Delcath Raises 2026 Outlook After HEPZATO Volume Accelerates

The Tip Desk · November 12, 2026 · 3 min read

Third-quarter revenue reached $35.1 million as the company lifted full-year guidance to $115 million to $117 million.

Delcath Systems, Inc. (DCTH), an interventional oncology company focused on primary and metastatic liver cancers, reported third-quarter revenue of $35.1 million, up 70% from $20.6 million a year earlier, and raised its 2026 revenue outlook to a range of $115 million to $117 million.

The Queensbury, New York company said HEPZATO KIT revenue was $32.7 million, compared with $19.3 million in the third quarter of 2025. CHEMOSAT revenue in Europe was $2.4 million.

HEPZATO volume growth accelerated. The company said volume rose approximately 72% in the third quarter versus the year-ago period, after approximately 30% growth in the second quarter. Active treatment centers increased to 33 from 31 in the second quarter.

Gross margin was 89%, compared with 87% a year earlier. Net income was $7.0 million, or $0.19 a share on a basic basis, versus $0.8 million, or $0.02 a share, a year earlier. Non-GAAP adjusted EBITDA was $11.5 million.

Cash provided by operations was $8.2 million in the quarter. Cash and investments were $104.3 million as of September 30, 2026, with no debt.

Research and development expenses were $11.0 million, which the company said was primarily due to increased clinical headcount and clinical trial activity. Selling, general and administrative expenses were $13.1 million, which the company said was primarily due to continued commercial expansion activities.

Chief Executive Officer Gerard Michel said the company was pleased with continued momentum in commercial operations and clinical development, citing growing physician experience with HEPZATO, engagement across the treatment-center network, and interest in its use alongside systemic therapies.

The company advanced the global Phase 2 DELUMA trial (NCT06875128), evaluating HEPZATO in combination with standard-of-care therapy versus standard of care alone in liver-dominant HER2-negative metastatic breast cancer. The first patient was dosed July 9, 2026, at the European Institute of Oncology in Milan. The randomized trial is designed to enroll approximately 90 patients at more than 20 U.S. and European sites.

Delcath said it plans an IND submission for cholangiocarcinoma in early 2027 and, pending FDA agreement, completion of ongoing preclinical development of an oxaliplatin-based PHP product by mid-2027.

The new 2026 outlook reflects an increase in HEPZATO KIT volume of at least 41% over 2025, up from a prior guide of at least 28%. Full-year gross margins are expected in the range of 87% to 89%, and the company again expects positive adjusted EBITDA.

HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. In Europe, the device-only configuration of the hepatic delivery system is sold as CHEMOSAT.