4/20/2026

speaker
Operator
Operator

Ladies and gentlemen, thank you for standing by. Welcome to the NANOC's fourth quarter 2025 earnings call. At this time, all participants are in the listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you would need to press star 1-1 on your telephone. You would then hear an automated message advising your hand is raised. And to withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would like now to turn the conference over to Mike Cavanaugh, investor relations. Please go ahead.

speaker
Mike Cavanaugh
Investor Relations

Good morning and welcome to the Nanox Imaging fourth quarter 2025 investor call. Earlier today, Nanox Imaging Limited released financial results for the quarter ending December 31st, 2025. The release is currently available on the investor section of the company's website. With me today are Erez Meltzer, Chief Executive Officer and Acting Chairman, and Ron Daniel, Chief Financial Officer. Before we get started, I would like to remind everyone that management will be making statements during this call that include forward-looking statements regarding the company's financial results, research and development, manufacturing and commercialization activities, regulatory process, and clinical activities, among other matters. These statements are subject to risks, uncertainties, and assumptions that are based on management's current expectations as of today and may not be updated in the future. Therefore, these statements should not be relied upon as representing the company's views as of any subsequent date. Factors that may cause such a difference include but are not limited to those described in the company's filings with the Securities and Exchange Commission. We will also refer to certain non-GAAP financial measures to provide additional information to investors. A reconciliation of the non-GAAP to GAAP measures is provided with our press release with the primary differences being non-GAAP net loss attributable to ordinary shares, non-GAAP cost of revenue, non-GAAP gross profit, non-GAAP gross profit margin, non-GAAP research and development expenses, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses, and non-GAAP gross loss per share. With that, I'd now like to turn the call over to Erez Meltzer.

speaker
Erez Meltzer
Chief Executive Officer and Acting Chairman

Thank you, Mike, and thank you all for joining us today. In the fourth quarter of 2025, we continued to move the business forward across multiple fronts. While our primary focus remains on expanding our commercial presence, given the current geopolitical situation, we spent a lot of effort during the quarter and the beginning of 2026 to secure our supply chain and strengthen our financial positions as well. On top of that, we made good progress advancing the capabilities of Nanos' platform and strengthening the operational infrastructure needed to support our long-term growth. I'm happy to report that we recently entered into an agreement with Howard Technology Solutions, a division of Howard Industries, which has a national reach and an established presence in healthcare and public sector markets, providing us with a scalable framework for expanding Nano-XR deployments. This agreement reflects our confidence in the commercial demand for the Nano-XR and our ability to engage partners that can support sustained growth in system placement across the U.S. Under the framework of this agreement, Howard is expected to deploy 300 Nano-XR systems over a three-year period, of which 60 are indicated to be deployed in the first year. We also recently announced multiple commercial agreements, which together accumulate to roughly 360 systems over a two to three years period. These partnerships expand our reach across imaging centers and specialty care settings where point-of-care imaging is integral to clinical workflow and patient management. This represents a fundamental shift in how we are poised to scale our business from providing our technology to deploying it in a meaningful volume, shifting toward a growing CapEx portion. This is what we see as getting us closer to our indicated revenue of 2026. The framework has the potential to become a meaningful contributor over time and gives us confidence in our ability to convert our robust pipeline into revenue as we move forward. We view this as continued momentum and see ourselves moving closer to an inflection point. We observed a clear shift in the market perception at major radiology conferences including RSNA in the US and ECR in Europe, where engagement and inbound interest increased meaningfully. We have also taken important steps to strengthen our operational foundation. A key component of this initiative is the restructuring of certain activities in our Korean manufacturing facilities in order to reduce our Korean operation OPEX and cash burn and improve efficiency while maintaining our supply of Nano-XR system components. We are very pleased with the progress we have made recently, but it is clear that the pace of deployment continues to be influenced by various external processes, including import licenses, construction, timeline, and regulatory requirements in certain markets. These steps take time to complete. And while we are not satisfied with the pace and would like to see deployments more faster, this reflects the current operating reality across multiple markets. We expect that many of these processes will be streamlined as additional sites move through the pipeline. Introducing new technology of any kind into a medical environment is always a complex process. It requires alignment across clinical workflow, regulatory frameworks, and operational infrastructure, as well as changing behaviors, which all takes time to achieve. While this can slow down the early stages of deployment, it is also a natural part of introducing innovative technology into the healthcare systems. Turning to revenues, we continue to target $35 million in revenue for the full year of 2026, based on the execution of our current plans. As part of the above mentioned, we have signed commercial agreements, which we believe could result in present and future placement of TBAG 400 systems globally over the next two, three years. Of this, approximately 38 systems are currently at various stages of deployment, including demonstration, commercial installation, and systems pending construction, and or regulatory approval. In addition, there are approximately 15 systems that are expected to be installed over the next few months as part of our announced imaging network. That said, it is important to emphasize that our current revenue base remains at an early stage, and part of this deployed base is not generating revenues, and the pace of RenProp will depend primarily on the timing of system activation, their transition into a revenue-generating operation, and the impact of the deployment by the business partners. As more systems move into operation and utilization increases, we expect revenue to build accordingly. However, the exact timing of this trend may vary and always depending on the deployment process and progress and our factors. I would like to provide some additional color on the career restructuring that I referenced in my opening remarks. Recently, we adopted a restructuring plan designed to better align our manufacturing cost structure with our long-term financial model, support our path towards improved gross margin, and align our manufacturing capabilities with the company's strategic priorities. As part of this plan and our broader cost reduction efforts, we are closing our chief manufacturing line in South Korea, downsizing our fabrication facilities, and shifting production to established international manufacturing partners, including SYSTEM, a Switzerland-based manufacturing partner. We currently hold substantial inventory, which we plan to work through as we transition to a more efficient outsourced production model, better aligned with current and projected demand. With these actions, we expect to reduce structural and overhead costs, lower cash burn, and enhance overall operation efficiency. With that overview, let's now take a detailed look at our various business segments, starting with the U.S. deployment. Beyond the hardware agreement, we also recently announced a distribution agreement with Imperial Imaging Technology, a U.S.-based provider of diagnostic imaging solution to support rollout across the Southeast, particularly in orophobic focused environments where there is strong demand for a point of care imaging. In addition, we signed agreements with distributors such as Integrity Imaging, a U.S.-based provider of medical imaging solution with established relationship across imaging centers and healthcare providers. Elite Surgical, which serves surgical and specialty care environments. Digital X-ray Imaging, a leading diagnostic imaging provider with deep regional presence across Arkansas. And most recently, a collaboration with NuvaDX, an imaging solution provider focused on expanding access to diagnostic imaging and radiology oncology system to support, all to support the deployment of NaloxARC systems. These collaborations aim to strengthen our distribution capability by adding sales resources and on-the-ground presence, expand our geographic coverage, and we believe it is the potential to become a meaningful contributor to revenues per time. In parallel, we remain in active discussion with additional partners reflecting continued interest from medical equipment providers and likely further expansion of our U.S. pipeline. Alongside our channel strategy, our U.S. direct sales team on the ground continues to make progress in targeted clinical segments. For example, we recently signed an agreement with Regional Sports Medicine in Orthopedic Group, our first orthopedic practice customer in the United States. This represents an important step into a segment where imaging plays a central role in diagnostic and treatment decisions and where providers benefit from having imaging available on sites orthopedics remain a high volume and imaging driven specialty with a strong incentives to retain imaging in-house additionally we are advancing the nano imaging network a focus initiative designed to build a network-based imaging services model in the U.S. This initiative targets segments such as the workers' compensation and specialized care where reimbursement dynamics may support higher per-scan pricing. We are currently deploying already systems across a number of sites in the U.S. Under this model, NanoX supports nanoARC system deployment, maintenance, and connectivity, while our partners manage site operation and local engagement. While still in the very early stage, we believe this initiative can become an important component of our long-term commercial strategy as utilization increases and the model is further validated. To provide additional context around this shift in engagement, where it participated in two major industry events during the period. At RSNA, the world's largest annual radiology conference held in the US, our booth featuring live demonstration of the NanoxARC system saw strong interest throughout the event. At the European Congress of Radiology, ECR, the largest radiology conference in Europe, we showcased the NanoxARC live in Europe for the first time and presented new clinical and AI data. Engagement levels were high, reflecting growing awareness of the system's clinical value and its potential role in routine imaging workflow. We were also proud to receive the Red Dot Award for Product Design 226 for the NanoX ArcX a prestigious international recognition that reflects the maturity, usability, and clinical readiness of our platform. Let's now turn to work outside of the U.S. As I mentioned earlier regarding ECR, we were also honored to receive the Newcomer Award at ECR 226, reflecting the growing recognition of NANUCs within the European radiology community. In February, Nano-X announced an exclusive distribution agreement with InterSRL, a leading medical distributor in Argentina with more than 35 years of experience. Under this agreement, Intec will oversee marketing, distribution, installation, and support for the Nano-X Arc system and related services across the country. The collaboration intended to support commercial expansion of NanoPS 3D digital tomosynthesis technology in Argentina and strengthen the company's presence in Latin America, leveraging index established relationship with healthcare providers and nationwide service capabilities. Commercialization will be subject to obtaining the required regulatory approval. In Latin America, we were expected for a significant presentation at the International Congress of Radiology, the ICR, in Cartagena, Colombia. The presentation would support clinical discussion around digital tomosynthesis and contribute to engagement with regional clinicians and industry stakeholders. In Europe, we continue to build momentum through partners and additional regional distributors. As a reminder, Over the past few quarters, we have announced multiple European collaborations, including France, Romania, Czech Republic, Serbia, alongside additional engagements in other European markets. These collaborations support our ability to navigate local regulatory environments and advance commercialization across multiple countries. Switching gears, we continue to advance the regulatory work that supports our commercial initiatives by expanding the use cases for our solution and making them accessible in more markets. We have advanced key milestones, including TAP2D clearance in the United States. As a reminder, TAP2D is a 2D view image output for the nanoSARC system, a practical tool for audiologists to enhance their diagnostic confidence as they become more experienced evaluating digital tomosynthesis images in part of our broader vision to alleviate adjunctive use limitation over time. We also updated the AMAR approval for Nano-X AR in Israel based on our existing CE mark enabling use of the systems without adjunct limitation. Removal of the agent use limitation in the U.S. remain a key regulatory priority. We believe this is an important step that can expand our addressable market and support broader adoption. We're also working to finalize our CMRT submission for the non-exarch Europe, which is currently anticipated in 2026, subject to change based on regulatory priorities. Turning to our AI business, we continue to strengthen our position as a comprehensive platform for the interpretation of medical images. I'm happy to report that Cedars-Sinai Medical Center in Los Angeles is joining a trial studying the benefits of NanoPS AI aortic valve calcification measurement solution, which is currently under development. We recently conducted an on-site re-evaluation of the model across approximately 600 retrospective cases. The results exceeded our expectations with six cases over severe classification identified and approximately 100 cases showing clinical relevant findings. The CITiSinai team has also expressed interest in collaboration on scientific publication based on these results. We are very pleased to be partnering with CITiSinai one of the nation's premier medical institutions. Overall, we are seeing growth in Nanox AI business driven by new customers, expansion of existing agreements, and the integration of Nanox Health IT. During the quarter, we completed the strategic acquisition of Vaso Healthcare IT, now Nanox Health IT, a healthcare IT provider serving hospitals and healthcare system across the United States, with expertise in healthcare IT implementation. Since completing the acquisition, we have been progressing with integration and alignment, while also signing several new customer agreements. We are seeing growth driven by new customers, expansion of existing agreements, and the integration of our health IT capabilities, and we expect this business contribute to revenue from day one. In addition to increasing our footprint in AI, the health IT platform enhance our ability to integrate into clinical workflow, expand customer cases, access, and support cross engagement across our ecosystems. Moreover, the rest of the organization is leveraging the health IT team's expertise and market presence, particularly as it pertains to lead generation for the U.S.-Arab Nano-X AI and Nano-X ARC. Similar to our regulatory work, clinical validation remains central to our strategy and supports our commercial efforts generating evidence across multiple applications and supporting the use of Nano-X solutions. I've already mentioned that Cedars-Sinai Medical Center is joining a trial of Nano-X AI ARC equal classification measurement solution and we have accomplished much more recently. In an exciting update from our collaboration with MDS Wellness, an independent provider of wellness screening programs located in Michigan, we secured our first institutional review board approval for a clinical trial within the U.S. The trial will focus on a lung cancer screening of high-risk patients and the applicability of NanoXR technology as it relates to patient population of nano-NPS. As I stated earlier, we attended the European Conference of Radiology, the ECR, where we were able to present several scientific achievements, and I'd like to share some highlights now. Dr. Noga Shabshin, ARC's chief medical officer, presented our scientific work on lung cancer screening using the Nano-X ARC in the work with our collaboration in what was shown that in the majority of patients, the screening outcomes based on the lung-rug category, the standard lung cancer screening calcification system was similar when analyzing the CT and digital tomosynthesis. This further strengthened the applicability of the DTS as a potential addition to screening activities ramping up globally. Dr. Ruth Windfeimer, Senior Medical and Clinical Advisor, presented the proven value of opportunistic screening for CT images using Nano-AI 3SDA-CLEAR algorithm enabling earlier detection of chronic disease. Our latest imaging addition Tomosynthesis augmented projection, known as TAP2D, was also featured in several scientific posters showing the value of TAP2D image as a supplemental image to BTS in lieu of the traditional 2D X-ray imaging with no additional dose or acquisition time inflicted on the patient. And in addition, at the recently concluded World Conference of Osteoporosis, Nanox AI bone solution were featured, including updates from our ADAPT trial conducted across four NHS trusts and led by the University of Oxford, as well as initial observation from our collaboration with the Greek Air Force. The data will show once more the clinical and economic benefits of AI-based opportunistic screening for routine CT exams. The validation abstract comparing the accuracy of the CCS 2.2 compared with cardiology expert reader as part of AI-informed trial was expected as a poster at the Society of Cardiovascular Computed Tomography annual scientific meeting in the coming July. Outside the U.S., We are excited about our recent collaboration with Meir Medical Center in Israel, which is part of the CLILIP, the Israel's largest health services organization, where we have an exciting relationship. The NanoxArc has been deployed in the emergency department and will be utilized by orthopedic staff as part of the clinical workflow to help establish the digital tomography as an effective tool with lower dose and more efficient workflow than today's CT-based workflow. This is the first time that NanoXR is installed within an emergency department in a major hospital and represents the confidence our collaboration has in NanoX solutions. I'll now provide an update on our robust OEM relationship. NanoXR continues to advance its technology pipeline with ongoing development of next-generation field-emission X-ray sources and tube architecture. Recent progress includes improvement in an emitter design and fabrication processes aimed to extending chip lifetime and enhancing performance, development of micro-focus and multi-zone emitter configuration for applications such as semiconductor inspection and handheld XRF, and continued advancement of the NanoX MDX, the multi-source tube platform, enabling new system architecture for 3D imaging. The company is also progressing a multiple OEM collaboration and pilot project across industrial semiconductor and security markets, supporting the expansion of NanoX technology into new applications. We recently received a purchase order from the leading semiconductor equipment manufacturer for developmental emitters, supporting exact inspection application at the leading edge of next-generation IC technologies. With Oak Ridge National Laboratories, a U.S. government agency, a second round of prototype is currently in progress and in process with preparations underway as required materials become available. In parallel, one global imaging component supplier has agreed to evaluate our micro-focused emitter technology and is preparing dedicated test infrastructure to support that work. Another major OEM continues to advance prototype development based on our emitter design with validation activities ongoing. Overall, these engagements reflect continued momentum across multiple development tracks as we work to validate our technology with established industry partners. Before I move on, I'd like to briefly note that despite the current geopolitical situation in the Middle East, we have not experienced any material disruption to our operation and our business continues to operate as planned. With that, I'll turn the call over to Ran to review our financials. Ran, over to you.

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