Delcath Systems, Inc. (NASDAQ: DCTH) has issued its full-year 2025 financial guidance, projecting a total revenue of $94 to $98 million. This marks a substantial increase of more than 150% over the 2024 total revenue. Additionally, the company anticipates gross margins to range between 83% to 85%. Delcath also aims to achieve positive adjusted EBITDA and cash flow in each quarter of 2025.
In line with its growth strategy, Delcath intends to enter into a National Medicaid Drug Rebate Agreement (NDRA) to enhance patient access. The company is poised to participate in the Medicaid Drug Rebate Program, which involves providing Medicaid rebates and 340B discounts to eligible entities. Delcath has initiated the process of entering into the NDRA with the Centers for Medicare and Medicaid Services and expects it to become effective at the beginning of the third quarter of 2025.
Gerard Michel, the Chief Executive Officer of Delcath, expressed confidence in the decision to enter into the NDRA, stating that it simplifies Medicaid access and enables eligible hospitals to access 340B drug pricing. Michel also highlighted the company's expectation of at least a 200% increase in total Hepzato treatment volume in 2025 compared to 2024, based on current center activation rates and rising utilization.
Delcath Systems, Inc. is known for its focus on the treatment of primary and metastatic liver cancers. The company's proprietary products, Hepzato Kit™ and Chemosat® Hepatic Delivery System for Melphalan, are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a percutaneous hepatic perfusion (PHP) procedure.
The Hepzato Kit is considered a combination drug and device product in the United States and is regulated and approved for sale as a drug by the FDA. In Europe, the device-only configuration of the Chemosat Hepatic Delivery System for Melphalan is regulated as a Class III medical device and is approved for sale under the trade name Chemosat. It has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of liver cancers.
Delcath's pursuit of the NDRA and the projected revenue growth for 2025 signals a significant expansion and advancement in its financial performance and market reach. Today the company's shares have moved -4.67% to a price of $16.435. Check out the company's full 8-K submission here.
