ZORYVE® (roflumilast) Cream 0.3%

May 06, 2025 — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) reported Q1 2025 financial results (quarter ended March 31, 2025) and provided a business update focused on its ZORYVE® (topical roflumilast) dermatology portfolio. Net product revenue was $63.8 million, up 196% versus Q1 2024 ($21.6 million) and down 2% versus Q4 2024 (attributed to typical deductible resets/insurance changes and a non-recurring Q4 2024 reserve adjustment). The company cited 10% continued demand growth for ZORYVE and stated it is the most prescribed branded non-steroidal topical across three major inflammatory skin conditions; all three largest national PBMs cover the full portfolio and Medicaid coverage is expanding.

Regulatory milestones include a May 22, 2025 PDUFA date for ZORYVE foam 0.3% for scalp/body plaque psoriasis (ages ≥12) and an October 13, 2025 PDUFA date for an sNDA for ZORYVE cream 0.05% in atopic dermatitis ages 2–5. Health Canada approved ZORYVE cream 0.15% for atopic dermatitis (≥6 years), with sales starting in April 2025. Q1 net loss was $25.1 million ($0.20/share) vs $35.4 million ($0.32/share) in Q1 2024; cash and marketable securities were $198.7 million as of March 31, 2025. The Padagis patent litigation was stayed (trial deadlines cancelled).