Delcath Systems: Unlocking Liver Cancer Treatment with a Promising but Halted Strategy.

Delcath Systems is a company that markets a liver-directed chemotherapy system. The medication is more patient-friendly and less toxic than traditional products. The company is currently running trials to expand its use to more common cancers. Despite the potential, the company's progress is currently limited by regulatory hurdles.

Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, announced its financial results and business highlights for the second quarter ended June 30, 2025. The company reported total revenue of $24.2 million, compared to $7.8 million in the second quarter of 2024. Revenue from HEPZATO KIT™, a key product, reached $22.5 million, up from $6.6 million in the same period last year. CHEMOSAT® revenue amounted to $1.7 million, compared to $1.2 million in the prior year [1].

The company achieved a gross margin of 86%, up from 80% in the second quarter of 2024, and reported net income of $2.7 million, compared to a net loss of $13.7 million in the same period last year. Non-GAAP positive adjusted EBITDA in the second quarter was $9.8 million, compared to a loss of $0.8 million in the prior year. The company also reported cash provided by operations of $7.3 million and cash and investments of $81.0 million as of June 30, 2025, with no debt [1].

Delcath Systems activated three new U.S. centers in the second quarter, bringing the total to 20 active centers, with an additional 10 centers accepting referrals. The company also announced its intention to enter into a Medicaid National Drug Rebate Agreement (NDRA) to expand patient access beginning July 1, 2025. Additionally, Delcath received authorization from the European Union and United Kingdom regulatory authorities for the clinical study of Melphalan for Injection/Hepatic Delivery System in patients with refractory metastatic colorectal cancer with liver dominant disease [1].

The company's CEO, Gerard Michel, expressed confidence in HEPZATO’s long-term growth prospects, citing positive feedback from treating physicians and expanding interest at sites not yet activated. Delcath is well-prepared to pursue additional indications for HEPZATO, with a strong financial outlook and growing physician engagement [1].

For fiscal year 2025, Delcath Systems expects total CHEMOSAT and HEPZATO KIT revenue to be in the range of $93 to $96 million, an increase of more than 150% over 2024. Gross margins are expected to be in the range of 83% to 85%, with positive adjusted EBITDA and cashflow in each quarter [1].

References:

[1] https://investors.delcath.com/news-releases/news-release-details/delcath-systems-reports-second-quarter-2025-results-and-business