Full Press Release Details
Delcath Systems Announces Preliminary Fourth Quarter and Full Year 2024 Financial Results
Fourth Quarter Revenue Approximately $15.1 Million and
Full Year Total Revenue Approximately $37.2 Million
QUEENSBURY, NY January 13, 2025, 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, today announced preliminary financial results for the fourth quarter and year-ended December 31, 2024.
Preliminary Fourth Quarter and Full-Year 2024 Financial Results (unaudited)
Final financial results for the fourth quarter and full year 2024 and a detailed business update
will be provided during Delcath s annual financial results release and investor call scheduled for March 6, 2025.
About Delcath Systems,
Inc., HEPZATO KIT and CHEMOSAT
Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver
cancers. The company s proprietary products, HEPZATO KIT (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and
CHEMOSAT Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and
associated side effects during a PHP procedure.
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 the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath s proprietary Hepatic Delivery System (HDS). The HDS is used to isolate the hepatic venous blood from the systemic
circulation while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful
tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) 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. Please see the full Prescribing Information,
including BOXED WARNING for the HEPZATO KIT.
In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is
approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the
Preliminary and Unaudited Nature of Reported Results
The Company has not yet completed its financial close process for the fourth quarter and full year 2024 and, as a result, actual results may vary from the
estimated preliminary results set forth in this press release due to a number of factors, including audit adjustments and other developments that may arise between now and the time the financial results for the fourth quarter and fiscal year ended
December 31, 2024, are finalized. The estimated preliminary financial results have not been audited or reviewed by the Company s independent registered public accounting firm. These estimates should not be viewed as a substitute for the
Company s full interim or annual audited financial statements.
Safe Harbor / Forward-Looking Statements
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This press
release contains forward-looking statements, which are subject to certain risks and uncertainties, that can cause actual results to differ materially from those described. The words anticipate, believe, continue,
could, estimate, expect, intend, may, plan, potential, predict, project, should, target, will,
would and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Factors that may cause such differences include, but are not limited to,
uncertainties relating to: changes to the estimated preliminary results set forth in this press release as a result of audit adjustments and other developments that may arise between now and the time the financial results for the fourth quarter and
fiscal year ended December 31, 2024, are finalized; the Company s commercialization plans and its ability to successfully commercialize the HEPZATO KIT; the Company s successful management of the HEPZATO KIT supply chain, including
securing adequate supply of critical components necessary to manufacture and assemble the HEPZATO KIT; successful FDA inspections of the facilities of the Company and those of its third-party suppliers/manufacturers; the Company s successful
implementation and management of the HEPZATO KIT Risk Evaluation and Mitigation Strategy; the potential benefits of the HEPZATO KIT as a treatment for patients with primary and metastatic disease in the liver; the Company s ability to obtain
reimbursement for the HEPZATO KIT; and the Company s ability to successfully enter into any necessary purchase and sale agreements with users of the HEPZATO KIT. For additional information about these factors, and others that may impact the
Company, please see the Company s filings with the Securities and Exchange Commission, including those on Forms 10-K, 10-Q, and
8-K. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, you should not place undue reliance on these
forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.
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