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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

MetricQ3 2024Q2 2025Q3 2025Q3 2025 vs Consensus*
Revenue ($m)$44.8 $81.5 $99.2 $99.2 vs $87.0 → Beat*
Diluted EPS ($)$(0.33) $(0.13) $0.06 $0.06 vs $(0.09) → Beat*
Net Income ($m)$(41.5) $(15.9) $7.4

Note: Consensus values marked with an asterisk (*) are from S&P Global.

Profitability and Margins (sequential view)

MetricQ2 2025Q3 2025
Gross Profit Margin %90.81%*91.25%*
Income (Loss) from Operations ($m)$(14.6) $8.5
Net Income Margin %(19.49%)*7.47%*
Total Operating Expenses ($m)$96.1 $90.7

Note: Margin values marked with an asterisk (*) are from S&P Global.

Product Mix Detail

Product Revenue ($m)Q2 2025Q3 2025
ZORYVE cream 0.3%$27.7 $30.5
ZORYVE cream 0.15%$14.6 $18.9
ZORYVE topical foam 0.3%$39.2 $49.8
Total$81.5 $99.2

Select KPIs

KPIQ3 2025
Total prescriptions (TRx) growth q/q+13%
TRx growth y/y+92%
4-week avg weekly scripts (peak)>17,000
Foam revenue growth vs Q2>+25%
GTN commentLimited improvement expected in Q4 vs Q3

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Net product revenueFY2026$455–$470m New
Cash flow breakevenTimingFY2026Q4 2025 Pulled forward
Gross-to-net trendQ4 2025Only nominal improvement vs Q3 Commentary
Peak sales narrative (ZORYVE)LT$2.6–$3.5B potential across current/future indications Long-term framework

Earnings Call Themes & Trends

TopicPrior Two Quarters (Q1–Q2 2025)Q3 2025Trend
Steroid conversion/market shareEmphasized ZORYVE non-steroidal adoption; broad PBM/Medicaid coverage ramping Intensifying “steroid stewardship” tailwind; ZORYVE ~half of branded topicals; share aspiration 15–20% Strengthening tailwind
Gross-to-net dynamicsGTN in the 50s; improving for 0.15% AD cream in 2025 Q3 uplift from patients hitting deductibles; limited GTN improvement expected in Q4 GTN stable near-term
Access expansionThree largest PBMs covering portfolio; expanding Medicaid Working to expand Medicaid further; aiming for Medicare in future Coverage broadening
Label/indication expansionPDUFA for Foam scalp/body (May) and pediatric AD 0.05% (Oct) FDA approved pediatric AD 2–5; launch late Oct Executing on label growth
Pipeline (ARQ-234)IND planned 2025 IND submitted; first-in-human start early 2026; CD200R agonist rationale and differentiation vs prior mAb efforts Advancing to clinic
Lifecycle managementEarly PoC in vitiligo/HS planned Phase 2a PoC enrolled/initiating (n≈20 each) leveraging pleiotropic PDE4 MOA Building optionality

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

Metric ($m)Q3 2024Q2 2025Q3 2025
Revenues44.8 81.5 99.2
Cost of Sales5.5 7.5 8.7
R&D19.5 19.5 19.6
SG&A58.8 69.2 62.4
Total Opex83.8 96.1 90.7
Income (Loss) from Operations(39.1) (14.6) 8.5
Other Income (Expense), net(2.5) (0.9) (1.0)
Net Income (Loss)(41.5) (15.9) 7.4
Diluted EPS ($)(0.33) (0.13) 0.06

Q3 2025 vs S&P Global Consensus

MetricActualConsensus*Surprise
Revenue ($m)99.2 87.0*+12.2
EPS ($)0.06 (0.09)*+0.15

Note: Consensus figures marked with an asterisk (*) are values retrieved from S&P Global.