Key Highlights

  • Total Revenue was USD 35.1 million, compared with USD 20.6 million a year earlier.
  • Net income was USD 7 million, compared with USD 0.8 million.
  • Adjusted EBITDA was USD 11.5 million, compared with USD 5.3 million.
  • Full year revenue guidance was raised to USD 115 million to USD 117 million.

Delcath Systems, Inc. (NASDAQ:DCTH) reported third quarter 2026 total revenue of USD 35.1 million, compared with USD 20.6 million in the third quarter of 2025. The company described it as a record quarter, with revenue up 71% from the third quarter of 2025, and tied it to growing adoption of HEPZATO KIT. Reported EPS was USD 0.17, compared with estimates of EPS of negative USD 0.09 and revenue of USD 25.99 million.

HEPZATO KIT revenue was USD 32.7 million, compared with USD 19.3 million, on a Volume increase of 19% from the prior quarter and 72% year over year. CHEMOSAT revenue was USD 2.4 million, compared with USD 1.3 million.

Profitability and Cash

Gross Margin was 89%, compared with 87%. Research and Development expense was USD 11 million, compared with USD 8 million, and selling, general and administrative expense was USD 13.1 million, compared with USD 10.3 million. Net Income was USD 7 million, compared with USD 0.8 million, and adjusted EBITDA was USD 11.5 million, compared with USD 5.3 million.

Cash generated from operations was USD 8.2 million, compared with USD 4.8 million. The company ended the quarter with USD 104.3 million in cash and investments and no debt.

Treatment Centers and Adoption

Chief executive Gerard Michel said growth was driven by new patient starts of approximately 0.6 per site per month. The company has 33 active treatment centers in the U.S., with two more having patients scheduled this month and at least one more activation projected before year-end, which would bring the total to at least 36. The addition of AdventHealth, a system with more than 50 hospitals, over 2,000 care sites and roughly 4 million unique patients served each year, was highlighted, and management described it as a platform for referral volume and system-wide utilization of HEPZATO.

The 1,000th commercial HEPZATO treatment in the United States took place during the quarter. University Hospital Southampton delivered its 500th CHEMOSAT procedure.

Pipeline and Guidance

The company plans an IND submission for cholangiocarcinoma in early 2027 and, pending FDA agreement, completion of ongoing preclinical development of an oxaliplatin-based PHP program by mid-2027 to support a subsequent IND. The company said it provides updates as the programs reach regulatory and operational milestones in 2027.

For 2026, the company raised total revenue guidance to USD 115 million to USD 117 million, with HEPZATO KIT volume growth of at least 41% over 2025. Fourth quarter revenue is guided to USD 25.8 million to USD 27.8 million, representing year-over-year growth of approximately 25% to 34%. Full year gross margin is guided to 87% to 89%, with positive adjusted EBITDA.

Treatment Centers, Pipeline and Guidance

Delcath reported revenue of USD 35.1 million, net income of USD 7 million and USD 104.3 million in cash and investments with no debt. Full year revenue guidance of USD 115 million to USD 117 million is positioned for at least 41% HEPZATO KIT volume growth over 2025. Management cited at least 36 treatment centers by year end, new patient starts per site per month, a fourth quarter revenue range and planned regulatory submissions in 2027.