Delcath Systems (DCTH) Q4 2024 earnings summary

Executive summary

• 2024 marked a transformative year with the U.S. launch of HEPZATO, generating $32.3M in U.S. revenue and $13.7M in Q4 from 14 active centers, contributing to total revenue of $15.1M in Q4 and $37.2M for FY2024.

• Achieved permanent J-code and NTAP for HEPZATO, supporting reimbursement and adoption.

• Ended 2024 with 16 active U.S. centers and 8 more accepting referrals; expanded clinical guidelines for HEPZATO.

• European CHEMOSAT volumes grew 137% year-over-year, with strategic expansion planned for France, Italy, and Spain.

• Ended 2024 with $53.2M in cash and investments, no debt, and positive adjusted EBITDA in Q4.

Financial highlights

• Q4 revenue: $15.1M; FY2024 revenue: $37.2M, both up significantly year-over-year.

• HEPZATO KIT generated $13.7M in Q4 and $32.3M for the year; CHEMOSAT contributed $1.4M in Q4 and $4.9M for the year.

• Gross margin: 86% in Q4, 83% for the year; expected to reach 90% by end of 2025.

• Q4 net loss: $3.4M; full year net loss: $26.4M, both significantly improved from 2023.

• Q4 adjusted EBITDA: $4.6M positive; full year adjusted EBITDA loss: $2.5M, improved from $30M loss in 2023.

Outlook and guidance

• Targeting 30 active U.S. treatment centers by year-end 2025, up from 16 currently.

• More than half of new centers expected to come online in the second half of 2025 as the commercial team expands.

• Modest but steady growth anticipated in Europe, with step changes possible upon reimbursement in new markets.

• Expansion into additional liver-dominant cancer indications, including metastatic colorectal and breast cancer, is underway.

• R&D expenses projected to increase to $35M–$40M in 2025 as new trials and indications are pursued.