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Jun 30, 2021
Ocugen Q2 2021 Earnings Report
Reported second quarter financial results and provided a business update.
Key Takeaways
Ocugen reported a net loss of $0.13 per share for the second quarter of 2021. The company's cash, cash equivalents, and restricted cash totaled $115.8 million as of June 30, 2021. Ocugen is focusing on regulatory submissions for COVAXIN™ and advancing its ophthalmic pipeline.
Completed rolling regulatory submission to Health Canada and initiated the review process.
Continued discussions with the U.S. FDA regarding COVAXIN™ regulatory approval pathway.
Progressed technology transfer activities between Bharat Biotech and Jubilant HollisterStier for COVAXIN™ manufacturing.
Anticipate moving OCU400 into two parallel Phase 1/2a clinical trials in the United States later this year.
Forward Guidance
Ocugen is focused on obtaining regulatory approvals for COVAXIN™ in North America and advancing its gene therapy clinical trial for OCU400.
Positive Outlook
- Completed regulatory submission to Health Canada for COVAXIN™.
- Ongoing discussions with the U.S. FDA for COVAXIN™ approval.
- Advancing OCU400 towards Phase 1/2a clinical trials in the United States.
- Technology transfer activities progressing between Bharat Biotech and Jubilant HollisterStier.
- Expanded rights to develop, manufacture, and commercialize COVAXIN™ into Canada.
Challenges Ahead
- Uncertainty regarding the timing and outcome of discussions with the FDA.
- Dependence on Bharat Biotech for clinical trial data and manufacturing.
- Potential delays in clinical trial commencement due to various factors.
- Risks associated with regulatory approval and commercialization of COVAXIN™.
Historical Earnings Impact
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Avg. Return Before/After Earnings
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