DCTH — Delcath Systems, Inc.

Summary of Delcath Systems, Inc. Q4 2025 Earnings Call

1. Key Financial Results and Metrics

• Q4 Revenue: $19 million from Hepzato and $1.7 million from ChemoSAT, up from $13.7 million and $1.4 million, respectively, in Q4 2024.
• Full Year Revenue: $85.2 million total, with $78.8 million from Hepzato and $6.4 million from ChemoSAT, significantly higher than $32.3 million and $4.9 million in 2024.
• Gross Margins: 85% in Q4 and 86% for the full year.
• Net Loss: $1.9 million in Q4, improved from a $3.4 million loss in Q4 2024; full-year net income of $2.7 million, a turnaround from a $26.4 million loss in 2024.
• Adjusted EBITDA: Positive $25.1 million for 2025, compared to a loss of $2.5 million in 2024.
• Cash Position: Approximately $91 million in cash and investments, with positive operating cash flow of $22.5 million for the year.

2. Strategic Updates and Business Highlights

• Volume Growth: Achieved over 40% volume growth in 2025, driven by expansion to 28 active treatment centers.
• CHOPIN Study: Anticipated results showing clinical benefits of Hepzato PHP with checkpoint inhibitors expected to drive further growth and site activations.
• Commercial Strategy: Focused on expanding site capacity, changing prescribing patterns, and building referral networks. Plans to increase active treatment centers to 40 by 2026.
• Clinical Trials: Ongoing trials in metastatic colorectal and breast cancer, with expectations to activate nearly all targeted sites by mid-2026.

3. Forward Guidance and Outlook

• 2026 Revenue Guidance: Projecting at least $100 million, reflecting over 20% growth in Hepzato Kit procedure volume and over 10% growth in ChemoSAT.
• Gross Margin Expectations: Forecasted between 84% and 87% for 2026.
• R&D and SG&A Expenses: Anticipated increases of nearly 90% and 50%, respectively, due to ongoing clinical trials and commercial expansion.

4. Challenges and Points of Concern

• Seasonality: Expected seasonal declines in Q3 due to physician schedules and staffing challenges at treatment centers.
• Pricing Variability: Ongoing uncertainty regarding the impact of 340B pricing changes on revenue and margins.
• Market Competition: Potential headwinds from competitive clinical trials affecting patient availability and recruitment.

5. Notable Q&A Insights

• CHOPIN Study Impact: Management expects the publication of CHOPIN results imminently, which could influence prescribing practices and site activations.
• Referral Development: Emphasis on educating oncologists in community settings to improve patient referrals for Hepzato treatment.
• Operational Focus: Management prioritizes long-term value over short-term cash flow, indicating a willingness to incur losses in pursuit of growth.
• Site Capacity: Challenges in increasing patient volume at existing centers due to operational constraints and physician availability.

Overall, Delcath Systems demonstrated significant growth in 2025, with a positive outlook for 2026, although challenges related to seasonality, pricing, and competition remain.