NANO-X IMAGING LTD

Greetings, and welcome to the Nanox Imaging Limited fourth quarter and full year 2020 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce Bob Yedit of LifeSci Advisors. Thank you. You may begin.

Thank you, Daryl, and thanks to everyone for joining the NANOX Imaging for the 2020 conference call. On the call today, we will hear from Rand Polyakin, Chairman of the Board of Directors and Chief Executive Officer, and Yitzhak Manyan, Chief Financial Officer. Before we begin, I'd like to remind everyone that management's remarks today may contain 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 and 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 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 non-GAAP to GAAP measures is provided with our press release, with the primary differences being stock-based compensation and class action-related expenses. With those prepared remarks, it's my pleasure to turn the call over to NANAC's chairman and CEO, Ran Polyakin. Ran?

Hey, hello. Thank you very much, Bob, and thank you, everyone, for joining our fourth quarter update call. As Bob mentioned, also joining me on this call this morning is Rakhmayan, our CFO. So, you know, we had a very exciting Q4 session our first quarter of the year, and we would like to share with you some of the outcome. Before I will dig down into the details, I would like to cover numerous number of things that we successfully accomplished in this quarter, which I think will give you a little bit of the feeling of the activity that is going on in the company. So first and foremost, we successfully demonstrated the NanoSoc system at the RSNA 2020 meeting. That was a huge milestone for the company as we demonstrated the technology, the system, and also got two radiologists from the U.S. to vet those images, and we'll touch upon it in a minute. We also further invested in Korea. As you well know, Korea is a major part of our supply chain, and during the last quarter, we invested a lot, a lot in human resources investment and actually a lot of work, basically making sure that our supply chain is in line with our plans, which are basically starting to ship products. Still with this year, we talked about 1,000 units that will get into Q1 of 2022. To do that, we rented an interim manufacturing facility in Korea for MEMS production. We invested a lot of capital into expenditure for the advance of semiconductor manufacturing equipment. And we even purchased the land, which will be the major site for nano-oxygen in the Far East. We purchased the land that will be our permanent establishment for the MEMS chief facility, as well as other R&D mentors. All of that in South Korea. The next point that we did and we accomplished in this quarter is really we added to the senior leadership team a new COO, CTO, and CMO. All of them came to guide the company expansion and execution plan to build out our team so that we can deliver on the promise. We expanded our technology collaboration by signing agreement with Umbra Health to facilitate the transfer of our files through Umbra Health's platform into medical hospitals and medical imaging providers in the U.S. That's something that is very much tuned to setting our operation in the U.S. to work. We added two additional strong board members. One of them is Dan Zuskin. He used to be a former CFO of Teva Pharmaceutical. Actually, for 25 years, he even served on the board as a board member there. And the second one is Noga Kainan. who is very known in Israel to be the head of the CFO Forum for Israel, both extremely experienced in publicly traded companies. I think this is the next one is the news that everybody wanted me to say. So, indeed, we submitted a comprehensive response to the U.S. Food and Drug Administration, the FDA, which none of us believe addresses the agency's outstanding questions on the company's 510K submission proposal. seeking USA regulatory clearance of its single source Nano-X ARC. Nano-X expect that it can obtain US regulatory clearance of this single source quite soon. And the last one I think that you all pretty much was publicly shown. We completed a successful offering of 3.1 million shares by certain non-director, non-officer selling pre-IPO shareholders. So that's kind of the highlight of how exciting this quarter was. And I will get into details in a minute, but just before then, allow me for an additional couple of minutes just to remind for those of you that are not following the company on a daily basis, just to kind of set the ground. So what we have developed is proprietary imaging technology based on novel digital MEMS semiconductor cathode. we believe that we can achieve the same functionality as a legacy X-ray system, analog cathode, while allowing for lower-cost production than existing medical imaging systems. So this is really our trick. Now, the NanoSarc, the product, is a 3D tomosynthesis full-body imaging system, generated high-resolution 3D X-ray images that reconstruct the human body or images' specific body parts, and can be read by medical professionals. So it's a multipurpose device, the NanoX ARC. This is a very important point. Attached to the ARC, we have the NanoX Cloud, which is a software piece which is now in prototype stage, and those images that we took from the NanoX ARC can be sent to the cloud where it can be viewed, stored, matched with radiologists, reviewed using diagnostic AI, and sent for billing and reporting. So that's the other side of the system. So we have the NanoX Arc and then the NanoX Cloud. Again, very quickly, so just to make everybody familiar with what we do, our business model is very innovative. We call it MSAS, which is medical screening as a service, but really it's a SAS model, business model, that provides NanoX Arc at no or little cost to the healthcare provider, removing the large capital expenditure associated with traditional systems that is upfront or in-list payment. We are building a global network to deliver imaging availability. We have signed nine of those MSAS agreements for global deployment of over 5,000 units of our Nano-X Arc and additional 5,500 units through a strategic collaboration agreement. So again, business model is very novel. It's all due to the fact that we can reduce the cost dramatically and the connectivity through the cloud. Now, the next point that I want to, everybody knows, but still, I want to mention it, that we have today a very strong balance sheet. And, of course, our CFO will touch upon it. But it's important to know that we ended the year 2020 with $213 million, zero debt. And all of that is to fund continued development, manufacturing, and distribution of Donald Stark. Or, in other words, this is the money we need for execution of our plan, and we're clearly going to use it for that. The next point is that we're continuing to build a coalition of strong business partners. So just to mention, you know, SK Telecom and Fuji and Foxconn, all of those relationships are heavily being managed. We have a lot of initiatives there, and it all comes together to an integrated solution that we hope we can achieve very soon. So that's kind of, again, going back to the beginning, what is Nano-X and what we're here to do. And with that in mind, I would like to start and give you a little bit more color on the different activities. So let's start with the RSNA demonstration. So we successfully demonstrated our Nano-X Arc next-generation X-ray prototype at the 2020 Radiology Society of North America. It was virtual this year. annual meeting. People know this as RSNA. We made a live demonstration which was viewed by a global audience of thousands, featured a range of 2D and 3D images procedures using our groundbreaking digital X-ray tube in a unique multi-source array structure. I would like to review a few highlights from the demonstration which featured analysis and commentary by two US-based radiologists of images generated by the NANOSARC as compared with images generated by legacy source. So in other words, we demonstrated the systems with technology, but not only the technology, we also brought on board two radiologists from the US to give the validation there. In the first demonstration, a single source 2D images to the image of my hand, my physical hand was captured. The radiologist noted that the NanoSARC-based image provided excellent image quality, even smaller details with good contrast between bone and soft tissues. They were quite impressed. And by the way, this movie of this demonstration is available on our website, so everybody that wants to see it is there. In the second demonstration, a multi-source NanoSARC employing multiple tubes was used to capture a 3D tomosynthesis of a phantom hand. The image was compared to a conventional 2D x-ray taken the day before at a nearby hospital. The radiologists were impressed with the high resolution of NanoXARC image and were able to see things on that image that were not able to see on a 2D study. Furthermore, with its overlapping images and angles, the multi-source nanoXARC generated 3D tomosynthesis images allows radiologists to address the problem of overlapping biomass that often obscure their ability to make accurate diagnosis using a conventional 2D image. Similarly, a comparison of images of the phantom chest allowed the radiologists to determine that what appeared to be lung nodules in the lateral 2D X-ray image were actually blood vessels, as determined by the 3D tomosynthesis generated by the NanoxARC. Additionally, actual lung nodules not seen on the X-ray were detected by the 3D tomo of NanoxARC. In actual clinical practice, the discovery of lung nodules typically results in an early intervention such as lung biopsy, which if determined to be malignant, could have significant increasing the patient chance of successful medical outcome and prolonging survival. So this is a key point that we demonstrated. This is our vision for the NanosARC and the NanosCloud, which it's reduced the complexity and lower cost compared to a legacy X-ray systems. We aim to deploy thousands of these machines around the world, providing access to imaging to roughly two-thirds of the world population that either have limited or no access to any images today or experience very long wait times. Our goal is not to compete with established industry players, but rather to expand the overall market with an innovation approach suitable for mass deployment to smaller healthcare facilities, including urgent care centers, outpatient clinics, and rural areas in both developed and developing countries. As we have said before, currently there is significant misopportunity since access to medical imaging allows for early detection of serious disease, such as cancer and cardiovascular disease, when they are more treatable. Early detection has the potential to drive improved patient outcome and reduce cost to healthcare systems around the world. A replay of the RSNA demonstration is included as part of the investor webinar that we hosted immediately after the RSNA and is available on the investor section of our website. I encourage all interested parties to view it if you have not already done so. So that really summarizes the point of the RSNA. Again, a major milestone for the company. I'm very proud of the team that we put together this type of demonstration, which was very powerful and actually started a flood of interest and, I would say, credibility to the company that involved reaching out to the company from all over the world following this show. Now, I want to take a step back and talk about the unmet need. I want to take a step back, and for those who may be new to the story, I want to say that we founded Nanox to address a significant unmet need in medical imaging since there has been a lack of meaningful innovation in legacy analog X-ray technology since its invention more than 120 years ago. I and X-ray products are costly and complex. resulting in machines that are very expensive to purchase, maintain, and require a large footprint. In short, these machines are too costly and too complex for mass global deployment, despite the fact that everybody realized the power of medical imaging in modern healthcare. We developed a novel x-ray source based on digital MEM system. It's based on semiconductors. It's a nano system, actually, on a chip. that took years to develop. At scale, this can be produced at a significant lower cost than analog estuary cathode. We believe our device, the NanoXARC, has the potential to revolutionize the global availability of medical imaging. Another key advantage of NanoXARC, in addition to its size and cost, will be its seamless integration with the NanoCloud, our cloud-based platform that seamlessly integrates connects through an API, NanoX Arc, with a medical professional who reviews and interprets the images, regardless of where they are located. And that's very, it's a key point to the audience because the ability to disconnect between the patient and the diagnostic is key today, especially after what happened in the last year with COVID-19, et cetera. Everybody realized that what's happening in Africa is very relevant to New York City and vice versa. And for that reason, The Nanos Cloud is answering or giving the capabilities of uploading a scan from one area in the world and getting it diagnosed in a totally different area. And that's a very key point of the Nanos overall offering. The Nanos Cloud will provide hospitals and physicians with a faster access to critical information, and we believe the Nanos Cloud will be an important part of our value proposition. Going back to the first quarter development, I just want to turn now into the recent development of the company since our last quarterly report. I covered in high level. Now I'm going to go a little bit more in detail. In January, we announced an extension of our strategic collaboration with USA RAD Holdings, a U.S. joint commission accredited teleradiology and telemedicine company. to launch an advanced radiology diagnostic service. The service combines over 300 expert radiologists and over 20 FDA-cleared, 510K-cleared artificial intelligence algorithms to support the medical diagnostic industry. We plan to use the X-ray-based algorithm, including 2D and 3D tomosynthesis, to provide analysis of large data sets combined with expert radiologists' interpretation through a unique proprietary workflow. Once operational, the NanoSoc system is cleared by the FDA. This AI-based second opinion service will be an integral part of nano service offering. And that's a key, key point because it's not only that we're going to provide the images, but the diagnostic and the assistance of third-party AI companies is something that is, again, it's a key in the new era of healthcare. Recall that in February of last year, we announced a strategic collaboration with USA Radiology to deploy 3,000 nanoSARC units across the U.S. subject to regulatory approval. This new venture strengthened our partnership while allowing us to jointly offer the latest in emerging AI technologies to our customers. So, again, this is a key, key development in what happened in the Q4. And we all look forward for a very successful integration of this second opinion platform into our overall offering. The next point is Umbra Health. So I'm sure that most of you know about Umbra. And again, during the fourth quarter, we announced an agreement with Umbra Health, the leading medical data and image management cloud software company, to facilitate the transfer of medical images between U.S. hospitals and medical images provider. In the U.S., Umbra will serve is an enterprise image exchange solution integrated with a planned NanoX Arc system deployment via the NanoX cloud infrastructure. The AMBRA suite consolidates multiple imaging systems into the cloud storage platform that lets medical imaging be accessed securely anytime, anywhere. Leading facilities use AMBRA to connect directly to multiple modalities, and imaging systems, creating a unified source of imaging data that is accessible to providers and patients. AMBRA is an ideal partner for NanoX, as their solution perfectly complements NanoX Arc and NanoX Cloud. The AMBRA network is vast. It includes seven of the top ten hospitals in the U.S. and six of the top ten children's hospitals. The network manages over 8 billion images, and it is utilized in over 50 countries. So again, this is the major development for the company. This is how we're setting up ourselves to actually execute on the value of accessibility. And AMBRA is a perfect partner for that. The next point that I touched upon before and I will touch upon it again is our Korean subsidiary. As many of you know, we manufacture the MEMSX chips at our facilities in Japan. In December, we established a Korean fully-owned subsidiary with support of SK Telecom and its affiliates company, SK Hynix. Now, for those of you that do not know, SK Group is the second or third largest company in Korea, and SK Hynix is one of the largest MEMS manufacturers in the world, so the help from them is very, very important. We got the help from them for the purpose of manufacturing our MEMS X-ray chips for the NanoX ARC, And indeed, we did get such a support for them. For 2021, we have secured an interim facility and are proceeding with tech transfer from our Japanese FAB and the purchase of capital equipment as we prepared to commence full-scale manufacturing later this year. We have also secured the land for a larger type of facility. It's a permanent chip facility. that we will build to collaborate in the collaboration with SK Hynix, which we anticipate will be operational during 2022. So that's really our long-term plan. And again, for the audience, as you know, NanoXID, we're going on a marathon here. If we are right in our thesis, we're going to change healthcare in many, many ways. And for that, you need to build an infrastructure, and that's exactly what we're doing. And we're doing it now. day in and day out, including the next topic, which is, again, to expand our leadership team. So in terms of leadership team, we announced several key hires since our last update. We announced the addition of Jim Dera as Chief Operating Officer, Ofer Korem as Chief Technology Officer, and Tamar Aron as Chief Marketing Officer. As we advanced along the U.S. regulatory path and worked towards shipping 1,000 commercial units by the end of the first quarter of 2022, having highly qualified individuals in these positions will be critical to further strengthening our operational capacity and preparing for continued business expansion. I'm pleased that Jim Ophir and Tamar have joined us at this important time for Nano-X, particularly as we ramp up manufacturing with our partners Foxconn and prepare for to transition to a commercial stage company. We also recently expanded our board of directors with the appointment of Dan Zuskind and Nogat Kainan, effective with our special general meeting of shareholders, which was held on February 9th. Dan serves as the chief financial officer of Teva Pharmaceutical from 1977 through 2008, and also served as director of Teva for various periods through 2018. Noga Kenan established a forum of owners, chairpersons, and CEOs of leading Israeli companies and also established the CFO Forum, which I referred to before, in 1997, which brings together leading Israeli CFOs. We welcome Dan and Noga to the board and look forward for their contributions. The next topic I want to touch upon is, of course, regulatory. I mean, we are all expecting the regulatory path to take place and that our units will be cleared so we can start and embark our execution plan in the U.S. and other countries. And at this point, I would like to provide a brief update on our U.S. regulatory approval process. Recall that in January 2020, we submitted the 510K application to the FDA under its third-party review program. For single source version of NanoXARC, in March 2020, we received a request for additional information from the third party reviewer, which we responded in September of 2020. We made an additional progress as the third party reviewer recommended the single source NanoXARC 2D system to the FDA for clearance in December. In late January of 2021, we received an additional information request from the FDA to which we have now submitted a complete and comprehensive response that we believe fully addresses the agency's remaining questions. Importantly, we are now in direct contact with the FDA in addition to the third-party reviewer, and we believe that the process towards 510 clearance will go smoothly from here. We continue to believe that we will receive FDA approval of both our single-source and multi-source device still within this year. If approved, we anticipate that the NanoSARC imaging procedure in the U.S. will be covered by existing radiology CPT reimbursement codes. Regarding the EU, we plan to submit the multi-source version on the NanoSARC CMR approval this year as well. At this point, I would like to turn the call over to Yitzhak to discuss the financials. Yitzhak, please.

Thank you very much, Ram. On our last conference call, which was our first as a public company, I went into great detail describing our MSAS paper scan-based business model. The significant upfront capital cost of acquiring an x-ray machine is a material obstacle for many healthcare facilities, particularly those that are smaller in rural areas or capital constraints. With the Nano-X Arc, however, we intend to ship and deploy units with no upfront cost to the facilities. We will be paid on a paper scan basis with certain minimum service fees stipulated in our standard contract with our service providers. This makes our technology more broadly attainable by healthcare facilities of all sizes while providing nanos with recurring and predictable long-term revenue. With our MSAS model together with our integrated AI image transfer capabilities, we are pioneering a new model and we expect the medical imaging industry to follow. Our MSAS model has clearly had a positive impact on our early sales efforts. As of today, we have executed contracts for the deployment of 5,150 systems with nine service providers in 13 countries, contingent upon regulatory approval, customer acceptance, and other factors. In addition, we have previously announced strategic collaboration with USA RAV for the deployment of 3,000 nanosauce machines in the U.S. during the next two years, as well as a multifaceted collaboration with SK Teleco that, among other things, call for the deployment of 2,500 nanosauce machines in South Korea and Vietnam. We are also in active negotiations in many additional countries suggesting that we are well positioned to achieve our primary goal of deploying 15,000 operational nano-clark units globally by the end of 2024. Now, turning to the financials. Non-GAAP net loss to ordinary shares for the fourth quarter of 2020 was $8.4 million, compared to the non-GAAP net loss of $2.8 million for the same period in 2019. A reconciliation between GAAP net loss and non-GAAP net loss for the three-month period end of December 31, 2020 and 2019 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 to ordinary shares is mainly due to share-based compensation and class action-related expenses. Non-GAAP research and development expenses for the fourth quarter 2020 were $2.1 million compared to $1.3 million for the comparable period in 2019, reflecting the increased development activities of our NANUC system. Non-GAAP marketing expenses for the fourth quarter 2020 were $1.6 million as comparable to $0.2 million for the comparative period in 2019 as we continue building our brand awareness and product marketing capabilities. Non-GAAP general administrative expenses for the fourth quarter of 2020 were $4.8 million as compared to $1.2 million for the comparative period in 2019 as we ramp up our investment in expanding our management team and the overall organizational infrastructure related with the company's IPO. Net cash used in operating activity during the fourth quarter were $13.3 million as compared to $3.5 million for the comparable period in 2019. As of December 31st, 2020, we had approximately 46.1 billion shares outstanding. We ended the fourth quarter of 2020 with cash and cash equivalent approximately $213.5 million, and no debt. We believe our current cash is sufficient to fully execute on our plan of manufacturing, shipping, and installing 16,000 system globally, which are targeting by the end of 2024, while continuing to expand our delivery capabilities and invest in our clinical and product roadmap. Before opening the call to questions, I would like to comment on the secondary offering of ordinary shares that we completed just a few weeks ago. As you may have seen, we priced the underwritten offering of approximately 3.1 billion ordinary shares by a certain selling shareholder. The company received no proceeds from this offering. A few points worth making. First, this was mostly long-term. long time story, pre-IPO shareholders, many of whom had been invested in the company since its founding more than eight years ago, looking for further portfolio diversification. Second, the selling shareholders and not the company were responsible for paying the underwriting fees associated with the offering, while the company was responsible for accounting, legal, and other costs. And third, and for us most importantly, Those same shareholders have agreed to enter into a new lockup for the remaining 845,000 shares for initial period of 90 days. And after that, they are restricted from selling more than one-third of the remaining position in each of their three subsequent 30-day periods for a total of 180 days with some selling restrictions. We see this as a sign of support and confidence that they would commit to this new restriction. And with that, we would like to open the call for questions. Operator, please start the Q&A session. Thank you.

We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press Star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the Star key. One moment, please, while we poll for your questions. Our first questions come from the line of Steve Halper with Cantor Fitzgerald. Please proceed with your questions.

Hi, good morning. So it sounds like I just want to confirm that you did send in the response to the last set of questions that you received in December of 2020. Is that correct?

That's absolutely correct.

Okay. So what is the window for the FDA response now for the single source? Is there a set time limit for them?

As far as we know, they should, given our call with the examiner, that should be within the next 30 days.

Okay. And so you've had direct communication with the examiner at this point?

Correct. Correct. We just clarified exactly.

Not just the third-party reviewer?

Correct. When we got the new letter, which was something we addressed, we decided to – to make sure that this time it's, we provide, we understand exactly, we provide exactly what the examiners want to see. So we conducted direct contact with the examiner at the FDA. We got the guidance, we got the clarification of what needs to be clarified. We worked hard to complete a very comprehensive answer that was submitted. That could take as long as 30 days. We hope, hopefully, we'll hear much before.

And then the other question is, can you just give us a timing update on the multi-source application?

Yeah, I mean, I think just to be cautious and, again, depending on, given the fact that we're depending on external laboratories, that it's very hard to predict their timeline, we're still in very good shape, we believe, to get clearance within this year, which means that we will need to submit in the coming weeks. I cannot confirm. I can confirm that from the company's point of view, we'll be ready. We are working with external laboratories for the different safety tests, et cetera, so that may shift a bit. But overall, we're still on the same timeline, which calls for clearance within this year and shipment of major amount of product still within this year. Thank you. Yeah, and moving into Q1 of 2022, that's another cautious move that we took, even though I think it was published on the Internet, Steve, you saw that we are in full production. I mean, we have three sites. We're producing products right now. So the products are in production and subject to regulatory clearance to be commercialized. That's it.

Great. And where are those products being produced? In Israel now?

Yeah, so again, as a mitigation for the for the corona situation, which do not allow us to travel much. We are working very closely with Foxconn. However, we also found a local partner that is making, as we speak, the first 1,000 units. And it's done in full transparency also to Foxconn.

Yeah. And does that change? That was a little bit of a change, obviously, due to COVID. But does that change the economics of those first devices?

No, I think we always envisioned that the first 100 units would be a bit more expensive than the target cost of between $10,000 to $15,000. However, for the 1,000 units or the 900 units, we are getting very close to the targeted price. That's our estimation.

Great. Thank you.

And the reason, Steve, is because the tubes and the semiconductors are coming from Korea and Japan. and the molded parts are coming from China. So basically what we're doing in Israel is integration and testing, which is not a big part of the overall machine.

Very helpful. Thank you.

Our next question has come from the line of Ravi Mizra with Berenberg. Please proceed with your questions.

Hi. Good morning, Ron and Zach. Thank you for taking the questions. So I guess I'm going to pass on the FDA questions for now. Leave those to others. But I want to talk a little bit about commercial prospects and some of the contract signings that you may be looking forward to doing. Just curious in terms of negotiations as they stand now, you know, when you came to market last year, you had announced a number of contracts with service providers in terms of, you know, commitments. But not really much since. Just curious, in terms of, you know, discussions or negotiations, number one, I mean, what kind of companies are you or what kind of kind of service providers are you speaking with? If you could give us some color around that. And then number two, do you think that kind of the next round of service providers are going to be more contingent on FDA or regulatory approval? Or what's the kind of thinking there around that? approval process as it pertains to the commercial process. Thanks.

Yeah, okay. Thank you, Ravi, and good morning. If you don't mind, I will take that, and you can add if you want. So I think what we are facing right now, we're trying to bridge the gap between our extreme success on the commercial side. I mean, before we had one product cleared, we managed to get – contracts for 5,150 units and additional 5,000 units as part of our strategic collaboration. Of course, everything is subject to regulatory approval at the designated country, but that's a huge achievement that we now need to live up to our promise. So the focus of the company right now is simply to make the products, get them through the approval process. We do receive a huge amount of inbound traffic from following the RSNA demonstration, and we're managing that, managing it slowly, because I think what we want to see, we want to see this year that we're clear that at least the U.S., Korea, and Israel, that's what we want to see. We want to find homes for thousands of, I'm sorry, for hundreds and thousands even of units still within this year or maximum end of first quarter of next year. We want to keep pushing the regulatory path with our existing contracts. So we are submitting the CE, and that will take some time. But we do have two contracts, very important, with key, key service providers in Italy and Spain. We also want to service other countries as we sign. So basically, I think right now my direction to the team is let's bridge the gap between the promise of the contract to actually be able to deliver. Let's focus on three territories that are key, which are U.S., Korea, and Israel, and continue to service the contracts we already signed and evaluate, as we speak, the other contracts that we are negotiating. I will not tell you what was not completed, but we are in negotiation with several service providers in different countries as we speak right now. The second source of commercial, I would say, development that I want you to be aware of is, of course, the OEM partners. As Yitzhak said before, I think, and me too, we are welcoming the big guys to really play with our technology and see how they can utilize it. And following the RSNA demonstration, when I believe the world actually seen the technology in action, we received a dramatic response. amount of new approaches that seems to be more serious from the top companies in the world. We're dealing with it and actually we're putting a team together to deal with it because it's a lot of work and of course in the future we would like to see our technology embedded within the systems of not only Nano-Sarc but also other big healthcare companies and to that end I think that we are building a good infrastructure of relationship and testing environment for those guys to get comfort and actually work with us very closely. So this is where we're at. I think 2021 is execution year, and we will see more commercial agreements, but what we need to show, I believe, is our ability to make those products in mass, deploy them, support the business model, and get our customers to be very happy, and that's what we're doing.

Great. Thanks for the detail. Maybe if I could just ask a follow-up on the partnerships that, you know, with the big guys, as you mentioned. Obviously, FDA approval is going to be contingent there, too.

But just ahead of that. No, no, it's not true. Ravi, it's not true.

No? Okay. So you could theoretically sign a partnership with before.

Oh, yeah. Oh, yeah, because it's a component. The FDA approved the system. Okay, so this partner of ours will need to clear the system as a whole, including our component anyways. So NanoSARC, just to clarify for the audience, I know you understand, but I want to clarify. We have a technology and we have a product. Our product is NanoSARC, and that's what needs to be, it's a full system that needs to be cleared by the FDA or the relevant regulatory authority. If, however, you collaborate like we did with Fujifilm, that was announced, and other companies that are coming now in line, you are actually providing your technology and it becomes their responsibility to clear the system. So it's not subject to FDA clearance to work with them.

Okay, thank you for the clarification.

Thank you. Our next question has come from the line of Suraj Kalia with Oppenheimer. Please proceed with your question.

Good morning, Ron. Can you hear me all right? Yes. Perfect. Hey, so Ron, congrats. I know Yola made a lot of progress. A bunch of questions from my side. What was the exact date of the single source submission that you believe starts the 30-day clock? I guess what I'm trying to understand is whether it's submitted mid-February, hence, you know, we are looking at another couple of weeks from now, or is it any guideposts you can provide?

Okay, so that's a good point. Actually, one of my team members clarified this to me. We had a management call just before this call, and my understanding is that it may be the date that we start the count may be the date that the letter was received. So in other words, we're looking at a couple of weeks, but to be conservative, I just answered 30 days just because I don't know for sure. It seems like The 30 days start from the letter we received rather than the submission. So that's why I gave you the 30 days. There are other views, but it's actually a couple of weeks from now. Got it.

Ron, the multi-source application, do you all intend to use a third party or go directly? I presume you're already preparing the multi-source application as we speak.

Yes. I think that... our team thinks right now that given the fact that we have this experience with a third party, we will submit the multi-source directly to the FDA in order to save some of the misunderstanding that obviously occurred in the single-source submission. I would tell you that talking directly and in communication with the third party, but directly to the examiner at the FDA helped us a lot to close the gaps of communication.

Are you all at liberty to talk about the predicate device for the multi-source?

I'm at liberty, but I don't want to do it right now because I think until we submit, my team is still looking at all the options and strategies.

Completely understood. Ron, the ten prototypes that you all had mentioned on the Q3 call for partner evaluation, Can you give us a status on that? Have they been shipped? Are your partners, your commercial partners already evaluating what's going on?

No. So, I mean, those 10 are becoming now 100. And actually, we're going to publish the new design for the system. It's just an industrial design that is a bit improved. I think it was leaked somehow already, so we're going to share with everybody the new design. We're building 100 of those. For those systems that we build, we are going through, I would say, two main activities. One is activity related to testing and compliance in order to submit perfect submission of the multi-source. And for that end, we need five systems, actually, or part of the systems. And the other systems are being used for the clinical validation. As you recall, we have what we call NanoX Atlas, which is basically the intended use or the ability to use our system, multi-source system, to meet multiple indications that are covered by CPT codes. So we have a group of cardiologists and clinicians that are working with the existing system we have and additional systems that we built actually in order to really create the recipe for different procedures. So all of the units that were produced so far are being used internally in order to complete the testing and the compliance to the different submissions. And remember, we have signed contracts for 13 countries, actually. So we have different submissions that we need to do. So a lot of work done there. And in parallel to the FDA submission, we envision that we're going to submit in many other countries, actually. And the second work is done by the clinician that are adding a new feature or new indication as they go to check different parts of the body and come up with a useful recipe for those multi-source devices.

Got it. And final question, Ron, from my side. This Korean subsidiary that you mentioned this morning, that, and please correct me if I misunderstood this, that is wholly owned by Nanox, right? I thought this was supposed to be a JV with SKA Telecom. And a subpart of that question is how long will this, before this facility is validated, the tech transfer is complete, and also are the ceramic tubes going to be manufactured in this facility? Thank you for taking my questions.

Okay, great. So let me clarify. It's a fully-owned subsidiary of Nano-Ox. Nano-Ox has a philosophy, and that's why we invest tens of millions of dollars in Korea. Our philosophy is that the secret sauce, the heritage we got from Sony's days, always need to be manufactured at home. And at home means by facility and by employees that are all employed by Nano. So this is our secret sauce. We have many patents, but we have a lot of know-how that we want to keep close to our chest. And for that reason, we asked and we received a huge amount of support from SK Telecom but not to the level that they became a JV partner for the manufacturing of the core of this technology, which is a chip. So that's answering maybe the question of fully-owned subsidiary, yes, by Nano-X, and the support by SK is giving to us simply because they are very good shareholders and big shareholders in the company, and they have access to a lot of resources that can help us in setting up the manufacturing. However, when it's all done, it's Nano-X only. So that's the answer to that. And the reason for that is actually that we want to keep the nanotechnology on the cheap proprietary for Nano-X and without any leaking of information outside of the company. Because we believe this is very, this is the core value of the company, of technology. As to the tubes, currently we're working on the ceramic tube with two partners in Korea, but the intent is definitely to acquire some of the technology of the tube and make it in-house. I'll give you an example. The tube itself is a standard ceramic tube that you can buy from Toshiba or any other thing. The trick is how to put the cold cathode and the chip to stand this temperature and to manage the thermodynamic and all of this. This is know-how. This know-how we want to have within Nano-X, and sometimes we'll use partners for some of this technology. production. And overall, we believe that the know-how of the full know-how of the tube should also reside within Nano-X for flexibility reasons and IP. So initial batch of ceramic tubes are coming from partners in Korea. Later on, we have the flexibility to manufacture or to final assembly, to make the final assembly in our own permanent facilities.

Thank you. Our next question has come from the line of Rahul Rakit with LifeSite Capital. Please proceed with your questions.

Hey, Ron, it's Zach. Good morning. Thanks for taking the questions. I guess the first one for me, just kind of echoing on the South Korea facility, how long will it take to get that facility up and running?

So the construction work is done as we speak. So again, just to clarify, for 2021 shipment, which is 1,000 units, we are all set. We have secured, actually, everything we need in terms of chips and tubes and actually a metal part for the system. So for the 1,000 systems that we intend to make and ship this year or later, first quarter of next year, we're set. The permanent establishment is... is built in order with a view of supplying 2022 demand and being able to supply a huge amount of demand above and beyond the 15,000 units that we are planning to the first wave. Now, the land was bought. Construction is, I mean, design is done. Construction is already started. We believe that we will open the factory for ramp-up of production of the semiconductors by let's say early December of this year. And we'll have first quarter of next year ramp up production with the hope that from Q2 of next year, everything that comes in terms of chip will come from our permanent facility and slowly we'll move also the tubes to be the final assembly to be in our permanent facility. So timeline is in production, pre-production, Q2 of next year.

Got it. Okay. That makes sense. And then just the other one for me was kind of in terms of thinking about your work with some of the AI partners and Ombra with image sharing. Can you remind us where you are in terms of integrating those services with the NADOC system? Are you supplying them with, you know, phantom images to guide the API development? or do they need access to prototypes as well to kind of get that to a place where it can be commercially viable? Thank you.

Yeah, so I think, yeah, I think the, first of all, the integration will be through an API, so it's very simple. We have the platform working, and we define the API for every day, every one of the third-party partners other than Umbra that already defined their API. So with Umbra, the case is a bit different because they haven't installed their customer that is huge, and they have multi-modality image storage, archive, and sharing system. So with Umbra, they are providing us the API, and we connect to our system. And with all the others, we're providing them the API, and they are connecting. This integration is not yet done, and it's supposed to be simple, but not yet done. I would expect that it's not a big technical issue, and it should get done before we are... starting to ship our first systems in the Q4 of this year.

Got it. Okay. And I can actually just ask one more. Do you guys still expect to submit an application for CE Mark in the first half of this year? And just off of that, assuming you get clearance, would that be sufficient to pursue regulatory approval in any of your target ex-U.S. markets?

Yeah, well, I think we are absolutely going to submit the CE mark submission for our NanoXARC, I would say shortly after we submit the FDA. We took, we believe that this could be cleared this year. However, if you know what's going on in Europe, they have an issue with a new rule of the notifying body, so Everybody's talking about some delays, and that's why we're being very conservative. I will tell you that we're absolutely going to submit it quite soon, and we will expedite as much as we can control it, the response. The response could be as soon as Q3, but it could also delay to next year. We don't know that. Now, of course, for us it's important because we do have two major customers so far in the big lead list. of customers in Europe. So that's very important to us. I would tell you that from the company's point of view, we're absolutely going to submit and expedite everything so it will be within this year. We cannot control the timing of the notifying bodies. And I think following the COVID-19 and the new rule, we should be aware of that there may be some delays.

Got it. Okay. No, that's really helpful. I appreciate that. Well, Now, thanks again for taking the questions.

You're welcome. Thank you. Rejoining the queue is Steve Halper with Cantor Fitzgerald. Please proceed with your questions.

Hi, Yitzhak. I just wanted to confirm that the operating cash and the cash use in the quarter was $13.3 million. Is that correct?

Correct.

Okay. Thank you.

Thank you. There are no further questions at this time. I would like to turn the call back over to Ron Faliaki for any closing comments.

Thank you very much, and I really want to thank everybody for joining us today. We concluded our call this morning having now successfully demonstrated our technology in a range of medical imaging applications. We are very excited We are as excited as ever about the potential of the NanoXAR to fundamentally disrupt the imaging market. As I said, 2021 is a very important year for us as we seek to gain regulatory approvals and prepare to ship commercial units, and we look forward to keeping you updated on our progress. Thank you again, and have a good day. Thank you for your participation this morning.

This does conclude today's teleconference. You may disconnect your lines at this time. Have a great day.