On August 6, 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 second quarter ended June 30, 2025 (Press release, Delcath Systems, AUG 6, 2025, View Source [SID1234654861]).
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Second Quarter 2025 Financial Results
Total revenue of $24.2 million, compared with $7.8 million in the second quarter of 2024
HEPZATO KIT revenue of $22.5 million, compared to $6.6 million in the second quarter of 2024
CHEMOSAT revenue of $1.7 million, compared to $1.2 million in the second quarter of 2024
Gross margins of 86%, compared to 80% in the second quarter of 2024
Net income of $2.7 million, compared to a net loss of $13.7 million in the second quarter of 2024
Non-GAAP positive adjusted EBITDA in the second quarter of $9.8 million, compared to a loss of $0.8 million in the second quarter of 2024
Cash provided by operations of $7.3 million in the quarter
Cash and investments of $81.0 million as of June 30, 2025
Business Highlights
Activated three new U.S. centers in the second quarter, which brings the current total to 20 active centers, with an additional 10 centers accepting referrals
Announced its intention to enter into a Medicaid National Drug Rebate Agreement (NDRA) to expand patient access beginning July 1, 2025
Received authorization from the European Union and United Kingdom regulatory authorities for the clinical study of Melphalan for Injection/Hepatic Delivery System in patients with refractory metastatic colorectal cancer with liver dominant disease
"The consistent utilization of HEPZATO at treating sites and continued positive feedback from treating physicians has increased our confidence in HEPZATO’s long term growth prospects," said Gerard Michel, Chief Executive Officer of Delcath. "Physicians are sharing positive results, which is expanding interest at sites not yet activated as well as interest in participating in the future development of HEPZATO. With growing physician engagement and a strong financial outlook, the company is well prepared to pursue additional indications for HEPZATO."
2025 Full Year Financial Guidance
The Company updates its financial outlook for fiscal year 2025:
Total CHEMOSAT and HEPZATO KIT revenue to be in the range of $93 to $96 million, an increase of more than 150% over 2024
Gross margins in the range of 83% to 85%
Positive adjusted EBITDA and cashflow in each quarter of 2025
Second Quarter 2025 Results
Total revenue for the quarter ending June 30, 2025 was $24.2 million compared to $7.8 million for the same period in the prior year. Revenue in the quarter includes sales of $22.5 million of HEPZATO in the U.S. and $1.7 million of CHEMOSAT in Europe.
Research and development expenses for the quarter ending June 30, 2025, were $6.9 million compared to $3.4 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 June 30, 2025, were $11.4 million compared to $6.8 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 June 30, 2025 was $2.7 million compared to net loss of $13.7 million for the same period in the prior year.
Non-GAAP adjusted EBITDA for the quarter ended June 30, 2025 was $9.8 million compared to adjusted EBITDA loss of $0.8 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 June 30, 2025, the Company had $81.0 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: Wednesday, August 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=fbe0333159
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