Delcath Systems Reports First Annual Net Income and Positive Operating Cash Flow, Driven by Strong HEPZATO/CHEMOSAT Sales and Positive Clinical Data

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This 10-K marks a pivotal moment for Delcath Systems, confirming a dramatic financial turnaround to profitability and positive operating cash flow, which is critical for a growing biotech company. The strong commercial performance of HEPZATO KIT and CHEMOSAT, coupled with highly positive clinical data from the CHOPIN trial, validates the company's liver-directed therapy platform and expands its market potential. The established reimbursement pathways in the US and the ongoing share repurchase program further underscore the company's improving financial stability and management's confidence. Investors should view these results as a strong indicator of sustained growth and reduced financial risk, potentially leading to a re-evaluation of the company's long-term prospects.

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• Financial Turnaround to Profitability

  The company achieved a net income of $2.7 million in 2025, a significant improvement from a net loss of $26.4 million in 2024.

• Strong Revenue Growth

  Total revenue more than doubled to $85.2 million in 2025 from $37.2 million in 2024, driven by increased demand for HEPZATO KIT in the US and CHEMOSAT in Europe.

• Positive Operating Cash Flow

  Delcath generated $22.5 million in cash from operating activities in 2025, a substantial reversal from using $18.7 million in 2024, indicating improved financial health and liquidity.

• Positive Phase 2 CHOPIN Trial Results

  The CHOPIN trial for metastatic uveal melanoma showed significantly improved 1-year progression-free survival (54.7% vs 15.8%), overall survival, and objective response rate for combination therapy, expanding product potential.

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This 10-K marks a pivotal moment for Delcath Systems, confirming a dramatic financial turnaround to profitability and positive operating cash flow, which is critical for a growing biotech company. The strong commercial performance of HEPZATO KIT and CHEMOSAT, coupled with highly positive clinical data from the CHOPIN trial, validates the company's liver-directed therapy platform and expands its market potential. The established reimbursement pathways in the US and the ongoing share repurchase program further underscore the company's improving financial stability and management's confidence. Investors should view these results as a strong indicator of sustained growth and reduced financial risk, potentially leading to a re-evaluation of the company's long-term prospects.