Delcath Systems Reports Preliminary Q3 2025 Results

10/18/2025 – 04:15 PM

Conference Call October 20, 8:45am EST

QUEENSBURY, N.Y.–(BUSINESS WIRE)– Delcath Systems, Inc. (NASDAQ: DCTH), a company specializing in interventional oncology with a focus on treating both primary and metastatic liver cancers, today announced preliminary revenue and financial figures for the third quarter ending September 30, 2025. The company also updated its revenue guidance for the full year 2025.

Preliminary Third Quarter Financial Results (unaudited)

• Total CHEMOSAT and HEPZATO KIT revenue reached approximately $20.5 million.
  • HEPZATO KIT revenue accounted for $19.2 million.
  • CHEMOSAT revenue contributed $1.3 million.
• Gross margins are projected to be 87%.

Net income stood at $0.8 million.

• Adjusted EBITDA showed a positive figure of $5.3 million.

The company reported positive operating cash flow of approximately $4.8 million.

As of September 30, 2025, Delcath Systems held approximately $88.9 million in cash, cash equivalents, and short-term investments, with no outstanding debt.

2025 Full Year Financial Guidance

• Total CHEMOSAT and HEPZATO KIT revenue is projected to range from $83 million to $85 million, representing an approximate 150% increase in treatment volume compared to 2024.
• Quarterly gross margins are expected to be between 85% and 87%.
• Positive adjusted EBITDA and operating cash flow are anticipated for each quarter of 2025.

“While our third-quarter revenue experienced a slight dip compared to the second quarter, this was primarily attributable to NDRA discounts and unexpected summer seasonality impacting the scheduling of new patient onboarding,” stated Gerard Michel, Chief Executive Officer of Delcath Systems. “We are confident in achieving robust growth in 2026 and beyond. This anticipation is based on the ongoing expansion of active treatment centers and the promising outcomes observed in the CHOPIN trial, showcasing significant efficacy and providing practical advantages for initiating patients on systemic therapy while concurrently preparing them for PHP therapy.”

Conference Call Information

Delcath Systems, Inc. will host a conference call and webcast on October 20, 2025, at 8:45 a.m. Eastern Time to discuss the Phase 2 CHOPIN Trial results and provide a brief overview of the financial results announced in this release. Joining Delcath management on the call with pre-recorded remarks will be Dr. Vincent T. Ma, Assistant Professor and Medical Oncologist at the University of Wisconsin Department of Medicine, a current user of HEPZATO KIT for the treatment of metastatic uveal melanoma patients, an expert in treating cutaneous melanoma, and a co-author on the seminal Nature Medicine paper exploring liver immune tolerance mechanisms in cancer.

To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call.

Event Date: Monday, October 20

Time: 8:45 AM Eastern Time

About Delcath Systems, Inc., HEPZATO KIT, and CHEMOSAT

Delcath Systems, Inc. is an interventional oncology company focused on developing therapies for primary and metastatic liver cancers. The company’s key offerings are HEPZATO KIT (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT Hepatic Delivery System (HDS) for Melphalan percutaneous hepatic perfusion (PHP); both are designed to deliver high-dose chemotherapy directly to the liver, minimizing systematic exposure and associated side effects.

In the United States, HEPZATO KIT, a drug-device combination, is regulated and approved by the FDA as a drug. The kit combines the chemotherapeutic drug melphalan with Delcath’s proprietary HDS, which facilitates the isolation of hepatic venous blood from systemic circulation while simultaneously filtering it during melphalan infusion and washout. This approach permits targeted delivery of a high melphalan dose, inducing notable tumor response with reduced hepatotoxicity and systemic exposure. HEPZATO KIT is approved in the United States for treating adult patients with metastatic uveal melanoma (mUM) featuring unresectable hepatic metastases affecting less than 50% of the liver, devoid of extrahepatic disease, or with manageable extrahepatic disease.

In Europe, CHEMOSAT, constituted of the HDS device, is approved for sale as a Class III medical device, used in percutaneous hepatic perfusion procedures at major medical centers for diverse liver cancers. The system shows promise to be more widely adopted as specialized cancer centers enhance experience with percutaneous hepatic perfusion therapy using the CHEMOSAT platform.

Preliminary Nature of Third Quarter Financial Results

The financial results for the third quarter ended September 30, 2025, are preliminary and unaudited. They are subject to adjustments following the completion of quarter-end financial and accounting procedures. These results represent management estimates and are classified as forward-looking statements involving risks and uncertainties. The preliminary results are not a comprehensive financial statement for the quarter. Future information or events may lead to material differences between these preliminary results and those in Delcath’s SEC filings. Investors are therefore cautioned against placing undue reliance on these preliminary financial results.

GAAP v. Non-GAAP Measures

In addition to presenting financial information in accordance with generally accepted accounting principles in the United States of America (GAAP), Delcath also discloses adjusted non-GAAP financial measures. Management believes that the non-GAAP adjusted EBITDA figures in this release provide useful supplemental information for investors to understand Delcath’s underlying performance, business trends, and facilitate period-to-period comparisons and industry benchmarking. This metric adjusts for items not generally indicative of core operations. However, it must be noted that Delcath’s non-GAAP metrics can diverge from those employed by other firms, are not uniformly applied, unaudited, and should not supplant GAAP-compliant results.

Delcath does not provide guidance for net loss, the most directly comparable GAAP measure to Adjusted EBITDA, and similarly cannot provide a reconciliation between its forecasted Adjusted EBITDA and net loss without unreasonable effort due to the unavailability of reliable estimates for certain components of net income and the respective reconciliations. The company’s ability to forecast these variables is limited; therefore, forecasts of GAAP measures are not provided.

Forward Looking Statements

This press release includes forward-looking statements covered by the Private Securities Litigation Reform Act of 1995. These statements address expectations regarding the transferability of the CHOPIN trial’s success to real-world clinical practice, CHEMOSAT and HEPZATO KIT’s potential to improve patient outcomes in metastatic uveal melanoma, strategies to increase HEPZATO KIT adoption, the CHOPIN trial’s impact on new treatment site openings and patient referrals, Delcath’s ongoing growth in liver-directed oncology, and its full-year 2025 revenue guidance, which is subject to various risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, but are not limited to: the company’s commercialization plans for HEPZATO KIT; its capacity to manage the HEPZATO KIT supply chain; the outcomes of FDA inspections; the company’s implementation of the HEPZATO KIT Risk Evaluation and Mitigation Strategy; the potential and realized benefits of HEPZATO KIT for liver-related diseases; Delcath’s ability to gain reimbursement for HEPZATO KIT; and the successful conclusion of sales agreements. Factors influencing these statements are detailed in Delcath’s filings with the Securities and Exchange Commission. Readers are advised not to base decisions entirely on forward-looking statements, which reflect conditions only as of their initial date, and the company undertakes no obligation to revise these statements publicly.

This release also includes forward-looking statements concerning the anticipated release of data from already completed clinical trials, contingent on risks and uncertainties potentially affecting the scheduled data presentations or other unforeseen issues. A comprehensive discussion of these and other risks is available in Delcath’s reports filed with the SEC.