Good day and thank you for standing by. Welcome to the Nanox Fourth Quarter 2023 Earnings Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to Mike Cavanaugh, Investor Relations. Please go ahead.

Good morning and thank you for joining us today. Earlier today Nano-X Imaging Limited released financial results for the quarter ended December 31, 2023. The release is currently available on the investor 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 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.

Thanks, Mike. And as always, thank you all for joining us today for our financial result call and corporate updates. Before we get started I would like to take a minute to acknowledge the passing of our founder Ran Poliakine back in January. We all owe him our gratitude, and I'm proud to lead our team as we seek to realize his vision of making medical imaging more accessible to improve early detection and treatment to help people achieve better health outcomes. My remarks will be a bit longer today than usual and I will provide a lot of details on the various business aspects of Nanox. As we share our fourth quarter update and review our financial results, I am extremely proud of the progress our team made over the course of 2023, highlighted by the exciting milestone of FDA clearance for the Nanox.ARC, a clear validation of our technology and mission and our first steps in the U.S. commercialization. On today's call, we will be focusing on our fourth quarter activities, as well as some of our achievements in early 2024, a year which I expect will be a transformation of Nanox. We are now in the process of expanding our commercialization of the Nanox.ARC system and are aiming for a steady increase in deployment as we raise awareness of the Nanox solution. Nanox is dedicating to accelerating the implementation of our commercial infrastructure and future strategic plans in the U.S. Our mission is to provide healthcare practices with a game-changing advantage through the Nanox.ARC and accessible cost-effective solution that not only provides advanced diagnostic imaging capabilities, but also elevates overall patient care. I'd like to start our call with an update on our U.S. deployment activities. As we have disclosed in the past, we have already deployed…

Thank you, Erez. We reported a GAAP net loss for the fourth quarter of 2023 of $10.2 million, which is the reported period, compared with a net loss of $52.8 million in the fourth quarter of 2022, which is the comparable period. The decrease was largely due to a goodwill impairment of $36.5 million and an accrual of $8 million in connection with the settlements of the cloud section which were recorded in the comparable period and a decrease of $4.4 million in the general and administrative expenses. Revenue for the fourth quarter of 2023 was $2.4 million and gross loss was $1.7 million on a GAAP basis. Revenue for the comparable period was $2.1 million and gross loss was $1.8 million on a GAAP basis. Non-GAAP gross profit for the reported period was $0.9 million, as compared to $0.8 million in the comparable period, which represents a gross profit margin of approximately 36% on a non-GAAP basis for the reported period, as compared to 39% on a non-GAAP basis in the comparable period. Revenue from the teleradiology services for the reported period was $2.3 million with a gross profit of $0.3 million on a GAAP basis, as compared to revenue of $2.1 million with a gross profit of $0.3 million on a GAAP basis in the comparable period, which represents a gross profit margin of approximately 14% on a GAAP basis for the reported period as compared to 13% on a GAAP basis in the comparable period. Non-GAAP gross profit for the company's teleradiology services for the reported period was $0.9 million, as compared to $0.8 million in the comparable period, which represents a gross profit margin of approximately 38% on a non-GAAP basis for the recorded period, as compared to 40% on a non-GAAP basis in the comparable…

Thank you all once again for joining our call today and your continued support of Nanox’s mission to make medical imaging more efficient, accessible and affordable worldwide. It has been two years since I stepped into the CEO role. And when I came here, Nanox was in a very different place. In just this year, we achieved an important milestone of ADA clearance and are seeking to potentially expand the use case for ARC with the FDA. We are also deep into the process of pursuing CE Mark designation in the European Union and have received local regulatory clearances in other countries like Ghana. We've also begun commercialization, earnest and RX systems are now deployed for the use by imaging center and hospital systems in Israel, three countries in Africa. And as of today's call, we know we have numerous deployed systems in the U.S. Over these two years, we have integrated our AI strategy across the company. Our leading Nanox AI solution provides the ability to use AI to highlight and help identify patients with asymptomatic undetected chronic disease, initiating early diagnosis and preventative management. In this year, we also achieved two FDA clearances, a substantial clinical validation of our AI solution. We understand this has been a long road, but our progress is tangible and we are very excited for even more progress in 2024. Before I end the call, I have 1 last piece of news to share, and this is something many of you have been anticipating. On Wednesday, April 10, we will demonstrate the use of the installed ARC system, a dynamic medical imaging in Union, New Jersey, beginning at 9:30 a.m. The demonstration will be followed by a roundtable discussion. Please contact our Investor Relations partners at ICR Westwicke if you are interested in attending, and note that space is limited. With that, I thank you once again and bring our fourth quarter and full year 2023 investor call at close.

We will now conduct the question-and-answer session. [Operator Instructions]

Just before we dive into the Q&A session, I would like to mention that we have updated our website with interesting clinical pathologies from the U.S. commercial site and CHEST from our clinical sites. In the U.S. sample, we note enhanced visualization, compared to traditional radiography. One example is cervical spine scan. Additionally, you can find the CHEST study from the Beilinson clinical trial. And in the CHEST study, while the X-ray only frankly shows a lesion, this lesion was clearly visualized on the Nanox.ARC images and in the CT scan of the patient scheduled for biopsy. So take a look and feel free to see it as well. Q&A?

Our first question will come from the line of Ross Osborn with Cantor Fitzgerald.

Hey guys, congrats on the progress and thanks for taking our questions. So starting off with ARC, would you discuss how many systems in the U.S. are operational across the five states deployed in during the fourth quarter? And also provide us with how 2024 has progressed thus far in terms of placements and visibility into your pipeline or backlog of orders? Thank you.

So Ross, we have already indicated that along the year, we will add more details. So far, we have not informed exactly how many systems. We just say that we have systems installed right now in five states. The one thing I would say is that we have already manufactured a few dozens of systems. And we have the systems installed in the clinical facilities as indicated. Next, I would say that in the next meetings, I will probably mention and give you more numbers. The numbers that we gave so far are scans per day, the dollars per scan, and the few dozens that were already been sold and shipped to the various locations.

And Ross, mind you that there's a difference between the amount or the number of the installed systems to the ones that are operated commercially since there's a gap of time between due to the local or state registration requirement.

Understood. And then maybe could you provide some color on what types of centers are adopting ARC, and how utilization has trended thus far, and their level of comfort with $30 per scan?

Yes. We actually. We can. So we have small and medium-sized medical imaging centers right now. One of them is big. And the other thing that we can indicate is that the -- what else do we have? Yes, I think that's most of them, yes. If I actually screen all of them, all of them are these type of clinical areas. The other one that we have is in the Georgia site of 626. And I would say, yes, a few installations are in orthopedic clinical centers. And yes, that's the numbers.

Got it. And then lastly for us, would you remind us of the economics on Connect, given your agreements in Peru and Mexico in terms of whether that's going to be a capital sale or MSaaS? And if it is MSaaS, how should we think about...

Most of them are MSaaS models in the same manner that we apply to the ARC. Sometimes, we do a capital sales model with regards to Connect. But as I said, most of them are MSaaS models.

Ross, it depends also on the countries. In certain countries, especially in Africa, we make a decision to sell the system. In a few of them, we sell for partial amount and then charge per scan. We have various models on the Connect.

Okay, got it. Thank you for taking my question.

No welcome.

Our next question will come from the line of Jeff Cohen with Ladenburg Thalmann.

Hi, Erez and Ran. How are you?

Good, good.

So I did want to follow-up on a couple of Ross' questions. Could you talk about Connect a bit in a little deeper scale and give us a sense of Connect versus ARC and how you anticipate both those platforms to play out both in the U.S. and OUS?

Okay. Right now, the connect is being sold outside of the U.S. Once the Connect is going to get the FDA in the U.S., we're going to sell it in the U.S. as well. We have right now Connect in more than 10 countries right now. And a lot of them are Africa, part of them are Latin America and in Israel. First of all, the purpose of the Connect was to extend or expand the line of products that we have. And the beauty of what we sell in the Connect is that we sell it not only as a piece of equipment, but bundled with AI system included in what we sell. So the system can analyze the image itself. In addition, we have systems that were sold in Morocco, for example, and it was used in the earthquake by the customer that the body there. It was used also in Israel in various extreme situations, when you can do a test in the field or screening in the field. And the idea behind them is twofold. The first one is that we say that sometimes we get the Connect and later on, we get the ARC, and second is the inclusion or how do we build the AI system into the imaging itself. And in terms of the process of the Connect, it's the same process. Sometimes they get the registration just before the ARC, sometimes after the ARC. If you take the Connect examples in Africa, in one or two countries, we have achieved, with the Connect, one of the countries a few days that the number of scans per day were above 120. And these are examples that can enable us actually to penetrate some clinics before. I will actually reemphasize the fact that for us, it's really gratifying to see that the ARC and Connect, the fact that they are marketed together as we envisioned from the very beginning, it's basically complementary and very beneficial for what we do. The fact that we are very flexible in terms of the business model and the hybrid model, the MSaaS and the CapEx-based sale, this actually adds a lot of value for us as well.

Sure. So I guess, Erez, what you're saying is depending on clearances that you would anticipate a lot of sites to or maybe the majority of sites to have both types of deployments, ARC and Connect?

I would not say majority because sometimes some country or would like to use the Connect more than the ARC. But I would say that in Latin America and in the U.S., it will be mainly ARC. In the rest of the world, we will see a lot of countries that will sell the Connect. Sometimes there's preparation to get access to medical imaging, because that's the mission that we took upon ourselves and we're trying to get it in various ways that as we do. But we saw a few countries that at the beginning was with the Connect and then we were able to sign for the ARC.

Got it. And could you clarify previous comments on manufacturing? Was that 2,000 systems manufactured?

No, no, no. We said that we have a few dozens of systems that were already manufactured. We are in the process of manufacturing a few more dozens. And if you think about the long-lead items and if you think about the availability of parts, this enabled us actually to cover the pace of the installation that we are doing right now. If you remember, in the Investors Day, we said that we are going in a very conservative approach. We don't have a second chance to make a first impression, especially not in the U.S. So we are installing the systems, we are analyzing the data. We are adding and improving the process of the installation. We have been able to shorten the time that we install the systems. We are getting -- we are negotiating right now another service company that will have a better coverage for the U.S. We have gained a lot of access or the ability to control the systems also from remote. We are opening the call center that will enable us to serve best these units we are increasing exponentially the number of people that are in the sales and the service team, and we are continuing to expand our professional teams and recruited personnel. And last but not least is that we have to, of course, to work on the referrals and to ensure that people will be aware of the changes that we are doing in the standard-of-care, and we'll do it professionally.

Got it. And lastly for Erez, any commentary on 2024 as far as first quarter sequential revenue changes, et cetera, et cetera? Thank you.

Yes. So first of all, part of the indication that I gave are where we are so far. And so the number will be growing. We are focusing on generating more revenues, more installations and more scans in the current installation in the systems that we're going to install. And I believe that next quarter, we'll be able to share more detailed update and as well as numbers of where we are and what's the process that we are heading. Right now, we are making progress according to the plan and exactly according to what was presented in the Investors Day. As you can imagine, we are right now, based on best experience, we are much more careful and conservative in what we say, what we indicate and we're trying to ensure that whatever we promise will be delivered.

Super, thanks for taking our questions.

[Operator Instructions] Our next question will come from the line of Anthony Petrone with Mizuho.

Thanks and congratulations on the strong end of last year and strong start to this year. Maybe, Erez, just on the utilization per system for Nanox.ARC, you mentioned $30 per scan, and some of the early systems are doing seven scans per day. Just on how you expect that to scale, which areas are you seeing utilization? Is it more on the orthopedic side? Are you seeing it in chest X-ray? Just a little bit on where you're seeing the early use cases for Nanox.ARC, and how you see that scaling over the 2024? And then I'll have a couple of follow-ups. Thanks.

Okay. No disrespect to the others, but great question. First of all, I can say that seven scans per day is actually the model that we built and it seems that from the early installations, that's what we see. I would say, however, more than that, but we had, in medical imaging centers, which are professionals and there are people who really understand what we are doing, we had days with 15 scans per day. So this is at the beginning. In terms of the dollars per scan, this is the $30 if you remember, compared to the $14 to $17 in the rest of the world. So U.S. is about $30. And this is in line of the CPT code and the reimbursement that could be generated, which actually leaves a lot of room for us, for the center, for the medical imaging center, and for the radiologists. So these are the numbers that we see right now. With respect to clinical indications, I'd like to remind the following, okay? In the U.S., we have right now the MSK FDA. Unlike the rest of the world, that we do a lot in Israel, in Africa, in other places, we do chest, we do abdomen, we do skull, we do all other kind of indications. Our 2024 FDA submissions will include other indications as stated in the comment that I made in the very beginning. So based on, for example, Beilinson Hospital in Israel, we do pulmonology cancer screening, and this is actually part of the test samples that we are taking. We actually uploaded on our website these examples and also the cervical spine scan that we do. I have to be very careful because of the regulation, because of the FDA, and because of all the clinical work that we do with other places, but right now, for us, it seems that we're going to have even more clinical indications as we move forward than originally anticipated. Even some of them were not part of the original plan.

That's helpful. And I have a couple of follow-ups on AI solutions and specifically HealthCCS for coronary artery calcification at InterMountain. It's deployed there, and it looks like it's getting up and running. How do you see that progressing in 2024? And when we think about InterMountain, just in terms of the volume of patients they're seeing with coronary artery disease, how many cases do you think we'll actually see being analyzed in CCS over the next few months and how will it trend over the next few years as this collaboration with Intermountain Health evolves? Thank you.

Okay. So with AI, I suggest to read an article that our Chief Medical Officer wrote and another one that I wrote in the Forbes about the usage of AI. It seems that right now, not only us, but other companies in the AI business have like engines with really high power. But right now they are -- because of the implementation and the deployment and the adoption by part of especially the U.S. health economy, it's not fast enough, which will be able to generate more revenues to each one of the institutions. But people are afraid from this situation. By the way, I think that it is right for any or almost any other business elsewhere. But the adoption is slower than the ability to provide the services. With respect to the CCS, calcium scoring, right now, most of the experience that we have is mostly from Spectrum or from Corewell, which we gave these indications, and also from the U.K. So if I talk about the cardiac solution, I would say that 60% of the patients in the study were undetected previously with the risk. And finally, they were with a cardiovascular event from the chest CTs that were not diagnosed. And the other experience that we had with a lot of people that were diagnosed, 1 of them by the way was in TV in the media is Beilinson in Israel. And in the U.K., which was mainly for the bones for the osteoporosis. But what you can see is that the -- I think we published the results of the ADOPT and the other one in our website. Yes. You can take a look at the website and see the indication that we gave there with the number of patients that were not detected with cardiac diseases. And I think that this gives an indication of the ability to do. The one that was mentioned with respect to the bone solution is with the Oxford University and this was published that they had identified up to 6 times more patients with vertebral compression structure than that was indicated in the other CT scans that were there. So I think that the AI and what we do is getting a lot of attention, and the more we go into the future, we will provide as much as we can, because this is under a lot of privacy restrictions, but the more we can share with the public and the more the institution, including, by the way, Intermountain, which is relatively new, the more they give us the ability to share, we'll definitely share with the public.

Thank you again.

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