Delcath Systems Inc (DCTH) Q4 2024 Earnings Call Highlights: Strong HEPZATO Revenue and ...
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.
Warning! GuruFocus has detected 3 Warning Signs with DCTH.
Release Date: March 06, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Delcath Systems Inc (NASDAQ:DCTH) 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 (NASDAQ: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.
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 (NASDAQ:DCTH) faces challenges in expanding its referral network, as more centers are needed to reduce patient travel distances.
Q: As you are bringing new sites online in the United States for HEPZATO, are you seeing any changes in the number of treatment cycles that patients are receiving? A: Gerard Michel, CEO: The label allows up to six treatments, and in the focus trial, it averaged 4.1 treatments. It takes about a year to determine if a patient will go the full six cycles. So far, it looks like we will meet or exceed the 4.1 average seen in the trial. The tolerability and results are at least as good as in the trial, which might lead to more than 4.1 treatments, but it's too early to confirm.
Q: Can you discuss the plans for expanding from 4 regions to 6 regions and how this will impact SG&A expenses? A: Sandra Pennell, CFO: We expect SG&A expenses to increase by 30% to 40% over 2024 levels. The expansion will be more pronounced starting in the second quarter and fully staffed by mid-year 2025.
Q: Regarding R&D expenses, how do you balance being aggressive in R&D while maintaining a potential cash flow break-even or profitability? A: Gerard Michel, CEO: We will be cash flow positive this year, but I don't promise maintaining positive cash flow if there are compelling R&D opportunities. We will invest in R&D if the cost of capital is reasonable, as we have high potential opportunities.
Q: Can you provide insights into the referral network and its effectiveness in driving patient referrals to treatment centers? A: Kevin Muir, General Manager: The referral network is working well, with referrals from community centers to larger academic centers. Some new sites are referring patients to existing sites until they are ready to treat. We have a dedicated oncology manager in each region to facilitate these referrals.
Q: What is the expectation for European expansion in 2025, particularly from a revenue perspective? A: Gerard Michel, CEO: We expect modest growth in Europe, around 20% to 30%. Significant growth will depend on reimbursement in major markets like the UK. The strategic value of Europe lies in supporting clinical trials and generating publications rather than immediate economic value.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.
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