Delcath Systems (DCTH) Issues Full Year 2025 Guidance

Delcath Systems, Inc. (Nasdaq: DCTH) (“Delcath” or the “Company”), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced full year 2025 financial guidance and its intention to enter into a Medicaid National Drug Rebate Agreement (NDRA) to expand patient access.

2025 Full Year Financial Guidance

The Company’s financial outlook for fiscal year 2025 is as follows:

• Total CHEMOSAT and HEPZATO KIT revenue of $94 to $98 million, an increase of more than 150% over 2024
• Gross margins between 83% to 85%
• Positive adjusted EBITDA and cashflow in each quarter of 2025

National Medicaid Drug Rebate Agreement

Delcath will participate in the Medicaid Drug Rebate Program, which entails providing Medicaid rebates and 340B discounts to eligible entities. The Company has initiated the process of entering into the NDRA with the Centers for Medicare and Medicaid Services and expects it to take effect at the beginning of the third quarter of 2025.

“Our decision to enter into the NDRA simplifies Medicaid access and enables eligible hospitals to access 340B drug pricing. We believe this will expand treatment availability and accelerate adoption of HEPZATO in the United States,” said Gerard Michel, Chief Executive Officer of Delcath. “Based on current center activation rates and rising utilization, we expect total HEPZATO treatment volume in 2025 to increase at least 200% versus 2024.”

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