Company Overview - Nanox Imaging Ltd (NASDAQ: NNOX) is an innovative medical imaging technology company focused on transitioning to preventive health care through affordable medical imaging technologies based on advanced AI and proprietary digital X-ray sources [3][4]. Upcoming Event - Nanox will participate in the Sidoti Small Cap Conference, scheduled for June 11-12, 2025, with management presenting on June 11 at 1:45 PM ET [1]. Technology and Solutions - The company aims to expand the reach of its technology beyond hospital settings, providing a seamless end-to-end solution from scan to diagnosis, enhancing efficiency in routine medical imaging processes [4]. - Nanox's ecosystem includes several components: - Nanox.ARC, a cost-effective multi-source digital tomosynthesis system - Nanox.AI Ltd., which offers AI-based algorithms to augment routine CT imaging readings - Nanox.CLOUD, a cloud-based platform for data management and imaging analysis - Nanox.MARKETPLACE, a decentralized marketplace for remote access to radiology and cardiology experts [4]. Vision and Goals - The company's vision is to improve early detection and treatment of diseases, ultimately enhancing health outcomes worldwide [4].

Financial Data and Key Metrics Changes - The company reported a GAAP net loss of $13.2 million for Q1 2025, compared to a net loss of $12.2 million in Q1 2024, reflecting an increase of $1 million largely due to a $1.1 million increase in gross loss [29] - Revenue for the reported period was $2.8 million, with a gross loss of $3 million on a GAAP basis, compared to revenue of $2.6 million and a gross loss of $2.1 million in the comparable period [29][30] - Non-GAAP gross loss for the reported period was $400,000, down from a gross profit of $600,000 in the comparable period, indicating a gross margin of approximately 15% [30] Business Line Data and Key Metrics Changes - Revenue from teleradiology services for the reported period was $2.6 million, with a gross profit of $400,000, compared to revenue of $2.4 million and a gross profit of $300,000 in the comparable period, representing a gross profit margin of approximately 17% [30] - Revenue from the sale and deployment of imaging systems and OEM services amounted to $33,000, with a gross loss of $1.6 million on a GAAP basis, compared to revenue of $47,000 and a gross loss of $400,000 in the comparable period [31] - The company's revenue from AI solutions for the reported period was $200,000, with a gross loss of $1.9 million on a GAAP basis, compared to revenue of $100,000 and a gross loss of $2 million in the comparable period [31] Market Data and Key Metrics Changes - The company has seen an increase in the number of scans performed by its systems, with an average target of seven scans per day for operational units [12] - The sales pipeline has doubled since January 2025, with the sales team handling over 1,000 leads, primarily from small and medium-sized health clinics in various countries [11][12] - The company is targeting over 100 ARC systems in various stages of deployment by the end of 2025 worldwide [12] Company Strategy and Development Direction - The company aims to improve medical imaging and enhance patient outcomes through strategic acquisitions and the integration of AI-powered imaging analysis [6][7] - The focus is on expanding the teleradiology business and AI solutions to create a comprehensive end-to-end medical imaging solution [8][9] - The company is preparing to ship its first systems to Puerto Rico and has made notable progress in forming distributor partnerships in the U.S. [15][19] Management's Comments on Operating Environment and Future Outlook - Management acknowledges recent market uncertainties but remains encouraged by the growing base of early adopters of the Nanox Arc [13] - The company expects its AI business to break even in 2026 and the ARC business to break even in 2027, with an inflection point anticipated in the second half of 2025 [61][62] - Management emphasizes the importance of clinical validation and regulatory approvals in driving future growth [23][35] Other Important Information - The company had cash, cash equivalents, restricted deposits, and marketable securities of approximately $72.9 million as of March 31, 2025 [33] - The company continues to strengthen its sales and clinical teams to support its commercialization efforts in the U.S. market [14] Q&A Session Summary Question: Can you provide details on the fleet of units expected by the end of the year? - Management indicated that the majority of units will be in the U.S., with about 15-20% in Europe and 10% in other regions, depending on regulatory approvals [40] Question: What is the pricing and reimbursement status for the second opinion services? - The second opinion service is priced at approximately $300 and is primarily a retail model, with growing business [45][46] Question: How many units are currently deployed and operational in the U.S.? - More than 20 units are currently installed, with some awaiting regulatory approvals [52] Question: When can the company expect to reach breakeven? - The AI business is expected to break even in 2026, while the ARC business is projected to break even in 2027, with an inflection point anticipated in the second half of 2025 [61][62]

Financial Data and Key Metrics Changes - The company reported a GAAP net loss of $13.2 million for Q1 2025, compared to a net loss of $12.2 million in Q1 2024, reflecting an increase of $1 million largely due to a $1.1 million increase in gross loss [27] - Revenue for Q1 2025 was $2.8 million, with a gross loss of $3 million, compared to revenue of $2.6 million and a gross loss of $2.1 million in the same period last year [27][28] - Non-GAAP gross loss for Q1 2025 was $400,000, down from a gross profit of $600,000 in Q1 2024, indicating a gross margin of approximately 15% for the reported period [28] Business Line Data and Key Metrics Changes - Revenue from teleradiology services for Q1 2025 was $2.6 million, with a gross profit of $400,000, compared to $2.4 million and a gross profit of $300,000 in Q1 2024, representing a gross profit margin of approximately 17% [28] - Revenue from imaging systems and OEM services was $33,000 with a gross loss of $1.6 million in Q1 2025, compared to revenue of $47,000 and a gross loss of $400,000 in the same period last year [29] - Revenue from AI solutions was $200,000 with a gross loss of $1.9 million in Q1 2025, compared to $100,000 and a gross loss of $2 million in Q1 2024 [29] Market Data and Key Metrics Changes - The sales pipeline has doubled since January 2025, with the sales team handling over 1,000 leads, primarily from small and medium-sized health clinics in various countries [9] - The company is targeting over 100 ARC systems in various stages of deployment by the end of 2025, with over 60 units currently in various stages of implementation [10][11] Company Strategy and Development Direction - The company aims to improve medical imaging and enhance patient outcomes through strategic acquisitions and the integration of AI-powered imaging analysis [6][7] - The focus is on expanding the commercialization of Nanox ARC and AI solutions, with a multi-pronged strategy involving direct sales, collaborations, and distributor engagements [8][12] - The company is also pursuing opportunities in the workers' compensation segment, which presents a significant potential market [14] Management's Comments on Operating Environment and Future Outlook - Management acknowledged recent market uncertainties but expressed optimism about the growing base of early adopters for Nanox ARC [11] - The company expects its AI business to break even by 2026 and the ARC business to reach breakeven by 2027, with an anticipated inflection point in the second half of 2025 [57][58] Other Important Information - The company has received FDA clearance for the Nanox Arc X, enhancing its regulatory standing [20] - The company is actively engaged in clinical trials to generate data supporting the use of Nanox Arc, which is crucial for future growth [21] Q&A Session Summary Question: Can you provide details on the fleet deployment by the end of the year? - Management indicated that the majority of units will be in the US, with about 15-20% in Europe and 10% in other regions, depending on regulatory approvals [38] Question: What is the pricing and reimbursement status for the second opinion services? - The second opinion service is priced at approximately $300 and is primarily a retail model, with growing business potential [42] Question: How many units are currently deployed and operational in the US? - More than 20 units are currently installed, with some awaiting regulatory approvals [47] Question: What is the timeline for reaching breakeven across business lines? - The teleradiology division is already profitable, while the AI business is expected to break even in 2026 and the ARC business in 2027 [56][57]

Core Insights - Nanox Imaging Ltd reported a net loss of $13.2 million for Q1 2025, an increase from a net loss of $12.2 million in Q1 2024, primarily due to a $1.0 million increase in gross loss [3][8][13] - The company generated revenue of $2.8 million in Q1 2025, up from $2.6 million in Q1 2024, driven by teleradiology services, imaging systems sales, and AI solutions [4][8] - Nanox received FDA 510(k) clearance for its updated Nanox.ARC X system, marking a significant milestone in its mission to enhance access to medical imaging technology [2][8] Financial Performance - The gross loss for Q1 2025 was $3.0 million, with a gross loss margin of 108%, compared to a gross loss of $2.1 million and a margin of 80% in the prior year [5][8] - Non-GAAP gross loss for Q1 2025 was $0.4 million, a decline from a non-GAAP gross profit of $0.6 million in Q1 2024 [14][45] - Revenue from teleradiology services was $2.6 million in Q1 2025, up from $2.4 million in Q1 2024, with a GAAP gross profit margin of approximately 17% [6][8] Operational Highlights - The company has over 60 imaging units in various stages of implementation for commercial, demonstration, and clinical use [2] - Research and development expenses for Q1 2025 were $5.0 million, a slight decrease from $5.2 million in the prior year [10] - Sales and marketing expenses increased to $0.9 million in Q1 2025 from $0.8 million in Q1 2024 [11] Liquidity and Capital Resources - As of March 31, 2025, the company had total cash and cash equivalents of $72.9 million, down from $83.5 million at the end of 2024 [17] - The company experienced negative cash flow from operations of $10.3 million during the reported period [17][38] Future Outlook - Nanox anticipates that the number of clinical, demo, and commercial units will exceed 100 by the end of 2025, assuming stable macroeconomic conditions [16]

Core Insights - Nanox Imaging Ltd will report its financial results for Q1 2025 on May 22, 2025, before market open [1] - The conference call to discuss these results will be hosted by CEO Erez Meltzer and CFO Ran Daniel at 8:30 a.m. ET [1] Company Overview - Nanox is focused on transitioning to preventive healthcare through affordable medical imaging technologies utilizing advanced AI and proprietary digital X-ray sources [3] - The company's vision includes expanding its technology's reach beyond hospital settings, providing a comprehensive solution from scan to diagnosis, and leveraging AI for improved diagnostic accuracy [4] Product Ecosystem - Nanox.ARC is a multi-source digital tomosynthesis system designed to be cost-effective and user-friendly [4] - Nanox.AI LTD offers an AI-based suite of algorithms that enhance routine CT imaging readings to detect early signs of chronic diseases [4] - Nanox.CLOUD is a cloud-based platform for managing data from Nanox devices and providing tools for in-depth imaging analysis [4] - Nanox.MARKETPLACE is a decentralized marketplace providing remote access to radiology and cardiology experts, along with teleradiology services [4]

Core Viewpoint - Nano-X Imaging has received FDA clearance for its Nanox.ARC X technology, which aims to revolutionize the medical imaging market by charging per X-ray rather than selling machines outright [2][3] Group 1: FDA Clearance and Technology - The FDA granted clearance for Nano-X to use its Nanox.ARC X technology to produce tomographic images for various medical indications [2] - The technology combines artificial intelligence with 2D X-ray scans to create a comprehensive three-dimensional view of the body [3] - The clearance was achieved in less than 30 days from the submission date, indicating a rapid approval process [3] Group 2: Financial Performance and Growth Potential - Nano-X reported trailing-12-month losses of $53.5 million and an annual cash burn of approximately $39 million [4] - The company experienced a sales growth of 14% last year, which is considered a positive start [5] - Analysts predict that Nano-X may not achieve profitability before 2028, although free cash flow could materialize sooner [5] Group 3: Market Strategy and Future Outlook - The company is focused on quickly establishing a market for its services, with the Nanox.ARC X system being plug-and-play and installable in one day [3] - The ability to generate cash flow is critical for Nano-X to sustain its operations and justify its valuation, especially with $73 million in cash reserves [5]

Core Insights - Nanox Imaging Ltd has received FDA 510(k) clearance for its new multi-source digital tomosynthesis system, Nanox.ARC X, in under 30 days from submission, allowing for tomographic imaging for various medical indications [1][7] - The Nanox.ARC X system features advanced technology that enhances imaging capabilities, reduces physical footprint, and allows for easy installation, making it suitable for diverse healthcare environments [2][3] Product Features - The Nanox.ARC X utilizes proprietary digital technology and cold cathode tomosynthesis to provide a comprehensive 3D view of the body, improving visualization and reducing structural overlap seen in traditional 2D X-rays [2][7] - The system is designed for minimal infrastructure requirements, operates on standard power, and has a cables-free design for improved safety and maintenance [3] Strategic Vision - The company aims to expand access to essential medical imaging technology, enhancing early detection and treatment capabilities through a seamless end-to-end solution that integrates AI and cloud-based data management [5][6] - Nanox plans to introduce the Nanox.ARC X later this year, expanding its product portfolio to cater to various customer needs and use cases [4]

Financial Performance - As of December 31, 2024, the company reported working capital of approximately $64.7 million and shareholders' equity of approximately $189.1 million[35] - For the year ended December 31, 2024, the company incurred a net loss of approximately $53.5 million and negative cash flow from operations of $36.4 million[35] - The company has an accumulated deficit of approximately $378.7 million as of December 31, 2024[35] - The company reported net losses of $113.2 million, $60.8 million, and $53.5 million for the years ended December 31, 2022, 2023, and 2024, respectively[58] - As of December 31, 2024, the company raised $37.8 million under its Controlled Equity Offering Sales Agreement, with an aggregate offering price of up to $100 million[58] - The company operates in a capital-intensive industry and may need additional financing to support ongoing operations and development[60] Business Models and Strategies - The company is pursuing three business models: Subscription Model, CapEx Model, and Licensing for OEM Model, with the Subscription Model being the primary focus[37] - The success of the company's Subscription Model is critical for increasing early detection of medical conditions, but it faces numerous risks including manufacturing delays and market acceptance[61] - The company has not entered into any licensing agreements to date, which may hinder the implementation of its Licensing Model[63] Regulatory Approvals and Compliance - The company has received FDA clearances for the Nanox.ARC, a multi-source 3D digital tomosynthesis system, and has produced a few dozen systems to date[32] - The FDA granted clearance for the Nanox.ARC and Nanox.CLOUD, but third-party payor coverage and reimbursement are not yet widely approved, impacting potential revenue generation[42] - The company received FDA clearance for the Nanox.ARC (including the Nanox.CLOUD) on April 28, 2023, allowing it to market a multi-source 3D digital tomosynthesis system[174] - The company plans to seek additional clearances or approvals for further uses of the currently cleared Nanox System[174] - Compliance with EU Medical Devices Regulation (EU) 2017/745 is essential for selling products in the European Economic Area (EEA), requiring a conformity assessment procedure[178] Market and Competitive Landscape - The commercial viability of the Nanox System, including the X-ray source technology, is uncertain and requires significant sales and marketing efforts for successful deployment[43] - The company faces intense competition in the medical imaging industry, with over 700 FDA-cleared AI products currently available[69] - The healthcare industry is focused on cost containment, which may limit reimbursement for the Nanox System and affect its commercial success[42] Operational Risks - The company is highly dependent on the successful development and market acceptance of its X-ray source technology and related products[25] - The company is still in the early stages of commercializing the Nanox.ARC and Nanox.CLOUD, with ongoing efforts to seek additional regulatory clearances[56] - The company relies on third-party manufacturers for the production of its Nanox.ARC and has engaged multiple suppliers to mitigate risks associated with manufacturing[73] - The company may need to enhance or redesign its MEMs X-ray chip to generate licensing revenue or for specific medical imaging applications[81] - The company relies on third-party cloud service providers, such as Microsoft Azure, for its MSaaS products, which could adversely affect its business if there are disruptions[103] Financial and Legal Liabilities - The company may incur significant legal expenses and management attention due to ongoing litigation and investigations, which could adversely affect financial condition[124] - The company entered into a formal settlement agreement for $8 million related to two securities class action complaints, which was approved by the court on May 7, 2024[125] - The company paid a civil penalty of $650,000 to the SEC and is permanently enjoined from violating certain sections of the Securities Act and Exchange Act[125] Cybersecurity and Data Protection - Cybersecurity breaches could result in significant data losses, operational disruptions, and reputational harm, affecting business operations and financial condition[119] - The company must ensure that third-party manufacturers comply with applicable regulations to avoid delays in product delivery and potential sanctions[187] - The company expects to be subject to HIPAA and HITECH regulations, which impose strict standards for the protection of individually identifiable health information[194] Intellectual Property Risks - The company relies on a combination of patents and trade secrets to protect its proprietary technologies, but may face challenges in ensuring their protection[141] - The company may face costly litigation if claims arise regarding infringement of third-party intellectual property rights, which could distract management and impact financial resources[151] - Changes in patent laws or their interpretation could adversely affect the company's ability to protect its inventions and enforce intellectual property rights[146] Economic and Geopolitical Risks - Geopolitical tensions, inflation, and rising interest rates may disrupt global financial markets, impacting the company's ability to access capital[58] - The company is subject to geopolitical risks, including the ongoing military conflict between Russia and Ukraine, which may disrupt supply chains and impact financial markets[132] - The company may experience adverse effects from changes in general economic conditions, including high interest rates and constrained capital spending, which could impact financial performance[128]

In its earnings release, Nanox attributed the deeper bottom-line shortfall to a one-time, $3 million income item that was booked in the third quarter. In more positive developments, Nanox provided a business update showcasing its two recent regulatory approvals. The first, earned in December, was the Food and Drug Administration's (FDA) nod for its Nanox.ARC, indicated for general use, and the second was the granting of a CE mark for the same system this past February. This is a quality designation required ...

Financial Data and Key Metrics Changes - The company reported a GAAP net loss of $14.1 million for Q4 2024, compared to a net loss of $10.2 million in Q4 2023, primarily due to an increase in gross loss and other expenses [48] - Revenue for the reported period was $3.0 million, with a gross loss of $2.9 million, compared to revenue of $2.4 million and a gross loss of $1.7 million in the comparable period [49] - Non-GAAP gross loss for the reported period was $0.3 million, compared to a gross profit of $0.9 million in the comparable period, indicating a significant decline in gross profit margin [49][50] Business Line Data and Key Metrics Changes - Revenue from teleradiology services was $2.8 million with a gross profit of $0.6 million, up from $2.3 million and a gross profit of $0.3 million in the comparable period, reflecting improved gross profit margins [50][51] - Revenue from the sale and deployment of imaging systems amounted to $136,000, with a gross loss of $1.5 million, compared to revenue of $17,000 and a gross loss of $44,000 in the comparable period [52] - Revenue from AI solutions was $83,000 with a gross loss of $2.0 million, consistent with the previous period, indicating challenges in this segment [52] Market Data and Key Metrics Changes - The company is expanding its market presence in the U.S. and Europe, having received FDA clearance and CE mark certification, which are expected to enhance commercialization efforts [10][24] - The company has added Tennessee to its commercial coverage in the U.S. and is negotiating with new channel partners to accelerate market presence [11][19] - The company anticipates that initial sales in the EU will primarily be through a CAPEX model, with additional revenue from service contracts and AI solutions [28][29] Company Strategy and Development Direction - The company aims to accelerate the deployment of its imaging systems and AI solutions in the U.S. while expanding into the European market following regulatory approvals [17][30] - The focus remains on building a strong network of strategic partnerships and channel partners to enhance market penetration [22][30] - The company is committed to generating clinical validation and raising awareness of its technology among healthcare professionals [26][27] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growing interest from healthcare facilities and the potential for increased referrals and scans as the technology gains traction [20][21] - The company views 2025 as a pivotal year for growth, particularly in AI solutions and imaging systems, as it continues to build its sales and clinical support teams [92][106] - Management highlighted the importance of clinical validation and market education in driving adoption of their technology [26][106] Other Important Information - The company had cash and marketable securities of approximately $83.5 million as of December 31, 2024, providing a solid financial foundation for ongoing operations [54] - The company issued approximately 5 million ordinary shares during the reported period, raising gross proceeds of $38.8 million [56] Q&A Session Summary Question: Can you elaborate on the DME partners in the U.S.? - Management confirmed that there are options for both direct CAPEX sales and typical MSAS models for DME partners [63] Question: Can you provide insights on the U.S. market and expected placements in 2025? - Management indicated that the team is expanding rapidly and that early adopters are primarily small to medium-sized medical imaging centers and orthopedic clinics [66][70] Question: How many systems were deployed in the U.S. during the quarter? - Management refrained from providing exact numbers but noted that installations are in various stages and that the pipeline remains robust [78] Question: What is the pricing strategy for ARC in Europe? - Management stated that the majority of sales in Europe will be through CAPEX, with installations expected to begin in the next two quarters [80][83] Question: What is the outlook for 2025? - Management did not provide specific guidance but indicated that 2025 is expected to be a strong year for AI and imaging solutions [92][106] Question: Can you discuss the capital raised and its deployment? - Management confirmed that approximately $38 million was raised, which will be used to accelerate commercialization efforts for both imaging and AI products [104][105]