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Delcath Systems (DCTH) investor relations material
Delcath Systems Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary4 Nov, 2025
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.
Strategy to counter competitive trial impact
Criteria for new IO combination trials
Approach to R&D capital allocation
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Next Delcath Systems earnings date
Q4 202527 Mar, 2026
Next Delcath Systems earnings date
Q4 202527 Mar, 2026
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Delcath Systems Inc. is a medical technology company focused on the development and commercialization of innovative therapies for cancers with limited treatment options. The company specializes in targeted drug delivery systems, designed to isolate and deliver high doses of chemotherapy to specific organs or regions while minimizing systemic exposure. The company is headquartered in Wilmington, Delaware, and its shares are listed on the NASDAQ.
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