On March 6, 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, reported financial results and business highlights for the fourth quarter and full year-ended December 31, 2024 (Press release, Delcath Systems, MAR 6, 2025, View Source [SID1234650953]).
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Fourth Quarter and Full Year 2024 Financial Results
Total fourth quarter and full year revenue of $15.1 million and $37.2 million, respectively
HEPZATO KIT fourth quarter and full year revenue of $13.7 million and $32.3 million, respectively
CHEMOSAT fourth quarter and full year revenue of $1.4 million and $4.9 million, respectively
Gross margins of 86% for the fourth quarter and 83% for the full year
Fourth quarter and full year net loss of $3.4 million and $26.4 million, respectively
Non-GAAP positive adjusted EBITDA for the fourth quarter of $4.6 million and full year adjusted EBITDA loss of $2.5 million
During the year, the exercise of warrants generated approximately $41.3 million in funding, resulting in year-end cash and investment balance of $53.2 million. The company’s fourth quarter operating cash burn was $1.0 million
As of December 31, 2024, there are no outstanding debt obligations
Business Highlights and Updates
Activated 4 U.S. centers in the fourth quarter and 2 more so far in the first quarter of 2025, bringing the current total to 16 active centers, with 8 additional centers currently accepting referrals
Received FDA Clearance of an IND Application for a Phase 2 Clinical Trial of HEPZATO in Liver-Dominant Metastatic Colorectal Cancer
Appointed Michael Brunner, M.D., as the Senior Vice President of Interventional Oncology to further Delcath’s research and development efforts. Dr. Brunner is the former President of the Society of Interventional Radiology with over 25 years of experience in academia and biotech leadership
The National Comprehensive Cancer Network (NCCN) updated its Clinical Practice Guidelines in Oncology (NCCN Guidelines) for metastatic uveal melanoma (mUM) treatment to include HEPZATO KIT as an option for patients with hepatic-dominant uveal melanoma, expanding from the previous guidance that limited its use to those with liver-confined metastases
"In 2024, the successful launch of HEPZATO drove strong financial and operational results, including positive adjusted EBITDA in the fourth quarter," said Gerard Michel, Delcath’s Chief Executive Officer. "As HEPZATO becomes more established as a leading treatment option for metastatic uveal melanoma, we’re seeing growing adoption across treatment centers and meaningful revenue growth. This momentum enables us to advance R&D programs targeting other liver-dominant cancers, including metastatic colorectal and breast cancer."
Fourth Quarter and Full Year 2024 Results
Total revenue for the quarter ended December 31, 2024 was $15.1 million compared to $0.5 million for the same period in the prior year. Revenue in the quarter includes sales of $13.7 million of HEPZATO in the U.S. and $1.4 million of CHEMOSAT in Europe.
Total revenue for the year-ended December 31, 2024 was $37.2 million compared to $2.1 million for the same period in the prior year. Revenue in 2024 includes sales of $32.3 million of HEPZATO in the U.S. and $4.9 million of CHEMOSAT in Europe.
Research and development expenses for the quarter and year-ended December 31, 2024, were $2.9 million and $13.9 million, respectively compared to $4.7 million and $17.5 million for the same periods in the prior year. The decrease is primarily due to lower costs associated with the NDA submission and expanded access program costs offset by an increase in medical affairs and regulatory costs associated with an approved product.
Selling, general and administrative expenses for the quarter and year-ended December 31, 2024, were $7.0 million and $29.6 million, respectively compared to $7.0 million and $22.1 million for the same periods in the prior year. The increase is primarily due to commercial launch activities including marketing-related expenses and additional personnel in the commercial team.
Net loss for the quarter and year-ended December 31, 2024 was $3.4 million and $26.4 million, respectively compared to net loss of $11.1 million and $47.7 million for the same periods in the prior year.
Non-GAAP adjusted EBITDA for the quarter and year-ended December 31, 2024 was $4.6 million and loss of $2.5 million, respectively, compared to adjusted EBITDA loss of $9.3 million and $30.0 million for the same periods in the prior year. A table reconciling non-GAAP measures is included in this press release for reference.
As of December 31, 2024, the Company had $53.2 million in cash and investments, and no debt.
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Event Date: Thursday, March 6, 2025
Time: 8:30 AM Eastern Time