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Earnings

Arcutis Raises 2026 ZORYVE Sales Outlook

Third-quarter ZORYVE net product sales reached $143.9 million, and the company lifted full-year net product sales guidance to $535 million–$545 million.

Arcutis Biotherapeutics (ARQT), a commercial-stage biopharmaceutical company focused on immuno-dermatology, reported ZORYVE net product sales of $143.9 million for the quarter ended September 30, 2026, up 45% from a year earlier and 11% from the second quarter.

The sequential and year-over-year increases were driven by increasing demand across products, the company said. Growth slowed from the second quarter, when ZORYVE sales of $129.9 million rose 59% year over year and 23% sequentially. Arcutis raised full-year 2026 net product sales guidance to $535 million–$545 million from $525 million–$540 million.

Product revenue of $143.9 million compared with $99.2 million in the year-ago quarter. All products grew. ZORYVE topical foam 0.3% contributed $75.1 million, cream 0.3% $37.8 million, cream 0.15% $27.3 million, and cream 0.05% $3.7 million. The company attributed the year-over-year and quarter-over-quarter increases predominantly to increased unit demand and modest improvements in gross-to-net deductions.

Cost of sales was $12.5 million, up from $8.7 million a year earlier, due to increasing ZORYVE sales volume. Research and development expenses were $22.4 million versus $19.6 million a year earlier, primarily from ARQ-234 clinical development and medical-affairs investment. Selling, general, and administrative expenses were $99.6 million versus $62.4 million a year earlier, driven by greater marketing spend including the Skin to Believe In campaign and personnel costs from the dermatology sales-force expansion and launch of primary-care and pediatric sales teams.

Net income was $8.8 million, or $0.07 basic and $0.06 diluted a share, compared with $7.4 million, or $0.06 basic and diluted, a year earlier. Net cash provided by operating activities was $18.9 million in the third quarter. Cash, cash equivalents, restricted cash, and marketable securities were $259.8 million as of September 30, 2026, versus $221.3 million as of December 31, 2025.

President and chief executive officer Frank Watanabe said ZORYVE continues to lead the branded non-steroidal topical segment and that the company is well positioned to drive continued growth with a potential FDA approval of ZORYVE cream 0.05% for infants as young as 3 months in the first quarter of 2027, indication-expansion trials, and the ARQ-234 Phase 1 trial.

The FDA has set a target action date of February 23, 2027, for the supplemental New Drug Application to expand ZORYVE cream 0.05% for mild to moderate atopic dermatitis to infants aged 3 to 24 months. Arcutis initiated a pivotal Phase 3 trial with ZORYVE cream 0.3% for moderate to severe atopic dermatitis in adults and children, distinct from the existing 0.15% mild-to-moderate indication. It remains on track to disclose topline results from the Phase 2 study of ZORYVE foam 0.3% in vitiligo and a decision on program advancement by the end of 2026, and expects hidradenitis suppurativa Phase 2 results and an advancement decision in the first quarter of 2027.

The company launched the Skin to Believe In awareness campaign with gymnast Simone Biles. It appointed Rob Lisicki as chief commercial officer effective November 4, 2026, and added Rob Scott, MD, to the board in October 2026.

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