Delcath Systems (DCTH) Q1 2025 earnings summary

Executive summary

• Achieved $19.8M in Q1 2025 revenue, up from $3.1M year-over-year, driven by HEPZATO KIT U.S. expansion and CHEMOSAT in Europe.

• Net income of $1.1M for Q1 2025, compared to a net loss of $11.1M in Q1 2024.

• Expanded to 19 active U.S. treatment centers, with 10 more pending activation and a goal of 30 by year-end.

• Positive operating cash flow of $2.2M and adjusted EBITDA of $7.6M, with no debt and $59M in cash and investments.

• FDA cleared INDs for Phase 2 trials in metastatic colorectal and breast cancer, with enrollment expected to begin in late 2025.

Financial highlights

• HEPZATO KIT U.S. sales reached $18M, up from $2M year-over-year; CHEMOSAT Europe sales were $1.8M, up from $1.1M.

• Gross margin improved to 86% from 71% year-over-year.

• R&D expenses rose to $5M (from $3.7M), SG&A to $11.3M (from $8.8M).

• Adjusted EBITDA swung to $7.6M positive from a $7.3M loss year-over-year.

• Cash and investments totaled $58.9M as of March 31, 2025, with no debt.

Outlook and guidance

• On track to reach 30 active U.S. centers by year-end, with 3–5 new centers opening per quarter.

• Average treatments per center expected just under two per month for the remainder of 2025.

• SG&A projected to increase 60% and R&D 150% over 2024; EBITDA expected to remain positive despite higher OpEx.

• Management expects current cash, equivalents, and investments to support operations for at least 12 months.

• Enrollment for Phase 2 trials in metastatic colorectal and breast cancer to begin in 2H 2025 and Q4 2025, respectively.