Delcath Reports Diluted Income of $0.17 per Share as Quarterly Revenue Rises
Key Facts
Delcath Systems reported diluted income of $0.17 per share in the third quarter of 2026, compared with $0.02 in the same period last year, according to a filing with the U.S. Securities and Exchange Commission. Quarterly revenue rose to $35.1 million from $20.6 million a year earlier. Net income was $7.0 million, compared with $0.8 million in the third quarter of 2025. Gross margin increased to 89% from 87%, while adjusted earnings before interest, taxes, depreciation and amortization were $11.5 million, versus $5.3 million. The results combine sales growth with expanding profitability, while spending on clinical development and commercial expansion remains part of the financial picture.
Most of the quarter’s revenue came from the U.S. product HEPZATO KIT, with sales of $32.7 million, while Europe’s CHEMOSAT generated $2.4 million in revenue. The company said HEPZATO KIT volume grew about 72% year over year during the quarter and that it had 33 active treatment centers when it reported results. The revenue mix reflects the commercial business’s heavy reliance on the U.S. product, alongside a contribution from the European product. The company said gross margin was 89%, up from 87% a year earlier. Delcath reported full-year 2025 revenue of $85.2 million, compared with $37.2 million in 2024, including $78.8 million in U.S. sales of HEPZATO KIT.
Revenue growth coincided with higher expenses tied to research and development and commercial operations. Research and development expenses rose to $11.0 million in the third quarter of 2026 from $8.0 million a year earlier, which the company attributed to an increase in clinical staff and greater trial activity. General and administrative expenses also climbed to $13.1 million from $10.3 million in the year-earlier period, due to commercial expansion. Cash and investments totaled $104.3 million on September 30, 2026, and the company said it had no debt. These figures provide context for funding commercial and clinical activity in parallel, while the quarter’s rise in expenses remains clear.
Delcath raised its 2026 revenue outlook for HEPZATO KIT and CHEMOSAT to a range of $115–117 million, with expected HEPZATO KIT volume growth of at least 41% compared with 2025. Guidance accompanying the results also pointed to fourth-quarter revenue of $25.8 million to $27.8 million, a full-year gross margin of 87% to 89%, and positive adjusted earnings for the year. The company describes HEPZATO KIT as a liver-directed treatment for a specific group of adults with metastatic uveal melanoma; it received U.S. Food and Drug Administration approval on August 14, 2023. The product’s performance and the expansion of treatment centers make the pace of commercial use a factor in assessing the annual outlook. The company is targeting at least 36 active U.S. treatment centers by the end of 2026.
In clinical development, the company said the first patient in its global Phase 2 DILOMA trial was dosed in Milan on July 9, 2026. The randomized trial is designed to enroll about 90 patients at more than 20 sites in the United States and Europe. The chief executive said combining the treatment with systemic therapies, or sequencing its use with them, has become more common, and that some doctors add it quickly when patients arrive at treatment centers after receiving those therapies. The company also outlined a potential timing for an interim analysis update from its colorectal cancer trial during the second or third quarter of 2027. The company scheduled a call to discuss its third-quarter results for November 9, 2026, at 8:30 a.m. Eastern time.
Delcath shares closed at $14.93 on November 6, before the results were announced. After the announcement, the stock rose 25.11% to $18.679 in premarket trading on November 9, according to Investing.com coverage. The shares in that trading exceeded the previous close of $14.93 and topped the 52-week high of $17.42. The move coincided with the announcement of revenue and net income growth and a higher full-year outlook. The results call was scheduled for the morning of the announcement to discuss performance and the company’s guidance.