental opportunities or whether there are opportunities to save money. In terms of the reinvestment. But we feel we're at the right point right now in terms of investing in ZARIEV growth. We do have a number of pipeline programs As Patrick outlined, And those will hopefully progress, but they're fairly early stage. So we don't expect really significant burn on those programs in the near term, but they eventually will impact our spend. And then with regard to business development, I would say that we remain very opportunistic We're always looking at interesting opportunities. And opportunities where we feel like we can grow shareholder value.

But we don't believe that business development is something that we have to do, right? It's not an imperative given the strength of our existing franchise and our internal pipeline. So It's sort of an odd question as a biotech company to think about profitability We're really focused on driving revenue growth and driving shareholder value first. And I think us paying dividends is probably not the right way to do that, at least not for the foreseeable future. So we'll continue to be very judicious in our investments, whether that's vis a vis a vis a REVE or the pipeline or business development if we do see opportunities to use the capital that we have to grow shareholder value, then we'll certainly take advantage of those opportunities.

Thank you.

Thank you. Our next question coming from the line of Irwind Mizuho Group. Your line is now Hey, guys. Thanks for taking your questions. So I two questions. The first one is, with the upcoming approval of the foam in psoriasis, Just wondering [indiscernible] What is the indication that you're expecting? Is it psoriasis in general or is it like psoriasis with scalp involvement? And how do you think that this what's the strategy for this indication or for this foam product, you think the deal probably cannibalized more of the cream or you expect more patients to convert to the foam just wondering what your thoughts are there? And secondly, What do you expect from the Phase 1b data for ARQ two fifty five? Thanks.

Sure. So Patrick, maybe if you could start out by addressing the two fifty five question.

And what we expect from our Phase one study. And then if you could also maybe comment on what we filed for and what we expect in terms of the indication for the expanded indication for ZReFOAM? And then Todd, if you could go into the strategy for the Foam launch in scalp and how we see that playing with the 0.3 cream. Absolutely. Thanks, Mike. Yes, so starting with two fifty five, this is a Phase 1b We have 12 healthy volunteers, then we had 30 plus alopecia areata patients that were treated for three months. Our goal with this is really to understand They're kind of PK exposure safety and tolerability first in this early stage trial.

And then also with the inclusion of alopecia areata patients, get an understanding from both a biomarker and an early clinical response, we whether or not there's some indication that we were getting [indiscernible] target, which has been a challenge for topical treatment in alopecia areata. And so we're really going to be focusing on those safety and tolerability data primarily And keep in mind, this is a three month treatment and the pivotal timeline for a alopecia trial is typically six months of therapy.

So we would really try just be seeing the first evidence of efficacy in that readout. Moving on to the scalp and body indication for psoriasis with the foam. In our pivotal trial we had co primary endpoints of [indiscernible] IGA as well as scalp IGA. And so we anticipate the indication to be inclusive of all psoriasis but then also specifically calling out scalp. In a similar way Remedy of what we saw with the cream indication where we had a broad indication for the treatment of psoriasis then it's specifically called out inclusive of those patients with intertriginib disease. So we would anticipate that kind of broad indication for the foam as well. Yes. And then I'll respond relative to the the strategy for the XERIFO and for scalp and body psoriasis. We're incredibly excited this upcoming approval. We want to be able to differentiate our be able to create and present optionality and choice We're going to provide a XERIV foam formulation for psoriasis and a XERIV cream to where the provider and the patient have the choice what is best suited for that patient to be determined by their dermatologist. And you have to remember relative to to psoriasis and this pertains to the ZARIFOAM is that for psoriasis patients approximately fifty percent of them have some type of scap involvement.

So we believe by offering that type of choice and optionality, we can drive significant conversions from the steroid market over to XERI foam or to XERI cream And this will accelerate the entire market as far as the up of these products and the conversion from steroids over to the two differentiated offerings that we'll have for providers on patients in psoriasis.

If I can maybe just add just a little bit more color because we continue to get this question I think that it is wrong to think about the foam cannibalizing the cream. What I think might happen is, is that there will be a shift in the growth pattern in psoriasis from cream to foam But I think it's very unlikely that the patient that's on the cream is actually going to switch then to the foam.

So cannibalization is probably not the right way to think about this. And ultimately what matters to us and what matters to shareholders is the growth of total XERIV point three in the psoriasis market. And we're quite confident that the addition of the foam and the addition of the scalp and body indication is going to accelerate the growth of Zaree 0.3 cream and foam in psoriasis and put us in a very, very strong position.

Okay. Thank you.

Thank you. Our next question coming from the line of Kamatayati. With Jefferies. Your line is now open.

Hey, team. Thanks for the questions.

Just a couple for me.

What proportion of 4Q sales are attributable to the Pella PCP partnership?

And the second question I have is, do you expect 1Q OpEx to remain roughly in line with 4Q excluding commissions to Caula, will Commissioned Takawa be included in the SG and A line of 1Q OpEx?

Thank you.

Sure. I think probably David you can address both of those. If you could address what contribution from coo was in Q what the contribution from COA was in Q4 and then also our thoughts around Q1 OpEx with and without the COA commission.

Sure. As we've been saying for several months now, the CoA sales force and their efforts really got started in September. And so at no time did we really expect a meaningful contribution from them in 2024. And in fact, while it was not certainly a non zero number, it was not a significant amount. We do expect a meaningful contribution in 2025. The commission that we that we pay COA is will be in the SG and A line. So you will see an increase there. And what we've committed to is that when that contribution becomes meaningful, that we will give information as we report quarterly results. We will give information on volumes and commissions and and so forth so that people understand the magnitude of that contribution.

Thank you.

And our next question coming from the line of Douglas Tsom with H. C. Wainwright. Your line is now open.

Hi, good afternoon. Thanks for taking the questions. Congrats on the progress in the quarter. Just one question for me. You spoke about the feedback you're getting in terms of clinicians wanting to move away from steroids obviously, I presume payers will continue to sort of want that as a first line option So I'm just curious from a reimbursement standpoint, how you actually see that playing out Do you think that physicians will just try steroids more briefly?

Or do you think outright that XERREASE can become first line therapy?

Sure. Yes, I think that's an important point probably to clarify. I think and Todd can comment on this too, but I think it's likely that we will continue to see a single step edit through a generic steroid to get to Zarev. The numbers that we were talking about on the call represent people who are already on a steroid. And therefore have already met the step requirement, right? So this issue of stepping through a topical steroid really is only relevant for the very small percentage of patients who are newly diagnosed or who have not been on any treatment for quite some period of time Typically, the insurance companies will look at any treatment in the last six twelve months depending on the insurance company. So what I think investors really need to focus are the 16,000,000 prescriptions out there already for topical steroids. Right? Those are all patients who have met the requirement for the step the step is irrelevant. And that's where we think the growth opportunity is going to come. And And Patrick, maybe you can talk a little bit more as well about the paradigm of steroids in an acute treatment for a chronic disease and how Zarev fits into that that picture.

Yes, I think that's one of the parts of the conversation that I think is going on right now is about what is the role that steroids have in the management of these diseases And a lot of the conversation is about the chronic treatment of these chronic diseases and the fact that in the absence of having non [indiscernible] steroids were trying to fill that gap even though they're not really well suited for chronic management of the diseases.

So I think this idea of having a steroid step through isn't really such a hurdle for patients for the reasons that Frank just said, which is that oftentimes when patients come in, they may get a steroid before it's realized that they're really going have a need for a long term management of the condition. And that's the appropriate time anyway from a medical management perspective to shift them over to a non steroidal product like XERIV that will be able to carry them the distance from there. So I don't really see that the utilization management criteria are too out of sync with clinical practice and how it's evolving right now? [indiscernible] Great. That's great help. Thank you.

Thank you. And I sit down now for the question Frank Watanabe for any closing remarks.

Okay. Well, I think we've covered everything. I just want to thank everyone again for making the time. To call in for the earnings call, and we look forward to talking to you all again the not too distant future when we have Q1 results. Thanks a lot.

This concludes today's conference call. Thank you for your participation. You may now disconnect. [indiscernible]