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.
Record Revenue: Delcath delivered record 2025 revenue of $85.2 million, up over 40% in volume, with $20.7 million in Q4 alone.
Profitability: The company turned profitable for the full year, reporting $2.7 million net income versus a $26.4 million loss in 2024.
Strong Gross Margins: Gross margins remained high at 86% for the year, with 2026 guidance for 84%–87%.
Growth Guidance: Management guided to at least $100 million revenue in 2026, driven by >20% HEPZATO volume growth and >10% CHEMOSAT growth.
Site Expansion: Delcath now operates 28 active treatment centers and aims for 40 by the end of 2026, expecting more activations in the second half.
Seasonality: Q3 is expected to see flat-to-modest growth due to summer seasonality, similar to 2025.
Rising Expenses: R&D expenses expected to rise by nearly 90% in 2026; SG&A by nearly 50%.
CHOPIN Catalyst: Highly anticipated CHOPIN study results are imminent and expected to boost adoption and possibly influence treatment guidelines.
