Delcath Systems Inc
delcath.comWhat Do They Do?
Sells drug-and-device systems that deliver chemotherapy to the liver for hospitals and cancer treatment centers treating liver cancers.
10-K for FY2025, filed Feb 26, 2026HEPZATO KIT™ (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT® Hepatic Delivery System for Melphalan percutaneous…View ↗
In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by…View ↗
The PHP procedure is an outpatient procedure performed in an interventional radiology suite in approximately two to three hours. Patients…View ↗
How Do They Make Money?
Hospitals and treating centers buy HEPZATO directly; consigned kits are sold when used in a procedure, while advance purchases are sold on delivery. European hospitals buy CHEMOSAT directly, with sales on shipment.
10-K for FY2025, filed Feb 26, 2026The Company ships and sells HEPZATO directly to hospitals and treating centers based on approved agreements. For certain customers, the…View ↗
Hospitals and treating centers may also elect to purchase HEPZATO prior to a procedure. For these sales, the purchasing hospital or…View ↗
CHEMOSAT is sold directly to hospitals in the European Union and United Kingdom based on contracted rates in an approved contract or sales…View ↗
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10-K for FY2025, filed Feb 26, 2026
FY2025 revenue by product or service ↗
$85.2M
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10-K for FY2025, filed Feb 26, 2026
$85.2M ↗
| Segment | Share | Revenue | How money arrives |
|---|---|---|---|
|
CHEMOSAT
Sold outright
|
7.5% |
CHEMOSAT, FY2025
$6.4M Sources
|
Sold outright |
|
HEPZATO KIT
Sold outright
10-K for FY2025, filed Feb 26, 2026 |
93% |
HEPZATO KIT, FY2025
$78.8M Sources
|
Sold outright |
Who Are Their Customers?
Hospitals and treating centers buy HEPZATO directly in the United States; hospitals in the European Union and United Kingdom buy CHEMOSAT directly.
10-K for FY2025, filed Feb 26, 2026
Do Revenues Turn Into Profits?
Yes. It kept 3 cents of every revenue dollar as net income in FY2025 and turned 25 cents into free cash flow.
10-K for FY2025, filed Feb 26, 2026
$660KView ↗
10-K for FY2025, filed Feb 26, 2026
$2.7MView ↗
10-K for FY2025, filed Feb 26, 2026
$21MView ↗
How Are They Changing?
10-Q for Q2 FY2026, filed Aug 6, 2026
Open tableView ↗
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Aug 6, 2026
Raises 2026 revenue guidance to $104M–$108M
The outlook reflects higher expected HEPZATO KIT volume.
Sources
8-K, filed Aug 6, 2026
Increases 2026 Revenue Guidance to a Range of $104M to $108MView ↗
Growing. Revenue grew 24.0x in 4 years, from $3.6M in FY2021 to $85.2M in FY2025, about 121% a year.
U.S. commercial launch
The older report described HEPZATO as an unapproved candidate; the latest describes an FDA-approved product with commercial use for eligible adults with metastatic uveal melanoma.
10-K for FY2022, filed Mar 27, 2023 10-K for FY2025, filed Feb 26, 2026
Who Do They Compete With?
Competes with Immunocore Holdings, Boston Scientific, Medtronic, Merit Medical Systems, Varian Medical Systems, Sirtex Medical, AngioDynamics, IDEAYA Biosciences, and Replimune Group
10-K for FY2025, filed Feb 26, 2026In January 2022, Immunocore Holdings plc announced FDA approval for KIMMTRAK (tebentafusp-tebn) for the treatment of HLA-A *02:01-positive…View ↗
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