DCTH · Delcath Systems, Inc.

Delcath Systems delivered Q1 2026 results with total revenue of $25.0 million, a 26% increase from $19.8 million in Q1 2025, primarily driven by HEPZATO KIT sales rising to $23.3 million from $18.0 million, reflecting approximately 36% volume growth and 20% sequential volume increase over the prior quarter. CHEMOSAT revenue in Europe remained stable at $1.7 million. Gross margins dipped slightly to 85% from 86%, amid scaling production. Operating expenses rose significantly, with R&D up to $9.8 million from $5.0 million due to clinical team expansion and Phase 2 trials for HEPZATO, and SG&A increasing to $13.1 million from $11.3 million from commercial activities, marketing, and headcount growth. This led to a GAAP net loss of $1.1 million versus prior-year income of $1.1 million, with non-GAAP adjusted EBITDA at $3.4 million down from $7.6 million. CEO Gerard Michel highlighted strong new patient starts and the impact of the CHOPIN Phase 2 trial results published in The Lancet Oncology, showing improved progression-free survival in metastatic uveal melanoma when combining percutaneous hepatic perfusion with ipilimumab and nivolumab; CHEMOSAT was also endorsed in new ESMO–EURACAN guidelines. The company now operates 29 active centers. For full-year 2026, guidance targets at least $100 million in total revenue with HEPZATO KIT volume up at least 20% over 2025, gross margins of 84-87%, and positive adjusted EBITDA. Balance sheet remains solid with $89.3 million in cash and investments, no debt, and $0.9 million operating cash flow; share repurchases of 316,023 shares for $3.0 million under the $25 million program signal confidence in valuation.