Arcutis Raises 2026 Sales Outlook as ZORYVE Revenue Rises 45%
Arcutis Biotherapeutics reported a 45% year-over-year increase in third-quarter product revenue, driven by strong ZORYVE prescription growth, and raised its full-year 2026 sales guidance to $535 million–$545 million. The company achieved GAAP net income of $8.8 million and positive operating cash flow, ending the period with $260 million in liquidity. Commercial expansion and ongoing clinical trials, including atopic dermatitis and vitiligo studies, remain strategic priorities. However, management noted that the outlook faces clinical, regulatory, and commercial risks, including trial outcomes, payer coverage, and competitive pressures.
Arcutis Biotherapeutics reported a 45% year-over-year increase in third-quarter product revenue and raised its 2026 product sales guidance, as prescription growth across the ZORYVE franchise supported continued profitability and positive operating cash flow.
The company now expects 2026 product sales of $535 million to $545 million. It also projected demand-driven, quarter-over-quarter net sales growth in the fourth quarter, while indicating that gross-to-net deductions should remain in the 50% range.
ZORYVE demand lifts quarterly revenue
Arcutis generated $143.9 million in net product revenue for the quarter ended in 2026, up from $99.2 million a year earlier and $129.9 million in the second quarter. Total prescriptions for the ZORYVE portfolio increased 11% sequentially and 34% year over year, reaching approximately 25,000 per week on a rolling four-week basis.
The company is seeking to broaden ZORYVE use through an expanded dermatology sales force and new outreach to primary care and pediatric healthcare providers. Its commercial strategy also includes patient-awareness campaigns, a virtual health platform and AI-enabled tools intended to support prescription fulfillment and patient access.
GAAP net income was $8.8 million, compared with $7.4 million in the prior-year quarter and $15.0 million in the second quarter. Diluted net income per share was $0.06, unchanged from the rounded year-earlier figure and down from $0.11 sequentially.
Operating costs increased alongside the commercial and clinical activity. Selling, general and administrative expense rose 60% year over year to $99.6 million, while research and development expense increased 14% to $22.4 million. Cost of sales was $12.5 million, up 43%, and total operating expense increased 48% to $134.5 million.
Arcutis generated $19 million in net cash from operating activities during the quarter. It ended the period with $260 million in cash, cash equivalents and marketable securities, along with $102 million of net long-term debt. Management said cash generation from ZORYVE would be reinvested in the franchise and the broader development pipeline.
Clinical expansion remains a priority
Arcutis initiated a Phase 3 trial of ZORYVE cream 0.3% in moderate-to-severe atopic dermatitis during the third quarter. A supplemental application for ZORYVE cream 0.05% in infants with atopic dermatitis has a Feb. 23, 2027, target action date under the Prescription Drug User Fee Act.
The company has also fully enrolled a Phase 2 proof-of-concept study of ZORYVE foam 0.3% in vitiligo and expects to make an advancement decision in the fourth quarter of 2026 after considering the Phase 2 data. Phase 2 studies in hidradenitis suppurativa continue to enroll, with an advancement decision expected in the first quarter of 2027.
For its earlier-stage pipeline, Arcutis is enrolling atopic dermatitis patients in the multiple-ascending-dose portion of a Phase 1a/1b study of ARQ-234. The company is also pursuing development activities involving nail-affected plaque psoriasis, itch and cutaneous adverse events associated with PD-(L)1 therapies.
The outlook remains subject to clinical, regulatory and commercial uncertainties. Arcutis identified trial enrollment and outcomes, regulatory timing, payer coverage, gross-to-net management, market acceptance, manufacturing dependence and competition among the factors that could cause actual results to differ from its expectations.
This article may include AI-generated content that is human-reviewed, which is for reference and general information purposes only and does not constitute investment advice.
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