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Sep 30, 2023
Delcath Q3 2023 Earnings Report
Delcath's financial performance reflected a decrease in revenue due to lower CHEMOSAT sales in Europe, alongside increased operating expenses related to HEPZATO's commercial launch preparation.
Key Takeaways
Delcath Systems reported a decrease in revenue for Q3 2023, with total revenue at $0.4 million compared to $0.9 million in the prior year. The company's operating expenses increased due to research and development and commercial launch preparations. They also received FDA approval for HEPZATO KIT and raised approximately $35 million through warrant exercises.
Received FDA approval for HEPZATO KIT for metastatic uveal melanoma (mUM) treatment.
Raised approximately $35 million through the exercise of Tranche A warrants.
Announced positive results from a retrospective study comparing CHEMOSAT with SIRT.
Advanced the CHOPIN trial studying CHEMOSAT and immune checkpoint inhibitor combination therapy.
Revenue by Geographic Location
Forward Guidance
Delcath anticipates launching HEPZATO KIT in January and aims to have at least 15 centers actively treating patients by the end of 2024.
Positive Outlook
- Planned launch of HEPZATO KIT in January.
- Building a commercial team to support the launch.
- Engaging with potential treating centers.
- Confident that at least 15 centers will be actively treating patients by the end of 2024.
- Positive reception of HEPZATO KIT from the medical oncologist community.
Challenges Ahead
- Uncertainties relating to the ability to commercialize HEPZATO
- Necessary financing to fund commercialization of HEPZATO in the U.S.
- The Company’s ability to generate revenue from HEPZATO
- Actions by the FDA or foreign regulatory agencies
Historical Earnings Impact
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Avg. Return Before/After Earnings
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