Arcutis Announces Third Quarter 2024 Financial Results and Provides Business Update

Core Insights - Arcutis Biotherapeutics reported a significant increase in net product revenues for the third quarter of 2024, totaling $44.8 million, representing a 452% increase compared to Q3 2023 and a 45% increase from Q2 2024 [1][12] - The company continues to see strong demand for its ZORYVE products, with a 25% increase in total U.S. franchise unit demand quarter over quarter [1][2] - The FDA accepted a supplemental New Drug Application (sNDA) for ZORYVE foam for treating scalp and body psoriasis, with a PDUFA action date set for May 22, 2025 [1][5] Financial Performance - Product revenues for Q3 2024 were $44.8 million, up from $8.1 million in Q3 2023, driven by strong unit demand and gross-to-net (GTN) improvements [12][21] - Cost of sales for the quarter was $5.5 million, compared to $1.2 million in the same period last year [13] - Research and development (R&D) expenses decreased to $19.5 million from $26.2 million year-over-year, attributed to reduced clinical development costs [14] - Selling, general, and administrative (SG&A) expenses increased to $58.8 million from $47.6 million year-over-year, primarily due to sales and marketing expenses related to ZORYVE launches [15] - The net loss for the quarter was $41.5 million, or $0.33 per share, compared to a net loss of $44.8 million, or $0.73 per share, in Q3 2023 [16][21] Product Updates - ZORYVE cream and foam continue to gain traction, with over 304,000 prescriptions filled for ZORYVE cream and over 168,000 for ZORYVE foam since their respective launches [3][4] - ZORYVE cream 0.15% was approved for treating mild to moderate atopic dermatitis in early Q3 2024, with commercial launch commencing at the end of July [3] - ZORYVE foam has been approved for seborrheic dermatitis in Canada, with plans for commercial launch by the end of 2024 [5] Pipeline Developments - The company is progressing with its pipeline, including the completion of enrollment in a Phase 1b study for ARQ-255, targeting alopecia areata, with data expected in the first half of 2025 [6] - ARQ-234, a potential biologic treatment for atopic dermatitis, is in preclinical development, with an Investigational New Drug Application (IND) submission planned for 2025 [7] Corporate Highlights - A co-promotion agreement was established with Kowa Pharmaceuticals America to market ZORYVE products to primary care practitioners and pediatricians [8] - The company amended a $200 million term loan, lowering the interest rate and extending the maturity to August 2029 [8] - Arcutis received two new U.S. patents related to ZORYVE in Q3 2024, enhancing its intellectual property portfolio [8]