Arcutis Biotherapeutics Inc 2025年度报告
Dear Arcutis Shareholders Since our founding a decade ago, Arcutis has been intently and deliberately focused on advancing meaningfulinnovations in immuno-dermatology. Our notable success to date, including multiple key achievements in 2025,demonstrates our commitment to delivering on this goal for individuals struggling with inflammatory skin diseases. Last year, ZORYVE®(roflumilast) continued to help transform the treatment of chronic inflammatory skin diseases.Our steady drumbeat of new and expanded indications, continued adoption across all three current indications –plaque psoriasis, seborrheic dermatitis, and atopic dermatitis – and our strong execution led to significant prescriptionand net product revenue growth. Underpinning our continued commercial success in 2025 was ZORYVE’s exceptionalutility, the growing confidence in our brand among clinicians and individuals with inflammatory skin diseases, and thebroader treatment shift away from topical steroids. In 2025, we raised the tally of FDA approvals for ZORYVE to six, with approvals of ZORYVE topical foam 0.3% for scalp and body psoriasisin adults and adolescents 12 years of age and older, and ZORYVE cream 0.05% for atopic dermatitis in children ages 2 to 5 years. We alsosubmitted an sNDA for ZORYVE cream 0.3% for psoriasis in children ages 2 to 5 years, with a target action date of June 29, 2026. Additionally,we completed enrollment in our Phase 2 study (INTEGUMENT-INFANT) of ZORYVE cream 0.05% in infants with atopic dermatitis ages 3 monthsto <2 years, and in February 2026, presented positive topline data and announced plans to submit an sNDA in the second quarter of 2026.We reached the critical corporate milestone of cash flow break-even in the fourth quarter of 2025, ahead of schedule as a result of the continuedmomentum of ZORYVE net sales growth combined with our expense discipline. This success enables investment in sustained growth. In 2025, we unveiled a three-pillar framework –grow, expandandbuild– to conceptualize our strategy for maximizing Arcutis shareholder value.We will continue togrowZORYVE as the foundational therapy for our current indications, meeting the increasing demand for safe and effectivetargeted topical therapies that can replace topical steroids. We will further engage with dermatology clinicians, expand into primary care andpediatric providers, and pursue incremental data generation opportunities to bolster ZORYVE’s position for our approved indications. We willexpandthe ZORYVE franchise through strategic life cycle management, leveraging ZORYVE’s pleiotropic mechanism of action, andinvestigate its impact in new inflammatory dermatoses. We are evaluating new potential indications that represent significant unmet needsand where case reports suggest ZORYVE’s unique profile could be beneficial. In 2025, we initiated Phase 2 proof-of-concept studies withZORYVE foam 0.3% in vitiligo and hidradenitis suppurativa, with additional studies planned. Finally, we willbuildout our pipeline by advancing other innovative medicines, leveraging the development and commercialization capabilitieswe have established. For example, in 2025, we submitted an IND application for ARQ-234, a novel biologic with best-in-class potential in atopicdermatitis, and are now underway with the first trial to support that development program. Our many achievements in 2025 strengthened Arcutis’ position as a leading medical dermatology biopharmaceutical firm, created shareholdervalue, and advanced our mission to champion meaningful innovation for individuals impacted by immune-mediated skin conditions. I want tothank the Arcutis team, whose dedication underlies our accomplishments to date and will enable our ambitious plans in the coming years.On behalf of Arcutis, our Board of Directors, and our entire team, thank you for your continued support. Frank Watanabe– President and Chief Executive Officer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