Nano-X Imaging (US:NNOX)2021-03-02 18:54Financial Data and Key Metrics Changes - Non-GAAP net loss for Q4 2020 was $8.4 million, compared to a non-GAAP net loss of $2.8 million for Q4 2019, indicating an increase in losses [45] - Non-GAAP research and development expenses for Q4 2020 were $2.1 million, up from $1.3 million in Q4 2019, reflecting increased development activities [46] - Non-GAAP general and administrative expenses for Q4 2020 were $4.8 million, compared to $1.2 million in Q4 2019, due to investments in management and IPO-related costs [47] - Cash and cash equivalents at the end of Q4 2020 were approximately $213.5 million, with no debt, sufficient to execute the plan of manufacturing and shipping 15,000 units globally by the end of 2024 [48] Business Line Data and Key Metrics Changes - The company has executed contracts for the deployment of 5,150 systems with nine service providers in 13 countries, contingent upon regulatory approval [42] - The business model, termed MSaaS (medical-screening-as-a-service), allows healthcare facilities to access the Nanox.ARC at no upfront cost, with payments based on a pay-per-scan basis [41] Market Data and Key Metrics Changes - The company aims to deploy over 5,000 units of Nanox.ARC through MSaaS agreements and an additional 5,500 units through strategic collaborations [16] - The company is focusing on expanding the overall market for medical imaging, particularly in smaller healthcare facilities and rural areas [24] Company Strategy and Development Direction - The company is focused on building a global network to deliver imaging availability and has signed multiple agreements to facilitate this [16][31] - The strategic collaboration with Ambra Health aims to integrate medical imaging data management, enhancing the accessibility of medical images [31] - The company is investing in its Korean subsidiary for MEMs X-ray chip production, with plans for a permanent facility operational by 2022 [34] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about obtaining FDA clearance for the Nanox.ARC, expecting a response within 30 days following their comprehensive submission [55][57] - The company is committed to executing its plan and believes that the current cash reserves are sufficient to support its growth strategy [48] - Management emphasized the importance of early detection in healthcare and the potential for Nanox's technology to improve patient outcomes [24] Other Important Information - The company completed a secondary offering of approximately 3.1 million shares by certain pre-IPO shareholders, with no proceeds going to the company [49] - The company has established a strong leadership team with key hires in operational and technological roles to support its expansion [35] Q&A Session Summary Question: Confirmation of FDA response submission - Management confirmed that they submitted the response to the FDA's last set of questions [54] Question: Timing for FDA response - Management indicated that they expect to receive a response within the next 30 days [55] Question: Update on multi-source application - Management stated that they are still on track for clearance within the year and are preparing for submission [58] Question: Production locations for initial units - Initial units are being produced in Israel, with components sourced from Korea and Japan [60] Question: Commercial prospects and contract negotiations - Management highlighted the successful signing of contracts for 5,150 units and ongoing negotiations with additional service providers [68] Question: Status of Korean subsidiary - Management clarified that the Korean facility is wholly owned by Nanox, with support from SK Telecom [88]