DELCATH SYSTEMS, INC. Q1 FY2025 earnings call

• Revenue: HEPZATO in the U.S. generated $18 million and CHEMOSAT in Europe generated $1.8 million in the first quarter of 2025, totaling $19.8 million.
• Center Activations: Ended the quarter with 17 treating sites, opened an additional 2 centers, bringing total active centers in the U.S. to 19. There are 10 centers accepting referrals and pending activation.
• Financials: Positive cash from operations of $2.2 million, net income of $1.1 million, positive adjusted EBITDA of $7.6 million, no debt, and $59 million in cash and investments.
• R&D: Leveraging cash from operations to support HEPZATO's R&D beyond metastatic uveal melanoma patients.
• Clinical Trials: Phase II trials for metastatic colorectal and breast cancer received FDA clearance. Colorectal trial to enroll ~90 patients at over 20 sites, expected to start by end of 2025, primary endpoint readout by end of 2027 or early 2028. Breast cancer trial to start by end of 2025, primary endpoint readout in late 2028 or early 2029.
• Market Potential: Addressable markets for colorectal and breast cancer are each ~7,000 patients, ~7 times larger than uveal melanoma's ~1,000 patients annually in the U.S., with significant unmet need.

HEPZATO in the U.S. contributed $18 million in revenue, while CHEMOSAT in Europe added $1.8 million, resulting in a combined revenue of $19.8 million for the first quarter of 2025. HEPZATO accounted for approximately 90.9% of the total revenue (18/19.8), and CHEMOSAT accounted for about 9.1% (1.8/19.8). The company had positive cash from operations of $2.2 million, net income of $1.1 million, positive adjusted EBITDA of $7.6 million, ended the quarter with no debt, and had approximately $59 million in cash and investments.

• Center Goal: Aim to have 30 active centers by year end.
• Treatment Per Center: Expect average monthly treatments per site to be just under 2 for the remainder of the year.
• Expenses: SG&A expected to increase ~60% over 2024, R&D expected to increase ~150% over 2024, but EBITDA to remain positive in 2025.
• Trials: Colorectal and breast cancer Phase II trials expected to start by end of 2025.

• Center Activation: Uncontrollable variables in center openings, such as barriers at hospitals.
• European Market: Reimbursement and pricing challenges in Europe, limiting immediate revenue contribution.
• Clinical Trials: Delays in trial enrollment, protocol approval, and endpoint readout.
• Patient Adoption: Variability in patient treatment frequency and uptake at new centers.

Q: Chase Knickerbocker asked about center activations, with expectation of majority in second half, and if more centers could come in Q2.

A: Gerard Michel said it might be more even, with a solid queue but uncontrollable variables, expecting 30 centers by year end, and treatments per center to be just under 2.

Q: Swayampakula Ramakanth asked about repeat procedures and European market.

A: Gerard Michel said treatment frequency in clinical trial averaged 4.1, and European market has reimbursement challenges but focuses on clinical data.

Q: Marie Thibault asked about patient access program.

A: Gerard Michel said it's for co-pay assistance and rare patients, billing going well.

Q: Sudan Loganathan asked about territories and trial initiation.

A: Gerard Michel and Vojislav Vukovic discussed trial initiation process taking 6-12 months in U.S. and 3-12 months in Europe, and consideration of in-licensing.

Q: Bill Maughan asked about revenue variability.

A: Gerard Michel said month-to-month variability due to small numbers, and insurance resets had less effect.

Q: Yale Jen asked about CRC trial sites, price increase, and patient referrals.

A: Vojislav Vukovic said CRC trial to have over 20 sites, price increased from $182.5 to $187.5 on Feb 1, and ~30-40% of patients are organic to sites.