Delcath Systems Reveals Release of Expert Review on Percutaneous Hepatic Perfusion for Uveal Melanoma Liver Metastases
Publication of Review: Delcath Systems announced a narrative review published in the Journal of Vascular and Interventional Radiology, detailing the use of percutaneous hepatic perfusion (PHP) with melphalan for treating liver metastases from uveal melanoma, highlighting its clinical outcomes and future research directions.
Clinical Evidence and Outcomes: The review consolidates data showing objective response rates of 36%-72%, median overall survival of 15-20 months, and disease control rates up to 89%, emphasizing PHP's advantages over other therapies, including reduced risk of hepatic fibrosis and minimal long-term decline in quality of life.
HEPZATO KIT Overview: Delcath's HEPZATO KIT is an FDA-approved treatment for adult patients with unresectable hepatic metastases from uveal melanoma, designed to deliver high-dose chemotherapy to the liver while minimizing systemic exposure and side effects.
Future Research Directions: Ongoing studies are exploring the potential of PHP in combination with immunotherapy and its application to other metastatic cancers, indicating a broader scope for Delcath's interventional oncology efforts.
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- Significant Revenue Growth: Delcath Systems achieved over 40% volume growth in 2025, with total revenue reaching $85.2 million, including $20.7 million in Q4, indicating strong market performance and sustained growth potential.
- Treatment Center Expansion Plan: The company aims to increase the number of active treatment centers from 28 to 40 by the end of 2026, with an anticipated acceleration in activations in the second half of the year, which will enhance market coverage and customer service capabilities.
- Increased R&D and Operating Expenses: R&D expenses are expected to rise by nearly 90% in 2026, while SG&A expenses will increase by nearly 50%, reflecting the company's intent to invest in clinical and commercial expansions to support future growth.
- Improved Cash Flow and Profitability: The net income for 2025 was $2.7 million, a significant improvement from a loss of $26.4 million in 2024, with approximately $91 million in cash and investments at year-end, demonstrating robust financial health and positive operating cash flow trends.
- Earnings Performance: Delcath Systems reported a Q4 GAAP EPS of -$0.05, missing expectations by $0.01, yet revenue reached $20.73 million, reflecting a 37.3% year-over-year increase and exceeding estimates by $0.05 million, indicating strong growth potential in the market.
- HEPZATO KIT Revenue: The HEPZATO KIT™ generated $19.0 million in Q4 revenue and $78.8 million for the full year, demonstrating sustained market demand for this product line, which is expected to drive future revenue growth.
- CHEMOSAT Revenue: CHEMOSAT® contributed $1.7 million in Q4 revenue and $6.4 million for the full year, providing a stable foundation for overall company revenue despite being relatively small, reflecting the product's market acceptance.
- Future Outlook: The company anticipates total revenue of at least $100 million for fiscal year 2026, with HEPZATO KIT volume expected to increase by at least 20% over 2025, while gross margins are projected to range between 84% and 87%, showcasing confidence in future growth.
- Earnings Announcement: Delcath Systems (DCTH) is set to announce its Q4 earnings on February 26 before market open, with consensus EPS estimate at -$0.03 and revenue expected at $20.68 million, representing a 37% year-over-year increase.
- Stable Earnings Performance: Over the past year, DCTH has met EPS estimates 50% of the time and revenue estimates 50% of the time, indicating a consistent performance in earnings capability.
- Upward Revision Trend: In the last three months, EPS estimates have seen two upward revisions with no downward adjustments, while revenue estimates have experienced three upward revisions, reflecting increased market confidence in the company's future performance.
- Annual Revenue Outlook: Delcath Systems anticipates FY 2023 revenue of $85.2 million, highlighting the company's growth potential and positive outlook for business expansion in the market.
- Earnings Call Announcement: Delcath Systems, Inc. has announced a conference call scheduled for February 26, 2026, at 8:30 AM Eastern Time to discuss its fourth quarter and full year results for 2025, aiming to provide investors with insights into its financial performance and future outlook.
- Participation Details: Participants are advised to dial in 5 to 10 minutes before the call begins, with toll-free access at 1-877-407-3982 for U.S. callers and 1-201-493-6780 for international participants, ensuring timely access to the latest company updates.
- Webcast and Replay Availability: The call will be available via webcast at https://viavid.webcasts.com/starthere.jsp?ei=1747469&tp_key=15ec7bd15c, and a replay will be accessible shortly after the call concludes, allowing investors who cannot attend live to catch up on the discussion.
- Company Overview: Delcath Systems focuses on interventional oncology for liver cancers, with its proprietary HEPZATO KIT and CHEMOSAT products designed to deliver high-dose chemotherapy while minimizing systemic exposure and side effects, highlighting significant clinical relevance in cancer treatment.
- Revenue Growth: Delcath anticipates fourth quarter and full-year 2025 revenues of approximately $20.7 million and $85.2 million, indicating sustained growth potential in the liver cancer treatment sector.
- HEPZATO KIT Performance: Expected revenues for HEPZATO KIT are around $19.0 million and $78.8 million, reflecting strong market demand for the product and further solidifying Delcath's position in liver cancer treatment.
- Share Buyback Program: As of December 31, 2025, the company repurchased 628,572 common shares for $6.0 million, demonstrating confidence in its own value and creating shareholder returns.
- Clinical Trial Progress: HEPZATO procedure volume grew approximately 140% in 2025, showcasing the company's success in promoting new treatment options, which is expected to drive future revenue growth.
- OPXS Business Growth: Optex Systems Holdings is experiencing rising revenue and expanding margins through the design and manufacture of advanced optical sighting systems, indicating stable demand and financial health in the defense market.
- DCTH Business Transformation: Delcath Systems is commercializing its FDA-approved liver cancer treatment, with revenue gradually increasing, marking a successful transition from development to execution and addressing a serious medical need.
- MAMA Expansion Momentum: Mama's Creations is growing revenue at a healthy pace through fresh food sales in supermarkets and club stores nationwide, while maintaining operational leverage and balance sheet discipline, showcasing sustainable growth potential.
- Common Traits: All three companies are improving financial quality alongside revenue growth, indicating their long-term investment value in the microcap market, quietly strengthening while the market is distracted.







