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spk07: Thank you for standing by. This is the conference operator. Welcome to the Nano-X Imaging second quarter 2021 earnings call. As a reminder, all participants are in listen-only mode and the conference is being recorded. After the presentation, there will be an opportunity to ask questions. To join the question queue, you may press star then one on your telephone keypad. Should you need assistance during the conference call, you may signal an operator by pressing star and zero. I would now like to turn the conference over to Bob Yedid of Investor Relations. Please go ahead.
spk10: Thank you, Operator, and thanks to everyone for joining the NANOX Imaging Second Quarter 2021 Conference Call. On today's call, we will hear from Rand Polyakin, Chairman of the Board and Chief Executive Officer, and Yitzhak Mayan, Chief Financial Officer. Before we begin, I'd like to remind everyone that management's remarks today contain forward-looking statements regarding the company's financial results, proposed acquisitions, 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 upon as representing the company's views as of any subsequent date. Factors that may cause such a difference include but are not limited to those described in the company's filings with the Securities 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. Completion of the proposed ZebraMed acquisition is subject to, among others, approval of the transaction by the equity holders of ZebraMed. The acquisition of USA RAD is subject to the completion of due diligence and to negotiations of a definitive agreement. The definitive agreement with USA RAD may not be entered into on terms or in the timeframe currently contemplated. Both acquisitions are subject to satisfaction of the conditions to closing in the definitive agreements, regulatory approvals, and other customary conditions. Therefore, neither of the proposed transactions may be consummated on a timely basis or at all. With those prepared remarks, it's my pleasure to turn the call over to NARC's Chairman and CEO, Bram Polviakon. Bram?
spk06: Thank you, Bob, and thank you, everyone, for joining our call this morning. Also joining me is Yitzhak Mayan, our Chief Financial Officer. After my preparatory remark, I will turn the call over to Yitzhak to review the financials before opening the call for questions. Well, during the second quarter and the following period, we made substantial progress toward our goal of democratizing medical imaging. As we've said many times before, roughly two-thirds of the world's population do not have meaningful access to medical imaging, and we believe expanded global access to medical imaging devices will lead to earlier detection of chronical condition. In order to fulfill our mission, we aim to tackle three significant worldwide challenges. The first one, of course, is global shortage of medical images devices. The second one is global shortage of radiologists to read these images. And the third one is lack of data connectivity between patients and physicians and lack of data crunching platforms. In the context of shortage of medical imaging devices, we have made significant progress in the production, signing more partners, and the regulatory pass. So concerning the first challenge, the NanoXARC production, we continue to make important progress toward building our global supply chain, including scaling up our semiconductor fabrication plant in South Korea as planned. We're also advancing as scheduled with our tube production using our two tube suppliers for the multi-source system in Italy and South Korea. Finally, our production assembly line in Israel is fully occupied integrating those chips and tubes into systems. Concerning the existing and new partners of EMSAS agreements, we recently signed an MSAS agreement with Eleno Pharma to deploy 1,000 Nano-SARC systems across Nigeria, a country with a population of over 200 million. This is our first entry into the West African market, where we aim to make medical imaging available to both public and private medical institutions. With this agreement, we now have contracts in place to deploy 6150 Nano-SARC So 6,150 NanoTAC units plus agreements with USA RAD and SK Telecom to deploy an additional 5,500 units across the U.S., Korea, and Vietnam, pending, of course, local regulatory approvals and passing user acceptance tests. We're in constant communication with our various MSAS partners around the globe. This includes ongoing webinar sessions held on a monthly basis. These webinars include virtual tours of our production sites, 3D tomosynthesis images review and analysis, system comprehensive review, and system technical support maintenance review as well. All of that being done toward the first deployment that's expected later on this year and early next year. The third one is regulatory pass. So let me just remind everybody that in April, we received FDA clearance for our single-source nanoXARC X-ray system, a critical achievement for our company, and an important reference point for our digital source. In the second quarter of 2021, we submitted to the FDA a 510K application for the first version of our multi-source nanoXARC, and this is in progress with the FDA as we speak. We're in preparation phase for CE submission and some other regulatory bodies in other countries expected to be submitted during the first half of 2022. In summary, the deployment of 15,000 units of Nano-SARC before the end of 2024 is our way of meeting the first challenge by increasing availability of medical imaging worldwide. So just to summarize this overall section, we made a huge leap forward addressing the first challenge of shortage of global medical imaging devices in terms of production, existing and new MSAS partners, and the regulatory path. Now let's talk about the second challenge, the global shortage of radiologists. And let me just explain, I mean when you have so many devices are propelled globally, the next gating item will be radiologists. In light of the global shortage of trained radiologists, which creates a significant bottleneck in the imaging process, we developed a way to connect our imaging device via the internet, securely upload the images to our NanoX cloud, and then to a third-party network of radiologists. Using AI-based technology, as a decision support software for radiologists to streamline and optimize the load of diagnosis. We are establishing an academic method, the NanoX Academy, to educate hundreds of radiologists and clinicians worldwide in a multiple segment to read and diagnose imaging from the NanoX Arc. I believe this can be achieved through two proposed acquisitions. The first one is USA RAD Holding Inc., and the second one is Zebra Medical Vision. Regarding USA RAD Holding Inc., USA RAD Holding operates a network of over 300 U.S.-certified radiologists across the United States who can read medical images remotely. We are already in partnership with them and have now signed a binding letter of intent for the acquisition of of USERAD Holding Inc. If consummated, it represents strategic opportunities for NANOX that is based on the following. Starting with the fact that USERAD is partially backed by Siemens HealthNear, which is significant. It will enhance our go-to-market strategy, potentially allowing us to place NANOX ARC into thousands of smaller US practices and provide this end-to-end globally connected medical imaging solution. Through the US-IRAD network, we will have direct access to relationships with hundreds of medical practices across multiple specialties. Additionally, this will provide us instant access to train radiologists, lower the barrier to US market entry and other countries around the globe. This will allow us to increase our share in the value chain by providing not only the upload of the image, but now the radiology services. USA-Rad is expected to play a significant role in NANOX Academy initiative. Under the USA-Rad letter of intent, NANOX intends to purchase all of the shares of USA-Rad and all of the assets of its affiliate company, Medical Diagnosis Web, or MDW. In terms of financial details, we expect to acquire U.S. ERAD for a total consideration of up to $27 million, comprised of $18 million of non-NOx shares and $9 million in cash. Of this total, $18.5 million in cash and shares is expected to be paid upon closing, and the remaining $18.5 million is expected to be paid in cash and shares based on the achievement of certain milestones. We also expect to acquire MDW for total consideration of up to $3 million in Anox shares. I'm also happy to announce that we've entered into an agreement to acquire Zebra Medical Vision, a deep learning medical imaging analytics company. If consummated, this will allow us to support our systems with highly advanced AI algorithms and bring to NanoX clinical regulatory and cloud deployment credibility. The strategic opportunities, if the acquisition is consummated, includes creating the next generation medical device with imaging AI solution, leading and shaping a new AI-enabled diagnosis space with hardware capabilities from NanoX and AI cloud delivery capabilities from Zebra, together with a proven regulatory and quality framework. Zebra is comprised principally of experts in AI applications and software engineers. Zebra uses a proprietary database of over 2 million images scans using machine and deep learning tools. It's analysis data in real time with human level accuracy. So radiologists can receive the assistance they need to manage their growing workload with precision, Some examples of Zebra capabilities include the fact that Zebra has dozens of patents, seven FDA-cleared products for radiology AI, and a CPT code for radiology. Zebra has some of the world's top healthcare institutes and customers, including Apollo India, Intermountain Health, Iramus, the UK and Scotland NHS, Albert Einstein Brazil, J&J, and many others. Zebra pricing is well aligned with NanoX per scan model and its goal of democratizing medical imaging. Adding Zebra capabilities will allow the combined companies to capture a larger share of the average $40 per scan included in our existing MSAS agreement. Touching now on a few financial details of the transaction, We expect to pay the shareholders and employees of Zebra up to $200 million in NanoX stocks for 100% of the shares capital of Zebra on a fully diluted basis. $100 million is expected to be payable by means of NanoX ordinary shares to be issued upon closing. $60 million in deferred consideration is expected to be payable by means of Nano-X ordinary shares to be issued upon signing of three new business contracts within six months of closing, and up to $84 million is expected to be payable by means of Nano-X ordinary shares to be issued upon achievement of certain milestones. Zebra is expected to operate as a wholly owned subsidiary under the Nano-X brand. The Nano-X shares are expected to be issued to Zebra U.S. ARAD and MDW shareholders are not expected to be registered and will be subject to restrictions on resale under the U.S. security laws. This is a full alignment with our goal to provide end-to-end medical imaging for all. If the combination of Zebra and U.S. ARAD with the company is completed, it has the potential to bring together the power of human radiologists, and advanced AI capabilities, helping us solve the second challenge, the challenge of shortage of radiologists. All of this actually leads us to the third challenge, lack of data connectivity between patients and physicians, a lack of sophisticated data analytics, and population health solution. Well, NanoX believes it can help solve this challenge. With our Nano-SARC system, and if our proposed transactions are consummated, we will have the radiologies of USA-Rad and the AI capabilities of Zebra. As such, we will be able to create a globally connected end-to-end radiology solution. Before turning the call over to Yitzhak to review the financials, I would like to provide an update on our leadership transition that we announced today. As we are preparing to scale globally, and integrate the new founded partnership, I have asked Erez Meltzer, who has served as director at Nanox for the last two years, to step forward and become our CEO. Erez is a world-class executive with tremendous amount of experience in scaling organizations to become global corporation. He was most recently the executive chairman of Hadassah University Hospital, and the chairman of Hadassit Medical Research Service and Development, in which he led a turnaround and the recovery plan. Erez served as an executive vice chairman and CEO of Gadot Chemical and Shipping Group. He was the CEO of Africa Israel LTD, a global holding company, and president and CEO of Netafim, the leading global agrotech company. Erez also led the largest ever IPO for an Israeli company, raising $1.3 billion in capital for AFI development on the LSE main list. We are greatly honored to have Erez join our team, and I'm sure that he has the executive experience and leadership skills to take NanoX forward to execute our expected deployment and beyond. I will continue as NANOC's executive chairman, focusing on long-term initiatives and future collaboration and fulfill our goal to provide a worldwide end-to-end medical imaging solution for everyone. We're also announcing today that Ron Daniel will replace Yitzhak Maayan, our chief financial officer, who will continue in his role until the end of September. I, along with the board and leadership team, would like to thank Yitzhak for his many contributions to get as to where we are today, including leading the organization through a very successful initial public offering last year. We are excited to welcome Ron Daniel, who will join us as of August 15. Mr. Daniel is a licensed and certified public accountant in both the United States and Israel, chartered financial analyst, and is admitted to practice law in the state of New York. With over 25 years of financial and business management experience, Mr. Daniel will be based in the USA, and we work to strengthen our U.S. presence and to leverage the relationship with investors and the overall market. At this point, I would like to turn the call over to Yitzhak to review the financials. Yitzhak?
spk04: Thank you, Ron, and just let me say that it has been a privilege working at Nanox and being a part of creating a vision aiming to change people's lives on a global scale. During the past two years, I believe we have built a solid foundation from which to drive future growth that Ron and the rest of the senior management team are very capable of driving forward. In addition, I have had the pleasure of working with Erez Meltzer as a member of the board of Nanox since late 2019 prior to the company's IPO, and I wish him well in his new role. Now, turning to the numbers, Nano-X reported a gap net loss applicable to ordinary shares for the second quarter of 2021 of $13.6 million compared to a net loss of $6.4 million for the comparable period in 2020. Non-gap net loss applicable to ordinary shares for the second quarter of 2021 was $8.6 million compared to a non-GAAP net loss of $2.9 million for the same period in 2020. A reconciliation between GAAP net loss and non-GAAP net loss for the three-month period ended on June 30, 2021 and 2022 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 secondary offering costs. Non-GAAP research and development expenses for the second quarter of 2021 were $3.4 million as compared to $1.5 million for the comparable period in 2020, reflecting the increased development activities of our NANOC system and the related regulatory costs. Non-GAAP marketing expenses for the second quarter of 2021 where $1 million is compared to $0.5 million for the comparable period in 2020, as we continue building our brand awareness and product marketing capabilities. Non-GAAP general and administrative expenses for the second quarter of 2021, where $4.1 million is compared to $0.9 million for the comparable period in 2020, as we ramped up our investment in expanding our management team and our global organizational infrastructure. For the six months ended June 30, 2021, Nano-X reported a gap net loss applicable to ordinary shares of $26.3 million compared to a net loss of $13.8 million for the comparable period in 2020. Non-gap net loss applicable to ordinary shares for the first half of 2021 was $15.7 million compared to non-gap net loss of $5.4 million for the same period in 2020. The difference between GAAP and non-GAAP net loss to ordinary shares is mainly due to share-based compensation and expenses related to the secondary share offering, which closed in the first quarter of 2021. Net cash used in operating activities during the first six months of 2021 was $11.7 million as compared to $4.7 million in the comparable period in 2020. As of June 30, 2021, we had approximately 47.8 million shares outstanding. We ended the second quarter of 2021 with cash, cash equivalents, and marketable securities in approximately $193.4 million and zero debt. For the quarter, cash users included funding our operating activities and investing $6.7 million in purchasing property and equipment, principally as we establish Memchis manufacturing capacity in Korea. And with that, we would like to open the call for questions. Operator, please start the Q&A session.
spk07: Thank you. We'll now begin the question and answer session. To join the question queue, press star, then one on your telephone keypad. If you're using a... Sorry, you'll hear a tone acknowledging your request. If you're using a speakerphone, please pick up your handset before pressing any keys. To withdraw your question, please press star then 2. Our first question is from Steve Halper with Cantor. Please go ahead.
spk08: A couple of questions. I appreciate the operational update. on the 15,000 units by 2024. Could you give us an update on the 1,000 units in 2022? And then my second question, can you give us a framework of the revenue and EBITDA contribution from the companies that you're acquiring?
spk06: Yes, sure. So, hi Steve. I will start with answering the first question and then Yitzhak will address the second one. So, we are on plan and we do have all the confidence that at least 1,000 units will be shipped during 2022. As we see things today, we have everything ready and we are getting the final integration VNV and of course waiting for the regulatory pass, but there is no reason for us to believe that we could not ship at least 1,000 units. As you know, we have at least 6,100 units booked by customers, so we should start to see a significant ramp-up as of 2022, and all as planned and reported before. Yitzhak, do you want to answer the second one?
spk04: Yeah, I will just say, Stephen, I will just say shortly, obviously we are not giving a distinct any kind of guidance on revenue, but I can tell you that our estimation, especially when it relates to Zebra, that it will move to profitability as it's ramping up into the population health product offering. It will reach profitability somewhere around 2023. This is one. The second one is it relates to U.S. ERAD. this acquisition and the performance of USRI currently is at cash neutral basis.
spk09: Thank you.
spk07: The next question is from Jeffrey Cohen with Leidenberg. Please go ahead.
spk01: Oh, hi, Ray. How are you?
spk06: Good. Excellent. Excellent. Very exciting day. Yeah.
spk01: So just a couple questions from our side, and I think I may have missed part of it. As far as the Zebra acquisition in totality, it sounds like 60-40 shares and cash. And could you just recap that with me and then also talk a little bit about the 100 milestones behind it? How many milestones are there, and are they related solely to sales numbers?
spk06: Yeah, well, first of all, maybe I misspoke. It's only shares, and it's divided to three tranches of shares. The first one is $100 million in ordinary shares of Nanox, and that's upon closing. And then there are three agreements, business development agreements, new ones, that will actually, if being signed, will account for an additional $16 million in ordinary shares, so all shares. And lastly, there is... maybe a group of seven different type of milestones that includes revenues, retention, et cetera, that if achieved, will be granting up to additional $84 million in Nano-X ordinary shares. And one point that is important, that will be done at the price at the time of the achievement. So the price will be relevant when achieved. So it's all...
spk04: shares based transaction I think that was pretty accurate maybe I can just you know just in terms of the milestone indeed there are about seven different milestones some of them related to attaining the business projection that came along with the acquisition obviously the other one is related to integrating the Zebra technology within the overall product offering at Nano-X, which makes it a very attractive acquisition from a performance standpoint for us.
spk01: Okay, got it. And then secondly, could you give us a little bit more color and update as far as the current manufacturing and its transfer to your South Korean temporary facility? and an update on the new facility in South Korea, and also an update perhaps on specific to manufacturing of the arc as far as production in tubes go.
spk06: Yes, absolutely. I will take this one. First of all, we are meeting all our timelines in terms of transferring the knowledge from Japan to Korea. As you recall, currently we have a semiconductor manufacturing facility in Japan that is providing a full solution for the chip. The production line right now is in Japan. As we scale up and toward the really big demand that we have, we've transferred the knowledge and the manufacturing line in two phases. The first one is when we put our equipment in a temporary manufacturing site in Korea, and that will be in charge of about half of the process. So half of it is in Korea, half in Japan. and this was a lot of work that was done in the last, I would say, six months, and this is done. So we can say that this capability of the combination of Japan-Korea temporary FAB with our equipment is done, and we're ready for prime time there, ahead of time, actually. The second initiative that we're doing, and there we're investing a lot of funds, actually, too, during this year. This is the new factory, and... This is also just developing on schedule, and we expect to finalize all the building and all the infrastructure there by the end of this year, starting to run some, I would say, pilot early next year and be in full operation, let's say, before the end of the first half of next year. It's important to say that this is a timeline, but also important to say that we have full capabilities and capabilities really scalable type of capabilities within the temp factory and Japan as we speak today. So this is not a concern at all. In terms of the tube making, we have two suppliers that completed basically the integration. And as you recall, we already demonstrated the 100 kV done from Italy. We've done that also in Korea. So both of those factories are integrated. invested a lot of efforts in I would say taking the prototypes into production and we feel that this is And we started to get tubes actually in Israel. We have the beautiful images From the new tubes in Israel when we integrate them into the system So overall we feel that also that is right on time and we feel that that there is no limitation there at all. We're edging in a way with two suppliers, one in Korea, one in Italy. Both of them are equipped to supply those tubes. One is ceramic, one is glass, but they demonstrated the ability within the Nano-X chip to have over 100 kV, which is what you need for the multi-source system. So this is the second part. On the assembly part, As you recall, given the COVID-19, we never really started the integration into the Foxconn facilities in Taiwan and China, and we mitigate this risk of people not being able to travel, especially engineers, by building a facility here in Israel in a place called Yad Binyamin, where we have our systems integration done, And I think the limitation there will be really making more than 1,000. So up to 1,000 units, we don't have any limitation there. And there we have a lot of activities related to V&V, what we call the validation and verification. As you know, every time we submit the FDA, it comes with a huge amount of external and internal documentation and testing that needs to be done. All of that is in place. We have systems that are already working and ready to be scaled up. And the only downside is that we may, for the first 100 units, we may be looking at a little bit higher cost than expected, simply because Israel is a little bit more expensive than Taiwan. As we clear with COVID-19, the transfer of knowledge will be done to Foxconn. And then when we ramp up mass production, I think it will be already meeting also our target cost.
spk01: Okay, got it. Ran, thank you very much. Yitzhak, thank you very much. And congrats on all the news in the quarter.
spk09: Thank you very much.
spk07: Our next question is from Siraj Khalia with Oppenheimer & Company. Please go ahead.
spk00: Good morning, everyone. Ran, can you hear me all right?
spk05: Yes.
spk00: Yes, Raj. Perfect. Perfect. So before I go on to my questions, Itzhak, it's been a pleasure working with you. We wish you the best in your next endeavor. Hey, Ron. A lot of things happening, right? So I want to ask the obvious. Why the management change now? And I'm curious how the process has gone about you know, the timing and when this all came, just kind of thread the needle for us in terms, especially the timing and the, you know, the switch in terms of other management.
spk06: Absolutely, absolutely. No, that's all good news. And I think it's pretty obvious. I think 2021 for us was a year of infrastructure building. We invested over $40 million in Korea and just establishing the new factories. We went through a very, very rapid growth in teams in terms of regulatory team as well as the V&V skill set you need for really scaling up everything from what we've shown in the RSNA last year to what is expected from the company in terms of deliveries and fulfill our commitment to our customers. So the year of 2021 is really about... building the infrastructure and getting ready to prime time. As such, I think that we had to deal with what is it that is missing in terms of the component needed in order to fulfill our mission. And I think we spoke always about our vision of democratizing medical imaging that includes not only the medical devices but also the software part of the cloud, the AI component, as well as the radiology. So that's pretty obvious why early on this year, when we saw that everything is on plan, we started to look at the proposed acquisition that's been announced today. And I will tell you, that's a long process. It's not started today. And in terms of management, what we also realized is, what we knew already, the year of 2022, while we're going to ship a lot of products, as we believe, is going to be really the year of execution. It's going to be execution, execution, execution. And as such, we really wanted to make sure that we put the right teams that can really globally manage this effort, including the integration of both USERAD and Zebra Medical into our overall Nano-X umbrella. And as such, we've looked to discuss, you know, among the board members as were the best people we know that could lead this change from an R&D vision company into execution company when we get ready to prime time. And the answer was pretty obvious. It took a bit of time to convince Erez Milter, but as he was serving already on the board and very involved in... a lot of the day-to-day processes. With his really exceptional background, at least in Israel, he's like a hero because he was CEO of the three largest out of ten companies in Israel. He was willing to take on the challenge and really help building a global company from Israel that includes the the vision of Nano-X overall. And that's how it came about. This is a month of discussion. As to myself, of course, the founder and the chairman, I will still be very much involved in the day-to-day by hunting elephants, but the execution part, which I think we will be judged by next year, is planned to be managed by Erez. Now, I cannot speak for Itzhak, but I can only tell you that the new CFO that's coming on board is, as we said, lives in New York, and that's part also of what we realize will happen next year as we integrate U.S. ERAD and we are working closer to investors and the capital market. We will need more presence and more access, I would say, daily access to our investors as well as the capital market in New York. And we felt that when Yitzhak decided to move on to his next challenge, that this would be the right profile for us Again, it took some time to identify, and we felt in full transparency that this is the right time to expose this information in the context of really the proposed acquisition and what we feel as readiness to prime time that will come in 2022.
spk00: So, Ron, two additional questions from my side, and I'll hop back in the queue. First on Zebra. And forgive me, I haven't looked at the filings, you know, in terms of additional information on Zebra. So maybe it's buried in there. Is there a color on the stock price for Zebra? And also, as I understand it, you know, Zebra has like a chest X-ray AI software cleared. And I'm curious, you know, how you see the implementation or integration playing out with Zebra? at least from what cursorily I was able to glean, you know, their AI is talking about deeper imaging or relatively deeper tissue and bone imaging. And based on at least what Nano-X's filings are, this is, you know, just kind of thread the needle again for us, Ron, in terms of timing and how you all thought that as a strategic fit in terms of what you guys are doing, and especially the valuation.
spk06: Yeah, absolutely. So I would just refer to that from a high level. As you all understand, we just completed a very, very long due diligence. We have some thoughts about the actual integration, but from signing to closing, we have some times, and that would allow us really to perfect our operational plan. But overall, from 30,000 feet, there is no doubt that diagnosis of AI for audiology will be part of the future. In developed countries, it may be a support system for audiologists, and in developing countries, there are a lot of talks of this software-based AI being the first line of defense to see if something is normal or not. Now, so the first usage of the way we look at this strategic usage of the very, very deep knowledge of Zebra into this domain is to perfect the products that are most frequent in terms of radiology and try to come up with modules that will enable, in essence, coupling each one of our NanoX arcs into this software solution that will go after the most common and frequent type of modalities. And that's something that we believe, after a lot of due diligence, that is within the capabilities of Zebra's team. They are one of the most impressive teams I've ever seen in terms of algorithm and AI, and also they are very much well-known in this domain for their ability to close the loop and actually get something through regulatory clearance and also with partners. So this is the first part. The second part is that Zebra is very busy now with some payers, actually, to build what will become, I mean, if we're talking in terms of annotation, this is like early detection, I would say, annotation. They're also very much busy these days in working on what will provide one-day prevention, and that's through population health domain. They've strike very, very interesting partnerships in that domain, all using the same capabilities of AI And that's, we believe, also a capability that will be very important for nanochs. Remember that we're going to place many, many units around the world that are going to scan globally, a lot of scans every day. And we need someone to look at those images to see if normal or not. And that's really the AI-based technology that will be helping, let's say, the radiologists that we look at that. And the second one, is really to crunch all this data and try to come up with a pathway that will indicate for specific patients something that means prevention. And that's part of the Population Health Initiative, that they are spearheading the way we look at that. So both of them are very relevant to NANOS, and if you look back to our vision and what we want to do, it's really fitting very well with our strategy. As we move forward in the transaction, we will come with a very detailed operational plan. But overall, we are very honored to have these capabilities of joining forces with Zebra because they're absolutely, as we feel, a huge addition to what we're trying to do and really adding the layer of intelligence to our hardware piece that is very much needed in order to fulfill our vision. So that's basically it. what we see there now it's true that Zebra has already 7 cleared FDA products which shows a lot about their strengths and it's not necessarily that their products will be fitting to our more frequent scanning needs but that's not a problem because their methodology and their technology and their platform is so impressive and versatile that there is no problem for them to adopt their technology into a modality that is requested by our customers. So that's really the answer to your question.
spk00: And finally, Ron, on USA RAD, if I could, when did the discussions with USA RAD start? How does the accounting now work for your USA RAD contracts? And is the goal moving forward now to... you know, essentially, let's say you have contracts in Belarus and Brazil and other places that even if the scans are done and radiologists are not present, you know, the remote monitoring with USA RAD is going to facilitate that? And if that is the case, maybe you can walk us through how you enforce the logistics and the payment portion. Thank you for taking my questions.
spk06: Yeah, okay, so I will let Ishak to answer the accounting, but again, I will answer a very simple question, a simple answer. Part of our total value to customers is also the ability, if they want, to get access to our AI modality as well as radiologists. And U.S. Erad have already demonstrated they have a business in the U.S. and also serving outside of the U.S. that is IPA compliant, that is able today, without NanoX, actually to generate a lot of transactions that are connecting between patients or imaging centers into radiologists. So they've already done that. The only thing we're asking or we envision that this proposed acquisition will do is that it will give us immediately the ability to offer that from within and will enable us to really climb up the value chain. As you recall, our business model is $14 per scan, but then up to $40 if we provide diagnosis. So that's the first thing. And then, of course, for all those countries that we sign contracts with that do not have not only medical devices, but also they do not have any radiologists around, that will be an instant and very important component to fulfill this mission. And, again, I will just say again that, again, having many, many devices that generate brilliant X-ray images will not be sufficient without the ability to read them. And that's really how we view their current operation is very relevant to where we start to ramp up in the U.S. following the FDA clearance. And it will pretty much be, we should see the fruit of that actually early 2022 in the U.S. and outside. The second one is actually that their audiologists are committed through the NANOX Academy to educate other skilled clinicians in order to read NANOX images, and that's an initiative that also will take place. So this is my answer to the synergies and why it's very relevant immediately. And I would like Yitzhak to talk about the accounting, please.
spk04: Yeah. You know, Suraj, it's going to be very hard at this earlier stage to go into specifics, but I want to lay out the principle of what we're doing. When you think about it, when we have initiated the goal of targeting $40 per scan to the patient, we were speaking about three different parties within that $40 framework. We were talking about Nanox, with the famous $14 per scan, we're talking about the service provider, and we're also talking about the radiologists, obviously on the low-end radiology annotation. What I think those two acquisitions is enabling us is actually to vertically integrate two of the different business offerings that until now we were completely relied on third parties. So even though that we still intend to maintain our third-party agreement with the AI companies, we do intend to vertically integrate the AI capability within the offering and obviously take bigger share of the margin associated with the AI portion within the $14. And the same thing when it comes to the Radology annotation, as a result of integrating U.S.-Iraq within the overall framework of NanoX, it will allow us to take a higher margin on something that until now was mostly a follow-through for the offering, that went all the way straight to the third-party radiology annotation. So without going to the principle, obviously that will allow nano-experimenting a higher margin profile once we fully vertically integrate the two businesses within the overall product offering.
spk09: The next question is from Ravi Musra.
spk07: with Barenberg. Please go ahead.
spk11: Hi, good morning. Can you hear me okay? Yes.
spk08: Hi, Ravi. Yes, Ravi.
spk11: Hi, Ron. Hi, Itzhak. Congrats, Itzhak. Best of luck to you on future endeavors. So just, I guess, you know, more questions on the acquisitions that you're announcing. First, you haven't mentioned, as far as I can tell, any kind of expectations around deal close timings. If you could kind of give us a a sense of when you think that could happen if these agreements go through. Second, you know, it's a little bit of a kind of grander strategy, it sounds like, that you're going after with both of these acquisitions and kind of the hardware and MSAS provider model that we've all been thinking about. So just help me understand in terms of, you know, You know, when you make that margin commentary, is that on gross margin? Like, how should we think about the kind of longer-term operating margin performance of the business here? Are the 300 radiologists that you're getting through USA RAD potentially, are those now going to be part of your kind of employee headcount? How should we think about, you know, some of the imaging AI integration that Deeper brings with your other partners? I mean, is this kind of mutually exclusive or complementary? and what else needs to be done to kind of develop that Nanix cloud and academy aspect of the engine. And I guess I'll just put my second follow-up really quick. There have been a lot of questions. The public streaming event that you discussed on August 16th, can you just give us some understanding of what that's all about? Thank you.
spk06: Sure. So maybe, Itzhak, you'll start on the numbers part. and I will try to provide some view on the strategy and also on the event on the 16th.
spk04: Yeah, I mean, in graphic meaning, it's going to be a killer for me just to relate right now at this early stage when it comes to accurate margin. But one way to think about it, and I want to make sure it's not being glossed with all the details, is the fact that As you think about the Zebra integration moving forward, it has two different components when it comes to Nano-X. First of all, I don't want to be completely missed that Zebra is continuing to be operating as a stand-alone business under the Nano-X brand. What it means is that they will continue and invest and deploy their move into population health as a transition from their very extensive triage-based business that they were very successful building with seven FDAs and so forth. So first of all, we do forecast and we do project that over time, okay, Zebra will bring revenue of its own coming for those population health product offering beyond their contribution to the MSAS model. So the overall margin impact as related to Zebra will have both components, both the impact on the, uh, nano sensors offering, but also their own, uh, their own revenue as they're going to be rapidly building, entering into the population health product offering.
spk05: Ron, I think it's, uh, yeah.
spk06: So let me again, uh, yeah, just, uh, we're a little bit, uh, I think getting to the end of the hour. So let me, uh, Let me just simply talk about strategy again. I think that the grand strategy is there from the IPO last year. I mean, the idea of democratizing medical imaging includes components of, number one, create access to medical devices. Number two, provide a secure platform that can actually create connectivity remotely between physicians and patients using and utilizing third-party services, including AI, radiologists, and doctors. And the third one is actually to have someone sufficient, no matter what, not exclusive, but no matter what, that can read those images. Again, because those images are not that important without someone that can analyze them. So if you look at this strategy, both acquisitions actually play perfectly into the strategy because on the medical device side, we feel that we are very near to prime time. We have all the component components. needed. 2021 was really a great year of infrastructure, and we feel very confident that we're going to ship many units next year. The second level of connectivity and HIPAA compliance cloud is actually what we needed to make sure we are there in terms of product readiness, and I think both MDW or USA RAD and Zebra has far more experience than us. then we do, and they could shortcut a lot of our initiatives, and that's a huge immediate value to what we do. And the third one really has to do with the, let's call it the analysis, whether it's human or by academy or by software, and both companies have proven, actually, their capabilities in terms of all of that. So USARAD is already operating, consultant, by the way, that are the network of 300 radiologists. Their manpower is about 15 people, and they're already running this business in a way that is working, and they're also providing, other than 50 states in the U.S., they're providing their services to other customers around the world successfully, so we are just coming into their... We're integrating them into our offering, but like Yitzhak said, they have also a standalone... ability to generate and be cash positive, actually. And then in terms of the AI capabilities of Zebra, I think they've already demonstrated, including one of the first AI-based technologies products that were clear at the FDA. So they are really leaders in that domain. So they've demonstrated their ability to come up with software that can look at millions of images and come up with something that makes sense for the acute care, which is really speak for the early detection and also for the prevention and that speaks for the population health. So I think this fits perfectly into our strategy when we go on prime time. I would add to that that Nano-X always was like an open source, so the same way that we are working with big companies of medical device and we offer them our technology in exchange for license, we will continue to be open to other services as they come, so in no way we're going to block ourselves to other opportunities. So all in all, we feel that this is a very, very good strategic fit that actually fit exactly well with our vision from the get-go, and it's a component that is much needed. We just didn't want to, in a way, do any moves before we felt that on the hardware side and the deep technology side, we are ready for prime time, or getting ready for prime time.
spk05: So that's really the context.
spk09: Great, thanks. And just the August 16th event? I'm sorry?
spk11: Just on that August 16th event, just curious what that's going to be like.
spk06: Yeah, so I think in August 16th, we're going to, I mean, okay, so let me just tell you that we know that we are sharing today a lot of information in one call. And that's why we think that we need to be engaging in a very robust way And not only in August 16, but actually I will announce later we have other dates from now until RSNA where we're going to devote much more time in order to not only talk about the things, but actually let everybody see, engage with the, let's say, with the production line to see the actual device in action, to see the actual images coming from the device, to see those images being uploaded to the cloud that includes also the USA Rad Cloud, to talk to the radiologists, and also to have the Zebra people just explaining everything about AI and how they fit into our strategy. So we start on August 16 with a webinar where we prepared actually a more informal, I would say, dialogue between the different components of what we have and, of course, the audience. We also will... that will become the CEO as of January of 2022 to join us so investors and analysts can actually meet him and that we feel will give much more color and the following event as I will tell very soon we'll have some more events planned because as you realize this is a very important day but also a lot of information so we will need to make sense out of all of it through some separate events devoted to, for instance, AI or the academy or this organ 16 where we are going to show practically our system at work.
spk07: The next question is from Rahul Rakit with LifeSci Capital. Please go ahead.
spk03: Hey, Ron. Hey, Itzhak. Thanks for taking the questions. I know there's been a bunch of questions so far, so I'll try to make it quick. But I just want to get some clarification on regulatory timelines. I know you mentioned that you've done the first 510 submission for the NANOC ARC. But is this system commercial ready? Or are you expecting to make another submission for the commercial ready system? What would be the timing of that? And I guess, what are the key differences between these two submissions? And then, you know, just following up from that, given, you know, the amount of back and forth that you had with the FDA for the single source system and the complexity of the multi-source submission, you know, I guess what is your thinking around the timing of an ultimate FDA clearance and whether you might see some ex-US approvals prior to that? Thank you.
spk06: Yeah, okay. Let me just address that. So actually, we view the Nano-SCART as a very significant FDA approval because basically it cleared the technology and the multi-source was submitted and immediately we got feedback from the FDA and some questions, so that's in process. As you all know, we cannot control the timing of the FDA, but we have all confidence that we're in good shape there. We're going to submit a second submission of the NanoXARC with the final, I would say, and the best performance level of the NanoXARC still during this year. And we expect that, as we said, that will allow us to, in the U.S. and outside of the U.S., to ship to the very minimum 1,000 units during 2022. Nothing has changed in that domain. The experience we had by the delay during the corona time, et cetera, with the FDA, is uh definitely not the same experience we have right now and i can only say that we already have some communication there which is all positive and uh we feel confident that we are in a good shape uh to meet everything we said so far which is basically submit and get clearance in a way that will allow us to ship products in the u.s and outside of the u.s as planned during 2022. got it i appreciate that and just one more quick one for me um sorry just
spk03: I haven't heard much around potential NanoX cloud filing. Is there anything that you could add there in terms of the timing of that and ultimately what that process may look like? Thanks.
spk06: Yeah, sure. We're going to submit everything needed in order to operate, including the NanoX cloud, but also we're going to very closely look at the two proposed acquisitions and what can we already utilize from there just again to reiterate, both Zebra and MDW actually have very, very strong cloud capabilities that are already working. In terms of USARod and MDW, they're already in operation for years. IPA compliance and everything is done. So we already integrated initial integration into their system just to see that it's working and it's working perfectly. And the same will be done with Zebra that also have very, very strong cloud capabilities. So the answer is A, we're going to submit to the very least our NanoX cloud, which is already in preparation for the submission. And we're going to also look very carefully and see if we can utilize what is already done for some time and cleared with our partners so that we can shortcut and streamline the way for prime time of our business operations. uh ramp up so that's really the uh the answer got it i appreciate that color uh thanks again for squeezing me in guys this concludes the question and answer oh pardon me go ahead sir no no okay so this is around speaking so um we know this is a lot of information for one call and uh that is why we will be engaging in a very robust investor outreach that includes both financial conferences and meeting roadshows, and we hope to meet with you either in person or virtually in the near future. Meantime, we have a few upcoming events to Ravi's point. First of all, we'll have an investor webinar, and this is where management will host a public streaming event on August 16 at 8.30 a.m. EST. Following that, On September 30th, we will do what's called the AI Day. It's being taken from the Battery Day of Elon Musk. So we'll do AI Day, basically. And this is where we're going to take you with the people of Zebra Medical and other people from our team through the AI initiative. And we'll go through everything that you need to know in terms of what is the direction that AI, medical in general, but also specifically, what we're going to do with all these skill sets that we're just looking to acquire. We're also planning to participate in the RSNA Radiology Society of North America, and that will be coming on November 28th, when you will be able to see an actual practice and demonstration of our end-to-end vertically integrated medical imaging solution, assuming we'll also show some components that will be added if those proposed transactions will be consummated. So, you know, to conclude, as you have just heard, NANOS continues to take significant steps to fulfill our vision together for better health. We're doing this in three ways. The first one is really continuing to scale up manufacturing of the NANOS arc while in parallel advance a long regulatory pathway in key territories, most noticeably in the U.S. Our new relationship with two great companies, USA RAD holding and Zebra Medical Vision, if consummated, will position us to make significant progress in realizing our goal, a globally connected end-to-end radiology solution, and finally, bringing in a world-class CEO to sustain the momentum that we currently enjoy and lead our company forward, with whom I will be working actively as Executive Chairman. So with that in mind, I would like to thank you, for your 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. With that, operator, we would like to start or we would like to finish the call. I'm sorry.
spk07: Thank you. This concludes today's conference call. You may disconnect your lines. Thank you for participating and have a pleasant day.
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