Delcath Systems Announces Preliminary Fourth Quarter and Full Year 2024 Financial Results

Rhea-AI Summary

Delcath Systems (NASDAQ: DCTH) has released preliminary financial results for Q4 and full-year 2024. The company reported Q4 revenue of approximately $15.1 million and full-year revenue of $37.2 million. Their primary product, HEPZATO KIT™, generated Q4 revenue of $13.7 million and full-year revenue of $32.3 million, while CHEMOSAT® contributed $1.4 million in Q4 and $4.9 million for the full year.

The company expects gross margins to range between 80%-85%. As of December 31, 2024, Delcath maintained a strong financial position with $53.2 million in cash, cash equivalents, and short-term investments, with no debt. Complete financial results and a detailed business update will be provided during their annual financial results release on March 6, 2025.

Positive

• Strong Q4 revenue of $15.1 million and full-year revenue of $37.2 million
• Healthy gross margins between 80-85%
• Solid cash position of $53.2 million with zero debt
• HEPZATO KIT represents 87% of total revenue, showing strong product adoption

Negative

• None.

Insights

Financial Analyst

Delcath's Q4 2024 results showcase remarkable commercial execution with $15.1 million in quarterly revenue, primarily driven by $13.7 million from HEPZATO KIT™. The robust 80-85% gross margins indicate strong operational efficiency and pricing power. The company's healthy balance sheet with $53.2 million in cash and zero debt provides substantial runway for continued commercial expansion.

The sequential revenue growth and successful HEPZATO launch demonstrate strong market adoption. The product mix shows HEPZATO generating 87% of revenues while CHEMOSAT contributes 13%, indicating successful penetration in the US market. The cash position covers approximately 12-15 months of operations at current burn rates, providing adequate runway for commercial expansion.

Market Research Analyst

The preliminary results validate Delcath's market positioning in the interventional oncology space. The $32.3 million full-year HEPZATO revenue suggests strong physician adoption and reimbursement success in its first full year post-approval. The revenue split between HEPZATO and CHEMOSAT reflects successful market segmentation strategy between US and European markets.

Key performance indicators point to accelerating market penetration:

• Quarterly revenue run-rate approaching $60 million annually
• Strong gross margins indicating premium pricing power
• Healthy balance sheet supporting continued commercial infrastructure build-out

The company's execution in establishing its commercial presence positions it well for continued growth in the liver-directed therapies market.

Fourth Quarter Revenue Approximately $15.1 Million and Full Year Total Revenue Approximately $37.2 Million

QUEENSBURY, N.Y.--(BUSINESS WIRE)-- 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)

• Total fourth quarter and full year revenue expected to be approximately $15.1 million and $37.2 million, respectively
• HEPZATO KIT™ fourth quarter and full year revenue expected to be approximately $13.7 million and $32.3 million, respectively
• CHEMOSAT^® fourth quarter and full year revenue expected to be approximately $1.4 million and $4.9 million, respectively
• Gross margins expected to be in the 80%-85% range
• As of December 31, 2024, the Company had approximately $53.2 million of cash, cash equivalents and short-term investments and no debt

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 liver.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250113360378/en/

Investor Relations:

ICR Healthcare

investorrelations@delcath.com

Source: Delcath Systems, Inc.

FAQ

What was Delcath Systems (DCTH) revenue for Q4 2024?

Delcath Systems reported preliminary Q4 2024 revenue of approximately $15.1 million.

How much revenue did HEPZATO KIT generate for Delcath (DCTH) in 2024?

HEPZATO KIT generated approximately $32.3 million in revenue for the full year 2024.

What are Delcath's (DCTH) gross margins for 2024?

Delcath expects gross margins to be in the 80%-85% range for 2024.

What is Delcath Systems' (DCTH) cash position as of December 31, 2024?

As of December 31, 2024, Delcath had approximately $53.2 million in cash, cash equivalents and short-term investments with no debt.

When will Delcath (DCTH) release its full 2024 financial results?

Delcath will release its full 2024 financial results and provide a detailed business update on March 6, 2025.