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Arcutis Biotherapeutics (ARQT)

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Earnings summaries and quarterly performance for Arcutis Biotherapeutics.

Recent press releases and 8-K filings for ARQT.

Arcutis Announces Positive Phase 2 Results for ZORYVE Cream in Infants
ARQT
Product Launch
New Projects/Investments
  • Arcutis Biotherapeutics announced positive topline results from the INTEGUMENT-INFANT Phase 2 study evaluating ZORYVE cream 0.05% in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis.
  • The study demonstrated that 58% of participants achieved a 75% improvement in Eczema Area and Severity Index (EASI-75) with ZORYVE cream 0.05% at Week 4.
  • Investigational ZORYVE cream 0.05% was well tolerated and showed a safety profile consistent with previous studies, with no new safety signals identified.
  • The company plans to submit a supplemental New Drug Application (sNDA) for ZORYVE cream 0.05% for this age group in Q2 2026.
4 days ago
Arcutis Biotherapeutics Terminates Promotion Agreement with Kowa
ARQT
Guidance Update
New Projects/Investments
  • Arcutis Biotherapeutics, Inc. and Kowa Pharmaceuticals America, Inc. mutually agreed to terminate their promotion agreement for ZORYVE® sales and promotion to primary care physicians and pediatricians on January 23, 2026.
  • Arcutis plans to assume responsibility for the sales and promotion of ZORYVE in the primary care and pediatric settings, with further updates to be provided during the Q4 earnings call on February 25, 2026.
  • The company expects to remain cash flow break even and does not anticipate this change will negatively affect its 2026 net product sales guidance.
Jan 26, 2026, 1:00 PM
Arcutis Biotherapeutics Discusses Zoryve Market Strategy, Q3 Performance, and Future Outlook
ARQT
Guidance Update
Product Launch
New Projects/Investments
  • The advanced topical therapy market, including Zoryve, experienced 50% volume growth last year, with Zoryve sales peaks projected at 15-20% market share.
  • Arcutis reported a "phenomenal" Q3 revenue with 22% quarter-over-quarter growth, driven by 13% volume and 9% price. The company expects to be cash flow breakeven starting in Q4 2025 and to sustain this position.
  • Zoryve's pricing strategy has resulted in 80% commercial access with a single step and access for over half of Medicaid recipients, with gross-to-net expected to remain in the 50s.
  • Zoryve recently received approval for AD 2-5 and is pursuing additional pediatric indications, along with new studies in HS and vitiligo. The company holds 23 issued U.S. patents for Zoryve, providing protection for the cream and foam through 2037, and the foam through 2041.
Nov 11, 2025, 1:30 PM
Arcutis Reports Strong Zoryve Growth and Positive Financial Outlook
ARQT
Revenue Acceleration/Inflection
Guidance Update
Product Launch
  • Arcutis's Zoryve is significantly disrupting the inflammatory skin conditions market, achieving 22% quarter-over-quarter revenue growth in Q3, with 80% commercial patient access and over half of Medicaid recipients covered. The company projects sales peaks with 15-20% market share.
  • The company anticipates reaching cash flow breakeven starting in Q4 2025 and sustaining it, with gross to net expected to remain in the 50s. Q4 is projected to show strong volume growth.
  • Recent approval for Zoryve in pediatric atopic dermatitis (AD 2-5) and ongoing studies for psoriasis (2-5) and younger AD patients (3-24 months) open substantial market opportunities. Arcutis is also expanding Zoryve into new indications like HS and vitiligo, and advancing its ARQ 234 program.
  • Zoryve is protected by 23 issued U.S. patents, ensuring coverage for the cream and foam through 2037, and the foam specifically through 2041.
Nov 11, 2025, 1:30 PM
Arcutis Biotherapeutics Reports Strong Zoryve Growth and Anticipates Q4 2025 Cash Flow Breakeven
ARQT
Guidance Update
Product Launch
Revenue Acceleration/Inflection
  • Arcutis Biotherapeutics (ARQT) reported 22% quarter-over-quarter revenue growth in Q3, driven by 13% volume and 9% price, with expectations for continued volume growth in Q4.
  • The company anticipates achieving cash flow breakeven starting in Q4 2025 and plans to sustain this, with reinvestment focused on Zoryve, life cycle management, and ARQ 234.
  • Zoryve maintains strong market access, covering 80% of commercial patients and over half of Medicaid recipients, attributed to its "orthogonal pricing strategy".
  • Arcutis is expanding Zoryve's market into pediatrics with recent approval for AD 2-5 and ongoing studies for psoriasis 2-5 and AD 3-24-month-old patients, addressing a significant unmet need.
  • The intellectual property portfolio for Zoryve is robust, featuring 23 issued U.S. patents that protect the cream and foam through 2037, and the foam specifically through 2041.
Nov 11, 2025, 1:30 PM
Palvella Therapeutics Reports Q3 2025 Financial Results and Pipeline Updates
ARQT
Earnings
Guidance Update
New Projects/Investments
  • Palvella Therapeutics reported cash and cash equivalents of $63.6 million as of September 30, 2025, which are expected to fund operations into the second half of 2027.
  • For the third quarter ending September 30, 2025, the company reported a net loss attributable to common stockholders of $11.3 million, or $1.03 per basic and diluted share.
  • Top-line results for the fully enrolled Phase 2 TOIVA trial evaluating QTORIN™ rapamycin for cutaneous venous malformations are anticipated in mid-December 2025, and for the Phase 3 SELVA trial for microcystic lymphatic malformations in the first quarter of 2026.
  • Palvella expanded QTORIN™ rapamycin's development into clinically significant angiokeratomas and announced a new product candidate, QTORIN™ pitavastatin, for disseminated superficial actinic porokeratosis, with Phase 2 study initiations for both anticipated in the second half of 2026.
Nov 11, 2025, 12:30 PM
Arcutis Biotherapeutics Launches ZORYVE Cream 0.05% for Pediatric Atopic Dermatitis
ARQT
Product Launch
New Projects/Investments
  • Arcutis Biotherapeutics has commercially launched ZORYVE cream 0.05% for the treatment of mild to moderate atopic dermatitis in children ages 2 to 5 years in the United States.
  • This once-daily, steroid-free topical treatment provides rapid clearance of atopic dermatitis, can be used anywhere on the body for any duration, and offers long-term disease control.
  • The U.S. Food and Drug Administration (FDA) approved ZORYVE cream 0.05% on October 6, 2025, and it will be available in pharmacies this week.
  • Atopic dermatitis is the most common type of eczema, affecting approximately 9.6 million children in the U.S..
  • The most common adverse reactions reported for ZORYVE cream 0.05% in pediatric patients 2 to 5 years of age include upper respiratory tract infection (4.1%), diarrhea (2.5%), and vomiting (2.1%).
Oct 30, 2025, 12:00 PM
Arcutis Biotherapeutics Reports Strong Q3 2025 Results and Accelerates Cash Flow Breakeven
ARQT
Earnings
Guidance Update
New Projects/Investments
  • Arcutis Biotherapeutics reported net product revenues of $99.2 million for Q3 2025, marking a 122% increase from Q3 2024 and a 22% increase from Q2 2025. The company achieved a net income of $7.4 million for the quarter, a significant improvement from net losses in the prior year and previous quarter.
  • The company now anticipates achieving cash flow breakeven in Q4 2025, accelerating its previous expectation of 2026. For the full year 2026, Arcutis provides net product revenue guidance in the range of $455 million to $470 million.
  • Arcutis aims to increase ZORYVE's share of the topical steroid market from its current approximate 3% to 15-20% or greater, projecting a peak market potential for the ZORYVE portfolio between $2.6 billion and $3.5 billion.
  • Strategic initiatives include expanding ZORYVE's indications, with ongoing Phase 2a proof-of-concept studies for vitiligo and hidradenitis suppurativa, and advancing its pipeline with ARQ-234 for atopic dermatitis. ZORYVE Cream recently received approval for atopic dermatitis in children aged two to five years old.
Oct 28, 2025, 2:30 PM
ARQT Reports Strong Q3 2025 Financial and Commercial Results, Provides 2026 Guidance
ARQT
Earnings
Guidance Update
Product Launch
  • ARQT reported Net Product Revenues of $99.2 million in Q3 2025, representing a 122% increase year-over-year and a 22% increase quarter-over-quarter.
  • The company achieved a Net Profit of $7.4 million and $0.06 Net Profit Per Share (Diluted) for Q3 2025.
  • ZORYVE's weekly total prescriptions (TRx) reached approximately 17,500 on a rolling 4-week basis, with 13% quarter-over-quarter growth and 92% year-over-year growth in Q3 2025.
  • ARQT issued 2026 Product Sales guidance of $455-$470 million and anticipates achieving cash flow breakeven in 2026.
  • Key product developments include the October 2025 approval of ZORYVE cream 0.05% for atopic dermatitis in patients aged 2-5, and the September 2025 submission of an sNDA for ZORYVE cream 0.3% for PsO patients aged 2-5 years old.
Oct 28, 2025, 2:30 PM
Arcutis Reports Strong Q3 2025 Results and Provides 2026 Revenue Guidance
ARQT
Earnings
Guidance Update
Revenue Acceleration/Inflection
  • Arcutis (ARQT) generated net product revenues of $99.2 million in the third quarter of 2025, reflecting a 22% sequential growth from Q2 2025 and a 122% increase compared to the same quarter of 2024.
  • The company reported a net income of $7.4 million for Q3 2025, a significant improvement from a net loss of $15.9 million in Q2 2025 and $41.5 million in Q3 2024.
  • Arcutis now anticipates achieving cash flow breakeven in the fourth quarter of 2025, accelerating from its previous expectation of 2026.
  • For the full year 2026, the company expects net product revenues to be in the range of $455 million to $470 million.
  • The growth was primarily driven by the ZORYVE portfolio, with total prescriptions increasing 13% compared to Q2 and 92% versus Q3 2024, supported by the successful launch of ZORYVE Foam 0.3% and the upcoming launch of ZORYVE Cream 0.15% for pediatric atopic dermatitis in Q4 2025.
Oct 28, 2025, 2:30 PM

Quarterly earnings call transcripts for Arcutis Biotherapeutics.