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Mar 31, 2021
Ocugen Q1 2021 Earnings Report
Reported financial results for the first quarter of 2021 and provided a business update.
Key Takeaways
Ocugen reported a net loss of $7.077 million, or $0.04 per share, for the three months ended March 31, 2021. The company's cash, cash equivalents, and restricted cash totaled $44.9 million as of March 31, 2021. They are continuing to pursue EUA for COVAXIN while advancing their ophthalmology pipeline.
COVAXIN demonstrated 100% efficacy against severe COVID-19 disease (including hospitalization).
A Master File was submitted for U.S. Food and Drug Administration review prior to a planned Emergency Use Authorization application for COVAXIN.
$100.0 million in gross proceeds was raised through a registered direct offering of common stock.
Key talent was acquired representing an instrumental step to position Ocugen for future growth.
Ocugen
Ocugen
Forward Guidance
Ocugen is focused on bringing COVAXIN to the U.S. market, advancing its ophthalmology gene therapy pipeline, and expanding its headcount.
Positive Outlook
- Continued progress toward U.S. Emergency Use Authorization for COVAXIN.
- Plans to consider clinical development in special populations, such as children, as well as booster doses for COVAXIN.
- Additional capital raised to fund ongoing and future operations.
- Recruitment of key talent to support growth.
- Continued advancement of ophthalmology pipeline with four Phase 1/2 clinical trials planned by the end of 2022.
Challenges Ahead
- Uncertainties inherent in research and development.
- Risk of unfavorable new clinical trial data and further analyses of existing clinical trial data.
- Possibility of differing interpretations and assessments of clinical trial data.
- Dependence on Bharat Biotech's clinical trials and data.
- Risk of FDA decisions impacting the availability or commercial potential of COVAXIN in the United States.