Release Date: November 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Co-Diagnostics Inc (CODX, Financial) has made significant progress in developing its Co-Dx PCR platform, which includes a low-cost, easy-to-use, and highly portable point-of-care real-time PCR instrument.
- The company is actively engaging with the FDA for the clearance of its Co-Dx PCR Pro instrument and COVID-19 test cup for over-the-counter use, which could expand its market reach.
- Co-Diagnostics Inc (CODX) is targeting international markets with unmet needs, such as Central and South America, Africa, the Middle East, and India, for its tuberculosis, HPV, and respiratory multiplex tests.
- The company has completed several preliminary analytical studies for its tuberculosis test and plans to initiate clinical trials in South Africa and India in early 2025.
- Co-Diagnostics Inc (CODX) is expanding its manufacturing capacity with a new facility in India, which will allow for cost-effective in-country manufacturing of its patented co-primer technology.
Negative Points
- Total revenue for the third quarter of 2024 decreased significantly to $0.6 million compared to $2.5 million in the same period last year.
- The company reported a net loss of $9.7 million for the third quarter of 2024, which is an increase from the $6.0 million loss reported in the prior year.
- Gross profit for the quarter decreased to $0.3 million from $2.2 million in the prior year comparable period.
- Co-Diagnostics Inc (CODX) cannot predict the timeline or outcomes of the FDA review process for its Co-Dx PCR platform, which adds uncertainty to its regulatory approval path.
- The company is facing challenges in maintaining a healthy balance sheet, with a focus on managing cash position and reducing expenses to position itself for future growth.
Q & A Highlights
Q: Are you able to disclose any feedback from the FDA for the 510-K application?
A: Co-Diagnostics has remained in discussions with the FDA regarding our submission, but we can't comment on regulatory decisions or timelines. Our focus has broadened to other geographic regions with large unmet needs, such as Central and South America, Africa, the Middle East, and India, where we see significant opportunities for our platform's commercial adoption. - Dwight H. Egan, CEO
Q: How is your demand split between the US and other global customers? Do you feel that you have the most opportunity outside of the US?
A: Historically, our revenues have been evenly split between international and domestic customers. The primary markets for Tuberculosis are in countries like India and South Africa, while the US is a key market for our upper respiratory tests and COVID. The broader mix has been about 50-50. - Dwight H. Egan, CEO
Q: Can you provide an update on the development of your tuberculosis test?
A: We have completed several preliminary analytical studies for TB and plan to initiate clinical trials in South Africa and India in early 2025. We aim to pursue regulatory pathways in these regions and engage with NGOs and potential customers to support our go-to-market strategy. - Dwight H. Egan, CEO
Q: What progress has been made on the HPV multiplex test?
A: The HPV multiplex test has been fully ported to test cups for the Co-Dx PCR Pro instrument, and chemistry optimization appears complete. We expect to begin clinical evaluations early next year, initially targeting India and Africa due to higher HPV prevalence. - Dwight H. Egan, CEO
Q: How is the company managing its financial position given the current revenue decline?
A: We continue to manage our spending to maintain a healthy balance sheet, focusing on operational and manufacturing efficiencies while reducing expenses. We are optimistic about 2025 and future developments within our test pipeline. - Brian L. Brown, CFO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
