Delcath Raises 2026 Revenue Outlook to $117 Million, Expects HEPZATO Growth of 41%
Key Facts
Delcath Systems raised its 2026 combined revenue outlook for HEPZATO KIT and CHEMOSAT to a range of $115 million to $117 million, expecting HEPZATO sales volume to grow at least 41% compared with 2025. The guidance was included in its third-quarter results, which showed quarterly revenue rising to $35.1 million from $20.6 million in the same period a year earlier. The annual outlook sets a path above the $100 million floor the company had previously targeted for 2026. The company had tied that earlier guidance to growth of at least 20% in HEPZATO volume compared with 2025. The new higher target reflects the revenue outlook's reliance on continued growth in product sales volume, while CHEMOSAT remains part of combined revenue.
HEPZATO KIT accounted for most third-quarter revenue, with sales of $32.7 million compared with $19.3 million a year earlier. CHEMOSAT revenue was about $2.4 million, compared with $1.3 million in the third quarter of 2025. The comparison shows that the quarterly increase covered both products, with HEPZATO making the larger contribution to total sales. For the previous fiscal year, Delcath reported revenue of $85.2 million in 2025, compared with $37.2 million in 2024. 2025 revenue included about $78.8 million from HEPZATO in the United States and $6.4 million from CHEMOSAT in Europe, according to the company's results published in February 2026.
The company's net income rose to $7.0 million in the third quarter, compared with $0.8 million in the same period of 2025. Gross margin increased to 89% from 87% a year earlier, while adjusted EBITDA was $11.5 million, compared with $5.3 million. These metrics show income, margins and adjusted earnings rising at the same time as quarterly revenue increased. The company had $104.3 million in cash and investments on September 30, 2026, and had no debt, according to the disclosure. These figures provide a picture of its financial position at the end of the quarter in which it raised its revenue outlook.
The chief executive said on the earnings call that Delcath currently has 33 active treatment centers in the United States and is targeting at least 36 centers by the end of 2026. That sets the operational expansion target at at least three additional centers from the current number, based on the two figures disclosed. The disclosure said the number of active centers was the level at the time of the call, while the other figure was a year-end target. Expanding the network is one aspect of the business outlook alongside expected growth in HEPZATO volume, but the company did not explicitly link the number of centers to achieving the annual revenue range. The center target therefore remains an operational indicator separate from the combined revenue guidance.
Management expected fourth-quarter 2026 revenue of $25.8 million to $27.8 million, with year-over-year growth of approximately 25% to 34%. The range follows revenue of $35.1 million in the third quarter, making the next quarterly guidance lower than sales recorded in the preceding quarter. Management compares fourth-quarter growth with the same period a year earlier, not with the third quarter. The guidance provides a near-term estimate alongside the annual target of $115 million to $117 million. Markets are set to track the next quarterly figures against this range and the expected growth in HEPZATO volume for 2026.
On development, the company said it plans to submit an IND application for cholangiocarcinoma treatment in early 2027. It also expects to complete preclinical development of its oxaliplatin-based PHP program by mid-2027, subject to U.S. Food and Drug Administration approval. These timelines place the two programs at different stages: the first concerns a planned application, while the timing of the second is tied to completing preclinical work and regulatory approval. The FDA approved HEPZATO KIT on August 14, 2023, as a liver-directed treatment for adults with unresectable metastatic uveal melanoma, subject to the extrahepatic spread restrictions in the prescribing information. Efficacy was evaluated in the FOCUS study of 91 patients, which recorded an objective response rate of 36.3% and a median duration of response of 14 months.
Delcath shares rose in premarket trading on November 9, climbing 25.11% to $18.679, compared with a previous close of $14.93. The move coincided with the announcement of third-quarter results and the higher annual guidance, according to Investing.com data. On clinical development, the company had said in its annual report that it expected patient enrollment to begin in the first quarter of 2026 in a Phase 2 trial for liver-dominant, HER2-negative metastatic breast cancer. The trial targets about 90 patients at more than 15 sites in the United States and Europe, and compares HEPZATO with standard treatment alone. The expected enrollment start date was stated in the annual report; the information available here does not indicate whether enrollment began or whether its status has since been updated.