NANO-X IMAGING LTD

Good day and thank you for standing by. Welcome to the NANOC's fourth quarter 2024 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to Mike Cavanaugh, Investor Relations. Please go ahead.

Good morning and thank you for joining us today. Earlier today, Nanox Imaging Limited released financial results for the quarter ended December 31, 2024. The release is currently available on the Investors section of the company's website. With me today are Eris 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, and 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.

Thank you, Mike. Thank you for joining us today for our financial result call. As always, we appreciate your continued support of Nano. During our call today, I will use my prepared remarks to provide selected operational updated covering the time since our last update call in November. Then, Ron will review our financials, and we will close the call with a quick question and answer session. Since our last call, the NANUX team achieved two notable regulatory successes. The first being the general use clearance from the FDA in December. Subsequent to the FDA clearance, we were informed that the CE mark designation was granted for NANUX ARC in February, 2025. Beyond these notable regulatory achievements, the fourth quarter and beginning of 2025 has been a period of significant progress and strategic advancement for Nano-X across our business areas as we continue to revolutionize the field of medical imaging with our innovative technology. I will cover a wide range of topics in my prepared remarks. In the key U.S. market, we continue to advance Nano-X art system deployment We received positive feedback on the Nano-X Arc for our first customers, while we also signed agreements with new channel partners, and we are negotiating additional ones as we speak. These agreements are expected to accelerate our market presence. We are also beginning our entry into the European market now that we have obtained the C-Mark, and I will talk about that in some detail. along with our progress outside of the U.S. market. Our Nano-X8 IT continued to make progress as we added new customers. I will wrap up my remarks with an update on our OEM relationship, as well as our clinical trials, which are designed to build on the body of the data supporting the use of Nano-X8 technology in the delivery of healthcare across varied settings. With that, let's begin. As was previously announced, we achieved a significant regulatory milestone with the FDA general use clearance received last December. The 510K clearance is for general use, including human musculoskeletal system, pulmonary, intra-abdominal, and paranasal sinus indications, adjunctive to conventional radiography, and we believe that will advance our commercializations as it validates and extends the use cases for our Nano-X Arc. Advancing our regulatory discussion with the FDA, we have submitted the Nano-X Arc X for FDA clearance, which will further enhance our product portfolio. The Nano-X Arc X will have an even smaller footprint than the existing Nano-X Arc system, enhancing one of our key differentiations. The new system will also be easy to deploy and use with an anticipated one-day setup time and plug-and-play functionality. Equally exciting is the announcement made just a few weeks ago that we received the CE Mark certification to market the multi-source Nanooks Arc system, including Nanooks Cloud. It's a company cloud-based infrastructure. Pursuing the CE Mark was a key priority to enable to market our device in the EU. With this in mind, we remained highly focused on fulfilling our promise to our investors that we would do everything within control to ensure a successful outcome in this crucial review process. I'm happy to say that we delivered on this and we view it in another earned validation of our unique and possible transformative technology. I would also like to emphasize that due to differences in standard of care approaches, the CE-MARK allows us to market the non-XR in Europe as a stand-alone modality, which does not require adjunctive use. Our primary focus remains on accelerating the deployment of the non-XR and our AI solution in the United States. As I have mentioned on previous calls, we have been carefully expanding the U.S.-based commercial team to help ensure that we have the appropriate sales, clinical education, and support infrastructure necessary to drive our deployment in the U.S. An important element of our go-to-market strategy in the U.S., as it will be another market, is to pursue the education of our potential customer base and key opinion leaders in medical imaging. Education and raising awareness are therefore key elements of our marketing effort as we are expanding our key opinion leaders' ecosystem and increasing clinical value evidence. Tinted commercial deployment, there are a few dozens of systems in various stages of shipment and deployment for both commercial and clinical use in the U.S. We are deployed across several states. We are focusing on expanding our network of strategic collaboration, channel partners, and client base. As of today, I can report that we added another state, Tennessee, to our commercial coverage. Of these units deployed, I can share that in one of the multi-specialty clinics, we scan about 10 scans a day out of which 20% are chest scans. Our Nano-XR pipeline remains robust, and we are currently targeting a few hundreds of clients. We are continuously recruiting to expand our sales and clinical support team in the U.S., and this expansion is crucial to support our growing customer base and ensure the successful deployment of our technology. We see a lot of interest from prospective and current customers and professional healthcare facilities. Introducing new innovative technologies into the conservative U.S. market is always challenging. However, we have a growing base of early adapters that have ordered and are using the ARC. As a result, we have seen an increase in the number of referrals, scans, and additional use cases. As we continue to pursue multiple avenues of commercialization, we made significant strides in establishing strong distributor partnerships. Working with well-known players in the durable medical equipment space makes good business sense as these companies are recognized by medical imaging customers and can rapidly enlarge our sales presence. We have recently engaged with Advanced Southern Med Imaging, known as ASI, based in Georgia. They will support the commercialization of the Nanooks art, and this is additive as it gives a new presence in the southern United States. Additionally, we are in advanced negotiations with more channel partners, and I will provide updates on our next calls. I would like to focus now on our strategy for penetrating the European market. As you all know, we recently got the very welcome news that the NanoX Arc was granted the CE mark, expanding our total addressable market. Our regulatory team has worked long and hard to secure this, and it is another strong validation of our technology. It also paves the way for our entry into a large and influential market, which has long and strategic goals for our company. This achievement represents a significant milestone in our global expansion effort and builds on the strong momentum we have generated since securing multiple FBA clearances. This certification for whole-body imaging in Europe, combined with our existing infrastructure and ongoing pursuit of strategic partnerships, positions us to accelerate our commercial introduction across the region. Just days after we announced that we received the CE mark, We presented data supporting the NanosARC performance at the 2025 European Congress of Radiology, the ECR, which took place recently in Vienna, Austria. New data was shared around three different abstracts at the conference. You can find the full details on this scientific abstract on our website. We take pride in our robust clinical efforts to generate data supporting the use of Nano-X ARC. We understand that bringing a new technology into the healthcare continuum, as we are doing introducing the Nano-X ARC to medical imaging industry, requires a great deal of data generation, clinical validation, and education. While we are bringing a valuable new tool to the radiology profession, the burden of proof is on Nano-X to demonstrate why hospitals and imaging centers need to add this new technology. By prioritizing clinical needs and development efforts in collaboration with the medical community, we ensure that our innovations are not only advanced, but also relevant and visible to those we serve. As the population ages and the demand for medical imaging increases in lockstep, there is an increasing need for accessible advanced imaging solutions across various care settings. We expect the NANUX ART to be a good fit for this backdrop because at its core, the NANUX ART offers an advanced medical imaging solution that is more accessible and affordable. We expect that most of the initial sales in the EU will be through the CAPEX model, meaning the systems will be purchased outright with no per-scan charges. However, there will be additional revenue generated through the use of service contracts and Nano-Clouds connectivity. We will also, of course, be seeking to sell our growing number of AI solutions and telemergeology services into our customer base as well. At this time, we anticipate that our sales strategy in the EU will mainly work indirectly through distributors. As I've just described, we have been gathering a geographically diverse group of distribution partners, and we will aim to do the same as we begin to penetrate the EU. With a CE mark in hand, we are not wasting any time and have already signed new distribution agreements for NanoXR in Romania and Greece, which will be our additional entry point into the market. We are also in advanced stages of additional negotiations of distribution agreements in additional countries in the EU. While the US market has been a major focus, the European Union is going to be a larger focus in 2025 as we increase our commercialization effort and our dedicated commercial team and continuous progress with our efforts in other international markets focusing on receiving local regulatory approvals in various countries. Turning now to our AI commercialization advances, our NanoX AI-powered images interpretation algorithms continue to gain traction. We've engaged with two new customers in the U.S. The first is one of the largest outpatient medical imaging providers in the U.S., which has signed up for a health host. The installation will utilize NanoPS AI imaging analytics platform within the Blackford platform marketplace. Highlighting the strategic value of our partnership followed by the success we already experienced in the UK, this represents our first significant success in the US with the health host in the imaging centers market and marks an important milestone for both NanoPS AI and Blackford the pioneering enterprise AI platform and solutions provider, which offers all NanoX AI solutions, including HealthOS, to healthcare providers worldwide. We also finalized the collaboration between NanoX AI and Ezra, a healthcare artificial intelligence company, revolutionizing early detection through full-body CT screening. Under the terms of the collaboration, Nano-X AI population health solution will be integrated into ESRA's medical screening process at 28 imaging center locations across the United States, which feature AI-powered full-body MRI and CT scans to screen adults for early detection, such as cancer and other serious conditions at their earliest and often most treatable stages. We are particularly excited about the Azure collaboration as it connects us to a consumer healthcare market indirectly through our business partners. Individuals today are better informed and technology enables people to manage more aspects of their healthcare journey themselves. Given this backdrop, we can see an emerging opportunity to provide imaging and early detection to consumers as part of their routine healthcare activities. We know the cost of technology tends to decrease over time, and in the future, proactive scanning would be an important part in maintaining a healthy lifestyle. We will continue exploring opportunities to leverage our AI technology to promote accessible early diagnosis and preventive management. We're constantly working on additional collaboration with different customer types and industries worldwide. We clearly have a lot to be excited about with our NanoX AI solutions. I will close my comments on NanoX AI by sharing that our total AI customer and pilot-based project has increased by 25%. As previously reported, we are developing a pulmonary solution which is expected to be the first AI application designed specifically for the NANUX-R. NANUX identified the need for tomosynthesis AI solution as prime requirement to support the growing market demand for cancer screening initiatives in the EU. These initiatives will increase the need for radiographers and radiologists to respond in a faster way for the increased readings, NanoPSAR solution will provide the pulmonary proper solution to increase imaging capacity. Another important aspect of our work is with our OEM partners, which is critical to ensuring that we have the components necessary to meet our growing demand for NanoPSAR systems. I would like to provide an update on the aforementioned technology development center in our headquarters, which was created to advance the development of our technology into the future. In addition to chip and tube level testing, this center includes a robotic laboratory. We will soon utilize the lab to perform multi-source application development. Multi-source involves placing several of our emitters into a single vessel with active pumping mechanism to ensure and optimal operating environment for a mission. The benefit of a multi-source approach can include minimized imaging times, system size, weigh-in complexity reduction, and more flexible approaches to imaging. Attaching a multi-source to our robot and manipulating the robot into different positions allow us to easily simulate and work to optimize various imaging positions and quantities towards developing the best solution for medical, security, and industrial inspection applications. This will become an important tool towards the development of additional advanced tomosynthesis and potentially stationary CT solutions. As reported before, tube utilizing system chips have been successfully built and tested and will remain on schedule for initial sub-production quality chips this quarter. This is another example of the NANUPS team's dedication to securing manufacturing agreements to ensure the supply of NANUPS Arc systems can meet our expected demand. Turning to one of our key OEM partners, Varex, continues production launch preparation as we continue system-level integration and pre-FDA submission testing on tubes to be used in NANUPS Arc. VARIC is also engaged in development of multi-source modules for us, utilizing the aforementioned NanoPS emitters, and will include their module in some of our application development robots, testing referenced above. Additionally, a leading global medical and diagnostic solution provider has assembled the first prototype tubes utilizing the NanoPS emitter. We are working closely with them and has delivered an AnuxArc demo kit to serve as a test bench for prototypes under development. We will continue to actively, but selectively, develop partnerships with tube manufacturers and X-ray solution providers as they will serve an important challenge to the market for our proprietary technology. An update on our U.S. government security application project The team has successfully completed component build, assembly and testing, and moved to finalize two unique tube designs for advanced prototyping. We are pleased that our demo kit, inclusive of our emitter tube, high voltage power supply and software, continue to enable potential clients and partners to more easily experience our technologies. In summary, We continue to develop strategic OEM partnerships, both to enhance our nano ARC supply chain, as well as develop channels to the various markets. We are increasing our resources and focused on OEM business development opportunities and continue to expand our funnel of potential opportunities. We will update on them as appropriate. I will close my prepared remarks with an update on our clinical activities which are designed to provide further validation and extended use cases for NANOX-R. As I mentioned earlier, NANOX attended ECR, the European Congress of Radiology, in February, which was very successful. Recently, radiologists in our Independent Review Committee, the IRC, confirmed that NANOX-R's digital tomosynthesis, DTS, provides superior detail and added clinical value over x-rays. Each expert independently review over 80-80 DTS studies, noting good image quality and ability to detect lesions and minimal learning curves. These insights further validate DTS as an advanced imaging solution. Our NANOX-R clinical trials are advancing well. The NANOX-R multi-site trial continues to progress in the UGMC and Bellingham Medical Center, and we are in discussion with prominent clinical sites in two locations in Europe to add them to our multi-site trial. To date, we have enrolled more than 100 patients into the various clinical trials. In conclusion, we are making significant strides in deploying our innovative imaging solution, expanding our market presence, and advancing our clinical and regulatory milestones. We remain committed to our mission of preventive healthcare and improving patient outcomes worldwide. With that, I would like now to turn the call over to Ren for a review of our financials.