Delcath Systems reported a mixed third quarter in 2025, with a notable impact from 340B pricing adjustments and seasonality affecting new patient starts, prompting a revised revenue guidance. However, positive clinical results from the CHOPIN trial highlight the potential for future growth.

• Revenue guidance for 2025 adjusted to $83M-$85M due to slower new patient starts and 340B pricing effects, resulting in a 13% decrease in average revenue per kit.
• Four new treatment sites activated recently, increasing total to 25 REMS-certified centers, with a target of 26-28 centers by the end of 2025.
• Strong clinical trial data from the CHOPIN trial reported at ESMO, showing significant improvements in progression-free survival and overall response rates, positioning HEPZATO as a key therapy for uveal melanoma.
• Competition from various clinical trials noted as a factor in slower patient initiation, though the CHOPIN trial’s compelling results may mitigate this challenge.
• Plans to expand the U.S. sales force further by 2026 to enhance site activation and referral networks to aid growth.