Nano-X Imaging (US:NNOX)2021-05-11 17:49Financial Data and Key Metrics Changes - The company reported a GAAP net loss applicable to ordinary shares of $12.7 million for Q1 2021, compared to a net loss of $7.4 million for Q1 2020, indicating a significant increase in losses [15] - Non-GAAP net loss applicable to ordinary shares for Q1 2021 was $7.1 million, up from a non-GAAP net loss of $2.6 million in the same period in 2020 [16] - As of March 31, 2021, the company had approximately 47.6 million shares outstanding and cash and cash equivalents of approximately $219.3 million, with no debt [19] Business Line Data and Key Metrics Changes - The company has contracts in place for the deployment of 5,150 Nanox.ARC units with 9 service providers in 13 countries, with additional collaborations for 5,500 units in the U.S., South Korea, and Vietnam [11][12] - Non-GAAP research and development expenses for Q1 2021 were $2.1 million, compared to $689,000 for the same period in 2020, reflecting increased development activities [17] Market Data and Key Metrics Changes - The company is experiencing increasing interest from service providers across many countries, resulting in a growing pipeline of potential opportunities for additional MSaaS agreements [12] - The company aims to deploy an initial wave of approximately 15,000 Nanox.ARC units by the end of 2024, with a focus on expanding delivery capabilities [19] Company Strategy and Development Direction - The company is focused on a unique business model called MSaaS (Medical Screening As a Service), which employs a pay-per-scale approach, making the technology more affordable for healthcare facilities [11] - The company is building a global supply chain and ramping up manufacturing, including a semiconductor fabrication plant in South Korea, expected to be operational by mid-2022 [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in meeting the goal of deploying 15,000 units, citing strong demand and a healthy pipeline of orders [27] - The company is actively working to mitigate supply chain risks by engaging multiple suppliers for critical components, including tubes and chips [25][57] Other Important Information - The company has made significant additions to its leadership team, indicating a commitment to building a world-class team for long-term success [14] - The company plans to submit a 510(k) premarket notification to the FDA for the multi-source Nanox.ARC and Nanox.CLOUD during 2021 [10] Q&A Session Summary Question: Can you provide more detail on the delays experienced by third-party manufacturers? - Management explained that delays were related to final assembly and testing issues with the leading supplier, and they have opened two additional suppliers to mitigate risks [24] Question: What is the level of confidence in meeting the 15,000 placement goal? - Management expressed confidence in meeting the goal due to strong demand and existing contracts, despite some delays in shipments [27] Question: What are the regulatory strategies for CE and other territories? - Management stated that they plan to submit the multi-source system to the FDA and other regulatory authorities shortly after, but do not expect to take the single source for clearance in other countries [43][44] Question: What is the status of software developments during the first quarter? - Management confirmed that software development is ongoing, with the operating system and cloud management progressing as planned [46] Question: What activities will occur at the new facility in Italy? - The facility in Italy will focus on supplying tubes, serving as a mitigation plan to ensure a steady supply for production [49]