Delcath Systems Inc
NASDAQ:DCTH
Delcath Systems Inc
Delcath Systems, Inc. is an oncology company, which focuses on the treatment of primary and metastatic liver cancers. The company is headquartered in New York City, New York and currently employs 45 full-time employees. The company went IPO on 2000-10-19. The firm's lead product candidate, the HEPZATO KIT (melphalan hydrochloride for injection/hepatic delivery system) is a drug/device combination product. HEPZATO KIT is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects. In Europe, its commercial product is a medical device having the same device components as the HEZPATO KIT but without the melphalan hydrochloride, is designated as a Class III medical device, and is sold under the trade name CHEMOSAT Hepatic Delivery System for Melphalan (CHEMOSAT), where it is being used at various medical centers to treat a range of cancers of the liver. In the United States, HEPZATO KIT is considered a combination drug and device product. The firm's product administers concentrated regional chemotherapy to the liver.
Delcath Systems, Inc. is an oncology company, which focuses on the treatment of primary and metastatic liver cancers. The company is headquartered in New York City, New York and currently employs 45 full-time employees. The company went IPO on 2000-10-19. The firm's lead product candidate, the HEPZATO KIT (melphalan hydrochloride for injection/hepatic delivery system) is a drug/device combination product. HEPZATO KIT is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects. In Europe, its commercial product is a medical device having the same device components as the HEZPATO KIT but without the melphalan hydrochloride, is designated as a Class III medical device, and is sold under the trade name CHEMOSAT Hepatic Delivery System for Melphalan (CHEMOSAT), where it is being used at various medical centers to treat a range of cancers of the liver. In the United States, HEPZATO KIT is considered a combination drug and device product. The firm's product administers concentrated regional chemotherapy to the liver.
Revenue Growth: HEPZATO sales more than doubled year-over-year for Q3, reaching $19.3 million, while CHEMOSAT sales were steady at $1.3 million.
Pricing Impact: Average revenue per kit fell by about 13% from Q2 due to 340B/NDRA program participation, with similar pricing expected in Q4.
Guidance Update: Management reaffirmed 2025 revenue guidance of $83–85 million and expects gross margins of 85–87% for the year.
Site Expansion: 25 REMS-certified centers are active; the company expects to reach 26–28 by year-end and target 40 by the end of next year.
Clinical Progress: The CHOPIN trial showed significantly better outcomes using combination therapy, which management and clinicians believe could shift standard practice.
R&D Pipeline: Company-sponsored trials in liver-dominant metastatic colorectal and breast cancer are underway, with key interim data expected between 2027–2029.
Profitability: Delcath posted Q3 net income of $0.8 million and maintained a strong cash position with no debt.
