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Jun 30, 2021
Arcutis Q2 2021 Earnings Report
Arcutis reported financial results for the second quarter of 2021 and provided a business update.
Key Takeaways
Arcutis Biotherapeutics reported a net loss of $42.0 million for the quarter ended June 30, 2021. The company's cash, cash equivalents, and marketable securities totaled $410.9 million as of June 30, 2021, which is expected to fund operations well into 2023. The company is on track to submit NDA and initiated Phase 3 trials.
Anticipates submission of an NDA for topical roflumilast cream as a potential treatment for plaque psoriasis late in the third quarter or early in the fourth quarter of 2021.
Initiated single pivotal Phase 3 trial of topical roflumilast foam in seborrheic dermatitis.
Anticipates initiation of single pivotal Phase 3 trial of topical roflumilast foam in scalp psoriasis in Q3 2021.
Enrolling pivotal Phase 3 trials of topical roflumilast cream in atopic dermatitis.
Arcutis
Arcutis
Forward Guidance
Arcutis believes that its current cash, cash equivalents, and marketable securities will be sufficient to fund its operations well into 2023. Anticipates multiple top-line readouts in 2022.
Positive Outlook
- NDA submission for plaque psoriasis on track.
- Initiation of Phase 3 program of topical roflumilast.
- Multiple top-line readouts in 2022 expected.
- Strong financial position allows building key capabilities.
- Positions well for an exciting next 18 months.
Challenges Ahead
- Phase 2 study of ARQ-252 in chronic hand eczema did not meet its primary endpoint.
- Analyses of the study pointed toward inadequate local drug delivery to the skin as a key driver of the lack of efficacy.
- Company announced the termination of the Phase 2a clinical trial evaluating ARQ-252 as a potential treatment for vitiligo, based on the aforementioned analyses of the Phase 2 chronic hand eczema study.
- Reformulation efforts are continuing.
- Risks inherent in the clinical development process and regulatory approval process.