Greetings and welcome to the Sanara MedTech Incorporated Fourth Quarter and 2022 Full Year Results and Business Update Call. At this time, all participants are in a listen-only mode and a question-and-answer session will follow the formal presentation. I will now turn the conference over to your host Mr. Callon Nichols. You may begin.

Thank you, and good morning, everyone. I'd like to welcome you to Sanara MedTech's earnings conference call for the quarter and year ended December 31st, 2022. We issued our earnings release yesterday afternoon. And I would also like to highlight that we have posted today's deck on the Investor Relations page of our website. This supplemental deck as well as a copy of the earnings release and Form 10-K for the year ended December 31st, 2022 are available on this page. We will reference this information in our remarks today. We expect today's prepared comments from Ron Nixon, Executive Chairman; Zach Fleming, Chief Executive Officer; and Mike McNeil, Chief financial Officer, to last approximately 15 minutes to allow time for Q&A. Certain statements in this conference call and in our press release and in our supplemental deck 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 vary materially from those projected or implied by forward-looking statements, please see our most recent annual report on Form 10-K. Now I'd like to turn the call over to Ron.

Thank you, Callon, and good morning, everyone. In 2022, Sanara generated $45.8 million in net revenue, representing a 90% increase from the prior year period. Fourth quarter of 2022 was another record quarter for Sanara as well as for our historical business lines prior to acquiring Scendia. In the fourth quarter, the company generated $15.3 million in net revenue and it was the first quarter during which the company generated over $5 million in net revenue in a single month. We continued to see strong growth in Cellerate sales as well as the sales from the products we licensed from Cook Biotech. The sales at Scendia were flat from Q3 to Q4 due to a stock out of our ALLOCYTE product, which we will discuss in more detail later. For the year, our net loss was $8.1 million in 2022 compared to $8 million in 2021. Mike will go into further detail, but the company had a loss before income taxes of $13.9 million compared to a loss before income taxes of $8.0 million in 2021. The higher loss in 2022 was due to increased SG&A costs, higher R&D expenses, the loss on the disposal of the investment related to the dissolution of Sanara Pulsar and higher amortization of our acquired intangible assets related to the acquisitions of Precision Healing and Scendia. Despite the record quarter and year, our sales were impacted in Q4 by a stock out of our ALLOCYTE product, which began in late Q3 due to a shortage of the source material. We're expecting improvements in our ability to source this product from our suppliers, but we do not anticipate a full resolution until the second half of the year. In December 2022, we dissolved Sanara Pulsar and ceased marketing the Sanara Pulsar II AWI Wound Debridement System. When we formed Sanara Pulsar, we believed the Pulsar products would provide clinicians with a novel debridement solution. We also believed that the Pulsar product would receive an expanded reimbursement code by which all clinician types could use. Ultimately, we decided we did not receive an additional reimbursement code, which limited the adoption and sales of the Pulsar Products. In Q4, the submission of our Precision Healing Imager 510(k) was delayed due to unexpected electrical and software issues as well as increased product validation testing, which we believe provides further validation related to FDA regulatory testing requirements following our submission. The 510(k) was filed subsequent to the end of the quarter on March 16th, 2023. Zach will go into more detail, but we continue to be focused on the commercial development of our Imager, LFA, and the Comprehensive Wound ARM strategy. It's an area of significant investment for the company that we believe will have a competitive differentiator for the company and should be well received by the market. Subsequent to the end of the quarter, we entered into a sale agreement for an ATM offering of our common stock equity. We've entered into this agreement for two purposes. The first is to raise capital for opportunistic acquisitions and partnerships, and the second is to increase the liquidity of our stock. We currently intend to use the net proceeds we received from this offering to fund potential acquisitions, further development of our products, services, and technology pipeline, clinical studies, expand our sales force, and for general corporate purposes. I'll ask Zach Fleming to discuss our business in more detail.

Thanks, Ron. Our product sales team continues to generate strong sales growth and we're penetrating further into our existing customer base and also expanding into new geographic areas. At the end of 2022, we had a total of 39 field sales representatives employed. CellerateRX was sold in 700 hospitals and ASCs across 29 states during the trailing 12 months ended December 31st, 2022, and was approved to be sold in over 1700 facilities. As we have discussed before, we believe there are approximately 12,000 hospitals and ambulatory surgery centers in the United States where CellerateRX Surgical could potentially be used. You'll notice that the number of approvals we have was relatively flat from Q3 to Q4. The reason for this is that we have made a strategic decision to focus our efforts on our existing accounts and facilities in terms of introducing our suite of products to new physicians and finding more cases in those facilities where patients and physicians would benefit from the use of our products rather than focusing on new facility approvals. As Ron mentioned, in the third and fourth quarters, we began to experience supply issues with Allocyte product line. The amount of qualifying eligible donor tissue was significantly reduced industry-wide due to the stringent screening that is required. During the fourth quarter of 2022, we were unable to fill certain orders for this product, which negatively impacted our sales. We are expecting to see some improvements, but we do not anticipate a full resolution of the supply issues until the second half of 2023. As we mentioned in our last call, in Q4, we submitted our 510(k) for BIASURGE, which is our surgical cleanser, and launched a partnership with InfuSystem. We continue to believe that BIASURGE will have a significant impact on both the Surgical Wound Care market and our sales when commercially available, which we believe will be sometime this year. Our InfuSystem partnership is focused on the negative pressure wound therapy in chronic wound care segments of the market and combines Sanara's product line and our deep expertise in wound care with InfuSystem's distribution and complex billing capabilities, their existing sales team, and national footprint. As Ron mentioned earlier, we submitted our 510(k) for our Precision Healing Imager to the FDA. We believe that our Imager is the final component we need in order to offer a comprehensive solution for wound and skin care. We plan to submit our 510(k) for our lateral flow assay, which will expand our wound diagnostic capabilities even further later this year. I want to take some time to discuss our comprehensive solution. Our goal with this offering is to lower costs through early diagnosis, decreased hospitalizations, decreased wound center visits, more advanced treatments at home, and improved outcomes. The platform has four key components that allow us to offer more advanced solutions than the current standard of care, including our proprietary advanced diagnostics and data analytics, our wound and dermatology EMR and mobile app, wound and dermatology telehealth services, and proprietary products for wound and skin conditions. These four components work together in a repeatable cycle as progress is validated. We are currently seeking out partnerships for this offering. Now I will turn it over to Mike to discuss our financial results.

Thank you, Zach. For the year, we generated revenues of $45.8 million compared to revenues of $24.1 million for the year ended December 31st, 2021, representing a 90% increase from the prior year period. Our 2022 revenues included $6 million of Scendia sales. SG&A expenses for 2022 were $46 million compared to SG&A expenses of $28.1 million for 2021. Our 2022 SG&A expenses included $2.9 million of costs related to Scendia operations. The higher SG&A expenses in 2022 were primarily due to higher direct sales and marketing expenses, which accounted for approximately $13.6 million or 76% of the increase compared to prior year. The higher direct sales and marketing expenses were primarily attributable to an increase in sales commissions of $9.6 million as a result of higher product sales and $2.7 million of increased costs as a result of sales force expansion and operational support. Costs related to travel and in-person promotional activities increased by $0.9 million in 2022 compared to 2021 due to the resumption of many in-person activities that were canceled or postponed in 2021 as a result of the COVID-19 pandemic. The increase in SG&A expenses was also partly attributable to increased non-cash equity compensation, higher payroll costs related to the mid-year addition of the Rochal workforce in July 2021, the Precision Healing workforce in April 2022, and the Scendia workforce in July 2022. R&D expenses for the year ended December 31st, 2022, were $3.4 million compared to $0.6 million in 2021. R&D expenses for 2022 included approximately $2.5 million of costs related to our newly acquired Precision Healing diagnostic imager and lateral flow assay. The higher R&D expenses in 2022 were also partly due to costs associated with several new development projects for our currently licensed products. Other expense for 2022 was $1.7 million compared to $0.6 million for 2021. The higher other expense in 2022 was primarily due to a $1 million loss recognized due to the dissolution of Sanara Pulsar. As Ron mentioned, Sanara Pulsar had minimal sales since its inception and was dissolved effective December 2022. We had a net loss of $8.1 million for the year ended December 31st, 2022, compared to a net loss of $8 million for 2021. Our net loss was positively impacted by recognition of a non-cash income tax benefit of $5.8 million related to purchase accounting for the Scendia and Precision Healing acquisitions. Our cash on hand at the end of 2022 was $9 million. With that, I'll turn it back to Ron for some closing remarks.

Thank you, Mike. As we've discussed, we continue to have record revenue quarters and years at Sanara driven by both our Cellerate product line as well as the addition of products from Scendia and the products we market through our partnership with Cook Biotech. Looking ahead to the remainder of 2023, we plan to continue to build upon the success and surgery while seeking new customers for the WounDerm value-based comprehensive strategy and acquisition opportunities which may further expand our business. That concludes our remarks. We look forward to answering any questions you may have. Operator, we're ready to open up the call for questions. Thank you.

Thank you. At this time, we will be conducting a question-and-answer session. Thank you. Our first question is coming from Ross Osborn with Cantor Fitzgerald. Please go ahead.

Hi. Good morning, everyone, and congrats on the record results. So starting off, could you provide some color on how cross-selling abilities trended in the 4Q between Scendia maybe outside of the shortage? And then the Sanara portfolio and how this is developed in 2023?

Yeah, Zach.

Sure. Yeah. So the cross-selling is going very well. The products are extremely complementary. As you know, the reason the Scendia transaction was so attractive is that they are typically used in many of the same cases. The bone biologics are there to complement the bone healing, while the tissue products that we sell are there to complement the tissue healing in compromised patients. And so you see that happen very regularly. And so our challenge has been to go out and gain approval for those additional products. We'll give you numbers, but typically that's gone very well. We've been able to gain great traction with those products. We are seeing good uptake with all products and there's great symbiosis between all those products working together and delivering solutions that the surgeons really appreciate for both bone and tissue.

Okay, great. And then maybe turning to Precision. Congrats on the 510(k) submission. Would you be able to remind us of the predicate offering you based your 510(k) on? And how does Precision compare to the predicate system? And then as a follow-up, are you able to share with us your commercialization plan for Precision in terms of it being offered via capital sale or lease, as well as the initial targeted geographies?

So Ross, one of the - so starting with the latter question. The way we anticipate marketing this as a comprehensive solution, and we believe that it would be better served for our customers to have a lease program, but we have not finalized that yet. That's what we anticipate. And the predicate device that we had used is MolecuLight, and the difference is that we provide more details through our imager for the wound than what MolecuLight does. And what we'll do is at a later point we will highlight those differentiated components and let you know that as soon as it's through the 510(k).

Okay, great. Then I guess post commercialization, do you plan to conduct studies demonstrating Precision's ability to track wound progression?

Yes, that's all part of the entire comprehensive strategy. So our EMR will gather the data that is collected at the wound by both our LFA and our Imager, and that detail will allow us to start to develop clinical practice pathways that we can suggest to clinicians in the field to show them that the data we have actually leads to better results for the patient. And as Zach mentioned earlier, one of our key components of our strategy is to have hospitalization avoidance and also wound center trips because the wound center bills at the same basic rates as the hospital. So those are two very high-cost settings. We view that where the future of wound care is will be treating these patients at home and that's what our focus will be on.

Okay. Got it. And then lastly, you highlighted an interest in acquisitions in your press release and prepared remarks. Would you share your view on private market valuations in this space and areas of interest that you would complement the existing portfolio between traditional Sanara and Scendia?

Yeah, Ross, quite candidly, the valuations in the market typically don't impact us because we are not a company that spends a lot of time in the process of bidding on other companies. What we are looking for is alignment of interest from other partners out there that may have a complementary business to what we offer. And so therefore we ended up in more of a negotiated transaction. If you see from our past with how we handled the Precision Healing, how we handled Scendia, how we've handled the WounDerm and WounDime and Pixalere, all of those acquisitions involve stock and cash. Not all of them actually had cash, but most of those had that componentry. But what it was, was alignment of interest of two parties where their technology would advance our strategy. And they saw that we had the entire comprehensive strategy as opposed to a single component. And so either they sought that out or we found them in the marketplace and did a negotiated transaction. We anticipate more of that in the future, not less of that.

Got it. Thank you for taking my questions and congrats on the progress.

Hey, thank you very much, Ross.

Thank you. Our next question is coming from Ian Cassel with IFCM. Please go ahead.

Yeah, I was wondering if you could talk a bit about the BIASURGE opportunity. You know, I'm just curious about the market opportunity itself, you know, if that's a greenfield opportunity or if you're displacing a competitor. And if so, the latter, you know what the competitive advantages are of BIASURGE.

Yeah. Zach, you want to take that?

I'll take that. Yeah, sure. So, yeah, we think that is somewhat of a greenfield opportunity. And here's why we think that. There are two competitors that have entered the market: one is called Irrisept, I believe that's the Irrimax Corporation, and then another is Bactisure. There are a few line extensions that have come from Bactisure, and that's the next science brand that Zimmer licensed. A couple of reasons. One, I think we fit in a price situation that will be very complementary or very appropriate for the facilities. I think they're going to appreciate where we will stand in the pricing realm. We also have a couple of distinct clinical advantages related to the other two products that are out in the market, and I think I'll withhold those advantages for now until we do the launch. But they will be distinct and noticeable to the clinician, and I think they're going to give them a great advantage in the operating theatre. And then I think it does complement Cellerate, so Cellerate being our lead product. That product does very well in clean ready-to-heal wounds. And so we want to be able to offer that. And so when you use a BIASURGE product, you're cleaning the field, you're reducing the bioburden in that wound, and then you can place the Cellerate, and Cellerate will have a greater effect.

Thank you. My next question is just overall, I mean, Cellerate continues to grow really, really fast. And, you know, I'm just kind of curious, what are the challenges to continuing that growth rate, you know, for the company moving forward?

Sure. I'll take that one too. The challenges are no different than they were before. We need our people in the field. It's a very promotionally responsive product. We need to continue to establish data, research base because you know we have some studies in the works that will come out fairly shortly. And of course, we already have printed published data today that supports us very well. And then I think we want to continue to build that story of what hydrolyzed collagen is. And I think we're doing a very good job of that in marketing and bringing that as well to light in our research. So those are the things I think that will take us to the next level is continued deployment research and then building the story of why hydrolyzed collagen matters.

Okay. Thank you.

I also just want to add to that, Ian, I think that Zach, correct me if I'm wrong, but I think that we get a lot of positive response from our surgical customers that are using this product. And I think the evidence of that will be the evidence that we will be providing shortly will be evident that it is working in the field. But we get nothing but positive responses about the impact of the product that they're using.

That's right.

I do think just, Ian, to just expand a little bit, I think the other opportunities that we are continuing to focus on is expansion into additional specialties. So there's a great benefit in the bone specialties, orthopedics and spine, podiatry, foot and ankle. Those are all excellent spots for people that have wounds in those spaces to use Cellerate. And then I think you have additional opportunities in plastic surgery in general, and we are quickly picking up these additional specialties. But as you know, there are very many of them. So we just need to continue to create those opportunities to meet those doctors and show them the benefits of the product. And that includes going to those shows for those societies and each of those specialties supporting the physicians in the field as well.

Thank you. I just have two more questions. I'll jump back in the queue. You mentioned the Allocyte supply disruption in Q4. That's continuing into H1 of this year. Is there any way that you guys can quantify sort of the effect of that disruption in Q4?

We haven't disclosed that. We know pretty much exactly what that is. It's fairly significant. I think we're very excited about that product. It was growing very quickly. There's a great need for it. The doctors really appreciated the benefits of the handling. I think that's the thing that you notice in this space for bone biologic-type products is that really matters how they handle, how they're able to be used in the surgery. And this product offers some extremely excellent benefits for the surgeon. And so we're excited about when it comes back. We definitely believe that that supply will open back up. We just didn't get it in the last, you know, four, five months. And so we're excited that that will be coming back online. And we are getting a little bit of a trickle of products. So we're not completely out, but we're just not seeing it for the supply that we have a demand for.

Yeah, and the good news is, Ian, is that we actually still achieved a record year and a record quarter even without the Allocyte production being at the levels where we'd hoped it would be.

And my last question is, I know, you guys spent a lot of time and resources on the comprehensive wound care offering. You know, I'm wondering, you know, a big part of that is getting payers to sign up to this wound care offering. I'm curious, Ron, if you think that's still doable in 2023 or do you think that happens in 2024? You know how should investors be thinking about that opportunity and monetizing that?

Yeah, we think it's going to happen in 2023. We have surveyed many of the payer participants in the field, and we know that wound care is top of mind for them. They know it's been a fee-for-service solution, and that no one has been brought a full comprehensive strategy to the table. So we believe that we still will be the first to market with that and we think it will be well accepted. As you know, getting the diagnosis is a key component to that because it's very hard for us to be able to prescribe what we believe needs to be done with the wound without having that data. And so that's why waiting on our Precision Healing and getting the Imager to be done has been critical for us, and we're hoping to get that through the 510(k) very quickly. And then secondly, the LFA will just add that much more data which will give us even more Precision in our healing process.

Excellent. Well, thanks and great quarter and great year. Thank you.

Yeah. Thank you, Ian.

Thank you. Our next question is coming from Chris Plahm with Tall Pines Capital. Please go ahead.

Hey, guys. Great year. Actually Ian asked two of the questions I was going to ask, but one Zach, maybe for you on the sales side, how do you guys feel about the sales force currently? I know you discussed it a bit. You have enough traction within the existing hospitals, so there's no need to go after approvals at this time. So how should we think about growing that sales force? And also the, I guess, the push-pull of selling in the existing hospitals and going out and getting new approvals and going after those?

We have a dedicated team that I believe sets us apart in the industry. Our structure is somewhat distinctive since we utilize regional sales managers who also oversee local 1099 agents. This approach provides excellent visibility, continuity, and market presence. It is crucial to our go-to-market strategy, and we have recruited top talent from leading companies in areas such as orthopedic spine and wound care. These individuals come with existing relationships that they can leverage quickly. The 1099 agents play a vital role by being present where operations occur, facilitating product introduction in a friendly manner, which is very beneficial. We are actively expanding and have successfully added numerous team members in line with our hiring plans. Our goal is for each territory to achieve profitability in stages as we hire. We typically bring in three or four people at once and ensure that they reach profitability before hiring additional staff. We have been cautious with our hiring strategy. As indicated in our earlier presentations, we are also expanding into new states, currently reaching 29 states with annual revenues exceeding $50,000, and this growth continues. A key addition to our team is a national accounts director with extensive experience and connections, enabling us to secure contracts at a high rate. Although I don’t have the exact figures, our contracting pace has been strong, allowing us to maintain robust relationships with hospital systems and providing our sellers with access to key opportunities. We also ensure that our 1099 agents are well-trained and compliant, making us an attractive partner for hospitals. Some competitors may not offer the same level of friendliness and accessibility, and we strive to excel in both customer service and in-field interactions.

Great. Thanks, guys. Good to hear.

Thank you. Our next question is coming from Michael Disalle with Sanara. Please go ahead.

Hey, guys, great fourth quarter. Just got three-part question here. So most of the increasing revenue is reported to be from Cellerate, the surgical power, which is a great product. The product is not manufactured or owned by Sanara. So I'm wondering in order to vertically integrate, mitigate the risk of unavailability of such an important part of the revenue stream, do you guys have any plans or a timetable to obtain ownership of that product line or a replacement if needed?

Ron, you want to take that?

Yeah, obviously, we actually have an exclusive license on that product. We work very closely with the manufacturing company, and so that's not something that we need to discuss today. But quite frankly, we're on top of exactly what we do. Our people go into the manufacturing facility. We have a very close relationship. So it's served us well.

Got you. And in terms of the Cellerate product...

Michael, can I just clarify one thing? The operator mentioned you were with Sanara. I don't...

Scans LLC is who I'm with. Scans.

We just want to clarify you weren't with the company. Thank you.

No, no. I'm not with the company. No, no. So in terms of the Cellerate product, it turns, you know, they have 20 other patent references of related products. Do you have any plans to use any of their other wound care products? And add to the portfolio?

Yes, we plan to utilize all of them. However, we have not yet established a timeline for their rollout.

Excellent.

But, yeah, they're either related to surgery or they're related to our comprehensive wound strategy.

Got you. Got you. So, okay, so lastly, since the significant growth in sales seems to be concentrated in some time, you kind of answered this question already, do you have any plans or timetable to expand where you kind of did answer this, but do you have any plans on taking it internationally like Mexico or Canada retail for instance?

Our main goal is to be present in all 50 states where we are currently located. While this isn't something we expect to achieve in the short term, I believe it will happen in the long run.

Okay, fantastic. Thank you.

Thank you. Our next question is coming from Robert Gross. Please go ahead.

Oh, yes. Thanks for the opportunity to ask a question. The question I have is related to the quality and efficacy of new products being offered. Now, since most of the wound care related products are surgically related and Cellerate is bovine based. I know that the company is introducing porcine based products from Cook and perhaps others. Now there are religious issues with Jewish and Muslim patients which are prevented from protecting our porcine products. And George Church, Ph.D. is a Robert Winthrop Professor of Genetics at Harvard Medical School reports negative for pork derived products which include pig genomes and have frequent cell incompatibilities with humans more easily transmit disease and have human rejection issues. Porcine products have potential issues also, according to the FDA, such as PERV, porcine endogenous retroviruses and also xenotransplantation issues. So what is the reasoning for the expansion of porcine based products versus bovine based collagen products?

Sure. I'll take that. So small intestine submucosa is widely studied and one of the most documented, well-researched products, and that is a porcine product from Cook Biotech as you noted. It's widely used across all types of bodily indications, approved and long studied. We felt very comfortable with the science behind that product. The behind that product line, I should say, the platform of SIS, small intestine submucosa of a pig. And of course, the team also had some experience in previous from areas where we had worked previously and sold a similar product. So there's a lot of internal experience and sort of a leg up on the industry that we have folks in our midst that are extremely impressive with that type of product. They've sold Oasis in the background just to cut through what I'm trying to say there. And so these products, the FORTIFY TRG, offer a very distinct benefit and that is an implant, an implantable indication for the reinforcement of soft tissue. And it is also allowed to be filled or coated with blood fluid, blood product. And that's part of the 510(k) and we felt that was attractive and differentiated in the market and allows for the surgeon to use his imagination how to use that to reinforce soft tissue. And then the FORTIFY FLOWABLE, that product is a robust extracellular matrix that is very complementary to Cellerate. Cellerate will help to seed into that infiltrate and then allow the tissues to migrate and fill up and grow within the ECM. So it's a complementary product. However, we also aren't selling them together. We aren't going out and promoting Cellerate with one or the other product. We just wanted products that are complementary and serve the surgeon's needs based on the patient's deficits. So if you had an area where the soft tissues gotten compromised in a surgery, they can grab for FORTIFY TRG. If they wanted to fill a deep deficit, then complement that would be ideal for FORTIFY TRG, and it allows for TRG allows for application against gravity. It turns into a gel, and you can squirt that up into a cavity that might be deep or even vertically challenged due to maybe it's on the heel of a patient. And so we thought that was a really good advantage for a product. So those are the main reasons we brought those products on. And again, very strong scientific base with a very big company behind it that has put a lot of research and effort behind all those products. Thanks for the question.

Thank you. We have a question from online from Adu Subramanian asking any progress publishing clinical studies with Cellerate.

Yes, we currently have four studies available, all of which involve over 80 patients in most cases. We also have one new study from Gitelman, which included over 50 patients. All of these studies have demonstrated excellent results in surgical settings. There is also historical research on wound forms that has been around longer, with some data available. Looking ahead, we will soon publish several studies, coinciding with many upcoming trade shows where these findings are typically revealed. While we haven't disclosed exact publication dates yet, one study will be presented at the SAWC, and another manuscript will be submitted this week, which we will announce shortly. So, there are two studies currently in progress and a few more on the horizon. Additionally, we are conducting research on BIAKOS BIASURGE and the new product lines we have introduced.

Thank you. As there are no further questions in queue, I will hand it back to Mr. Nixon for any closing comments.

Thank you very much. We really appreciate everybody's attendance today. Thank you for the good questions. And we hope to continue to provide good results to you in the future. And thank you, everybody, for being a shareholder. Take care.

Thank you.

Thank you. Ladies and gentlemen, this does conclude today's call. You may disconnect your lines at this time and have a wonderful day and we thank you for your participation.