Arcutis Biotherapeutics, Inc.

Company focus

Arcutis Biotherapeutics is a commercial-stage biopharmaceutical company focused on developing and commercializing dermatology therapies for conditions with high unmet medical need. The company centers its strategy on validated biological targets in inflammation and immunology and uses a dermatology-focused drug development platform to create best-in-class products and extend the ZORYVE franchise.

Current commercial products (as of 12/31/2025)

• ZORYVE cream 0.3% (roflumilast)
  • Indication: plaque psoriasis (including intertriginous areas) in individuals 12+; expanded to 6+ in Oct 2023.
• ZORYVE foam 0.3% (roflumilast)
  • Indication: seborrheic dermatitis in individuals 9+; launched in US Jan 2024 and in Canada Dec 2024.
• ZORYVE cream 0.15%
  • Indication: atopic dermatitis in adults and pediatric patients 6+; approved Jul 2024.
• ZORYVE foam (scalp/body) 0.3%
  • Indication: plaque psoriasis of scalp and body in adults and adolescents 12+; approved May 2025 (US); Health Canada approval Oct 2025; launch Nov 2025.
• ZORYVE cream 0.05%
  • Indication: atopic dermatitis in children 2–5; approved Oct 2025.

The company has publicized ongoing pediatric development efforts, including INTEGUMENT-INFANT program results announced Feb 2026 and plans for potential supplemental NDA submissions.

Pipeline and development

• ARQ-234 (CD200R checkpoint agonist fusion protein; formerly Ducentis DS-234)
  • Targeting atopic dermatitis. IND submitted July 2025; Phase 1 study anticipated to begin in Q1 2026.
• ARQ-252 and ARQ-255 (ivarmacitinib formulations)
  • ARQ-252 (topical) for hand eczema and vitiligo: Phase 1/2b did not meet primary endpoint; development terminated.
  • ARQ-255 (topical JAK1 inhibitor for alopecia areata): Phase 1b completed mid-2025; further development halted.
• Strategy
  • Focus on in-licensing and acquiring dermatology and inflammation & immunology assets; no in-house discovery program.

Key partnerships and collaborations

• Kowa Promotion Agreement (US)
  • Exclusive marketing/promotion for ZORYVE through July 2029; terminated Jan 23, 2026. Kowa ceased sales and promotions and no further payments are due.
• Sato Pharmaceutical (Japan)
  • Exclusive license for roflumilast formulations in Japan; upfront $25.0 million; potential milestones (up to $10.0M regulatory; up to $30.0M sales milestones); tiered royalties.
• Huadong (Greater China & Southeast Asia)
  • Exclusive license for roflumilast topical products in Huadong territories; upfront net $27.0 million (Sept 2023) and additional payments in Dec 2024, Mar 2025, and Nov 2025; potential up to $15.0M development/regulatory and up to $40.3M sales milestones; tiered royalties in the low double-digits to high-teens.
• AstraZeneca (AZ-Licensed Products)
  • Exclusive worldwide license to roflumilast topical products for dermatology; upfront $1.0M and several milestone payments (including $7.5M for FDA approval of ZORYVE 0.3% in Aug 2022, plus later sales-related milestones). Royalties on net sales in a low-to-high single-digit range with certain termination provisions and a potential termination fee of $11.3M under specified conditions.
• Jiangsu Hengrui Medicine (Hengrui)
  • Exclusive option/license for ivarmacitinib in specified territories (initially US, Japan, UK, EU; later expanded to Canada). Ongoing development obligations; potential milestones up to $20.5M (development/regulatory) and up to $200.0M (sales); tiered royalties and rights of first negotiation/ROFR on related products.
• Ducentis Biotherapeutics (ARQ-234)
  • ARQ-234 acquired in 2022; potential contingent payments up to approximately $400M plus mid-single-digit to higher percentages of net sales on certain milestones; none recognized as of 12/31/2025.

Financial snapshot (highlights)

• Employees: 354 full-time employees as of 12/31/2025.
• Net loss: approximately $16.1 million for the year ended 12/31/2025.
• Accumulated deficit: $1,138.1 million as of 12/31/2025.
• Cash and liquidity: $221.0 million in cash, cash equivalents, and marketable securities as of 12/31/2025.
• Debt: $100.0 million outstanding under the Loan Agreement with SLR Investment Corp. as of 12/31/2025; loan matures Aug 1, 2029.
• Recent liquidity actions: 2024 partial prepayment of $100.0 million with associated penalties and final fee; potential drawdowns of up to $50M each for tranche C-1 and C-2 subject to revenue conditions.

Commercial operations

• Built an in-house sales and marketing infrastructure in the US and Canada.
• Kowa termination in Jan 2026 affected promotional activities; Canada commercialization continues while other markets are accessed through partners.

Market position and opportunities

• Estimated addressable US market for actively prescription-treated patients across plaque psoriasis, seborrheic dermatitis, and atopic dermatitis: approximately 17.0 million patients.
  • About 8.4 million treated in dermatology offices and 8.6 million treated outside dermatology.
  • Of those treated in dermatology offices, approximately 3.7 million are covered by Medicare/Medicaid and about 4.7 million by private payers.

Intellectual property

• Extensive patent portfolio around roflumilast cream and foam: 64 issued US and foreign patents and 107 pending foreign applications. Orange Book listings include roflumilast 0.15% and 0.3% cream and roflumilast 0.3% foam.
• ARQ-234 patents cover CD200R-related proteins, including an issued US patent through 2038 (subject to potential extensions).
• Patent expirations and term restoration considerations include potential Hatch-Waxman extensions and UPC-related issues in Europe.

Corporate background

• Founded in 2016 (originally Arcutis, Inc.; renamed Arcutis Biotherapeutics, Inc. in 2019).
• Headquartered in Westlake Village, California: 3027 Townsgate Road, Suite 300, Westlake Village, CA 91361.

Capital structure and governance

• Public company with financing options that include equity and debt to fund operations. The company has undergone transitions in commercial strategy and governance practices as a public company.

Core business

• Develops and commercializes dermatology-focused therapies, primarily topical roflumilast (a PDE4 inhibitor) marketed under the ZORYVE brand across multiple indications: plaque psoriasis, seborrheic dermatitis, and atopic dermatitis.
• Expands the pipeline through strategic collaborations and in-licensing, with ARQ-234 as the leading biologics program.
• Manages global reach through licensing and collaboration agreements for Japan, Greater China, Southeast Asia, and other markets while maintaining U.S. and Canada commercialization capabilities.