Nano-X Imaging (NNOX)2022-11-10 16:43Financial Data and Key Metrics Changes - The company reported a GAAP net loss of 13.5 million in Q3 2021, primarily due to the consolidation of Nanox.AI and USARAD, increased R&D expenses, and higher general and administrative expenses [13][17][18] - Revenues for Q3 2022 were 1.4 million, reflecting an increase in revenue from data monetization projects [14][18] - Non-GAAP net loss for Q3 2022 was 8.4 million for the same period in 2021 [18] Business Line Data and Key Metrics Changes - Revenue from teleradiology services in Q3 2022 was 2.2 million in Q2 2022, driven by new client additions and organic growth [10] - The company signed nine new client agreements for teleradiology services during Q3 2022, indicating growth in this segment [10][28] Market Data and Key Metrics Changes - The company has a total of 6,850 pre-ordered units globally, with plans to deploy the multi-source Nanox.ARC system in Nigeria and other early adopting countries [8] - The company received an import license for Nigeria and is preparing to ship the first system upon securing regulatory approval [8] Company Strategy and Development Direction - The company aims to begin deploying the multi-source Nanox.ARC system in 2022 and is actively pursuing CE Mark approval in the EU [8] - The strategy includes a stepwise approach to FDA submissions, utilizing Q submissions for ongoing dialogue with the FDA [33] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made in Q3 2022 and the potential for future growth as regulatory approvals are secured [21] - The company is focused on making medical imaging accessible globally and is preparing for large-scale commercialization [11] Other Important Information - The company has engaged with VSI for CE Mark approval in the EU and is conducting clinical trials in Israel with expected results in Q4 2022 [9][58] - As of September 30, 2022, the company had cash, cash equivalents, and marketable securities of approximately $117.1 million [19] Q&A Session Summary Question: Update on Nigeria and available units - Management confirmed that they are ready to ship units once regulatory approvals are obtained and are preparing for customer engagement and training in Nigeria [25][27] Question: Teleradiology account growth and utilization trends - The company added nine accounts this quarter, bringing the total to approximately 40 accounts, with a significant portion of revenue coming from a few key clients [28][29] Question: Goodwill impairment for the quarter - There was no impairment expense for Q3, but management indicated that they would continue to assess goodwill impairment based on changing discount rates [30][31] Question: FDA review status and expectations - Management refrained from predicting the timing of FDA responses but emphasized their efforts to enhance the likelihood of clearance [32][33] Question: Update on the Ghana contract - Management stated they are awaiting regulatory processes and will provide updates once approvals are secured [36] Question: Workflow for commercialization in Nigeria - The manufacturing and assembly processes involve collaboration between facilities in Korea and Israel, with training and installation conducted on-site in Nigeria [44][45] Question: Confidence in fulfilling pre-orders - Management expressed that confidence in contracts is contingent on regulatory approvals and ongoing dialogue with business entities [49][50] Question: Initial utilization levels at Northwell - Management noted ongoing discussions with Northwell and indicated potential for higher revenues from the partnership [52][56] Question: Clinical trials in Israel - The company received permits to conduct trials and anticipates generating images of multiple body organs in Q4 2022 [58]