Delcath Systems (DCTH) investor relations material

Executive summary

• Achieved total revenue of $25.0 million in Q1 2026, up from $19.8 million year-over-year, driven by HEPZATO KIT growth and commercial expansion in the U.S., with CHEMOSAT sales continuing in Europe.

• Net loss of $1.1 million for Q1 2026, compared to net income of $1.1 million in Q1 2025, reflecting increased R&D and SG&A expenses.

• Adjusted EBITDA was $3.4 million, down from $7.6 million year-over-year.

• HEPZATO KIT received FDA approval in August 2023 and saw first commercial use in January 2024; 29 REMS certified sites active and 36% HEPZATO volume growth year-over-year.

• 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 million, up 26% year-over-year; HEPZATO KIT contributed $23.3 million and CHEMOSAT $1.7 million.

• Gross margin was 85%, slightly down from 86% year-over-year.

• R&D expenses rose to $9.8 million from $5 million; SG&A increased to $13.1 million from $11.3 million.

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

• Repurchased $3 million in shares in Q1 under a $25 million buyback program; $9 million total repurchased to date.

Outlook and guidance

• 2026 revenue guidance is at least $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.

• R&D spending for 2026 now expected to increase 70-75% over 2025, lower than previously forecasted 90%.

• Site activation goal revised to 37 by year-end 2026, with 40 active centers targeted for Q1 2027.