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Nano-X Imaging (NNOX) - 2021 Q1 - Earnings Call Transcript
2021-05-11 17:49
Financial 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]
Nano-X Imaging (NNOX) - 2020 Q4 - Annual Report
2021-04-06 20:05
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 19 ...
Nano-X Imaging (NNOX) - 2020 Q4 - Earnings Call Transcript
2021-03-02 18:54
Financial 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]