Delcath Systems (NASDAQ: DCTH) released preliminary financial results for the fourth quarter and the full year ended December 31 2025, reporting total revenue of $85.2 million—up 128% from $37.2 million in 2024—and a Q4 revenue of $20.7 million, a 3.5% beat over the consensus estimate of $19.99 million. The company’s guidance for 2026 is expected to build on this momentum, with management projecting continued growth in both revenue and profitability.
The results are driven almost entirely by the HEPZATO KIT, which generated $78.8 million of the full‑year revenue—an increase of 112% from $35.8 million in 2024—and $19.0 million in Q4, up 121% from $8.9 million in the same quarter last year. CHEMOSAT contributed $6.4 million for the year and $1.7 million in Q4, a modest 5% rise. The surge in HEPZATO sales reflects the company’s expansion to 25 active treatment centers, intensified physician education, and the positive impact of the CHOPIN trial results, which have accelerated adoption among interventional oncologists.
Gross margin for the year was 86%, a slight improvement over the 85% margin reported in 2024, driven by the high‑margin mix of HEPZATO KIT and the company’s efficient cost structure. Operating margin expanded to 12% from 10% in 2024, reflecting the scale advantage of the new product and disciplined operating expenses. The company’s EBITDA margin is projected to remain above 20% for the remainder of 2025, underscoring its ability to convert revenue growth into profitability.
Cash and liquidity remain robust, with $91.0 million in cash and short‑term investments and no debt on the balance sheet. Delcath has also completed a $6.0 million share‑buyback under a $25.0 million program, signaling management’s confidence in the company’s intrinsic value. The 340B pricing program continues to be a tailwind, providing a stable revenue stream from government‑affiliated hospitals, while the company is monitoring potential headwinds from NDRA discounts and seasonal scheduling patterns that impacted Q3 2025.
CEO Gerard Michel emphasized that the company is “well positioned to sustain growth and profitability” as it expands its commercial footprint and leverages the CHOPIN data to drive further adoption of HEPZATO KIT. He also noted that the strong cash position “enables us to invest in both commercial expansion and the initiation of additional clinical programs in 2026.” The company’s guidance for 2026 is expected to reflect continued demand acceleration, with a focus on increasing procedure volume and expanding into new geographic markets.
Market analysts reacted positively to the results, citing the revenue beat, the company’s strong cash reserves, and the accelerated growth of HEPZATO KIT as key drivers. The positive sentiment reflects confidence in Delcath’s commercial strategy and its ability to translate clinical evidence into market share gains.
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