Arcutis Biotherapeutics (ARQT) 3rd Annual Guggenheim Healthcare Innovation Conference summary

Commercial momentum and 2027 outlook

• 2026 guidance was raised twice; performance was attributed to ZORYVE’s efficacy, safety, tolerability and convenience, the shift from topical steroids, and strong commercial execution.

• 2026 dermatology sales-force expansion is beginning to contribute; primary-care and pediatric teams are being built, with further impact expected in 2027.

• Pediatric approval is expected in late February, with an AD infant indication expected in March; both are anticipated growth catalysts for 2027.

• Q4 2026 is expected to follow typical seasonality as the strongest quarter; limited price impact is expected after reaching steady-state gross-to-net, with volume growth anticipated.

• Simone Biles was named a brand spokesperson to increase awareness of seborrheic dermatitis, eczema and ZORYVE.

Market opportunity

• Branded non-steroidals are expected to represent 10% of the market by year-end, leaving 90% of the opportunity ahead; topical steroids were prescribed 16 times more often last year.

• Management cited $2.3B-$3.5B in peak sales potential and said 15%-20% share could support that range; ZORYVE is expected to generate over $0.5B in 2026.

• AAD pediatric guidelines now prefer non-steroidals over topical steroids due to long-term safety concerns; physician and patient groups petitioned FDA to update steroid labels.

• Current use across seborrheic dermatitis, psoriasis and eczema averages two to three units per patient annually; vitiligo use may be similar or higher, depending on treated body-surface area.

Pipeline and development

• Studies are underway in vitiligo and hidradenitis suppurativa (HS); a phase III study in moderate-to-severe AD was recently announced, with an AD infant indication expected in March.

• Vitiligo phase II results need to show activity in a reasonable number of patients with meaningful magnitude; any efficacy advantage or deeper response could support a best-in-class profile, to be assessed in phase III.

• HS opportunity includes mild patients and adjunctive use with biologics; foam delivery may suit affected areas, while anti-inflammatory, antifibrotic, itch and pain effects could differentiate treatment.

• ARQ-234 phase I multiple-ascending-dose enrollment is underway; a small proof-of-concept study follows, with phase I data planned alongside POC results to guide progression to phase II.

• If ARQ-234 shows activity in AD, other indications may be explored; management characterized the asset as a differentiated approach to AD and potentially other autoimmune disorders.