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Mar 31, 2022
Delcath Q1 2022 Earnings Report
Delcath reported first quarter results with revenue primarily from CHEMOSAT sales in Europe and is preparing for HEPZATO NDA filing.
Key Takeaways
Delcath Systems reported first quarter 2022 financial results, with a total revenue of $0.3 million, primarily from CHEMOSAT sales in Europe. The company's net loss was $8.2 million, and they are preparing to file an NDA for HEPZATO in the third quarter of 2022.
Held a pre-NDA meeting with FDA and plan to file an NDA in Q3 2022.
Accepted a poster presentation updating results from the FOCUS Phase 3 Trial at ASCO 2022.
Resumed direct responsibility for sales, marketing, and distribution activities for CHEMOSAT in Europe.
Achieved medical device regulation (MDR) certification for CHEMOSAT in Europe.
Delcath
Delcath
Delcath Revenue by Geographic Location
Forward Guidance
Delcath is focused on filing the HEPZATO NDA, preparing for the US launch, and expanding clinical development of HEPZATO and CHEMOSAT.
Positive Outlook
- Filing of the HEPZATO NDA
- Preparing for the subsequent US launch when approved
- Expanding the clinical development of HEPZATO
- Expanding the clinical development of CHEMOSAT
- Focusing on additional indications of high unmet medical need