Arcutis Biotherapeutics, Inc.

Ladies and gentlemen, thank you for standing by. Welcome to the Arcutus Biotherapeutics Inc's fourth quarter fiscal year 2025 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would like now to turn the conference over to Brian Sholkoff, Head of Investor Relations. Please go ahead.

Thank you, Michelle. Good afternoon, everyone, and thank you for joining us today to review our fourth quarter and full year 2025 financial results and business updates. Slides for today's call are available on the investor section of the RQDIS website. Joining me on the call today are Frank Watanabe, President and CEO of RQDIS, Todd Edwards, Chief Commercial Officer, Patrick Burnett, Chief Medical Officer, and Lata Vyravan, Chief Financial Officer. I'd like to remind everyone that we will be making forward-looking statements during this call. These statements are subject to certain risks and uncertainties, and our actual results may differ. We encourage you to review all of the company's filings with the Securities and Exchange Commission, including descriptions of our business and risk factors. With that, let me hand it over to Frank to begin today's call.

Thanks, Brian, and thanks, everyone, for joining us today. I want to start out today's call by reviewing some key highlights and achievements from 2025, a year that was characterized by tremendous growth and progress for Acutis. as we pursue our mission of serving individuals living with chronic inflammatory skin conditions. We'll then transition to Todd for a commercial update, and then Patrick for an R&D update, and Lata for a review of our financial results. So in 2025, we made significant strides to solidify our QTASIS position as one of the industry's foremost leaders in delivering meaningful innovation in medical dermatology. Throughout the year, we saw robust net product sales revenue growth, steady prescription growth, and a strong market share growth across all of our improved indications and formulations of Zareve or topical roflomelastin. We are incredibly humbled by the increasing number of healthcare practitioners and patients who are placing their trust in Zareve as an innovative, safe, and effective treatment option for chronic inflammatory skin conditions, an important and welcome alternative to topical steroids. In 2025, we saw explosive revenue growth for Xareve, strengthening its position as the number one branded non-steroidal topical treatment across all of our approved indications, psoriasis, seborrheic dermatitis, and atopic dermatitis. There hasn't previously been a drug for chronic inflammatory conditions with a profile or the reach of Xareve, an advanced topical, targeted topical that can be used safely and effectively for any duration, anywhere on the body, across multiple indications and age groups. This unique profile of Zareve, and at a moment in time when there's increasing calls by both providers and patients for innovative safe alternatives to topical steroids, has really fueled Zareve's robust commercial growth and success. So in 2025, net product revenues grew to $372 million, representing a 123 percent year-on-year increase versus 2024. This revenue growth was driven by year-on-year doubling in total prescription volume and has further cemented our leadership position in the branded non-steroidal topical segment, where we now hold roughly 45 percent and a growing share of prescription volume across our approved indications. Zareef's commercial growth in 2025 was bolstered by FDA approvals of Xareve foam 0.3% for patients with psoriasis of the scalp and body 12 years of age and older, as well as the approval of Xareve cream 0.05 for the treatment of atopic dermatitis in children ages two to five years of age. These approvals, which mark our fifth and sixth Xareve approvals respectively, demonstrate our commitment to ensuring that we can bring the benefits of Xareve to as broad a group of patients with psoriasis, sebderm, and AD as possible. The approval of Xareve Foam's expanded indication offered an important new option for individuals who struggle with psoriasis of the scalp and other sensitive areas. These patients now have a formulation that can be used anywhere on their body, affording them a new level of convenience to manage their chronic skin condition. And we're particularly proud of the approval of Xareve Cream 0.05% in young children with AD given the frequent early onset of this disease and the meaningful number of patients in this age group. For far too long, there has been a significant unmet need and we are proud now to be in a position to address it with Zareve. In 2025, we also submitted a supplemental NDA for Zareve cream 0.3% for psoriasis in children ages two to five with a target action date of June 29th of this year. And if approved, this will mark another critical step in serving the unmet needs of this pediatric demographic and their parents and caregivers. On the clinical development front, in 2025, we completed enrollment in the Phase 2 Integument Infant Trial, evaluating Zareeb Cream 0.05 in infants ages 3 to 24 months with atopic dermatitis. And earlier this month, we were delighted to report positive top-line results from that study, which Patrick will review later on call. And we're now preparing to submit this data to the FDA for a further label expansion. This is another important milestone as we work diligently to ensure that we can serve this youngest and most vulnerable population who have nearly no FDA-approved treatment options. In 2025, we also initiated Phase II proof-of-concept studies with Xarev foam 0.3% in vitiligo and hydradenide to suprativa, or HS. marking an important step as we explore potential new indications that would enable us to expand the benefits of Xareve to additional individuals in need of effective treatment options and further maximize the pipeline in a molecule opportunity that Xareve represents. Finally, last year we submitted an IND application for ARQ234, our novel biologic with best-in-class potential to address a large unmet need in atopic dermatitis as we look to expand our pipeline and extend our mission to deliver meaningful innovation to patients with chronic inflammatory skin conditions. In short, we have had a tremendous year of progress, and we are confident that these accomplishments have set the stage for a successful 2026 and well beyond. None of this, of course, would be possible without the incredible talent, hard work, and persistence of the Arcutus team. So I'd like to take a moment to acknowledge and thank each and every one of our team members for their deep and continued dedication to our company's mission and above all, to the patients that we serve. Moving to slide six, to frame the rest of today's discussion, I'd like to recap the three-pillar corporate strategy that we introduced a few months ago to describe how we will sustain both near and long-term growth for our acutus. We have already made progress across all three of these pillars. On the growth front, I just mentioned the compelling data from the Integument Infant Trial and our plans to pursue a label expansion based on that data. And as you'll hear more from Todd in just a minute, we've recently announced an expansion of our dermatology specialty sales force to drive further Zareve growth, as well as our decision to take over promotion of Zareve to primary care physicians and pediatricians. In terms of the expand pillar, as Patrick will expound on shortly, we continue to progress our phase two POCs in HS and vitiligo and look forward to sharing data from these trials later this year or early next. And we are evaluating additional POC studies for other diseases. Finally, we look forward to enrolling the first patients in the phase one study of ARQ234 shortly, and eventually sharing data from that study with the investment community. These concrete steps in realizing our strategy are evidence of our dedicated and disciplined strategic approach to ensuring our QDIS is well positioned for both a near and long-term success. Before turning the call over to Todd and Lata to review our fourth quarter results in more detail, I want to give an update on some key points about the revenue guidance that we gave during our investor day in November of last year. First, we are raising our 2026 full year net product revenue guidance range from originally the $455 million to $470 million to now $480 million to $495 million to reflect both the strong momentum for Zareve as demonstrated by our fourth quarter results and also the investments that we continue to make in the franchise that the team will detail further today. We will evaluate our revenue guidance throughout the year and may update that when appropriate. Second, not only did we achieve positive cash flow in Q4 as promised, but we are reaffirming that we will maintain positive cash flow on a quarterly basis throughout 2026, even as we continue to increase our investment in Zaria's growth and our pipeline. And with that, I'll hand the call over to Todd for a Q4 commercial update.