SMTI - NASDAQ

Good day, and welcome to the Sanara MedTech Fourth Quarter and Full-Year 2024 Earnings Conference Call. Please not that this conference call is being recorded and a replay will be available on the investor relations page of the company's website shortly. The company issued its earnings release earlier today. Before we begin I would like to remind everyone that certain statements on today's call include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. For more information about the risks and uncertainties involving forward-looking statements and factors that could cause actual results to differ materially from those projected or implied by the forward-looking statements, please see the risk factors set forth in the company's most recent annual report on Form 10-K. This call will also include references to certain non-GAAP measures. Reconciliation of those non-GAAP financial measures to the most comparable measures calculated and presented in accordance with GAAP are available in the earnings materials available on the investor relations portion of our website. Today's call will be hosted by Ron Nixon, Executive Chairman and CEO; and feature additional remarks from Elizabeth Taylor, Chief Financial Officer; Seth Yon, President of Commercial; Tyler Palmer, Chief Corporate Development and Strategy Officer, and Sam Muppalla, who leads Tissue Health Plus. I would now like to turn the call over to Mr. Nixon. Please go ahead, sir.

Thanks, operator, and welcome everyone to our fourth quarter and full-year 2024 earnings call. Let me provide a quick agenda for today's call. I'll start with a high level overview our full-year financial results and key operational highlights in 2024. Seth will review our fourth quarter revenue performance and the commercial progress made in our Sanara Surgical segment in 2024. Sam will discuss the progress made in our Tissue Health Plus segment in 2024 and our priorities for 2025. Tyler will then provide an overview of our recent announcement agreement with Biomimetic Innovations, and Elizabeth will cover our fourth quarter financial results in full -- further detail before opening the calls for questions. With that as the backdrop, let's begin with an overview of our full-year 2024 financial highlights. I'd like to thank our entire team for this tremendous effort this past year, which made our strong financial performance and progress possible. The company generated net revenue of $86.7 million for the full-year 2024 representing growth of 33% year-over-year. Our net revenue growth in 2024 was largely driven by strong sales of our self-tissue products, which increased 39% year-over-year to $76.1 million, along with contributions from our sale of bone fusion products, which increased 6% year-over-year to $10.5 million. We generated positive adjusted EBITDA in 2024 generating $2.7 million of adjusted EBITDA an increase of $2.6 million, compared to 2023. Importantly this performance reflected significant profitability improvements within our Sanara Surgical segment. Sanara Surgical generated segment adjusted EBITDA of $9.1 million in 2024, an increase of $3.9 million or 73% year-over-year. This performance was offset partially by our Tissue Health Plus segment as we continue to invest in our THP platform and infrastructure to prepare for commercialization. Lastly, we were essentially break even in terms of net cash use and operating activities in 2024 with approximately 24,000 of cash used, compared to $3.2 million of cash used in 2023. As of December 31, 2024, there was $15.9 million of cash on hand and $24.5 million available for future borrowings under the facility. In addition to our strong financial performance this past year, we made significant progress across multiple areas of our strategy. In our Sanara Surgical segment, our team delivered impressive execution with respect to our commercial strategy, expanding our sales coverage and penetrating hospitals across the U.S. and facilitating surgeon awareness and adoption of our products. In our Tissue Health Plus segment, we continue to establish our team and develop the technology, capabilities, and infrastructure required to bring this innovative, value-based wound care program to market. We continue to evaluate and pursue new partnerships and acquisitions, culminating in two exclusive distribution agreements and minority investments for innovative products, including the ChemoMouthpiece agnostic. We also made progress in developing our intellectual property portfolio, submitting 11 provisional patent applications in 2024, covering innovations in proprietary antimicrobial technologies and hydrolyzed collagen. Lastly, we secured a new debt facility for up to $55 million of potential borrowings to enhance our balance sheet and provide increased financial flexibility in the form of non-dilutive capital as we pursue our growth strategy. In summary, we are proud of our financial results and operational progress made possible by our team in 2024. As we continue to advance our strategy in surgical, chronic wound, and skin markets, I want to deliver a special thanks to our customers and investors for their support. Looking ahead to 2025, we expect to further enhance our sales coverage and increase our penetration of the market, driving greater surgeon adoption of our Sanara Surgical segment products in both new and existing accounts. We also expect to see a variety of new clinical manuscripts submitted for publication, further strengthening our portfolio of clinical evidence. In our Tissue Health Plus segment, we will continue to invest in preparation for the planned launch of our first pilot with a wound care provider group during the second quarter. Additionally, we continue to evaluate, pursue partnerships and other opportunities to enhance our capabilities and further our long-term strategy in each of our two segments. As our recent performance demonstrates, we remain focused on empowering physicians and clinicians to improve patient outcomes at a lower cost to the healthcare system, while positioning scenario to deliver long-term growth and value to our shareholders. I'll now turn it over to Seth to discuss our fourth quarter revenue performance and commercial execution.

Thanks, Ron. Our team delivered strong commercial execution in the fourth quarter, culminating in net revenue growth of 49% year-over-year to $26.3 million. Our net revenue performance was largely fueled by sales of our soft tissue repair products, which increased 56% year-over-year to $23.5 million, reflecting strong sales of our CellerateRX surgical and Biosurge products. Sales of our Bone Fusion products increased 8% year-over-year to $2.8 million, driven by balanced growth across multiple products. As discussed in our preliminary result press release on January 21, fourth quarter BIASURGE sales were driven in part by increased demand following the disruption caused by Hurricane Helene last fall, which caused industry shortages of IV fluids and saline solutions. Setting aside the approximate $1.8 million we saw related to this unique dynamic, we remain pleased with our net revenue performance in the quarter. Turning to an update on commercial strategy and execution in the Sanara Surgical segment. At year-end, our commercial team included 40 field sales reps, compared to 39 at the end of 2023. Our sales performance in 2024 primarily reflected strong commercial execution in 3K areas. First, we continued to increase our sales coverage and presence in the U.S. by selectively expanding our distributor network. Our team made significant progress on this core element of our commercial strategy, identifying and securing new selling agreements with additional distributor partners in key areas. We ultimately increased our distributor network to include selling agreements with over 350 distributor partners by year-end, up from more than 250 at the end of 2023, demonstrating our continued momentum and strengthening our sales coverage. As a reminder, our distributors do not stock inventory beyond some limited trunk stock in the event that additional product is needed during a procedure. Our field sales reps are responsible for managing the relationship with our distributor partners inside their respective territories, providing them with training, assistance, and technical support needed to educate prospective surgeon customers about our products. Second, we increased our surgeon customer base by driving adoption of our technologies in both existing and new facilities. Third, we continue to grow our number of approved facilities, adding new accounts for our team to sell into each year. At year-end, our products were sold in over 1,300 facilities, up from more than 1,000 at the end of 2023. This growth was primarily driven by gaining VAC approvals at new hospitals where we had not previously sold our products. Despite our progress in recent years, we remain in the early innings of our commercialization effort with a significant greenfield opportunity to expand our customer base. In 2025, we aim to build on our recent commercial traction by leveraging and expanding our independent sales coverage of the U.S. market and raising awareness of our products with surgeon customers in both existing and new facilities. We look forward to getting our products into the hands of new surgeon customers, who remain unaware of the benefits that they bring. With that, I'll turn it over to Sam to write an update on Tissue Health Plus.

Thanks Seth. 2024 was a significant year of development for THP. The effort was carried out by a coordinated, multidisciplinary global team and divided into three main initiatives. Our first initiative was to develop a clinical model for holistic wound care that leverages science to integrate wound prevention, treatment, and maintenance. Simply put, this clinical model details an intervention playbook for many types of wounds, phases, and complexity levels. Each intervention playbook implements a team-based approach across multiple medical disciplines and care settings. We have built and validated over 35 of these playbooks to cover all chronic wound ideologies. Our second initiative was focused on building the technology platform that uses our integrated care model to scale the delivery of transformative wound care by our provider partners. Our tech platform is also built to enable Tissue Health Plus to design, contract, and implement savings generating programs for our paired customers. Our third initiative was focused on enabling a 2025 market launch. This includes the development of our [pair savings] (ph) model and its validation by a third-party actuarial firm using a study of 1 million insurance claims. We have also designed our value-based pricing approaches for both provider and care programs. We believe our progress across these three initiatives has put us on track to launch our first pilot program with the Wound Care Group during the second quarter of 2025. We are initially targeting wound provider groups and podiatry practices with 10 or more practitioners. Lastly, with respect to payers, we intend to launch our first pilot program with [Indiscernible] during the second-half of this year. I would now like to turn it over to Tyler to discuss our recently announced partnership with Biomimetic Innovations.

Thanks, Sam. On January 21, we announced a strategic relationship with Biomimetic Innovations, or BMI, a privately held medical device company based in Ireland. This relationship includes both an exclusive license and distribution agreement and also a minority investment in BMI. The licensing agreement provides us with the exclusive rights to market and sell two innovative products in the U.S., both of which are designed to manage periarticular fractures or fractures that occur inside or around the joint. The first product is a synthetic injectable, Bio-Adhesive Bone Void Filler known as OsStic. The second product is a hardware agnostic adjunctive internal fixation technology, which is designed to promote the targeted application of OsStic. OsStic has been granted breakthrough device designation by the FDA. According to the FDA, this designation is granted to devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. We believe receiving this designation underscores the incremental clinical value that OsStic brings to the treatment of periarticular fractures. Periarticular fracture repair procedures require surgeons to address the fragmented bone and ultimately restore the surface where the patient's bones meet in order to allow the joint to function properly again. With this in mind, OsStic is designed to enhance the process of repairing periarticular fractures by enabling surgeons to address three important clinical needs. Number one, reducing periarticular fractures in and around the patient's joint; number two, achieving provisional bone fixation; and number three, filling bone voids. OsStic is specifically formulated to allow the product to more readily flow and disperse into a patient's bone defects, and then interlock and adhere firmly with the surrounding porous tissue of the bone. We believe these properties allow OsStic to deliver exceptional structural integrity and mechanically enhanced Bio-Adhesion, making it uniquely suited to address the three clinical needs I mentioned earlier. Ultimately, we believe OsStic will provide surgeons with a unique and compelling solution to enhance fracture repair in the more than 100,000 periarticular fracture procedures that occur in the U.S. annually. In terms of the path ahead, BMI is engaging with the FDA through sprint discussions, one of the many benefits afforded to breakthrough device designated products, and is working to secure regulatory clearance. Our timeline continues to assume having cleared technology to introduce to the U.S. market in the first quarter of 2027. Once cleared, we expect OsStic to enhance and complement our current bone fusion portfolio in our Sanara surgical segment, leveraging both our existing call points and our commercial infrastructure. Before turning the call over to Elizabeth, let me share a quick introduction. Elizabeth joined our executive leadership team in January as Chief Financial Officer following a more than 25-year career in the financial services and healthcare industries. During this time, she has served as CFO of a Medtech company, focused on the treatment of wounds, as COO of multiple hedge funds, and as a member of the investment team at a leading private equity firm. I'd like to take the opportunity on today's call to formally welcome her to our team on behalf of everyone here at Sanara MedTech. Elizabeth will now review our fourth quarter financial results in more detail.

Thanks, Tyler. I'm excited to join Sanara during a pivotal time in the company's history and to have strong financial performance to outline on my first earnings call with the company. As Seth covered our fourth quarter revenue performance, I will begin my discussion at the gross profit line. Unless otherwise noted, all references to fourth quarter financial results will be on a year-over-year basis. Fourth quarter gross profit increased $8.2 million or 51% to $24.1 million. Gross margin increased approximately 160 basis points to 91.4% of net revenue, driven by increased sales of our soft tissue repair products. Fourth quarter operating expenses increased $8.3 million or 51% to $24.4 million. The change in operating expenses was driven by a $6.1 million or 37% increase in selling general and administrative expenses, a $1.8 million or 270% increase in research and development expenses, and a $0.5 million, or 47% increase in non-cash depreciation and amortization expenses. The increase in depreciation and amortization expenses was due to a $0.5 million non-cash charge to write-off the remaining net bulk value of certain internal use software assets in our Tissue Health Plus segment. Operating loss in the fourth quarter was $0.4 million, compared to a loss of $0.2 million last year. Other expense was $1.3 million, compared to 36,000 of expense last year. The increase in other expense was primarily due to higher interest expense related to our CRG term loan and, to a lesser extent, the absence of a gain on disposal of investment, which lowered total other expense in the prior year period. Net loss for the fourth quarter was $1.7 million, or $0.20 per diluted share, compared to net loss of $0.3 million, or $0.03 per diluted share last year. By segment, our Sanara Surgical Segment generated net income of $0.9 million, compared to a net loss of $0.7 million. And our Tissue Health Plus segment generated a net loss of $2.6 million, compared to net income of $0.5 million. Adjusted EBITDA for the fourth quarter of 2024 was $0.9 million or 3.6% of $26.3 million of net revenue, compared to $0.4 million or 2.5% of $17.7 million of net revenue. By segment, Sanara Surgical Segment adjusted to the dial with $4.1 million or 15.4% of $26.3 million of Sanara Surgical Segment net revenue, compared to $1.5 million or 8.6% of $17.7 million of Sanara Surgical Segment net revenue last year. And our Tissue Health Plus generated segment adjusted EBITDA loss of $3.1 million, compared to a loss of $1.1 million last year. Lastly, with respect to our balance sheet, as of December 31, 2024, we had $15.9 million of cash, $30.5 million of principal debt obligations outstanding, and $24.5 million of available borrowing capacity. This compares to $5.1 million of cash and $9.8 million of principal debt obligations outstanding, and $2.3 million of available borrowing capacity as of December 31, 2023. Subsequent to year-end, we amended the terms of our CRG term loan to provide more flexibility in terms of both the timing and amount of potential future borrowings. As a reminder, our CRG term loan initially provided for one additional borrowing of up to $24.5 million, which was required to be made on or before June 30, 2025. We amended the terms of our loan agreement to provide for up to two additional borrowings, totaling $24.5 million in aggregate. These additional borrowings are now permitted to be made on or before December 31, 2025. Lastly, while Sanara does not provide formal financial guidance, we would like to share a few considerations to bear in mind. This year, our team remains focused on building on the progress made in 2024, delivering another year of growth driven by the performance of our Sanara Surgical Segment. We are pleased with our start to 2025, which continues to track with our expectations. In 2025, we remain focused on improving the profitability and our Sanara Surgical Segment while continuing to invest in our Tissue Health Plus segment in preparation for the planned launch of our first pilot program with the Wound Care Provider Group during the second quarter. Specifically, we expect our continued investment in Tissue Health Plus of the first half of 2025 to be between $7.5 million to $10 million. Importantly, we are pursuing financial partners to invest in the execution of our Tissue Health Plus strategy. With our existing cash on hand, expected incremental borrowing on our existing facility, and the expected cash generation in our surgical segment in 2025, we believe we have the requisite capital to pursue our strategic growth initiatives. With that, I'll turn it back to the operator to open the call for questions.

Thank you. [Operator Instructions] Thank you. Our first question today is coming from Ross Osborn with Cantor Fitzgerald. Your line is live.

Hi guys, Good morning and congrats on the progress and thank you for taking our questions. Starting off, would you just run through ChemoMouthpiece and the game plan for 2025 there?

Sure. Happy to, Ross. ChemoMouthpiece is being introduced into the market as we speak. And you have the following events that have to take place. One, they are waiting on their health economics study that will be published and out very shortly. Secondly, the clinical study that was done for the ChemoMouthpiece that involved, you know, numerous patients in that trial. And those both will be coming out in the very near-term. And then lastly, they've got a very nice code that's associated with this, but they need to get that onto the commercial pay contracts. So they're making their effort now to go back to their existing customer base, which you may recall they have a very large population of commercial contracts. And they will be continuing to go to those to get approvals to add ChemoMouthpiece to a treatment for oral mucositis. So all that will be happening as we speak and as that goes, so we'll go ChemoMouthpiece.

Understood. Thank you. And then turning to THP, how would you guys judge a successful pilot launch during the 2Q?

Yes, Sam, would you mind taking that?

Sure. Great question, Ross. I think the best way to think about it is to really understand why the pilot customer actually signed on with us. And if you take a step back, there are a wound provider group in about six states and 11 different locations. And there are three strategic objectives. One is to become lean in fee-for-service, where they want to achieve clinical standardization and reduce their reimbursement risk exposure. Second, they want to innovate on their services and add to their portfolio services. Third, they want to actually transition to advanced payment models. So when we think about success for the pilot, we really focus on the first piece is can we integrate with their systems and standardize clinical workflows and can we help them standardize their reimbursement posture by increasing their documentation quality. That's how we would measure success. But a simpler way of looking at it is going live, which should happen shortly.

Great. Thanks for taking my questions and congrats on the progress.

Thank you very much Ross.

Thank you.

Thank you. [Operator Instructions] Thank you. Our next question is coming from Tom Johnston, who is a Private Investor. Your line is live.

Hey, Ron and team. Congratulations on another amazing quarter and year. My questions are also around THP. Number one, just want to confirm that the pilot is in U2, not the second half. I think there may have been a misstatement there. The second, I'm really curious, it seems like most of the investment thus far has gone into developing the clinical model and the tech platform. I'm curious as to any business development efforts beyond the initial pilot system that you've identified that is signed on?

Yes [Multiple Speakers] Sorry, Tom. No, yes. Thank you for the question, Tom. Yes, a significant effort has, first, it is in Q2, the pilot, just to kind of confirm that. Second is while a significant effort has gone into the clinical and the tech side, we have actually put a significant amount into the commercial side as well. And when we think about the commercial side, we really looked at two things, is can we create the right pricing model and does it fit the value proposition for our customers? So we have designed a value-based pricing for both the provider and the payer markets, and that's been market tested. The other piece we really looked at is how do you generate the leads and put the business development efforts in place, and that's the point you were hinting at. And in order to do that, we’ve recruited a sales team, and then we're also in the process of finishing of recruiting an additional BD team, which will feed into that sales team. So -- and we have started tracking a pipeline. And while you are not giving revenue guidance, we are very pleased with the initial interest in it, Tom.

That's great, thank you, Sam.

Thank you, Tom.

Thank you. We do have a question via webcast. In the Tissue Health Plus segment, how should we expect a third-party investment to potentially offset the spending in this segment?

Sam, you want to take that?

Sure. So, as we've been talking about in the last couple of calls, we are looking for financial partners. Elizabeth indicated that in this call as well. So what we are really looking for are partners to both offset some of our burn or investment, but really also looking for giving us a strategic advantage. So finding the right balance is really the key goal for us. And just in -- go head.

Those discussions are underway with several parties.