Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) announced its third-quarter 2024 financial results, highlighting substantial revenue growth driven by its ZORYVE (roflumilast) franchise. The company reported net product revenues of $44.8 million for the quarter, a 452% increase compared to the same period in 2023. This growth was fueled by strong demand for ZORYVE cream 0.3% ($22.0 million), ZORYVE topical foam 0.3% ($20.3 million), and ZORYVE cream 0.15% ($2.5 million).
ZORYVE Franchise Performance
The ZORYVE franchise continues to demonstrate robust growth, with a 45% increase in sales compared to the second quarter of 2024. The company also reported continued improvement in gross-to-net (GTN), with blended GTN across products now in the low 50 percent range, an improvement from the high 50 percent range in the previous quarter. Total U.S. franchise unit demand increased by 25% quarter over quarter, reflecting strong prescription growth for both the cream and foam formulations.
Frank Watanabe, president and chief executive officer of Arcutis, stated, "Arcutis continues to execute our strategy successfully, with 45% revenue growth this quarter, marking sequential quarter growth since January of 2023. Product revenue for the quarter was driven by strong demand growth, and product preference by both patients and providers for ZORYVE across our three approved indications, as well as continued improvements in GTN."
Regulatory and Market Expansion
The FDA accepted Arcutis's supplemental New Drug Application (sNDA) for ZORYVE foam for the treatment of scalp and body psoriasis in adults and adolescents ages 12 and over, with a Prescription Drug User Fee Act (PDUFA) action date of May 22, 2025. This regulatory milestone could significantly expand the market for ZORYVE foam.
In addition, Health Canada approved ZORYVE foam for seborrheic dermatitis on October 18, and Arcutis plans to commercially launch the product in Canada by the end of 2024. This marks the first international approval for ZORYVE foam and represents a significant step in expanding the drug's global reach.
Pipeline Development
Arcutis is also advancing its pipeline of innovative therapies. Enrollment is complete in a Phase 1b study evaluating ARQ-255, a topical suspension formulation of ivarmacitinib, for the treatment of alopecia areata. Data from this study is expected in the first half of 2025. ARQ-255 is a potent and highly selective topical Janus kinase type 1 (JAK1) inhibitor designed to preferentially deliver the drug deep into the hair follicle.
The company is also progressing towards submitting an Investigational New Drug Application (IND) in 2025 for ARQ-234, a fusion protein that is a potent and highly selective checkpoint agonist of the CD200 Receptor (CD200R), being developed as a potential biologic treatment in atopic dermatitis.
Financial Position
Arcutis reported having $331.2 million in cash, cash equivalents, restricted cash, and marketable securities as of September 30, 2024, compared to $272.8 million as of December 31, 2023. The company made a partial prepayment of $100 million of the principal on its term loan with SLR Investment Corp. on October 8, 2024, further strengthening its financial position.
