Arcutis ZORYVE Sales Reach $105.4M in Q1 with Infant sNDA Submission
Arcutis reported Q1 net product revenue for ZORYVE of $105.4 million, marking a 65% year-over-year gain despite a 17% sequential decline due to typical Q1 seasonality, and generated $2.2 million in positive operating cash flow. The company submitted an sNDA for ZORYVE cream 0.05% in infants and initiated a Phase 1 trial for investigational ARQ-234 in atopic dermatitis.
1. Q1 2026 Financial Performance
Arcutis delivered ZORYVE net product revenue of $105.4 million in Q1 2026, up 65% year-over-year but down 17% sequentially due to typical first-quarter patient deductible resets and insurance changes. Operating activities generated $2.2 million in positive cash flow, reflecting ongoing financial discipline.
2. Commercial Expansion and Regulatory Filings
The company completed its dermatology sales force expansion and began building a primary care and pediatrics team led by new head Katie Swolfs. It submitted an sNDA to expand ZORYVE cream 0.05% for infants ages 3 to 24 months and awaits a June 29, 2026 PDUFA date for ZORYVE cream 0.3% in children.
3. Clinical Pipeline Progress
Enrollment concluded in the ZORYVE foam 0.3% MUSE trial for children ages 2 to 11, supporting an upcoming sNDA submission for that age group. Arcutis initiated a Phase 1a/1b first-in-human study of ARQ-234 in healthy volunteers and adults with moderate to severe atopic dermatitis.
4. Strategic Highlights and Future Outlook
ZORYVE cream 0.05% received a strong recommendation in pediatric atopic dermatitis clinical guidelines. Phase 2 proof-of-concept studies in vitiligo and hidradenitis suppurativa remain ongoing, with results expected in late 2026 and early 2027.