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Dec 31, 2020
Arcutis Q4 2020 Earnings Report
Arcutis reported financial results for Q4 2020, highlighting progress in clinical trials and pipeline development.
Key Takeaways
Arcutis Biotherapeutics reported a net loss of $34.0 million for Q4 2020, with R&D expenses increasing to $27.4 million due to the initiation of multiple clinical trials. The company's cash, cash equivalents, restricted cash and marketable securities were $286.0 million as of December 31, 2020, which, combined with proceeds from a recent equity offering, is expected to fund operations into 2023.
NDA submission for topical roflumilast cream in plaque psoriasis anticipated in the second half of 2021.
Positive Phase 3 data on topical roflumilast cream in plaque psoriasis reported in February.
Advancing topical roflumilast into Phase 3 programs for atopic dermatitis, seborrheic dermatitis, and scalp psoriasis during 2021.
Strong financial position with over $470 million in cash, cash equivalents and marketable securities, providing cash runway into 2023.
Arcutis
Arcutis
Forward Guidance
Arcutis anticipates a transformational year in 2021, with plans to submit an NDA for topical roflumilast cream for plaque psoriasis and advance three additional programs into pivotal Phase 3 trials.
Positive Outlook
- NDA submission for topical roflumilast cream as a potential treatment for plaque psoriasis anticipated in the second half of 2021.
- Pivotal Phase 3 trials in patients with atopic dermatitis (INTEGUMENT-1 and INTEGUMENT-2) initiated in January 2021 with topline data anticipated in the second half of 2022.
- Advancement of seborrheic dermatitis into Phase 3 development, anticipating initiation of a single pivotal Phase 3 study (STRATUM) in the second or third quarter of 2021, with topline data anticipated in the second or third quarter of 2022.
- Initiation of a Phase 2a study in vitiligo in the first quarter of 2021.
- Completion of enrollment of the ongoing Phase 1/2b study in chronic hand eczema, with topline data anticipated by mid-2021.
Challenges Ahead
- Risks inherent in the clinical development process and regulatory approval process.
- Uncertainties related to the timing of regulatory filings.
- Potential challenges in defending intellectual property.
- The company's actual results may differ materially from forward-looking statements due to various risks and uncertainties.
- Pending discussions with regulators, the Company expects to initiate its Phase 3 program in scalp psoriasis in the second half of 2021, with topline data anticipated in the second half of 2022.