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Arcutis Biotherapeutics, Inc.: Q4 FY2025 earnings call

What management said about Q4 FY2025, from the documents filed with the SEC on 25 February 2026: press release. Guidance figures: 1 raised. The quarter’s numbers.

Key takeaways

  • Q4 net product revenue up 84%: ZORYVE net product revenue was $127.5 million in the fourth quarter, up 84% from a year earlier and 29% from the third quarter. Total revenues were $129.5 million. Source
  • Full-year net product revenue up 123%: Full-year 2025 ZORYVE net product revenue was $372.1 million, up 123% on 2024. Total revenues were $376.1 million, against $196.5 million in 2024. Source
  • Pediatric cream launched for ages 2 to 5: ZORYVE cream 0.05% launched for atopic dermatitis in children aged 2 to 5 after FDA approval in early October 2025. Source
  • Fourth-quarter net income reported: Fourth-quarter net income was $17.4 million, or $0.13 per diluted share, against a $10.8 million net loss a year earlier. Source
  • Quarterly cash inflow, full-year use: Operating cash flow was $26.2 million in the fourth quarter, while net cash used in operating activities was $5.6 million for the full year 2025. Source
  • INTEGUMENT-INFANT positive topline results: The Phase 2 INTEGUMENT-INFANT trial of ZORYVE cream 0.05% in children aged 3 to 24 months with mild to moderate atopic dermatitis reported positive topline results. Source

“successful execution across multiple product launches that leveraged ZORYVE’s differentiated profile, and early penetration into the large topical steroid market”

Frank Watanabe, president and chief executive officer of Arcutis

Guidance

AreaPeriodFigureAgainst last quarter
Net product revenue Sourcefull year 2026$480 million - $495 millionRaised from $455 million - $470 million

What changed from last quarter

  • Guidance raised: Full-year 2026 net product revenue guidance raised to $480 million - $495 million from $455 million - $470 million. Source
  • Ended: Promotion agreement with Kowa terminated by mutual agreement in January 2026. Source
  • New: Dermatology sales force expansion announced to optimize prescriber targeting and call frequency. Source
  • New: Positive topline results reported for the INTEGUMENT-INFANT Phase 2 study of ZORYVE cream 0.05% in ages 3 to 24 months. Source
  • New: Medicare access secured from January 2026; about one in three Medicare patients now have non-preferred access. Source
  • New: Positive operating cash flow reported for the fourth quarter, with $26.2 million from operations. Source
  • New: sNDA accepted for ZORYVE cream 0.3% in plaque psoriasis down to age 2, with a PDUFA date of June 29, 2026. Source
  • New: Amit Munshi appointed to the Board of Directors in December 2025, following the retirement of Bhaskar Chaudhuri. Source

Revenue and growth drivers

  • Q4 net product revenue up 84%: ZORYVE net product revenue was $127.5 million in the fourth quarter, up 84% from a year earlier and 29% from the third quarter. Total revenues were $129.5 million. Source
  • Full-year net product revenue up 123%: Full-year 2025 ZORYVE net product revenue was $372.1 million, up 123% on 2024. Total revenues were $376.1 million, against $196.5 million in 2024. Source
  • Sequential growth from demand and pricing: Management attributes sequential growth to higher demand across products and better gross-to-net pricing. Source
  • 2024 other revenue lifted by Sato payment: Other revenue was $4.0 million in 2025 against $30.0 million in 2024, when a $25.0 million Sato Japan upfront payment was recorded. Source

Products, customers and market access

  • Pediatric cream launched for ages 2 to 5: ZORYVE cream 0.05% launched for atopic dermatitis in children aged 2 to 5 after FDA approval in early October 2025. Source
  • Third-quarter product revenue split: Third-quarter 2025 revenue was $30.5 million for cream 0.3%, $18.9 million for cream 0.15% and $49.8 million for foam 0.3%. The fourth-quarter split was not given.
  • Golfer joins seborrheic dermatitis campaign: Max Homa, a six-time PGA Tour winner, joined the Free to Be Me Awareness campaign for individuals with seborrheic dermatitis. Source

“We enter the next phase of our growth with a solid cash position and the resources to invest both in ZORYVE’s continued growth and expansion”

Frank Watanabe, president and chief executive officer of Arcutis

Commercial model and sales coverage

  • Targeted primary care and pediatric effort: The company started a targeted commercialization effort for primary care and pediatric providers, separate from the expanded dermatology sales force. Source
  • Company takes over Kowa promotion: After ending the Kowa promotion agreement, the company plans to sell and promote ZORYVE itself in pediatric and primary care settings using a targeted team. Source
  • Dermatology sales force expanded: The company expanded its dermatology sales force to improve prescriber targeting and call frequency, aiming to deepen ZORYVE adoption. Source

Costs and profitability

  • Cost of sales rose with volume: Cost of sales was $11.7 million in the fourth quarter, up from $6.9 million, with the company tying the increase to ZORYVE sales volume. Source
  • R&D rose on roflumilast programs: R&D was $20.5 million in the fourth quarter, up from $14.5 million, reflecting higher clinical development and medical affairs costs for roflumilast. Source
  • SG&A rose on ZORYVE commercial spend: SG&A was $79.0 million in the fourth quarter against $57.6 million a year earlier, mainly from higher sales and marketing spend for ZORYVE. Source
  • Fourth-quarter net income reported: Fourth-quarter net income was $17.4 million, or $0.13 per diluted share, against a $10.8 million net loss a year earlier. Source
  • Full-year net loss: The full-year 2025 net loss was $16.1 million, or $0.13 per basic and diluted share, compared with $140.0 million in 2024. Source

Cash, liquidity and balance sheet

  • Quarterly cash inflow, full-year use: Operating cash flow was $26.2 million in the fourth quarter, while net cash used in operating activities was $5.6 million for the full year 2025. Source
  • Cash and securities lower year over year: Cash, equivalents, restricted cash and marketable securities were $221.3 million at December 31, 2025, against $228.6 million a year earlier and $191.4 million at September 30, 2025. Source
  • Trade receivables rose year over year: Trade receivables, net, were $146.2 million at December 31, 2025, up from $73.1 million a year earlier, alongside inventories of $22.6 million. Source

Pipeline and regulatory milestones

  • INTEGUMENT-INFANT positive topline results: The Phase 2 INTEGUMENT-INFANT trial of ZORYVE cream 0.05% in children aged 3 to 24 months with mild to moderate atopic dermatitis reported positive topline results. Source
  • Foam program decisions due: Decisions on advancing ZORYVE foam 0.3% in vitiligo are expected in Q4 2026, and in hidradenitis suppurativa in Q1 2027. Enrollment continues in both. Source
  • ARQ-234 first patient planned: The company plans to enroll the first patient in the ARQ-234 Phase 1 study, a CD200 receptor checkpoint agonist fusion protein for atopic dermatitis, in Q1 2026. Source
  • Patent extends foam exclusivity: A new U.S. patent on roflumilast foam compositions extends U.S. exclusivity for the foam formulation from 2041 to 2042. Source

Coming up, as management said on 25 February 2026

  • Infant sNDA to be submitted: The company plans to submit an sNDA for ZORYVE cream 0.05% in infants aged 3 to 24 months in Q2 2026. Source
  • Cream 0.3% FDA action date: The PDUFA target action date for the ZORYVE cream 0.3% plaque psoriasis sNDA, which is accepted down to age 2, is June 29, 2026. Source
  • Foam program decisions due: Decisions on ZORYVE foam 0.3% in vitiligo and hidradenitis suppurativa are expected in Q4 2026 and Q1 2027. Source
  • ARQ-234 first patient enrollment: The company is preparing to enroll the first patient in the ARQ-234 Phase 1 study in Q1 2026. Source
  • Positive quarterly operating cash flow: The company anticipates maintaining positive operating cash flow on a quarterly basis going forward. Source

Figures management reported

FigureReported
ZORYVE net product revenue, Q4 2025 Source$127.5 million
ZORYVE net product revenue, full year 2025 Source$372.1 million
ZORYVE cream 0.3% revenue, Q3 2025$30.5 million
R&D expense, full year 2025 Source$77.1 million
PDUFA target action date, ZORYVE cream 0.3% SourceJune 29, 2026
INTEGUMENT-INFANT sNDA submission timing SourceQ2 2026
Trial readout, INTEGUMENT-INFANT Phase 2 SourcePositive topline results
U.S. exclusivity, foam formulation Source2042

Earlier plans management reported on

  • Met: The third-quarter release said the launch would follow FDA approval in early October with a launch by end of October. The fourth-quarter release says the product was launched. Source
  • Not stated: The third-quarter release said the company was preparing to initiate the ARQ-234 Phase 1 study. The fourth-quarter release gives Q1 2026 for first patient enrollment.

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.