Financial Data and Key Metrics Changes - Total revenue for Q3 2024 decreased to 2.5 million in the same period last year [35] - Gross profit for the quarter decreased to 2.2 million in the prior year [35] - Net loss for Q3 2024 was 0.32 per fully diluted share, compared to a net loss of 0.20 per fully diluted share in the prior year [37] - Adjusted EBITDA was a loss of 6.5 million in the prior year [38] - Cash, cash equivalents, and marketable investment securities at the end of the quarter totaled 0.4 million, while product revenue was 4.9 million from 10.6 million from $11.1 million in the third quarter of 2023, primarily due to reduced stock-based compensation and clinical trial expenses [36] Market Data and Key Metrics Changes - The company is focusing on expanding its market reach in regions with unmet needs, including Central and South America, Africa, and India [10][42] - The primary markets for tuberculosis testing are identified as India and South Africa, while the U.S. remains a key market for upper respiratory tests [43] Company Strategy and Development Direction - The company is advancing the development of its Co-Dx PCR platform, which includes a low-cost, portable testing instrument and mobile app [6] - Plans to initiate clinical trials for tuberculosis tests in South Africa and India in early 2025 [17] - The company aims to broaden its potential reach by developing tests for tuberculosis, respiratory multiplex, HPV multiplex, and Strep A [7][20][22] - The focus is on international markets where there is a high demand for decentralized, portable, low-cost testing systems [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the quality and integrity of the Co-Dx PCR platform despite uncertainties in the FDA review timeline [7] - The company remains optimistic about its future developments and pipeline initiatives, particularly for 2025 [39] - Management highlighted the importance of operational and manufacturing efficiencies to reduce expenses [38] Other Important Information - The company has been actively engaging with NGOs and potential customers to support its go-to-market strategy for tuberculosis testing [19][28] - The expansion of the oligo synthesis facility in India is nearly complete, which will enhance manufacturing capacity [31] Q&A Session Summary Question: Any feedback from the FDA for the 510(k) application? - Management stated that discussions with the FDA are ongoing, but they cannot comment on regulatory decisions or timelines [42] Question: How is demand split between the U.S. and global customers? - Historically, revenues have been evenly split between international and domestic customers, depending on the indication [43][44]
CDI(CODX) - 2024 Q3 - Earnings Call Transcript