Delcath posts $7.0M quarterly profit as HEPZATO drives raised full-year outlook

Delcath Systems reported on 9 November that sales for the quarter ended September reached $35.1M, an increase of about 70%, and it narrowed its sights on a higher full-year revenue figure of $115-117M. The company credited demand for HEPZATO KIT for the growth. The facts on file do not include the previous guidance range, so the size of the increase cannot be stated.

HEPZATO KIT generated $32.7M of the quarter's revenue, roughly 93% of the total. CHEMOSAT, the company's other product, added $2.4M. The business was profitable in the period, with net income of $7.0M, and it closed the quarter holding $104.3M in cash and carrying no debt.

HEPZATO delivers melphalan directly to the liver and is approved by the US Food and Drug Administration for metastatic uveal melanoma. It is now in use at 33 treatment sites. Because the therapy requires specialised procedures, the number of sites capable of administering it is a practical constraint on how fast sales can grow.

Delcath also gave a pipeline update. The first patient has been dosed in DELUMA, a Phase 2 trial in HER2-negative metastatic breast cancer. The company intends to submit an investigational new drug application for cholangiocarcinoma in early 2027. Both programmes would test the same melphalan delivery approach in tumour types beyond uveal melanoma.