Earnings release
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NANOX Nanox Announces First Quarter 2021 Results and Provides Business Update May 11 , 2021 Announced FDA 510 ( k ) clearance for the single source Nanox Cart X - Ray System Scaling up Company's semiconductor fabrication plant in South Korea Ended Q1 with cash and cash equivalents of $ 219 million and no debt Management to host conference call and webcast today , May 11 , at 8:30 AM ET NEVE ILAN , Israel , May 11 , 2021 ( GLOBE NEWSWIRE ) NANO - X IMAGING LTD ( NASDAQ : NNOX ) ( " Nanox " or the " Company " ) , an innovative medical imaging technology company , today announced results for the first quarter ended March 31 , 2021 and provided a business update . " We were very pleased in April to receive FDA clearance for our single source Nanox Cart X - Ray System , a critical achievement for our company , and an important reference point as we prepare to submit for approval of our multi - source device this year , " stated Ran Poliakine , Chairman and Chief Executive Officer of Nanox . " In addition , we are making solid progress , despite the impact of the pandemic , on the technology transfer of MEMs chip technology to our interim clean - room facility in Korea and the construction of our new state - of - the - art fabrication facility . " Due to delays with the original third - party supplier of the second - generation high - power ceramic tube , which were compounded by the COVID - 19 pandemic , Nanox is currently working with two alternative tube suppliers for the multi - source system . As a result , while the Company does not expect to meet its previously announced milestone of shipment of 1,000 multi - source Nanox units by the first quarter of 2022 , the Company believes that it will be able to gain ground during the year to reach the shipment milestone of 1,000 multi - source Nanox units during 2022 , and possibly more , if the multi - source Nanox.ARC is cleared by the FDA and authorized by other similar regulatory agencies . Nanox continues to expect submission of a 510 ( k ) premarket notification to the FDA with respect to the multi - source Nanox.ARC and the Nanox.CLOUD during 2021 and deployment of an initial wave of approximately 15,000 Nanox.ARC units by the end of 2024 . " While we have experienced delays , compounded by the world pandemic , in the production of our second - generation high - power tube by a third - party manufacturer , which caused us to revisit certain timelines associated with the shipment of multi - source units , we believe that the manufacture and shipment of at least 1,000 multi - source systems will be accomplished in 2022 , " added Mr. Poliakine . " We continue to believe that our novel digital x - ray source incorporating our MEMs chip can be manufactured at a fraction of the cost of legacy analog x - ray source tubes . This , along with our innovative Medical Screening as a Service ( MSaaS ) business model of working with healthcare providers , will allow us to achieve our mission of democratizing medical imaging and making access to imaging more widely available to people who currently have limited or no access or experience long wait times . We have a growing , highly qualified management team and a strong balance sheet , and are working tirelessly toward this goal . " " Our vision is to provide a worldwide end - to - end medical imaging solution , including remote services such as : image repository , radiologist matching , online and offline diagnostics review and annotation , connectivity to medical imaging Al systems , and billing and reporting . This will enable us to offer a more comprehensive and differentiated medical imaging solution to our customers , " stated Mr. Poliakine . First Quarter 2021 and Recent Developments : • Received FDA 510 ( k ) clearance for its single - source Nanox Cart X - Ray System on April 2 , 2021 • Commenced technology transfer to Nanox's wholly owned Korean subsidiary to enable production of the silicon MEMs chip that is integral to the Nanox digital X - ray source . The subsidiary is leveraging SK Telecom's expertise in semiconductors under the joint collaboration between the two companies in establishing permanent chip facility . ● Appointed global medical business development and sales executive Moshe Shtengel as Chief Business Officer Financial results for three months ended March 31 , 2021 For the three months ended March 31 , 2021 , the Company reported a net loss of $ 12.7 million , compared to a net loss of $ 7.4 million for the three - month period ended March 31 , 2020 . Research and Development expenses for the first quarter 2021 were $ 2.7 million , as compared to $ 2.4 million for the corresponding prior year period in 2020. The slight increase was due to higher development costs related to the Nanox System , including increased R & D headcount , and costs related to the ongoing regulatory approval process , offset by a decrease in share - based compensation . Marketing expenses for the first quarter 2021 were $ 1.7 million , as compared to $ 1.0 million for the corresponding prior year period in 2020. These expenses increased due to higher investments in brand awareness and product marketing capabilities as well as share - based compensation . General and administrative expenses for the first quarter 2021 were $ 8.2 million , as compared to $ 4.0 million for corresponding prior year period in 2020. The increase in general and administrative expenses in the first quarter of 2021 as compared to the corresponding prior period was due to secondary offering expenses and share - based compensation . Net cash used in operating activities during the first quarter 2021 was $ 4.4 million . The Company ended the first quarter 2021 with cash and cash equivalents of $ 219.3 million , including $ 13.6 million cash in transit which was paid soon after the quarter ended .