Good day, and welcome to the Nano-X Q4 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker, Mr.

Mike Cavanaugh, Investor Relations. Please, go ahead..

Good afternoon and thank you for joining us today. Earlier today, Nano-X Imaging Limited released its financial results for the quarter ended December 31, 2022. The release is currently available on the Investors section of the company's website.

Erez Meltzer, Chief Executive Officer; and Ran 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. 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 basic and diluted loss per share.

With that, I'd now like to turn the call over to Erez Meltzer..

Thank you, Mike. And thank you all for joining us on the call today. As in previous calls, I will provide a business overview before turning the call over to Ran Daniel for a review of our financial results to be followed by a Q&A session to close.

Reporting on our first quarter and the full year of 2022, which was also my first full year as a CEO of Nano-X, this year marked our transformation into a more mature organization.

I'm pleased with the progress our team had made on multiple fronts, as we move forward towards the commercialization of Nanox.ARC system alongside our regulatory efforts in the US and Europe.

Key commercialization work to include the work to begin deploying the Nanox.ARC in the first market in Africa, establishment of additional production facilities and the new commercial collaborations.

During the year, we established organizational processes, efficiencies, business integrations and cost-saving initiatives that will help drive our company forward. We believe that the work to create a more efficient infrastructure has put us in a good position.

I'll start with our efforts to obtain regulatory clearance in the US and Europe, both of which are high priority for us. As previously announced on September 26, 2022, we submitted a 510(k) premarket notification to the FDA for the second version of our multi-source Nanox.ARC 3D digital tomosynthesis system.

As part of the continuous dialogue with the FDA, we have been providing and continue to provide the FDA with additional information and address any questions in the timely manner when requested during its valuation process, including in the past few weeks. We will announce the FDA final decision once we receive it.

On other regulatory news, we continue to perceive the CE mark in the European Union with a notified body, who previously engaged. Nanox is currently upgrading its systems and processes to comply with the requirements of the new Medical Device Regulation, MDR in Europe.

We understand, that the EU and the notified bodies are experiencing high-volume of requests for CE marking and technical files updating due to the changes to regulation from MDD to MDR. Therefore, the CE marking process and timeline are yet to be determined by the notified body.

I would like to now take a few minutes to discuss our progress stories of commercialization of the Nanox.ARC system, which we are aiming to begin first in Nigeria and Ghana. Since our last update call, I'm happy to report on our first shipments of Nanox.ARC system for training and demonstration purposes to Nigeria and Ghana.

Demo units of the Nanox.ARC have received import licenses for installment and testing both in Ghana and Nigeria.

In Ghana, the Nanox.ARC unit has been installed in the University of Ghana Medical Center Limited, UGMC, one of the largest and most advanced hospital in Ghana for demo and training purposes, including clinical use, which is pending local regulatory clearance.

I recently visited Ghana with ARC division team representatives for the launch of the Radiology Learning Center in UGMC. Particular event was organized by our local distributor and it was successful with full attendance.

In Nigeria, the system is in process of installation and is currently undergoing regulatory review by the Nigerian Nuclear Regulatory Authority, the NNRA.

Both Nanox.ARC installments will serve as locations for testing, training and education before we expect our commercial partners to take steps to rollout the medical imaging solution to areas without current access to medical imaging systems and address patient needs.

Launching the Nanox.ARC first in West Africa, where many communities like medical imaging and advanced health care is in line with our vision to increase early detection of medical conditions that are discoverable by x-ray by improving access to imaging.

These are the first steps of many toward our goal for closing the health equity gap in Medical Imaging.

In line with these efforts, we've also launched the previously announced partnership with BIO Ventures for Global Health, BVGH, a non-profit organization dedicated to solving global health issues by forming connections between people, resources and ideas.

This program is near completion of its first phase, which includes an education and training series of expert-led seminar to train Nigeria and African health care professionals on imaging topics. I would now like to provide few updates regarding R&D and manufacturing.

We are in the process of consolidating our intellectual property and R&D located in different locations around the world with a goal of establishment of facility in Israel that will serve as knowledge and R&D center, which will complement the facilities we now have in Korea and Japan.

We are in the process of entering into agreements with additional third-party manufacturers for tubes and MEMs X-ray chips based on among other things, cost effectiveness to help ensure an adequate supply to meet our future production goals and facilitate systems enhancement over time.

Now turning to our Nanox AI and teleradiology business, which were fully integrated into the Nanox organization over the course of 2022. Following the acquisitions of Nanox AI and USARAD in November 2021, we continue to see revenue generation from these important business segments.

These revenues help conserve cash and continue to demonstrate the utility -- these additional services to healthcare systems and support our belief that our complementary deep learning analytics and teleradiology services will add significant value to the fully integrated Nanox ARC system upon deployment.

I'm also very excited about a new partnership.

Last month, we announced a key collaboration between Nanox AI and Nuance Precision Imaging Network, a Microsoft company, more than 12,000 healthcare facilities and the 80% of US radiologists, we use a Nuance PowerScribe Radiology Reporting and PowerShare Image Sharing Solution will now be able to seamlessly excess Nanox AI solutions.

With that, I would like to turn the call over to Ran Daniel, Chief Financial Officer, to review our financial results..

Thank you, Erez.

We reported a GAAP net loss for the fourth quarter of 2022 of $44.8 million, compared with a net loss of $22.0 million in the fourth quarter of 2021, which increase was largely due to expenses related to increased research and development expenses and goodwill impairments related to the acquisitions of Nanox AI, which was mitigated by decrease in our general and administrative expenses and an increase in our obligation in connection with the merger and acquisitions, mainly due to the settlement with the former shareholders of Nanox AI.

Revenues for the fourth quarter of 2022 were $2.1 million and gross loss was $1.7 million on a GAAP basis.

Revenue from teleradiology services for the same period was $2.0 million with a gross profit of $0.3 million on a GAAP basis and a gross profit of $0.8 million on a non-GAAP basis, which represents a gross profit margin of approximately 40% on a non-GAAP basis.

The decrease in the company's revenue and the gross profit margin in the fourth quarter of 2022 is mainly due to the revenues from the data monetization project in the amount of $0.3 million that did not recur in the fourth quarter of 2022.

Research and development expenses for the fourth quarter of 2022 were $7.1 million as compared to $6.4 million for the comparable period in 2021. The increase in our research and development expenses was mainly due to the development of the multi-source Nanox ARC and the Nanox CLOUD.

Sales and marketing expenses for the fourth quarter of 2022 were $1.5 million as compared to $1.9 million for the comparable period in 2021. The decrease was mainly due to a decrease in our cost of labor and share based compensation.

General and administrative expenses for the fourth quarter of 2022 were $8.2 million, as compared to $10.9 million for the comparable period in 2021.

The decrease was largely due to a decrease in our cost of labor and share-based compensation, which was mitigated by the company's legal fees due to the SEC litigation and class action litigation as described in the company's from 6-K filed today and Form 20-F for the year ended December 31, 2021, filed on May 2, 2022, and subsequent filings with the US Securities and Exchange Commission.

Turning to our balance sheet. As of December 31, 2022, we had cash, cash equivalents and marketable securities of approximately $102.9 million, which are composed from $77.7 million of cash, cash equivalents and short-term marketable securities and $25.2 million of long-term marketable securities.

Further, we had $3.5 million loan from bank as of December 31, 2022. As of December 31, 2022, we had property and equipment net of approximately $43.6 million. During the year, we completed the construction of the company's fabrication facility in Korea and primarily purchased machinery equipment to be used in our operations.

As of December 31, 2022, we had approximately 55.1 million shares outstanding, as compared to 5.8 million shares outstanding as of December 31, 2021.

The increase was mainly due to the issuance of 2.6 million ordinary shares to the former shareholders of Nanox.AI under a settlement agreement with respect to any additional amount that could be granted under the merger agreement dated August 3, 2021. With that, I will hand the call back over to Erez..

Thank you, Ran. 2022 was a year during which we laid our multiple building blocks for our future success, and we believe that we are in a good position for an equally productive 2023. We made good progress toward commercializing the Nanox.ARC in Ghana in Nigeria.

We successfully integrated the Nanox.AI and USARAD acquisitions, which added important components to our anticipated end-to-end imaging solutions, and importantly, we are advancing our regulatory work in the US and EU.

It has taken a lot of work to get to this point, and we are excited to be deploying demonstration units of the Nanox.ARC in our first markets in Africa and working to receive FDA clearance in the US. As always, we appreciate your support of Nano-X and look forward to engaging with you our investors in the coming months.

I would like to mention that the Nano-X management team will be in New York City from March 20 through March 22 for investor meetings. If you would like to meet with us there, please contact our Investor Relations partner at an ICR Westwicke. Operator, please open up the call for questions..

Thank you. [Operator Instructions] And today's question will come from the line of Jeff Cohen with Ladenburg. Your line is open..

Hi, Erez and Ran.

How are you?.

We are okay. Thank you, Jeff..

Great. So firstly, could you talk about the R&D consolidation? I know, you've been building out the facility in Korea. And also, you have some facilities in Japan, facility singular.

Could you talk about the consolidation there as far as manufacturing and throughput on both devices, tubes, MEMs, et cetera?.

Yes, of course. First of all, as you know, we are manufacturing the MEMs in the facility in Korea. Right now, we are getting the tubes from Korea. And at the same time, we are developing other sources for both the chips and the tubes in the US and Europe.

At the same time, what we thought and I think that I mentioned it in the last call, what we believe is that, as we go for the future, we have to centralize all the activities and especially the knowledge of future chips and future tubes in Israel. And therefore, we are building the center of knowledge.

The people that we are hiring and we have hired already who are expert in semiconductors and MEMs, as well as the tubes. Everything will be consolidated in Israel. And from there, we will develop the future products.

In the future, since we spoke about more x-Ray Rx [ph] and more products will be part of the hardware, we would like to ensure that all the – all of this will be in Israel.

We mentioned that we plan to source and explore tubes from various suppliers, as mentioned, and basically to have our own subsidiary most advanced supplying tubes, but in addition to not to rely on one source and to have the knowledge in Israel as mentioned..

Okay. Got it.

And Ran, on the impairment charge, the 36.5, does that conclude the case in hand and that was a non-cash or cash charge that you took in the fourth quarter?.

No, this is a non-cash charge. It's – and you can find it is as part of our non-GAAP adjustments, in the 6-K, you'll see the schedule of the non-GAAP. And as you know, this is a non-GAAP item..

Okay. Got it..

A GAAP item, sorry. It's adjusted for non-GAAP purposes..

Got it.

And the units in Nigeria and Ghana, it's one in each territory thus far?.

To begin with, yes. And more are planned to be shipped to other territories that we are in the process of getting the approvals. The one thing, I can mention, and I will probably elaborate about Ghana. Ghana is the first operating units in a medical organization, or a medical hospital. I was there two weeks ago.

We actually had the opening, because that it was the first system. As you can imagine for us, it's a big thing. The interesting part was that the installation was very quick. The -- we have right now more sustainable product or system.

And the event that was organized by the distributor was with a few hundred people, with radiologists, with clinicians, with hospital managers, with bankers, with financial people from all kinds of financial, and of course, government people. And it was very impressive.

And we have to have these type of events or these type of launches in the very near future. We already started the training center there. So there is a training room and training facility and it's part of the education that the physicians and the radiologists are getting there..

Got it.

And then lastly for us, could you talk about -- it doesn't look like there's any guidance or outlook, but could you give us some general commentary as far as the AI business? And how 2023 may read out or grow?.

First, so the answer is, of course, we announced the agreement with Nuance. I think it was two weeks ago or something like that. Only in the last week, we signed two new agreements.

We have a team on the ground right now in the US and with a full effort and full steam ahead to get on board, we have over also engaged with the strategic group that help us to build the go-to-market strategy and action plans. So we are -- all the engines are full stream ahead..

Got it. Okay. Perfect. That does for us. Thanks for taking the question..

Thank you..

Thank you, Jeff..

Thank you. One moment for our next question. And that will come from the line of Ross Osborn with Cantor Fitzgerald. Your line is open. .

In progress. Thank you for taking our questions. So pleased to see the initial deployments. So maybe I'll start there.

When were the systems deployed in Ghana and Nigeria? And when you would expect them to transition from training to commercial?.

The system -- first, these are a few steps in the process. First, you have to get an import license, which we received in both countries. Then you build the demo center or the demo unit, which were built in both countries, then the unit is being installed first in Ghana in later in Nigeria.

The system in Ghana is already operating, and Nigeria is on the process to following the approval of the NNAR [ph] to import the system then we are waiting for the license to operate and then to license to sell. Same with Ghana, we are waiting for the license to sell.

And -- as soon as we have this license, we can ship more units to Ghana as soon as we get it..

Thanks, Erez. A bit further along. So maybe I'll start there. I believe it includes 350 systems to operate..

I hope that I heard your question. I said the agreement with Ghana is yes, 350 and we will start deployment it as soon as we have the local regulatory approval there. One of the things that regarding to the previous question that you said, we already have a system in one of the hospitals in Israel.

We’re just about to install another hospital in Israel. In the first one, the system is operating. We got a lot of samples from this operation or this unit. And the other one, we are in the final process of getting another approval from Israel to do another hospital as soon as we get it, we'll start to get the samples in the other hospitals as well..

For us, is there any update on your work for the Nanox AI expanded indication?.

What was the question? Is there any update on Nanox AI? Ross, what was the question?.

It seems as though we have lost Ross. [Operator Instructions].

What I'll try to do, I'll try to address what I think was the Ross’s question. With respect to Nanox AI, as indicated, we have already signed agreement about – about a year -- about, I would say, a year ago with one of the IDNs.

Lately, they have extended the agreement and even signed for another year with a 50% increase in the revenues, which are being generated from the hospital. We signed the agreement with the marketplace and with Microsoft Micros, the Nuance. And we are starting to work with their clients.

This week, we signed another agreement with one of the -- another marketplace, which we're going to get the access to their customers as well. And in the last few days, we signed another agreement, the first one in Europe, also for the implementation of our Nanox AI system.

So I hope this addressed actually the question that I hope that I understood what was it?.

Thank you. Our next question will come from the line of Rahul Rakhit with LifeSci Capital.

Hey, guys. Thanks for taking the question. I apologize if asked already. I'm kind of bouncing between a couple of calls. But I was just wondering if you could touch on your progress in the EU and maybe help us understand the timing there? I know there were some updates last quarter, but just hoping to get a read on it in the New Year as well..

Yes. I think that basically, there are no real news from the previous call, we signed the engagement letter with the notified body. We are aware that right now, there is a lot of pressure on these units, by the way, not to mention the -- a lot of pressure that we understand that the FDA has with people and resources and with a lot of requests.

And -- but with respect to the CE, we are waiting for their -- for the process to be initiated or to start as soon as we get, we have already all the package and all the information ready to be shipped and submitted as soon as we get it. And we hope that this process will start shortly..

Got it. Thank you. And then one more. I think in the previous quarter, you talked a little bit about the clinical trials that you were conducting in Israel.

I was wondering if you could provide a bit more color on any future plans on clinical trials, what images that would ultimately -- what images would ultimately come out of those? And how you kind of use those images to guide the business and drive additional contracts moving forward..

Okay. So -- so right now, under the Helsinki permit that we are -- that we received already in the first hospital, we started to collect clinical samples images of multiple human body anatomies. And this one basically with a lot of many types of BMI many – the body organs, a lot of samples.

We have so far collected probably a few dozen of healthy volunteers scans from scalp to toe, including chest, okay? And right now, we are planning, as indicated before, we are planning really shortly to get the permit following in depth, I would say, inspection of the official bodies of Israel, the independent one to allow us to go to the next hospital in Israel, in which we're going to take another angle of all kinds of modalities and all kinds of samples that will be received.

So altogether, what we are planning to do is to have in Israel, two locations -- maybe in the -- at the end of the year, another third location that will take clinical samples and to do the -- it's not really clinical trials because we don't need right now to -- clinical trials.

We take clinical samples, and we do it, as mentioned with all the modalities.

Right now, all the other hospitals or educational offices, by the way, like the one in Ghana, what we are working with them is to get a special permit by the way, in Europe and in the US, to get special permit and to get the clinical trials or clinical samples to be taken working with the hospital in order to expand first of all, the variety, but also to expand the presence and the understanding of the art and the tomosynthesis and to ensure that we are in a process to get it ready once we start the mass deployment.

Rahul?.

Thank you. As I'm showing no further questions in the queue at this time. Thank you all for participating in today's question-and-answer session as well as today's conference call. This concludes today's program. You may now disconnect..

Thank you very much..