Arcutis Biotherapeutics Q4 2024 Earnings Report

Arcutis Biotherapeutics EPS Results

• Actual EPS: -$0.09
• Consensus EPS: -$0.28
• Beat/Miss: Beat by +$0.19
• One Year Ago EPS: N/A

Arcutis Biotherapeutics Revenue Results

• Actual Revenue: $71.36 million
• Expected Revenue: $60.52 million
• Beat/Miss: Beat by +$10.84 million
• YoY Revenue Growth: N/A

Arcutis Biotherapeutics Announcement Details

• Quarter: Q4 2024
• Date: 2/25/2025
• Time: After Market Closes
• Conference Call Date: Tuesday, February 25, 2025
• Conference Call Time: 4:30PM ET

Arcutis Biotherapeutics (NASDAQ:ARQT), a biopharmaceutical company, focuses on developing and commercializing treatments for dermatological diseases. Its lead product candidate is ARQ-151, a topical roflumilast cream that has completed Phase III clinical trials for the treatment of plaque psoriasis and atopic dermatitis. The company is also developing ARQ-154, a topical ZORYVE for the treatment of scalp and body psoriasis and seborrheic dermatitis; ARQ-252, a selective topical janus kinase type 1 inhibitor for hand eczema and vitiligo; ARQ-255, a topical JAK1 inhibitor for alopecia areata; and ARQ-234, a CD200R fusion protein for the treatment of moderate-to-severe atopic dermatitis. The company was formerly known as Arcutis, Inc. and changed its name to Arcutis Biotherapeutics, Inc. in October 2019. Arcutis Biotherapeutics, Inc. was incorporated in 2016 and is headquartered in Westlake Village, California.

Arcutis Biotherapeutics Q4 2024 Earnings Call Transcript

Presentation

[Operator]

Good day, and welcome to Acunus BioTherapeutics twenty twenty four Fourth Quarter and Full Year Financial Results Conference Call. At this time, all participants are in a listen only mode. After the speakers' 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 Latavarabend, Vice President of Finance and Corporate Controller.

[Operator]

Please go ahead.

[Latha Vairavan, Vice President of Finance & Investor Relations at Arcutis Biotherapeutics]

Thank you. Good afternoon, everyone, and thank you for joining us today to review our fourth quarter and full year twenty twenty four financial results and business update. Slides for today's call are available on the Investors section of the Arcutis website. On the call today are Frank Watanabe, President and CEO Patrick Burnett, Chief Medical Officer Todd Edwards, Chief Commercial Officer and David Topper, Chief Financial Officer. I would like to remind everyone that we will be making forward looking statements during this call.

[Latha Vairavan, Vice President of Finance & Investor Relations at Arcutis Biotherapeutics]

These statements are subject to certain risks and uncertainties, and our actual results may differ. We encourage you to review all of 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.

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

Thank you, Lasse, and thank you to everyone for joining us today. Before we get started, I want to highlight key three key themes that we're going to focus on throughout the call today. First of all, we had very strong execution throughout 2024. Second, we believe we are nicely set up to continue growing through even 2025 and beyond. And third, the key to our success going forward is going to be driving the shift away from topical steroids.

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

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 Zari 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 and exceptional execution in 2024. We are building a leading Topgolf brand, one that we believe will outperform historical predicates based on its remarkable efficacy and safety, rapid onset, unique formulation and the ease of use for both clinicians and patients. This past year, we launched Zareve Foam for seborrheic dermatitis and Zareve Foam zero point one five percent cream for atopic dermatitis and also broadened patient access across indications.

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

In 2025, we'll further expand Zareve'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, which will provide another opportunity for doctors to prescribe XERIFOAM to meet a substantial unmet medical need. We continued our strong sequential revenue growth. For the quarter, we had revenues of $71,000,000 with $69,000,000 of that coming from the ZAREVE franchise. This includes a non recurring adjustment of $4,000,000 that David will address in detail later.

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

On an annual basis, we had total revenues of $197,000,000 with Cere product sales of $167,000,000 4 70 1 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 throughout 2025. 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 revenue strong revenue growth.

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

Our psoriasis and seb derm 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 80 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 8,000,000 patients across our approved indications and we've already secured broad access to the roughly 4,500,000 commercially insured patients treated by derms.

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

We're now making great progress in gaining Medicare and Medicaid coverage, which is expanding Zurich usage into the almost 4,000,000 dermatologist treated patients with government insurance. Furthermore, our Koa 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 Zareeb 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.

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

Moving to Slide seven, we are confident in our ability to sustain our growth because of four significant tailwinds that are going to propel Zareve 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 Zareve product label. As mentioned, we have an expected approval on scalp and body psoriasis in May, as well as anticipated expanded indications for pediatric patients in both atopic dermatitis and eventually psoriasis. These expanded pediatric indications are especially important for our commercial partner, Kola, and reinforce DEREV as a first line topical agent to a broad prescriber base that now encompasses primary care physicians and pediatricians.

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

Second, with our commercial coverage established, we are now engaging with government payers across both Medicare and Medicaid, which encompass approximately three point seven million 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 in two Medicaid patients and Todd will provide some more color on that front. Third, our partners at Koa are now promoting Zareve 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.

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

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 Zareef and its ease of use and access make us highly optimistic regarding our future prospects and committed to grow Zareef 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.

[Todd Edwards, CCO at Arcutis Biotherapeutics]

Thank you, Frank. We're extremely enthusiastic about the growth and expansion of our product portfolio, the strong response from HCPs and patients and the immense opportunities that lie ahead. This quarter, we achieved $69,400,000 60 5 point 4 million dollars before the non recurring adjustment in net product revenue for Zurich, 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. The strong performance continued the robust quarter over quarter growth trend that we have seen throughout the year.

[Todd Edwards, CCO at Arcutis Biotherapeutics]

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 and 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 trim back to steady state in subsequent quarters. Turning to volume, we anticipate sustained growth and are encouraged by the trend 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.

[Todd Edwards, CCO at Arcutis Biotherapeutics]

And we are seeing such a decline for many of the other branded topical nonsteroidals. While the typical Q1 gross to net fluctuation will affect total net product revenue, we are encouraged that we've been able to sustain and even expand the number of scripts written to date in 2025 compared to Q4 'twenty four. Speaking of Q4 prescription volume, on Slide 10, you can see that ZAREIT prescription volume has reached another record high at 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 XERIFOAM and SEVERDURM and 0.15% cream for atopic dermatitis.

[Todd Edwards, CCO at Arcutis Biotherapeutics]

However, in Q4, I want to emphasize that 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 to the 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.

[Todd Edwards, CCO at Arcutis Biotherapeutics]

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 team. The second growth factor is our sales force expansion that occurred in late June, which has significantly enhanced our share 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 Zuri 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.

[Todd Edwards, CCO at Arcutis Biotherapeutics]

By this, I mean that doctors now have a spectrum of options with respect to which Zuri's strength and formulation is tailored to each specific indication. This optionality and flexibility drive an overall increase in the use of the entire Zorin 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 in subsequent pediatric label expansion. 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 steroid market. Slide 12 is an important slide where I want to make two key points.

[Todd Edwards, CCO at Arcutis Biotherapeutics]

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 seb derm at eighty percent 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.

[Todd Edwards, CCO at Arcutis Biotherapeutics]

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's 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 improvements in our blended gross to net over time.

[Todd Edwards, CCO at Arcutis Biotherapeutics]

Our blended gross to net across all three indications in Q4 was similar to Q3 in the low 50s. Our 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 of 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.

[Todd Edwards, CCO at Arcutis Biotherapeutics]

We recently conducted research to assess unaided awareness of Zareeb as well as the most effective Zareeb messages that doctors 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 fifty five percent in the second quarter to sixty three percent in the fourth quarter. Our foam formulation used in SEVERDYM is even more widely recognized and unaided awareness grew from seventy five percent in Q2 to eighty eight percent in Q4. This means that just about every dermatologist is aware of Xirefone and can rapidly recall it when prescribing to an appropriate patient.

[Todd Edwards, CCO at Arcutis Biotherapeutics]

For the atopic dermatitis zero point one five percent ZERIE cream formulation, which launched in mid-twenty twenty four, unaided 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. Tolerability and ease of use are really the standout messages for ZAREBI. Doctors remember that we are the only topical nonsteroidal agent approved across three inflammatory skin indications. Additionally, the most motivating message for dermatologists focuses on CERRI's ease of use, which we view as a clear differentiator for our product.

[Todd Edwards, CCO at Arcutis Biotherapeutics]

Earlier this month, we were delighted to announce a partnership with Odell Beckman Jr. Or OBJ, an iconic professional football player who was affected by seborrheic dermatitis and who is a current Xirefoam user. In the past twenty years, patients with Sebdarm 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.

[Todd Edwards, CCO at Arcutis Biotherapeutics]

They lived with the embarrassing itchy flaky redness on their scalp, face and body and had to endure repeated shampoos and steroids causing more frustration. We believe that increasing patient awareness of SEVERDURM and destigmatizing the disease will prompt a return to treatment for many of these patients. This important next step in the ZAREV foam promotion strategy aligns well with the high level of unaided awareness for ZAREV and positive clinical experience for the dermatologist as well as the strong coverage position. OBJ will be key in the coming year to executing our Xirefone patient awareness initiatives. OBJ's personal story of struggling with sept derm, his symptoms and all the treatments he tried will resonate with these patients.

[Todd Edwards, CCO at Arcutis Biotherapeutics]

And as a Xirefone patient himself, he will share the meaningful difference using Xirefone 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.

[Todd Edwards, CCO at Arcutis Biotherapeutics]

Thus, while there is some incremental SG and A spending associated with this partnership, we 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 AZRIB indications are for topical steroids. Of the 24,000,000 topical prescriptions written by dermatology clinicians and our three current indications during 2024, roughly sixteen million were for topical steroids, when in contrast one point four million prescriptions were for branded topical nonsteroidals and around zero point five million were for ZAREIB, 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 Zareeb growing the entire branatopical marketplace. As we are already the leading branatopical in INRXs, we believe that by focusing our energy on start with steroid conversion, we can impact more patients and continue to grow Zareve.

[Todd Edwards, CCO at Arcutis Biotherapeutics]

Slide 16 highlights the strength of the ZAREV differentiated offering, which encompasses three formulations of ZAREV and the expected fourth indication of scalp and body psoriasis with the PDUFA upcoming in May 2025. Saris 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 co pay 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?

[Patrick Burnett, Senior VP & Chief Medical Officer at Arcutis Biotherapeutics]

After a strong series of accomplishments in 2024. First, we have an upcoming FDA PDUFA action date for XERIEF foam 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 XERIEF 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 ZERIEV cream at the zero point zero five percent dose in mild to moderate AD patients ages three to 20 four months during 2025.

[Patrick Burnett, Senior VP & Chief Medical Officer at Arcutis Biotherapeutics]

Moreover, we continue to generate the necessary additional data that should ultimately support expanding the psoriasis indication down to the age of two. In our early stage pipeline, we look forward to the Phase 1b readout for ARQ-two fifty five, our topical JAK and alopecia areata in the first half of twenty twenty five. We expect to file the IND for ARQ-two thirty four, our biologic CD200 receptor agonist for atopic dermatitis later in 2025. However, we do acknowledge that Lilly has deprioritized their CD200R program and will continue to evaluate our own asset as we progress this program. Now on Slide 19, we can see that the 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.

[Patrick Burnett, Senior VP & Chief Medical Officer at Arcutis Biotherapeutics]

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 amounts. For example, the Journal of Clinical Anesthetic Dermatology 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 non steroidal agents like DEREV. We're also now in the busiest season for DIR meetings with several major meetings just wrapping up and the AAD a week away. So I want to share some of what we're hearing.

[Patrick Burnett, Senior VP & Chief Medical Officer at Arcutis Biotherapeutics]

Indicative of this evolution in thinking are statements such as those two that we've included at the bottom of Slide 19, reflecting the stance from the podium at Maui Durham 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 and this is not a conversation that I've heard before. It is reminiscent of what took place when biologics came onto the scene and old school immunosuppresses were set aside in the long term management of psoriasis and AD. Importantly, the profile of Zareb 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 Zareb is well positioned both as first line treatment as well as for those patients who've already tried and failed topical steroids.

[Patrick Burnett, Senior VP & Chief Medical Officer at Arcutis Biotherapeutics]

And 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 study, we showed that Zareb 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 that will benefit patients and our brand. With that, I'll pass it over to David.

[David Topper, Senior VP & Chief Financial Officer at Arcutis Biotherapeutics]

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 believe we are still very much in the early stages of our growth with significant upside remaining. In January, ahead of the JPM conference, we pre announced 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 Excluding this non recurring adjustment, we had net product revenues of $65,300,000 for the fourth quarter.

[David Topper, Senior VP & Chief Financial Officer at Arcutis Biotherapeutics]

That non recurring amount should be excluded for forward looking calculations. For the fourth quarter, our R and D expenses were $14,500,000 which is down 39% from $23,800,000 in the fourth quarter of twenty twenty three due to decreases in the development cost of topical rofemulaz programs and 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 Fumilest 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.

[David Topper, Senior VP & Chief Financial Officer at Arcutis Biotherapeutics]

Our continued strong revenue growth supports our belief that we are investing appropriately in the tremendous growth potential of our Zuri portfolio and we continue to believe that we will reach cash breakeven in 2026. On Slide 22, for the full year 2024, we generated net product revenues of $166,500,000 which is up 471% year over year. Total revenues in 2024 were $196,500,000 up 230% year over year. Based on the Zareve 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.

[David Topper, Senior VP & Chief Financial Officer at Arcutis Biotherapeutics]

For the full year 2024, our R and D expenses were $76,400,000 down 31% from 2023 due to decreases in development costs of topical or fumiglas programs. Recall that a large portion of the expenses included in the R and D line item are comprised of medical affairs activities supporting Zareid commercialization, which will not decline over time. In 2025, we expect a similar level in R and D as in 2024, a year in which we will advance ARQ234 and February with minimal spend for our topical refumilast programs and continued investment in our medical affairs activities. SG and A expenses were $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 supporting all Zareid's indications.

[David Topper, Senior VP & Chief Financial Officer at Arcutis Biotherapeutics]

On Slide 23, you can see we had cash and marketable securities of $228,600,000 on our balance sheet as of 12/31/2024, 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 due to 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, we 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.

[David Topper, Senior VP & Chief Financial Officer at Arcutis Biotherapeutics]

We have the option to redraw that $100,000,000 in whole or in part at our discretion in 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 ZAREIT revenue stream and improving economies of scale will 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. With that, I'll hand it back to Frank for some closing comments.

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

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 Zareeb 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.

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

After our significant efforts last year, Zareeb 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 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. Thank

[Operator]

you. Our first question coming from the line of Vikram Prohet with Morgan Stanley. Your line is now open.

[Vikram Purohit, Analyst at Morgan Stanley]

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 the pre announcement 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, set a question for you on IP.

[Vikram Purohit, Analyst at Morgan Stanley]

There's been some investor interest in 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 a delivery franchise going forward and how you feel about that process? Thank you.

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

Okay. Sure, Vikram. Thanks for your question. So David, maybe can you go into a little more detail around the delta between what we had pre announced for Q4 and this final Q4 print and what was driving that?

[David Topper, Senior VP & Chief Financial Officer at Arcutis Biotherapeutics]

Sure. Couple of things I'd 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 $1,000,000 in change of that was due to the fourth quarter of twenty twenty four itself. So we can't refer to that as an adjustment.

[David Topper, Senior VP & Chief Financial Officer at Arcutis Biotherapeutics]

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.

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

And then Vikram, with regard to your second question, I think it's a completely understandable question, it's one we get a lot.

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

What I can say at

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

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 and our ability to maintain exclusivity of Zareev and we intend to vigorously defend our intellectual property rights as appropriate.

[Vikram Purohit, Analyst at Morgan Stanley]

Fair enough. Thank you.

[Operator]

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

[Tyler Van Buren, Managing Director, Senior Biotech Equity Research Analyst at TD Cowen]

Hey guys, thanks and congratulations on the exceptional execution of commercial front heading into year end. 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?

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

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

[Tyler Van Buren, Managing Director, Senior Biotech Equity Research Analyst at TD Cowen]

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.

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

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?

[Todd Edwards, CCO at Arcutis Biotherapeutics]

Portfolio growth is mentioned. Portfolio growth is primarily driven by volume growth, the slight our net revenue is 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 Zareb Cream for psoriasis, we think about the I'll call the versatility effect that I mentioned earlier within my script. Providers are now being able to get clinical experience with Zareve across three different products across one for SEVERDURM, 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 Zareb Cream for psoriasis.

[Todd Edwards, CCO at Arcutis Biotherapeutics]

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 right sized for the dermatology market with the portfolio that we're managing today.

[Operator]

Thank you. Our next question coming from the line of Seamus Fernandez with Guggenheim. Your line is now open.

[Seamus Fernandez, Senior Managing Director at Guggenheim Partners]

Thanks for the question. So just wanted to circle up on the momentum in the business. 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 refill 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?

[Seamus Fernandez, Senior Managing Director at Guggenheim Partners]

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? Thanks.

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

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 happened and then also maybe comment on our current thinking around two per year consumption. And then also if you could maybe touch on the opportunity for sustained growth again?

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

And then David, I think it'd be helpful if you can give maybe some color around our current thinking around consensus for 2025?

[Todd Edwards, CCO at Arcutis Biotherapeutics]

Yes, Frank, I'll start. Relative to the tubes per year, as we've communicated before, we expect Sereprene 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 SEVERDURM likely around two to three, excuse me, cans per year. For atopic dermatitis, it's still early within the launch, but we expect on average two to three year for an atopic dermatitis patient. And then in reference to Q4 and refills, we're very encouraged by the refill rates with Zareeb cream for psoriasis, which was around 40% of the total volume as refills.

[Todd Edwards, CCO at Arcutis Biotherapeutics]

And then for Zareebone for Sebderm, it was around 38% refills and atopic dermatitis still early in the launch and for the refills. But nonetheless, once we mature that product, it will likely be similar to XERIF cream and psoriasis 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 for product like ZAREV and we fully expect to continue this momentum throughout 2025.

[David Topper, Senior VP & Chief Financial Officer at Arcutis Biotherapeutics]

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 product 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.

[David Topper, Senior VP & Chief Financial Officer at Arcutis Biotherapeutics]

And I'll just think about how to distribute that $2.80 to two eighty five across the four quarters.

[Operator]

Thank you. And our next question coming from the line of Surjit Bellinger with Needham. Your line is now open.

[Serge Belanger, Senior Analyst at Needham & Company]

Hi, good afternoon. Couple of questions. The first one, I guess a follow-up to the guidance or the consensus number and how we should model 2025. On Slide six, you highlighted about four million patients are covered by Medicare and Medicaid. Just curious how many of them had coverage at the start of the year and when do you expect they will have coverage throughout the year?

[Serge Belanger, Senior Analyst at Needham & Company]

And then second question, more of a broader strategy question. David highlighted how well the company has capitalized and 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.

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

Sure. So, Todd, if you could maybe address the 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 four?

[Todd Edwards, CCO at Arcutis Biotherapeutics]

'20 '5.

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

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 into 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.

[Todd Edwards, CCO at Arcutis Biotherapeutics]

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 Zareep. And one of the things very important to highlight is not only the improved access we've had relative to Medicaid, but the quality of that access.

[Todd Edwards, CCO at Arcutis Biotherapeutics]

And what I mean by that, as an example, if you look at the State of California with Medi Cal, there is no step edit for Zareve. 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 ZAREBI to be able to access VITAMA within psoriasis. So high quality Medicaid coverage and one in two Medicaid beneficiaries have access to ZAREBI. 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 the implementation of the IRA, the Inflation Reduction Act.

[Todd Edwards, CCO at Arcutis Biotherapeutics]

Act. Implementation of the IRA has operationally slowed those discussions down in 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 2025.

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

And then, Serge, with regard to your question around profitability, this is obviously something that the leadership team thinks a lot about at Acutis. 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 Zareef. 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 Zareef investment.

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

But we feel we're at the right point right now in terms of investing in Zareef 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?

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

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 REVE or the pipeline or business development.

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

But 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.

[Serge Belanger, Senior Analyst at Needham & Company]

Thank you.

[Operator]

Thank you. Our next question coming from the line of Erwin Mizuho Group. Your line is now open.

[Uy Ear, Vice President at Mizuho Financial Group]

Hey guys, thanks for taking our questions. So I have two questions. First one is, with the upcoming approval of the foam in psoriasis, just wondering, 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?

[Uy Ear, Vice President at Mizuho Financial Group]

Do you think that they'll probably cannibalize 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 ARQ255? Thanks.

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

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 Zuri Foam. 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?

[Patrick Burnett, Senior VP & Chief Medical Officer at Arcutis Biotherapeutics]

Absolutely. Thanks, Mike. Yes, so starting with two fifty five, this is a Phase 1b study. We had 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 the kind of PK exposure, safety and tolerability first in this early stage trial.

[Patrick Burnett, Senior VP & Chief Medical Officer at Arcutis Biotherapeutics]

And then also with the inclusion of alopecia areata patients to get an understanding from both a biomarker and an early clinical response whether or not there's some indication that we were getting an engagement of the target, which has been a challenge for a topical treatment of 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 LPC area trial is typically six months of therapy. So we would really just be seeing the first evidence of efficacy in that readout. Now moving on to the scalp and body indication for psoriasis with the foam.

[Patrick Burnett, Senior VP & Chief Medical Officer at Arcutis Biotherapeutics]

In our pivotal trial, we had co primary endpoints of body 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 reminiscent of what we saw with the cream indication where we had a broad indication for the treatment of psoriasis, but then it's specifically called out inclusive of those patients with intertriginous disease. So we would anticipate that kind of broad indication for the foam as well.

[Todd Edwards, CCO at Arcutis Biotherapeutics]

Yes. And then I'll respond relative to the strategy for the Xirefoam for scalp and body psoriasis. We're incredibly excited about this upcoming approval. We want to be able to differentiate our offering to both dermatologists and patients. And what I mean by that is we want to be able to create and present optionality and choice.

[Todd Edwards, CCO at Arcutis Biotherapeutics]

I mean that we're going to provide a ZAREIB foam formulation for psoriasis and a ZAREIB 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 psoriasis and this pertains to the Zareve Foam is that for psoriasis patients approximately fifty percent of them have some type of scalp involvement. So we believe by offering that type of choice and optionality, we can drive significant conversions from the steroid market over to Xiref Foam or to Zareef Cream. And this will accelerate the entire market as far as the uptake of these products and the conversion from steroids over to the two differentiated offerings that we'll have for providers and patients in psoriasis.

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

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 that there will be a shift in the growth pattern in psoriasis from cream to foam. But I think it's very unlikely that a 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.

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

And ultimately what matters to us and what matters to shareholders is the growth of total ZAREV 0.3 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 ZAREV zero point three cream and foam in psoriasis and put us in a very, very strong position.

[Uy Ear, Vice President at Mizuho Financial Group]

Okay. Thank you.

[Operator]

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

[Kambiz Yazdi, Vice President - Equity Research at Jefferies Financial Group]

Hey, team. Thanks for the questions. Just a couple for me. What proportion of 4Q sales are attributable to the CALA PCP partnership? And the second question I have is, do you expect 1Q OpEx to remain roughly in line with 4Q excluding commissions to CALA?

[Kambiz Yazdi, Vice President - Equity Research at Jefferies Financial Group]

Will commissions to Kala be included in the SG and A line of 1Q office? Thank you.

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

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

[David Topper, Senior VP & Chief Financial Officer at Arcutis Biotherapeutics]

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.

[David Topper, Senior VP & Chief Financial Officer at Arcutis Biotherapeutics]

The commission that we pay Koa 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 so forth, so that people understand the magnitude of that contribution.

[Operator]

Thank you. Our next question coming from the line of Doug Wissam with H. C. Wainwright. Your line is now open.

[Douglas Tsao, Managing Director at H.C. Wainwright & Co.]

Hi, good afternoon. Thanks for taking the questions. Congrats on the progress on the quarter. Just one question for me, you spoke about sort of 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.

[Douglas Tsao, Managing Director at H.C. Wainwright & Co.]

So I'm just curious from a reimbursement standpoint, how you potentially see that playing out? Do you think that physicians will just try steroids more briefly? Or do you think outright that Zorese can become first line therapy? Thank you.

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

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 Zareve. 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.

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

Typically the insurance companies will look at any treatment in the last six to twelve months depending on the insurance company. So what I think investors really need to focus on 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 and the step is irrelevant. And that's where we think the growth opportunity is going to come. 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 Zareve fits into that picture.

[Patrick Burnett, Senior VP & Chief Medical Officer at Arcutis Biotherapeutics]

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 steroidals, 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 to have a need for a long term management of the condition and that's the appropriate time anyway from a medical management perspective to ship them over to a non steroidal product like Zareve they will be able to kind of 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.

[Douglas Tsao, Managing Director at H.C. Wainwright & Co.]

Great. That's great help. Thank you.

[Operator]

Thank you. And I sit down and open the questions in the queue at this time. I will turn the call back over to Mr. Frank Watanabe for any closing remarks.

[Frank Watanabe, President & CEO at Arcutis Biotherapeutics]

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 in the not too distant future when we have Q1 results. Thanks a lot.

[Operator]

This concludes today's conference call. Thank you for your participation and you may now disconnect.

Participants

Executives

• Latha Vairavan, Vice President of Finance & Investor Relations
• Frank Watanabe, President & CEO
• Todd Edwards, CCO
• Patrick Burnett, Senior VP & Chief Medical Officer
• David Topper, Senior VP & Chief Financial Officer

Analysts

• Vikram Purohit, Analyst at Morgan Stanley
• Tyler Van Buren, Managing Director, Senior Biotech Equity Research Analyst at TD Cowen
• Seamus Fernandez, Senior Managing Director at Guggenheim Partners
• Serge Belanger, Senior Analyst at Needham & Company
• Uy Ear, Vice President at Mizuho Financial Group
• Kambiz Yazdi, Vice President - Equity Research at Jefferies Financial Group
• Douglas Tsao, Managing Director at H.C. Wainwright & Co.