4th Quarter and Full Year 2025 Financial Results Forward-looking statements are based on our management's beliefs and assumptions and on information currently available to management. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions, and other factors including, but not limited to, those related to the success, cost and timing of our product candidate development activities and ongoing and planned clinical trials; our plans to develop and commercialize targeted t ...

Core Insights - Arcutis Biotherapeutics has received FDA approval for ZORYVE (roflumilast) topical foam 0.3% for treating plaque psoriasis in patients aged 12 and older, marking a significant advancement in immuno-dermatology [1][5] - ZORYVE foam is a once-daily, steroid-free treatment that is now widely available, addressing the needs of nearly 9 million people in the U.S. living with plaque psoriasis, particularly those with scalp involvement [2][5] Product Details - ZORYVE foam demonstrated significant improvements in clinical trials, achieving Scalp-Investigator Global Assessment (S-IGA) Success in 66.4% of patients compared to 27.8% for the vehicle foam at Week 8 [8] - The foam also provided rapid itch relief, with 65.3% of patients experiencing a clinically significant reduction in scalp itch compared to 30.3% for the vehicle [10] - ZORYVE is indicated for both plaque psoriasis and seborrheic dermatitis, with a focus on hard-to-treat areas such as the scalp and body [14][15] Clinical Trial Results - The approval was supported by positive results from Phase 2 and pivotal Phase 3 trials, enrolling 736 adults and adolescents with mild to severe plaque psoriasis [7] - In the ARRECTOR study, 45.5% of individuals treated with ZORYVE foam achieved Body-IGA Success compared to 20.1% for the vehicle foam at Week 8 [8] - The treatment was well tolerated, with low incidence of adverse events, primarily mild to moderate in severity [12] Market Context - The approval of ZORYVE foam is the fifth for the product in less than three years, highlighting Arcutis' commitment to addressing urgent needs in dermatology [3][5] - The company aims to provide predictable access to ZORYVE through programs that assist patients with adherence and reduce out-of-pocket costs [4][21] Future Engagement - Arcutis will host a virtual Key Opinion Leader Event on June 2, 2025, to discuss the treatment landscape for plaque psoriasis, featuring insights from a leading expert [4][5]