Arcutis Biotherapeutics (ARQT) investor relations material

Business performance and growth outlook

• Achieved cash flow positivity, enabling reinvestment in both ZORYVE growth and R&D for new indications and biologics.

• ZORYVE continues strong growth, with peak sales projected at $2.5–3 billion, supported by market size and product profile.

• Strategy set last year is being executed successfully, with the company now self-sustaining and not burning cash.

• Recent quarter saw 65% year-over-year sales growth, despite a 17% sequential decline due to seasonal and weather effects.

• GTN (gross-to-net) favorability is expected to persist through the year, with strong volume growth in Q2.

Pipeline and regulatory catalysts

• FDA approval for ZORYVE in psoriasis for ages 2–5 expected by end of June; atopic dermatitis filing for ages 3–24 months pending, with approval likely early next year.

• Phase II trials for vitiligo and hidradenitis suppurativa (HS) ongoing, with vitiligo data expected by year-end and HS data in early next year.

• ARQ-234, a CD200 checkpoint agonist, is in phase I for atopic dermatitis, with trial progress dependent on dose escalation outcomes.

Market access and payer dynamics

• About one-third of Medicare lives now have access to ZORYVE; further expansion anticipated in January formulary updates.

• Non-preferred formulary status is considered a significant achievement, with little expectation of moving to preferred due to pricing constraints.

• Step edits for ZORYVE are minimal, with some Medicaid and commercial plans already allowing first-line use.

• New indications are typically added to formularies within two months of approval.