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Delcath Systems (DCTH) investor relations material

Delcath Systems H.C. Wainwright 27th Annual Global Investment Conference summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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H.C. Wainwright 27th Annual Global Investment Conference summary10 Sep, 2025

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.

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Frequently asked questions

Delcath Systems Inc. is a medical technology company focused on the development and commercialization of innovative therapies for cancers with limited treatment options. The company specializes in targeted drug delivery systems, designed to isolate and deliver high doses of chemotherapy to specific organs or regions while minimizing systemic exposure. The company is headquartered in Wilmington, Delaware, and its shares are listed on the NASDAQ.

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