CDI(US:CODX)2023-03-16 22:37Financial Data and Key Metrics Changes - For fiscal year 2022, revenue decreased by 65.0% to $34.2 million compared to $97.9 million in fiscal 2021, primarily due to the global decline in COVID testing [22][25] - Total operating expenses increased to $55.7 million from $40.2 million in fiscal 2021, attributed to a goodwill impairment charge of $15.4 million [23][25] - Net loss for fiscal 2022 was $14.2 million, or a loss of $0.45 per fully diluted share, compared to net income of $36.7 million, or $1.23 per fully diluted share in the prior year [25][32] - Gross profit decreased to $28.7 million from $86.3 million in fiscal 2021, with a gross margin percentage of 84.0%, down from 88.2% [32] Business Line Data and Key Metrics Changes - The company is focusing on the Co-Dx PCR Home platform, which is expected to support multiple tests for respiratory diseases, STIs, and tuberculosis [3][11] - The centralized laboratory business channel continues to drive most sales, providing cash flow for R&D efforts [16][31] Market Data and Key Metrics Changes - The market for COVID testing is expected to persist, but the demand is not anticipated to return to pandemic levels [6][35] - The company is exploring collaborations with NGOs for increased access to diagnostics for diseases like tuberculosis, which remains a significant health concern [83] Company Strategy and Development Direction - The company aims to leverage its patented Co-Primers technology to enhance multiplex testing capabilities and expand its product pipeline [15][18] - The commercialization strategy is guided by market research to identify high-throughput locations for the initial launch of the Co-Dx PCR Home platform [20][31] - The company is committed to maintaining a strong balance sheet and investing in R&D to support long-term growth initiatives [34][47] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the ongoing challenges in the COVID testing market but remains optimistic about the potential of the Co-Dx PCR Home platform [35][48] - The company believes that 2023 will be a pivotal year for positioning itself for long-term success [48] Other Important Information - The company has made significant investments in R&D, with increased expenses offset by a decrease in sales and marketing costs [45] - The company has a solid cash position of $81.3 million as of December 31, 2022, down from $89.9 million the previous year [34] Q&A Session Summary Question: Can you comment on the current enrollment speed of the ongoing clinical trial of the Co-Dx PCR Home device? - Management stated that enrollment is consistent with expectations, but specific numbers cannot be disclosed due to the nature of the clinical trial [36][50] Question: How many sales reps will it take to successfully market this product when approved by the FDA? - Management indicated that they are adequately staffed for the launch and may add personnel as needed [38][66] Question: Will you be able to secure reimbursement from CMS and private payers for tests conducted on this platform? - Management confirmed that they are actively monitoring reimbursement processes and will pursue opportunities for securing coverage [53]