Arcutis Delivers Strong ZORYVE Growth and Achieves Profitability, Sets Sights on Expanding Pipeline and Indications

Q3 2025 Sales Jump Over 120%, Propelling Arcutis to First-Ever Profit

Arcutis Biotherapeutics posted a significant inflection in its financial results for the third quarter of 2025, with ZORYVE sales reaching $99.2 million—a 122% increase compared to the prior year and a 22% jump from the previous quarter. This revenue growth, combined with disciplined operating expenses, led to Arcutis' first-ever profitable quarter, recording net income of $7.41 million, or $0.06 per share. The momentum comes on the heels of several key commercial and clinical developments, solidifying ZORYVE as a foundational asset in dermatology.

*NM = Not Meaningful (shift from loss to profit)

Momentum Fueled by ZORYVE Approvals and Expanded Access

ZORYVE continues to carve out a growing presence in immuno-dermatology. Notably, the FDA recently approved ZORYVE cream 0.05% for treating atopic dermatitis in children as young as two, marking a key step in reaching the pediatric market. This, alongside strong launches of ZORYVE foam and sustained commercial execution, underpins the company’s optimism about further market share gains in the highly prescribed topical corticosteroid segment. With over 17 million relevant prescriptions annually, the opportunity for broader uptake remains substantial.

Operational Efficiency Enables Profitable Growth

Arcutis’ rapid sales expansion did not come at the expense of cost discipline. The company held R&D spending flat at $19.60 million compared to the prior year, while SG&A grew modestly to $62.40 million, mainly to support commercialization. With gross-to-net rates stable and a significant uptick in reimbursed prescriptions, profitability emerged much sooner than many anticipated.

Guidance: Full-Year 2026 Sales Forecast Reflects Confidence

Arcutis projects 2026 net product revenue of $455–470 million, pointing to management’s expectation for continued strong growth and broader ZORYVE adoption. Peak annual sales estimates for ZORYVE now range from $2.6 to $3.5 billion based on future indication expansion and market penetration assumptions.

Pipeline Progress: Multiple Opportunities on the Horizon

The company is pushing ahead on multiple development fronts. Enrollment has begun for Phase 2 studies evaluating ZORYVE foam 0.3% in vitiligo and hidradenitis suppurativa, two underserved areas in dermatology. Meanwhile, a Phase 1 study for ARQ-234—a next-generation biologic for atopic dermatitis—is also being prepared, signaling ongoing investment in innovative therapies that build on Arcutis’ expertise.

Key Takeaways: Execution, Growth, and Potential Risks

Arcutis is executing on a clearly articulated growth plan, evidenced by record revenues, positive earnings, and prudent capital management. The business is gaining recognition for both clinical and workplace achievements—recently earning industry awards for ZORYVE and repeated recognition as a top workplace in biotech. Still, risks persist, including clinical trial outcomes, market competition, and reliance on continued commercial execution. Investors and market watchers will want to follow how new indications and future launches sustain this newfound profitability.

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