NANO-X IMAGING LTD

Good afternoon and thank you for joining us today.

Earlier today, Nanox Imaging Limited released financial results for the quarter ended March 31st, 2023. The release is currently available on the investor section of the company's website. Perez Meltzer, Chief Executive Officer, and Ron Daniel, Chief Financial Officer, will host this morning'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 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 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 financial measures to the nearest GAAP financial measure is provided in our press release. The non-GAAP financial measures include non-GAAP net loss attributable to ordinary shares, non-GAAP cost of revenue, non-GAAP gross profit, non-GAAP gross profit margin, non-GAAP research and development expenses, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses, and non-GAAP gross loss per share. With that, I'd now like to turn the call over to Erez Meltzer.

Thank you, Mike, and thank you all for joining the call today. I will provide an overview of our recent operational accomplishments before handling the call over to Ren to review our financial results, and then we will close as usual with a question and answer session. With that, I'll get right into it, and I'll start with the news. that I'm sure is at the top of everyone's mind, which is the recent FDA clearance for Nano-X Arc system. As a reminder, on April 28, 2023, we received a 510 clearance from the FDA to market the Nano-X Arc, including the Nano-X Cloud. It's a company cloud-based infrastructure. The approved device is intended to be used in professional healthcare facilities or radiological environments such as hospitals, clinics, imaging centers, and other medical practices by trained radiographers, radiologists, and physicians. Representing a major advancement in the X-ray tube technology, the NanoARC is a multi-source 3D tomosynthesis system that utilizes novel cold cathode X-ray tubes which the company intends to offer using an innovative paper scan business model. We believe that the NANUX ART has the potential to increase availability to medical imaging globally once approved by local regulatory authorities and deployed in scale. We intend to deploy this version of the NANUX ART that was cleared by the FDA which has the power level necessary to scan the MSK system. We believe the FDA clearance will assist in our efforts to gain regulatory clearance in certain other jurisdictions, including in other countries that are FDA clearance-based markets. Following this clearance, NANUCS will continue to work with the FDA to pursue additional regulatory clearances and intends to expand clinical indications. Other applications may be available in other markets per local regulatory approvals. With FDA clearance secured, we are in the process of setting up a U.S. demo center located in Fort Lauderdale, Florida, which will be used for commercial purposes. We are currently working to secure an import license and expect to ship the NANUC's ARC units later this quarter. Additionally, we continue pursuing the European Union CMARC and continue our work with our notified body, BSI, to whom we've already submitted the contract package. While it is gratifying to see the commercial and regulatory process of recent months, at the same time, we are collecting additional data supporting the use of the Nano-XR system. Under the Helsinki permits, which we have previously disclosed, we started to collect clinical sample images of multiple human body anatomies with Nano-XR system that was deployed in the Shamir Hospital in Israel. Additionally, we recently passed independent evaluation of the device by the Israeli Ministry of Health, which facilitates further clinical trials in Israel utilizing the Nano-X Arc. We are planning to conduct a clinical trial in Israel to evaluate the diagnostic potential of the Nano-X Arc for chest and lung diseases on patients with these pathologies. The trial is expected to be executed in collaboration with a local hospital in Israel and is expected to begin in the second half of 2023. Turning to commercial deployment activities, NANOS has entered into a three-year distribution agreement with a local partner in Morocco, Vitaltech SARL. Under the distribution agreement, Vitaltech will purchase, deploy, and operate an estimated 270 NANOS ARC units over three years for clinical use. The execution is subject to acceptance tests of the first units and regulatory clearances. We have already received an import license. We have sent the first unit, and our deployment team is on the ground as we speak. Morocco is enhancing our footprint in Africa in addition to work we are doing to deploy in Nigeria and Ghana, which we have discussed on previous calls. I will now take a few minutes to introduce and discuss a new commercial partnership which extends the reach of Nano-X AI. During this quarter, we entered the global partnership with Blackford Analytics to market our Nano-X Arc product. Blackford Analytics is a global imaging AI solution provider, and this partnership is intended to broaden the reach of Nano-X AI cardiac and bone solutions by presenting the NanoX AI algorithms on Blackford's platform, which offers a wide portfolio of imaging AI software and services. We believe partnering with Blackford is an important step in expanding the reach of NanoX AI, Health OST, and Health CCS&G solutions into radiology department globally, including the US and Europe, NanoXAI solution may also benefit downstream physicians in cardiology and endocrinology by enhancing their abilities and help detect subclinical levels of osteoporosis and cardiovascular disease. Moreover, we have already completed the installation of our application in four out of five NHS clinical institutions in the UK, and our system has been installed in 10 clinical institutions in the U.S. for the purpose of initial clinical pilot. Turning to technology and manufacturing, and as previously mentioned in our previous learning calls, since the beginning of this year, we have been improving our production line capabilities and establishing an operational assembly line to enable the expected ramp-up in the production and preparation for the shipments of the Nano-X Arc system later this year. With deployment as a key focus, I am pleased to report that the production line at Begesh is now fully operational. Furthermore, I am happy to share that Nano-X Korea received the ISO 123485 certificate on April 5, 2023. The scope of this certificate obtained by Nanox Korea covers design, development, manufacturing, and sales of X-ray tubes for medical use. Before turning the call over to Ron, I'd like to touch on the Nanox AI and Telluridology business segment, which continue to generate revenue. This business has generated top-line revenues of $2.4 million compared to $2.1 million revenues in Q4 2022. almost a quarter-to-quarter increase of 15%. Ron will review the financials in more detail, but as I've stated before, these businesses are attracting customers, thereby demonstrating the utility of these services to healthcare systems, and we are confident they will add significant value to the fully integrated NanoXARC system upon deployment. Our work is not done, but we are now at an inflection point in our company's history and are now looking ahead to deploying the Nano-X Arc at a large scale globally. With that, I'd like to turn the call over to Rand Daniel, Chief Financial Officer, to review our financial results.

Thank you, Eric. We reported a government look for the first quarter of 2023 of $11.8 million, compared with a net loss of $21.7 million in the first quarter of 2022, which decrease was largely due to the decrease in earn-out liabilities in the amount of $5.0 million and the decrease in our general and administrative expenses in the amount of $3.5 million. Our non-GAAP net loss for the first quarter of 2023 was $10.5 million, compared to a non-GAAP net loss of $11.6 million for the same period in 2022. Revenue for the first quarter of 2023 were $2.4 million, and gross loss was $1.5 million on a GAAP basis. Revenue from teleradiology services for the same period was $2.4 million, with a gross profit of 0.2%. $5 million on a gas basis and a gross profit of $1.1 million on a non-gas basis, which represents a gross profit margin of approximately 21% on a gas basis and 44% on a non-gas basis. The increase in the company's revenue and gross profit margin in the first quarter of 2023 is mainly due to the increase in the amount of the radiologic interpretation and read and our rates for teleradiology services during the three months ended March 31, 2023, as compared to the comparable period. Research and development expenses for the first quarter of 2023 were $6.3 million, as compared to $6.8 million for the comparable period in 2022. The decrease of $0.5 million was mainly due to the decrease in the company's cost of labor in the amount of $0.5 million and a decrease in share-based compensation in the amount of $0.8 million, which was mitigated by an increase of $0.2 million in development expenses. General and administrative expenses for the first quarter of 2023 were $7.8 million as compared to $11.3 million for the comparable period in 2022. The decrease was largely due to a decrease in the company's cost of labor in the amount of $0.8 million, a decrease in share-based compensation in the amount of $4.5 million, and a decrease in the company's director's and officer's liability insurance premium of $0.3 million, which was offset in part by an increase in professional services in the amount of $0.5 million and increase in the company's legal fees in the amount of $1.4 million due to an increase in the company's legal fees in connection with the SEC investigation and class action litigation as described in the company's Form 6K filed on May 22, 2023. During the fourth quarter of 2022, we had accrued $8 million for future settlement expenses in connection with the two pending class action lawsuits against the company. On April 28, 2023, we signed a term sheet with the lead plaintiff in both actions to settle all claims in both actions in consideration for $8 million. The settlement is subject to finalizations of a formal settlement agreement and court approval of the settlement. Changing contingent earnings on liabilities was minus $4.7 million in three months ended March 31, 2023, as compared to $0.4 million in the comparable period in 2022. Due to the decrease in the company's contingent earnings earn out liability as a result of the amendment of the stock purchase agreement that we entered into with the former shareholders of U.S. Rod on April 28, 2023. Under this amendment, the company shall pay an aggregated amount of approximately $0.3 million in cash and $45,392 ordinary shares to the former stockholders of U.S. Rod. in consideration for the achievement of certain milestones in connection with the first annulment period as defined in the U.S. RAD stock purchase agreement. In addition, the company and the former shareholders of U.S. RAD agreed that the company shall pay an aggregate of $0.5 billion in cash and 210,000 ordinary shares to the former stockholders of U.S. RAD as consideration for the remainder of the milestones and applicable earners under the U.S. RAD stock purchase agreement. Turning to our balance sheet, as of March 31, 2023, we had cash, cash equivalents, and marketable securities of approximately $91.0 million and had $3.5 million loans from banks. We ended the quarter with a property and equipment with a net of $45.1 million. As of March 31, 2023, we had approximately 55.2 million shares outstanding as compared to 52.1 million shares outstanding as of December 31, 2022. On April 28, 2023, we issued approximately $255,000 ordinary shares to the former stockholders of U.S. RAD under the amendment to the U.S. RAD stock purchase agreement previously discussed. With that, I'll hand the call back over to Eric.

Thank you, Operator, and thank you all once again for your support of Nano-X. I've been the CEO of Nano-X for over a year now and have been looking forward to sharing the welcome news of FDA clearance. The U.S. regulatory clearance also paves the way for NAMUX ARC to be approved in other countries that are FDA clearance-based markets. Other applications will be available in other markets for local regulatory approvals. We will continue to push ahead on multiple fronts, commercialization and deployment across multiple geographies, continue to strengthen our manufacturing capabilities of the supply chains, and continue to generating and collecting imaging data that supports the use of NanooksArts across multiple pathologies and uses. I look forward to our next update call in August when we will discuss our Q2 results. In the meantime, and if you want to connect with us, please contact our investor relations partner It's ICR West Wing.

Have a good day.

Ladies and gentlemen, if you'd like to ask a question, please press star 1-1. If your question hasn't answered and you'd like to remove yourself from the queue, please press star 1-1 again. Our first question comes from Jeffrey Cohen with Leidenberg-Dalman. Your line is open.

How are you? Great. Good morning, Jeff. So congratulations again on the clearance. It's very exciting. Can you walk us through and talk about a little bit as far as the backbone of production? where that's existing now, and you mentioned fully operational, and then talk about all the components and subcomponents and to manufacturing and tie that into the facility in Korea as well.

Okay. Thank you, Jeff. First of all, indeed, we are very excited about the FDA clearance and the work that is ahead of us. um we've indicated in the um in the um what we we talked actually in the last uh 15 minutes first in any of the uh press release that we did that a we continue to uh manufacture um the chips in korea same goes with the tubes that currently we are manufacturing in korea we've indicated in the future we have plans to have more than one or two sources for each one of the components, including the tubes. This will come in the future. In addition, in terms of the assembly, we have actually opened the facility at Dagesh in Israel, where we're going to manufacture all the systems that that we're going to assemble this year and shift to the various locations that will be part of the deployment. So this is what we mean by fully operational. In the future, we have already mentioned that we will consider and also explore opportunities to assemble in other countries when we go to the mass production other than Israel specifically as we do right now.

Thank you. Our next question comes from Ross Osborne with Cancer Fitzgerald. Your line is open.

Hi, guys. Congrats on the progress. Thanks for taking our questions. Hey, Ross. How are you?

Hi, Ross.

So maybe starting off, could you provide an update out of Ghana and Nigeria? Where does the company stand in beginning to generate scans there and also related revenue?

Okay. So right now we've just started, so revenues are expected later this year. In terms of the deployment about those that you mentioned, We are working country by country with the local regulation starting with the import license and the local regulation in those countries that are FDA-based clearance and are not FDA-based clearance and have their local regulation. We have indicated that we are focusing on Africa and we are exploring and expanding the business in Africa. In Ghana, the system is already there, installed, operating. In Nigeria, the system is there, will be operating shortly when we get all the permits and certificates to operate it. We have also indicated today that we signed another big agreement or meaningful agreement in Morocco. The system is already at the hospital as we speak, and we have a team in the ground which are going to operate it, and it will start to generate, of course, images. This is with respect to Morocco. In terms of the others, right now we're going one by one of the agreements that we have in order to ensure that we'll have a path and roadmap for the deployment. At the same time, we have indicated today something very important that originally we thought that U.S. will be only next year. We really understand right now that we have to find a way and do our best in order to accelerate the process of the deployment and the go-to market in the U.S., and it's going to be It's going to be this year, and we've already indicated that the demo center that we talked about in the script, in the PR, and also the machine that will be sent this quarter.

Great. Maybe I'll follow up on your Morocco contract. You mentioned deploying 270 units over three years. If you're able to receive the required license, let's say tomorrow and begin deployment, based upon your current manufacturing capabilities, would you be able to meet the three-year window?

The answer is there is no reason why not.

Okay. That's great to hear. And then maybe one more, if I may. Just on the U.S. commercialization, Is the plan to deploy systems in the U.S. also on the pay-per-stand model rather than a capital sale? And then if so, should we think about price around $14, similar to your global average?

The short answer is, without going into the details, the short answer is basically yes. But I think it's too early to say. Once we start the deployment, we'll see the various – the various models that can be explored, the various type of units or clinics or hospitals that we'll hear. Right now, from what we hear for the market, the answer is yes. We may explore and then decide something else, but this is too early to say. But I will say once again, in general, the answer is yes. Not necessarily the $14 that was mentioned, but it might be that it will be different or higher.

But right now, that's the plan. Thanks for taking my questions. Congrats again on the progress. Thank you, Ross.

Thank you. That is all the time we have for questions. Thank you for your participation in today's conference. You may now disconnect. Everyone, have a great day.