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QUEENSBURY, N.Y. - Delcath Systems, Inc. (NASDAQ:DCTH), a company specializing in interventional oncology treatments for liver cancers, has projected a significant revenue increase for fiscal year 2025 and announced its intention to participate in the Medicaid National Drug Rebate Agreement (NDRA). The company, which has seen an impressive 119% return over the past year and is currently trading near its 52-week high of $18.23, has demonstrated strong momentum in the market. According to InvestingPro data, the company maintains robust gross margins of approximately 85%.
The company anticipates total revenue from its CHEMOSAT and HEPZATO KIT products to be between $94 to $98 million for the year 2025, marking an increase of over 150% from the previous year. This projection aligns with the company’s recent growth trajectory, as InvestingPro analysis shows a remarkable revenue growth of over 1,000% in the last twelve months. Additionally, Delcath expects to maintain gross margins in the range of 83% to 85% and achieve positive adjusted EBITDA and cash flow in each quarter of the year.
Delcath’s decision to enter the NDRA is aimed at simplifying Medicaid access and enabling eligible hospitals to benefit from 340B drug pricing. The process to finalize the agreement with the Centers for Medicare and Medicaid Services is underway, with the expectation that it will become effective at the start of the third quarter of 2025. Gerard Michel, CEO of Delcath, expressed that this move is anticipated to broaden treatment availability and hasten the adoption of HEPZATO in the U.S., with the company forecasting at least a 200% increase in total HEPZATO treatment volume in 2025 compared to 2024.
HEPZATO KIT, a combination drug and device product approved by the FDA, includes the chemotherapeutic drug melphalan and Delcath’s proprietary Hepatic Delivery System (HDS). The HDS is designed to administer high-dose chemotherapy to the liver while minimizing systemic exposure and side effects. The product is currently approved as a liver-directed treatment for adult patients with metastatic uveal melanoma with specific conditions.
In Europe, the device-only configuration of the HDS, known as CHEMOSAT, is approved as a Class III medical device and is used in major medical centers for percutaneous hepatic perfusion procedures to treat various liver cancers.
The information in this article is based on a press release statement from Delcath Systems, Inc. It should be noted that forward-looking statements are subject to risks and uncertainties that could cause actual results to differ from those projected. Delcath has made these projections based on current expectations, and they are not guarantees of future performance. For deeper insights into Delcath’s financial health and market position, investors can access comprehensive analysis and 13 additional ProTips through InvestingPro, which currently shows the stock trading slightly below its Fair Value.
In other recent news, Delcath Systems reported its first-quarter 2025 earnings, surpassing expectations with an earnings per share (EPS) of $0.03 against a forecast of $0.02. The company also exceeded revenue forecasts, posting $19.8 million compared to the projected $15.51 million. Notably, Delcath demonstrated a significant improvement in net income, reporting $1.1 million compared to a $11.1 million loss in the previous year. Gross margins improved to 86%, up from 71% in 2024, indicating enhanced operational efficiency.
In addition, Clear Street analysts increased their price target on Delcath Systems shares from $22.00 to $26.00, maintaining a Buy rating. The analysts cited Delcath’s strong commercial performance and the ongoing growth of its liver cancer treatment, Hepzato, as key factors for their positive outlook. They also highlighted the expansion of treatment sites and a growing referral network as catalysts for sustained progress. These developments reflect Clear Street’s increased confidence in Delcath’s future financial performance.
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