Thank you for standing by. Welcome to the Nano-X Imaging, third quarter 2021 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. [ Operator Instructions].

I would now like to turn the conference over to your speaker today, Mike Cavanagh, Investor Relations with ICR Westwicke. You may begin..

Good afternoon and thank you for joining us today. Earlier today, Nano-X Imaging Limited released financial results for the quarter ended September 30, 2021. The release is currently available on the Investors section of the Company's website.

Ran Poliakine, Chairman of the Board and Chief Executive Officer, Erez Meltzer, Executive Board Member and incoming Chief Executive Officer, and Ran Daniel, Chief Financial Officer, will host this afternoon'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, commercialization activities, regulatory process operations, the impact of COVID-19 on its business 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 may cause such a difference.

Those 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 stock-based compensation and class-action related expenses. I'd now like to turn the call over to NANO-X Chairman and CEO, Ran Poliakine..

Thank you, Mike. And thank you all for joining the call today. Today, I will give an overview of our achievements during the quarter, as well as corporate update before turning the call over to Ran Daniel our CFO to review your financial results. We will then open the call to questions.

We've been busy since our last earnings call, advancing the NANO-X system which has a potential to improve accessibility and aims to drive a significant increase in the delivery of medical imaging, all over the world. Besides greater availability and accessibility, we believe the Nanox.

ARC system, and its end-to-end ecosystem will enable healthcare providers to obtain crucial information which has the potential to shorten diagnostic and treatment time and promote early detection. It is well known that; earlier intervention is the key contributor to better health outcomes for patient.

Before I begin, I would like to have Erez Meltzer, NANO-X 's incoming CEO, say a few words and introduce some of our latest development. Erez..

Thank you, Ran. And thank you all for being on the call today. I'm excited about the leading and dedicated and talented Nanox team as we move ahead towards commercializing the Nanox.ARC system.

I'm working closely with the team to prepare for assuming the CEO role beginning on January 1st, 2022 and look forward to participating in the Q&A session at the end of today's call. Turning for accomplishments during the quarter, as many of you know, we recently completed our 3 previously announced strategic transactions.

First, we completed the merger with Nanox AI, formerly known as Zebra Medical Vision. Second, we completed the acquisition of USARAD holdings. And third, completed the acquisition of the assets of MBW.

We believe that having a more accessible medical imaging technology would not be enough to transform the global marketplace, but we also had to have an AI capability to complete and complement our technology.

Nano-X AI will fulfill its needs and provide the image analytics necessary to hold, locate a problem, and begin the process of diagnosis and treatment.

The acquisition of USARAD and MBW provide a connected team of professional radiologists and decentralized marketplace that connects facilities and patients with radiologists that, begin the next step of evaluation process in the AI alerts to a potential problem.

These transactions helped to fulfill our AI-powered workflow and provide some of the important final pieces of the Nano-X card system, as we head toward commercialization. With that, I'll turn the call back over to Ran Poliakine..

Thank you, Erez. And I would like to quickly highlight a few other achievements since our last report.

In October, we announced that we entered into an MSaaS agreement with International Clinics Group and medical equipment distributors that serves hospital's health systems, clinics, and other medical facilities in Chile, Bolivia, and Peru, which adds to the growing future demand for our Nanox.ARC system.

The agreement calls for the deployment of 350 Nanox.ARC devices across the region. To date, the Company enter into MSaaS agreements for deployment of 6,500 Nanox.ARC units. In September Nanox AI received its 8th 510(k) FDA clearance, in this case for Coronary Artery Calcium solution known as CAC, as part of its population health offering.

CAC is a key biomarker indicating risk of cardiovascular disease and can help Nanox AI identify potential medium and high-risk patient, which can then be flagged for further evaluation. And as another enhancement of the AI-powered workflow that we feel will lead to better value-based population health.

Operationally, we continue to progress towards commercial production of the silicon MEMs chip, Nanox 's only owned Korean subsidiary, that is integral to Nanox digital X-ray source. We expect production at the new facility to begin pilot production in 2022.

This key initiative is especially important given the current supply chain shortage for many products worldwide.

This will not only help to secure the stable supply of the chips that we need for the production of the Nanox.ARC, but will also ensure that the quality of our chips is not a concern for us or the healthcare professionals using the Nanox.ARC systems.

And finally, before I turn the call over to Ran Daniel, I would like to take a moment to update you on our commercialization efforts, including the regulatory process with the FDA. We are still in the process of responding to the FDA, after receiving their comments on our first submission.

As you all know, we are planning a second submission in the near term that, will cover the next version of the multi-source Nanox.ARC. And we believe that, the feedback we have received from our first submission will help inform any subsequent submission. With that, I would like to turn the call over to Ran Daniel, Chief Financial Officer.

Thank you, Ran. Before I get started in my first earnings commentary as the CFO of Nanox, I would like to say how excited I am to be part of the team that is working to up on the future of medical imaging. I am looking forward to the work ahead with the talented team. I would also like to mention another change.

We're recently partnered with ICR Westwicke, a leading S-curve-focused integrated communications firm, as our new Investor Relations advisor. They are highly experienced in the medical technology space and will be a good addition to the team, adding into the important year of 2022. With that, on to the financials.

Nanox supported a GAAP net loss for the third quarter of 2021 of $13.6 million compared to a net loss of $11.1 million for the same period in 2020, largely to due to an increase in our research and development expenses and general administrative expenses, which were mitigated by a decrease in our marketing expenses.

Non-GAAP net loss applicable to the ordinary shares for the third quarter of 2021 was $8.5 million compared to a non-GAAP net loss of $5.1 million for the same period in 2020.

A reconciliation between GAAP net loss and a non-GAAP net loss for the three-month period ended on September 30, 2021 and 2020 is provided in the financial results that are part of the press release we issued this morning.

The difference between GAAP and non-GAAP Net loss is mainly due to the share-based compensations and legal fees related to the SEC inquiry and class actions litigations.

Research and development expenses for the third quarter of 2021, were $3.7 million as compared to $2.1 million for the same period in 2020, reflecting the increased development activities for our Nanox systems and the related regulatory costs.

Marketing expenses for the third quarter of 2021, were $1.5 million as compared to $2.7 million for the same period in 2020, due to a decrease in share-based compensation. G&A expenses for the first quarter of 2021, were $8.2 million as compared to $6.3 million for the same period in 2020.

The increase was due largely to an increase in our labor cost of approximately $500,000 due to an increase in our headcount in the connection with the expansions of the Company's management team, and the overall organization infrastructure, increasing our D&O insurance expenses of approximately $0.5 million increase in our legal fees in the amount of approximately $0.6 million due to the SEC inquiry and class-action litigation as described in our Form 6-K filed today and transaction expenses with connection to the acquisitions of Nanox AI, USARAD Holdings and the assets of MBW, in the amount of approximately $0.5 million.

Net cash used in operating activities during the third quarter of 2021 was $7.0 million. For the 9 months ended September 30, 2021, Nanox reported a GAAP net loss applicable to the ordinary shares of $39.8 million, compared to a net loss of $24.9 million for the same period in 2020.

Non-GAAP net loss for the first 9 months of 2021 was only $4.2 million, compared to a non-GAAP net loss of $10.5 million for the same period in 2020.

The difference between GAAP and non-GAAP to net loss to the ordinary shares mainly due to a share-based compensation, expenses related to the secondary share offering which closed in the first quarter of 2021and legal fees in response to the SEC inquiry and class action litigation as reported in our 6-K filed to date.

As of September 30th, 2021, with approximately $47.9 million shares outstanding. We ended the third quarter of 2021 with cash equivalents and marketable securities of over $180 million, and $3 million loans from banks.

Before we take your questions, I would like to mention that the Company has been providing documents and information to the SEC in connection with an investigation, and has now received a subpoena from the SEC requesting that the Company provide documents and other information relating to the development of the Company's Nanox.ARC prototypes, as well as the Company's estimates for the cost of assembling the final Nanox.ARC product at scale.

The Company is cooperating with the SEC in responding to its request. With that, I will hand the call back over to Ran Poliakine. Thank you for the financial update, Ran. I understand that, this is a lot of information to digest and that many of you likely have more question than we can address on the call today.

We're committed to being accessible to the investment community and for this reason, we will engage in a robust investor outreach in the coming month. Additionally, as was noted in our last press release last week, we will be attending the 2021 Radiology Society of North America Annual Meeting in Chicago, from November 28 to December 2nd.

While there, we will demonstrate new features of the Nanox.ARC system. Nanox AI we will host an onsite booth there, while the Company will showcase its AI -enabled medical imaging software, Population Health solution and on December 1, Nanox will broadcast a virtual tour of Nanox.ARC in clinic setting from the Shamir Hospital in Israel.

We will close our attendance at the RSNA annual meeting with an exclusive webinar, specifically for investors. We hope to see many of you there. We hope to meet you soon again. Thank you for the time today and continued support and especially for your belief in our vision. A vision that will improve the health of all of us. Thank you very much.

We will now open up the call for question which Ran Daniel and Erez will handle today. Operator, please begin the Q&A session..

Thank you. [Operator instructions]. Our first question comes from Jeffrey Cohen with Ladenburg Thalmann. Your line is open..

Good morning.

How are you?.

Good..

A couple of questions from our end.

You have $0.6 million of legal expenses for Q3, any insight into what that may look like for the fourth quarter?.

Ran..

Yes. We don't have any insight for the moment. But as we said, we filed the 6-K today and we refer to the information that we closed over there. That's what we can update at the moment..

Okay. Got it. You had some commentary, Ran, about pilot production. I think the press release read early '22 and you stated 2022.

Can you give us a walk-through of this facility in South Korea, as far as the construction and how that looks now and how the timelines looking over the next number of months, please?.

With respect to the Korean facility?.

Yes, please..

Okay. I think we've indicated that, we have launched the new site, we have already site that which is operating right now on a temporary basis.

We expect that the new site will be operating second quarter of -- I would say highly likely that it will be operating in the second quarter of next year and it's in line of the original expectations and in line with the plans..

Okay. Got it. And then could you walk us through what you stated about the FDA timeline. I know that you stated that you're responding to the first set of questions from the FDA.

Will that go in as a response to the first other questions and would that be separate from a second submission as you called it for the ARC?.

First of all, I think that Ran addressed it very clearly that basically we are going to meet the 180 days window that we currently have to the latest submission.

That basically we are going to use all the feedback that we get, including the future feedback that we'll get in order to work on the future applications and future submissions that we're planning to do.

This is basically with respect to the ARC as you can see on the Nanox.AI, we always, and we are -- continue to submit other FDAs and to connect to work with them, to get another approvals, FDAs and CPT codes..

Okay, got it. Thank you very much. That does it for us..

Thank you, Jeffrey..

Thank you very much..

Thank you. Our next question comes from Suraj Kalia with Oppenheimer. Your line is open..

Good morning, everyone.

Can you hear me all right?.

Yes. We're trying to. Yes, we do..

Okay.

So, Ran, Erez, anyone, I'll throw it out there, what does consider filing another 510(k) mean? There's a change in the word again, I'm curious what is driving that or am I reading too much into it?.

I'm not sure that I understand what is referring -- that is not clearly written in the documents..

Yes, your earnings release sales. You're considering filing another 510(k).

And I'm curious, why -- is there any other mitigating factor that is causing some sort of reconsideration of filing or am I reading too much into the word considering filing?.

You're reading too much. I think that, if you can see that's basically on all fronts someday, Nanox AI, including the ARC, where all the time developing more and more. We are going to show in the RSNA, new applications and new ways of using the ARC. So, it will be presented in the RSNA.

Having said that, it doesn't say anything that they don’t say that we're not going in the future to submit more FDA approvals or more requests for FDA approvals to our future uses of the -- our system, including both, the source and the ARC itself..

Got it.

And in terms of the multi-source, has it been independently validated, i.e., non - Nanox affiliated people? Has any other independent expert evaluated it so far?.

First of all, this happens all the time. But I would suggest that as Ran said, wait for the RSNA, and you will see what's coming up..

Okay. And, Erez, forgive me if I missed this. The thousand-unit production run that has been talked about in the past, I don't -- I'm not sure if I heard an update on that.

Maybe you could provide some color?.

We don't have any reason right now to believe that, this is not the target that we would like to continue to stand behind..

And finally, on the SEC 's subpoena, when was the original request for documentation information received? When was it first received?.

As we file d -- as we said in our filings today, the original written requests for documentation from the SEC was received on November 8th..

November 8. Okay. Perfect. Gentlemen, thank you very much for the time and answering my questions. I do appreciate it..

You're more than welcome..

Thank you. And our next question comes from Ravi Misra with Berenberg Capital. Your line is open..

Good morning Erez. Good morning, ran..

Hi, Ravi..

Good morning..

So, I want to just kind of go back to that 1,000 units production cycle that, you're discussing. Can you just kind of give us in light of the updated commentary on the Korean facility? I think you said, second quarter and kind of the original commentary from earlier this year saying, some of these units will be produced in Israel.

What is the kind of production schedule right now, as you see it? In terms of where the first thousand will be made? And is there any risk if there are delays in Korea that you're unable to hit that number next year?.

So first of all, we have not disclosed any specific on this one. Bear in mind that we have already enough chips that will enable us to do what we do from the original manufacturer, from the Japanese. Currently we have a lot which is independent to the manufacturing of the Korean one.

Right now, all the units are being assembled in Israel and we have not made a decision yet when we're going to switch to -- gear up to the -- to scale up the process of assembly.

Once we do, and it's maybe some time during the first -- third of next year, if there are any changes, we're going to let the market knows on any changes that will be -- will take place on this one. Right now, we don't see the -- we're making load of orders in their supply chain in order to be ready..

Okay. And then on the potential second submission to the FDA.

Can you just help us think about what is going to be the key difference between that and the original submission?.

I think that it was clear that it's not a second submission. We are planning a lot of submissions in the future to the FDA once we move on and we develop more applications and more releases in terms of the use of the system, then we're going to submit further.

I think that after the RSNA when you see the system, you will probably be more into the understanding of what has to be not and what kind of further submission we would like to do in the future..

And is that RSA -- RSNA? Is that -- are you going to be attending the event? Or is it going to be virtual like last year? And then my last question would be, just on the SEC investigation, November 8, is when you said they've started the first line of inquiry.

The subpoena, I guess was received what, today? Yesterday? Or a few days after that? Can you just help put some timing around that? Thank you..

So now, I will give Ran to answer the SEC and then I will address the RSNA..

As for the SEC matter, the subpoena was received on November 8. We had informal and verbal discussion with the SEC..

With respect to RSNA, the ARC is going to be presented virtual. And then actually, what used to be Zebra, has secured a booth in present -- in the RSNA and they are going to be -- Nanox.AI would be presented there, as people will be there as well in present. A part of our people will be there, including people from the ARC Division..

Okay. Thanks. And then just maybe one final clarification, and thank you very much. If the subpoena is November 8, just curious, when did the original SEC investigation begin? Thanks..

During the short period before..

Okay. Our next question comes from Rahul Rakhit with LifeSci Capital. Your line is open..

Hey guys, thanks for taking the questions. Just two questions -- two from me.

In terms of the upcoming filing -- maybe could you comment on the x-ray tube that you guys want to use maybe on what the KVP could be or whether it's going to be glass or ceramic tube and maybe an update on the manufacturing there as well?.

First of all, I think I mentioned it, we are with the original process and plans for the manufacturing. Right now, it's being done in Israel. We have no -- nothing needed to add in terms of the [Indiscernible] that we have already achieved. It will be all presented live in the -- not live, but in present.

But live in -- when it takes place in their virtual presentation at the RSNA. So, you'll be able to see -- also answer to the question that you asked.

In addition, I think that the more we go into the deployment process, right now in the countries that we're going to operate, and initially start to implement and put our systems next year in place, we will probably be more exposed to what further applications, requests, details have to be further presented and submitted to the FDA.

So, the more we go into the future, the better we know about this one as well..

Got it. I appreciate that color. And just last one for me. Once again, congrats on the most recent contract. Maybe you could talk a little bit about the interest that you're seeing -- it's also geographically, where you guys expect to see a bit of interest there or the next few contracts? Thanks for taking the questions..

You mean next contract?.

Yes, looking forward..

Once we decided then we announced. This is the next 6-K. I would say that there is a kind of craze between few of the players that we're trying to engage in future. Who is going to sign first? I'm kidding.

But, seriously speaking, I think that once we have more clarity on the next agreement then we know what to tell and when it's going to be implemented. But right now, as you can imagine and see, we are getting more and more attraction to the two future deals that are to be signed. And as we speak there are a lot in the process and the pipeline. Got it.

Good to hear. I appreciate it, guys, Thank you..

Thank you. And we have a follow-up from Jeffrey Cohen with Ladenburg Thalmann. Your line is open..

Thanks again for taking the question. So, I wondered on the regulatory front outside the U.S.

for the multi-source, is there any update or any progress on timing with regard to our CE and other territories?.

No, that's -- nothing due in this respect. We will be working on the [Indiscernible] (ph) and simultaneously with the FDA.

Once -- as you can imagine since we work on a global basis, not everywhere we need FDA or [Indiscernible] Some countries will require local, so we -- generally speaking, we work on a global basis to get the FDA and the [Indiscernible] and others, but at the same time we're going to implement the deploying.

In other countries ' works not necessarily, we will require to these specific regulatory approvals..

Okay. Perfect. Thanks again..

Thank you and I am showing no other questions in queue. I'd like to turn the call back to Erez Meltzer for closing comments..

So, thanks for the support and for participating in this call. We'll further discuss this run we're seeing and we'll probably have more discussions either on what went on or others that will come in the near future. Feel free to get in touch with Michael or with either one of us to further and thank you so for being part of today's call..

Thank you all..

This concludes today's conference call. Thank you for participating. You may now disconnect..