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Arcutis Biotherapeutics, Inc. (ARQT)·Q3 2025 Earnings Summary
Executive Summary
- Strong beat on top line and EPS: ZORYVE net product revenue $99.2m (+22% q/q, +122% y/y) and diluted EPS $0.06 vs S&P Global consensus -$0.09; revenue beat $99.2m vs $87.0m*; drivers were demand growth, ZORYVE Foam launch, and improved gross-to-net .
- Initial FY2026 net product revenue guidance set at $455–$470m; management also pulled forward cash flow breakeven to Q4 2025 from prior 2026, citing operating leverage and GTN dynamics .
- Regulatory momentum: FDA approved ZORYVE cream 0.05% for pediatric AD (ages 2–5) on Oct 6; commercial launch began Oct 30, expanding the addressable market ahead of Q4 seasonality .
- Strategic narrative: management targets 15–20% share of topical steroid prescriptions over time and frames ZORYVE peak sales potential at $2.6–$3.5B across current and potential future indications, underpinning a multi-year growth runway .
Note: Consensus figures marked with an asterisk (*) are values retrieved from S&P Global.
What Went Well and What Went Wrong
What Went Well
- Broad-based growth with operational leverage: revenue +22% q/q to $99.2m and return to GAAP profitability (net income $7.4m; EPS $0.06), with opex down ~$5m sequentially and CFO calling out improving leverage from ZORYVE .
- Commercial execution and GTN: sequential growth aided by strong Foam adoption and improved gross-to-net as patients progressed through deductibles; management expects only nominal GTN improvement in Q4, implying demand is the primary driver into year-end .
- Regulatory/label expansion: FDA approval of ZORYVE cream 0.05% for pediatric AD (2–5) and imminent launch by end of October provide a near-term incremental growth vector .
What Went Wrong
- Continued reliance on GTN patterns: management highlighted that Q3’s non-volume uplift was largely GTN; they cautioned limited further GTN benefit in Q4, which may cap price/mix tailwinds near term .
- SG&A remains elevated y/y due to commercialization investments (Q3 SG&A $62.4m vs $58.8m y/y), though down ~10% vs Q2 on timing; ongoing spend is required to expand prescriber breadth (PCP/pediatrics) .
- Pipeline beyond ZORYVE remains early: ARQ-234 to start clinical in early 2026; lifecycle expansion (vitiligo/HS) in small Phase 2a PoC (n≈20 each), leaving limited near-term clinical catalysts outside ZORYVE label moves .
Financial Results
Headline Results vs Prior Periods and Consensus
Note: Consensus values marked with an asterisk (*) are from S&P Global.
Profitability and Margins (sequential view)
Note: Margin values marked with an asterisk (*) are from S&P Global.
Product Mix Detail
Select KPIs
Guidance Changes
Earnings Call Themes & Trends
Management Commentary
- “We achieved yet another strong quarter with robust net product revenue growth and continued steady growth of prescriptions across all approved formulations and indications for ZORYVE.” — CEO Frank Watanabe .
- “We now expect to achieve cash flow breakeven in the fourth quarter of 2025.” — CFO Latha Vairavan .
- “ZORYVE net product sales…were $99.2 million, reflecting 22% sequential growth and 122% year-over-year growth…driven by…ZORYVE foam 0.3%…and improved gross-to-net pricing.” — Press release .
- “We believe increasing ZORYVE’s share to 15% to 20% of topical steroid prescriptions…is both realistic and achievable.” — CCO Todd Edwards ; echoed by CEO .
- “Drive to potential peak ZORYVE sales of $2.6–$3.5 billion per annum across current and potential future indications.” — Press release/Investor Day .
Q&A Highlights
- Steroid conversion acceleration: Management sees an organic clinician-led shift, supported by SDNP/SDPA statements; Arcutis will lean in via salesforce coverage, access, and targeted marketing .
- Market share glidepath: From ~3% of steroid market today toward 15–20% over 5–10 years, aided by PCP/pediatrics activation and incremental data in hard-to-treat subsets (nail, palmar plantar) .
- ARQ-234 differentiation: Fusion protein targeting native CD200R site with higher affinity and extended half-life vs a prior mAb approach; first clinical study planned early 2026 .
- Vitiligo/HS LCM rationale: Once-daily dosing, potential faster onset (vitiligo), and topical anti-inflammatory for mild/moderate HS to complement systemic therapies; small PoC trials underway .
- Revenue bridge: 13% TRx growth to 22% revenue growth mainly from GTN improvement as patients moved through deductibles; expect stable GTN from Q3 to Q4 .
- Foam vs cream: Limited cannibalization, with Foam capturing new psoriasis starts; economics similar across SKUs .
Estimates Context
- Q3 2025 actual vs S&P Global consensus: Revenue $99.2m vs $87.0m (beat); EPS $0.06 vs -$0.09 (beat)* .
- Q4 2025 outlook (consensus): Revenue ~$109.8m; EPS ~$0.073*; management expects continued strong net sales growth into Q4 driven by demand, with only nominal GTN improvement .
Note: Values marked with an asterisk (*) are retrieved from S&P Global.
Key Takeaways for Investors
- ZORYVE is scaling into a durable, cash-generative franchise: sequential growth (+22%) with a swing to GAAP profitability and breakeven pulled forward to Q4 2025 .
- The steroid-conversion narrative is a material multi-year tailwind; early data show ZORYVE as the leading branded non-steroidal topical, with a plausible path to mid-teens share over time .
- Pediatric AD approval (2–5) and immediate launch expand reach ahead of seasonally stronger periods; expect prescriptions to benefit as access ramps .
- FY2026 sales guide ($455–$470m) anchors a higher revenue base; investors should watch Q4 demand momentum and payer coverage evolution as near-term proof points .
- Mix breadth (Cream/ Foam, multiple strengths/indications) and access strength should mitigate SKU cannibalization risk; growth remains volume-led as GTN normalizes .
- Optionality from lifecycle and pipeline: small, cost-efficient PoCs in vitiligo/HS and a differentiated CD200R agonist (ARQ-234) entering the clinic in 2026 support the medium-term innovation story .
Appendix: Additional Tables
Detailed Income Statement Line Items
Q3 2025 vs S&P Global Consensus
Note: Consensus figures marked with an asterisk (*) are values retrieved from S&P Global.