Tuesday's market closing saw Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT) announce its financial results, and the company's stock price spiked significantly as a consequence. ARQT's shares increased 22.88% to $9.99 in the after-market trading, extending its regular session gain of 1.75% that ended at $8.13.
Table of Contents
Toggle- Outstanding Growth Propelled By ZORYVE's Release
- Financial Overview And Strategic Developments
- Regulatory Progress And Future Outlook
Outstanding Growth Propelled By ZORYVE's Release
With the successful introduction of ZORYVE foam for seborrheic dermatitis and the ongoing expansion of ZORYVE cream for the treatment of psoriasis, Arcutis Biotherapeutics announced a strong first quarter performance. This triumph underscores the need for inventive, non-steroid therapeutic alternatives and the robust physician uptake of ZORYVE's assortment.
$15.0 million from ZORYVE (roflumilast) cream and $6.5 million from ZORYVE (roflumilast) topical foam accounted for the company's $21.6 million in product revenues. Revenue growth was driven by strong unit demand and improvements in GTN sales deductions.
Financial Overview And Strategic Developments
In the first quarter of 2024, Arcutis Biotherapeutics recorded other sales of $28.0 million, which were ascribed to upfront and milestone payments from licence and cooperation agreements with Huadong Pharmaceutical and Sato Pharmaceutical. Demand for ZORYVE cream in treating plaque psoriasis continues to grow, with over 208,000 prescriptions filled to date by nearly 12,000 unique prescribers, reflecting high patient and physician satisfaction.
The cream is covered by the three largest Pharmacy Benefit Managers and several other commercial insurers, with Medicare and Medicaid coverage anticipated to begin in 2024. The company experienced a significant improvement in GTN in the first quarter compared to Q4 2023 and expects further improvements throughout 2024 as the GTN for the cream approaches a steady state.
Regulatory Progress And Future Outlook
The FDA has authorized Arcutis Biotherapeutics' supplemental new drug application (sNDA) for roflumilast cream 0.15% to treat mild to moderate atopic dermatitis in adults and children six years of age and older. The PDUFA target action date is set for July 7, 2024.