Delcath Systems Stock Earnings Reports

Key points for investors: Delcath reported strong clinical momentum driven by the investigator-sponsored CHOPIN trial, which met its primary endpoint (1-year PFS 54.7% combination vs. 15.8% perfusion) and showed statistically significant improvements in median OS and objective response rate. Commercially, Q3 was impacted by a ~13% reduction in average revenue per kit due to 340B/NDRA participation and by seasonality/competition that slowed new patient starts in summer; the company expects similar average price levels in Q4 and has modestly tempered 2025 revenue guidance to $83M–$85M. Operationally, the company has 25 REMS-certified treatment sites, expects 26–28 active treating centers by year-end 2025 and plans to expand its U.S. sales footprint from 6 to 9 regions by mid-2026 to accelerate site activation and referral network building. Delcath is advancing company-sponsored trials in liver-dominant metastatic colorectal cancer (dosing began Aug 2025; interim data possible Q2 2027; primary endpoint mid‑2028) and metastatic breast cancer (expected dosing Q1 2026; interim data possible Q4 2027). Financial highlights: Q3 HEPZATO revenue $19.3M, CHEMOSAT $1.3M; gross margin ~87%; R&D and SG&A increased (R&D $8.0M, SG&A $10.3M); Q3 net income $0.8M; positive adjusted EBITDA ($5.3M) and positive operating cash flow ($4.8M); cash and investments ~ $89M; no debt or outstanding warrants. Management expects continued high gross margins (~85%–87% for 2025) and reiterated ability to fund programs from internal resources while prioritizing program-by-program R&D spend. Risks called out include ongoing seasonality, competitive clinical trials, NDRA participation effects, and typical forward-looking uncertainties.