Delcath Systems (DCTH) investor relations material

Executive summary

• Achieved record Q1 2026 revenue of $25.0 million, up from $19.8 million year-over-year, driven by HEPZATO KIT growth, commercial expansion, and four new center activations.

• U.S. commercial expansion nearly complete, covering nine regions with 29 REMS certified sites and active discussions with over 50 potential new centers.

• CHOPIN trial results published in The Lancet Oncology are influencing treatment patterns, increasing adoption of combination protocols, and driving guideline inclusion.

• Referral network development and physician education are key strategies to sustain long-term growth.

• Ongoing Phase 2 clinical trials for HEPZATO in metastatic colorectal and breast cancer, with enrollment underway or planned.

Financial highlights

• Q1 2026 revenue was $25.0 million, with HEPZATO KIT contributing $23.3 million and CHEMOSAT $1.7 million.

• Gross margin was 85%, slightly down from 86% in Q1 2025.

• R&D expenses rose to $9.8 million from $5.0 million, and SG&A increased to $13.1 million from $11.3 million.

• Net loss of $1.1 million versus net income of $1.1 million in Q1 2025; adjusted EBITDA was $3.4 million, down from $7.6 million.

• Cash and investments totaled $89.3 million as of March 31, 2026, with no debt.

Outlook and guidance

• 2026 revenue guidance set at a minimum of $100 million, reflecting at least 20% HEPZATO KIT volume growth over 2025.

• Gross margin expected to remain between 84%-87% for 2026.

• Positive adjusted EBITDA anticipated for the remainder of 2026.

• Current cash, equivalents, and investments expected to support operations for at least 12 months.

• Seasonal trends expected in Q3 and Q4, with efforts underway to mitigate capacity constraints and patient scheduling delays.