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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.
Co-Diagnostics
Co-Diagnostics
Co-Diagnostics Revenue by Segment
Revenue by Segment
Grant Revenue
CapyFin.comProduct Revenue
CapyFin.com 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.
- Actual results may differ materially from those contemplated or anticipated by such forward-looking statements.
- There can be no assurance that any of the anticipated results will occur on a timely basis or at all due to certain risks and uncertainties.
Revenue & Expenses
Visualization of income flow from segment revenue to net income