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Dec 31, 2022
Arcutis Q4 2022 Earnings Report
Arcutis reported net revenues for ZORYVE driven by unit demand and expanded commercial payer coverage. Positive topline results were announced from Phase 3 trials in atopic dermatitis, and an NDA was submitted for roflumilast foam for seborrheic dermatitis.
Key Takeaways
Arcutis Biotherapeutics, Inc. reported financial results for Q4 and full year 2022. ZORYVE net revenues were $3.0 million for the quarter. The company has a strong financial position with approximately $410 million in cash, cash equivalents, and marketable securities.
Net revenues of $3.0 million for ZORYVE in the first full quarter since launch, driven by unit demand growth.
Expanded commercial payer coverage for ZORYVE in plaque psoriasis with the second of the top three pharmacy benefit managers in the U.S., as well as an additional national health plan.
Positive topline results were announced from INTEGUMENT-1 and INTEGUMENT-2, the two pivotal Phase 3 trials in individuals with atopic dermatitis ages 6 years and older.
Submitted New Drug Application (NDA) for roflumilast foam for the treatment of seborrheic dermatitis in adults and adolescents.
Arcutis
Arcutis
Forward Guidance
Arcutis anticipates potential FDA approval for ZORYVE for expanded indication in children in Q4 2023 and potential FDA approval for roflumilast foam at the end of 2023.
Positive Outlook
- Continued patient demand growth and penetration into the topical steroid market as formulary coverage builds.
- Submitting a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for ages 6 and above in the second half of 2023.
- Potential FDA approval in the fourth quarter of 2023 for ZORYVE for an expanded indication for the treatment of plaque psoriasis in children down to 2 years of age.
- Anticipates submitting an sNDA for scalp and body psoriasis to the FDA in the first quarter of 2024, following the potential approval of roflumilast foam for seborrheic dermatitis.
- Company continues its reformulation efforts to develop an enhanced formulation of ARQ-252 that delivers more active drug to targets in the skin.
Challenges Ahead
- Risks inherent in the clinical development process and regulatory approval process.
- Uncertainty of future commercial sales and related items that can impact net sales.
- Ability to defend intellectual property.
- Timing of regulatory filings.
- Timing, expenses and success of commercialization efforts