NANO-X IMAGING LTD

Good day and thank you for standing by. Welcome to the Nano QX Q1 2025 Earnings Conference 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 will need to press star 1 1 on your telephone. You will then hear an automated message advising that 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 your speaker today, Mike Cavanaugh of 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 March 31, 2025. The release is currently available on the investor section of the company's websites. 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, 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 administrative expenses, and non-GAAP gross loss per share. With that, I'd now like to turn the call over to Erez Meltzer.

Good morning, everyone. Thank you for taking the time to review NANUPS Imaging's Q1 2025 financial results with us today. I'm pleased to report that we have made progress in our mission to improve medical imaging and enhance patient outcomes. At Nano-X, we pride ourselves on our comprehensive end-to-end solution that supports preventive healthcare and expand access to imaging services. With that goal in mind, we made two strategic acquisitions in 2021. USA-Rad, our teleradiology business, and Zebra Medical Imaging, which is now Nano-X AI, to build out our end-to-end solution around the core Nano-X Arc technology. Integrating AI-powered imaging analysis and a global teleradiology solution with our groundbreaking Nanux R technology takes us one step closer to creating a global connected medical imaging solution with the potential to meaningfully expand the delivery of healthcare. These acquisitions have proven to be good strategic decisions. Since the acquisitions less than four years ago, We have doubled the revenues generated by U.S. ARAD, and at the same time, Nano-X AI has progressed from a pre-revenue business to one that is now generating growing revenue. To highlight another benefit of our end-to-end solution, most of our Nano-X ARAD customers also use our teleradiology services, and this not only provides more effective imaging and diagnosis for providers, and patients, but also increases revenues per customer and creates value for our shareholders. Nano-X AI continues to be a key part of our strategy, driving forward our commitment to integrating artificial intelligence into medical imaging. By leveraging advanced AI capabilities, we aim to streamline workflows support clinical decision-making, and improve efficiency across the imaging ecosystem. Our innovative technologies, including Nanook's Arc and our AI solutions, are gaining traction in the market, and we are excited about the future of our company. Let's review some operational highlights. Beginning with our commercial efforts, we are employing a multi-proven strategy to generate a robust sales pipeline. This is led not only by our direct sales force in the US and in the EU, which calls on imaging providers directly, but also by forming business collaborations which leverage the marketing expertise of our medical imaging companies. We've also begun to engage with distributors worldwide, especially in the EU, which we believe will be an efficient way of potentially penetrating a market comprised of 27 different countries. Complementing our efforts to commercialize Nano-X ARC, we are benefiting from a steady revenue growth driven by our U.S.-Iraq teleradiology business and growing revenues from the sales of AI solutions. We are also supporting these marketing initiatives with marketing campaigns, and I'll touch on these aspects of our commercial plan today. And we've seen an increase in the number of scans performed by our systems, both in the US and worldwide, and we're beginning to see initial revenue streams for Nano-XR customers reflecting that we are gaining traction with our NanoX Arc systems, and customers can see the value in using the system. Our sales pipeline has doubled since January 2025, and our sales team, as of today, is handling over 1,000 leads. Our growing pipeline primarily consists of standalone multi-specialty, small and medium-sized health clinics, not only from the U.S., but also from countries around the world such as Peru, France, Azerbaijan, Hungary, and Poland, and various countries in the U.S. Since its commercial deployment at the beginning of this year, there are now over 60 units that are in various stages of implementation and execution of the deployment plan for commercial, demo, and clinical use. For the operational units, we are achieving an average target of seven scans per day. As we grow, we intend to share more information as our business evolves, and with a promise previously made to provide more details, we will do so today. We are targeting over 100 Arc systems in various stages of deployment by the end of 2025 worldwide. We are happy to now be in a position to share guidance on our commercial progress. But as we are all aware, recent market uncertainties could make our guidance subject to change as the year progresses. Introducing new and innovative technology in the U.S. market is always challenging. However, we are encouraged by the growing base of early adopters that have ordered and are using the NanoX Arc furthermore, the nature of our sales process is clinical, meaning that we've dedicated time and resources to our prospective customers to educate them on the benefits of the NanoX Arc, to their practices, how to use it, and why they should use it, all of which takes time. The US deployment of NanoX Arc is progressing, and we are preparing to ship the first systems to Puerto Rico. From the beginning of the year, we continue to strengthen our sales team with representatives now covering the west, east, and mid-coast regions. Additionally, we continue to expand our clinical team by structuring a continuous professional group along with continual enhancement to our operational team and an efficient interface with our local services partner. As we continue our accelerated U.S. commercializations, we provide all the necessary resources to our sales and services personnel in the U.S. to support our expanding client base. Along with various channel partners, our team on the ground will be critical to our accelerating rollout. and we will steadily but clearly continue to add to this team. We are making hiring decisions wisely. With 22 U.S. personnel on the ground, we are moving ahead towards our target of 30 to 40 sales, service, marketing, and support personnel in place by the end of 2025, depending on needs and progress. Now let's move on to some specific U.S. market commercial accomplishments and updates. We have made notable progress in forming solid distributor partnerships while continuing to pursue commercialization options. Beyond the engagement we announced last quarter with Advanced Southern Imaging, known as ASI, we have expanded a third-party service and support agreement with Srisway in Bridgewater, New Jersey. Srisway is one of the foremost experts in digital radiography from sales through installation, setup, training, and service. This relationship is off to a good start, and in addition to the support and services agreement, we enter into a non-exclusive distribution agreement for the sales of our system and services to government official public health authorities, and medical institutions in the U.S. Furthermore, we are in negotiation with additional leading national distributors. And finally, we are in the finalization stages of a new project around workers' compensation segments. With over 100 million workers estimated To be covered on the workers' compensation in the U.S., this business segment presents a large potential opportunity for NANOPs, helping to promote the recovery of injured workers by providing imaging services to individuals and insurers. The project is structured to build a network of medical imaging centers, starting with two to three proof of concept sites, with plans to expand from there. If the POC be completed successfully, the collaboration will kick off its commercial binding level. The engagement relies on attractive terms based on contractual rates of 120 to 180 per patient. If achieved, this potential line of business will be part of the NANOX Services Division, which will oversee the program's development. Turning to our efforts in markets outside of the US, we have also made strides in deploying our NanoX Arc systems since our last update call. Our efforts in the EU have been assisted by the recent key milestones of securing the CE mark for the NanoX Arc in February. As of today's call, we are ready to ship NanoX Arc and make our first installations in Europe subject to local approvals by country with our distributors. We are working on deploying systems to Greece and Romania with demo units expected to be shipped to those countries soon, and we are also preparing for demo units to be shipped to Mexico. These are necessary steps to create a commercial presence that we can build from in which of these countries and we will work hard to maintain this momentum. Turning to our AI solutions business, we are seeing tremendous momentum. Trial data has shown that our AI solutions provide strong and proven data, and customer feedback has been overwhelming. We are seeing strong interest in our solutions as they grow and the sales pipeline expands. I believe that our AI business is also getting an added boost from the secular growth of AI in the broader economy, as well as the excitement surrounding AI in general. On our last call, we announced an agreement with Ezra AI. a healthcare artificial intelligence company revolutionizing early detection through full-body MRIs and low-dose chest CT screens. This agreement is moving ahead, and we expect to expand the use of our AI solutions in dozens of Ezra locations throughout the U.S. To continue with our commercial efforts, we have engaged with new AI marketplaces and are currently in negotiation with several companies. These collaborations will help us expand on a global scale, especially in the US, providing a steady stream of new client referrals. We also have three pilot programs running with similar AI platform companies, and we will provide more details once these pilots are completed. As previously mentioned, we continue to cooperate with various prestigious academic centers that are using our AI solutions, including Oxford University Hospitals, NHS Foundation Trust in the UK, which has published trial data on the Health Host Don't solution, and following that secured a three-year contract for Health Host. We are also working with Duke University Hospital in North Carolina, UVA Health in Virginia, UW Health in Wisconsin on various AI-related projects. With respect to regulatory, we have also had some notable regulatory success recently. And in April, we were proud to announce that we have received 510 clearance from the FDA for the Nano-X ARC-X, our updated multi-source digital tomosynthesis systems. Now for an update on our clinical work, which is always going on behind the scenes, and the reason is simple. Clinical validation is one of the key drivers of our future growth. It is imperative to generate fresh clinical data to support the use of a medical device, especially when introducing new technology and to encourage a change to the standard of care. Recognizing this reality, we continue to expand our efforts to implement our clinical trials with the goal of producing a robust database supporting the use of the Nano-X Arc. Regarding our ongoing multi-site trial, we are working on clinical sites collaboration in two new sites in Europe, a leading teaching hospital as well as a large private hospital. We are excited to welcome these two prominent healthcare providers into our trial. I can also announce that the NanoX ArcX system was installed successfully in the Shamir Hospital to be used for a multi-site trial. It is now being used to actively scan patients. Finally, U.S. RAD, our color radiology subsidiary, continues to provide valuable outsourced radiology services to healthcare imaging centers, and most of our NanoXR customers also utilize this service. We have recently signed an agreement with a large U.S.-based company to provide technology services for their self-insurance program, which will further strengthen our position in the market. Our second opinion services is a consumer-oriented platform provided by U.S. ERAD, which connects patients with radiologists and other subspecialty physicians for additional consultation on their medical diagnosis. Second Opinion has integrated all three of NADOC's AI SBA cleared AI solutions and is now generating revenues and interpreting approximately 20 scans per month. We are very active with our OEM partners, particularly to ensure adequate supply of components for the ARC, but also with the intention of finding additional applications for our nanos proprietary technology. One such active engagement is with the U.S. government agency Oak Ridge National Laboratories to develop novel and compact mobile x-ray technologies. We began our partnerships in Q2 of last year and have progress to developing and building prototypes due to be completed this summer. More good news is from Varix, who recently delivered to Israel several tubes for our next generation ARCX. They also passed incoming inspections and are now being assembled into ARCs to complete system level integration. Additionally, we have technical staff at VARICS this month for validation and training on multi-source demonstration units we are producing for future applications development. The Nanooks team is excited to attend the RSNA 2025, which is the annual meeting of the Radiological Society of North America to be held in Chicago from November 30 through December 4. We are especially excited for RSNA 2025 as we will be presenting the full Nano-X end-to-end solution at this high-profile industry event for the first time. Our booth will feature the new Nano-X ArcX cold tomography system and ArcAI teleradiology services and AI solutions. We hope to see some of you there, and we welcome you to stop by the Nano-X booth to meet some members of our team and see the Nanook solutions for yourself. With that, I will close my prepared remarks and turn the call over to Rand Daniel to review our financials. Rand, over to you.

Thank you, Erez. We reported a gap net loss for the first quarter of 2025 of $13.2 million, which is the reported period. compared with a net loss of $12.2 million in the first quarter of 2024, which is the comparable period. The increase of $1.0 million was largely due to an increase of $1.1 million in our gross loss. Revenue for the reported period was $2.8 million, and gross loss was $3.0 million on a gap basis. Revenue for the comparable period was $2.6 million and gross loss was $2.1 million on a gap basis. Non-gap gross loss for the reported period was $0.4 million as compared to a gross profit of $0.6 million in the comparable period, which represents a gross loss margin of approximately 15% on a non-gap basis for the reported period as compared to a gross profit margin of 22% on a non-GAAP basis in the comparable period. Revenue from the teleradiology services for the reported period was $2.6 million with a gross profit of $0.4 million on a GAAP basis as compared to revenue of $2.4 million with a gross profit of $0.3 million on a GAAP basis in the comparable period. which represents a gross profit margin of approximately 17% on a GAAP basis for the reported period, as compared to 14% on a GAAP basis in the comparable period. Non-GAAP gross profit of the company's tele-radiology services for the reported period was $1.0 million, as compared to $0.9 million in the comparable period. which represents a gross profit margin of approximately 39% on a non-GAAP basis for the reported period, as compared to 37% on a non-GAAP basis in the comparable period. The increase in the company's revenue and gross profit margin from the teleradiology services was mainly attributable to customer retention, increased rates, and increased volume of the company's reading services during the weekday shift. During the reported period, the company generated revenue through the sale and deployment of its imaging system and OEM services, which amounted to $33,000 for the reported period, with a gross loss of $1.6 million on a gas basis and $1.5 million on a non-gas basis. Compared to revenue of $47,000, with a gross loss of $0.4 million on a GAAP basis and $0.3 million on a non-GAAP basis in the comparable period. The company's revenue from its AI solutions for the reported period was $0.2 million with a gross loss of $1.9 million on a GAAP basis compared to a revenue of $0.1 million with a gross loss of $2.0 million in the comparable period. SunGap gross loss of the company's AI solutions for the reported period was $0.1 million, compared to a gross profit of $29,000 in the comparable period. Research and development expenses net for the reported period were $5.0 million, compared to $5.2 million in the comparable period, reflecting a decrease of $0.2 million. The decrease was mainly due to a decrease of $0.2 million in share-based compensation and a decrease of $0.8 million in expenses related to our research and development activities, which were offset by a decrease of $0.8 million in grants received due to the completion of the NHSX project and the commencement of its commercial phase. Sales and marketing expenses for the reported period were $0.9 million compared to $0.8 million in the comparable period. General and administrative expenses for the reported period were $5.1 million compared to $5.0 million in the comparable period. The increase of $0.1 million was mainly due to an increase of $0.2 million in salaries and wages, an increase of $0.2 million in our IT expenses and $0.2 million in our recruiting expenses to our commercialization efforts in the U.S. market. The increase was offset by a decrease of $0.5 million in our legal expenses and a decrease of $0.2 million in our DNO insurance expenses. Turning to our balance sheet. As of March 31st, 2025, we had cash, cash equivalents, restricted deposits, and marketable securities of approximately $72.9 million. And we had $3.1 million in short-term loan from a bank. We ended the quarter with a property and equipment net of $45.3 million. As of March 31st, 2025 and December 31st, we had approximately 63.8 million shares outstanding. With that, I will hand the call back over to Eric.

Thank you, Ron. To close our call, I would like to extend our appreciation for your continued support of NANOX. We understand that our investors are key to the journey that NANOX is undertaking to transform medical imaging. Like many companies over the past several years, we have experienced challenges. But our belief in the NanoX vision, as well as the support of our investors, encourage us to keep pushing ahead. We are making steady progress commercializing the NanoX Arc and NanoX AI, utilizing multiple different initiatives. And our teleradiology business continues to provide a revenue base to help fund our continued growth. We are also doing much work behind the scenes to support our commercialization through clinical data generation, securing more regulatory clearances, and marketing campaigns designed to raise awareness of the nano end-to-end solution. We are advancing our clinical trials with promising initial results. We continue to increase the number of our commercial collaborations and we are working with our growing customer base to help them integrate the Nanooks Arc into their practices. In closing, we remain committed to making medical imaging more accessible and improving patient outcomes through innovative technologies and strategic collaborations. We thank you for joining us today and look forward to providing additional updates on our next call. Operator, please open the call for questions.

Certainly. As a reminder, to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please limit yourself to one question in the follow-up and please stand by. And our first question will be coming from Jeffrey Cohen of Leidenberg Salmon & Company. Your line is open.

Good morning, Eris and Ram. Thanks for taking our questions. I wondered, Eris, if you could talk about the fleet by the end of the year, where you're speaking of 100 units. Could you give us a sense or flavor for geographies, at which point you anticipate placements to occur during this year or already placed? Thank you.

OK. Still, the majority of the units will be in the US. Based on the progress of the regulation approvals in the countries that we are planning to place ARCs in Europe, it seems that I would say maybe 15 or 20% will be in Europe. And I would say Israel and other probably 10% will be in other places like Israel, like Africa, like Latin America. It all depends on the progress of the ability to speed up the regulation approvals and the imports license. in the various countries that we operate. And of course, the other thing which is very important is how fast are we going to be able to install the systems that we currently have in orders, agreements that were signed, the projects that we mentioned. In a nutshell, I would say that this is a very important element of what I was trying to deliver in this earnings, that the feeling of the building blocks of our short-term future in terms of the ability to generate The arcs that are going to be installed from the sales team, from the campaigns that we are leading, one of them, each one of these campaigns generate about 1,000 leads, and we're starting the process to implement them. The workers' comp portion, the business partners that we work with, and of course, the Europe and the rest of the world. that we do the visa installation. But in a nutshell, that's what I gave you.

Got it. And then as a follow-up, could you talk a little more about the USA RAD second opinion services? Is there a particular list price for that service? And is it being reimbursed by the payers out there? Any further color would be appreciated. Thank you.

Okay, you and Sirad, we are lately, we have achieved, I would say, some peaks or high numbers in terms of the weekly revenues which are being generated or scans that they are reading. In addition, it seems that what we were trying to do and we have been amazingly successful in implementing the end-to-end solution where U.S. ERAD are doing a lot of the readings of the places that we are installing the arcs. So we are generated from the same unit and the same scan more revenues to the company. In addition, the workers' comp is going to be based initially or to begin with at least based on U.S. ERAD radiologists that are going to read And last but not least is what you have asked is the second opinion. Second opinion is about $300. It's mostly private. It's growing business. And, yeah, so that's... It's a retail model. Yeah, it's more of a retail model. By the way, in addition, you know, by the same token, I would say that it's interesting to see that the... Part of the increase in revenues or business that we're doing is what we call the B2B2C. So we are serving someone who is serving the consumer or the retail, and this is what we do with Ezra. In Ezra, for example, every reading is about $75 right now, and if we do more applications of AI other than the CCS, it's going to increase above the $100 per scan. As you remember, the workers' comp I mentioned . And so basically, it's growing this part of the business.

Perfect. Thanks for taking our questions. Good quarter. Thank you.

And one moment for our next question. Our next question comes from Ross Osborne of Cantor Fitzgerald. Your line is open, Ross.

Hey, guys. Thanks for taking our questions. So starting off, you mentioned 60 units in various stages of deployment. How many of these were placed, approved, and operating in the U.S.? And why have we not seen the associated inflection revenue based upon those units being used?

So I'll start with the first number. Right now, to your reference of the question, it's more than 20. as some of them are being installed as we speak. Some of them are installed but waiting for approval from regulation or a physicist or the building or the city or the state. I think we passed most of the approvals. So this is with respect to the numbers. Ramzi, would you like to address the revenues?

Yes. You have to bear in mind that from the time that we deploy the machine until we generate revenue, there's a few phases that we need to go through with the machine. First of all, it's the registration with the state and all kinds of other permits. Sometimes there's a setup to be made, and more importantly, it's all the process with getting the approved EOB for the procedure itself. But once we get the EOB that we see in certain places, then the number of the scans increase, and then the revenue generation is following up.

The interesting part, Ross, is that we have indeed mentioned the the average of the seven scans per operating day, which was the base of the model. But definitely, I would say that we can see that in the segment of the market that we are putting the systems in multi-specialty medical centers, we can see days with 11 scans per day, even days with 17 scans per day. The workers probably will generate more than seven scans per day. So the ramp-up takes time. And the reimbursement, although there is a CPT code and all of this, the reimbursement and the EOB sometimes takes time, and they increase the revenue following after.

But once we get the EOB, we do see a mining inflection point where the operator increase significantly the number of the skins.

Okay, I appreciate the color there. Then moving down the P&L to gross margin, how should we be thinking about you guys getting to a break-even point or turning positive between your three business lines?

Okay, so if you look at the 20F, so you can see that our tele-radiology And I'm talking about on a non-GAAP basis because you have to, if you look at the face of the P&L, so you look at the measurement, you look at the numbers on a GAAP basis, and there's all kinds of amortization of intangible and share-based compensation and all kinds of items that we are actually adding back when we talk about the non-GAAP basis. But even when we talk about non-GAAP basis, you can see that our tele-radiology division is already profitable. And the gross profit margins varies between 36%, 37% to 41%, 42%. The AI business should be with the higher gross profit margin. And the ARC division will be somewhere between. Of course, once we'll transition from... to the ARCICs where we have the glass tube rather than the ceramic tube, then we should expect our gross profit margins to increase over there. Since, as we know, the cost of the machine of the ARCICs is much lower.

Thanks for taking our question. Thank you.

And our next question will be coming from Scott Henry of AGP. Scott, your line is open.

Thank you. Good morning or afternoon, depending where one is. It seems to me in the quarter there's a lot of really strong technological progress, and people that have the machines are using it. But the quarterly placement level of 10 to 15 per quarter, it's going to take a while to get to break even. How should we think about when there may be an inflection point to get to higher placements per quarter?

Thank you. I would like to answer your question and by the same token to also to refer to the tale of Ross, to Ross' question, okay? So under all the fact that, you know, the safe harbor and the and the uncertainties in the market and all the results that what is happening right now in the markets, et cetera, we are indicating expectations that U.S. is making money right now. The AI is going to break even. Our AI business is going to break even next year, 2026. And the ARC business are going to break even in 2027. So that's actually right now the plan, and these are the indications that we expect. We work hard in order to be there. You like the word inflection point. I would say that the inflection point will be probably the second half of 2025, where we are going to see a lot of the results. You are right that there are a lot of progress in the technology in this quarter. But if you notice, we made progress in the ARC. We made progress with the AI customers and revenues. We made progress with the second opinion. We made progress with the teleradiology. We made progress with the clinical efforts and clinical education and brand awareness. We have made progress with regulatory. We've made progress with cooperation, with new market segments, with the OEM business, with the implementation of the end-to-end solution, and also with what we call the cost of the product. I think that what this quarter actually shows, first of all, that we are delivering what we promised. But second, we are making progress all the time. Yet, we are saying getting a new medical equipment to the market is not an easy one. And getting something which is, as you all write, disruptive, changing the standard of care, is not an easy one. It requires a lot of education, a lot of efforts in terms of the clinical support, but that's what we are doing, and that's the reason why we have indicated that in the RSNA this year, we're going to present the new product that we're going to install, the Arc AI or the solution of the AI to the Arc that is going to be built in in the system. the fact that the ARC is going to do 2D x-ray as well, built-in in the system, and a lot of other goodies which are part of the ARCX.

Okay, great. Thank you. A lot in that answer. I appreciate that. If I could just double-click on one thing you mentioned. You said ARC business potentially profitable or cash flow break even in 2027. Should we be thinking about a at a quarterly run rate exiting 2027 as breakeven? And I don't know if you want to answer this question or not, but could you give us a sense of what kind of revenue run rate it would take to breakeven? We could do the math ourselves, but I thought I would ask.

Thank you for taking the question. It really depends on the mixture of the revenue. And this is not really a formal guidance, but we previously, you know, we have spoken, we gave some unit numbers of 1,500 to 2,000 units that's been deployed in order to get to a break-even point. And of course, if we get more attraction from the tele-radiology business rather than the AI and the art, so it comes with low gross margin, but we will get more from the hardware and the AI. and we'll see more growth over there, then the break-even point will be even faster, just because it comes with the higher gross profit margin.

It really depends on the mix between the CAPEX sales, hybrid sales, and the EMSA sales, which right now, I don't think that we are in a position to indicate the mix between these three elements. But the more we get into getting more experience in the market and starting to penetrate to the European market as well as the Latin America market, I think that we will be able to shed some more light and to give some more guidance with respect to what will be the mix of these type of sales. But it definitely depends on the mix. Okay, great. Thank you for taking the question.

Thank you. And I'm showing no further questions. This will conclude today's conference call. Thank you for participating. You may now disconnect.