CDI(US:CODX)2024-08-10 15:14Financial Data and Key Metrics Changes - Total revenue for Q2 2024 increased to $2.7 million compared to $0.2 million in the same period last year [20] - Gross profit for the quarter increased to $2.4 million from a loss of $0.3 million in the prior year [20] - Net loss for Q2 2024 was $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 [21] - Adjusted EBITDA loss improved to $5.9 million from a loss of $9.6 million in the prior year [21] - Cash position at the end of the quarter was $44.9 million [21] Business Line Data and Key Metrics Changes - Grant revenue in Q2 2024 was $2.5 million, while product revenue was $0.2 million [20] - Research and development expenses decreased to $5.6 million from $6.0 million in the prior year [20] - Total operating expenses decreased to $10.1 million from $11.7 million in the second quarter of 2023 [20] Market Data and Key Metrics Changes - The global total addressable market for tuberculosis (TB) testing is projected to exceed $3.6 billion within the next four years [11] - Approximately 17 million near point-of-care TB tests are performed annually in South and East Asia, with an additional 10 million in Africa [11] Company Strategy and Development Direction - The company is focused on commercializing its Co-Dx PCR platform, with a 510(k) application submitted to the FDA for over-the-counter use [5][6] - Plans to target high-volume care centers and skilled nursing facilities for the initial rollout of the Co-Dx PCR platform [8] - The company aims to expand its test pipeline, including tests for tuberculosis, respiratory multiplex, HPV, and strep [10][12][14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made in the first half of the year and the potential of the Co-Dx PCR platform to transform diagnostics [5][17] - The company is committed to maintaining a healthy balance sheet and operational efficiencies to support long-term growth [21][22] Other Important Information - The company attended two major trade shows, FIME and ADLM, to showcase its Co-Dx PCR platform and engage with potential customers [9] - The vector control business is expanding, with new offerings for mosquito-borne illness surveillance [15] Q&A Session Summary Question: Has there been any feedback from the FDA regarding the 510(k) submission? - Management confirmed regular contact with the FDA but could not comment on specific regulatory decisions [24][25] Question: Are there potential customers showing interest in placing orders once the 510(k) is cleared? - Management indicated constructive conversations with potential customers but emphasized that sales cannot occur until FDA clearance is obtained [26] Question: Is the potential market primarily domestic or international? - Management stated that interest in the product spans both domestic and international markets, with sales in over 50 countries [27]