Nano-X Imaging Ltd. Q3 FY2023 Earnings Call

Good afternoon, and thank you for joining us today. Earlier today, Nano-X Imaging Ltd. released financial results for the quarter ended September 30, 2023. The release is currently available on the Investors section of the company's website. Erez Meltzer, Chief Executive Officer, and Ran Daniel, Chief Financial Officer, will host this 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 processes, 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. Management will also refer to certain non-GAAP financial measures to provide additional information to investors. A reconciliation of each non-GAAP financial measure to the nearest GAAP financial measure is provided in the company's press release filed today. 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, non-GAAP other expenses, and non-GAAP gross loss per share. With that, I'd like to turn the call over to Erez Meltzer.

Thanks, Mike, and as always, thank you all for joining us today for our financial results call and corporate update. As previously noted, we have intensified our efforts and focus on the US market to jumpstart our commercialization effort in the region. To support these important efforts, our team and I have increased our presence in the United States over the last few months, and I'm currently in the US. We have engaged in discussions with potential customers, clinical partners, particularly US healthcare sector professionals, focusing on reimbursement and medical workflow and other key stakeholders. We aim to expedite the implementation of our commercial infrastructure and advance our future strategic plans. Moving to the recent developments in deployments, I'm pleased to announce that we have established the first US-based commercial site and demonstration center for the Nanox.ARC, which is part of our initial wave in the US. The Nanox.ARC system has been installed in a New Jersey-based imaging center, which marks the beginning of Nanox’s commercial expansion into the US market. The system passed all necessary tests conducted by a licensed and certified physicist, enabling us to commence scanning of patients to acquire medical imaging using the Nanox.ARC, a stationary X-ray system intended to produce 3D thermographic images of the musculoskeletal system. The clinic staff will manage the operational, professional, and administrative services, allocating human resources and equipment for the efficient operation of the Nanox system in the imaging center. This center will also serve as a demonstration center for our medical professionals, offering them an opportunity to familiarize themselves with the system and facilitate the implementation process. More updates on the progress on installments in the US are expected on the Investor Day on December 4th. We are enhancing our US sales and service team, and I'm happy to announce we have signed an agreement with 626, a national healthcare technology and equipment management company. They will provide services for the Nanox.ARC, including warehousing, installation, training, maintenance, and customer support. Headquartered in Boca Raton, Florida, 626 offers tools necessary for imaging centers to achieve maximum uptime and maintain better patient care. 626 has expertise in modalities and medical imaging equipment and provides customized services tailored to their client's needs. With their ISO 13485 certification, national footprint, and over 160 field service engineers, they are an ideal company to partner with as we ramp up our commercialization efforts in the US. In addition to them supporting installations, maintenance, and services in the field, we intend to install an ARC system in their suburban Atlanta 626 Imaging Academy for training and demonstration purposes. Turning now to our deployment efforts in the rest of the world. Outside of the key US market, we have begun to generate revenues from hardware deployment in Africa. While these revenues are currently small, they are growing. Additionally, as previously announced, a Nanox.ARC unit has been installed in the University of Ghana Medical Center Ltd., one of the largest and most advanced hospitals in Ghana. We are pleased to announce that our local partner has obtained approval from the Ghana Food and Drug Authority, and it will soon be operational for clinical scanning of patients. In the meanwhile, we have received an order for additional units in Ghana. We're also actively working on establishing a presence in Latin America. One of our distribution partners is in the process of securing an import license for Nanox.ARC, as well as laying the groundwork for a demonstration center. A potential location for the demo site has been identified at a large hospital offering this very space and expertise to provide the Nanox.ARC. We will provide further details on these developments as we make substantial progress. Turning to our OEM initiatives. To meet the anticipated demand for our system, we entered into an original equipment manufacturing agreement with Varex, a leading global manufacturer of imaging components based in Utah. We have since held formal partnership kickoff meetings at Varex headquarters in Salt Lake City, where the company's executive and technical teams came together to continue final tool design efforts and map out all the roadmaps towards production. Expanding on our own related activity, we’re currently engaged with an industrial imaging equipment manufacturer on a tube development and manufacturing program we expect to formalize by the year-end to ensure an adequate future supply of tubes. Additionally, our collaboration with a US government agency exploring Nanox.ARC technology for use in security screening applications is advancing with the acquisition of tubes and further testing and evaluation. Finally, a leading global medical technology company has purchased ammeters for internal testing and application development projects. Regarding our regulatory test, despite our efforts to gain regulatory approval in a number of markets across the world, sometimes our regulatory progress is slower than we would like, in some instances, such as with the FDA in the US. Each jurisdiction has its independent set of regulations, contributing to the complexity of the process. We are diligently navigating these challenges, prioritizing swift approvals while ensuring accuracy and regulatory compliance. Nevertheless, we have not stopped pushing ahead with our regulatory efforts, which continue to be of foremost importance to Nano-X. As previously communicated, we partnered with BSI Group and a credible notified body based in the United Kingdom for the eventual CE marking review and approval. I'm happy to announce that we have submitted our technical file for obtaining the CE mark. BSI's formal review will begin in the first quarter of 2024, according to the planned timeline, and I look forward to providing updates upon the conclusion of this process. We have also made substantial progress in our home market, Israel. The medical device division of the Ministry of Health, known as AMAR, is the regulatory body that oversees medical devices. On November 22, 2023, Nanox.ARC received AMAR approval from the Israeli Ministry of Health, and it is now registered as a medical device in the Israeli market. Following this approval, the Israeli Ministry of Health granted Nanox.ARC a free sale certificate, which is a requirement for regulatory submission in some markets. Turning to our clinical efforts, as previously disclosed, the second phase of collecting clinical sample images of multiple human body anatomies with the Nanox.ARC system deployed at Shamir Hospital in Israel is continuing. Additionally, Nanox reached an agreement with Beilinson Hospital, a part of Clalit Health Services, the largest health service organization in Israel, and one of the largest in the world. According to this agreement, a human trial designed to assess diagnostic capabilities of the Nanox.ARC in detecting chest and lung diseases will be launched at the Beilinson Hospital. All required Israel Ministry of Health approvals and Institutional Ethics Committee approvals have been obtained, and the trial is scheduled to commence by the end of 2023. Now, I would like to provide an update on our Nanox.AI business segment. We generated $141,000 in revenue during this quarter, and Ran will review it in more detail shortly. At the end of the quarter, we announced compelling study results which demonstrated that the Nanox.AI product found that approximately 60% of patients unknowingly had moderate to severe levels of coronary artery calcium, also known as CAC, a proven indicator of future cardiac events. The study was sponsored by Nanox.AI and conducted by Beilinson Hospital, utilizing Nanox.AI HealthCCSng, an FDA-cleared and CE-marked tool designed specifically for cardiac health assessment. HealthCCSng solution utilizes medical imaging data from routine chest CT scans to automatically quantify and analyze PAC, potentially offering an early detection mechanism for cardiovascular conditions and preventing cardiac events. In other Nanox.AI news, a 510(k) submission for Nanox fatty liver detection known as Health FLD was submitted in September and is pending FDA 510(k) clearance. Health FLD is designed to detect early signs of fatty liver diseases from routine chest and abdominal CT scans. These updates are highly promising, and I look forward to providing additional updates on the Nanox.AI business throughout 2024. Before turning the call over to Ran, I’d like to revisit one of the AI products agreements that we announced previously. In mid-2022, we announced a strategic agreement with Spectrum Health, now known as Corewell Health, one of the leading integrated delivery systems, to use our AI population health solutions. Corewell management reports that their team has successfully integrated the Nanox.AI HealthCCSng solution into their patient care flow, recognizing its significant value in identifying new patients with medium and high calcium levels on chest CT scans. We have also received similar positive feedback from another healthcare system using Nanox.AI solutions. And with that, I'd like to now turn the call over to Ran Daniel to review our financial results.

Thank you, Erez. We have reported a GAAP net loss for the third quarter of 2023 of $21.4 million, compared with a net loss of $19.1 million in the third quarter of 2022, which is the comparable period. The increase was largely due to a goodwill impairment of $7.4 million, an increase of $0.4 million in the sales and marketing expenses, which was offset by a decrease in our general and administration expenses in the amount of $5.6 million. Our non-GAAP net loss for the third quarter of 2023 was $9.4 million, compared with a net loss of $8.1 million in the comparable period. The increase was largely due to an increase of $0.4 million in the sales and marketing expenses and $0.31 million in other expenses. Revenues for the third quarter of 2023 were $2.5 million, and gross loss was $1.7 million on a GAAP basis. Revenue for the comparable period was $2.4 million, and gross loss was $1.5 million on a GAAP basis. Non-GAAP gross profit for the three months ended September 30, 2023, was $0.9 million, as compared to $1.1 million in the comparable period, which represents a gross profit margin of approximately 37% on a non-GAAP basis for the three months ended September 30, 2023, as compared to 46% on a non-GAAP basis in the comparable period. Revenue from teleradiology services for the three months ended September 30, 2023, was $2.2 million, with a gross profit of $0.2 million on a GAAP basis, as compared to revenue of $2.4 million, with a gross profit of $0.6 million on a GAAP basis in the comparable period, which represents gross profit margins of approximately 11% on a GAAP basis for the three months ended September 30, 2023, as compared to 26% on a GAAP basis in the comparable period. Non-GAAP gross profit of the company's teleradiology services for the three months ended September 30, 2023, was $0.8 million, compared to $1.2 million in the comparable period, which represents gross profit margins of approximately 36% on a non-GAAP basis for the three months ended September 30, 2023, as compared to 49% on a non-GAAP basis in the comparable period. The decrease in the gross profit margins on a GAAP and non-GAAP basis is mainly due to an increase in the cost of the company's radiology services and payments of incentive payments which the company paid to the company's radiologists engaged in the readings during the overnight and weekend shifts. During the three months ended September 30, 2023, the company started to generate revenue through the sales and deployment of its imaging systems, which amounted to $99,000, with a gross profit of $36,000 on a GAAP and non-GAAP basis, which represents a gross profit margin of approximately 37% on a GAAP and non-GAAP basis. Those revenues stem from the sales and deployment of our 2D systems in Africa. Research and development expenses for the third quarter of 2023 were $0.6 million, compared to $6.1 million for the comparable period in 2022. The decrease of $0.1 million was mainly due to a decrease in the cost of labor of $0.6 million, which was offset by an increase in the company's development of the ARC system's expenses in the amount of $0.5 million. Further, marketing expenses for the third quarter of 2023 were $1.1 million, as compared to $0.7 million for the comparable period in 2022. The increase was mainly due to our go-to market efforts in the US market in anticipation of the soft launch of our products in the US market. General and administrative expenses for the third quarter of 2023 were $5.0 million as compared to $10.6 million for the comparable period in 2022. The decrease of $5.6 million was mainly due to a decrease in our legal expenses in the amount of $2.9 million, largely as a result of the finalization of the SEC investigation, a decrease in share-based compensation in the amount of $2.7 million, and a decrease in the cost of directors and officers liability insurance premium in the amount of $0.3 million. Goodwill impairment for the third quarter of 2023 was $7.4 million due to the goodwill impairment related to the teleradiology reporting unit in the amount of $7.0 million, and the Nanox.AI reporting unit in the amount of $0.4 million, largely due to the increasing discount rate, and management estimates that it would take longer than we originally expected to generate robust growth of revenues, gross profit, and positive operating cash flow in the AI and teleradiology business segments. During the first nine months of 2023, we had accrued $0.7 million for future settlement expenses in connection with the SEC investigation. As previously discussed, the company and Ran Poliakine team, our Chairman of the Board of Directors, have reached a settlement agreement with the SEC. During October 2023, the company paid $650,000 in civil penalties under this agreement. Turning to our balance sheet, as of September 30, 2023, we have cash, cash equivalents, restricted deposits, and multiple securities of approximately $95.6 million, and we have a $3.3 million loan from a bank. We ended the quarter with property and equipment net of $45.1 million. As of September 30, 2023, we had approximately 57.7 million shares outstanding as compared to 52.1 million shares outstanding as of December 31, 2022. The increase was mainly due to the sales of approximately 2.1 million shares and warrants, the purchase of 2.1 million shares in a registered direct offering in consideration of gross proceeds of $30 million, a net proceed of approximately $27.1 million, and the issuance of approximately 255,000 ordinary shares to the former shareholders of USARAD under the amendment to the USARAD stock purchase agreement previously discussed.

Thank you all once again for joining our call today and for your ongoing support of Nano-X. We are making significant progress toward deployment of the Nanox.ARC system at scale in both the US and other markets, and I'm looking forward to our Investor Day next week and our Q4 update call in early 2024. If you would like to register for our Investor Day or meet with the Nano-X team while we are in the New York area, please contact our Investor Relations partners at ICR Westwicke. Have a good day. Operator, please open the session to Q&A.

Our first question will come from Jeff Cohen of Ladenburg Thalmann. Your line is open.

Good morning, Erez, and Ran. How are you?

Great.

Good morning, Jeff.

So, a few questions from our end. You spoke about a government agency and some security screening, and this may be a stupid question, but is that for people or is it for goods such as luggage?

No, we indicated last time - by the way, it's the same agency that acquired the first one and the first trial was successful, so they now go to the next step. We don't know exactly what's the purpose of their use. The only thing that we know is that the indication that we got is that it's for some kind of defense, but we don't know exactly what it is for. So, that's all I can say.

Okay, got it. And can you go back to your EU submission and notified body? Walk us through the timeline there, as all the documentation has gone in or will be going in shortly, and what would you anticipate on a timeline being that there's some further precedent in the US now?

So, in a way, we are kind of ahead of what we anticipated to do it next year. We have already submitted all the information. The way it goes is that the notified body opens a kind of window or a site that you upload all the information. It's thousands of pages. Then once all the information is uploaded, you go through questions, further visits at the site, and all kinds of checks. I don't want to give any specific timeline. We have been saying all the time that regulation in medical equipment is something that is always challenging and very complicated and has a lot of facets, but we assume that with the quality of the information, the quality of the clinical trials that we have, and the quality of the ISO that we passed, all of this will be reasonably faster than originally expected. I have an estimation, but I think it would be better to wait until we get better clarity in 2024.

Okay. Is it safe to say you're hopeful currently that you'll get EU clearance in 2024?

Say from whose point of view? I would say that it would be reasonable to say.

Got it. Okay. And then lastly for us, could you go back to the Varex facility in Utah and talk about their capabilities there as far as anticipated number of units that could be assembled and produced per month or per quarter or per year?

So, as you know, Varex is the largest player in tubes for imaging in the world. I was there a few weeks ago. We had a long day session of the kickoff, both for the future roadmap of future breakthrough technologies, and the other thing is the continuous supply. From the capacity point of view, they will be able to supply whatever we need going forward. We're not going to be dependent on just one supplier. We will continue with our strategy to ensure that we have at least two or three suppliers for each one of the components that we have. So, the tubes will be included, and they will be a major supplier, but not the sole supplier.

Okay. Perfect. That does it for us. Thanks for taking the questions.

Thank you. One moment please for our next question. Our next question will come from Ross Osborn of Cantor Fitzgerald. Your line is open.

Hey, guys, good morning. Congrats on the progress. Thanks for taking our questions, and hope your loved ones and employees are safe as possible given the war. So, starting off with the New Jersey Imaging Center, would you provide some more color on the types of patients the center manages and when we can expect the center to be up and running at scale?

Okay, up and running right now. The second is at scale right now is what we are focusing on, and we hope that it will be at scale probably by the end of the year or the beginning of next year in January. We are planning to open this site for demonstrations for people who would be willing to visit and see. I would say this will be another solution that we have managed to create since right now in Israel, although we do business as usual and everything that we're planning, some visits that were supposed to come to Israel have been postponed. So, they will be able to come to New Jersey and see us. It's going to be a friendly environment for us to ensure that we're going to take all the benefits of the proof of concept, both for demonstration purposes and for operations. We mentioned also that as we speak, we are making the next installations before the end of the year. The go-to-market strategy and action plan in the US is up and running. We're building the team, we signed the agreement, and we aim to scan the first US patients in the coming days. We have all the necessary approvals, but this is something that we're planning to do. We have managed to get all the certification, finding the physicists to enable us to commence the scanning of patients, etc. So, it’s good. We are happy with it.

Sounds great. And then turning to Morocco, can you discuss the level of utilization in terms of scans per day or your metric of choice there, and then the amount of systems you have delivered to date?

I think that's something that we will shed light on in the Investors' Day next week.

Okay, fair enough. Looking forward to that. And then maybe …

But basically, right now, it's in line with what we anticipated.

Okay, got it. And then starting to think about next year, given some of your recent manufacturing agreements, when should we expect an inflection in system deployments and expansion into new geographies outside of Morocco, Ghana, and Nigeria? Just trying to get an understanding of system placement cadence for 2024, given you're now commercial and have contracts with these geographies for hundreds of systems.

So, you asked about next year. I think we have indicated already that we're starting the planning to work to fulfill the orders that we had originally mentioned. The agreements that we have, in each one of them we're making progress in terms of the regulatory approvals. Some of them will be in other countries in Africa, some in Latin America, and part of them will be in Asian and European countries that are not dependent on the EU. So, that's the plan so far. But it all depends on the process and progress that we made with the regulatory approvals, but this is also something that we will give some more color on next week.

Sounds good. Thanks for taking our questions.

Thank you. Again, one moment please for our next question. Our next question will come from Ben Haynor of the Alliance Capital Partners. Your line is open.

Good day, gentlemen. Can you hear me okay?

Yes, Ben. Good morning.

Great. So, just looking to understand the Nanox.ARC revenue a little bit better for the quarter. It sounds like some of that came from sales. So, if you could give me a sense of - or give us a sense of how much capital revenue was included in there, and then would you expect the revenue that you're generating out of Africa from these systems to grow from the Q3 level going forward?

Yes, so you referred to the $99,000 that we recorded in the quarter. Correct?

Correct, yes.

Okay. So, that actually stems from the sales revenue from our 2D imaging systems. The split is between three countries. The first one is Cameroon. The second one is Morocco, and the third one is Ghana. We're talking about a few systems in each region. Some of the revenue comes from the sales of those units, and the other portion comes from the usage of those units.

Okay. I guess what I'm getting at - that's helpful, but what I'm getting at is, would you expect the revenue from those systems to pick up from the $99,000 level, the ones that are currently in those geographies?

Generally speaking, yes, because some of those systems are provided for demo and training purposes, and we expect those units to become commercially used. Of course, we'll add more units along with them. We also expect to start generating revenue from the ARC systems themselves in those regions and in the US. By the way, the number of scans per day where they’re operational is actually exceeding our original expectations.

Okay. That's good to hear and helpful. And then just on the Varex agreement, I was curious about the minimal annual amount on that. Is that something that's relatively easy to achieve, or is it kind of a small fraction of the anticipated utilization, or what's the right way to think about that?

Easy from whose side?

Sorry, say that again?

From your point or our point of view?

Well, maybe both.

Well, first of all, we have not disclosed the details of the agreement yet, but we'll add more details in our next 20F. What can I tell you? There's some formula over there that is going to involve some minimums, but not at this moment. Yes, and some percentage, but we don't want to delve into that just because the way we structured the agreement is very beneficial for us in terms of managing our business.

Okay, fair enough. I think that's all we have.

You have to remember that it's a long-term agreement. There's a build-up in the agreement in a way that both sides can execute.

Okay, got it. But I think that’s all we have. So, we'll see you guys at the NYC next week.

Thank you. And that is all the time we have for questions, thus ending the Q&A session. I would now like to turn the conference back to Erez Meltzer for closing remarks.

So, thank you all for being with us today. Looking forward to seeing part of you and that the others will be able to hear next week when we have the Investor Day. We are going to shed light on technology, the go-to-market in the US, operations, as well as clinical updates. Management will present there. So, see you next week, and thank you for being with us and for the support of Nano-X. Good day.

This concludes today's conference call. Thank you all for participating. You may now disconnect and have a pleasant day.