Arcutis Biotherapeutics (NASDAQ:ARQT) reported fourth-quarter and full-year fiscal 2025 results highlighted by sharp growth in ZORYVE net product revenue, additional FDA approvals, and an outlook that management said reflects continued momentum alongside stepped-up investment in commercialization and pipeline programs.
2025 growth and updated 2026 outlook
President and CEO Frank Watanabe said 2025 was marked by “tremendous growth and progress,” pointing to expanding prescriptions and market share across ZORYVE’s approved indications in psoriasis, seborrheic dermatitis, and atopic dermatitis. The company characterized ZORYVE as the “number one branded non-steroidal topical treatment” across its approved indications, emphasizing its positioning as a steroid-sparing option.
Management raised 2026 full-year net product revenue guidance to $480 million to $495 million from the prior $455 million to $470 million range. Watanabe said the higher range reflects strong fourth-quarter momentum and planned investments across the franchise. The company also reaffirmed it expects to maintain positive cash flow on a quarterly basis throughout 2026, even as it increases spending on commercialization and pipeline development.
Fourth-quarter performance and seasonality expectations
Chief Commercial Officer Todd Edwards said fourth-quarter net product revenues were $127.5 million, representing 84% year-over-year growth and 29% sequential growth from the third quarter of 2025. Edwards attributed sequential performance primarily to a 19% increase in prescription volume, alongside stronger-than-anticipated price improvement driven by reduced co-pay card utilization as patients met deductibles and out-of-pocket maximums.
Edwards also noted a “very small contribution” from a channel inventory build that accounted for approximately 2%, or $2.5 million, of fourth-quarter revenue, which the company expects to unwind in the first quarter.
Looking ahead, Edwards said Arcutis anticipates a typical first-quarter seasonal decrease versus the fourth quarter, driven largely by patient deductible resets that increase co-pay usage. The company expects gross-to-net to rise to the high 50s in the first quarter before improving through the year and ending with the lowest gross-to-net in the fourth quarter, similar to 2025. Edwards added that demand in January was affected for “a couple weeks” by Winter Storm Fern, contributing to what he described as a more pronounced Q4-to-Q1 step-down than the company saw in 2025.
Market access and competitive positioning
On market access, Edwards said Arcutis does not anticipate “material erosion” in gross-to-net from access-related actions in 2026. He stated that more than 80% of commercially insured patients have access to ZORYVE with “high-quality access,” described as a single step edit through a steroid. He also said the company has “exceptional Medicaid access,” with more than half of the Medicaid patient population able to access ZORYVE with a single step edit or less.
The company also highlighted Medicare Part D formulary wins effective January 1, with Edwards saying roughly one-third of Medicare Part D recipients now have access to ZORYVE. He described ZORYVE as the only branded non-steroidal topical on those Medicare formularies, while noting that it is on a non-preferred tier and that demand could be tempered by higher patient cost-sharing. In Q&A, Edwards said the Medicare out-of-pocket cap in 2026 is $2,100, with coverage thereafter; Watanabe added that the cap applies to total out-of-pocket spending across all drugs and noted an optional “smoothing” approach that spreads costs over the year.
Asked about broader reimbursement dynamics and potential reforms, Watanabe said it is “too early” to predict how changes in Washington could affect the environment, but added that the company believes it is well positioned to keep ZORYVE widely available while generating returns.
Commercial investments: dermatology expansion and move into primary care/pediatrics
Arcutis outlined two commercial initiatives intended to drive growth in 2026. First, Edwards said the company will expand its dermatology specialty sales force by approximately 20% to roughly 160 sales personnel. The stated goal is to increase call frequency among mid-decile prescribers while maintaining engagement with top-decile dermatologists. Edwards said the company expects to begin seeing the impact in the second half of 2026 and anticipates the expansion will be “accretive in the first year” as new hires ramp.
Second, Arcutis said it is building an internal, targeted sales force to promote ZORYVE to primary care physicians and pediatricians. Edwards said the company is taking a stepwise approach, beginning with a limited pilot and an initial team of approximately 30 sales reps and supporting personnel. Management said this effort is additive to the dermatology expansion, and Watanabe indicated it is premature to quantify the 2026 contribution from the primary care initiative given the early-stage rollout.
In Q&A, Watanabe said the company decided to bring primary care and pediatric promotion in-house because Arcutis is now in a financial position to do so and because it believes “when something really matters to you, it’s often best to do it yourself,” while also retaining the economics. He also described the primary care market as large but “diffuse,” and said Arcutis plans to focus on a concentrated group of high-volume prescribers.
R&D updates: infant AD data, pediatric psoriasis filing, and new indications
Chief Medical Officer Patrick Burnett reviewed positive top-line results from the Phase 2 INTEGUMENT-INFANT trial evaluating ZORYVE cream 0.05% in infants aged 3 to less than 24 months with mild-to-moderate atopic dermatitis. Burnett said 58% of participants achieved EASI-75 at week 4, and about one-third achieved EASI-75 by week 2. He reported no treatment-emergent serious adverse events and said only one patient discontinued due to an adverse event.
Burnett said the company plans to submit an sNDA for ZORYVE cream 0.05% in infants in the second quarter and expects to present full trial results at a future medical conference. He also referenced Arcutis’ previously submitted sNDA for ZORYVE cream 0.3% to expand plaque psoriasis treatment to children ages 2 to 5, with a PDUFA date of June 29. If approved, Burnett said, it would be the first topical PDE4 inhibitor indicated for plaque psoriasis in children as young as two.
Beyond life-cycle expansion, Burnett said Phase 2 proof-of-concept studies of ZORYVE foam 0.3% in vitiligo and hidradenitis suppurativa are ongoing. He said Arcutis anticipates reporting a decision on whether to advance the vitiligo program in the fourth quarter of 2026 and an advancement decision in HS in the first quarter of 2027. Burnett also said the company expects to begin dosing patients “very soon” in a Phase 1 trial of ARQ-234, a biologic targeting CD200R.
Financial results and balance sheet
Chief Financial Officer Latha (referred to as “Lata” in the transcript) reported fourth-quarter cost of sales of $11.7 million, R&D expense of $20.5 million, and SG&A expense of $79.0 million. Net income for the quarter was $17.4 million, compared with a net loss of $10.8 million in the prior-year quarter.
For full-year 2025, Arcutis reported:
- Net product revenue: $372.1 million
- Cost of sales: $36.7 million
- R&D expense: $77.1 million
- SG&A expense: $274.6 million
- Net loss: $16.1 million (vs. $140.0 million in 2024)
The company ended 2025 with $221.3 million in cash and marketable securities and reported $26.2 million of positive cash flow from operations for the period. It also reported $108 million in total debt and said it has the option to withdraw an additional $100 million through the middle of 2026.
About Arcutis Biotherapeutics (NASDAQ:ARQT)
Arcutis Biotherapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for immuno-inflammatory skin diseases. The company’s research and development efforts center on targeted treatments that address the underlying biology of conditions such as plaque psoriasis, atopic dermatitis, seborrheic dermatitis and vitiligo. Arcutis employs a precision-medicine approach to deliver topical therapies designed to improve efficacy and tolerability compared with existing treatment options.
In August 2022, Arcutis received U.S.
