DELCATH SYSTEMS, INC. (DCTH) SEC Filings & Earnings Calls

Customer Concentration

“For the six months ended June 30, 2026, two customers each accounted for more than 10% of our total product revenue, representing in the aggregate approximately 29.2% of revenue.” · word for word

Clinical Trial Dependency

“We expect our research and development expenses to increase for the foreseeable future relating to the costs required to complete these Phase 2 clinical trials.” · word for word

Adjusted EBITDA declined 22.4% YoY despite revenue growth, due to increased R&D and SG&A expenses.

“Non-GAAP adjusted EBITDA of $7.6 million, compared to $9.8 million in the second quarter of 2025.” · word for word

R&D expenses increased to $10.4M from $6.9M, reflecting higher clinical activity.

“Research and development expenses for the quarter ending June 30, 2026, were $10.4 million compared to $6.9 million for the same period in the prior year.” · word for word

Customer concentration

“For the three months ended March 31, 2026, two customers each accounted for more than 10% of our total product revenue, representing in the aggregate approximately 26.5% of revenue.” · word for word

Clinical trial dependency

“Our future growth depends on the success of ongoing Phase 2 clinical trials for mCRC and mBC.”

Increased R&D and SG&A expenses may pressure profitability if revenue growth slows.

“Research and development expenses increased to $9.8 million from $5.0 million; SG&A increased to $13.1 million from $11.3 million.”

Dependence on HEPZATO KIT for growth; any regulatory or competitive setback could impact revenue.

“HEPZATO KIT revenue represents 93% of total revenue; reliance on FDA approvals and reimbursement.”

Dependence on successful commercialization of HEPZATO KIT and supply chain management.

“uncertainties relating to: the Company’s commercialization plans and its ability to successfully commercialize the HEPZATO KIT; ... securing adequate supply of critical components necessary to manufacture and assemble the HEPZATO KIT” · word for word

Regulatory and reimbursement risks for HEPZATO KIT.

“successful FDA inspections of the facilities ... the Company’s ability to obtain reimbursement for the HEPZATO KIT” · word for word

Dependence on single product HEPZATO/CHEMOSAT

“Our lead product, the HEPZATO KIT ... was approved by the FDA on August 14, 2023.”

Clinical trial and regulatory risk for pipeline expansion

“Our IND application for a Phase 2 clinical trial evaluating HEPZATO in combination with SOC for liver-dominant mCRC was cleared by the FDA in December 2024.” · word for word

Reimbursement and pricing pressure

“On October 23, 2025, the Company entered into a National Drug Rebate Agreement (NDRA) with CMS, which also subjected the Company to entering into a Pharmaceutical Pricing Agreement (PPA) with the Public Health Service and a master agreement with the U.S. Department of Veterans Affairs (VA).” · word for word

Competition from other liver cancer treatments

“CHEMOSAT and HEPZATO compete with all forms of liver cancer treatments, including surgery, systemic chemotherapy, focal therapies, and palliative care.” · word for word

Preliminary results subject to revision; audit adjustments possible.

“Delcath has not yet completed its financial close process for the fourth quarter and full year 2025 and, as a result, actual results may vary” · word for word

Revenue concentration on HEPZATO KIT; dependency on commercial expansion and reimbursement.

“HEPZATO KIT revenue represents 94% of total revenue; uncertainties regarding commercialization and reimbursement.”

R&D and SG&A expenses increasing faster than revenue, pressuring near-term profitability.

“R&D expenses up 105% YoY; SG&A up 47% YoY; net income declined despite revenue growth.”

Dependence on successful commercialization and reimbursement of HEPZATO and CHEMOSAT

“Our ability to successfully commercialize CHEMOSAT, HEPZATO KIT, and future products, if any, generate revenue and successfully obtain reimbursement for the products and/or the associated procedures.” · word for word

Clinical trial risks for pipeline expansion into mCRC and mBC

“The Phase 2 trial will evaluate the safety and efficacy of HEPZATO in combination with trifluridine-tipiracil and bevacizumab compared to trifluridine-tipiracil and bevacizumab alone in patients with liver-dominant mCRC receiving third-line treatment.” · word for word