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| Statement |
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| As we look ahead, I'd like to discuss the reasons why we are so excited about the near future |
| All we can tell you is that we believe our application will be is a very solid application when we make it |
| In summary, Co-Diagnostics is well capitalized and disciplined in its capital allocation strategy, while also receiving support from world class organizations who are aligned with our long-term strategy |
| To close, we remain confident that the quality, ease of use, affordability and quick turnaround time of our platform will deliver an impact to patients and communities around the world |
| Since 2019, CoSara has received approval from the Indian CDSCO for 14 in vitro diagnostic tests that utilize our Co-Primers technology, which gives us additional confidence in our regulatory and commercialization approach in that country |
| These assays provide reliable PCR diagnostics results, which can drive improve healthcare outcomes |
| We are excited about the future of Co-Diagnostics and the value that our disruptive technology can provide to a global healthcare infrastructure |
| The assays or tests that run on our new platform utilize our patented Co-Primers PCR technology developed by Co-Diagnostics, which improves the quality of test results by dramatically reducing the occurrence of amplification errors known as primer dimers, which can lead to false positive results |
| We are committed to maintaining a strong cash position through diligent expense management to ensure Co-Diagnostics is well capitalized to execute our long-term growth initiatives |
| Over time, we believe the new platforms ability to support these initiatives will become another competitive differentiator for our end users |
| As we discussed on our second quarter earnings call, we believe our success should be measured in terms of progress made toward our development and operational goals |
| And we are pleased to have additional evidence from third parties that supports the value and utility of our platform |
| Recognition from global thought leading organizations highlights the disruptive nature of our technology and the value we believe our company can provide to a global healthcare infrastructure |
| We are confident that CoSara has the capacity to effectively manufacture and support the commercialization of our TB test |
| Overall, it has been a busy time at Co-Diagnostics and we anticipate the next several months to be an exciting time for the company as well |
| Our company is well funded with $63.4 million in cash and equivalents on the balance sheet, grant support from notable international leaders in health care |
| We expect that demand for our platform in India will be robust, and we plan to utilize our most recent grant to offset additional costs |
| And we are confident that her expertise in regulatory affairs, including regulatory submissions for point-of-care, and in vitro diagnostic products will be invaluable to Co-Diagnostics’s future regulatory submissions |
| When combined, our Co-Primers technology and multiplexing capabilities augment the already disrupted nature of the Co-Dx PCR platform |
| We believe that a significant opportunity exists for Co-Diagnostics within the global TB market |
| We believe this test will provide extensive value across many end markets, including those we initially planned to target with our COVID test |
| One of the most exciting features of the Co-Dx PCR platform will be direct real time HIPAA compliant integration into the EMR, creating additional use cases for our platform, including outbreak monitoring |
| Notably, we were pleased to also recently announced a nearly $9 million grant from the Bill and Melinda Gates Foundation for the tuberculosis assay under development to be run on the Co-Dx PCR platform |
| Data from this study with PATH demonstrated the performance and ease of use of the COVID-19 tests on the new platform, which confirmed our belief in the potential effectiveness of the test in both at home and point-of-care settings |
| And there are lots of those around the country that is one of our primary targets, they have a very strong need to continue to test patients and employees for COVID |
| Additionally, because our platform is real time PCR, it is better suited for multiplexing or testing for multiple disease indications within the same sample and reaction when compared to other technologies |
| We are particularly encouraged by the Pandemic and All-Hazards Preparedness Act, PAHPA in which the federal government is contemplating a significant set of initiatives in the context of outbreak and monitoring capabilities |
| We also showcased our platform at other trade shows and expos where our presence has reinforced the global unmet need for an easy to use, accurate and affordable point-of-care diagnostic platform |
| We are closer to a commercial launch for our Co-Dx PCR platform and continue to make progress towards our development goals |
| Ultimately, we believe that our COVID-19 tests will serve as the first in a series of indications That will open the diagnostics market opportunity for other tests on the Co-Dx PCR platform |
| Statement |
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| Product revenue was $0.2 million, which declined year-over-year due to the impact of decreased global demand for COVID-19 testing |
| For the third quarter of 2023, total revenue decreased to $2.5 million as compared to $5.1 million in the prior year same period |
| Gross profit for the quarter decreased to $2.2 million, compared to $4.3 million in the prior year comparable period |
| A lack of accessibility to TB testing is a global problem |
| Adjusted EBITDA for the third quarter of 2023 was a loss of $6.5 million compared to an adjusted EBITDA loss of $4.1 million in the prior year period |
| Net loss for the third quarter of 2023 was $6.0 million, or a loss of $0.20 per fully diluted share compared to a net loss of $1.4 million or $0.04 per fully diluted share in the prior year same period |
| For the third quarter of 2023, income before tax is decreased to a loss of $8.1 million, as compared to a loss of $3.5 million reported in the prior year same period, we experienced an income tax benefit for the third quarter of $2.1 million, representing an effective tax rate of 26.1% |
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