Delcath Systems (DCTH, Financial) has received clearance from the U.S. Food and Drug Administration to begin a Phase 2 clinical trial assessing Hepzato. This development follows the FDA's completion of a 30-day review of Delcath's investigational new drug application. The trial will focus on patients with liver-dominant metastatic breast cancer, specifically those with HER2-negative status, who have not responded to previous treatments.
The study will compare the effectiveness and safety of Hepzato combined with standard of care (SOC) treatments against SOC alone. The SOC alternatives will be chosen by physicians from eribulin, vinorelbine, or capecitabine. Delcath plans to enroll approximately 90 patients at over 20 sites across the U.S. and Europe, with the recruitment phase slated to begin in the fourth quarter of 2025.
The primary goal of the trial is to determine hepatic progression-free survival, which is expected to be reported by the end of 2028. Results concerning overall survival, a secondary objective of the study, are anticipated in 2029.
Wall Street Analysts Forecast
Based on the one-year price targets offered by 6 analysts, the average target price for Delcath Systems Inc (DCTH, Financial) is $22.50 with a high estimate of $25.00 and a low estimate of $21.00. The average target implies an upside of 85.80% from the current price of $12.11. More detailed estimate data can be found on the Delcath Systems Inc (DCTH) Forecast page.
Based on the consensus recommendation from 6 brokerage firms, Delcath Systems Inc's (DCTH, Financial) average brokerage recommendation is currently 1.7, indicating "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.
Based on GuruFocus estimates, the estimated GF Value for Delcath Systems Inc (DCTH, Financial) in one year is $25.04, suggesting a upside of 106.77% from the current price of $12.11. GF Value is GuruFocus' estimate of the fair value that the stock should be traded at. It is calculated based on the historical multiples the stock has traded at previously, as well as past business growth and the future estimates of the business' performance. More detailed data can be found on the Delcath Systems Inc (DCTH) Summary page.
DCTH Key Business Developments
Release Date: March 06, 2025
- HEPZATO Revenue (Q4 2024): $13.7 million from 14 active US treatment centers.
- HEPZATO Revenue (Full Year 2024): $32.3 million.
- CHEMOSAT Revenue (Q4 2024): $1.4 million.
- CHEMOSAT Revenue (Full Year 2024): $4.9 million.
- Gross Margin (Q4 2024): 86%.
- Gross Margin (Full Year 2024): 83%.
- R&D Expenses (Q4 2024): $2.9 million.
- R&D Expenses (Full Year 2024): $13.9 million.
- SG&A Expenses (Q4 2024): $7.0 million.
- SG&A Expenses (Full Year 2024): $29.6 million.
- Net Loss (Q4 2024): $3.4 million.
- Net Loss (Full Year 2024): $26.4 million.
- Adjusted EBITDA (Q4 2024): Positive $4.6 million.
- Adjusted EBITDA (Full Year 2024): Loss of $2.5 million.
- Cash and Investments (End of 2024): $53.2 million.
- Operating Cash Burn (Q4 2024): Approximately $1 million.
- Debt: No outstanding debt obligations.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Delcath Systems Inc (DCTH, Financial) achieved $32.3 million in HEPZATO revenue in the US for 2024, with $13.7 million in the fourth quarter alone.
- The company secured a permanent J-code and a new technology add-on payment (NTAP) for HEPZATO, enhancing reimbursement prospects.
- Delcath Systems Inc (DCTH) ended 2024 with $53.2 million in cash and investments and no debt, providing financial stability for future growth.
- The company achieved a positive adjusted EBITDA of $4.6 million in the fourth quarter, marking a significant financial milestone.
- European CHEMOSAT volumes grew by 137% in 2024, with notable increases in Germany, the UK, and Turkey, supporting strategic growth in the region.
Negative Points
- Incremental revenue from Europe remains modest due to pricing and reimbursement structures, limiting immediate financial impact.
- The average treatment rate per site was slightly under two per month, indicating a slow ramp-up in utilization at new centers.
- Research and development expenses remain high, with $13.9 million spent in 2024, impacting overall profitability.
- The company anticipates a 30% to 40% increase in SG&A expenses in 2025, which could pressure margins.
- Delcath Systems Inc (DCTH) faces challenges in expanding its referral network, as more centers are needed to reduce patient travel distances.
