Good day and welcome to the Sensus Healthcare Fourth Quarter and Full Year 2023 Financial Results Conference Call. All participants will be in a listen-only mode. After today's presentation, there will be an opportunity to ask questions. Please also note that this event is being recorded today. I would now like to turn the conference over to Kim Golodetz. Please go ahead.

Thank you, operator. This is Kim Golodetz with LHA. Thank you all for participating in today's call. Joining me from Sensus Healthcare are Joe Sardano, Chairman and Chief Executive Officer; Michael Sardano, President and General Counsel; and Javier Rampolla, Chief Financial Officer. As a reminder, some of the matters that will be discussed during today's call contain forward-looking statements within the meaning of federal securities laws. All statements other than historical facts that address activities Sensus Healthcare assumes, plans, expects, believes, intends or anticipates and other similar expressions will, should or may occur in the future are forward-looking statements. The forward-looking statements are management's beliefs based on currently available information as of the date of this conference call, February 8, 2024. Sensus Healthcare undertakes no obligation to revise or update any forward-looking statements except as required by law. All forward-looking statements are subject to risks and uncertainties, as described in the company's Forms 10-K and 10-Q. During today's call, references will be made to certain non-GAAP financial measures. Sensus believes these measures provide useful information for investors; yet, they should not be considered as a substitute for GAAP, nor should they be viewed as a substitute for operating results determined in accordance with GAAP. A reconciliation of non-GAAP to GAAP results is included in today's financial results press release. With that said, I'd like to turn the call over to Joe Sardano. Joe?

Thank you, Kim, and good afternoon, everyone. Our fourth quarter financial results reflect our customers' acclimation to an inflationary environment as well as their understanding of the compelling financial proposition and better patient outcomes of SRT to treat non-melanoma skin cancer and keloids. Sales improved substantially as we shipped 33 systems during the quarter, including three SRT systems outside the United States. This brings the total number of units shipped in 2023 to 66 units. We are fast approaching a total unit installation of 800 systems. For Q4, revenues were $12.6 million versus $13.1 million a year ago, up more than threefold sequentially. We expect an uptick in the fourth quarter, our seasonally strongest, as utilization of SRT to treat non-melanoma skin cancer continues to increase. This increased utilization is being driven by favorable reimbursement, an aging population, and clinical results that are at least as good, if not better, than most surgery. For quite some time, customers and prospects alike have been asking for new ways to add SRT to their practices. As always, we listen closely to our market and we're delighted to meet their needs with a highly competitive offering. This new recurring revenue model complements our capital equipment sales model, which you'll recall was enhanced with our fair market value lease that we introduced in 2021. This new model provides recurring revenue to Sensus and expands our market by providing another viable option to bring SRT to dermatology practices. During the fourth quarter, we made our first placement under this model. We've been carefully preparing this recurring revenue model over the past year, making sure that the economics work for both our customers and for Sensus, and ensuring we were abiding by all applicable laws and regulations. Note also that the capabilities of SRT-100 Vision with image-guided ultrasound and Sentinel technology make the recurring revenue model possible. I've mentioned on previous quarterly calls that this advanced technology is expected to play a key role in our growth, and now you may understand why we've been so excited with Sentinel. This is our HIPAA-compliant software with clinical, billing, and asset management utility that also allows us to track utilization in real time. This technology is ideal for better managing dermatology clinics for all of our customers and is a Sensus Healthcare exclusive. During 2023, we also introduced an important new and improved high-resolution ultrasound technology to provide see-and-treat capability. This leads to great clinical outcomes because the physician can actually see the impact of each treatment on the lesion and lesion resolution after treatment. We're looking forward to more directly benefiting from the SRT treatment growth rates we've seen. Recall that earlier in 2023, we found in our surveys of Medicare that SRT experienced a 27% year-over-year treatment growth rate for the six years we reviewed. Should this growth rate continue, SRT will soon become the treatment of choice for non-melanoma skin cancer. We're very excited to be interacting with customers and prospects during the coming weeks. This weekend, we'll be showcasing our SRT products, in particular the SRT-100 Vision IG-SRT system and the Sentinel technology and Sensus cloud capabilities at the South Beach Symposium, which begins today in Miami. We'll also be at the Winter Clinical, also in Miami, beginning February 16. We'll follow those conferences up with the American Academy of Dermatology's Annual Meeting being held March 8 through 12 in San Diego, where we will have a very strong presence. While dermatology is our primary market, we continue to engage with the radiation oncology market, which is mainly a hospital-based channel. As mentioned last quarter, we've had good success in this area, having recently placed an SRT system at Cape Cod Hospital. As a reminder, this market has a longer sales cycle as we continue to see increased interest. With respect to the transdermal infusion product, we filed our 510(k) application with the U.S. FDA in October of 2023, and are hopeful that we'll be hearing from the agency in the coming weeks. This system will, for example, allow platelet-rich plasma, or PRP, to be applied to the scalp in a pain-free hair restoration experience. In addition, posters have already been presented on the application of hyperhidrosis, or overactive sweat glands. Our transdermal system includes Sentinel IT solution capabilities, as do all six of our Sensus-branded aesthetic smart lasers. We will be exhibiting our TDI product at the upcoming dermatology trade shows as a works-in-progress. With those remarks, I'll turn the call over to Michael Sardano, who, in addition to his duties as President and General Counsel, joined our Board of Directors last week. He'll give you a brief update on our international business and talk about our new collaboration with CureRays. Michael?

Thanks, Joe. We've spent the last year working to open up new international territories, which requires both regulatory approvals and strategic engagement of distributors. We continue to support our international distributors across Asia, Europe, and the Middle East, and we are developing a number of promising opportunities to supplement our strong demand in China. We sold a total of 13 SRT systems internationally in 2023, which includes sales to three new territories for Sensus during the year, namely Ireland, Guatemala, and Turkey. As I stated in our last earnings call in November, our plan is to expand our Latin American, European, and Asian footprint as quickly as possible, with Brazil and Japan being longer-term prospects, as they are highly regulated. Our goal is to open two to three new territories per year, which we achieved in 2023. Turning back to the U.S. market, earlier this week we announced a collaboration with CureRays. CureRays is led by two radiation oncologists, Dr. Mohammad Khan, who is on the Sensus Medical Advisory Board and is Vice Chair for Radiation Oncology Education at Emory University in Atlanta, and Dr. Clayton Hess, who is the Director of Dignity Health at Sierra Nevada Memorial Hospital in California. CureRays has purchased an SRT-100 Vision and will be treating patients out of their California headquarters. CureRays is focused on three main endeavors: the treatment of patients for non-melanoma skin cancer and keloids, treatment oversight for Sensus' dermatology customers, and conducting clinical trials with the use of Sensus' SRT technology. CureRays will be instrumental to our recurring revenue model, and we are very excited to be partnering with them. With that, I'll turn the call over to Javier for a discussion of our financial results.

Thanks, Michael, and good afternoon, everyone. As Joe mentioned, our revenues for the fourth quarter of 2023 were $12.6 million, compared with revenues of $13.1 million a year ago and revenues of $3.9 million in the third quarter of 2023. The decrease versus the prior year reflects a lower number of SRT units sold. Gross profit for the fourth quarter of 2023 was $7.8 million, or 62.3% of revenues, compared with gross profit of $8.4 million, or 63.7% of revenues for the fourth quarter of 2022. The decrease was primarily due to the lower number of units sold in the 2023 quarter. Selling and marketing expense for the fourth quarter of 2023 was $0.6 million, compared with $1.6 million for the fourth quarter of 2022. The decrease was primarily attributable to lower compensation expense, partially offset by higher tradeshow costs. General and administrative expense for the fourth quarter of 2023 was $1 million, compared with $1.4 million for the fourth quarter of 2022. The decrease was due to lower compensation expense in the 2023 quarter and higher budget expense in the prior year quarter. Research and development expense for the fourth quarter of 2023 was $0.7 million, compared with $1.2 million in the same quarter last year. The decrease was primarily due to the completion of development of a drug delivery system for the aesthetic market. We have submitted a 510(k) application to the U.S. Food and Drug Administration and have completed most of the work on this project. Other income of $0.2 million for the fourth quarter of 2023 was mostly related to interest income and was unchanged from the fourth quarter of 2022. Net income for the fourth quarter of 2023 was $4.2 million, or $0.26 for diluted share, and this compares with net income of $2.8 million, or $0.17 per diluted share for the fourth quarter of 2022. Adjusted EBITDA, which we define as earnings before interest, taxes, depreciation, amortization, and stock-compensation expense, was $5.7 million for the fourth quarter of 2023, up from $4.3 million for the fourth quarter of 2022. Let me touch on our full-year financial results highlights. Revenues for 2023 were $24.4 million, compared with $44.5 million for 2022, reflecting a lower number of units sold as customers deferred purchases due to microeconomic conditions and lower sales to our customers in 2023. Gross profit was $14.1 million for 2023, or 57.6% of revenues, compared with $29.6 million, or 66.5% of revenues for 2022, reflecting a lower number of units sold and higher costs charged by vendors in 2023. Selling and marketing expense was $5.6 million for 2023, compared with $6.3 million for 2022, due to lower compensation expense offset by higher tradeshow expenses. General and administrative expense was $5.2 million for 2023, compared with $5 million for 2022, with the increase reflecting higher professional fees and compensation expense. R&D was $3.7 million for 2023, compared with $3.5 million for 2022, with an increase largely due to expense related to the development of a drug delivery system for aesthetic use. Other income net of $1 million for 2023 was mostly related to interest income. Other income net of $13.2 million for 2022 was related primarily to the gain of $4.8 million on the sale of a non-core asset. Net income for 2023 was $0.5 million, or $0.03 per diluted share, and this compares with net income for 2022 of $24.2 million, or $1.46 per diluted share. Net income for 2022 includes a $12.8 million gain on the sale of a non-core asset. Adjusted EBITDA for 2023 was $0.3 million, compared with $28.1 million for 2022. Turning now to our balance sheet. Cash and cash equivalents as of December 31, 2023 were $23.1 million versus $25.5 million as of December 31, 2022. The company had no outstanding borrowings under its revolving line of credit as of year-end 2023 or 2022. We built finished goods and inventory, and prepaid for materials earlier during 2023, in part to get ahead of any price increases and to prepare for the anticipated growth, especially from the recurring revenue models. At the end of 2023, inventories were $11.9 million, well above $3.5 million as of the end of 2022. Prepaid inventory was $3 million at the end of 2023, versus $6.6 million at year-end 2022. Our cash spend continues to be very focused and highly disciplined. Nevertheless, our balance sheet positions us well to take advantage of the compelling growth opportunities we may come across or that we may create ourselves. As a final comment, please see the table in the news release we issued earlier today for the reconciliation of GAAP to non-GAAP financial measures. With that, I'll turn the call back to Joe.

Thanks, Javier and Michael. The ROI for our premium SRT system under our fair market value leasing program continues to be compelling, and although it's early, our initial introductions of our recurring revenue model are being met with a great deal of interest. With the many upcoming medical meetings, I'm sure we'll gain momentum for this program as the word spreads. Published studies have shown that SRT clinical results are as good or better than most surgery and certainly it's non-invasive, leaving no scar. There's no question that SRT and IG-SRT have become the number one option for surgery. As I've said many times, we are still in the early stages of tapping the enormous market opportunity for SRT just in non-melanoma skin cancer and keloids. Our systems are well positioned in a large and largely untapped market. They provide a compelling alternative to surgery for millions of patients and arguably the only solution to prevent the recurrence of keloids following excision. As an overlay to all of this, an estimated one in five Americans will develop skin cancer during their lifetime. This tells us that nearly 70 million people will have non-melanoma skin cancer. So clearly, there's a need for our SRT systems both now and even more so in the future. We are confident that Sensus is positioned for success and we have a great team to drive growth and implement our strategies. With those comments, I thank you for your time and attention and now operator, we're ready to take questions.

Our first question will come from Alex Nowak with Craig-Hallum Capital. Please go ahead.

Okay. Great. Good afternoon, everyone. Joe, I was hoping you could expand on the new recurring model that you placed here, maybe kind of walk through how this came together, all the work you've been doing in the background to make it possible, maybe something to touch on the economics, just some more detail as you're venturing into the recurring model versus the CapEx model that we certainly know very well?

Sure. First of all, we've been evaluating this model for quite some time, and we wanted to make sure that our timing is right for when we would bring it to market. And I would tell you that over the last year to two years, we've been engaged with our customer base, our prospect base, who have continued to ask us to get involved in a recurring revenue model such as this. Listening to them, we've decided this is the right time for us to come into this market. And it is a good opportunity to complement the existing offerings that we have in fair market value leases as well as the other SRT-100 products that we have. So with that being said, the model is a model where we can provide a service using our technology along with professionals that would assist. We've provided some support with the CureRays team being able to provide oversight for these customers. We're working closely with independent dermatology-based coding and billing experts that could help us and help our customers with that endeavor. So, we think that we have all the tools necessary to provide a turnkey position with the SRT-100 Vision, IG-SRT program that gives them another choice in getting SRT into their practice.

Makes total sense. You might not want to go into the economic piece on the call here, but I'll try for it anyway. If you place an SRT Vision, is this something that will, under normal utilization, pay itself back over, help us out around there?

Yes. Of course, you know, it has to work out for both sides. For us, it will allow us to get involved with the recurring revenue model. And I would tell you this: I think we will target a bunch of units that will be installed this year. Probably in the first and second quarter of next year before we start recognizing substantial or incremental revenues that we can claim for the following year. I don't see significant revenues happening this year, but I think that it will be a start. And I think as we continue to place systems over the coming years, it will generate a lot of revenue for the company long-term, along with selling the products as well.

Yes, no doubt. Does the model change the SkinCure relationship at all?

No, it shouldn't. But I think, you know, this complements the offering that we have. SkinCure is doing very, very well on their own. They have an excellent format and an excellent model that works very, very well for the customer base that they have. But it seemed like over the last year or so that there were customers, or prospects that were left out of that, where they didn't want to go one way or the other, and this provides them with an alternative. So for us, it's just an additional tool that allows a lot more prospects to come into play. If you look at what we did with the fair market value lease, that provided a lot of customers the opportunity to move up from an SRT-100 to an SRT-100 Vision. So it made it more affordable. This is going to further enhance, the more customers to want to get involved with SRT-100, especially the SRT-100 Vision IG-SRT product. What we're trying to do overall is make this more available to more patients who are looking to get this done. So, this just adds to our vocabulary, if you will, or the armamentarium that we have, the tools in our toolbox.

And then just maybe just - this is last set of questions. You know, big Q4 bounce back after what has been a difficult, let's call it, 18 months with the market environment that's out there in aesthetic and dermatology. Just expand on what you're seeing out there. Q4, is this the turn and back? We're going to be, 2024, it's going to be back in positive momentum from here. What is it, how are Q1 places looking like? And then just lastly, on the cost cuts, it looks like you implemented a number of cost cuts. Maybe walk through a little bit more there what's it going to be?

Sure. Well, if you recall, we announced after the first quarter that we had been speaking to a lot of our customers, thanks to the early meetings and conferences that we had in February and March, as we are coming upon those same types of meetings again this year. In listening to those customers, we started to understand where they were hurting and how they were getting impacted by the economy and inflation. With less people coming through their doors, getting the aesthetics work that they required, which was cash business for them. Based on that, and then following up at the AAD, I mean, it was pretty clear where the market was going. After the first quarter, we announced that to a lot of people. Not many people believed us at that time, but I think it proved out over the course of the year. Quite frankly, everything that we said would happen as we forecasted the order and provided what we thought was guidance for where the year was going, I think it proved out exactly where we were. We think we did a little better than where the market actually was leading us from the first, second, and third quarters, and then when we got into the fourth quarter. So, how does this look for the first quarter and beyond for 2024? Of course, we have excitement as we're moving into the New Year because we ended the year with some great momentum. We're introducing a new model, which we think is going to take up a lot of space, as far as taking on a lot of products that we're going to install. But I think it's also going to lead to more sales because I think people are going to continue to buy the product versus having to share revenues with anybody. I think it's going to bring some customers to base and give us a whole lot more flexibility on what we're offering. We're pushing really, really hard with the FDA for the TDI product, and we're gaining a lot of interest in that. We can't really push it or sell it. We can show it as a works in progress, but once we get FDA clearance for that, I think it's going to generate some good revenue. You're looking at, you know, $1 million to $2 million is what we're predicting or identifying as that potential revenue for the entire year. So with all that being said, yes, we hope that there's no more world strikes. We hope that there's no more inflation. These are all things that we can't control. We're in the middle of an election year. Take all that away, and we're enthusiastic about what we're doing. Because more and more patients are going to have access to SRT, which means that they're going to have more treatments being done on SRT, and we want to participate in that, and that, in the short and long term, is going to generate more revenue for us. I think we're establishing ourselves with a total solutions turnkey operation to address almost every instance that our customers are looking for to acquire SRT. They recognize the fact that they need SRT to treat skin cancer because there are just not enough doctors to go around for the amount of skin cancer that exists. So we're excited it’s going to hit on all the revenue points that we possibly can get, including recurring revenues now that we're looking at on top of service revenues that continue to increase. I have to say that we're very enthusiastic, and we're just going to drive and execute as we have. Again, I'm going to thank the entire team headed by Javier that's kept us extremely disciplined on our expenses, and we've always been extremely mature about those, and disciplined about it. I think we continue to be even more disciplined as the years and months go on. So, again, overall, we're excited.

It's great to hear. Appreciate the update. Thank you.

No, thank you, Alex.

Thanks, Alex.

And our next question will come from Yi Chen with H.C. Wainwright. Please go ahead.

Thank you for taking my questions. My first question is the number of systems shipped in the quarter that includes the system under the recurring revenue model, correct?

No, it doesn't.

No, it doesn't? Okay.

No, it doesn't.

So….

66 units that we talked about were ones that recognized revenue.

Okay. So, for 2024, do you expect the models under the recurring revenue - I mean systems shipped under the recurring revenue model could increase significantly? And maybe potentially overtake the number of systems shipped under the capital purchase?

We don't feel that way, Yi. We think that it's going to complement our selling, but, again, it's not going to overtake selling the equipment outright, but it's just another way for our customers to acquire the system. Now, I don't know what it's going to be like in a year or two years from now, but I would tell you that in this first year of initiating the recurring revenue model, we still expect to sell more units than provide in the recurring revenue model platform.

Got it. Do you have to share any part of the recurring revenue with CureRays?

No.

Okay. Got it. And can you provide a rough guidance at this point on how many systems you expect to ship to be shipped in 2024?

I don't want to go there. We're always going to try to push for more, but again, it all depends on how the year works out. I mean, when we started last year at this time, we were expecting some big things happening in 2023 after such a great fourth quarter as well. But things didn't turn out that way. Inflation hit really hard. So it makes you worry about predicting things and saying things. We would rather overachieve and undercommit versus going the other way. We don't want to disappoint anybody, but I can assure you that everybody in the team is going to work very, very hard to make sure that we achieve better than what we did the year before.

Okay. Got it. And shall we expect the gross margin to improve in 2024 as you place more units under the recurring revenue model?

So I will keep the margins, Yi, the way they are right now. We're basically in the early stage of this program. So I will just keep them the way it is and then we'll continue to improve as we continue developing this program.

Okay. Got it. Thank you.

Thank you, Yi.

And our next question will come from Anthony Vendetti with Maxim Group. Please go ahead.

Thanks. Thanks. So, if we could just dig in a little more into the utilization trends that you're seeing for the systems that you have out there. And do you have a total install base at this point number that you can share? And then just an update. I know you're awaiting FDA approval for your transdermal infusion system. Where is that exactly? And I guess obviously up to the FDA, but what's your expectation for final approval?

Okay. Number one, we have over 750 installations of SRT products around the world, so we're closing in. Hopefully, sometime in this fiscal year, we'll hit 800 and go beyond. We submitted the TDI product in October of 2023. I couldn't predict when the FDA will finally approve it, but we sure would like to get FDA clearance by the time we get to the AAD in March, the second week in March. If we had that approved, I think that we could start shipping units in April. We've begun the process of working with manufacturing and getting things lined up for that process. So I think that we'll be ready to ship in the second quarter of this year, as long as we get FDA clearance in the first quarter.

Okay. I know that's great. Any just and type of utilization trends that you're able to glean from your Sentinel system or just from what you're hearing from physicians?

Yes. I think that we're seeing the same as we've seen in the past with the 27% increase year-over-year. Clearly, the volumes continue to go up. And so, there are more and more people that are getting their bodies scanned for skin cancer, and they seem to be choosing the non-invasive way of being treated. So it's a fast way. It's a more productive way. It's a good cash flow for the doctors. There are a lot of good points for all of this to happen, and I think that trend is going to continue to grow. There's no question in my mind. As I've stated before, this will sooner or later become the number one choice for the treatment of non-melanoma skin cancer. I think it will be the treatment of choice very, very shortly.

Okay. Great. And then just lastly, in terms of the recurring model, you know, is there a minimum number of treatments? I know in the fair market lease, it's relatively - it's two, two and a half, depending on the interest rate, I guess, treatments per month, or whatever, to just breakeven, which is obviously not a large number. But in terms of how many treatments do they have to perform in order to get the placement, or is it a placement and it's just a revenue sharing program?

Yes. First of all, although two patients is the approximate breakeven to own a system or to buy a system, there's not a minimum number of units or patients that must be delivered with a recurring revenue. I would tell you that we don't have any of our customers currently with SRT that do less than 10 patients a month, for the most part. We have some customers that are doing 50 and 60 patients a month. So, we're seeing some very high volumes at those sites. Clearly, we're going to approach the customers, and the customers who are interested in this model are the ones that know that they have some decent volumes. They're going to come to us, and we're going to come to whatever agreement we're going to establish. But clearly, I think the model that we're going to have is that if the doctors do a lot of patients, they're going to have the ability to keep most of their money. I think that's going to be a fair valuation for us, and I think that it's going to be profitable for us and for them. So, we're looking forward to introducing this model to them. I think that they'll agree this is something that is going to be worthwhile for them to review. I would also tell you this: If we make 10 presentations to 10 different customers on the recurring revenue model, I'll bet you five end up buying it anyway.

Right, right. Okay. Especially as you're saying that, you know, on average, the physicians that purchase the product see 10 patients a month, and some see many more than that. They may decide the fair market lease is a better way of going if they are sharing revenue. So. But you've given them the option, which theoretically, for some that are reticent necessarily to either go the lease route or lay out the cash, could increase the adoption rate in 2024?

Yes. Additionally, this is Michael. How are you? Part of this model also is that we're going to be taking away some of the work from an operations standpoint that goes into the practices. So certain practices are actually willing to pay fast on the outside to supply some personnel that would take away some of the operational work from the practice itself so that they could concentrate on other areas of the business. We would be supplying those personnel to take away that work.

Okay, interesting. Okay. Great. That's helpful color. I appreciate it. I'll hop back in the queue. Thanks.

Thanks, Anthony.

Thanks, Anthony.

This concludes our question-and-answer session. I'd like to now turn the conference back over to Joe Sardano for any closing remarks.

Thank you. Thank you once again for your time this afternoon and for your interest in Sensus Healthcare. I'd like to mention that we'll be participating in the 36th Annual Roth Conference being held in Dana Point, California from March 17 through the 19, and I hope to see some of you there. We'll speak with you again when we report first-quarter financial results in May. In the meantime, thanks again for joining us today.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines.