NANO-X IMAGING LTD

Ladies and gentlemen, thank you for standing by and welcome to the NANDOX Imaging Q4 and full year 2021 earnings conference call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you need to press star 1 on your telephone. If you require any further assistance, please press star 0. I would now like to turn the call over to Mike Cavanaugh, Investor Relations. You may begin.

Thank you. Good afternoon and thank you for joining us today. Earlier today, Nanox Imaging Limited released financial results for the full year and quarter ended December 31, 2021. The release is currently available on the investor section of the company's website. Eris Meltzer, Chief Executive Officer, and Ron Daniel, Chief Financial Officer, will host this afternoon's call. Before we get started, I would like to remind everyone that management will be making statements during this call that include forward-looking statements regarding the company's financial results, research and development, manufacturing and commercialization activities, regulatory process operations, the impact of COVID-19 on its business, and other matters. These statements are subject to risks, uncertainties, and assumptions that are based on management's current expectations as of today and may not be updated in the future. Therefore, these statements should not be relied on as representing the company's views as of any subsequent date. Factors that may cause such a difference include, but are not limited to, those described in the company's filings with the Securities and Exchange Commission. We will also refer to certain non-GAAP financial measures to provide additional information to investors. A reconciliation of the non-GAAP to GAAP measures is provided with our press release, with the primary differences being stock-based compensation and class action-related expenses. I'd now like to turn the call over to Nanox's CEO, Erez Meltzer.

Thank you, Mike, and thank you all for joining the call today. As most of you know, I assumed my role as CEO on January 1st. It's what I consider to be a pivotal time in Nanox's development trajectory. We have made several advancements since our last earnings call. I look forward to sharing some exciting developments with you today. I will give an overview of our achievements since our last earnings call, as well as share our outlook on the year ahead. Before turning the call over to Rand Daniel, our CFO, to review our financial results, we will then open the call up to questions. I would like to start by providing an update on our regulatory and commercialization progress as it pertains to our conversations with the FDA around the NanoX ARC system. We announced last quarter that we would be reviewing feedback from the FDA pertaining to our first submission relating to our multi-source NanoX ARC. In January of this year, after careful review of the FDA's feedback on our first submission, we filed a pre-submission towards an additional 5.0K application for the second version of NanoXARC, our high-performance multi-store system via the agency's Q-Submission Program. We are in continuous communication with the FDA and believe that this route will be the most expeditious pathway to further FDA feedback, which will be followed by formal submission. We expect that the Q submission will lead to thoughtful improvements to the NanoPSAR, and that if cleared by the FDA, the system will be suitable for development later this year. We have made considerable headway towards commercialization over the past year, and our team remains committed to deployment of the NanoX Arc units and is focused on execution in the months ahead. We are pleased to report that we have begun generating revenues, in large part due to our three previously announced strategic transactions, the combination of which create a path to streamlined commercialization. Combined with our patented x-ray technology, the acquisitions of Zebra Medical Vision, now Nanox AI, a deep learning machine analytics company, MDW LLC, a decentralized marketplace connecting imaging facilities with radiologists, and USA Rod Holdings Inc., a leading provider of teleradiology services, we are well on the path to provide more accessible and affordable health care We believe that integrating AI-powered imaging analysis and global teleradiology solution with our nanospark technology takes us one step closer to creating a global streamlined medical imaging continuum from image capture through analysis to intervention by trained radiologists. Under one umbrella, we now have the potential capabilities to significantly improve access, reduce cost, and enhance efficiency, which could increase the chances of early detection as well as patient access to care in a meaningful manner. We are pleased with our ongoing integration of the companies we acquired at the end of 2021 and have taken a number of cost reduction measures in order to streamline operations and benefit from synergies. As these companies begin to contribute to NANUC's top line, we believe they will enhance the services provided by NANUC's system. We intend to explore collaborations for additional solutions and wider product offerings. In December 2021, we were excited to announce that USA-RUS was rectified with the Joint Commission's Gold Seal of Approval, which reflects the high standards that USA-RUS has maintained since its inception. By meeting the quality standards of most widely recognized medical credentialing program in the country. Furthermore, I'm pleased to share that we have strengthened the leadership team of Nanos AI. Effective March 1st, 2022, we appointed Peter Benalazar as General Manager of Nanos AI. Mr. Benalazar brings 20 years of strategic and commercial expertise in the healthcare industry, and is uniquely equipped to help drive the integration of Nano's collective roadmap and vision. Having served on the board of Zebra Medical Vision since its inception, Mr. Benalazar understands the joint vision and mission of the merged company. Mr. Benalazar was one of the architects of Zebra Clalit Health Services, Clalit is the largest health maintenance organization in Israel and is the second largest HMO in the world, strategic collaboration. Mr. Ben-Elzar previously also served as CEO of More Research Application, a technology transfer organization of Clalit. We are confident that he has the vision and the expertise to help drive Nanox AI into the global market. I would like to also highlight a few other achievements since our last report. In January 2022, we announced that the American Medical Association issued a new category three current procedural terminology, CPT code, for quantitative CT tissue categorizations, enabling potentially broader use of NANOX AI's health cardiac calcium scoring, our FDA cleared, AI-enabled cardiac imaging solution that detects coronary artery calcium, CHP, for patients in the U.S. The code will become effective on July 1, 2022. We consider this important validation of our technology and a key step towards advancing detection and treatment of cardiovascular diseases. We believe focusing on reimbursement of our technology will result in further interest and demand for the nanosystem. I would like to announce another agreement that has recently been signed for Nanos AI. Earlier this month, Nanos AI entered into an agreement with a large integrated healthcare organization based in the U.S. that provides care and coverage with the potential to create a more equitable model of health and wellness. Under this agreement, the healthcare organization will deploy the NanoxAI-enabled software designed to promote increased early detection of risks for cardiovascular diseases and osteoporosis in chest, computerized tomography, CT scans. We believe that the partnership between NanoxAI and the integrated healthcare organization will enable physicians to efficiently identify many previously under-detected patients who may be at risk for cardiovascular diseases and or osteoporosis, which could improve individual patient lives as well as having broader implications for population health and management of chronic disease. Implementation will begin immediately and the tools are expected to be rolled out to hospitals within the organization's network of hospitals in the coming months. As for NanoxART, as previously reported, we have signed 11 MSAS agreements for global deployment of 6,500 units of NanoxART multi-store system. These agreements are for different territories, including Africa, Central America, and Europe. and the system will be deployed in such markets according to the local regulations subject to requisites clearance in each market. Since the beginning of the year, we have made significant progress in materializing a revision both within the company and outside of it. We've been focused mainly on establishing our production capabilities towards the deployment of PhenomXR system later this year establishing new partnerships, and enhancing our regulatory path. Our assembly efforts are primarily conducted at our Tagesh facility in Israel. Since the beginning of the year, we have been improving our production line capabilities and establishing an operational assembly line to enable the expected rent up in production and preparation for shipments of the non-exotic system later this year. Operationally, our technology transfer to NanoT's wholly-owned Korean subsidiary to enable production of the silicon MEMS chip has been completed. This is an integral piece of the NanoT's digital X-ray source, and with the launch of the production at the facility now underway, we anticipate being in full production by mid-year 2022. The key initiative is especially important given the current supply chain shortages for chips worldwide. We believe this will help to secure a stable supply of chips that we need for the production of the non-XR while ensuring the quality of our chips for us and the healthcare professionals who will use our non-XR systems. With that, I would like to turn the call over to Rand Dario, Chief Financial Officer.

Thank you, Ares. We reported a gap net loss for the full year of 2021 of $61.1 million, compared with a net loss of $43.1 million for 2020. We reported a gap net loss for the fourth quarter of 2021 of $22 million, compared to a net loss of $19 million for the same period in 2020. Our revenue for the year ended on December 31st, 2021, and for the fourth quarter of 2021 was $1.3 million, and our gross loss was $1.5 million. Our revenue stems from the sales of radiology services and AI solutions resulting from the acquisitions of Nanox AI, U.S. RAD, and the Nanox Marketplace platform, which we closed during the fourth quarter of 2021, and in fact, those revenues represent two months of operations. Of such revenue, our revenue from radiology services for the same period was $1 million, with a gross profit of $0.0 million on a gap basis and a gross profit of $0.4 million on a non-gap basis, which represents a gross profit margin of approximately 40%. In addition, our revenue from licensing of AI applications for the same period of time was $0.3 million with a gross loss of $1.5 million on a GAAP basis and $0.2 million on a non-GAAP basis. Research and development expenses for the year ended on December 31, 2021, where $17.1 million compared to $9.2 million in 2020. Research and development expenses for the fourth quarter of 2021 were $6.5 million as compared to $3.0 million for the same period in 2020. The increase in our research and development expenses was mainly due to the merger with Nanox AI, the development of our multi-source and cloud systems, increasing our R&D ad count, share-based compensation, and costs related to the ongoing regulatory approval process. Sales and marketing expenses for the year ended on December 31, 2021, were $7.0 million as compared to $12.4 million in 2020, while marketing expenses for the fourth quarter of 2021 were $1.9 million as compared to $8.0 million for the same period in 2020. The decrease was mainly due to the decrease in share-based compensation. General and administrative expenses for the year ended on December 31, 2021, worth $34.7 million, as compared to $22.3 million in 2020. General and administrative expenses for the fourth quarter of 2021 were $10.9 million, compared to $8.2 million for the same period in 2020. The increase was due largely to the mergers with NXAI, the acquisitions of U.S. RAD and the assets of MDW, increasing our labor costs due to an increase in our ad count in connection with the expansion of the company's management team and the overall organization infrastructure, and increasing our legal fees in connection with the SEC probe and class action litigation. Non-GAAP net loss applicable to the ordinary shares for the year ended on December 31, 2021 was $39.2 million, compared to $18.9 million in 2020. The non-GAAP net loss for the fourth quarter of 2021 was $15.0 million, compared to a non-GAAP net loss of $8.4 million for the same period in 2020. A reconciliation between our GAAP net loss and our non-GAAP net loss for the full years and the fourth quarters of 2021 and 2020 is provided in the financial results that are part of the press release that we issued this morning. The difference between GAAP and non-GAAP net loss is mainly due to the amortization of intangible assets, shared base compensations, fees related to our secondary offering, which was closed during the first quarter of 2021, and legal fees in connection with the SEC probe and the class action litigation. Turning to our balance sheet, as of December 31, 2021, our cash equivalents and marketable securities were $156.6 million, and we had $3.8 million in loans from banks. We ended the year with plant property and equipment net of $37.4 million. The increase of $23.4 million during the year of 2021 is mainly due to the completion of the construction of our fabrication facility in South Korea. We also ended the year with intangible assets of $160.1 million as opposed to none at the end of 2020. The increase is due to the merger with Nanox AI, the acquisitions of U.S. RAD, and the assets of MDW. As of December 31, 2021, with approximately 51.8 million shares outstanding, as compared to 46.1 million shares outstanding as of December 31, 2020, the increase was mainly due to the issuance of shares in connection with the three acquisitions that we have completed during the fourth quarter of 2021. With that, I will hand the call back over to Aaron.

Thank you for the financial update, Ron. I was delighted to assume the role of CEO for this exciting company, and I'm pleased to have so much positive news to report in my first earnings call as Nonos leader. We thank you for joining us today, and as always, appreciate your continuous support. We will now open the call for questions. Operator, please begin the Q&A session.

Ladies and gentlemen, if you have a question or a comment at this time, please press the star key on your touchtone telephone. If your question has been answered or you wish to move yourself from the queue, please press the pound key. Our first question comes from Shiraj Khalid with Oppenheimer.

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

Yes, we are.

Hey, so Aries, historically, Q-Subs usually yield the pathway by, at least by guidelines, by around 75 days. And by our calculation, you're somewhere around 77. Maybe if you could give us some additional color of the type of communications, if you've had any written feedback. And specifically, as we stand today, What is your update expectation on approval or clearance for the multi-source?

Okay. Thank you, Suraj. First of all, with respect to the 75 days, when we decided a few months ago to go through the Q-Sub pathway, we indeed thought that it will be 75 days before they get a response to us. Having said that, I think it took them about four to five weeks to respond, schedule a meeting, and we had already a few discussions with them over time. The one thing that I said already a few times, that the decision to go to a continuous dialogue with the FDA has proven to be the right one. We are talking to them quite a lot, so it's not only Q-Sub, waiting for the answers, respond, et cetera. The Q-Sub that we have made was based on the indications, all the comments that they have in the past when we initially sent the the submission for the multi-source, they send us a lot of comments. In the Q-Sub, we have already fixed all their comments. It seems that right now, from their point of view, especially due to the fact that it's a new technology, it seems that they are now internalizing what we are tried to do, and the decision last time was that they gave us a few guidance, guidelines, what to do for supplement information as part of the Q-Sub. So this will be, and I don't think that, I don't expect that, they had the 75-day, but I don't expect that it will take the 75 days. They will probably respond at least based on the notion of the calls that we had, they will respond earlier. Having said that, right now, you know, we hope for the good, but we can't estimate exactly what will be the time. But the one thing I would reiterate is the fact that, first of all, we are making a lot of progress in this area, and the fact that we have decided to go to a continuous dialogue proven to be the right one.

Ares, has the discussion come up for a de novo 510 case?

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

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

Uh...

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

Okay. So, Eris, one quick one for you, and Ron, I'll throw in one for you also. Eris, what are the yields now on the MEMS chips with this technology transfer to your Korean partners? Because if memory serves me right, in Japan, the yields were roughly around 50%. So I'm curious on that. And Ron, if you could, what are the annualized revenue run rates? and growth rates that we should assume for the Nano-X AI and the USA RAD segments for FY22? Gentlemen, thank you for taking my questions.

Okay, so with respect to the Korean, since we have indicated that in the very near future we're going to go for the mass production, once we start the mass production, we will know to indicate what's the yield. Definitely it's better than it used to be in the past, of course. But the next production will be the one that will indicate where we are. Okay. With respect to RUN, would you like to address the... Yes.

So you would expect a growth rate of 50% growth more than the two lines that you have mentioned. That was the question, correct? Correct.

Right, and how should we think about the revenue run rate for the AI and the USA RAD tech?

Okay, so about the revenue run rate of US RAD, you should expect for $8 million to $9 million on an annual basis. And as for the AI section of the business, you should expect to $3 million to $4 million a year. As of now, as of the business right now, correct?

Thank you.

Our next question comes from Jeffrey Cohen with Leidenberg-Feldman.

Oh, hi, Harrison. How are you?

Good.

Hi, Jeffrey. So just to fire you a bunch of questions. So firstly, what was the litigation expense in the fourth quarter?

Are you referring to the SEC probe and the cloud section?

Yes. Okay.

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

Okay, got it. And I know that, you know, we've heard about manufacturing and delivery. So any commitment on deliveries or units for 2022 from the company as far as production and or deliveries?

Right now, we don't change anything with respect to what has been indicated. Right now, I would say that due to the fact that we have identified what are the low-need items to be ready for the assembly, we have already ordered what is needed for the foreseeable future, as we can say. The other thing that we have indicated is in the first quarter, our assembly line in the Dagesh will be ready for hundreds of machines on a quarterly basis. So right now, that's where we are.

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

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

Got it. Okay. Could you talk about this large integrated healthcare organization in the case of cardiovascular? Can you give us a sense of the number of lives covered by this organization? Is it over a million? Is it over 10 million?

You mean the number of subscribers?

Just the, I'm trying to get a sense of the size of the integrated healthcare organization.

Okay. I would say that it's among the top, I would say top 30 in the U.S. I would even dare to say that it's among the top 25. It's a pretty advanced organization. in the way they think about AI and future healthcare providing, providing healthcare, and it's pretty sizable. We have also indicated that we are in continuous dialogue with a few others, and at least one of them is even more sizable than the one that we've signed already.

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

We have indicated already that we have orders for the 6500. none of which have been either canceled or so it's still what we currently have. And since we have already indicated and we repeatedly saying that the first country that we're going to install are countries with different regulation that the FDA is not necessary, another regulation is necessary over there. And the indication that we currently have that the regulation that will be required for the first part of the deployment, which also will be shortly announced, we will get it again, once again, in the very near future. I don't have the exact date, but once we have it, we will announce it.

Okay, and one more if I may. Was the resolution on the glass versus ceramic tube manufacturing, or is it currently two sources on the manufacturing front for the tubes?

Okay, so right now we are really working on a very wide range of solutions, okay? And I'm not talking about one or two suppliers. I'm talking about five suppliers. four or five suppliers that we are currently exploring. One or two of them is exploring the ceramic solution, and one or two of them are exploring the gas solution. And right now we are doing both. The decision on which one we actually focus will probably be in the next few months, once we get the yield, once we get the power, and once we pass the FDA as well.

Okay, and can you give us a sense of which one was followed with the FDA queue?

We don't disclose it, but I think that shortly it will be disclosed.

Perfect. Okay, that does it for us. Thanks for taking the questions.

Thank you.

Thank you.

And I'm not showing any further questions at this time. I'd like to turn the call back to Eris for any final remarks.

Okay, so... Thank you all for being with us today. We really appreciate the support, the continuous support in the company and its future. It's interesting that the ecosystem that we are building with a combination of the Nano-X Arc with other equipment that will be joining this in the future and with the reading by Teleradiology provided by USA RAD and the MDW. And, of course, the layer that we are adding with the AI is definitely something that we see when we talk to customers and to potential players and to partners that it's something that resonates quite well, to say the least. And we hope that it will be fulfilled in the very near future and will generate the expected outcome for the company. Thanks once again. And we'll talk soon.

Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.