Delcath Systems (DCTH) Q2 2025 earnings summary

Executive summary

• Achieved total revenue of $24.2 million in Q2 2025, up over 20% sequentially and from $7.8 million year-over-year, driven by HEPZATO and CHEMOSAT sales, with net income of $2.7 million, reversing a $13.7 million loss in Q2 2024.

• Expanded to 20 active U.S. centers treating at least one patient with HEPZATO in the first half of 2025, up from 7 a year ago, and initiated new clinical studies in Europe.

• Positive adjusted EBITDA of $9.8 million, compared to a loss of $0.8 million in Q2 2024.

• Ended the quarter with $81 million in cash and investments, no debt, and strong liquidity to support operations for at least 12 months.

• Initiated Phase II trials for metastatic colorectal and breast cancer, with regulatory clearances in the US, EU, and UK, and first patient randomized in CRC trial.

Financial highlights

• Q2 2025 revenue was $24.2 million, up from $7.8 million in Q2 2024; six-month revenue reached $43.9 million, up from $10.9 million year-over-year.

• Gross margin reached 86% in Q2 2025, up from 80% in Q2 2024.

• Adjusted EBITDA was $9.8 million, compared to a loss of $0.8 million in Q2 2024.

• Operating income for Q2 2025 was $2.6 million, compared to a loss of $3.9 million in Q2 2024.

• R&D expenses rose to $6.9 million, and SG&A expenses to $11.4 million, both significantly higher year-over-year.

Outlook and guidance

• Full-year 2025 revenue guidance adjusted to $93–$96 million due to slower U.S. site activations, representing over 150% growth from 2024.

• 2025 gross margin forecast remains 83–85%, with continued positive adjusted EBITDA and cash flow expected.

• HEPZATO treatment volume projected to increase by over 175% versus 2024.

• Expect 25–28 operational centers by year-end, with a goal of 40 by end of next year.

• R&D expenses expected to increase as Phase II clinical trials progress.