NANO-X IMAGING LTD

Good day, and thank you for standing by. Welcome to the Nano-X Q3 2023 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 that session, you'll need to press star 1-1 on your phone. 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, and I would now like to hand the conference over to your speaker today, Mr. Mike Kavanagh, Investor Relations. Sir, please go ahead.

Good afternoon, and thank you for joining us today. Earlier today, Nanox Imaging Limited released financial results for the quarter ended September 30, 2023. The release is currently available on the investor section of the company's website. Erez Meltzer, Chief Executive Officer, and Ron Daniel, Chief Financial Officer, will host this morning's call. 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 operations, 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. Management will also refer to certain non-GAAP financial measures to provide additional information to investors. A reconciliation of each non-GAAP financial measure to the nearest GAAP financial measure is provided in the company's press release issued today. The non-GAAP financial measures include 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, non-GAAP other expenses, and non-GAAP gross loss per share. With that, I'd now like to turn the call over to Erez Meltzer.

Thanks, Mike. And as always, thank you all for joining us today for our financial results call and corporate updates. As previously noted, we have intensified our efforts and focus on the U.S. market to jumpstart our commercialization effort in the region. To support these important efforts, our team and I have increased our presence in the United States over the last few months, and I'm currently in the U.S. We have engaged in discussions with potential customers clinical partners, particularly U.S. healthcare sector professionals, focusing on reimbursement and medical workflow, and other key stakeholders. We aim to expedite the implementation of our commercial infrastructure and advance our future strategic plans. Moving to the recent developments in deployments, I am pleased to announce that we have established the first U.S.-based commercial site and demonstration center for the Nanooks Arc, which is part of our initial wave in the U.S. A Nanooks Arc system has been installed in the New Jersey-based imaging center, which marks the beginning of Nanooks' commercial expansion into the U.S. market. The system passed all necessary tests conducted by a licensed and certified physicist enable us to commence scanning of patients to acquire medical imaging using the NANUX Arc, a stationary x-ray system intended to produce 3D tomographic images of the MSK system. The clinic staff will manage the operational, professional, and administrative services, allocating human resources and equipment for the efficient operation of NANUX system in the imaging center. This center will also serve as a demonstration center for our medical professionals, offering them an opportunity to familiarize themselves with the system and facilitate the implementation process. More updates on the progress on installments in the U.S. are expected on the investor on December 4th. We are enhancing our U.S. sales and service team, and I'm happy to announce we have signed an agreement with 626, a national healthcare technology and equipment management company. They will provide services for the Nanooks Arc, including warehousing, installation, training, maintenance, and customer support. Headquartered in Boca Raton, Florida, 626 offers tools necessary for imaging centers to achieve maximum uptime and maintain better patient care. 626 has expertise in modalities and medical imaging equipment and provides customized services tailored to their clients' needs. With their ISO 134085 certification, national footprint, and over 160 field service engineers, they are an ideal company to partner with as we ramp up our commercialization efforts in the U.S. In addition to them supporting installations, maintenance, and services in the field, we intend to install an ARC system in their suburban Atlanta 626 imaging academy for training and demonstration purposes. Turning now to our deployment efforts in the rest of the world. Outside of the key US market, we have begun to generate revenues from hardware deployment in Africa. While these revenues are currently small, they are growing. Additionally, as previously announced, Anamux Art Unique has been installed in the University of Ghana Medical Center Limited, UGMC, one of the largest and most advanced hospitals in Ghana. We are pleased to announce that our local partner has obtained approval from the Ghana Food and Drug Authority, the GFDA, and it will soon be operational for clinical scanning of patients. In the meanwhile, we have received an order for additional units in Ghana. We're also actively working on establishing a presence in Latin America. One of our distribution partners is in the process of securing an import license for NANUC's ARCS, as well as laying the groundwork for a demonstration center. The potential location for the demo site has been identified as a large hotel offering this very space and expertise both in the Nanak's Arc. We will provide further detail on this development as we make substantial progress. Turning to our OEM initiatives. To meet the anticipated demand of our system, as previously announced, We entered into original equipment manufacturing agreement with Varex, a leading global manufacturers of imaging component based in Utah. We have since held formal partnership kickoff meetings at Varex headquarters in Salt Lake City, where the company's executive and technical teams came together to continue final tube design efforts and map out all the roadmaps towards production. Expanding on our own related activity, We're currently engaged with an industrial imaging equipment manufacturer on a tube development and manufacturing program we expect to formalize by the year end to ensure an adequate future supply of tubes. Additionally, our collaboration with the U.S. government agency exploring technology for use in security screening application is advancing with the acquisition of tubes and further testing and evaluation. Finally, a leading global medical technology company has purchased amateurs for internal testing and application development projects. We are not in our regulatory task. Despite our efforts to gain regulatory approval in a number of markets across the world, sometimes our regulatory progress is slower than we would like in some instances, such as with the FDA in the US. Each jurisdiction has its independent set of regulations contributing to the complexity of the process. We are diligently navigating these challenges, prioritizing swift approvals while ensuring accuracy and regulatory compliance. Nevertheless, we have not stopped pushing ahead with our regulatory efforts, which continue to be of paramount importance to NANUCS. As previously communicated, we partnered with BSI Group and a credible notified body based on the United Kingdom for eventual CE marking review and approval. I'm happy to announce that we have submitted our technical file for obtaining the CE mark. BSI's formal review will begin in the first quarter of 2024, according to the planned timeline. and I look forward to providing updates upon the conclusion of this process. We have also made substantial progress in our home market, Israel. The medical device division of the Ministry of Health, known as AMAR, A-M-A-R, is the regulatory body that oversees medical devices. On November 22nd, 2023, Nanook's Arc received Amar approval from the Israeli Ministry of Health, and it is now registered as a medical device in the Israeli market. Following this approval, the Israeli Ministry of Health granted Nanook's Arc a free cell certificate, which is a requirement for regulatory submission in some markets. Turning to our clinical efforts. As previously disclosed, the second phase of collecting clinical sample images of multiple human body anatomies with a Nano-XR system deployed at Shamir Hospital in Israel is continuing. Additionally, Nano-XR reached an agreement with Baylinson Hospital, a part of the Kralit Health Services, the largest health service organization in Israel and one of the largest in the world. According to this agreement, a human trial designed to assess diagnostic capabilities of the non-XR in detecting chest and lung diseases will be launched at the hospital. All required Israel Ministry of Health approval and institutional ethics committee has been obtained, and the trial is scheduled to commence by the end of 2023. Now I would like to provide an update on our NANUX-AI business segment. We generated $141,000 in revenue during this quarter, and Ron will review it in more detail shortly. At the end of the quarter, we announced compelling study results which demonstrated that NANUX-AI product found that approximately 60% of patients unknowingly had moderate to severe level of coronary artery calcium, also known as CAC, a proven indicator of future cardiac events. The study was sponsored by Nanox AI and conducted by Bellinsville Hospital utilizing Nanox AI Health CCS, an FDA cleared and CMR tool designed specifically for cardiac health assessment. Health CCS solution utilizes medical imaging data from routine chest CT scans to automatically quantify and analyze TAC, potentially offering an early detection mechanism for cardiovascular calcium and preventing cardiac care. In other NanoxIA news, a 510K submission for Nanox FETI liver detection known as Health FLD was submitted in September and is pending FDA 510 clearance. HealthSLD is designed to detect early signs of fatty liver diseases from routine chest and abdominal CT scans, not specifically for fatty liver assessment. These updates are highly promising, and I look forward to providing additional updates on the NanoxAI business throughout 2024. Before turning the call over to Ren, I'd like to revisit one of the AI products agreement that we have announced previously. In mid 2022, we announced a strategic agreement with Spectrum Health, now known as Corwell Health, one of the leading integrated delivery system IDNs to use our AI population health solutions. Coldwell Management reports that their team has successfully integrated the NanoSAI HealthCCS solution into their patient care flow, recognizing its significant value in identifying new patients with medium and high calcium level on chest CT scans. We have also received similar positive feedback from another healthcare system using NanoSAI solutions. And with that, I'd like to now turn the call over to Ran Daniel to review our financial results. Ran?

Thank you, Eric. We reported a gap net loss for the third quarter of 2023 of $21.4 million, compared with a net loss of $19.1 million in the third quarter of 2022, which is the comparable period. The increase was largely due to a goodwill impairment of $7.4 million, an increase of $0.4 million in the sales and marketing expenses, which was offset by a decrease in our general and administration expenses in the amount of $5.6 million. Our non-GAAP net loss for the third quarter of 2023 was $9.4 million, compared with a net loss of $8.1 million in the comparable period. The increase was largely due to an increase of $0.4 in the sales and marketing expenses and $0.7 million in other expenses. Revenues for the third quarter of 2023 were $2.5 million, and growth loss was $1.7 million on a GAAP basis. Revenue for the comparable period were $2.4 million and growth loss was $1.5 million on a GAAP basis. Non-GAAP growth profit for the three months ended September 30th, 2023 was $0.9 million as compared to $1.1 million in the comparable period. which represents a gross profit margin of approximately 37% on a non-GAP basis for the three months ended September 30th, 2023, as compared to 46% on a non-GAP basis in the comparable period. Revenue from tele-radiology services for the three months ended September 30th, 2023 was $2.2 million, with a gross profit of $0.2 million on a GAP basis. as compared to revenue of $2.4 million with a gross profit of $0.6 million on a gap basis in the comparable period, which represents a gross profit margin of approximately 11% on a gap basis for the three months ended September 30, 2023, as compared to 26% on a gap basis in the comparable period. Non-GAAP gross profit of the company's cellular radiology services for the three months ended September 30th, 2023 was $0.8 million, compared to $1.2 million in the comparable period, which represents a gross profit margin of approximately 36% on a non-GAAP basis for the three months ended September 30th, 2023, as compared to 49% on a non-GAAP basis in the comparable period. The decrease in the gross profit margins on a gap and non-gap basis is mainly due to an increase in the cost of the company's radiologists due to the decrease in the read rate and payments of incentive payments which the company pays to the company's radiologists engaging the reading during the overnight and weekend shifts. During the three-month end of September 30, 2023, the company started to generate revenue for the sales and the and deployment of its imaging systems, which amounted to $99,000 with a gross profit of $36,000 on a gap and non-gap basis, which represents a gross profit margins of approximately 37% on a gap and non-gap basis. Those revenues stems from the sales and deployment of our 2D systems in Africa. Research and development expenses for the first quarter of 2023 were $0.6 million, as compared to $6.1 million for the comparable period in 2022. The decrease of $0.1 million was mainly due to a decrease in the cost of labor of $0.6 million, which was offset by an increase in the company's development of the ARP system expenses in the amount of $0.5 million. Sales and marketing expenses for the first quarter of 2023 were $1.1 million, compared to $0.7 million for the comparable period in 2022. The increase was mainly due to our go-to-market efforts in the U.S. market in anticipation for the soft launch of our products in the U.S. market. General and administrative expenses for the third quarter of 2023 were $5.0 million, as compared to $10.6 million for the comparable period in 2022. The decrease of $5.6 million was mainly due to a decrease in our legal expenses in the amount of $2.9 million, largely as a result of the finalization of the SEC investigation, a decrease in share based compensation in the amount of $2.7 million, and a decrease in the cost of directors and officers liability insurance premium in the amount of $0.3 million. Goodwill impairment for the third quarter of 2023 was $7.4 million, due to the goodwill impairment related to the tele-radiology reporting unit in the amount of $7.0 million and the NALUX AI reporting unit in the amount of $0.4 million, largely due to the increasing discount rate and management estimates that it would take longer than we originally expected to generate the regional growth of revenues, gross profits, and positive operating cash flows in the AI and teleradiology business segments. During the first nine months of 2023, we had accrued $0.7 million for the future settlement expenses in connection with the SEC investigation. As previously discussed, the company and Ron Kodiakhin our chairman of the board of directors, has reached a settlement agreement with the SEC. During October 2023, the company paid $650,000 in civil penalties under this agreement. Turning to our balance sheet, as of September 30, 2023, we have cash, cash equivalents, restricted deposits, and multiple securities of approximately $95.6 million and a $3.3 million loan from a bank. We ended the quarter with a property and equipment net of $45.1 million. As of September 30, 2023, we had approximately 57.7 million shares outstanding as compared to 52.1 million shares outstanding as of December 31, 2022. The increase was mainly due to the sales of approximately 2.1 million shares and warrants to purchase up to 2.1 million shares in a registered direct offering in consideration of a gross proceeds of $30 million and a net proceeds of approximately $20.7.1 million and the insurance of approximately 255,000 ordinary shares to the former shareholders of U.S. RAD under the amendment to the U.S. RAD stock purchase agreement previously discussed. With that, I will end the call back over to Eric.

Thank you all once again for joining our call today and for your ongoing support of NanoX. We are making significant progress toward deployment of the NanoX Arc system at scale in both the US and other markets. And I'm looking forward to our investor day next week and our Q4 update call in early 2024. If you would like to register for our investor day or meet with the NanoX team, While we are in the New York area, please contact our investor relations partners at ICR Wesley. Have a good day. Operator, please open the session to Q&A.

Thank you. As a reminder, to ask a question, please press star 1-1 on your phone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Stand by as we compile the Q&A roster. And one moment, please, for our first question. Our first question will come from Jeff Cohen of Leidenberg Thalmann. Your line is open.

Good morning, Eris and Rand. How are you? Great. Good morning, Jeff. So a few questions from Aaron. You spoke about a government agency and some security screening. And this may be a stupid question, but is that for people or is it for goods such as luggage?

No, we indicated last time. By the way, it's the same agency that acquired the first one, and the first trial was successful. they now go to the next step. We don't know exactly what's the purpose of the use it. The only thing that we know that the indication that we got that it's a kind of a defense, but we don't know exactly what it is for.

So that's the, that's what I can say.

Okay, got it. Can you go back to your EU submission and notified body? Walk us through the timeline there as all the documentation has gone in or will be going in shortly? And what are we going to anticipate on the timeline being that there's some further precedent in the U.S. now?

So in a way, we are kind of ahead of what we anticipated to do it next year. We have already submitted all the information. The way it goes, the notified BATU opens kind of a window or a site that you upload all the information. You know, it's thousands of pages. Then once all the information is on, then you go to questions, further visits at the site, all kind of checks. I don't want to give any, you know, we have been saying all the time that regulation in medical equipment is something that is always challenging and very complicated and has a lot of facets, but we assume that with the quality of the information and the quality of the clinical trials that we have and with the quality of the ISO that we passed, all of this, it will be reasonably faster than what and I have an estimation, but I think that it would be better to wait until we get a better clarity when in 2024 we will get it.

Okay. Is it safe to say you're hopeful, Curly, that you'll get a EU clearance in 2024?

Safe from whose point of view? I would say that it would be reasonable to say.

Got it. Okay. And then lastly for us, could you go back to the Varex facility in Utah and talk about their capabilities there as far as anticipated number of units that could be assembled and produced per month or per quarter or per year?

So, as you know, Varex is the largest player in tubes. for the imaging in the world. I was there a few weeks ago. We had a long day session of the kickoff, both for the future roadmap of future breakthrough technologies roadmap for products. And the other thing is the continuous supply. And from the capacity point of view, they will be able to supply whatever we need going forward. We're not going to be dependent on our audience. We're going to continue with our strategy to ensure that we have at least two or three suppliers for each one of the components that we have. So the tubes will be included, and they will be a major supplier, but not the sole supplier.

Okay. Perfect. That does it for us. Thanks for taking the questions. Thank you, Jeff.

Thank you. One moment, please, for our next question. Our next question will come from Ross Osborne of Cantor Fitzgerald. Your line is open.

Hey, guys. Good morning. Congrats on the progress. Thanks for taking our questions. And hope your loved ones and employees are safe as possible given the war. So starting off with the New Jersey Imaging Center, would you provide some more color on the types of patients the center manages and when we can expect the center to be up and running at scale?

Okay. Up and running right now, The second is at scale right now is what we are focusing on, and we do hope that it will be, I would say, will be in scale probably by the end of the year or beginning of the next year, in January. We are planning to open this site for demos for people who would be willing to visit and see. I would say also that this will be another solution that we have managed to create since right now in Israel, although we do business as usual and everything that we're planning we're doing, Some people or some visits that were supposed to come to Israel have postponed their visits, so they will be able to come to New Jersey and come and see, and we're going to be there. It's going to be served as the 626, for example, the one that we mentioned already were part of the installations that we had there. So it's kind of a friendly environment for us to ensure that we're going to take all the benefits of the proof of concept, both for demonstration purposes and for operational. We mentioned also that as we speak, we are making the next installations before the end of the year. So basically, the go-to-market strategy and the go-to-market action plan in the U.S. is up and running. We're building the team. We signed the agreement, and we are aiming to scan the first U.S. patients in the coming days. So we have all the necessary approvals, but this is something that we're planning to do. We have managed to get all the certification, finding the physicists that came to be there and enable us to commence the scanning of patients. et cetera, so it's good, or we are happy with it.

Sounds great. And then turning to Morocco, can you discuss the level of utilization in terms of scans per day or your metric of choice there, and then the amount of systems you have delivered to date?

I think that this is something that we will shed some light in the investors' day next week.

Okay, fair enough. Looking forward to that.

But basically, right now, it's in line of, I would say that it's in line of what we anticipated.

Okay, got it. And then starting to think about next year, given some of your recent manufacturing agreements, you know, when should we expect an inflection in system deployments and expansion into new geographies outside of Morocco, Ghana, and Nigeria? Yeah. Just trying to get an understanding of system placement cadence for 2024, given you're now commercial and have contracts with these geographies for hundreds of systems.

So you asked about the next, I think that we indicated already in the planning to work to fulfill the orders that we had originally mentioned. The agreements that we have in each one of them. We are making progress in terms of the regulation approvals So part of them will be other countries in Africa a part of them will be in Latin America and part of them will be in Asia and and European countries which are not dependent on on you so that's That's the plan so far, but it's all dependent on the process and the progress that we made with the regulation approvals. But this is also something that we will give some more color on next week.

Sounds good. Thanks for taking our questions.

Thank you. Again, one moment, please, for our next question. Our next question will come from Ben Hainor of the Alliance Capital Partners. Your line is open.

Good day, gentlemen. Can you hear me okay?

Yeah, Hunter.

Good morning. Great. So just looking to understand the NAICS ARC revenue a little bit better for the quarter. It sounds like some of that came from sales. So if you could give me a sense or give us a sense of how how much capital revenue was included in there, and then would you expect the revenue that you're generating out of Africa from these systems to grow from the Q3 level going forward?

Yes. So you refer to the $99,000 that we recorded in the research, correct? Correct, yes. Okay, so those are actually stems from the sales revenue from our 2D imaging systems. The split is between three countries. The first one is Cameroon, the second one is Morocco, and the other one is Ghana. We're talking of a few systems in each region. And some of the revenue comes from the sales of those units and the other one from the usage of those units.

Okay. So I guess what I'm getting at, that's helpful, but what I'm getting at is would you expect the revenue from those systems to pick up from the 99,000 level, the ones that are currently in those geographies?

Generally saying yes, because some of those are provided for demo and training purposes, and we expect that those units will become commercially used. Of course, we'll add more units on those ones. And, of course, we expect to start generating revenue from the ARC systems itself in those regions and in the U.S.

itself. In these units, by the way, I would say that the numbers of scans per day where they're operational is actually – the numbers are exceeding our original expectations.

Okay. That's good to hear and helpful. And then just on the VERIX agreement, I was curious about the minimal annual amount on that. Is that something that's relatively easy to achieve, or is it kind of a small fraction of the anticipated utilization, or what's the right way to think about that?

From whose side?

From our point of view. Well, maybe both.

First of all, we have not disclosed the details of the agreement yet, but We'll add more details in our next 20F. What can I tell you? There's some formula over there that is going to build in some minimums, but not in the current point of time.

Yeah, and there's some percentage, but we don't want to get into this just because... The way we structure the agreement is very beneficial for us in terms of the way we want to manage our business. Okay, fair enough.

I think that's all we have.

You have to remember that it's a long-term agreement. There's a built-up agreement in a way that both sides can execute.

Okay, got it. But I think that's all we have. So we'll see you guys at the analyst day next week.

Thank you. Thank you.

Thank you. And that is all the time we have for questions, thus ending the Q&A session. I would now like to turn the conference back to Erez Meltzer for closing remarks.

So thank you all for being with us today. Looking forward to see part of you and that the others will be able to hear next week when we have the Investor Day, when we're going to – shed and give some colors on technology, on the go-to-market in the U.S., and on the operational as well as some clinical. The management team will present there. So see you next week, and thank you for being with us and the support of NUNX. Good day.

This concludes today's conference call. Thank you all for participating. You may now disconnect, and have a pleasant day.