Summary of Delcath Systems FY Conference Call - September 10, 2025 Company Overview - **Company**: Delcath Systems (NasdaqCM:DCTH) - **Industry**: Oncology, specifically focused on liver cancers - **Lead Product**: HEPZATO KIT, a minimally invasive percutaneous perfusion technology launched in January 2024 for treating primary and secondary liver tumors [2][4] Core Business Strategy - **Initial Focus**: Targeting metastatic uveal melanoma, an ultra-orphan indication where the liver is often the life-limiting organ [4][5] - **Market Potential**: Over 100,000 patients annually in the U.S. have liver as a life-limiting organ due to cancer [4] - **Expansion Plans**: Revenue from the initial indication will fund expansion into other cancers, including metastatic colorectal cancer (40,000 patients annually), breast cancer, and pancreatic cancer [5][6] Competitive Advantages of HEPZATO KIT - **Unique Treatment Method**: Unlike other liver-directed therapies (Y-90, microwave ablation, TACE), HEPZATO KIT perfuses the entire liver with chemotherapy, allowing for treatment of multiple small metastases that are not visible on imaging [6][7][8] - **Liver Function Preservation**: High doses of melphalan can be administered without losing liver function, unlike other methods that can compromise liver health [8] Commercial Growth and Center Activation - **Current Status**: 22 active commercial centers in the U.S. with plans to grow to 40 centers next year [9][10] - **Revenue Guidance**: Revised guidance for the year is $93 million to $96 million, with growth linked to the number of active centers [9][10] - **Procedure Volume**: Average of two procedures per center per month, with potential for growth through referrals and operational improvements [10][14] Training and Operational Challenges - **Team Composition**: Each treatment team consists of an Interventional Radiologist, Anesthesiologist, and Perfusionist, which requires coordination and training [18][19] - **Training Complexity**: Training involves didactic learning and proctoring, which can be logistically challenging [18][19] Medicaid National Drug Rebate Agreement (NDRA) - **Impact on Revenue**: NDRA participation results in a 11% to 13% decrease in revenue per kit, affecting Q3 financials but potentially increasing patient access [20][23] - **Reimbursement Changes**: New guidelines have expanded the number of customers under NDRA, which may help in patient access despite the revenue decrease [21][24] Clinical Development and Future Indications - **Current Trials**: Ongoing trials for metastatic colorectal cancer and breast cancer, with interim data expected in 1997-1998 [25][26] - **Future Studies**: Potential for additional studies based on the safety and efficacy of combining HEPZATO with immuno-oncology agents [27] Financial Health - **Cash Position**: Company is cash positive with no debt, indicating a strong financial position for future growth [29][30][32] Conclusion - **Outlook**: Delcath Systems is positioned for growth with a unique product offering in the oncology space, a solid commercial strategy, and a focus on expanding treatment indications while maintaining a strong financial position [29][30]