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Nano-X Imaging (NNOX) - 2023 Q1 - Quarterly Report
2023-03-09 13:05
Exhibit 99.1 Nanox Announces Fourth Quarter 2022 Financial Results and Provides Business Update Reports progress towards global supply chain development Ended the fourth quarter of 2022 with cash, cash equivalents and marketable securities of $102.9 million Management to host conference call and webcast Thursday, March 9, 2023 at 8:30 AM ET NEVE ILAN, Israel— March 9, 2023 -- NANO-X IMAGING LTD (NASDAQ: NNOX) ("Nanox" or the "Company"), an innovative medical imaging technology company, today announced resul ...
Nano-X Imaging (NNOX) - 2022 Q3 - Earnings Call Transcript
2022-11-10 16:43
Financial Data and Key Metrics Changes - The company reported a GAAP net loss of $19.1 million for Q3 2022, compared to a 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 $2.4 million, with a gross loss of $1.4 million, reflecting an increase in revenue from data monetization projects [14][18] - Non-GAAP net loss for Q3 2022 was $8.1 million, compared to a non-GAAP net loss of $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 $2.4 million, up from $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]
Nano-X Imaging (NNOX) - 2022 Q2 - Earnings Call Transcript
2022-08-16 14:35
Financial Data and Key Metrics Changes - Nano-X generated top line revenue of $2.2 million in Q2 2022, compared to $1.8 million in Q1 2022, indicating a quarter-over-quarter growth [10] - The GAAP net loss for Q2 2022 was $19.6 million, compared to a net loss of $13.6 million in Q2 2021, largely due to acquisition-related expenses and increased R&D costs [25] - Non-GAAP net loss for Q2 2022 was $8.2 million, compared to a non-GAAP net loss of $8.6 million for the same period in 2021 [31] Business Line Data and Key Metrics Changes - Revenue from teleradiology services was $2.1 million with a gross profit of $0.0 million on a GAAP basis, and $0.9 million on a non-GAAP basis, representing a gross profit margin of approximately 43% [26] - The AI solutions business generated $0.1 million in revenue with a gross loss of $2.1 million on a GAAP basis [26] - The company signed 14 new client agreements for teleradiology services during Q2 2022, indicating accelerated revenue growth [12] Market Data and Key Metrics Changes - The company is preparing for global deployment of the Nanox.ARC system, with significant progress in Nigeria and Ghana [18][19] - A strategic agreement was signed with Spectrum Health, an integrated healthcare network in Michigan, to use the AI population health solution [14] Company Strategy and Development Direction - The company aims to advance the Nanox.ARC system towards commercialization and is focused on obtaining FDA clearance [8] - A technology development center is being established in Israel to enhance R&D capabilities, complementing existing facilities in Korea and Japan [22] - The company is pushing forward with the deployment of the Nanox.ARC in Nigeria and has signed an agreement to deploy 350 units in Ghana [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made in the FDA clearance process and the potential for accelerated revenue growth from teleradiology services [15][12] - The management team acknowledged the challenges posed by supply chain issues but remains committed to advancing production and deployment timelines [42] Other Important Information - The company was added to the Russell 2000 and Russell 3000 indexes effective June 27, 2022, which is seen as a positive development [24] - Cash, cash equivalents, and marketable securities as of June 30, 2022, were approximately $126.7 million [33] Q&A Session Summary Question: Can you talk about the technology center in Israel and its capabilities? - The technology center will focus on advanced technologies and will complement existing facilities in Korea and Japan, which are more manufacturing-oriented [41] Question: What is the anticipated number of ARCs manufactured by the end of the year? - Production is being accelerated, with the first 1,000 units expected to be assembled in Israel, and further discussions on mass production are ongoing [42] Question: Will there be any goodwill impairment in Q3 or Q4? - Future goodwill impairment will depend on market parameters and internal management estimates [46] Question: What is the status of the CE Mark for Nanox.ARC? - All necessary documentation for CE marking has been submitted, and the company is hopeful for a timely process [57] Question: Can you provide an update on the AI agreements and their revenue potential? - The integration of AI solutions is ongoing, with revenue potential ranging from a few hundred thousand to several million dollars [66]
Nano-X Imaging (NNOX) - 2022 Q2 - Quarterly Report
2022-08-16 12:13
Financial Performance - The company generated $2.2 million in revenue for Q2 2022, up from $1.8 million in Q1 2022, representing a growth of over 15% in sales of radiology services [4]. - The company reported a net loss of $19.6 million for Q2 2022, compared to a net loss of $13.6 million in the same period last year [6]. - Revenue for the six months ended June 30, 2022, was $4,008 thousand, compared to $0 for the same period in 2021 [32]. - Gross loss for the six months ended June 30, 2022, was $(3,674) thousand, with a gross loss of $(1,755) thousand for the three months ended June 30, 2022 [32]. - Net loss for the six months ended June 30, 2022, was $(41,280) thousand, compared to $(26,294) thousand for the same period in 2021, representing a 57.1% increase in loss [32]. - The company reported a basic and diluted loss per share of $(0.79) for the six months ended June 30, 2022, compared to $(0.56) for the same period in 2021 [32]. - The company reported a basic and diluted loss per share of $0.38 for the six months ended June 30, 2022, compared to $0.33 for the same period in 2021 [44]. Expenses - Research and development expenses increased to $6.5 million in Q2 2022 from $4.3 million in the comparable period, primarily due to the consolidation of Nanox.AI [7]. - Total operating expenses for the six months ended June 30, 2022, were $40,451 thousand, an increase of 54.5% from $26,168 thousand in the same period of 2021 [32]. - Research and development expenses for the six months ended June 30, 2022, were $13,323 thousand, up from $7,052 thousand in the same period of 2021, reflecting an increase of 88.5% [32]. - GAAP research and development expenses for the six months ended June 30, 2022, were $13.32 million, compared to $7.05 million in 2021, representing an increase of 89% [45]. - The company incurred $11.53 million in share-based compensation for the six months ended June 30, 2022, compared to $9.53 million in 2021, a 21% increase [44]. Cash and Assets - The company ended Q2 2022 with cash, cash equivalents, and marketable securities totaling $126.7 million [14]. - Cash and cash equivalents decreased to $51,676 thousand as of June 30, 2022, from $66,645 thousand as of December 31, 2021 [28]. - Total assets decreased to $317,724 thousand as of June 30, 2022, from $363,170 thousand as of December 31, 2021 [28]. - The company had total current assets of $89.8 million and total current liabilities of $40.6 million, resulting in working capital of $49.2 million as of June 30, 2022 [14]. - Cash and cash equivalents at the end of the period were $51.80 million, down from $116.86 million at the end of the same period in 2021, a decrease of 56% [41]. Liabilities and Equity - The company reported a goodwill impairment of $14.3 million in Q2 2022 due to changes in management estimates [10]. - Total liabilities decreased to $55,448 thousand as of June 30, 2022, from $71,022 thousand as of December 31, 2021 [28]. - The company had a total shareholders' equity of $262,276 thousand as of June 30, 2022, down from $292,148 thousand as of December 31, 2021 [28]. - Non-GAAP net loss attributable to ordinary shareholders for the six months ended June 30, 2022, was $19.78 million, up from $15.73 million in 2021, indicating a 25% increase [44]. Financing and Investments - Cash used in operating activities for the six months ended June 30, 2022, was $22.28 million, compared to $11.75 million in 2021, reflecting a 90% increase in cash outflow [41]. - Net cash provided by financing activities was $14.08 million for the six months ended June 30, 2022, compared to $3.90 million in 2021, indicating a significant increase in financing [41]. - The company’s total cash outflow from investing activities was $6.77 million for the six months ended June 30, 2022, compared to $89.08 million in 2021, showing a significant reduction in investment cash outflow [41]. Strategic Initiatives - The company secured an agreement with BIO Ventures for Global Health to develop a medical imaging training initiative in Nigeria [4]. - The company plans to make a 510(k) submission to the FDA for the multi-source Nanox.ARC system [3]. - The company was added to the Russell 2000® and Russell 3000® Indexes effective June 27, 2022 [4]. - The company reported a change in contingent earnout liability of $12.26 million for the six months ended June 30, 2022, which was not present in the previous year [41].
Nano-X Imaging (NNOX) - 2022 Q1 - Earnings Call Transcript
2022-05-19 14:49
Nano-X Imaging Ltd (NASDAQ:NNOX) Q1 2022 Earnings Conference Call May 19, 2022 8:30 AM ET Company Participants Mike Cavanaugh - IR, ICR Westwicke Erez Meltzer - Chief Executive Officer Ran Daniel - Chief Financial Officer Conference Call Participants Suraj Kalia - Oppenheimer Jeffrey Cohen - Ladenbrug Thalmann Rahul Rakhit - LifeSci Capital Operator Good day, and thank you for standing by. Welcome to the NANO-X IMAGING First Quarter 2022 Earnings Conference Call. At this time, all participants are in a list ...
Nano-X Imaging (NNOX) - 2021 Q4 - Annual Report
2022-05-02 12:14
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, 2021 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) - 2021 Q4 - Earnings Call Transcript
2022-03-31 15:57
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) - 2022 Q1 - Quarterly Report
2022-03-31 11:59
Exhibit 99.1 Nanox Announces Fourth Quarter 2021 Financial Results and Provides Business Update Management to host conference call and webcast today, March 31, at 8:30 AM ET NEVE ILAN, Israel—March 31, 2022 -- NANO-X IMAGING LTD (NASDAQ: NNOX) ("Nanox" or the "Company"), an innovative medical imaging technology company, today announced results for the fourth quarter ended December 31, 2021 and provided a business update. Fourth Quarter Highlights and Recent Developments: "The fourth quarter and fiscal year ...
Nano-X Imaging (NNOX) - 2021 Q3 - Earnings Call Transcript
2021-11-17 16:45
Nano-X Imaging Ltd. (NASDAQ:NNOX) Q3 2021 Earnings Conference Call November 17, 2021 ET Company Participants Ran Poliakine ??? Chairman of the Board and Chief Executive Officer Mike Cavanaugh ??? Investor Relations Erez Meltzer ??? Executive Board Member and incoming Chief Executive Officer Ran Daniel ??? Chief Financial Officer Conference Call Participants Jeffrey Cohen ??? Ladenburg Thalmann Suraj Kalia ??? Oppenheimer Ravi Misra ??? Berenberg Capital Rahul Rakhit ??? LifeSci Capital Operator Thank you fo ...
Nano-X Imaging (NNOX) - 2021 Q3 - Quarterly Report
2021-09-30 20:30
Exhibit 99.1 NANO-X IMAGING LTD The Communications Center Neve Ilan, Israel 9085000 Telephone: 972 2 5360360 NOTICE OF ANNUAL GENERAL MEETING OF SHAREHOLDERS To Be Held on November 4, 2021 To our Shareholders: You are invited to attend the Annual Meeting of Shareholders of Nano-X Imaging Ltd ("we" or the "Company") to be held at the Company's offices at The Communications Center, Neve Ilan, Israel on November 4, 2021 at 15:00 Israeli time (9:00 am EST), and thereafter as it may be adjourned from time to tim ...