Delcath Systems Q2 2025: Contradictions Unveiled on NDRA Impact, Activation Timelines, and European Growth

Impact of NDRA program on center activations, expected timeline for center activations, impact of NDRA program on center activations, and growth expectations from European expansion are the key contradictions discussed in Delcath Systems' latest 2025Q2 earnings call.



Revenue Growth and Site Activations:
- Delcath Systems reported revenue of $24.2 million for Q2 2025, an increase of over 20% compared to the first quarter of 2025.
- The growth was driven by the fifth consecutive quarter of site and HEPZATO volume growth, with U.S. sales of HEPZATO reaching $22.5 million.

Adjusted EBITDA and Cash Flow:
- The company achieved adjusted EBITDA of $9.8 million and ended the quarter with approximately $81 million in cash and investments.
- This was supported by positive cash flow from operations, which was $7.3 million for the quarter.
- The improvement was attributed to strong revenue growth and effective cost management.

Participation in National Drug Rebate Agreement (NDRA) and 340B Program:
- Delcath Systems entered the NDRA with the U.S. Department of Health and Human Services, enabling Medicaid and Medicare coverage for HEPZATO.
- This program requires participation in the 340B drug pricing program, allowing eligible hospitals to purchase HEPZATO KIT at reduced prices.
- The move is expected to increase market access and align with Medicaid and Medicare coverage requirements.

Clinical Trial Initiatives:
- Delcath Systems is progressing with company-sponsored trials in liver-dominant metastatic colorectal cancer and breast cancer, seeking to expand HEPZATO's applications beyond its first ultra-orphan market.
- The trials aim to evaluate the safety and efficacy of HEPZATO in combination with standard of care against standard of care alone.
- These initiatives are part of Delcath's strategy to approach larger patient populations in newly indicated areas where there is a high unmet need.