Delcath Systems (DCTH) Q3 2025 earnings summary

Executive summary

• Achieved strong revenue growth driven by commercial expansion of HEPZATO in the US and CHEMOSAT in Europe, with 22 facilities treating at least one patient with HEPZATO in the first nine months of 2025, up from 11 in the prior year period.

• Q3 2025 saw strong clinical progress, including positive Chopin trial results and first patient dosed in the CRC trial.

• Net income was $0.8 million in Q3 2025, down from $1.9 million in Q3 2024, but for the nine months ended September 30, 2025, net income was $4.6 million, compared to a net loss of $23.0 million in 2024.

• Commercial performance was impacted by a 13% reduction in average revenue per kit due to 340B/NDRA pricing.

• Expansion of the U.S. sales force from four to six regions in 2025, with plans for nine by Q2 2026.

Financial highlights

• Q3 2025 revenue: $19.3M (HEPZATO), $1.3M (CHEMOSAT), up from $10M and $1.2M in Q3 2024; total revenue for the nine months ended September 30, 2025 was $64.5M, up from $22.1M year-over-year.

• Gross margin: 87% in Q3 2025, up from 85% in Q3 2024; gross profit for the nine months was $55.7M.

• R&D expenses: $8.0M in Q3 2025, up from $3.9M year-over-year; $19.9M for the nine months, reflecting clinical trial activity.

• Adjusted EBITDA: $5.3M in Q3 2025, up from $1.0M; operating income for the nine months was $2.8M, compared to a loss of $15.4M in 2024.

• Ended Q3 with $88.9M in cash/investments and no debt; positive operating cash flow of $4.8M.

Outlook and guidance

• 2025 annual revenue guidance adjusted to $83–$85M due to slower new patient starts; HEPZATO treatment volume projected to increase nearly 150% vs. 2024.

• 2025 gross margin expected at 85–87%; continued positive adjusted EBITDA and cash flow.

• Site additions expected to accelerate in late 2025 and 2026 with nine sales regions.

• Ongoing and planned clinical trials in metastatic colorectal and breast cancer are expected to drive future growth.

• Current cash, cash equivalents, and investments are expected to support operations for at least 12 months from the reporting date.