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Jun 30, 2024
Co-Diagnostics Q2 2024 Earnings Report
Reported financial results for the quarter ended June 30, 2024.
Key Takeaways
Co-Diagnostics reported their financial results for the second quarter of 2024, highlighting the progress made, including the 510(k) application submission to the FDA for their new instrument and COVID-19 test kit for over-the-counter use.
Submitted a 510(k) application to the FDA for a new instrument and COVID-19 test kit intended for over-the-counter use.
OTC-cleared medical devices are automatically categorized as CLIA-waived, making them suitable for point-of-care use.
Preparing to pursue FDA clearance for the Co-Dx PCR COVID-19 test on the new instrument specifically for point-of-care use.
Planning to begin clinical evaluations for a multiplex test later this year.
Revenue by Segment
Forward Guidance
The company anticipates expanding the market and value of its new platform following the 510(k) submission and is looking forward to beginning clinical evaluations for their multiplex test later this year.
Positive Outlook
- OTC clearance expands the market and value of the new platform.
- CLIA-waived categorization makes devices suitable for point-of-care use.
- Pursuing FDA clearance for Co-Dx PCR COVID-19 test for point-of-care use.
- Advancing the development of TB, multiplex respiratory, and HPV tests.
- Clinical evaluations for multiplex test expected to begin later this year.
Challenges Ahead
- Co-Dx PCR platform is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale.
- The Co-Dx PCR Pro instrument and Co-Dx COVID-19 Test are currently under review by the FDA.
- Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances.
Revenue & Expenses
Visualization of income flow from segment revenue to net income
Historical Earnings Impact
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Avg. Return Before/After Earnings
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