On November 4, 2025 Delcath Systems, Inc. (Nasdaq: DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported financial results and business highlights for the third quarter ended September 30, 2025.

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Third Quarter 2025 Financial Results

Total revenue of $20.6 million, compared with $11.2 million in the third quarter of 2024
HEPZATO KIT revenue of $19.3 million, compared to $10.0 million in the third quarter of 2024
CHEMOSAT revenue of $1.3 million, compared to $1.2 million in the third quarter of 2024
Gross margins of 87%, compared to 85% in the third quarter of 2024
Net income of $0.8 million, compared to a net income of $1.9 million in the third quarter of 2024
Non-GAAP positive adjusted EBITDA in the third quarter of $5.3 million, compared to a positive adjusted EBITDA of $1.0 million in the third quarter of 2024
Cash provided by operations of $4.8 million in the quarter; compared to $3.6 million used by operations in the third quarter of 2024
Cash and investments of $88.9 million as of September 30, 2025
Business Highlights

There are currently 25 active centers across the U.S.
In August, the first patient was dosed at City of Hope National Medical Center in the global Phase 2 trial of HEPZATO in combination with trifluridine-tipiracil and bevacizumab for liver-dominant metastatic colorectal cancer. The study will enroll approximately 90 patients across 20+ sites in the U.S. and Europe, with topline data expected in 2028
Announced that results from the investigator-initiated Phase 2 CHOPIN trial at Leiden University Medical Center evaluating CHEMOSAT with ipilimumab and nivolumab in metastatic uveal melanoma were presented at the October 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress by Principal Investigator Ellen Kapiteijn, MD, showing a significant improvement in one-year progression-free survival versus CHEMOSAT alone
"In the third quarter, we made strong progress with our clinical programs, reporting compelling positive CHOPIN results and first-patient dosing in our global Phase 2 trial in liver-dominant metastatic colorectal cancer," said Gerard Michel, Chief Executive Officer of Delcath Systems. "While revenue results in the quarter reflected the impact of NDRA discounts and seasonal factors, our fundamentals remain strong. We are confident that the growing clinical validation of HEPZATO positions us well to drive continued progress and long-term value for patients and shareholders."

2025 Full Year Financial Guidance

The Company’s financial outlook for fiscal year 2025:

Total CHEMOSAT and HEPZATO KIT revenue to be in the range of $83 to $85 million, an increase in volume of approximately 150% over 2024
Gross margins in the range of 85% to 87%
Positive adjusted EBITDA and cashflow in each quarter of 2025
Third Quarter 2025 Results

Total revenue for the quarter ending September 30, 2025 was $20.6 million compared to $11.2 million for the same period in the prior year. Revenue in the quarter includes sales of $19.3 million of HEPZATO in the U.S. and $1.3 million of CHEMOSAT in Europe.

Research and development expenses for the quarter ending September 30, 2025, were $8.0 million compared to $3.9 million for the same period in the prior year. The increase is primarily due to costs associated with expanding the clinical team including the share-based compensation expense related to an increase in headcount and initiation of the Phase 2 clinical trial evaluating HEPZATO in combination with standard of care for metastatic colorectal cancer and Phase 2 clinical trial in metastatic breast cancer. In 2024, these costs primarily related to medical affairs and regulatory costs associated with the approved products.

Selling, general and administrative expenses for the quarter ended September 30, 2025, were $10.3 million compared to $7.0 million for the same period in the prior year. The increase is primarily due to continued commercial expansion activities including marketing-related expenses, additional personnel in the commercial team and share-based compensation expenses.

Net income for the quarter ended September 30, 2025 was $0.8 million compared to net income of $1.9 million for the same period in the prior year.

Non-GAAP adjusted EBITDA for the quarter ended September 30, 2025 was $5.3 million compared to adjusted EBITDA of $1.0 million for the same period in the prior year. A table reconciling non-GAAP measures is included in this press release for reference.

As of September 30, 2025, the Company had $88.9 million in cash and investments, and no debt.

Conference Call Information

To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call.

Event Date: Thursday, November 6, 2025
Time: 8:30 AM Eastern Time

Participant Numbers:
Toll Free: 1-877-407-3982
International: 1-201-493-6780
Webcast: View Source;tp_key=a3bb91787b

A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website View Source

(Press release, Delcath Systems, NOV 4, 2025, View Source [SID1234659352])