Arcutis Biotherapeutics NASDAQ: ARQT reported first-quarter 2026 net product revenues of $105.4 million, a 65% increase versus the same period last year, as the company pointed to continued demand growth for its topical therapy ZORYVE and progress across a “grow, expand, build” strategy that includes new label-expansion filings, earlier-stage studies in additional dermatology indications, and advancement of a pipeline biologic candidate.
Quarter results show growth despite seasonal and weather headwinds
Chief Commercial Officer Todd Edwards said the quarter’s performance came “despite the customary first quarter seasonality” that affects branded therapies, citing patient deductible resets, insurance transitions, and refill pull-forwards into the fourth quarter. Edwards added that the typical seasonal pattern “was further amplified this year by the impact of severe weather events” across the country.
Edwards said the company believes the weather affected dermatology prescribing broadly, noting that sequential prescription volumes declined across topical categories—including generic-heavy segments such as topical corticosteroids and antifungals—not just branded products. In that context, he said ZORYVE prescriptions declined 6% sequentially in the quarter, compared with a 15% decline for other branded nonsteroidal topicals, contributing to share gains.
According to Edwards, ZORYVE’s share of total branded nonsteroidal topical prescriptions rose to 48% in the first quarter, up three percentage points from the end of 2025. On a rolling four-week average, weekly prescriptions reached about 21,000 per week across indications and formulations, he said.
Looking ahead, Edwards said the company expects quarter-over-quarter net sales growth in the second quarter, driven by patient demand and gross-to-net improvement. He also said that, quarter-to-date through April 24, ZORYVE showed 13% growth versus the first quarter over the same time period.
Gross-to-net trends and 2026 guidance
Management repeatedly emphasized that gross-to-net is expected to remain “in the 50s” during 2026. Edwards said first-quarter gross-to-net improved compared to the year-ago period due to changes in payer contracting—specifically “improvements in formulary status with more preferred versus non-preferred position with some of our commercial plans.” He said preferred positioning typically lowers patient copays, which in turn reduces Arcutis’ copay buydown expenses.
Chief Financial Officer Latha Vairavan said the year-over-year revenue increase was driven primarily by increased demand and also benefited from “lower gross to net in the first quarter of 2026 versus a year earlier,” again attributing the improvement to payer contracting.
Arcutis maintained its full-year 2026 revenue guidance of $480 million to $495 million. When asked about the rationale for not raising guidance, President and CEO Frank Watanabe said the company updated guidance in February and did not intend to revise it every quarter. He added that with what he described as a “slightly anomalous Q1,” management felt it was prudent to hold guidance steady for now.
Commercial investments: dermatology expansion and new primary care/pediatrics team
Watanabe said Arcutis has “essentially completed” an expansion of its dermatology sales force and that the expanded team is in the field “as of this week,” though he cautioned it could take a few months to see an impact on sales. Edwards said Arcutis expects to see the impact of those new representatives beginning in the third quarter, after typical ramp time.
The company is also building a dedicated primary care and pediatric sales team. Edwards said Arcutis hired Katie Swalls as head of the new franchise and described the approach as “high targeted,” focused on high-volume primary care and pediatric clinicians in major metropolitan areas who also have a demonstrated willingness to adopt branded products. The team is expected to launch into the field in the third quarter, with initial demand impact beginning in the fourth quarter, he said.
Edwards also highlighted continued direct-to-consumer activity, pointing to the “Free to Be Me” campaign featuring Tori Spelling, Stella McDermott, and professional golfer Max Homa, which he said has driven meaningful patient engagement and awareness across indications.
Clinical and regulatory updates: infant AD filing, pediatric psoriasis milestones, and itch study
On the clinical front, Watanabe said Arcutis submitted a supplemental NDA in April for ZORYVE cream 0.05% in atopic dermatitis patients aged 3 to 24 months. Chief Medical Officer Patrick Burnett described infants under age 2 as “the most vulnerable patients” with limited approved options, stressing the importance of safe and well-tolerated therapies in that group.
Burnett provided additional details from the INTEGUMENT-INFANT phase II trial and said the company’s abstract was selected for a late-breaker session at the American Academy of Dermatology meeting, presented by Dr. Lawrence Eichenfield. Among the outcomes discussed:
Burnett said “over a third” of participants completing four weeks achieved vIGA-AD success (clear or almost clear with at least a 2-grade improvement).
He said “close to half” achieved a vIGA-AD score of clear or almost clear at week 4, and 24% did so by week 2.
For infants with at least mild scalp involvement at baseline, he said “more than two-thirds” achieved vIGA scalp success at week 4.
Burnett reiterated that 58.3% achieved EASI-75 at week 4, and “three-quarters” achieved EASI-75 at week 2.
Burnett also emphasized itch relief as a differentiating attribute. He said in INTEGUMENT-INFANT, nearly 50% of patients experienced a 25% improvement in itch within 10 minutes of application as measured by caregiver-reported Dynamic Pruritus Score, and two-thirds experienced relief within four hours. Arcutis has initiated a 40-patient trial, INTEGUMENT-ITCH, to further characterize pruritus over time with ZORYVE 0.15% cream in atopic dermatitis.
For pediatric plaque psoriasis, Watanabe and Burnett said the company completed enrollment in a MUSE (maximum use) trial for ZORYVE foam 0.3% in children ages 2 to 11 with scalp and body psoriasis, intended to support a future sNDA to extend labeling to that age group. Burnett also noted that the supplemental NDA for ZORYVE cream 0.3% to extend psoriasis labeling down to age 2 is under FDA review, with a PDUFA action date of June 29.
When asked to quantify the infant AD opportunity, Edwards estimated the addressable population at “about 2 to 2.5 million” patients in that age group, and said Arcutis expects to pursue uptake through both dermatology and the planned primary care/pediatrics team, supported by caregiver-directed outreach.
Pipeline progress: ARQ-234 and phase II programs in vitiligo and HS
Arcutis reported it has initiated a phase I trial for ARQ-234, a biologic targeting CD200R, in healthy volunteers and adults with moderate to severe atopic dermatitis. Burnett said the study includes a single ascending dose portion in healthy volunteers and a multiple ascending dose component followed by a proof-of-concept cohort in atopic dermatitis patients.
The company also continues phase II proof-of-concept efforts to expand ZORYVE into additional indications. Watanabe said Arcutis is nearing full enrollment in vitiligo and continues enrolling in hidradenitis suppurativa (HS). Burnett said the company remains on track to provide vitiligo trial results and a development-plan update in the fourth quarter of 2026, with an HS readout expected in the first quarter of 2027.
Discussing what Arcutis is looking for in those studies, Burnett said the company is assessing ZORYVE’s profile versus current standards of care—pointing in vitiligo to response timing relative to Opzelura and, in HS, to the potential for an effective topical option that could fit earlier in the treatment paradigm or as adjunctive therapy.
Expenses, cash flow, and balance sheet
Vairavan reported first-quarter cost of sales of $9.8 million, compared to $8.8 million a year earlier, reflecting higher sales volume. R&D expense rose to $30.6 million from $17.5 million, primarily due to a $10 million milestone obligation to Ducentis shareholders triggered by dosing the first subject in the ARQ-234 phase I trial.
SG&A expense was $74.1 million, up from $64.0 million in the year-ago quarter, which Vairavan attributed to continued commercialization investment. She said Arcutis expects a modest increase in SG&A in the back half of 2026, driven by headcount-related costs from the dermatology expansion and the primary care/pediatrics build-out. Addressing questions about quarterly cadence, she said the expanded field force began in the second quarter and that costs should “normalize” as those expenses start to flow through.
Arcutis ended the quarter with $224.3 million in cash and marketable securities as of March 31, 2026. Vairavan said the company generated positive operating cash flow, with $2.2 million of net cash provided by operating activities, and reiterated management’s intent to maintain positive cash flow on a quarterly basis throughout 2026 through disciplined investment.
The company reported total debt of $101.5 million and said it has the right to withdraw an additional $50 million “in whole or in part” through mid-2026. Vairavan said Arcutis expects meaningful operating leverage and cash flow expansion in 2027 and beyond as investment needs moderate and ZORYVE sales continue to grow.
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.
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