**Arcutis Biotherapeutics, Inc. Reports Fiscal Year 2025 Results, Highlights Commercial Growth**

Arcutis Biotherapeutics, Inc., a commercial-stage biopharmaceutical company focused on dermatological diseases, reported a net loss of $16.1 million for the year ended December 31, 2025, compared to a net loss of $140.0 million for the previous fiscal year. The company's total product revenue, net, reached $372.1 million, a 123% increase from $166.5 million in 2024. This growth was primarily driven by increased patient demand for ZORYVE cream 0.3% and ZORYVE foam, as well as the commercial launches of ZORYVE cream 0.15% and ZORYVE cream 0.05%.

The company's financial performance in 2025 reflects significant commercial progress, with ZORYVE cream 0.3% revenue increasing by 42% to $121.0 million, ZORYVE foam revenue increasing by 154% to $181.9 million, and ZORYVE cream 0.15% contributing $68.3 million following its launch in July 2024. ZORYVE cream 0.05% also added $0.9 million in revenue after its launch in October 2025. Other revenue, primarily from licensing agreements, decreased from $30.0 million in 2024 to $4.0 million in 2025, reflecting the timing of milestone payments. Cost of sales increased to $57.6 million, driven by higher sales volume and increased royalty expenses.

Strategic developments during the year included the FDA acceptance of a supplemental New Drug Application (sNDA) for ZORYVE cream 0.3% to expand its indication to children aged 2-5, with a PDUFA target action date of June 29, 2026. The company also announced positive topline data from the INTEGUMENT-INFANT trial, evaluating ZORYVE cream 0.05% in infants as young as 3 months with atopic dermatitis, with plans to submit an sNDA in the second quarter of 2026. Effective January 23, 2026, Arcutis mutually agreed to terminate its promotion agreement with Kowa Pharmaceuticals America, Inc.

Key operational developments included the submission of an Investigational New Drug (IND) application to the FDA for ARQ-234 in July 2025, with a Phase 1 study anticipated to commence in the first quarter of 2026. As of December 31, 2025, Arcutis had 354 full-time employees. The company's cash, cash equivalents, and marketable securities totaled $221.0 million, with $100.0 million outstanding under its loan and security agreement with SLR Investment Corp. Looking ahead, Arcutis plans to focus on growing its core ZORYVE business, expanding the ZORYVE franchise into additional indications, and advancing innovative medicines for patients, leveraging its drug development capabilities.

About Arcutis Biotherapeutics, Inc.

Arcutis Biotherapeutics, Inc. is a commercial-stage biopharmaceutical company specializing in developing and marketing innovative topical and systemic treatments for immune-mediated dermatological diseases. Its core products include ZORYVE, a portfolio of PDE4 inhibitor creams and foams approved for plaque psoriasis, atopic dermatitis, and seborrheic dermatitis. Arcutis targets dermatologists, primary care providers, and pediatricians, leveraging proprietary formulations and a focused development platform to address unmet needs in chronic skin conditions.

This description was generated via AI from an annual report. Updated 8 months ago.

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