Financial Data and Key Metrics Changes - The company reported a GAAP net loss of $61 million for the full year 2021, compared to a net loss of $43 million in 2020 [19] - For Q4 2021, the GAAP net loss was $22 million, compared to a net loss of $19 million for the same period in 2020 [19] - Revenue for the year ended December 31, 2021, was $1.3 million, with a gross loss of $1.5 million [19][20] - Non-GAAP net loss for the full year 2021 was $39.2 million, compared to $18.9 million in 2020 [25] Business Line Data and Key Metrics Changes - Revenue from radiology services for Q4 2021 was $1 million, with a gross profit of $0.0 million on a GAAP basis and a gross profit of $0.4 million on a non-GAAP basis, representing a gross profit margin of approximately 40% [20] - Revenue from licensing of AI applications for Q4 2021 was $0.3 million, with a gross loss of $1.5 million on a GAAP basis [21] Market Data and Key Metrics Changes - The company signed 11 MSaaS agreements for the global deployment of 6,500 units of the Nanox.ARC multi-source system across various territories, including Africa, Central America, and Europe [15] Company Strategy and Development Direction - The company aims to streamline commercialization through strategic acquisitions, including Zebra Medical Vision (now Nanox.AI), USARAD Holdings, and MDW LLC, to enhance healthcare access and affordability [9][10] - The leadership team of Nanox.AI has been strengthened with the appointment of Pini Ben Elazar as General Manager [12] - The company is focused on establishing production capabilities for the Nanox.ARC system and enhancing regulatory pathways [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about ongoing communication with the FDA regarding the Nanox.ARC system and expects thoughtful improvements based on FDA feedback [7][8] - The company anticipates being in full production of the Nanox.ARC system by mid-2022, which is crucial given current global chip supply shortages [17] Other Important Information - As of December 31, 2021, the company had cash equivalents and marketable securities of $156.6 million and $3.8 million in loans from banks [27] - The company ended the year with approximately 51.8 million shares outstanding, an increase from 46.1 million shares at the end of 2020, primarily due to acquisitions [28] Q&A Session Summary Question: What is the update expectation on approval or clearance for the multisource? - Management indicated that they do not expect the FDA response to take the full 75 days and are hopeful for a quicker response based on ongoing discussions [35][36] Question: What are the annualized revenue run rates and growth rates for Nanox.AI and USARAD segments for FY 2022? - Expected annual revenue for USARAD is around $8 million to $9 million, while for the AI segment, it is projected to be $3 million to $4 million [41] Question: What was the litigation expense in the fourth quarter? - The litigation expense related to the SEC probe and class action was $455,000 for the quarter [47] Question: Can you provide a sense of the size of the integrated healthcare organization? - The organization is among the top 25 in the U.S., indicating a significant size and influence in the healthcare sector [52] Question: What is the status of the production and delivery commitments for 2022? - Management confirmed that they have ordered necessary components for assembly and expect to produce hundreds of machines quarterly [48]
Nano-X Imaging (NNOX) - 2021 Q4 - Earnings Call Transcript