Release Date: March 27, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Co-Diagnostics Inc (CODX, Financial) advanced the development of the Co-Dx PCR platform and associated test pipeline in 2024, strengthening the foundation for commercialization.
- The company completed its first application to the U.S. FDA for 510(k) clearance for the Co-Dx PCR Pro instrument and COVID-19 test for over-the-counter use.
- Co-Diagnostics Inc (CODX) has identified a procedure to simplify and affordably prepare patient TB samples for PCR analysis, with clinical evaluations planned in South Africa and India.
- The company inaugurated new manufacturing facilities in Utah and India, enhancing its capacity to support commercialization efforts and meet anticipated demand.
- Co-Diagnostics Inc (CODX) received a test license from the CDSCO in India, a vital step towards regulatory submission and IVD clearance for its products.
Negative Points
- Total revenue for fiscal year 2024 decreased to $3.9 million from $6.8 million in the prior year.
- The company experienced a net loss of $37.6 million in 2024, compared to a net loss of $35.3 million in the prior year.
- Legal expenses increased significantly to $7.0 million in 2024 due to funding the defense of securities class action lawsuits.
- The company had to withdraw its 510(k) submission for the COVID-19 test due to the need for updated clinical data, delaying regulatory clearance.
- Adjusted EBITDA was a loss of $33.5 million in 2024, slightly higher than the adjusted EBITDA loss of $33.0 million in the prior year.
Q & A Highlights
Q: Are you considering developing an Avian flu test for either birds or humans?
A: Dwight Egan, Chairman of the Board, Chief Executive Officer: We have developed an H5N1 test and are prepared to expand on it if necessary. Our ambition is for it to be used for both humans and livestock/birds, with potential optimizations for different applications.
Q: Is the H5N1 test currently being used, and what is its intended application?
A: Dwight Egan, Chairman of the Board, Chief Executive Officer: The test is intended for both human and animal use. We developed it in response to the initial interest in H5N1 and are ready to deploy it as needed.
Q: What are the financial highlights for Co-Diagnostics in 2024?
A: Brian Brown, Chief Financial Officer: Total revenue decreased to $3.9 million from $6.8 million in the prior year. Gross profit increased to $2.9 million, while operating expenses decreased to $43.0 million. The net loss for 2024 was $37.6 million, or $1.24 per share.
Q: What are the plans for the Co-Dx PCR platform's commercialization?
A: Dwight Egan, Chairman of the Board, Chief Executive Officer: We are focused on completing a new 510(k) submission for the COVID-19 test and Co-Dx PCR Pro instrument in 2025. We also plan to initiate clinical evaluations for other tests in our pipeline.
Q: Can you provide an update on the development of the TB test?
A: Dwight Egan, Chairman of the Board, Chief Executive Officer: We have identified a procedure to prepare TB samples for PCR analysis and plan to commence clinical evaluations in South Africa and India in the second half of 2025. We aim to support regulatory submissions in these regions.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
