Arcutis Reports Q3 2024 Financials and Business Update

Arcutis Biotherapeutics, Inc., a company focused on immuno-dermatology, released its financial results for the quarter ending September 30, 2024, with significant revenue growth and updates on various programs. The company's total net product revenues for the ZORYVE® franchise reached $44.8 million. This included $22.0 million from ZORYVE cream 0.3%, $20.3 million from ZORYVE topical foam 0.3%, and $2.5 million from ZORYVE cream 0.15%. This reflects a 452% increase compared to the third quarter of 2023 and a 45% increase from the second quarter of 2024.

ZORYVE cream, a potent phosphodiesterase-4 (PDE4) inhibitor, has been well-received in the market for treating plaque psoriasis and atopic dermatitis. The cream has seen growing demand with over 304,000 prescriptions filled by more than 14,000 unique prescribers. The product is covered by the largest Pharmacy Benefit Managers (PBMs) and several commercial insurers. Medicaid coverage expanded to states such as Michigan, Arizona, California, and Indiana. The GTN improvement for ZORYVE cream 0.3% is approaching a steady state.

The company also achieved FDA approval for ZORYVE cream 0.15% for mild to moderate atopic dermatitis in adults and children aged six and above. Launched commercially at the end of July, it is covered by two of the largest national PBMs, with further coverage improvements expected.

ZORYVE foam, designed for topical application in hair-bearing areas, has also shown progress. With over 168,000 prescriptions filled since its launch, it addresses the significant unmet need in seborrheic dermatitis treatment. The foam sees steady coverage improvement and favorable GTN metrics. An sNDA for ZORYVE foam for scalp and body psoriasis has been submitted to the FDA, with a PDUFA action date of May 22, 2025. Health Canada approved the foam for seborrheic dermatitis on October 18, with a commercial launch expected by the end of 2024.

Arcutis’ pipeline includes ARQ-255, a topical suspension formulated to treat alopecia areata. The company completed enrollment for a Phase 1b study for ARQ-255 in September 2024, with data expected in the first half of 2025. Additionally, ARQ-234, a fusion protein being developed for atopic dermatitis, is progressing towards an Investigational New Drug Application (IND) in 2025.

Corporate highlights include a co-promotion agreement with Kowa Pharmaceuticals America, Inc. to market ZORYVE products to primary care practitioners and pediatricians. The $200 million term-loan with SLR Investment Corp. was amended, reducing the interest rate and extending the maturity to 2029. Arcutis also obtained new U.S. patents related to ZORYVE and ARQ-255 formulations.

Financially, Arcutis reported $44.8 million in product revenues for Q3 2024, compared to $8.1 million for the same period in 2023. The cost of sales was $5.5 million, while R&D expenses decreased to $19.5 million from $26.2 million year-over-year. SG&A expenses rose to $58.8 million from $47.6 million, attributed to sales and marketing costs for the ZORYVE launches. The net loss was $41.5 million, or $0.33 per share, compared to a net loss of $44.8 million, or $0.73 per share, in the same period the previous year. The company had $331.2 million in cash and equivalents as of September 30, 2024.

Arcutis is optimistic about future revenue growth, expansion into new markets, and the continued development of its pipeline. The company is positioned strongly with a robust balance sheet to support its growth trajectory.