Arcutis Announces Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

Core Insights - Arcutis Biotherapeutics reported a strong performance in 2025, achieving over 90% year-over-year growth in net product revenue, primarily driven by the demand for ZORYVE and successful product launches [2][5]. Financial Performance - Q4 2025 net product revenue for ZORYVE was $127.5 million, an 84% increase compared to Q4 2024, and a 29% increase compared to Q3 2025 [5][6]. - Full year 2025 net product revenue for ZORYVE reached $372.1 million, reflecting a 123% increase over the prior year [5][6]. - Total revenues for Q4 2025 were $129.5 million, compared to $71.4 million for the same period in 2024, driven by strong unit demand growth [9]. - Total revenues for the year ended December 31, 2025, were $376.1 million, compared to $196.5 million for 2024 [9]. Cost and Expenses - Cost of sales for Q4 2025 was $11.7 million, up from $6.9 million in Q4 2024, driven by increased ZORYVE sales volume [10]. - Research and development (R&D) expenses for Q4 2025 were $20.5 million, compared to $14.5 million in Q4 2024, due to higher clinical development costs [11]. - Selling, general, and administrative (SG&A) expenses for Q4 2025 were $79.0 million, compared to $57.6 million in Q4 2024, primarily due to increased sales and marketing expenses [12]. Profitability - The company reported a net income of $17.4 million for Q4 2025, compared to a net loss of $10.8 million in Q4 2024 [13]. - For the full year 2025, the net loss was $16.1 million, significantly improved from a net loss of $140.0 million in 2024 [13]. Cash Flow and Guidance - Arcutis achieved positive cash flow with $26.2 million from operations in Q4 2025, driven by ZORYVE sales growth [15]. - The company raised its 2026 full-year net product sales guidance to between $480 million and $495 million [16]. Product Development and Market Access - ZORYVE cream 0.05% was launched for treating atopic dermatitis in children aged 2 to 5 years following FDA approval [6]. - The company secured Medicare access for ZORYVE starting January 2026, with approximately one in three Medicare patients having non-preferred access [6]. - Positive topline data was reported for the INTEGUMENT-INFANT Phase 2 trial of ZORYVE cream 0.05% in infants with atopic dermatitis, with an sNDA submission expected in Q2 2026 [5][6].