Delcath Systems, Inc. reported significant financial growth for the fiscal year ending December 31, 2024, driven primarily by the commercial launch of its HEPZATO KIT, which generated approximately $37.2 million in product revenue, a substantial increase from $2.1 million in 2023. The company also noted a rise in demand for its CHEMOSAT product in Europe, contributing an additional $4.9 million in revenue. Despite this growth, Delcath incurred a net loss of $26.4 million, a decrease from the previous year's loss of $47.7 million, reflecting improved operational efficiency and revenue generation.
The company's operational metrics indicate a strategic shift following the FDA approval of the HEPZATO KIT in August 2023, which is indicated for the treatment of adult patients with unresectable hepatic-dominant uveal melanoma. The first commercial use of the product occurred in January 2024, and as of March 2025, 16 facilities had treated patients with the HEPZATO KIT. Delcath's focus on expanding its market presence is evident, with plans to initiate clinical trials for HEPZATO in combination with standard care for liver-dominant metastatic colorectal cancer and breast cancer in 2025.
Delcath's workforce has grown to approximately 96 employees, with a significant portion dedicated to sales and marketing efforts for HEPZATO and CHEMOSAT. The company has also made strides in geographic expansion, with CHEMOSAT now available in over 23 cancer centers across Europe. The increase in employee headcount and operational capacity is aligned with the company's goal to enhance its commercialization strategy and market penetration.
The financial outlook for Delcath remains cautious, as the company continues to navigate the complexities of reimbursement and market acceptance for its products. The establishment of a permanent J-Code for HEPZATO by the Centers for Medicare and Medicaid Services (CMS) and the granting of New Technology Add-on Payment (NTAP) status are positive developments that may facilitate broader adoption. However, the company acknowledges the ongoing need for additional capital to support its operations and product development, particularly as it seeks to expand its clinical trials and market presence.
In summary, Delcath Systems, Inc. has demonstrated significant revenue growth and operational advancements in 2024, primarily due to the successful launch of the HEPZATO KIT. While the company faces challenges related to profitability and market acceptance, its strategic initiatives and recent regulatory approvals position it for potential future success in the interventional oncology market.
About DELCATH SYSTEMS, INC.
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