Sanara MedTech - Q4 2023

Transcript

Operator (participant)

Greetings. Welcome to the Sanara MedTech Inc. fourth quarter and 2023 full-year results and business update conference call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, Callon Nichols. You may begin.

Callon Nichols (Director of Investor Relations)

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, 2023. We issued our earnings release yesterday afternoon, and I would 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 the Form 10-K for the quarter and year ended December 31st, 2023, are also available on this page. We will reference this information in our remarks today. With us today are Ron Nixon, our Executive Chairman, Zach Fleming, our Chief Executive Officer, and Mike McNeil, our Chief Financial Officer. Please note that certain statements in this conference call, 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 differ materially from those projected or implied by forward-looking statements, please see the risk factors set forth in our most recent annual report on Form 10-K. Also, this conference call, our earnings release, and supplemental deck reference certain non-GAAP measures. In that regard, I direct you to the reconciliation of these measures in the earnings materials that are available on our website. Now I'd like to turn the call over to Ron.

Ron Nixon (Executive Chairman)

Thank you, Callon, and good morning, everyone. Fourth quarter of 2023 was another record revenue quarter for Sanara, and 2023 was another revenue record year. The company generated $17.7 million in revenue in Q4 and $65 million in revenue for the year. For the three months ended December 31st, 2023, the company had a net loss of $300,000. For the year ended December 31st, 2023, we had a net loss of $4.4 million. We were break-even on an Adjusted EBITDA basis in Q4 and generated a $300,000 Adjusted EBITDA loss for the year. We incurred expenses of $400,000 in the second half of 2023 due to an acquisition opportunity that didn't materialize.

Looking ahead to 2024, we expect to further expand our sales force and focus on new geographic areas, further penetrate additional specialties outside of Ortho and Spine, and continue to drive new product development, including expanding the CellerateRX platform intellectual property, as well as begin developing the peptides we recently licensed from Tufts University to expand our peptide platform. We're also continuing to seek complementary partnerships and platform expansion opportunities that could be beneficial to our business. I'd like to also provide a brief overview of Tissue Health Plus, our value-based care strategy for post-acute wound care. This strategy fits well with Sanara's goal to lower cost and improve outcomes within the healthcare system.

However, there are significant differences between THP and our surgical business, which is focused on the acute market related to healing and preventing infections of surgical sites, while THP is being developed to address the prevention and treatment of chronic wounds at home. Given the differences in the site of care, selling channels, and payment systems between our surgical business and Tissue Health Plus, we believe this is very complementary to our post-acute strategy partnership with InfuSystem. We envision the InfuSystem wound care partnership being an integral part of the Tissue Health Plus strategy, given their focus on overall wound care and the common objective of improving outcomes and lowering costs for the healthcare system.

We have begun to have discussions with other potential partners to share the development cost of our strategy that could result in Sanara potentially owning less than a majority of Tissue Health Plus but carrying out this very important strategy. I will now turn it over to Zach to go into more details on our achievements during 2023.

Zach Fleming (CEO)

Thanks, Ron. I'd like to start by discussing the strategic and operational achievements that the company realized in 2023. In August, we acquired all rights for human wound care uses for CellerateRX and HYCOL, in addition to other wound care assets. Since the transaction, we have eliminated the royalty we pay on these two products, and we now have full rights to develop our own proprietary products. As we previously discussed, we had supply issues related to our Allocyte product line in 2023. In late 2023, we solved this issue and successfully launched and recorded our first sale of Allocyte Plus. This product replaces our Allocyte, excuse me, replaces our Allocyte product and is processed by an alternative supplier with in-house processing capabilities. This will afford us greater control of product supply. Excuse me.

The company now has a sufficient supply of Allocyte Plus to meet currently expected demand, and we have measures in place to adequately stock the product in the future. In addition to our first sale of Allocyte Plus in November 2023, we launched and recorded our first sale of BIASURGE Advanced Surgical Solution. We view this product as a significant addition to the portfolio, excuse me, I can't catch my breath, portfolio and believe that it can be used in any surgery where Sanara products are currently used. In November 2023, Sanara announced the publication of a retrospective study involving 5,335 patients. The study demonstrated the effectiveness of CellerateRX Surgical Powder in promoting surgical wound healing. Specifically, a significant decrease in surgical site infections was observed. This exhibited a significant reduction in surgical site infection rates of 59%. That was among patients undergoing elective surgery.

This reduction was most pronounced in clean cases, with a 69% decrease in surgical site infection rates. In December, we executed a license agreement with Tufts University for 18 unique peptides. We are currently exploring opportunities to incorporate these peptides into new products that we could develop at Rochal Industries. Turning to our sales results, in 2023, our products were approved, or excuse me, were sold in over 1,000 facilities across a. 34 states and the District of Columbia Our products were approved to be sold into more than 3,000 facilities as of December 31, 2023. Sales and approvals of BIASURGE continued to grow, and we are pleased with the traction we have seen in this product. At the end of 2023, we had 39 field sales representatives.

We've made significant strides in our data analytics and the use of various sales metrics to both measure our performance as well as penetrate further into our existing accounts and hospital approvals. These efforts have given us detailed insights into our business and allowed us to refine our model for the steps that need to be taken to develop a successful sales manager and territory. Sales of both our soft tissue products and our bone fusion products continue to grow. Sales of soft tissue products were $54.8 million in 2023 compared to $41.7 million in 2022. Sales of bone fusion products were $10 million in 2023 compared to $4 million in 2022. I'd now like to provide additional details beyond what Ron mentioned earlier on Tissue Health Plus, our value-based care strategy for the chronic wound market.

We're currently in discussions with prospective partners to facilitate commercialization of Tissue Health Plus and share in the development cost of the complete strategy. Excluding non-cash items, our full-year operating expenses for Tissue Health Plus in 2023 were approximately $5.2 million. While we work to find the right partners, we'll continue to build out the key capabilities needed to commercialize Tissue Health Plus. These include a Care Hub, a Management Services Organization, and a Technology Platform. The Care Hub will include a virtual care coordination and navigation center. The Management Services Organization will be a network of providers delivering a high standard of patient-side wound care. The Technology Platform will be an automation and integration platform to scale the Care Hub and MSO network workflows. We believe this comprehensive strategy will be unique and impactful in lowering costs and improving outcomes for wound care patients, providers, and payers.

I will now turn it over to Mike to discuss our financial results.

Mike McNeil (CFO)

Thank you, Zach. As Ron mentioned earlier, we generated revenue of $65 million in 2023 compared to $45.8 million in 2022, a 42% year-over-year increase. The higher net revenue in 2023 was primarily due to increased sales of soft tissue repair products, which include CellerateRX, and bone fusion products as a result of our increased market penetration, geographic expansion, and our continuing strategy to expand our independent distribution network in both new and existing US markets. Full-year 2023 SG&A expenses were $57 million compared to $46 million in 2022. SG&A is a percent of revenue decrease from 100.3% in 2022 compared to 87.7% in 2023. The higher SG&A expenses were primarily due to higher direct sales and marketing expenses, which accounted for approximately $8.1 million or 74% of the increase compared to the prior year period.

The higher direct sales and marketing expenses in 2023 were primarily attributable to an increase in sales commissions of $6.9 million as a result of higher product sales. 2023 SG&A expenses also included $1.2 million of increased costs as a result of Salesforce expansion and operational support and $0.4 million of costs associated with an acquisition opportunity that didn't materialize. We expect our SG&A expenses to continue to decline as a % of net revenues as our sales growth outpaces the cost of Salesforce expansion and corporate overhead. 2023 R&D expenses were $4.1 million compared to $3.4 million in 2022. The higher R&D expenses in 2023 were primarily due to costs related to the Precision Healing Diagnostic Imager and LFA. R&D expenses for 2023 also included costs associated with ongoing development projects for our products currently in development.

We had a loss before income tax of $4.4 million for the year ended December 31st, 2023, compared to a loss before income tax of $13.9 million in 2022. The lower loss in 2023 was primarily due to increased gross profit and changes in fair value of earnout liabilities, partially offset by higher SG&A costs, higher R&D expenses, and higher amortization of our acquired intangible assets. For the year ended December 31st, 2023, we had a net loss of $4.4 million compared to a net loss of $8.1 million in 2022. The lower net loss in 2023 was primarily due to additional gross profit realized on higher 2023 revenues. Our cash on hand at the end of the year was $5.1 million. With that, I'll turn it back to Ron for some closing remarks.

Ron Nixon (Executive Chairman)

Thank you, Mike. As we mentioned before, Sanara had both a record quarter and record year in 2023. We continue to build the infrastructure that we need to support our growth in the future, and we're grateful for the hard work and dedication of the entire team. That includes our remarks, and we look forward to answering any questions you may have. Operator, we're ready to open the call for questions. Thank you.

Operator (participant)

Certainly. At this time, we will be conducting a question-and-answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we pull for questions. Your first question for today is from Ross Osborn with Cantor Fitzgerald.

Ross Osborne (Director and Lead Research Analyst of MedTech and Diagnostics)

Hey, guys. Good morning and congrats on the strong results. So starting off maybe with BIASURGE, could you discuss how many centers you sold in during the fourth quarter, or maybe how many you're approved to be sold in? And then as a follow-up, any feedback you could share following the initial launch. Thank you.

Ron Nixon (Executive Chairman)

Zach, do you want to take that? Zach, you're on mute.

Zach Fleming (CEO)

I'm sorry. I heard the first part. You said how many centers in the fourth quarter. What was the second part?

Ross Osborne (Director and Lead Research Analyst of MedTech and Diagnostics)

Just any feedback you could share.

Zach Fleming (CEO)

Yeah. So BIASURGE has been very well-liked out in the market. As you know, we had kind of a pre-launch soft trial where we sent product out to facilities and were able to get feedback from surgeons. And that yielded quite a few pre-sales approvals, and we began to sell those immediately. And then we've spent a lot of time since the launch, really November and December, just gaining additional traction in the market, getting additional trials going. As you recall, when we do approvals, we have to go through sort of the back analysis, but oftentimes it's a trial as well where they want to take a look at the product for a few patients. And so we've done that. And we have not disclosed the number total for the fourth quarter, but we feel really good about where we are.

We have about, at this point, right around 51 through the fourth quarter. Cal just texted me. So we did add 51 in the fourth or have 51 through the fourth quarter, and are actively selling to those. And we're continuing to add to those, which we'll discuss next quarter where we progress. But we're really happy with the product. And the doctors have really found it to be a really nice adjuvant to the same cases that they're already using Cellerate in as well as some of our bone biologics. So as you can imagine, they want to prepare the site by getting rid of the biologic contaminants, any of the biofilm, etc. And then they add in our product like Cellerate to help close the wound.

Ron Nixon (Executive Chairman)

Ross, obviously, it's very complementary to Cellerate, as Zach mentioned. Given that we have published the retrospective study that we did for reduction of surgical site infection, this just goes hand in hand with that and very complementary. I think it's going to be well received by the surgeons that already use Cellerate.

Ross Osborne (Director and Lead Research Analyst of MedTech and Diagnostics)

Got it. Great to hear it. And then maybe lastly for me, just on Cellerate, what do you hope to improve with that offering following the acquisition of the 18 peptides?

Ron Nixon (Executive Chairman)

Zach, you want to take that?

Zach Fleming (CEO)

Ron, do you want to take that?

Ron Nixon (Executive Chairman)

I didn't actually hear the question.

Zach Fleming (CEO)

Yeah. He just asked, "What are we trying to accomplish by getting the 18 peptides?" It's a different set of peptides, but there's yeah, go ahead.

Ron Nixon (Executive Chairman)

I'm happy to take that. So Ross, obviously, CellerateRX falls into the category of having collagen peptides. And one of the keys that we're trying to do is increase our IP around the whole collagen strategy that we've got going forward with CellerateRX. And as we mentioned, we want to expand our coverage into other specialties. There might be uniqueness needed or required based on certain specifics of collagen peptides that we would like to develop. And so they've got a number of indications for use through those 18. And as we sort through that and begin to look at what those priorities are going to be for us going forward, we will obviously keep it centered around CellerateRX, which is obviously a great product today. It will continue to be in the future.

Just want to strengthen that platform but also expand it into more usages within the surgical arena. Some of those peptides actually have application outside of that. More than likely, in that case, we will be seeking partners that have stronger capabilities on the marketing front for us with those. The dominant reason that we did that is to continue to secure more and more technological advantage in the marketplace through our IP.

Ross Osborne (Director and Lead Research Analyst of MedTech and Diagnostics)

Sounds great. Thanks for taking my questions, and congrats again on the strong results.

Ron Nixon (Executive Chairman)

Thank you, Ross.

Zach Fleming (CEO)

Thank you.

Operator (participant)

Your next question is from Neil Cataldi. You mentioned Allocyte sales began to pick up back up in October of last year. However, we didn't see much of an increase in its revenue segment during the fourth quarter. Can you give us a sense for where you're at today with Allocyte in terms of ramping back to a normal run rate, and how should we think about that run rate in terms of annual size?

Zach Fleming (CEO)

Sure. I can take that. So yeah, we did see kind of a delay and inability to get full supply late last year, starting around September, and then actually extended into October. We did a good job of managing based on the sizes available. And so to your point, we didn't see a tremendous drop-off. Then she had a tremendous increase from that particular product because of the management of just the sizes as they were demanded out in the market. And so what we've done is, with Allocyte Plus, you have to go back out to the facilities, get a new approval, becomes like a line extension or a new product that has to get added. And so we've done that and gone back to facilities where we had had some momentum and had lost the ability to sell because of supply.

And then now we're back on page with most of those facilities. Some of them had moved on to other products, but for the most part, we were able to get back on track with all those facilities. But then there's the additional time that it takes to stock and then start to ramp up. And then we're trying to regain some of the business from the surgeons and so forth. And of course, the distributors that work with us as well, and retrain them, coach them back up on this particular product, and then get it started again. So that's where we see that. And it's kind of like that whole fourth quarter was to kind of regain our footing and then into this year, start to sell and proactively approach new facilities and go beyond where we were. So we kind of treaded water, if you will.

Now we're on the move forward, and we feel confident in our approach and where we're headed with that product. It's starting to move forward very nicely.

Operator (participant)

Your next question is from Michael Liu at IFCM.

Michael Liu (Analyst)

Hi guys. Thanks for taking my questions. Congrats on the quarter. My first question, could you potentially clarify the sales force growth throughout the year? I think you disclosed last year that you ended the year at 39, and you're at 39 now. It sounded like you added a couple throughout the year, and it seems to be about flat. Could you just maybe take us through the cadence of how many sales force reps you've had throughout the year and where the major changes have happened?

Zach Fleming (CEO)

Yeah. I think the simple way to think of it is that 3 folks got reclassified, and then roughly 4 got no, it was 4 that got terminated in Q4. And then so you had kind of reclassifications. Promotions would be part of that, and then terminations.

Michael Liu (Analyst)

Okay. Broadly, it was.

Ron Nixon (Executive Chairman)

Yeah, Michael, the one thing that I think is the most noteworthy is that we accomplished a 42% increase in revenue growth with the same number at the beginning of 2023 or ending of 2022 and where we ended 2023. Our data analytics, as Zach mentioned earlier, are being well utilized. We're seeing much better efficiency. And so we have a much better speed to profitability per rep. We also have a much better understanding of their potential and how to achieve that potential within each one of the areas that they're selling in. So I think the efficiency gains we've gotten there have given us great leverage on our sales force. And then we'll just continue to expand as needed into the marketplace.

Zach Fleming (CEO)

Yeah. We're always making adjustments to the team. Whenever we see all this data and analytics, we're really trying to make adjustments that optimize the team. So you'll continue to see that. That's not going to change. We always want to increase efficiency where we can. So that's the second component of that, where Ron said, "We're going to look at that data. We're going to optimize location, and we're going to optimize the call points." And so in doing that, that's the kind of plus-minus. We have to always let people go that maybe aren't working out as well. So that just will continue to happen.

Michael Liu (Analyst)

Okay. Great. And on the tissue health plus potential spinout or partnership, and I appreciate you can't provide too many details yet, but I was curious if you could tell us what stage you are in the talks of doing that spinout. And my main question is, when you do a transaction that one way or another gets tissue health plus off your books, would that be a cash inflow to Sanara or a cash outflow for you, or would it not impact your cash?

Ron Nixon (Executive Chairman)

Yeah. So here's how I would describe it, Michael. We're very much big believers in Tissue Health Plus. No one has ever accomplished pulling the comprehensive strategy together the way that we've described it today to you. And our overarching goals are achieve funding for the strategy with partners that can actually help implement the strategy. As you saw, that we've got the MSO network as part of what we do, that is not something that we would own. So that's a partnership. And we have other needs out there related to the strategy that could be fulfilled with partners that have a better focus on certain areas of that. So those are the types of value-added partners that we're seeking. We want to have that accomplished in 2024. We then want to begin to commercialize in 2025.

We assume there would be some sort of a pilot launch either probably sometime in the beginning of Q1 and then go full commercial. The overall expectation is that this will be a cash flow generator long term. Whether or not that is accounted for under the equity method where there'll be distributions kicked out to Sanara or whether we still own the majority of it and it's kicked out, one way or the other, we want to secure those partners that will help fund this strategy to completion and not be a significant drag on Sanara's overall performance.

Michael Liu (Analyst)

Okay. Thanks. So to clarify, you're not looking at potential deal structures where, for example, Sanara would have to fund a JV along with a partner or something like that. It would definitely be.

Ron Nixon (Executive Chairman)

Not in any significant way.

Michael Liu (Analyst)

The burn goes down over time.

Ron Nixon (Executive Chairman)

We've already made lots of investment into that. And so that would be our contribution into the partnership.

Michael Liu (Analyst)

Okay. Thanks for taking my questions.

Ron Nixon (Executive Chairman)

You bet.

Operator (participant)

As a reminder, if you would like to ask a question, please press star one. Your next question is from Chris Plamp with Paulson Investment Company.

Chris Plamp (Analyst)

Morning, guys.

Ron Nixon (Executive Chairman)

Morning, Chris. How are you?

Chris Plamp (Analyst)

Zach, probably a question for you on CellerateRX. Could you give us maybe a little more color on two things? One, kind of the organic growth from the existing 1,000 hospitals you guys are already selling into for this year and beyond, and then also maybe a little more color on the gap that you want to close on sales with the 2,000 gap on approvals and where we're selling into today.

Zach Fleming (CEO)

Sure. Thanks for the question. Yeah. So for the 1,000, one of the main things we're trying to do there is expand to new specialties. We've done a good job, I think, getting into ortho and spine and the foot and ankle. Those are fairly straight lines for our representatives as well as the 1099 agents we contract with. And I think those particular specialties have a great need for this type of product. They're putting in fairly expensive hardware and material. And then, of course, we want to make sure that the tissue closes uneventfully around it. And then, of course, any potential problems they might have whereas the wound would move forward, they could use Cellerate to help that wound heal.

And so we also see a big opportunity with plastics in general, vascular, primarily those three, but additional specialties as well where they're really challenging patients and really challenging wounds. And we think that there's a lot of opportunity of seeing a lot of this already where we've started to access these new specialties. So we're coming out with additional case studies. We're going to do some additional case reports. We're going to do things to really explore and exploit those particular specialties so that they see the benefits of the product just like we've seen with ortho, spine, and podiatry. So that's the main goals is to expand kind of horizontally in the facilities, get a little deeper. We're also doing a lot of education to the clinical staff.

So in every surgery, you have scrub techs, circulators, different types of nurses that support the case as well as nurse practitioners and first assist. And those people are really critical to the closures in the cases as well as the postoperative care. So we've done a lot of effort just because BIASURGE is such a great product to have hand-hold CellerateRX is really educating the one, two punch of those products and the power there. So you can prepare the wound, and then you can close the wound or help biologically support the wound as it continues to healing. So that's really the goal with the 1,000 is to continue to expand and grow around those. And some of that is just gaining more headcount. We talked about headcount a moment ago.

We're going to have to put a few people in to support larger accounts because there's just a demand there. There's a lot of time associated with supporting the cases. So we want that to have people in the cases at all times and really own the account. So we do have the TM model, which you may remember, that's a supportive component to the regional sales manager. So that'll continue as well. And then to gain access to the additional 2,000, a lot of those are just additional partners, 1099 agencies that we can contract with and access into those accounts. We've obviously gotten great data, which allows us to identify and prioritize which facilities have the most opportunity within those 2,000.

So we're going to target those and have our people run to those particular accounts and then identify the surgeons within as well because that data is available. Really, they're dealing with potential problems. They're patients that have high risk. That's the type of person we would, of course, want to try to call on and use as a champion. And that happens through a lot of different things, trade shows where we're meeting and being in front of different surgeons and meeting new distributors. It also happens through podium talks, things of that nature, and then additional papers that we'll have written and published. So all those things kind of help to surround sound and create more demand in these additional accounts.

Ron Nixon (Executive Chairman)

Chris, we don't actually put out a forecast or penetration into what markets we're going into, but I can tell you that the greenfield opportunities both for the current 1,000 plus the overall approvals that we have is significant. So we see plenty of potential runway for the CellerateRX product.

Chris Plamp (Analyst)

Great. Thanks, guys.

Ron Nixon (Executive Chairman)

Thank you.

Chris Plamp (Analyst)

You're welcome.

Operator (participant)

We have reached the end of the question and answer session, and now I'll turn the call over to management for closing remarks.

Ron Nixon (Executive Chairman)

Thank you, everyone, for joining our call this morning. We greatly appreciate your support, and thank you for being patient and great long-term shareholders with us.

Operator (participant)

This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.