Ladies and gentlemen, thank you for standing by and welcome to the Nano-X Imaging Q4 and Full Year 2021 Earnings Conference Call. [Operator Instructions] I would now like to turn the call over to Mike Cavanaugh, Investor Relations. You may begin..

Thank you. Good afternoon and thank you for joining us today. Earlier today, Nano-X Imaging Limited released financial results for the full year and quarter ended December 31, 2021. 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 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 and 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 on 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 stock-based compensation and class action-related expenses. I would now like to turn the call over to Nanox’s CEO, Erez Meltzer..

Thank you, Mike and thank you all for joining the call today. As most of you know, I assumed my role as CEO on January 1 as what I considered to be a pivotal time in Nanox development trajectory. We have made several advancements since our last earnings call. We look forward to sharing some exciting developments with you today.

I will give an overview of our achievements since our last earnings call as well as share our outlook on the year ahead. Before turning the call over to Ran Daniel, our CFO, to review our financial results, we will then open the call up to questions.

I would like to start by providing an update on our regulatory and commercialization progress as it pertains to our conversations with the FDA around the Nanox.ARC system. We announced last quarter that we would be reviewing a feedback from the FDA pertaining to our first submission relating to our multi-source Nanox.ARC.

In January of this year, after a careful review of the FDA’s feedback on our first submission, we filed a pre-submission towards an additional 510(k) application for the second version of Nanox.ARC, our high-performance, multi-source system via the agency Q-Submission program.

We are in continuous communication with the FDA and believe that this route will be the most expeditious pathway to further FDA feedback, which will be followed by formal submission.

We expect that the Q-Submission will lead to thoughtful improvements to the Nanox.ARC and they have been cleared by the FDA, the system will be suitable for development later this year.

We have made considerable headway towards commercialization over the past year and our team remains committed to deployment of the Nanox.ARC units and is focused on execution in the months ahead.

We are pleased to report that we have begun generating revenues, in large part, due to our three previously announced strategic transactions, the combination of which create a path to streamline commercialization.

Combined with our patented X-ray technology, the acquisitions of Zebra Medical Vision, now Nanox.AI, a deep learning machine analytics company and MDW LLC, a decentralized marketplace connecting imaging facilities with our geologists and USARAD Holdings, Inc., a leading provider of teleradiology services, we are well on the path to provide more acceptable and affordable healthcare.

And we believe that integrating AI powered imaging analysis and global teleradiology solution with our Nanox.ARC technology, takes us one step closer to creating the global streamlined medical imaging continuum from image capture through analysis to intervention by trained radiologists.

Under one umbrella, we now have potential capabilities to significantly improve access to reduce cost and enhance efficiency, which could increase the chances of early detection as well as patient access to care in a meaningful manner.

We are pleased with our ongoing integration of the companies we acquired at the end of 2021 and have taken a number of cost reduction measures in order to streamline operations and benefit from synergies. As these companies begin to contribute to Nanox top line, we believe they will enhance the services provided by a Nanox system.

We intend to explore collaborations for additional solutions and wide array of product offering.

In December 2021, we were excited to announce that USARAD was rectified with the Joint Commission’s Gold Seal of Approval, which reflects the high standards that USARAD has maintained since its inception, by leading the quality standards of most widely recognized medical credentialing program in the country.

Furthermore, I am pleased to share that we have strengthened the leadership team of Nanox.AI. Effective March 1, 2022, we appointed Pini Ben Elazar as General Manager of Nanox.AI. Mr.

Ben Elazar brings 20 years of strategic and commercial expertise in the healthcare industry that is uniquely equipped to help drive the integration of Nanox collective roadmap and vision. Having served on the Board of Zebra Medical Vision since its inception, Mr. Ben Elazar understands the joint vision and mission of the merged company. Mr.

Ben Elazar was one of the architects of Zebra Clalit Health Services. Clalit is the largest health maintenance organization in Israel. It is the second largest HMO in the world, strategic collaboration. Mr. Ben Elazar previously also served as CEO of Mor Research Applications, a technology transfer organization of Clalit.

We are confident that he has the vision and the expertise to help drive Nanox.AI into the global market. I would like to also highlight a few other achievements since our last report.

In January 2022, we announced that the American Medical Association issued a new Category 3 Current Procedural Terminology, CPT code, for quantitative CPT issues capitalizations, enabling potentially broader years of Nanox.AI help cardiac calcium scoring, our FDA-cleared AI-enabled cardiac imaging solution that detects coronary artery calcium, CAC for patients in the U.S.

The code will become effective on July 1, 2022. We consider this important validation of our technology and a key step towards advanced detection and treatment of cardiovascular disease. We believe focusing on reimbursement of our technology, where it results in further interest and demand for the Nanox system.

I would like to announce another agreement that has recently been signed for Nanox.AI. Earlier this month, Nanox.AI entered into an agreement with a large integrated healthcare organization based in the U.S. that provides caring coverage with the potential to create a more equitable model of health and wellness.

Under this agreement, the healthcare organization will deploy the Nanox.AI-enabled software designed to promote increased early detection of risk for cardiovascular diseases and osteoporosis in chest, computerizing tomography, CT scans.

We believe that the partnership between Nanox.AI and the integrated healthcare organization will enable physicians to efficiently identify many previously under adapted patients who maybe at risk for cardiovascular diseases and/or osteoporosis, which could improve individual patient’s lives as well as having broader implications for population health and management of chronic diseases.

Implementation will begin immediately and the tools are expected to be rolled out to hospitals within the organization’s network of hospitals in the coming months. As for Nanox.ARC, as previously reported, we have signed 11 MSaaS agreement for global deployment of 6,500 units of Nanox.ARC multi-source system.

These agreements are for different territories, including Africa, Central America and Europe and the system will be deployed in such markets according to the local regulation subject to requisite clearance in each market.

Since the beginning of the year, we have made significant progress in materializing our vision both within the company and outside of it. We have been focused mainly on establishing our production capabilities towards the deployment of Nanox.ARC system later this year, establishing new partnerships and enhancing our regulatory path.

Our assembly efforts are primarily conducted at our [indiscernible] facility in Israel. Since the beginning of the year, we have been improving our production line capabilities and establishing an operational assembly line to enable the expected ramp up in production and preparation for shipments of the Nanox.ARC system later this year.

Operationally, our technology transfer to Nanox’ wholly-owned Korean subsidiary to enable production of the silicon MEMs chip has been completed. This is an integral piece of the Nanox digital X-ray stores. And with the launch of the production and the facility now underway, we anticipate being in full production by midyear 2022.

The key initiative is especially important given the current supply chain shortages for chips worldwide. We believe this will help to secure a stable supply of chips that we need for the production of the Nanox.ARC, while ensuring the quality of our chips for us and the healthcare professionals who will use our Nanox.ARC systems.

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

Thank you, Erez. We reported a GAAP net loss for the full year of 2021 of $61 million compared with a net loss of $43 million for 2020. We reported a GAAP net loss for the fourth quarter of 2021 of $22 million compared to a net loss of $19 million for the same period in 2020.

Our revenue for the year ended on December 31, 2021, and for the fourth quarter of 2021, was $1.3 million. And our gross loss was $1.5 million.

Our revenue stems from the sales of radiology services and AI solutions, resulting from the acquisitions of Nanox.AI, USARAD and the Nanox marketplace platform, which we closed during the fourth quarter of 2021. And in fact, those revenue represent 2 months of operations.

Of such revenue, our revenue from radiology services for the same period was $1 million, with a gross profit of $0.0 million on a GAAP basis and a gross profit of $0.4 million on a non-GAAP basis, which represents a gross profit margin of approximately 40%.

In addition, our revenue from licensing of AI applications for the same period of – was $0.3 million, with a gross loss of $1.5 million on a GAAP basis and a $0.2 million on a non-GAAP basis. Research and development expenses for the year ended on December 31, 2021, were $17.1 million compared to $9.2 million in 2020.

Research and development expenses for the fourth quarter of 2021 were $6.5 million as compared to $3.0 million for the same period in 2020.

The increase in our research and development expenses was mainly due to the merger with Nanox.AI, the development of our multi-source and cloud systems, increase in our R&D headcount, share-based compensation and costs related to the ongoing regulatory approval process.

Sales and marketing expenses for the year ended on December 31, 2021, were $7.0 million as compared to $12.4 million in 2020, while marketing expenses for the fourth quarter of 2021 were $1.9 million as compared to $8.0 million for the same period in 2020. The decrease was mainly due to the decrease in share-based compensation.

General and administrative expenses for the year ended on December 31, 2021, were $34.7 million as compared to $22.3 million in 2020. General and administrative expenses for the fourth quarter of 2021 were $10.9 million compared to $8.9 million for the same period in 2020.

The increase was duly largely to the mergers with Nanox.AI, the acquisitions of USARAD and the assets of MDW.

The increase our labor cost, due to an increase in our headcount in connection with the expansion of the company’s management team and the overall organization infrastructure, and increasing our legal fees in connection with the SEC, probe and class action litigation.

Non-GAAP net loss applicable to the ordinary shares for the year ended on December 31, 2021, was $39.2 million compared to $18.9 million in 2020. The non-GAAP net loss for the fourth quarter of 2021 was $15.0 million compared to a non-GAAP net loss of $8.4 million for the same period in 2020.

A reconciliation between our GAAP net loss and our non-GAAP net loss for the full year and the fourth quarters of 2021 and 2020 is provided in the financial results that are part of the press release that we have issued this morning.

The difference between GAAP and non-GAAP net loss is mainly due to the amortization of intangible assets, shared base compensation, fees related to our secondary offering, which was closed during the first quarter of 2021 and legal fees in connection with the SEC probe and the class action litigation. Turning to our balance sheet.

As of December 31, 2021, our cash equivalents and marketable securities were $156.6 million. And we had $3.8 million in loans from banks. We ended the year with planned property equipment net of $37.4 million.

The increase of $23.4 million during the year of 2021 is mainly due to the completion of the construction of our fabrication facility in South Korea. We also ended the year with intangible assets of $160.1 million as opposed to none at the end of 2020. The increase is due to the merger with Nanox.AI, the acquisitions of USARAD and the assets of MDW.

As of December 31, 2021 we had approximately 51.8 million shares outstanding compared to 46.1 million shares outstanding as of December 31, 2020. The increase was mainly due to the issuance of shares in connection with the three acquisitions that we have completed during the fourth quarter of 2021. With that, I will hand the call back over to Erez..

Thank you for the financial update, Ran. I was delighted to assume the role of CEO for this exciting company, and I’m pleased to have so much positive news to report in my first earnings call as Nanox leader. We thank you for joining us today, and as always, appreciate your continued support. We will now open the call for questions.

Operator, please begin the Q&A session..

[Operator Instructions] Our first question comes from Suraj Kalia with Oppenheimer..

Good morning, good afternoon. Erez, Ran, hope everyone is safe and healthy..

Yes, we are..

So Erez, historically, Q-Subs usually yield the pathway by – at least by guidelines by around 75 days. And by our calculation, you’ll are rough – somewhere around 77.

Maybe if you could give us some additional color on the type of communications? If you’ve had any written feedback? And specifically, as we stand today, what is your update expectation on approval or clearance for the multisource?.

Okay. Thanks, Suraj. The – first of all, with respect to the 75 days, when we decided a few months ago to go through the Q-Sub pathway, we, indeed, thought that it will be 75 days before they get a response to us.

Having said that, I think it took us – it took them about 4 to 5 weeks to respond, schedule a meeting, and we had already a few discussions with them over time. The one thing that I said over a few times that the decision to go to a continuous dialogue with the FDA has proven to be the right one. We are talking to them quite a lot.

So it’s not only waiting Q-Sub waiting for the answers, a respond, etcetera. The Q-Sub that we have made was based on the indications, all the comments that they have in the past when we initially sent the submission for the multi-source, they send us a lot of comments. In the Q-Sub, we have already fixed all their comments.

It seems that right now, from their point of view, especially due to the fact that it’s a new technology. It seems that they are now internalizing what we are trying to do. And the decision last time was that they gave us a few guidance – guidelines what to do and for supplement information as part of the Q-Sub.

So this is – this will be – and I don’t think that – I don’t expect that they had 75 days, but I don’t expect that this will take the 75 days. They will probably respond at least based on the notion of the calls that we had that will respond earlier.

Having said that, right now, we hope for the good, but we can’t estimate exactly what will be the time. But the one thing I would reiterate the fact that, first of all, we are making a lot of progress in this area and the fact that we have decided to go to a continuous dialogue proven to be the right one..

Erez, has the discussion come up for a de novo 510(k)?.

Can you please say it again? I couldn’t hear..

Sorry, Erez.

What I was asking is, do you think there is a chance that the FDA might want you all to go down a de novo pathway?.

Right now, the answer is no. And we are not going into the details, but it seems that it’s not going to be this way. It’s going to be – I would say it’s not going to be identified as such..

Okay. Erez, one quick one for you, and Ran, I will throw in one for you also. Erez, what are the yields now on the MEMS chips with this technology transfer to your Korean partners, because if memory serves me right, in Japan, the yields were roughly around 50%. So, I am curious on that.

And Ran, if you could, what are the annualized revenue run rates and growth rates that we should assume for the Nanox.AI and the USARAD segments for FY ‘22?.

Okay. So, with respect to the – with respect to the Korean, since we have indicated that, in the very near future, we are going to go for the mass production. Once we started the mass production, we will know to indicate what’s the yield. Definitely, it’s better than it used to be in the past, of course.

But the mass production will be the one that will indicate where we are, okay.

With respect to Ran, would you like to address the…?.

Yes. So, you would expect the growth rate of – grossly of 50% growth of more than two lines that you have mentioned.

That was the question, correct?.

Right. And what is the – how should we think about the revenue run rate for the AI and the USARAD? Thanks..

Okay. So, about the revenue run rate of USARAD, you should expect for around $8 million to $9 million on an annual basis. And as for the AI section of the business, we should expect $3 million to $4 million a year as of now, based on the business right now. Correct..

Thank you..

Our next question comes from Jeffrey Cohen with Ladenburg Thalmann..

Hi Erez and Ran.

How are you?.

Good..

So, just for you a bunch of questions.

So firstly, what was the litigation expense in the fourth quarter?.

Are you referring to the SEC probe and the class action?.

Yes..

It’s actually mentioned in our non-GAAP adjustment between GAAP and non-GAAP. It was $455,000 for the quarter..

Okay. Got it. And I know that – we have heard about manufacturing and delivery.

So, any commitment on deliveries or units for 2022 from the company as far as production and/or deliveries?.

Right now, we don’t change anything with respect to what have been indicated. Right now, I would say that due to the fact that we have identified what are the long lead items in the – to be ready for the assembly. We have already ordered what is needed for the foreseeable future as we can say.

The other thing that we have indicated that in the first quarter our assembly line in the [indiscernible] will be ready for hundreds of machines on a quarterly basis. So, right now, that’s where we are..

Okay.

So, with the Korean facility up, you would anticipate next quarter that a few hundred could be produced by the end of this year?.

We haven’t disclosed yet, but I think that in the very near future, you will hear something about it, which will not be far away from what you anticipate, I believe..

Got it. Okay. And could you talk about this large integrated healthcare organization.

In the case of cardiovascular, is that – can you give us a sense of the number of lives covered by this organization, is it over 1 million, is it over 10 million?.

You mean the number of the subscribers?.

Just – I am trying to get a sense of the size of the integrated healthcare organization..

Okay. I would say that it’s among the top – I would say, top 30 in the U.S. I would even dare to say that it’s among the top 25. It’s pretty advance in the way they think about AI and future healthcare – providing healthcare. And it’s pretty sizable. We have also indicated that we are in continuous dialogue with a few others.

And at least one of them is even more sizable than the one that we have signed already..

Okay. Got it. And one more, if we could.

Could you give us a sense of initially, I don’t know what the initial period is, as far as ARC placements or system purchases? Any insight there into one over the other, or what we should anticipate for the coming year?.

We have indicated already that we have orders for the 6,500. None of which have been either canceled or so – it’s still what we currently have. And since we have already indicated that we repeatedly saying that the first country that we are going to install are countries with different regulation, that the FDA is not necessary.

Another regulation is necessary over there. And the indications that we currently have is the regulation that we will be required for the first part of the deployment, which obviously will be shortly announced will be – we will get it, again, once again in the very near future. I don’t have the exact date. But once we have it, we will announce it..

Okay. And one more if I may.

Was the resolution on the glass versus ceramic to manufacturing, or is it currently two sources on the manufacturing front for the tubes?.

Okay. So, right now, we are really working on a very wide range of solutions, okay? And I am not talking about one or two suppliers, I am talking about four or five suppliers that we are currently exploring. One or two of them is exploring this ceramic solution, and one or two of them are exploring glass solutions. And right now, we are doing both.

The decision on which one we actually focus will probably be in the next few months once we get the yields, once we get the power and once we pass the FDA as well..

Okay.

And can you give us a sense of which one was filed with the FDA queue?.

We don’t disclose it. But I think that shortly, it will be disclosed..

Okay. Perfect. Thanks for taking the questions..

Thank you..

Thank you..

And I am not showing any further questions at the time. I would like to turn the call back to Erez for any final remarks..

Okay. So, thank you all for being with us today. We are – really appreciate the support – the continued support in the company and its future.

It’s interesting that the ecosystem that we are building, with the combination of the Nanox.ARC, with other equipment that will be joined this in the future and will be reading by teleradiology provided by USARAD and MDW.

And of course, the layer that we are adding with the AI is that definitely something that we see when we talk to customers and to potential players and to partners that it’s something that resonates quite well, to say the least. And we hope that it will be fulfilled in the very near future, and will generate the expected outcome for the company.

Thanks once again and we will talk soon..

Ladies and gentlemen, this does conclude today’s presentation. You may now disconnect and have a wonderful day..