Arcutis Biotherapeutics Delivers Strong Revenue Growth and Profitability in Q3 2025

Arcutis Biotherapeutics, Inc., a commercial-stage biopharmaceutical company focused on developing and commercializing treatments for dermatological diseases, reported its financial results for the third quarter of 2025. The company delivered impressive revenue growth and profitability, driven by the continued commercial success of its lead product ZORYVE.

Financial Highlights

• Total product revenue, net, increased by 122% to $99.2 million in Q3 2025, compared to $44.8 million in Q3 2024. This growth was primarily driven by strong demand for ZORYVE cream 0.3%, ZORYVE foam, and ZORYVE cream 0.15%.
• ZORYVE cream 0.3% revenue increased by 38% to $30.5 million, ZORYVE foam revenue increased by 146% to $49.8 million, and ZORYVE cream 0.15% revenue increased by 673% to $18.9 million.
• The company reported net income of $7.4 million in Q3 2025, compared to a net loss of $41.5 million in Q3 2024.
• As of September 30, 2025, Arcutis had $191.4 million in cash, cash equivalents, restricted cash, and marketable securities, and $100.0 million in outstanding debt.

Operational Highlights

• In September 2025, Arcutis submitted a supplemental New Drug Application (sNDA) to the FDA to expand the indication of ZORYVE cream 0.3% for the treatment of plaque psoriasis in children down to the age of 2.
• In June 2025, the company initiated INTEGUMENT-INFANT, a Phase 2 study to evaluate the safety and efficacy of investigational ZORYVE cream 0.05% in infants as young as 3 months to less than 2 years with atopic dermatitis.
• In September 2022, Arcutis acquired Ducentis BioTherapeutics and its lead asset, ARQ-234, a fusion protein that is a potent and highly selective checkpoint agonist of the CD200 Receptor (CD200R). The company plans to develop ARQ-234 in atopic dermatitis and potentially other inflammatory conditions.
• In July 2024, Arcutis entered into a co-promotion agreement with Kowa Pharmaceuticals, Inc. to leverage Kowa’s primary care sales force to exclusively market and promote ZORYVE in the United States to primary care practitioners and pediatricians.

Revenue Growth Driven by ZORYVE Franchise

Arcutis’ strong revenue performance in Q3 2025 was primarily driven by the continued commercial success of its ZORYVE franchise, which includes ZORYVE cream 0.3%, ZORYVE foam, and ZORYVE cream 0.15%. The company’s ability to expand the indications and patient populations for ZORYVE has been a key driver of this growth.

ZORYVE cream 0.3%, the company’s first FDA-approved product, saw a 38% increase in revenue compared to Q3 2024, reflecting higher end-customer demand in the United States and Canada. The approval of ZORYVE cream 0.3% for the treatment of plaque psoriasis, including in the intertriginous areas, in individuals 12 years of age and older, has allowed Arcutis to address a significant unmet need in the psoriasis market.

The launch of ZORYVE foam for the treatment of seborrheic dermatitis in the United States and Canada, as well as the more recent approval and launch of ZORYVE foam for the treatment of plaque psoriasis of the scalp and body in the United States, contributed to a 146% increase in ZORYVE foam revenue compared to Q3 2024. The availability of a steroid-free, once-daily foam formulation has been well-received by healthcare providers and patients.

ZORYVE cream 0.15% for the treatment of mild to moderate atopic dermatitis in adults and pediatric patients 6 years of age and older also saw a significant revenue increase of 673% compared to Q3 2024, driven by higher end-customer demand and net price improvement in the United States. The approval of ZORYVE cream 0.15% has provided a new treatment option for patients with atopic dermatitis, addressing the need for long-term disease control without the limitations associated with topical corticosteroids.

Profitability and Cash Position

Arcutis reported net income of $7.4 million in Q3 2025, a significant improvement from the net loss of $41.5 million in Q3 2024. This profitability was driven by the strong revenue growth, as well as a decrease in interest expense due to the company’s $100.0 million principal paydown on its long-term debt in October 2024.

As of September 30, 2025, Arcutis had $191.4 million in cash, cash equivalents, restricted cash, and marketable securities, providing the company with a solid financial foundation to support its ongoing operations and future growth initiatives. The company’s ability to generate positive cash flow from its commercial operations has been a key strength, reducing its reliance on external financing.

Expanding the ZORYVE Franchise and Advancing the Pipeline

Arcutis continues to focus on expanding the ZORYVE franchise and advancing its pipeline of product candidates. In September 2025, the company submitted an sNDA to the FDA to expand the indication of ZORYVE cream 0.3% for the treatment of plaque psoriasis in children down to the age of 2. This potential label expansion would further broaden the addressable patient population for ZORYVE cream 0.3%.

Additionally, the company initiated a Phase 2 study, INTEGUMENT-INFANT, to evaluate the safety and efficacy of investigational ZORYVE cream 0.05% in infants as young as 3 months to less than 2 years with atopic dermatitis. If successful, this study could serve as the basis for a further expansion of the ZORYVE cream 0.05% indication to this younger patient population.

Arcutis also continues to advance its pipeline, including the development of ARQ-234, a fusion protein that is a potent and highly selective checkpoint agonist of the CD200 Receptor (CD200R). The company acquired ARQ-234 through the acquisition of Ducentis BioTherapeutics in 2022 and plans to develop it as a potential treatment for atopic dermatitis and other inflammatory conditions. The company submitted an Investigational New Drug (IND) application to the FDA in July 2025 and anticipates commencing a Phase 1 study of ARQ-234 in the first quarter of 2026.

Strengthening Commercialization Capabilities

In July 2024, Arcutis entered into a co-promotion agreement with Kowa Pharmaceuticals, Inc. to leverage Kowa’s primary care sales force to exclusively market and promote ZORYVE in the United States to primary care practitioners and pediatricians. This partnership is expected to further expand the reach and adoption of ZORYVE, particularly in the primary care and pediatric settings.

The company’s ability to effectively commercialize its products has been a key driver of its success. Arcutis has built a strong commercial infrastructure, including a dedicated sales force, to support the launch and ongoing commercialization of ZORYVE. The co-promotion agreement with Kowa is expected to complement Arcutis’ existing commercial capabilities and help drive increased awareness and utilization of ZORYVE among healthcare providers.

Outlook and Conclusion

Arcutis Biotherapeutics has delivered impressive financial and operational results in the third quarter of 2025, demonstrating the continued commercial success of its ZORYVE franchise and the company’s ability to execute on its strategic priorities. The strong revenue growth, profitability, and solid cash position provide Arcutis with the resources to further invest in the development and commercialization of its product portfolio, including potential label expansions for ZORYVE and the advancement of its pipeline candidate, ARQ-234.

As Arcutis looks to the future, the company remains focused on driving the growth of its ZORYVE franchise, expanding its addressable patient populations, and advancing its pipeline to address unmet needs in dermatology. With a strong commercial foundation, a robust product portfolio, and a promising pipeline, Arcutis is well-positioned to continue delivering value to patients, healthcare providers, and shareholders.