Delcath Systems (DCTH) investor relations material

Executive summary

• Achieved record annual revenue of $85.2 million in 2025, up over 40% year-over-year, with $20.7 million in Q4 alone.

• HEPZATO KIT drove $78.8 million in annual revenue, with CHEMOSAT contributing $6.4 million.

• Ended 2025 with 28 active treatment centers and 140% growth in HEPZATO procedure volume compared to 2024, targeting 40 centers by end of 2026.

• CHOPIN trial data demonstrated significant clinical benefit for PHP when sequenced with checkpoint inhibitors, with publication imminent.

• Commercial strategy focuses on expanding site capacity, changing prescribing patterns, and building referral networks.

Financial highlights

• Q4 2025 revenue: $19 million from HEPZATO and $1.7 million from CHEMOSAT; full year: $78.8 million HEPZATO, $6.4 million CHEMOSAT.

• Gross margins: 85% in Q4 and 86% for 2025, up from 83% in 2024.

• Q4 2025 net loss: $1.9 million (improved from $3.4 million loss in Q4 2024); full year 2025 net income: $2.7 million (vs. $26.4 million loss in 2024).

• Adjusted EBITDA for 2025: $25.1 million, up from a $2.5 million loss in 2024.

• Ended 2025 with $91 million in cash and investments; $22.5 million operating cash flow for the year.

Outlook and guidance

• 2026 revenue guidance: at least $100 million, with >20% HEPZATO KIT volume growth and >10% CHEMOSAT growth.

• Gross margin guidance for 2026: 84%-87%, with potential to reach 90% in 2027 and beyond.

• R&D expenses expected to increase by nearly 90% in 2026; SG&A to rise by nearly 50%.

• Anticipates accelerated adoption and utilization driven by new site activations and positive clinical data.

• Average selling price for HEPZATO projected at $175,000 per kit, reflecting a 10% discount due to 340B pricing.