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Sep 30, 2024
Arcutis Q3 2024 Earnings Report
Arcutis reported a strong Q3 2024 with significant revenue growth and progress in product development and commercialization.
Key Takeaways
Arcutis Biotherapeutics reported Q3 2024 financial results, featuring a 45% increase in product revenue compared to the previous quarter, driven by strong demand for ZORYVE products and improved gross-to-net adjustments. The company also highlighted key regulatory milestones, including the acceptance of the sNDA for ZORYVE foam and approval in Canada, as well as advancements in their pipeline programs.
Net product revenues for the ZORYVE franchise reached $44.8 million, demonstrating a 452% increase compared to Q3 2023.
Blended gross-to-net improved to the low 50 percent range, up from the high 50 percent range in the previous quarter.
Total U.S. franchise unit demand increased by 25% quarter over quarter, indicating sustained growth in prescriptions for both cream and foam formulations.
The FDA accepted the sNDA for ZORYVE foam for scalp and body psoriasis, with a PDUFA action date of May 22, 2025, and Health Canada approved ZORYVE foam for seborrheic dermatitis.
Arcutis
Arcutis
Forward Guidance
Arcutis anticipates a strong revenue trajectory, driven by Medicaid and Medicare coverage wins, expansion into pediatric and primary care practices, and potential FDA approval of ZORYVE foam for scalp and body psoriasis. The company is also progressing its pipeline programs and maintains a strong financial position to support growth.
Positive Outlook
- Large addressable market that will continue to expand.
- Further Medicaid wins expected.
- Expected Medicare coverage wins.
- Expansion into pediatric and primary care practices.
- Expected FDA approval next year of ZORYVE foam for scalp and body psoriasis.
Challenges Ahead
- Uncertainty of future commercial sales and related items that can impact net sales.
- Risks inherent in the clinical development process and regulatory approval process.
- The timing of regulatory filings.
- The timing and expenses of commercialization efforts.
- Ability to defend their intellectual property.