Core Insights - Arcutis Biotherapeutics is presenting new data on ZORYVE (roflumilast) efficacy for seborrheic dermatitis, atopic dermatitis, and psoriasis at the EADV Congress in Paris from September 17-20, 2025 [1] Efficacy of ZORYVE - ZORYVE foam 0.3% shows significant improvement in seborrheic dermatitis, with an Investigator Global Assessment (IGA) Success rate of 79.5% compared to 58.0% for the vehicle at Week 8 [5] - The treatment is effective across diverse populations, with similar efficacy observed among different races and ethnicities [5] - ZORYVE cream 0.05% demonstrates improved quality of life and reduced family impact in children aged 2-5 years with atopic dermatitis [4][6] - Both ZORYVE cream 0.3% and foam 0.3% improve signs and symptoms of plaque psoriasis in individuals with facial and/or genital involvement [7] Safety and Tolerability - ZORYVE foam 0.3% is well tolerated, with improvements in hypopigmentation and hyperpigmentation observed across all subgroups [5] - The treatment has shown minimal irritation at the application site in children, indicating good tolerability [6] Product Information - ZORYVE is the leading prescribed topical therapy for atopic dermatitis, seborrheic dermatitis, and plaque psoriasis [10] - The product is a selective phosphodiesterase-4 (PDE4) inhibitor, targeting inflammatory mediators [10] - ZORYVE cream 0.3% and foam 0.3% are FDA-approved for various age groups, with specific indications for plaque psoriasis and seborrheic dermatitis [11][12][13] Company Commitment - Arcutis Biotherapeutics emphasizes its commitment to advancing innovative therapies for inflammatory skin diseases, aiming to improve patient lives [9][17]

Core Insights - Arcutis Biotherapeutics' product ZORYVE has received the 2025 Best of Beauty Breakthrough Award from Allure magazine, marking it as the first prescription topical medication for eczema, plaque psoriasis, and seborrheic dermatitis to achieve this recognition [1][6][9] Company Overview - Arcutis Biotherapeutics, Inc. is a commercial-stage biopharmaceutical company focused on innovations in immuno-dermatology, with a commitment to addressing urgent patient needs in dermatological conditions [17] Product Highlights - ZORYVE is recognized for its unique profile in dermatology, being the number one prescribed branded topical therapy for eczema, plaque psoriasis, and seborrheic dermatitis [3][7][9] - The product is a highly selective and potent phosphodiesterase-4 (PDE4) inhibitor, designed to be safe and effective for various inflammatory skin diseases [4][10] - ZORYVE is available in a once-daily, steroid-free topical foam or cream formulation that can be applied anywhere on the body, suitable for all skin and hair types [4][11] Award Significance - The Allure Best of Beauty Breakthrough Award is a prestigious honor, with fewer than 10 products typically winning in this category, highlighting ZORYVE's revolutionary impact on skincare [6][9] Clinical and Safety Information - ZORYVE has been shown to be safe and well-tolerated, providing rapid symptom relief and has been prescribed over 1 million times by healthcare providers [9][11] - The product is indicated for use in patients aged 6 years and older for various conditions, including mild to moderate atopic dermatitis and plaque psoriasis [12][13]

Financial Performance - Q2 2025 net product revenue reached $81.5 million, a 164% increase compared to Q2 2024[28,39] - Net product revenues increased by 28% quarter-over-quarter from Q1 2025 to Q2 2025[39,73] - Net loss decreased by 70% from $(52.3) million in Q2 2024 to $(15.9) million in Q2 2025[73] - Cash, cash equivalents, and marketable securities totaled $191.1 million as of June 30, 2025[75] Product & Commercial Updates - ZORYVE portfolio achieved approximately 16,500 weekly total prescriptions on a rolling 4-week basis[40] - Total prescriptions growth was +13% from Q1 2025 to Q2 2025 and +117% compared to Q2 2024[41] - Over 80% of ZORYVE prescriptions are covered by insurance[49] - Launched ZORYVE foam 0.3% for plaque psoriasis of the scalp and body[28] Research & Development - Anticipated approval of ZORYVE cream 0.05% for atopic dermatitis ages 2-5 with target PDUFA October 2025[28,58] - Phase 2 trial initiated for ZORYVE cream 0.05% in ages 3-24 months for atopic dermatitis[58,62]

Financial Performance - Q1 2025 net product revenue reached $63.8 million for ZORYVE®[28], a 196% increase compared to the prior year[37] - Total revenues for Q1 2025 were $65.8 million, a $16.3 million increase year-over-year[73] - Net loss for Q1 2025 was $(25.1) million, an improvement of $10.3 million compared to Q1 2024[73] - Cash, cash equivalents, and marketable securities totaled $198.7 million as of March 31, 2025[77] Commercial Progress - Prescription demand for ZORYVE grew by 10%[28] from Q4 2024 to Q1 2025[39] - Over 80% of ZORYVE prescriptions are covered by insurance[43] - ZORYVE's TRx share in the branded topical segment has grown from 11% to 41%[50] - The branded topical segment grew by 50%[47] Pipeline and Regulatory Milestones - Anticipated FDA approval of ZORYVE foam 0.3% for scalp & body psoriasis with a target PDUFA date in May 2025[28, 59] - The company submitted a supplemental New Drug Application (sNDA) for ZORYVE Cream 0.05% in ages 2-5 for Atopic Dermatitis with an anticipated target action date of October 13, 2025[59]