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Dec 31, 2021
Arcutis Q4 2021 Earnings Report
Arcutis reported financial results for the fourth quarter and full year 2021 and provided a business update.
Key Takeaways
Arcutis Biotherapeutics reported a net loss of $71.3 million for Q4 2021, with cash, cash equivalents, and marketable securities totaling $388.6 million. The company believes its financial resources will fund operations into 2024.
FDA accepted the New Drug Application (NDA) for roflumilast cream for plaque psoriasis in adults and adolescents.
Enrollment completed for the pivotal Phase 3 trial of roflumilast foam in seborrheic dermatitis.
Pivotal Phase 3 trials are ongoing for roflumilast cream in atopic dermatitis and roflumilast foam in scalp and body psoriasis.
Secured $225 million in non-dilutive debt financing, extending cash runway into 2024.
Arcutis
Arcutis
Forward Guidance
Arcutis anticipates multiple Phase 3 clinical data readouts and prepares for potential product launch in 2022.
Positive Outlook
- Topline data from INTEGUMENT-1 and INTEGUMENT-2 are anticipated by the end of 2022.
- Company intends to submit a supplemental New Drug Application (sNDA) for topical roflumilast cream for the treatment of atopic dermatitis patients aged six years or older in 2023 based on the results of INTEGUMENT-1 and -2.
- Topline data from pivotal Phase 3 trial for the treatment of seborrheic dermatitis is anticipated in mid-year 2022.
- Company expects the data to be sufficient basis for an NDA submission in the first half of 2023.
- Topline data from pivotal Phase 3 trial for the treatment of scalp and body psoriasis is anticipated in the second half of 2022.
Challenges Ahead
- Topline data from INTEGUMENT-PED in 2023.
- Company intends to submit a subsequent sNDA for the younger age cohort based on INTEGUMENT-PED following the potential initial atopic dermatitis approval in patients aged six years or older.
- Risks inherent in the clinical development process and regulatory approval process.
- Timing of regulatory filings.
- Timing and expenses of commercialization efforts.