• Total Revenue: $2.7 million, up from $0.2 million in the prior year same period.
• Grant Revenue: $2.5 million in the second quarter of 2024.
• Product Revenue: $0.2 million in the second quarter of 2024.
• Gross Profit: $2.4 million, compared to negative $0.3 million in the prior year comparable period.
• Total Operating Expenses: Decreased to $10.1 million from $11.7 million in the second quarter of 2023.
• Research and Development Expenses: $5.6 million, down from $6.0 million in the prior year period.
• Income Before Taxes: Loss of $7.7 million, compared to a loss of $11.2 million in the prior year.
• Net Loss: $7.6 million or a loss of $0.25 per fully diluted share, compared to a net loss of $8.9 million or a loss of $0.31 per fully diluted share in the prior year.
• Adjusted EBITDA: Loss of $5.9 million, compared to a loss of $9.6 million in the prior year.
• Cash Position: $44.9 million in cash, cash equivalents, and marketable investment securities.

• Warning! GuruFocus has detected 5 Warning Signs with CODX.

Release Date: August 08, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Co-Diagnostics Inc (NASDAQ:CODX) submitted their first 510(k) application to the FDA for their Co-Dx PCR Pro and Co-Dx PCR COVID-19 test kit, marking a pivotal milestone towards commercial launch.
• The company made significant progress in developing tests for tuberculosis, respiratory multiplex, HPV, and strep, positioning them well for future advancements.
• Co-Diagnostics Inc (NASDAQ:CODX) showcased their Co-Dx PCR platform at major trade shows, strengthening relationships with key suppliers and potential customers.
• The company reported a substantial increase in total revenue to $2.7 million for Q2 2024, compared to $0.2 million in the prior year period.
• Co-Diagnostics Inc (NASDAQ:CODX) ended the quarter with a strong cash position of $44.9 million, supporting their long-term growth and commercial launch plans.

Negative Points

• The Co-Dx PCR platform and COVID-19 test kit are still awaiting FDA clearance, delaying their commercial availability.
• Despite revenue growth, Co-Diagnostics Inc (NASDAQ:CODX) reported a net loss of $7.6 million for the second quarter of 2024.
• Operating expenses remain high at $10.1 million, although they have decreased from the previous year.
• The company is not yet permitted to sell their new products until FDA clearance is obtained, limiting immediate revenue opportunities.
• There is uncertainty regarding the timeline for FDA approval, which could impact the company's ability to meet its 2024 goals.

Q & A Highlights

Q: Have you heard back from the FDA regarding the 510(k) submission for the Co-Dx PCR platform? A: We have regular contact with the FDA since our submission. However, we cannot comment on regulatory decisions. We are pleased with their response so far. - Dwight Egan, CEO

Q: Have potential customers shown interest in placing purchase orders following the trade shows? A: We have had constructive conversations with potential customers at various trade shows. However, we cannot sell the product until we receive FDA clearance. The market response has been very positive. - Dwight Egan, CEO

Q: Is the potential market for your products both domestic and international? A: Yes, our potential market is both domestic and international. We have sold our products in over 50 countries and have a wide network of distributors globally. - Dwight Egan, CEO

Q: Can you share any guidance from the FDA on when you might expect clearance? A: We cannot provide specific guidance on FDA decisions. We maintain regular communication with them and are satisfied with the progress. - Dwight Egan, CEO

Q: What is the focus of your commercial strategy for the Co-Dx PCR platform? A: Our strategy focuses on high-volume care centers and skilled nursing facilities, where there is a significant need for COVID testing. We aim to expand our market reach upon receiving FDA clearance. - Dwight Egan, CEO

For the complete transcript of the earnings call, please refer to the full earnings call transcript.