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Jun 30, 2022
Arcutis Q2 2022 Earnings Report
Arcutis reported second quarter 2022 financial results and provided a business update.
Key Takeaways
Arcutis Biotherapeutics reported a net loss of $67.4 million for the quarter ended June 30, 2022. The company received FDA approval for ZORYVE and completed enrollment in INTEGUMENT-1.
Received FDA approval for ZORYVE for plaque psoriasis treatment.
Announced positive topline results from Phase 3 trial of roflumilast foam in seborrheic dermatitis.
Completed enrollment in INTEGUMENT-1, a pivotal Phase 3 trial for atopic dermatitis.
Strengthened balance sheet with over $285 million from recent financings.
Arcutis
Arcutis
Forward Guidance
Arcutis anticipates topline clinical data readouts in atopic dermatitis and scalp and body psoriasis later this year, as well as the NDA submission for seborrheic dermatitis early in 2023. The company believes its current cash, cash equivalents, and marketable securities, including the net proceeds from its recent debt financing, will be sufficient to fund its operations into 2024.
Positive Outlook
- Potential for topical drugs in development to address large markets with significant unmet need
- Expectations with regard to the timing of clinical trial results and regulatory events anticipated during 2022
- Anticipated successful commercial launch of ZORYVE in plaque psoriasis
- Cash, cash equivalents, and marketable securities will be sufficient to fund its operations into 2024
- Advancing the Company’s pipeline development initiatives
Challenges Ahead
- Risks inherent in the clinical development process
- Risks inherent in the regulatory approval process
- Uncertainties regarding the timing of regulatory filings
- Uncertainties regarding the timing, expenses and success of commercialization efforts
- Risk of inability to defend intellectual property