Delcath Systems Reports Fourth Quarter and Full Year 2025 Results
MWN-AI** Summary
Delcath Systems, Inc. (Nasdaq: DCTH), a company focused on interventional oncology for liver cancers, reported strong financial results for the fourth quarter and full year ended December 31, 2025. The company achieved total revenues of $20.7 million for the fourth quarter and $85.2 million for the full year, marking significant growth from the previous year. Specifically, the HEPZATO KIT, its flagship product for hepatic chemotherapy, generated $19.0 million in Q4 and $78.8 million for the full year, while CHEMOSAT contributed $1.7 million and $6.4 million, respectively.
Delcath noted an impressive gross margin of 85% in Q4 and 86% for the full year. While the fourth quarter ended with a net loss of $1.9 million, the company reported a net income of $2.7 million for the entire year, an improvement compared to a loss of $26.4 million in 2024. The adjusted EBITDA figures were particularly noteworthy—positive adjustments of $2.4 million for Q4 and $25.1 million for the year indicated robust operational strength.
The company's activities included the repurchase of shares totaling $6.0 million as part of a previously approved buyback program, and as of December 31, 2025, Delcath's cash and short-term investments stood at $91.0 million, with no debt.
Significantly, Delcath announced a 140% increase in HEPZATO procedure volume compared to 2024, alongside the expansion of active treatment centers to 28. The publication of key clinical trial results has further established the therapeutic efficacy of HEPZATO, underlining Delcath’s promising trajectory as it looks toward 2026 with an optimistic revenue target of at least $100 million.
MWN-AI** Analysis
Delcath Systems, Inc. (DCTH) has recently reported its fourth-quarter and full-year results for 2025, showcasing a robust upward trajectory with total revenues reaching $20.7 million for the quarter and $85.2 million for the year. The standout performer has been the HEPZATO KIT, generating nearly $79 million over the fiscal year, reflecting a significant increase in adoption of its interventional oncology solutions for liver cancer treatment.
From a financial perspective, Delcath has demonstrated a sound operational model, with gross margins consistently high at 85-86%. Notably, the company achieved a full-year net income of $2.7 million, which is a significant turnaround compared to prior losses, hinting at improved profitability metrics and operational efficiency. The positive adjusted EBITDA figures of $25.1 million for the year further support the view that Delcath is on a path towards sustainable growth.
For potential investors, the company’s outlook for 2026 is promising, with projections indicating total revenue exceeding $100 million. The expectation of at least a 20% increase in HEPZATO KIT volume is feasible given the 140% growth experienced in 2025. The favorable clinical data emerging from studies, particularly the promising results from the CHOPIN trial, highlight compelling efficacy, potentially accelerating physician adoption rates of the HEPZATO KIT.
The absence of debt, combined with a robust cash position of approximately $91 million, provides Delcath with the necessary liquidity to continue its expansion strategies while navigating any potential market fluctuations.
In conclusion, investors may find Delcath Systems an appealing opportunity, especially with the company positioned for continued growth in a critical segment of oncology. However, careful consideration of market dynamics and ongoing clinical development should be factored into any investment decision.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
Conference Call Today at 8:30 a.m. Eastern Time
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 reported financial results and business highlights for the fourth quarter and full year-ended December 31, 2025.
Fourth Quarter and Full Year 2025 Financial Results
- Total fourth quarter and full year revenue of $20.7 million and $85.2 million, respectively
- HEPZATO KIT ™ fourth quarter and full year revenue of $19.0 million and $78.8 million, respectively
- CHEMOSAT ® fourth quarter and full year revenue of $1.7 million and $6.4 million, respectively
- Gross margins of 85% for the fourth quarter and 86% for the full year
- Fourth quarter net loss of $1.9 million and full year net income of $2.7 million
- Non-GAAP positive adjusted EBITDA for the fourth quarter and full year of $2.4 million and $25.1 million, respectively
- Repurchased 628,572 common shares for $6.0 million through December 31, 2025 under the approved $25 million Share Buyback Program
- As of December 31, 2025, the Company had approximately $91.0 million of cash and short-term investments and no debt
Business Highlights
- Currently 28 active centers
- Approximately 140% growth in HEPZATO procedure volume in 2025 compared to 2024
- Announced the publication of additional results from the FOCUS study, “Subgroup Analyses of the Phase 3 FOCUS Study of Melphalan/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma” in Journal of Cancer Research and Clinical Oncology
- Announced the publication of results from multiple studies by independent investigators, including:
- Results from the Phase 2 CHOPIN trial sponsored by Leiden University Medical Center evaluating CHEMOSAT with ipilimumab and nivolumab in metastatic uveal melanoma at the 2025 European Society of Medical Oncology Annual Congress showing a significant improvement in one-year progression-free survival versus CHEMOSAT alone
- A long-term retrospective study conducted by researchers at the University Hospital Tübingen, Germany, “Characterization of long-term survivors with liver metastases from uveal melanoma diagnosed between 2005 and 2021”, in International Journal of Cancer
- A long-term retrospective study conducted by researchers at the Asklepios Hospital Barmbek, Germany, “Survival Outcome After Percutaneous Hepatic Perfusion with High-Dose Melphalan for Liver-Dominant Metastatic Uveal Melanoma: A 10-Year Single-Center Experience” in Cancers
“2025 was a pivotal year in which we delivered robust procedure-volume growth, positive operating cashflow and successfully navigated temporary headwinds to stabilize the HEPZATO revenue base in the fourth quarter,” said Gerard Michel, President and Chief Executive Officer of Delcath “With 28 active treatment centers now delivering therapy and compelling CHOPIN data demonstrating clear clinical benefit when PHP is sequenced with checkpoint inhibitors, we enter 2026 with strong momentum. Through continued site activations, commercial expansion, and heightened physician awareness of the CHOPIN results, we expect accelerated adoption and utilization that will drive long-term value for patients and shareholders alike.”
2026 Full Year Financial Guidance
The Company’s financial outlook for fiscal year 2026:
- Total CHEMOSAT and HEPZATO KIT revenue to be at least $100 million, reflecting an increase in HEPZATO KIT volume of at least 20% over 2025, and
- Gross margins in the range of 84% to 87%.
Fourth Quarter and Full Year 2025 Results
Total revenue for the quarter ended December 31, 2025 was $20.7 million compared to $15.1 million for the same period in the prior year. Revenue in the quarter includes sales of $19.0 million of HEPZATO in the U.S. and $1.7 million of CHEMOSAT in Europe.
Total revenue for the year-ended December 31, 2025 was $85.2 million compared to $37.2 million for the same period in the prior year. Revenue in 2025 includes sales of $78.8 million of HEPZATO in the U.S. and $6.4 million of CHEMOSAT in Europe.
Research and development expenses for the quarter and year-ended December 31, 2025, were $9.4 million and $29.2 million, respectively compared to $2.9 million and $13.9 million for the same periods in the prior year. The increase is primarily due to costs associated with expanding the clinical team including share-based compensation expense related to an increase in headcount and initiation of the Phase 2 clinical trial evaluating HEPZATO in combination with standard of care for mCRC and mBC. In 2024, these costs are primarily related to medical affairs and regulatory costs associated with the approved products.
Selling, general and administrative expenses for the quarter and year-ended December 31, 2025, were $10.5 million and $43.5 million, respectively compared to $7.0 million and $29.6 million for the same periods in the prior year. The increase is primarily due to continued commercial expansion activities including marketing-related expenses and additional personnel on the commercial team. In addition, the increase in personnel along with higher grant date exercise prices has increased the share-based compensation expense.
Net loss for the quarter ended December 31, 2025 was $1.9 million and net income for the full year was $2.7 million, compared to net loss of $3.4 million and $26.4 million for the same periods in the prior year.
Non-GAAP positive adjusted EBITDA for the quarter and year-ended December 31, 2025 was $2.4 million and $25.1 million compared to adjusted EBITDA gain of $4.6 million and loss of $2.5 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, 2025, the Company had $91.0 million in cash and investments, and no debt.
Conference Call Information
To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call.
Event Date: Thursday, February 26, 2026
Time: 8:30 AM Eastern Time
Participant Numbers:
Toll Free: 1-877-407-3982
International: 1-201-493-6780
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1747469&tp_key=15ec7bd15c
A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company's website https://investors.delcath.com/news-events/events-and-presentations .
GAAP v. Non-GAAP Measures
Delcath’s reported earnings are prepared in accordance with generally accepted accounting principles in the United States, or GAAP, and represent earnings as reported to the Securities and Exchange Commission. Delcath has provided in this release certain financial information that has not been prepared in accordance with GAAP. Delcath’s management believes that the non-GAAP adjusted EBITDA described in this release, which includes adjustments for specific items that are generally not indicative of our core operations, provides additional information that is useful to investors in understanding Delcath’s underlying performance, business and performance trends, and helps facilitate period-to-period comparisons and comparisons of its financial measures with other companies in Delcath’s industry. However, the non-GAAP financial measures that Delcath uses may differ from measures that other companies may use. Non-GAAP financial measures are not required to be uniformly applied, are not audited and should not be considered in isolation or as substitutes for results prepared in accordance with GAAP.
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 (HDS) 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 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.
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, including the Company’s statements regarding the possible synergy seen in the successful Phase 2 CHOPIN Trial being transferable to clinical practice; Company’s 2026 financial outlook, 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: the Company’s commercialization plans and its ability to successfully commercialize the HEPZATO KIT; contributions to adjusted EBITDA; 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.
DELCATH SYSTEMS, INC. | |||||||
December 31, | December 31, | ||||||
Assets | |||||||
Current assets | |||||||
Cash and cash equivalents | $ | 43,454 | $ | 32,412 | |||
Short-term investments | 47,582 | 20,821 | |||||
Accounts receivable | 11,744 | 10,890 | |||||
Inventories | 10,252 | 6,933 | |||||
Prepaid expenses and other current assets | 6,498 | 2,704 | |||||
Total current assets | 119,530 | 73,760 | |||||
Property, plant and equipment, net | 3,166 | 1,790 | |||||
Right-of-use assets | 936 | 1,039 | |||||
Total assets | $ | 123,632 | $ | 76,589 | |||
Liabilities and Stockholders’ Equity | |||||||
Current liabilities | |||||||
Accounts payable | $ | 2,658 | $ | 961 | |||
Accrued expenses | 8,191 | 5,078 | |||||
Lease liabilities, current | 101 | 105 | |||||
Total current liabilities | 10,950 | 6,144 | |||||
Lease liabilities, non-current | 835 | 933 | |||||
Other liabilities, non-current | 628 | 766 | |||||
Total liabilities | 12,413 | 7,843 | |||||
Commitments and contingencies | |||||||
Stockholders’ equity | |||||||
Preferred stock, $.01 par value; 10,000,000 shares authorized; 24,819 and 11,357 shares issued and outstanding at December 31, 2023 and 2022, respectively | — | — | |||||
Common stock, $.01 par value; 80,000,000 shares authorized; 22,761,554 shares and 10,046,571 shares issued and outstanding at December 31, 2023 and 2022, respectively | 347 | 331 | |||||
Additional paid-in capital | 639,145 | 599,881 | |||||
Accumulated deficit | (528,848 | ) | (531,548 | ) | |||
Accumulated other comprehensive income | 575 | 82 | |||||
Total stockholders’ equity | 111,219 | 68,746 | |||||
Total liabilities and stockholders’ equity | $ | 123,632 | $ | 76,589 | |||
DELCATH SYSTEMS, INC. | |||||||||||||||
Three months ended | Year ended | ||||||||||||||
2025 | 2024 | 2025 | 2024 | ||||||||||||
Product revenue | 20,728 | 15,100 | $ | 85,231 | $ | 37,205 | |||||||||
Cost of goods sold | (3,010 | ) | (2,126 | ) | (11,797 | ) | (6,188 | ) | |||||||
Gross profit | 17,718 | 12,974 | 73,434 | 31,017 | |||||||||||
Operating expenses: | |||||||||||||||
Research and development expenses | 9,371 | 2,914 | 29,246 | 13,874 | |||||||||||
Selling, general and administrative expenses | 10,531 | 7,021 | 43,528 | 29,553 | |||||||||||
Total operating expenses | 19,902 | 9,935 | 72,774 | 43,427 | |||||||||||
Operating income (loss) | (2,184 | ) | 3,039 | 660 | (12,410 | ) | |||||||||
Change in fair value of warrant liability | — | (6,679 | ) | — | (14,071 | ) | |||||||||
Interest income, net | 857 | 295 | 2,920 | 125 | |||||||||||
Other expense | (7 | ) | (53 | ) | (70 | ) | (30 | ) | |||||||
Income (loss) before income taxes | (1,334 | ) | (3,398 | ) | 3,510 | (26,386 | ) | ||||||||
Income tax expense | 562 | — | 810 | — | |||||||||||
Net income (loss) | (1,896 | ) | (3,398 | ) | 2,700 | (26,386 | ) | ||||||||
Other comprehensive income (loss): | |||||||||||||||
Unrealized gain on investments adjustments | (198 | ) | 125 | 394 | (22 | ) | |||||||||
Foreign currency translation adjustments | (102 | ) | (54 | ) | 99 | (31 | ) | ||||||||
Total comprehensive income (loss) | $ | (2,196 | ) | $ | (3,327 | ) | $ | 3,193 | $ | (26,439 | ) | ||||
Common share data: | |||||||||||||||
Basic income (loss) per common share | $ | (0.05 | ) | $ | (0.11 | ) | $ | 0.08 | $ | (0.93 | ) | ||||
Weighted average number of basic shares outstanding | 36,445,905 | 32,014,365 | 35,821,157 | 28,511,393 | |||||||||||
Diluted income (loss) per common share | $ | (0.05 | ) | $ | (0.11 | ) | $ | 0.07 | $ | (0.93 | ) | ||||
Weighted average number of diluted shares outstanding | 36,445,905 | 32,014,365 | 39,919,557 | 28,511,393 | |||||||||||
DELCATH SYSTEMS, INC. | |||||||||||||||
(in thousands) | Three months ended | Twelve months ended | |||||||||||||
2025 | 2024 | 2025 | 2024 | ||||||||||||
Net income (loss) | $ | (1,896 | ) | $ | (3,398 | ) | $ | 2,700 | $ | (26,386 | ) | ||||
Stock-based compensation expense | 4,512 | 1,612 | 24,232 | 9,767 | |||||||||||
Depreciation | 80 | 38 | 238 | 134 | |||||||||||
Net interest (income) expense | (857 | ) | (295 | ) | (2,920 | ) | (125 | ) | |||||||
Fair value warrant adjustment | — | 6,679 | — | 14,071 | |||||||||||
Income tax expense | 562 | — | 810 | — | |||||||||||
Adjusted EBITDA (Non-GAAP) | $ | 2,401 | $ | 4,636 | $ | 25,060 | $ | (2,539 | ) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20260226305802/en/
Investor Relations Contact:
ICR Healthcare
investorrelations@delcath.com
FAQ**
How has the significant revenue growth for Delcath Systems Inc. (DCTH), particularly in HEPZATO KIT sales, influenced investor sentiment and projections for future financial performance?
What strategies is Delcath Systems Inc. (DCTH) implementing to enhance physician awareness of the CHOPIN study results, and how might this impact market adoption of their therapies?
Given the reported net income for 2025, what are Delcath Systems Inc. (DCTH)'s plans for reinvesting profits, and how could this affect shareholder value moving forward?
With $91 million in cash and no debt, how does Delcath Systems Inc. (DCTH) intend to utilize its financial position for growth and potential expansion in 2026?
**MWN-AI FAQ is based on asking OpenAI questions about Delcath Systems Inc. (NASDAQ: DCTH).
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