Nano-X Imaging Ltd. Q2 FY2022 Earnings Call

Good day, and thank you for standing by. Welcome to the Nano-X Imaging Second Quarter 2022 Earnings Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Mike Cavanaugh, Managing Director of Investor Relations. Please go ahead.

Good morning, and thank you for joining us today. Earlier today, Nano-X Imaging Limited released its financial results for the quarter ended June 30, 2022. 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 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 to GAAP measures is provided with our press release, with the primary differences being goodwill impairment, change in obligation in connection of the merger and acquisitions, stock-based compensation, amortization of intangible assets, and class action litigation and SEC and COVID-related expenses. I'd now like to turn the call over to Erez Meltzer.

Thank you, Mike, and thank you all for joining us on the call today. As always, we appreciate your continued support of Nano-X. As in our last call, I will give an overview of our recent achievements and share our outlook on the coming months before turning the call over to Ran Daniel, our Chief Financial Officer, to review our financial results. We have continued to make progress during the past quarter to advance the Nano-X ARC system towards commercialization, and we continue to proceed full force ahead to make headway in the FDA clearance process. On the call today, I will discuss the advances we have made since our last earnings call by breaking my comments into three distinct segments: regulatory, commercialization, and finally AI and teleradiology. I will discuss what we have done in each of these segments and how we have moved closer to our goal of system deployment at scale. Before I do that, I'll touch on our financial results at a high level, but we will leave most of the details to Ran’s commentary later in the call. Nano-X generated top line revenue of $2.2 million in the second quarter of 2022, compared to $1.8 million in Q1 2022. As in the previous quarter, all revenue was generated by Nano-X teleradiology services business unit and by Nano-X AI, our deep learning machine analytics company. As most of you know, these business units began generating revenue since their acquisitions in November 2021, and it's gratifying to see our teleradiology services growing quarter-over-quarter. These revenues, while relatively small at this time, are important for two reasons: First, they help us to improve our cash flow and its management. And second, we believe they demonstrate that customers and other stakeholders such as hospitals and integrated health systems value these services, which in turn strengthens our belief that these applications and services will add value within our multisource system when integrated with our proprietary imaging technology. I'm happy to report that during the second quarter of 2022, we signed 14 new client agreements for teleradiology services. Our clients in the teleradiology segment include hospitals, outpatient imaging centers, urgent cares, multi-specialty physicians groups, research facilities, and mental health facilities. We continue to see accelerated revenue growth in our teleradiology services, driven by new client additions as well as organic growth from existing clients. The AI solution business continued to gain traction both in the U.S. and abroad. For example, Nano-X had its first go-live at five Northwell Health Outpatient Centers on July 26th, followed by South Shore Hospital on August 8th. Additional hospitals and outpatient sites throughout the system are anticipated to go live throughout the remainder of August and into September. In addition, we previously reported a large strategic agreement with one of the leading IDNs in the Northwest of the U.S. to use our AI population health solution; we can now share that this customer is Spectrum Health, an integrated healthcare network based in Michigan with 15 hospitals and health facilities. I'd now like to discuss our progress on the regulatory front. Beyond the beneficial revenue streams, I just mentioned, we made further progress in our efforts to gain FDA clearance for the Nanox.ARC multisource system. Recently, we received feedback from the FDA on our Q submission supplement that we previously submitted to the agency. The feedback we have received has been valuable, and it's helping us to optimize our 510(k) submission. Subsequently, we are now preparing our 510(k) submission to the FDA for our multisource Nanox.ARC, which we expect will have the full power levels and indications that we believe will result in a successful deployment of the Nanox.ARC. In parallel, we are preparing for the global deployment of our multisource Nanox.ARC according to local regulations and subject to requisite approval in each market. Regarding regulatory efforts to obtain the CE mark for Nanox.ARC, we have submitted all necessary documentation to begin the process for CE marking. We look forward to providing additional updates as this process advances. Moving on to commercialization, we have continued to progress toward commercialization of the multisource Nanox.ARC in several areas. I'm happy to announce that we have taken steps to advance deployment of the multisource Nanox.ARC in Nigeria. In April, we sent a preliminary deployment team to be on the ground there and are preparing to send our first commercial unit for demonstration and training purposes. Our shipment plan to Nigeria is progressing hand in hand with a local relationship process. I also have the pleasure to announce another new agreement that we have signed recently with a distributor in Ghana, under which we agreed to deploy 350 units subject to local regulatory requirements, which brings our total contracted units to 68,150 worldwide. This is a great milestone for the company, and we are pushing forward on the development and the deployable system to fulfill these orders. We believe that once we begin to deploy the multisource Nanox.ARC in Nigeria and other early adoption areas, health systems, hospitals, and distributors will see the service that the Nanox.ARC provides and that we will then begin to fulfill the backlog of orders that have built up. Additionally, we have an agreement in place with a non-governmental organization, Bio Ventures for Global Health, known as BVGH, for developing and implementing a medical imaging training initiative in Nigeria. BVGH is a Seattle-based non-profit organization that strategically develops and manages programs across the full profit and non-profit sectors to accelerate research and development for poverty-related diseases, build biomedical R&D capacity in low and middle-income countries, and improve cancer patient care in Africa. Some new collaborations and developments. Finally, I'd also like to take a minute to announce another milestone on the path to commercialization that we are excited about. We are in the process of establishing a technology development center based in Israel to develop the chips and the tubes that will be used for the Nanox.ARC in the years to come. This center will complement our facilities in Korea and Japan. To close my remarks, I wanted to thank the Nano-X team for all their hard work and progress achieved in this quarter. But most of all, I want to thank all our investors for their continued support for our mission to democratize healthcare by making imaging affordable and available anywhere in the world. We look forward to reporting more progress on our next earnings call. With that, I would like to turn the call over to Ran Daniel, Chief Financial Officer, to review our financial results.

Thank you, Erez. First, I'm delighted to announce that we were added to the Russell 2000 and Russell 3000 Indexes, effective after the U.S. market opened on June 27th as part of the 2022 Russell indexes annual reconstitution. This is a great development for our company. As for our financial results, we reported a GAAP net loss for the second quarter of 2022 of $19.6 million, compared to a net loss of $13.6 million in the second quarter of 2021, largely due to expenses related to the acquisition of the Nano-X market platform in November 2021. The consolidation of Nano-X AI and USARAD with the company since the fourth quarter of 2021 and increasing research and development expenses, goodwill impairment, and an increase in our general and administrative expenses which was mitigated by a decrease in our sales and marketing expenses and a decrease in our obligation in connection with mergers and acquisitions. Our revenues for the second quarter of 2022 were $2.2 million and gross loss was $1.8 million, revenue from teleradiology services for the period was $2.1 million with a gross profit of $0.0 million on a GAAP basis and a gross profit of $0.9 million on a non-GAAP basis, which represents gross profit margins of approximately 43% on a non-GAAP basis. Revenue from licensing of AI solutions for the period was $0.1 million with a gross loss of $2.1 million on a GAAP basis and $0.1 million on a non-GAAP basis. Research and development expenses for the second quarter of 2022 were $6.5 million, compared to $4.3 million for the comparable period in 2021. The increase in our research and development expenses was mainly due to the consolidation of Nano-X AI with the company since November 2021, increasing our share-based compensation and the balance due to the development of the multisource Nanox.ARC system and Nanox.CLOUD. Sales and marketing expenses for the second quarter of 2022 were $1.1 million, compared to $1.8 million for the comparable period in 2021. The decrease was mainly due to a decrease of $0.6 million in our share-based compensation. General and administrative expenses for the second quarter of 2022 were $11.1 million, compared to $7.4 million for the comparable period in 2021. The increase of $3.7 million was mainly due to the acquisitions of the Nano-X market platform in November 2021, the consolidation of Nano-X AI and USARAD with the company since the fourth quarter of 2021, an increase in the company's headcount and the overall organization infrastructure, and an increase in the company's legal fees due to the U.S. Securities and Exchange Commission Inquiry and the class action litigation as described in the company's Form 20-F for the year ended December 31st, 2021 filed on May 2nd, 2022. The change in obligation in connection with mergers and acquisitions for the second quarter of 2022 was $2.6 million, compared to none for the second quarter of 2021. The increase was mainly due to the change in the company's contingent earnout liability. Goodwill impairment for the three months ended June 30, 2022 was $14.3 million, due to the goodwill impairment in connection with the acquisition of Nanox.AI. Our non-GAAP net loss for the second quarter of 2022 was $8.2 million, compared to a non-GAAP net loss of $8.6 million for the same period in 2021. A reconciliation between GAAP net loss and non-GAAP net loss for the second quarter of 2022 and 2021 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 is mainly due to goodwill impairment, change in obligation in connection with mergers and acquisitions, amortization of intangible assets, share-based compensation expenses, legal fees in connection with the class action litigation and the SEC inquiry and the secondary offering expenses. Turning to our balance sheet, as of June 30, 2022 we had cash, cash equivalents and marketable securities of approximately $126.7 million. We ended the quarter with property and equipment net of $42.9 million, compared to $37.4 million as of December 31, 2021. The net increase of $5.5 million during the first half of 2022 is mainly due to the completion of the construction of the company's fabrication facility in South Korea and the purchase of machinery and equipment. As of June 30, 2022, we had intangible assets of $140.5 million, as compared to $160.1 million as of December 31, 2021. The decrease is mainly due to the periodic amortization of intangible assets and impairment of goodwill. As of June 30, 2022, the company had approximately 52.2 million shares outstanding, compared to 51.8 million shares outstanding as of December 31, 2021. The increase was mainly due to the exercise of 192,927 warrants and the exercise of 141,067 options. The company generated approximately $0.5 million in gross proceeds from the exercise of such options and warrants. In addition, during the first half of 2022, the company issued 89,286 shares to the former equity holders of Nanox.AI, due to the achievement of a milestone pursuant to the terms of the Agreement and Plan of Merger, dated August 9, 2021, as amended, among the company, Nanox.AI, and Perryllion Ltd., as representative of Nanox.AI’s equity holders. With that, I will hand the call back over to Erez.

Thank you, Ran, for the financial update. And once again, thank you all for joining us today. I feel very good about Nano-X's results in the second quarter; as CEO, I recognize there is more to do. We hope to provide additional updates in the coming weeks and months. I would also like to share with you all that the Nano-X management team will have a non-deal roadshow with investors in late September; if you would like to schedule a meeting, please contact our Investor Relations partners at ICR. With that, I'd like now to open the call for questions. Operator, please begin the Q&A session.

Thank you. Our first question comes from Jeff Cohen with Ladenburg. Your line is now open.

Hi, Erez and Ran. How are you?

Great, and yourself?

Just fine. A couple of questions from our end. So could you talk about the technology center you're planning on opening in Israel and the capabilities that you anticipate there versus the current and anticipated capabilities in the facilities in Korea and Japan?

First of all, it's going to be very similar, but we're going to strengthen the fact that we are willing to base our future on further advanced technologies. Right now, we have both centers in Japan and Korea for the chips and the tubes. We thought that it would be appropriate that the core technology and knowledge will be developed very close to where we do the R&D, product design, roadmaps, our future products, etc. And that Korea will be more focused on manufacturing and supply for the chips, with further development that will be on the engineering side.

Okay, got it. Could you talk about ARC manufacturing and the number of ARCs that have been manufactured, and maybe the anticipated number of ARCs manufactured by the end of the year? And then tie that into your anticipated timeline at the FDA as far as your product today?

We are increasing production as previously stated. We are aware of the market realities, including the supply chain and the various components involved in assembly. Some of the systems will be pushed to early 2023. Before the year ends, we plan to make progress towards mass production, aiming for more than 1,000 units in one or two locations outside of Israel. The first 1,000 units will be assembled in Israel, and we expect to establish arrangements for the assembly of all systems following those units either in Q4 or Q1 of next year. Regarding the FDA, I was pleased with the meeting we had last week, which was an important step before our final submission preparation. The feedback from the FDA was very helpful and significant for us. We are in the final stages of preparing for our formal submission, which will align with our future plans. I believe that engaging in continuous dialogue with the FDA over the past eight months was a wise decision as we move forward.

Got it. And then finally, talk about Ghana as far as manufacturing and delivering ARC units. How many would you expect to be delivered there in the coming quarter or two?

Right now, I would say that we explained in the past that not all the countries that we're working in require FDA regulation, like we mentioned, Nigeria, one of them, and Ghana will be another one. We have another two that are not really related to the submission of the formal approval of the FDA. Ghana has a special process that we are going through; they gave us indications, but I wouldn't actually commit until I see it with my own eyes. We hope to have the approval to send the systems during the fourth quarter. I would say the starting gun for next year will likely be to send more systems. Overall, the agreement is for 350 units.

Got it. And then one quick question for Ran. Would you expect any goodwill impairment in the back half of the year for Q3 or Q4?

As we say in the press release, it really depends on the market parameters, but the interest rates, yes, there will be an increase, or there will be any change in other capital market formats. So we may have to do an impairment again; we have to test it at least. It also depends on our internal management estimate.

Okay, perfect. That does it for us. Thanks for taking the questions.

Thank you, Jeff.

Thank you, Jeff.

Thank you. Our next question comes from the line of Suraj Kalia with Oppenheimer. Your line is now open.

Good morning, Erez, Ran. Can you hear me alright?

Loud and clear.

Perfect.

Perfect. Hope everyone is safe and healthy. Hey, so, Erez, just following up on Nanox.ARC's multisource submission. Was the full power level ever in doubt? Maybe I'm misreading your comments on the feedback from the FDA. If I remember correctly, last quarter, I think you all mentioned that from 40 to 120 KVP, it would cover the entire gamut. So maybe if you could kindly shed some additional light on your specific comments on the full power level feedback?

First of all, I hope that I understand the question, but it has never been in doubt.

Okay, fair enough. So, Ran, can you provide a timeframe for when the multisource 510(k) will be filed and when you expect to receive clearance?

As you know, I can only commit to things that I am completely certain will be on time. Currently, I believe I have provided enough background and information regarding the timeline. We are in the final stages of preparation for the submission, which will be completed soon. I think the positive feedback we've received from the FDA has allowed us to include a few additional elements in the submission, which will be integrated into the system over the next few weeks. Therefore, I anticipate that the submission will happen shortly. Once it is submitted, I am confident you will be informed.

So you will file more than likely in Q4?

You said so? Basically, I'm always trying to do things earlier on all level and all fronts.

Erez, the CE Mark, generally speaking, companies have voiced a lot of concern; just the MDR process has become very cumbersome. CE process has overall become very cumbersome, and maybe I missed it in your prepared remarks on the updated timelines for CE Mark for Nanox.ARC multisource?

We have submitted all the necessary documentation for registration with the notified body and have selected that body. We provided them with all the required information. In my earlier days, I learned the importance of taking control where possible and being patient where it's not, while hoping to gain the wisdom to know the difference. This applies to both the CE and the FDA processes. We don’t have control over the CE or the FDA, and we hope that their current system overload won't negatively impact us. We trust that the preparations we've conducted over the past few months will yield results sooner rather than later.

Got it. Erez, I have two final questions and I'll go back in the queue. In regards to Ghana, what validation testing has been completed before you start shipping these units? Also, about the 6,850 units you mentioned regarding contractual amounts, if I recall correctly, a significant portion of these contracts are over three years old, from 2019. Could you clarify whether they are still valid or if there have been any amendments? Any additional information would be greatly appreciated. Thank you, gentlemen, for taking my questions.

Okay. So first of all, I'm not sure about the first question about the validation. What exactly are you referring to with respect to the systems that we check? The answer is yes. So I would say positive to the second question. With respect to the clearance in the region, are you referring to what kind of validation in terms of technology or in terms of regulation in Ghana?

No, Erez, what I meant was before you launch any product commercially, you have to go through a slew of testing, performance testing.

Yes, yes, of course. Yes, yes. The answer is basically yes.

Thank you. Our next question comes from the line of Rahul Rakhit with LifeSci Capital. Your line is now open.

Hey, guys. Thanks for taking the question. So you mentioned that there are two other countries that don't necessarily require FDA clearance for deployment. Maybe if you could talk about where you are in conversations in those geographies and provide any indication on timing there?

The answer is no, because since we have not announced it to the public, as soon as we are going to announce that the public will actually share. My preference would be that only when we sign agreements we let the market know. In the past, you know that in the 20-F there are a few countries which do not necessarily need the FDA.

Right, right. Okay, that makes sense. And then really excited to hear about some of these AI agreements that you guys announced. Maybe could you help us think about the broader revenue potential there? I mean, it's obviously big health systems; what does integration look like there? And ultimately, what is the broader revenue opportunity?

So first of all, with respect to integration, I think we mentioned this in the script in the 6-K that we have already implemented a few and installed the system over there. There is a timeline right now in the next few months. I think the last one is going to be in October and November. November will be the last month that we're going to install the system in all the hospitals that Northwell has given us as part of the plan. In terms of business model, it can vary anywhere between a few hundred thousand dollars to a few million dollars in scale.

Got it. Okay. I appreciate that. And then just based on a lot of the Q&A so far, it sounds like the conversations with the FDA have been very fruitful. I know you don't want to lock in on a specific timing for the submission. But maybe can you help us understand what the impact of these conversations in the Q submission has had on the actual timing of the decision? So once you do submit the 510(k) filing, how long do you expect it to take to actually obtain FDA clearance from there?

I believe that ideally, in a reasonable market and timeline, the Q submission would be valuable for us as it helps expedite the process. However, we understand the workload the FDA is facing, and our ongoing cooperation with them leads me to hope that it will ultimately benefit us. Overall, I feel that the process has positively influenced what I hope will be a favorable outcome in the clearance process.

Got it. Makes sense. Appreciate it.

Thank you. That's all the time we have for questions today. I'd now like to turn the call back over to Erez Meltzer for closing remarks.

Once again, I'd like to thank you all for being part of this call today. We'll see you shortly for those of you who are in the U.S. sometime in September, at the end of September. We're always willing to address any questions that may come from investors or any audience related to our activities and what we are doing so far. Thank you so much, and have a great day.

This concludes today's conference call. Thank you for participating. You may now disconnect.