On February 26, 2026 Delcath Systems, Inc. (Nasdaq: DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported financial results and business highlights for the fourth quarter and full year-ended December 31, 2025.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Fourth Quarter and Full Year 2025 Financial Results
Total fourth quarter and full year revenue of $20.7 million and $85.2 million, respectively
HEPZATO KIT fourth quarter and full year revenue of $19.0 million and $78.8 million, respectively
CHEMOSAT fourth quarter and full year revenue of $1.7 million and $6.4 million, respectively
Gross margins of 85% for the fourth quarter and 86% for the full year
Fourth quarter net loss of $1.9 million and full year net income of $2.7 million
Non-GAAP positive adjusted EBITDA for the fourth quarter and full year of $2.4 million and $25.1 million, respectively
Repurchased 628,572 common shares for $6.0 million through December 31, 2025 under the approved $25 million Share Buyback Program
As of December 31, 2025, the Company had approximately $91.0 million of cash and short-term investments and no debt
Business Highlights
Currently 28 active centers
Approximately 140% growth in HEPZATO procedure volume in 2025 compared to 2024
Announced the publication of additional results from the FOCUS study, "Subgroup Analyses of the Phase 3 FOCUS Study of Melphalan/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma" in Journal of Cancer Research and Clinical Oncology
Announced the publication of results from multiple studies by independent investigators, including:
Results from the Phase 2 CHOPIN trial sponsored by Leiden University Medical Center evaluating CHEMOSAT with ipilimumab and nivolumab in metastatic uveal melanoma at the 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress showing a significant improvement in one-year progression-free survival versus CHEMOSAT alone
A long-term retrospective study conducted by researchers at the University Hospital Tübingen, Germany, "Characterization of long-term survivors with liver metastases from uveal melanoma diagnosed between 2005 and 2021", in International Journal of Cancer
A long-term retrospective study conducted by researchers at the Asklepios Hospital Barmbek, Germany, "Survival Outcome After Percutaneous Hepatic Perfusion with High-Dose Melphalan for Liver-Dominant Metastatic Uveal Melanoma: A 10-Year Single-Center Experience" in Cancers
"2025 was a pivotal year in which we delivered robust procedure-volume growth, positive operating cashflow and successfully navigated temporary headwinds to stabilize the HEPZATO revenue base in the fourth quarter," said Gerard Michel, President and Chief Executive Officer of Delcath "With 28 active treatment centers now delivering therapy and compelling CHOPIN data demonstrating clear clinical benefit when PHP is sequenced with checkpoint inhibitors, we enter 2026 with strong momentum. Through continued site activations, commercial expansion, and heightened physician awareness of the CHOPIN results, we expect accelerated adoption and utilization that will drive long-term value for patients and shareholders alike."
2026 Full Year Financial Guidance
The Company’s financial outlook for fiscal year 2026:
Total CHEMOSAT and HEPZATO KIT revenue to be at least $100 million, reflecting an increase in HEPZATO KIT volume of at least 20% over 2025, and
Gross margins in the range of 84% to 87%.
Fourth Quarter and Full Year 2025 Results
Total revenue for the quarter ended December 31, 2025 was $20.7 million compared to $15.1 million for the same period in the prior year. Revenue in the quarter includes sales of $19.0 million of HEPZATO in the U.S. and $1.7 million of CHEMOSAT in Europe.
Total revenue for the year-ended December 31, 2025 was $85.2 million compared to $37.2 million for the same period in the prior year. Revenue in 2025 includes sales of $78.8 million of HEPZATO in the U.S. and $6.4 million of CHEMOSAT in Europe.
Research and development expenses for the quarter and year-ended December 31, 2025, were $9.4 million and $29.2 million, respectively compared to $2.9 million and $13.9 million for the same periods in the prior year. The increase is primarily due to costs associated with expanding the clinical team including 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 mCRC and mBC. In 2024, these costs are primarily related to medical affairs and regulatory costs associated with the approved products.
Selling, general and administrative expenses for the quarter and year-ended December 31, 2025, were $10.5 million and $43.5 million, respectively compared to $7.0 million and $29.6 million for the same periods in the prior year. The increase is primarily due to continued commercial expansion activities including marketing-related expenses and additional personnel on the commercial team. In addition, the increase in personnel along with higher grant date exercise prices has increased the share-based compensation expense.
Net loss for the quarter ended December 31, 2025 was $1.9 million and net income for the full year was $2.7 million, compared to net loss of $3.4 million and $26.4 million for the same periods in the prior year.
Non-GAAP positive adjusted EBITDA for the quarter and year-ended December 31, 2025 was $2.4 million and $25.1 million compared to adjusted EBITDA gain of $4.6 million and loss of $2.5 million for the same periods in the prior year. A table reconciling non-GAAP measures is included in this press release for reference.
As of December 31, 2025, the Company had $91.0 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: Thursday, February 26, 2026
Time: 8:30 AM Eastern Time
(Press release, Delcath Systems, FEB 26, 2026, View Source [SID1234663067])