Delcath Systems Reports $19.8 Million Revenue in Latest Quarter, Significant Growth from Previous Year

Delcath Systems, Inc. reported significant financial improvements in its latest quarterly results, with total revenues reaching $19.8 million for the three months ended March 31, 2025, a substantial increase from $3.1 million in the same period last year. This growth is primarily attributed to the commercial expansion of its lead product, the HEPZATO KIT, which was approved by the FDA in August 2023 and began commercial use in January 2024. The company also reported a gross profit of $16.9 million, compared to $2.2 million in the prior year, reflecting a gross margin increase driven by higher product sales.

In terms of operational performance, Delcath's customer base has expanded significantly, with 17 facilities treating patients with the HEPZATO KIT as of March 31, 2025, up from just four facilities a year earlier. The increase in product revenue was complemented by a rise in cost of goods sold, which totaled $2.8 million, up from $0.9 million in the previous year, reflecting the increased demand for the HEPZATO KIT and CHEMOSAT products. The company reported an operating gain of $642,000, a notable turnaround from an operating loss of $10.3 million in the first quarter of 2024.

Delcath's strategic developments include the initiation of Phase 2 clinical trials for HEPZATO in combination with standard care for liver-dominant metastatic colorectal cancer and metastatic breast cancer, with patient enrollment expected to begin in the second half of 2025. The company has also made significant investments in research and development, with expenses rising to $5 million from $3.7 million year-over-year, reflecting the costs associated with expanding its clinical team and trial activities.

Financially, Delcath's liquidity position remains strong, with cash and cash equivalents totaling $12.8 million and short-term investments of $46.1 million as of March 31, 2025. This is an increase from $32.4 million in cash and $20.8 million in short-term investments at the end of 2024. The company generated $2.2 million in cash from operating activities during the quarter, a significant improvement from the $9.6 million used in the same period last year. Delcath anticipates that its current cash resources will be sufficient to support operations for at least the next 12 months.

Looking ahead, Delcath Systems is focused on increasing the clinical adoption of its products and expanding its market presence. The company aims to leverage the positive results from its clinical trials to enhance reimbursement opportunities and drive further growth. However, it remains aware of the risks associated with the biopharmaceutical industry, including regulatory challenges and market competition, which could impact its future performance.