Delcath Systems, Inc. Q3 FY2025 earnings call

• Clinical: Compelling results from CHOPIN trial, first patient dosed in CRC trial, 25 REMS-certified treatment sites, aiming for 26-28 active treating centers by end 2025 and 40 by end 2026 (excluding clinical sites).
• Commercial: Sales force grew from 4 to 6 regions in 2025, plans to expand to 9 regions by Q2 2026; slowdown in new patient starts due to seasonality, but patients under treatment return as expected; competition from other clinical trials, but CHOPIN results expected to lessen impact.
• R&D: Conducting trials in CRC and breast cancer, evaluating other tumor types like cholangiocarcinoma, cutaneous melanoma, NSCLC.

In the third quarter of 2025, revenue from HEPZATO sales was $19.3 million and CHEMOSAT was $1.3 million, compared to $10 million for HEPZATO and $1.2 million for CHEMOSAT in the same period of 2024. Gross margins were 87% in Q3 2025 versus 85% in the prior year. Research and development expenses for the quarter were $8.0 million compared to $3.9 million in the same period of 2024. Selling, general and administrative expenses were $10.3 million vs $7.0 million in the prior year. Net income was $0.8 million vs $1.9 million in Q3 2024. Non-GAAP positive adjusted EBITDA for Q3 2025 was $5.3 million vs $1.0 million in Q3 2024. Ended the quarter with approximately $89 million in cash and investments and quarterly positive operating cash flow of $4.8 million. Forecast for 2025 gross margins are between 85% and 87%, with total HEPZATO treatment volume projected to increase by nearly 150% vs 2024.

• Adjusted 2025 annual guidance to $83 million to $85 million.
• Assumed modest seasonality in Q4 and factored in clinical trial competition.
• Plan to expand sales force to 9 regions by Q2 2026.
• Forecast 2025 gross margins between 85% and 87%, with positive non-GAAP adjusted EBITDA and cash flow.

• Seasonality affecting new patient starts.
• Competition from other clinical trials.
• Impact of NDRA participation on average revenue per kit.
• Uncertainty in site activation progress and utilization of lower volume accounts.

Q: Marie Thibault asks about Q4 expectations regarding seasonality and clinical trial competition.

A: Gerard Michel says they factored both in.

Q: John Newman asks about site additions in 2026.

A: Gerard Michel says site additions might accelerate in back half of 2026.

Q: Jake on for Chase Knickerbocker asks about improving utilization on lower volume accounts.

A: Gerard Michel mentions building referral networks and changing physician prescribing behavior, with CHOPIN data expected to impact in 2026.

Q: Kesav on for Sudan Loganathan asks about addressing neutropenia in HEPZATO combo trial.

A: Vojo Vukovic says patients will be managed with supportive care, G-CSF, and dosing adjustments.

Q: RK from H.C. Wainwright asks about NDRA program influence.

A: Gerard Michel says NDRA causes one-time revenue step down, expects average revenue per kit to stay same; Sandra Pennell says gross margins expected 85%-80% in 2026, potentially high 80% beyond.

Q: Yale Jen asks about European investigator study and capital allocation.

A: Gerard Michel says SCANDIUM-3 trial recruiting slowly; capital allocated program-by-program.

Q: Bill from Clear Street asks about read-through from CHOPIN to other combinations and competition from Thomas Jefferson.

A: Gerard Michel discusses potential of combining HEPZATO with checkpoint inhibitors in some indications; Vojo Vukovic says Thomas Jefferson has 109 patients in their single center trials.