Delcath Systems, Inc. (NASDAQ: DCTH) reported fourth‑quarter revenue of $20.7 million, up 37% from $15.1 million in Q4 2024, and full‑year revenue of $85.2 million, more than double the $37.2 million recorded in 2024. HEPZATO kit sales accounted for $19.0 million of the quarterly top line and $78.8 million of the annual figure, while CHEMOSAT sales contributed $1.7 million quarterly and $6.4 million annually, underscoring the company’s expanding international presence.
The company posted a net loss of $1.9 million for the quarter but turned a $2.7 million net income for the year, a turnaround from the $26.4 million loss in 2024. Adjusted EBITDA rose to $2.4 million in Q4 and $25.1 million for the year, reflecting improved operating cash flow. Gross margins reached 85% for Q4 and 86% for the full year, up from 83% in 2024, driven by the higher mix of high‑margin HEPZATO kit sales and disciplined cost management.
HEPZATO kit sales dominated the revenue mix, representing 92% of quarterly revenue and 93% of annual revenue. CHEMOSAT sales, while smaller, grew modestly, reflecting continued demand in Europe. The company cited “temporary headwinds” that were mitigated in Q4, allowing the HEPZATO revenue base to stabilize. R&D and SG&A expenses increased, reflecting investment in clinical teams, new trials, and commercial expansion, but were offset by the margin expansion from the HEPZATO mix.
"2025 was a pivotal year, delivering over 40% volume growth and record revenue of $85.2 million, including $20.7 million in the fourth quarter alone," said CEO Gerard Michel. He added that the company now operates 28 active treatment centers and that the CHOPIN data, demonstrating clinical benefit when PHP is sequenced with checkpoint inhibitors, is slated for publication. CFO Sandra Pennell noted that SG&A expenses rose due to continued commercial expansion and that the company’s gross margin outlook for 2026 is between 84% and 87%, with the 340B pricing program providing a stable revenue stream.
Delcath guided for full‑year 2026 revenue of at least $100 million, a figure below the analyst consensus of approximately $115.7 million. Investors reacted to the guidance shortfall, though the company’s strong Q4 performance and EPS beat of $0.05 versus an estimate of $-0.06 or $-0.08 were highlighted as positive signs of execution. The guidance reflects management’s cautious view of demand growth, while the EPS beat underscores effective cost control and a favorable product mix.
The company’s record revenue, profitability turnaround, and expanding commercial footprint position it well for continued growth. Ongoing clinical trials, including studies for metastatic colorectal and breast cancer, and the CHOPIN data are expected to broaden the total addressable market. Delcath’s share buyback program signals confidence in its valuation, and the 340B pricing program continues to support a stable revenue base.
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