Delcath Systems (DCTH) investor relations material

Commercial strategy and growth

• Focus on treating liver cancers, starting with metastatic uveal melanoma as the initial ultra-orphan indication to fund expansion into broader cancer types.

• Revenue from the first indication will support trials and commercialization in metastatic colorectal and breast cancers, with ongoing trials in both.

• The HEPZATO KIT was launched in January 2024, with 22 active commercial centers and plans to reach 40 centers next year.

• Expansion of active centers is directly tied to revenue growth, with a long-term potential of up to 70 centers for optimal efficiency.

• Regional teams are structured to open, support, and manage centers, and to build referral networks to increase patient access.

Product differentiation and operational execution

• HEPZATO KIT offers whole-liver perfusion with high-dose melphalan, preserving liver function better than other therapies.

• Competing therapies like Y-90 and TACE are less effective for widespread metastatic disease due to limited tumor targeting.

• Average procedure volume per center is two per month, with some high-volume centers performing up to six.

• Growth in procedure volume will come from improved referral patterns, training additional teams, and increasing daily procedure capacity.

• Training new teams involves didactic and hands-on learning, with logistical challenges in assembling multidisciplinary teams.

Financial outlook and reimbursement

• Guidance for 2024 revenue is $93–96 million, with a recent change in Medicaid National Drug Rebate Agreement (NDRA) compliance impacting revenue per kit by 11–13%.

• NDRA compliance may improve access for some patients and remove reimbursement headwinds, though the net impact is difficult to quantify.

• The company is currently cash positive, has no debt or warrants, and does not anticipate needing to raise capital in the near to medium term.