Nano-X Imaging Ltd. (NNOX) Q4 2024 Earnings Report, Transcript and Summary

Good day, and thank you for standing by. Welcome to the Nano-X Fourth Quarter 2024 Earnings Call. [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, 2024. The release is currently available on the Investors section of the company's website. With me today are Erez Meltzer, Chief Executive Officer and Acting Chairman; and Ran Daniel, Chief Financial Officer. 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 and clinical activities, 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.

Thank you, Mike. Thank you for joining us today for our financial results call. As always, we appreciate your continued support of Nano-X. During our call today, I will use my prepared remarks to provide selected operational updates covering the time since our last update call in November. Then Ran will review our financials, and we will close the call with a question-and-answer session. Since our last call, the Nano-X team achieved 2 notable regulatory successes. The first being the general use clearance from the FDA in December. Subsequent to the FDA clearance, we were informed that the CE Mark designation was granted for Nanox.ARC in February 2025. Beyond these notable regulatory achievements, the fourth quarter and beginning of 2025 have been a period of significant progress and strategic advancements for Nano-X across our business areas as we continue to revolutionize the field of medical imaging with our innovative technologies. I will cover a wide range of topics in my prepared remarks. In the key U.S. market, we continue to advance Nanox.ARC system deployment. We received positive feedback on the Nanox.ARC for our first customers, while we also signed agreements with new channel partners, and we are negotiating additional ones as we speak. These agreements are expected to accelerate our market presence. We are also beginning our entry into the European market now that we have obtained the CE Mark, and I will talk about that in some detail, along with our progress outside of the U.S. market. Our Nanox.AI team continued to make progress as we added new customers. I will wrap up my remarks with an update on our OEM relationship as well as our clinical trials, which are designed to build on the body of the data supporting the use of Nanox.AR technology in the delivery of health care across various settings. With that, let's begin. As was previously announced, we achieved a significant regulatory milestone with the FDA general use clearance received last December. The 510(k) clearance is for general use, including human musculoskeletal system, pulmonary, intra-abdominal, and paranasal sinus indication, adjunctive to conventional radiography, and we believe that will advance our commercialization as it validates and extends the use cases for our Nanox.ARC. Advancing our regulatory discussion with the FDA, we have submitted the Nanox.ARC-X for FDA clearance, which will further enhance our product portfolio. The Nanox.ARC-X will have an even smaller footprint than the existing Nanox.ARC system, enhancing one of our key differentiations. The new system will also be easy to deploy and use with an anticipated 1-day setup time and plug-and-play functionality. Equally exciting is the announcement made just a few weeks ago that we received the CE Mark certification to market the multisource Nanox.ARC system, including Nanox.CLOUD, it's a company cloud-based infrastructure. Pursuing the CE mark was a key priority to enable to market our device in the EU. With this in mind, we remain highly focused on fulfilling our promise to our investors that we will do everything within our control to ensure a successful outcome in this crucial review process. I'm happy to say that we delivered on this, and we view it as another early validation of our unique and possible transformative technology. I would also like to emphasize that due to differences in standard of care approaches, the CE mark allows us to market the Nanox.ARC in Europe as a stand-alone modality, which does not require adjunctive use. Our primary focus remains on accelerating the deployment of the Nanox.ARC and our AI solutions in the United States. As I have mentioned on previous calls, we have been carefully expanding the U.S.-based commercial team to help ensure that we have the appropriate sales, clinical education, and support infrastructure necessary to drive our deployment in the U.S. An important element of our go-to-market strategy in the U.S. as it will be another market is to pursue the education of our potential customer base and key opinion leaders in medical imaging. Education and raising awareness are, therefore, key elements of our marketing efforts as we are expanding our key opinion leaders' ecosystem and increasing clinical value evidence. Since its commercial deployment, there are a few dozens of systems in various stages of shipment and deployment for both commercial and clinical use in the U.S. We are deployed across several states. We are focusing on expanding our network of strategic collaboration, channel partners, and client base. As of today, I can report that we added another state, Tennessee, to our commercial coverage. Of these units deployed, I can share that in one of the multi-specialty clinics, we scan about 10 scans a day, out of which 20% are chest scans. Our Nanox.ARC pipeline remains robust, and we are currently targeting a few hundreds of clients. We are continuously recruiting to expand our sales and clinical support team in the U.S., and this expansion is crucial to support our growing customer base and ensure the successful deployment of our technology. We see a lot of interest from prospective and current customers and professional healthcare facilities. Introducing new innovative technologies into the conservative U.S. market is always challenging. However, we have a growing base of early adopters that have ordered and are using the ARC. As a result, we have seen an increase in the number of referrals, scans and additional use cases. As we continue to pursue multiple avenues to commercialization, we made significant strides in establishing strong distributor partnerships, working with well-known players in the durable medical equipment space makes good business sense as these companies are recognized by medical imaging customers and can rapidly enlarge our sales presence. We have recently engaged with advanced Southern Med Imaging known as ASI based in Georgia. They will support the commercialization of the Nanox.ARC and this is additive as it gives a new presence in the Southern United States. Additionally, we are in advanced negotiations with more channel partners, and I will provide updates on our next call. I would like to focus now on our strategy for penetrating the European market. As you all know, we recently got the very welcome news that the Nanox.ARC was granted the CE mark, expanding our total addressable market. Our regulatory team has worked long and hard to secure this, and it is another strong validation of our technology. It also paves the way for our entry into a large and influential market, which has long and strategic goal for our company. This achievement represents a significant milestone in our global expansion effort and builds on the strong momentum we have generated since securing multiple FDA clearances. This certification for whole body imaging in Europe, combined with our existing infrastructure and ongoing pursuit of strategic partnerships, positions us to accelerate the Nanox.ARC commercial introduction across the region. Just days after we announced that we received the CE mark, we presented data supporting the Nanox.ARC performance at the 2025 European Congress of Radiology, the ECR, which took place recently in Vienna, Austria. New data was shared around 3 different abstracts at the conference. You can find the full details on this scientific abstract on our website. We take pride in our robust clinical efforts to generate data supporting the use of Nanox.ARC. We understand that bringing a new technology into the health care continuum as we are doing, introducing the Nanox.ARC to medical imaging industry requires a great deal of data generation, clinical validation and education. While we are bringing a valuable new tool to the radiology profession, the burden of proof is on Nanox to demonstrate why hospitals and imaging centers need to add this new technology. By prioritizing clinical needs and development efforts in collaboration with the medical community, we ensure that our innovations are not only advanced but also relevant and visible to those we serve. As the population ages and the demand for medical imaging increases in lockstep, there is an increasing need for accessible advanced imaging solutions across various care settings. We expect the Nanox.ARC to be a good fit for this backdrop because at its core, the Nanox.ARC offers an advanced medical imaging solution that is more accessible and affordable. We expect that most of the initial sales in the EU will be through the CapEx model, meaning the systems will be purchased outright with no per-scan charges. However, there will be additional revenue generated through the use of service contracts and Nanox.CLOUD's connectivity. We will also, of course, be seeking to sell our growing number of AI solutions and teleradiology services into our customer base as well. At this time, we anticipate that our sales strategy in the EU will mainly work indirectly through distributors. As I've just described, we have been gathering a geographically diverse group of distribution partners, and we will aim to do the same as we begin to penetrate the EU. With the CE mark in hand, we are not wasting any time and have already signed new distribution agreements for Nanox.ARC in Romania and Greece, which will be our additional entry point into the market. We are also in advanced stages of additional negotiations of distribution agreements in additional countries in the EU. While the U.S. market has been a major focus, the European Union is going to be larger focused in 2025 as we increase our commercialization efforts and our dedicated commercial team and continue to progress with our efforts in other international markets, focusing on receiving local regulatory approvals in various countries. Turning now to our AI commercialization, our Nanox.AI-powered images interpretation algorithms continue to gain traction. We've engaged with 2 new customers in the U.S. The first is one of the largest outpatient medical imaging providers in the U.S., which has signed up for HealthOST. The installation will utilize Nanox.AI imaging analytics platform within the Blackford platform marketplace, highlighting the strategic value of our partnership followed by the success we already experienced in the U.K., this represents our first significant success in the U.S. with the HealthOST in the imaging centers market and marks an important milestone for both Nanox.AI and Blackford, the pioneering enterprise AI platform and solutions provider, which offers all Nanox.AI solutions, including HealthOST to health care providers worldwide. We also finalized the collaboration between Nanox.AI and Ezra, a healthcare artificial intelligence company revolutionizing early detection through full-body CT screening. Under the terms of the collaboration, Nanox.AI population health solution will be integrated into Ezra's medical screening process at 28 imaging center locations across the United States which feature AI-powered full body MRI and CT scans to screen adults for early detection such as cancer and other serious conditions at their earliest and often most treatable stages. We are particularly excited about the Ezra collaboration as it connects to a consumer healthcare market indirectly through our business partner. Individuals today are better informed and technology enables people to manage more aspects of their health care journey themselves. Given this backdrop, we can see an emerging opportunity to provide imaging and early detection to consumers as part of their routine healthcare activities. We know the cost of technology tends to decrease over time. And in the future, proactive scanning would be an important part in maintaining a healthy lifestyle. We will continue exploring opportunities to leverage our AI technology to promote accessible early diagnosis and preventive management. We're constantly working on additional collaboration with different customer types and industries worldwide. We clearly have a lot to be excited about with our Nanox.AI solutions. I will close my comments on Nanox.AI by sharing that our total AI customer and pilot-based project has increased by 25%. As previously reported, we are developing a pulmonary solution, which is expected to be the first AI application designed specifically for the Nanox.ARC. Nanox identified the need for tomosynthesis AI solution as prime requirement to support the growing market demand for cancer screening initiatives in the EU. These initiatives will increase the need for our geographers and radiologists to respond in a faster way for the increased readings. Nanox.ARC solution will provide the pulmonary proper solution to increase imaging capacity. Another important aspect of our work is with our OEM partners, which is critical to ensuring that we have the components necessary to meet our growing demand for Nanox.ARC systems. I would like to provide an update on the aforementioned technology development center in our headquarters, which was created to advance the development of our technology into the future. In addition to cheap and tube-level testing, this center includes a robotic laboratory. We will soon utilize the lab to perform multisource applications development. Multisource involves placing several of our emitters into a single vessel with active pumping mechanism to ensure an optimal operating environment for emission. The benefit of a multisource approach can include minimized imaging times, system size, weigh and complexity reduction, and more flexible approaches to imaging. Attaching a multisource to our robot and manipulating the robot into different positions allow us to easily simulate and work to optimize various imaging positions and quantities towards developing the best solution for medical security and industrial inspection applications. This will become an important tool towards the development of additional advanced thermosynthesis and potentially stationary seating solutions. As reported before, tube-utilizing system chips have been successfully built and tested, and we remain on schedule for initial fab production quality chips this quarter. This is another example of the Nanox team dedication to securing manufacturing agreements to ensure the supply of Nanox.ARC system can meet our expected demand. Turning to one of our key OEM partners, Varex continue its production launch preparations as we continue system-level integration and pre-FDA submission testing on tubes to be used in Nanox.ARC. Varex is also engaged in development of multisource modules for us utilizing the aforementioned Nanoxemeters and will include their module in some of our application development robot testing referenced above. Additionally, a leading global medical and diagnostic solution provider has assembled the first prototype tubes utilizing the Nanoxemeter. We are working closely with them and have delivered a Nanox.ARC demo kit to serve as a test bench for prototypes under development. We will continue to actively but selectively develop partnerships with tube manufacturers and X-ray solution providers as they will serve an important channels to the market for our proprietary technology. An update on our U.S. government security application project. The team has successfully completed component build, assembly, and testing and moved to finalize 2 unique tube designs for advanced prototyping. We are pleased that our demo kit, inclusive of our [indiscernible] tube, high-voltage power supply and software continue to enable potential clients and partners to more easily experience our technologies. In summary, we continue to develop strategic OEM partnerships, both to enhance our Nanox.ARC supply chain as well as develop channels to the various markets. We are increasing our resources and focus on business development opportunities and continue to expand our funnel of potential opportunities. We will update on them as appropriate. I will close my prepared remarks with an update on our clinical activities, which are designed to provide further validation and expanded use cases for Nanox.ARC. As I mentioned earlier, Nanox attended ECR, the European Congress of Radiology in February, which was very successful. Recently, radiologists in our independent review committee, the IRC, confirmed that Nanox.ARC's digital tomosynthesis DTS provides superior detail and added clinical value over X-ray. Each expert independently review over 880 DTS studies, noting good image quality and ability to detect lesions and minimal learning curve. These insights further validate DTS as an advanced imaging solution. Our Nanox.ARC clinical trials are advancing well. The Nanox.ARC multisite trial continues to progress in the UGMC and Bellington Medical Center, and we are in discussion with prominent clinical sites in 2 locations in Europe to add them to our multisite trial. To date, we have enrolled more than 100 patients into the various clinical trials. In conclusion, we are making significant strides in deploying our innovative imaging solutions, expanding our market presence and advancing our clinical and regulatory milestones. We remain committed to our mission of preventive health care and improving patient outcomes worldwide. With that, I would like now to turn the call over to Ran for a review of our financials.

Thank you, Erez. We reported a GAAP net loss for the fourth quarter of 2023 of $14.1 million, which is the reported period compared with a net loss of $10.2 million in the fourth quarter of 2023, which is the comparable period. The increase was largely due to an increase of $1.2 million in the gross loss and increase of $2.7 million in other expenses, mainly due to a one-time income in the amount of $3 million that was recorded in the comparable period since the company received that amount in the fourth quarter of 2023 from its D&O insurance carrier under the settlement agreement in connection with the class action lawsuit against the company. Revenue for the reported period was $3.0 million and gross loss was $2.9 million on a GAAP basis. Revenue for the comparable period was $2.4 million and gross loss was $1.7 million on a GAAP basis. Non-GAAP gross loss for the reported period was $0.3 million as compared to a gross profit of $0.9 million in the comparable period, which represents a gross loss margin of approximately 9% on a non-GAAP basis for the reported period as compared to a gross profit margin of 36% on a non-GAAP basis in the comparable period. Revenue from the teleradiology services for the reported period was $2.8 million with a gross profit of $0.6 million on a GAAP basis as compared to revenue of $2.3 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 21% on a GAAP basis for the reported period as compared to 14% on a GAAP basis in the comparable period. Non-GAAP gross profit for the company's teleradiology services for the reported period was $1.1 million as compared to $0.9 million in the comparable period, which represents a gross profit margin of approximately 41% on a non-GAAP basis for the reported period and as compared to 38% on a non-GAAP basis in the comparable period. The increase in the company's revenue and gross profit margins from the teleradiology services was mainly attributable to customer retention, increased rates, and increased volume of the company's reading services during the weekday shift. During the reported period, the company generated revenue through the sale and deployment of its imaging systems, which amounted to $136,000 for the reported period with a gross loss of $1.5 million on a GAAP basis and $1.4 million on a non-GAAP basis compared to revenue of $17,000 with a gross loss of $44,000 on a GAAP and non-GAAP basis in the comparable period. The increase in the revenue stems mainly from the sales and deployment of our 2D systems and the sale of our OEM project in the U.S. The company's revenue from its AI solutions for the reported period was $83,000 with a gross loss of $2.0 million on a GAAP basis compared to a revenue of $84,000 with a gross loss of $2.0 million in the comparable period. Non-GAAP gross profit for the company's AI solutions for the reported period was $6,000 compared to $21,000 in the comparable period. Research and development expenses net for the reported period were $5.4 million compared to $6.8 million in the comparable period, reflecting a decrease of $1.4 million. The decrease was mainly due to a decrease of $0.2 million in salaries and wages, a decrease of $0.5 million in share-based compensation, and $0.7 million in expenses related to our research and development activities. Sales and marketing expenses for the reported period were $0.9 million compared to $1.0 million in the comparable period. General and administrative expenses for the reported period were $5.8 million compared to $3.8 million in the comparable period. The increase of $2.0 million was mainly due to an increase of $1.7 million in our legal expenses since the company received $2 million from the company's director and officer liability insurance carrier during the comparable period under the company's policy and the settlement agreement, which reduced the company's legal expenses in the same amount during the comparable period. Turning to our balance sheet. As of December 31, 2024, we had cash, cash equivalents, restricted deposits, and marketable securities of approximately $83.5 million and had $3.1 million in loan from a bank. We ended the quarter with a property and equipment net of $45.4 million. As of December 31, 2024, we had approximately 63.8 million shares outstanding. As of December 31, 2023, we had approximately 57.8 million shares outstanding. Per the controlled equity offering sales agreement with our 2 agents dated June 7, 2024, the company may offer and sell ordinary shares up to $100 million from time to time through the agent pursuant to the sales agreement. The agents are entitled to compensation at the commission rate of 2.5% of the aggregate gross proceeds from each sales of the ordinary shares. During the reported period, the company issued approximately 5 million ordinary shares in gross consideration of $38.8 million and net consideration of $37.8 million under the sale agreement. Additionally, during 2024, approximately 1 million option to purchase ordinary shares were exercised to ordinary shares in consideration of approximately $1.7 million including 706,000 options to purchase ordinary shares that were exercised by the state of the late companies' Chairman of the Board in consideration of $1.6 million. With that, I will hand the call back over to Erez.

Thank you, Ran. To close my prepared remarks, I want to thank you all for your continued support of Nano-X. Our team continues to deliver in its promises with advance on the AI technology, regulatory and clinical fronts during the quarter. And at the beginning of 2025, we advanced U.S. commercializations and have entered a new market in the EU. I'm especially proud for our FDA general use clearance and the recent CE Mark designation for the Nanox.ARC. We added new deployments, distribution agreements, and new customers for the Nanox.AI technology. Nano-X's strategic approach to regulatory milestones and commercial rollout, including targeted installations and phase of scaling underscore a disciplined path to sustainable growth. I'm proud of what we have accomplished so far, and I look forward to sharing details of more successes to come on our Q1 2025 investor call. Thanks again for joining us today. And operator, please open the call for questions.

[Operator Instructions] Our first question comes from the line of Jeffrey Cohen with Ladenburg Thalmann.

Erez, could you expound upon the DME partners in the U.S. under DMEs, will you be selling the ARC outright with the opportunity for imaging revenue behind it? Or could DMEs place that under the imaging-only scenario?

So we have both options. Part of them will be that we're going to sell CapEx direct. They will do their installation and the selling process. And part of them will be the MSaaS, the typical MSaaS model that we currently have.

Could you talk about the...

You asked about the U.S., yes?

Yes. And in the U.S., it looks like congrats, I think you're up to 7 states, I believe. Can you give us a sense of the platform in the U.S.? And you just talk about the target market in the U.S. and how we may expect placements to occur during 2025?

Okay. So right now, it seems that we are sort of doubling the team like every quarter. We have right now 5 salespeople that are currently working. We are extending the support, the clinical support and clinical education in order to build the market and brand and value awareness and to ensure that we expand the number of physicians who will be able to refer to the tomosynthesis to the ARC. This seems to be very successful. One of the examples I gave in the call that in one of the clinics that we started to work, we have been facing that a lot of physicians have been referring, and we achieved like 10 scans per day, which is more than the average that we expect. This is with respect to the team. We are planning to get a major impact as a result of the channel partners that we signed with in specific states or coverage or states that we want to extend our coverage, and we're not planning specifically with our own salespeople. And a lot of introduction. We have people who are actually working on building the deal flow that currently is pretty large. And I gave an indication also in the comments about what do we expect in 2025 in terms of the numbers that we are either negotiating or starting the process of either building the room or getting the regulation, the local regulation of the approval of the state or approval of the city and the physics that are coming to check, et cetera, the whole process that we mentioned. Right now, what we can see definitely is that the sectors who are the early adopters are either small and medium-sized medical imaging centers in orthopedic clinics and chiropractors. And in addition, the one that we are accelerating right now, and we expect more to be built on the success of the first one is what is called the multi-specialty medical centers. This is definitely an area where we can add value to their X-ray capability. And in some of them, we are replacing the city, the old city that they had in the past. Last but not least is the one that we mentioned is the medical imaging chains. We have already a few that were signed. We have placed systems also in a few of them already. And this is an area that we are working and we have a focus on in order to extend the number of chains that we're going to be in touch with and place our system.

And one more quick one. Could you talk about the manufacturing sites out there for tube chips and other components? And has there been any material change on any of those channels in the past quarter?

No. We work according to the plan that was presented. CI in Italy are manufacturing the tubes for us. Varex started to ship tubes also for us, both manufacturing facilities, the Nano-X in Korea and System in Switzerland are both manufacturing the chips. And we are building that. And we are working right now while we do the scale in the manufacturing facility and the future manufacturing of the ARC-X to have the low-cost manufacturing facility in addition to the one that we have in Israel.

Our next question comes from Ross Osborn with Cantor Fitzgerald.

Starting off, how many systems were deployed and operating in the U.S. during the quarter that resulted in $136,000 in system revenue?

So we have already indicated that we don't give the exact numbers. They are all in various stages of those that were already installed. This is -- these are that are ready to be installed in the -- when the rooms are getting ready. We are adding states. We expect that the channel partners will add another value. What we see also that every salesman that we are hiring is able to expand the number of places that we are installing. And I think that the more we go into the 2025, we'll give more details on this one. By the way, one thing we actually also mentioned in the call that the pipeline that remains pretty robust. And the only thing that we're trying to do is make sure that they are going to be converted to installations and scans that they are going to create. And also, I gave an education of the scans that we're able to create in the places that the system is installed.

And then how should we think about pricing for ARC in Europe, given you're going to be selling the system there as a capital sale? And how do you think this will impact gross margin this year and next?

I hope that I heard the question. So in Europe, we have also -- last month, we have extended the team when we got the CE clearance. The show that we attended in Vienna was very successful. We have engaged with quite a lot new distributors that we will work with them. In the -- so right now, we have 3 salespeople, regional salespeople. We have added Romania and Greece, as mentioned, to the new distributors. We are working with the distributors in Italy and Spain. And we have also a few more distributors in the pipeline, and we do hope that this will extend our presence. I think that it's fair to say that we will start installations probably sometimes during the next 6 months or quarter or 2 quarters that we'll start to install systems and sell systems. In Europe, I would say that it will be -- probably a major part of it will be CapEx sales and a smaller part of it will be the [indiscernible]

Our next question comes from Scott Henry with Alliance Global Partners.

I guess the first question, and then I'll go in a little more detail, but do you want to give any thoughts to the outlook for 2025 in terms of big picture, any guidance, or if you're going to provide any -- and then I did have a couple more specific items on that.

What specifically are you referring to?

Well, I guess if we go by category, it looks like Teva radiology services tends to grow around the 10% range. Is anything changing there? Or should we expect that to continue to grow at similar rates?

Scott, we don't provide guidance, as you remember. But if you look at the consensus of the analysts, I think that the service segment of the company actually was -- came out in line with the consensus.

And I won't ask for guidance. But just in terms of directionally in magnitude, AI solutions, should we -- I mean, that's moved around a lot. It dipped down in Q4 after a very strong Q3. Should we expect a strong year for that in 2025? Just not specific numbers, but what are you seeing there that would indicate how we should think about it?

Well, as you remember, in the third quarter, we saw a one-time income over there as we completed the projects as we noted then. But as we mentioned -- as Erez mentioned in the portion of the call, we do see an increase in the number of the clients and the number of the pilots. So you can assume that, that will be translated -- may be translated into an increase in the revenue. But of course, we'll give better numbers when we publish the upcoming quarter results. But from a general perspective, we view 2025 as a strong year for AI.

And then probably the most important question that I have is when we look at the Imaging Solutions line, the percent gains have been substantial, doubling year-over-year, but the numbers are still relatively small. Obviously, as the rollout goes, we'll start to reach an inflection point where those numbers will get bigger. When would you expect that inflection point? Is that a kind of a middle of 2025 event or second half? Just trying to get a sense of when we should see that really kind of curve upwards.

Again, we don't provide any kind of guidance. So I can't tell you exactly when it will be the inflection point, but you should look at some about the trend about how we work together with channel partners in the U.S. market, including distributors and with distributors in the Europe. We also announced that we submitted the new version of the ARC to the FDA. So that may be also an inflection point, once we get the clearance for that device. And I think as the time goes and we accumulate more experience and expanding our team and our effort and the market education and the market awareness and increase and showing the clinical value in our devices, that should be translated into what you call coming towards the inflection point.

Just a couple of modeling questions. Typically, OpEx, operating expenses, we think about growth with inflation, all else being equal. Is there anything unique in the OpEx that we should factor into 2025 or maintain similar trends?

Not really. But don't forget that some of our labor costs and other overhead is actually linked to the Israeli shekels and some of it a little bit to the Korean currency. So in terms of any kind of impact on the OpEx, it's only there's going to be some kind of sharp fluctuations with those currencies. Other than this, everything is in line. You can see that our G&A -- actually our G&A are more so in the range in the past 2 years. It's actually decreasing with the completion of the SEC and the class action lawsuit last year. So it's more of the same of the same. Of course, once we'll issue the 20-F, you can have more details about it.

[Operator Instructions] Our next question comes from Jason Kolbert with D. Boral Capital.

I basically have the same question that Scott does, which is I'm looking for guidance. I'm trying to understand system placement and when we're going to see that inflection point. I understand that you don't want to provide that. The problem is it's very hard to kind of understand as an analyst following the company, where that inflection point is. And given the fact that the stock is down by almost 50% from its recent high, I think investors are trying to understand where that inflection point is also. You raised some capital in the period. Can you talk a little bit about the capital you raised and how you might deploy that capital in order to drive system placement? Thanks.

Okay. I'll give you an answer about the second part of your question. You raised approximately 38 gross, $37 net million during the fourth quarter of 2024, and that was under the ATM programs that are in place. That's a program that we already put in place already in mid-2024. We had an opportunity to use it in -- after we announced the general use clearance that we have received in the U.S., and we have done so. What is going to be used, of course, is going to be used for the acceleration of the commercialization of our products, both the imaging and the AI. And we don't think that -- we do think that most of the efforts will be concentrated in commercialization at the moment.

The one other thing, Jason, that I would say that you have enough -- not enough, always not enough for analysts. But I would say that we have a lot of indications that can explain or give you an indication of where the inflection point will be as a result of the fact that the increase in revenue will be generated from the EU penetration, from the fact that we moved in the U.S. and the FDA for general use from the MSK only in the past and the fact that we are going to have the ARC-X clearance from the FDA sometimes in the -- during 2025, and this will be part of the scale that we are doing. We also gave some indication about the pipeline. We gave an indication about the number of scans that we are going to generate. Right now, for us, it's hard to predict what will be the percentage of the CapEx sales, namely that the system will be sold and served and what will be the part which is going to be based on the MSaaS. Right now, almost all of our systems are MSaaS model, but EU probably will be more of a CapEx sales and last but not least, I think that what we are trying to show that basically, we say something and we ensure that we are delivering. And this went from the regulation point of view, from building the clinical validation point of view, the clinical trials, the market awareness of the ARC and its clinical use, the key opinion leaders that are joining us all the time, the number of salespeople that were very -- we are very conservative in adding expenses to the -- so when we see that the salesman is generating enough sales and revenues, then we will add and not flooding the company with people that before we know that we're going on a very strong base moving forward. So this with respect to the teams that we have. So yes, we always said that 2025 will be a meaningful year for us going forward. And that's where we are.

Can you give us some idea of either how long the existing cash on the balance sheet will last you or when you think you're going to be cash flow positive?

It's -- again, we don't provide any guidance. But you can look at our earnings release and analyze it and come to your own conclusion.

I think the positive and very supportive feedback that we mentioned in the very beginning of the call that we're getting from the customers and people are -- really believe that it's a game changer in this medical imaging market. And the value that we saw in the review that -- the independent review that we had in Europe and what we see right now following the CHEST approval that we see the for pulmonologists and for the lung screening and what we see in terms of the MSK and as mentioned, sinusitis and kidney stones and other indications or use cases. I think this actually gives us a lot of positive and backwinds to move forward and to ensure that we're going to add value to our customers and ensure that we are going to make a change in the health and standard of care.

Do you anticipate continuing to use the ATM facility this year?

But again, we don't give any indication on any forward-looking actions that we may take. Yes, there are a lot of investors that are pushing us to go with them and raise and take money, but we are very conservative, and we also consider very carefully the existing shareholders. So when the stock is down, the decision is accordingly.

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