Core Viewpoint - Arcutis Biotherapeutics has initiated a Phase 2 open-label study for ZORYVE (roflumilast) cream 0.05% in infants with atopic dermatitis, marking a significant step in addressing unmet needs in pediatric dermatology [1][2][3] Company Overview - Arcutis Biotherapeutics, Inc. is a commercial-stage biopharmaceutical company focused on innovations in immuno-dermatology, with a commitment to addressing urgent needs in dermatological diseases [15] Study Details - The INTEGUMENT-INFANT study will enroll approximately 35 infants aged 3 months to less than 2 years with mild to moderate atopic dermatitis, evaluating the safety and tolerability of roflumilast cream applied once daily over four weeks [3][9] - This study builds on previous successful results from the ARQ-151-105 (MUSE) study, which also evaluated roflumilast cream in infants [3] Atopic Dermatitis (AD) Insights - Atopic dermatitis is a chronic condition affecting approximately 9.6 million children in the United States, with up to 60% of cases developing symptoms within the first year of life [5][9] - The condition significantly impacts families by disrupting sleep and increasing the risk of skin infections, highlighting the need for effective treatments [2] ZORYVE Product Information - ZORYVE is the first and only branded topical therapy for atopic dermatitis, seborrheic dermatitis, and plaque psoriasis, representing a next-generation topical PDE4 inhibitor [6][7] - ZORYVE cream 0.15% is currently under FDA review for the treatment of mild to moderate atopic dermatitis in children aged 2 to 5 years, with a target action date of October 13, 2025 [8]

Core Insights - Arcutis Biotherapeutics, Inc. is presenting five posters at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference, showcasing new data on the long-term safety and efficacy of ZORYVE cream in treating atopic dermatitis (AD) in children aged 2 to 5 [1][2] Group 1: Study Findings - The INTEGUMENT-OLE study demonstrated that ZORYVE cream 0.05% has long-term safety and durable efficacy in children aged 2 to 5 with AD, with a median duration of disease control of 238 days for those switching to a proactive twice-weekly application [2][5] - In the study, 32.7% of participants aged 6 years and older and 28.8% of participants aged 2 to 5 achieved a validated Investigator Global Assessment (vIGA-AD) score of clear or almost clear by Week 4, improving to 55.7% and 63.1% respectively by Week 52 [3][5] - Significant improvements in itch were observed, with 30.9% of participants aged 6 years and older and 41.2% of participants aged 2 to 5 achieving a clinically meaningful reduction in itch at the conclusion of the parent studies, improving to 55.3% and 60.7% respectively after up to 56 weeks of treatment [3][5] Group 2: Clinical Implications - The data highlight the critical need for effective, long-term, steroid-free treatment options for young children with AD, as chronic use of topical steroids can lead to significant adverse events [4][5] - ZORYVE cream formulations were well tolerated, with treatment-related adverse events reported in 4.7% of participants aged 6 years and older and 2.5% of participants aged 2 to 5 [4][5] - The investigational ZORYVE cream 0.05% is currently under FDA review, with a target action date of October 13, 2025, indicating potential for future market introduction [13]

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]

Core Insights - Arcutis Biotherapeutics announced positive results from a pivotal Phase 3 study of ZORYVE (roflumilast) foam 0.3% for treating psoriasis of the scalp and body, published in JAMA Dermatology [1][9] Efficacy Results - ZORYVE foam demonstrated significant improvements in co-primary efficacy endpoints, with 66.4% achieving Scalp-Investigator Global Assessment (S-IGA) Success and 45.5% achieving Body-Investigator Global Assessment (B-IGA) Success at Week 8, compared to 27.8% and 20.1% for the vehicle, respectively (P<0.0001) [4][5] - Clinically meaningful improvements in scalp itch were observed, with 65.3% of ZORYVE-treated individuals achieving a significant reduction in itch compared to 30.3% for the vehicle at Week 8 (P<0.0001) [6][8] - At Week 8, 70.9% of ZORYVE-treated individuals achieved at least 75% improvement in Psoriasis Scalp Severity Index (PSSI-75) compared to 31.3% for the vehicle (P<0.001) [13] Study Design - The ARRECTOR study was a Phase 3, randomized, double-blinded, vehicle-controlled trial involving 432 participants aged 12 years and older across 49 sites in the U.S. and Canada [3][5] Safety and Tolerability - ZORYVE foam was well-tolerated, with low incidence of Treatment Emergent Adverse Events (TEAEs) similar to the vehicle group; common adverse events included headache, diarrhea, and nausea [8][9] - Investigator-rated application-site tolerability showed no evidence of irritation for at least 99.2% of patients at all time points [8] Regulatory Status - A Supplemental New Drug Application (sNDA) for ZORYVE foam 0.3% is under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) action date set for May 22, 2025 [5][11] Market Context - Psoriasis affects approximately nine million people in the U.S., with more than half experiencing scalp involvement, highlighting the need for effective treatment options [10][11]

1 st Quarter 2025 Financial Results & Business Update May 6, 2025 Legal Disclaimers This presentation and the accompanying oral presentation contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our current and future financia ...