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Jun 30, 2021
Delcath Q2 2021 Earnings Report
Delcath reported an increase in product revenue and a net loss for the second quarter of 2021.
Key Takeaways
Delcath Systems, Inc. reported an increase in product revenue for the second quarter of 2021, driven by sales of CHEMOSAT procedures in Europe. The company also announced positive efficacy results from its FOCUS Phase III trial of HEPZATO™ KIT and entered into a debt facility with Avenue Venture Opportunities Fund, L.P.
Product revenue for Q2 2021 was $536 thousand, compared to $379 thousand for the prior year period.
The company had positive efficacy results from its FOCUS Phase III trial of HEPZATO™ KIT.
Delcath entered into a debt facility with Avenue Venture Opportunities Fund, L.P. providing up to $20 million.
The company recorded a net loss of $6.4 million for the quarter, compared to a net income of $4.3 million for the same period in 2020.
Delcath
Delcath
Delcath Revenue by Geographic Location
Revenue by Geographic Location
Europe Revenue
CapyFin.com Forward Guidance
Delcath plans to file the HEPZATO NDA in early 2022 and prepare for the subsequent US launch, while also expanding the development of HEPZATO into additional areas of high unmet need.
Positive Outlook
- Filing of the HEPZATO NDA in early 2022.
- Preparing for the subsequent US launch of HEPZATO.
- Expanding the development of HEPZATO into additional areas of high unmet need.
- New patient level data at ASCO strengthens the case for HEPZATO's clinical benefit.
- Secured additional capital from Avenue Venture Opportunities Fund.
Challenges Ahead
- Uncertainties relating to the timing and results of clinical trials.
- Impact of the COVID-19 pandemic on the completion of clinical trials.
- Actions by the FDA or foreign regulatory agencies.
- The Company’s ability to successfully enter into strategic partnership and distribution arrangements in foreign markets and the timing and revenue, if any, of the same.
- Uncertainties regarding the Company’s ability to obtain financial and other resources for any research, development, clinical trials and commercialization activities.