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spk02: Good morning and welcome to the Sonara MedTech 3rd Quarter 2024 Earnings Conference Call. The company issued its earnings release yesterday and will post today's supplemental deck on the Investor Relations page on the company's website. With us today are Ron Nixon, Executive Chairman and CEO, Mike McNeil, Chief Financial Officer, Seth Yon, President, Commercial, and Sam Mopala, who leads Tissue Health Plus. 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 the company's most recent annual report on Form 10-K, as supplemented by the risk factors in the company's most recent quarterly report on Form 10-Q. Also, this conference call, the earnings release, and supplemental deck reference certain non-GAAP measures. In that regard, please refer 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 Nixon.
spk03: Thank you, Operator, and good morning, everyone. During the third quarter of 2024, the company generated $21.7 million in net revenue. This was an increase of 35% year-over-year and represented our 12th consecutive year record revenue quarter. The strong sales performance in Q3 is a testament to the hard work and dedication of our entire organization in executing our strategy. We remain focused on continuing our growth and delivering exceptional value to both our customers and shareholders. Third quarter also achieved improved adjusted EBITDA results, scenario generated adjusted EBITDA of $800,000 during the third quarter of 2024 compared to adjusted EBITDA of $300,000 for the same period in 2023. In Q2, we began reporting additional financial performance metrics of our surgical division and Tissue Health Plus as separate business segments. This transition to segment reporting better aligns with how our leadership team views the business. Our surgical segment generated a $200,000 net loss in the third quarter and a net loss of 2.9 million year-to-date through September 30th of 2024. On a segmented EBITDA basis, the surgical segment generated 2.6 million and 5.1 million of segmented EBITDA during the third quarter and year-to-date through September 30th, 2024, respectively. We continue to see strong growth opportunities for both segments, which Sam and and Seth will discuss in further detail. We plan to continue investing in THP technology platform and related infrastructure through the expected commercial launch in mid-2025. And as a reminder, we are pursuing like-minded financial partners that will bring value to the strategy, including capital. In September, we invested $5 million in exchange for an ownership percentage of approximately 6.6 in Chemo Mouthpiece LLC, which owns and manufactures a 510K cleared cryotherapy device designed to reduce the incidence and severity of chemotherapy-induced oral mucositis. In connection with the investment, we announced the execution of an exclusive U.S. distribution agreement through RJV with Ipu Systems for chemo mouthpiece. This product aligns well with Senera's wound and skin care strategy, which includes our Licensed College of Peptides from Tufts University with one particular peptide focused on radiation dermatitis. SI Healthcare Technologies LLC, a joint venture entity, owned 50-50 by Senera and Ipju System and will be an exclusive distributor of the chemotherapy kits by our partner, Ipju System. We look forward to working with Infosystem team commercializing this product in 2025. I'll now turn it over to Seth to discuss our surgical business results and momentum.
spk07: Thank you, Ron. As of the end of the third quarter, our products had been sold in over 1,200 hospitals across 34 states and the District of Columbia during the trembling 12 months and were contracted or approved to be sold in more than 4,000 facilities. We currently have selling agreements with over 300 distributors representing 2,900 plus potential sellers. Looking at the growth of the territories and the facilities in which we sell, in Q3, our products were sold into over 900 facilities compared to over 600 facilities in the third quarter of 2023. Sales of our soft tissue products grew from 13.6 million in the third quarter of 2023 to 18.9 million in the third quarter of 2024. Sales of bone fusion products grew from 2.3 million in the third quarter of 2023 to 2.8 million in the third quarter of 2024. We continue to build momentum within our network of over 4,000 contracted or approved facilities, diligently working to expand our surgeon user base in our core orthopedic and spine areas. We have also intensified our focus on non-traditional users to drive growth in both active and new accounts. Expanding into additional geography remains a top priority for our regional sales managers, particularly through the engagement of key distribution partners. The commercial team is working closely with our operations team to constantly enhance our sales analytics, which will uncover greater opportunities through a strategic focus across all the areas that we serve. In addition to our organic growth, we are regularly evaluating opportunities for surgical M&A and partnerships Our management team sees synergistic potential transactions as a key growth driver that complements our strong organic growth. With that, I'll turn it over to Sam to provide an update on Tissue Health Plus.
spk00: Thanks, Seth. Last call, we outlined THP strategies to disrupt the 100 billion plus non-acute wound care market. As planned, Q3 was focused on enhancing our execution capacity. and building the platform to support the scaled delivery of our distinctive care model. We have established a world-class leadership team with extensive expertise in wound care and technology to oversee the execution of our global multidisciplinary team. The development of THP's state-of-the-art wound assessment software has a medical device and innovative real-time EMR integrated clinical decision support is on track for release in the first half of 2025. Early previews have been well received by the provider community, demonstrating its transformative value. We are compiling a list of enthusiastic pilot partners. On the payer side, we have successfully collaborated with the leading value-based care consulting firm to refine our program economics model ensuring alignment with standard payer reimbursement strategies and infrastructure. This engagement reaffirmed the efficacy of our innovative episodic risk sharing model. In preparation for market entry in mid-2025, we have launched an introductory website, www.tissuehealthplus.com, to say hello to the world. We have also recruited a Luminary Clinical Advisory Board to help us anticipate and overcome real-life adoption hurdles. I would now like to turn it over to Mike to discuss our financial results in more detail.
spk08: Thank you, Sam. During the third quarter of 2024, SNARE generated net revenue of $21.7 million compared to $16 million in the third quarter of 2023, a 35% increase over the prior year period. The higher revenue in Q3 was primarily to increase sales of soft tissue repair products, including Celerate RX, as a result of increased market penetration, geographic expansion, and our continuing strategy to expand our independent distribution network in both new and existing U.S. markets. Third quarter gross profit of $19.7 million increased $5.4 million, or 38% compared to prior year. Year-to-date gross profit of $54.5 million increased $13.3 million or 32% compared to the same period in 2023. SG&A expenses for the third quarter were $19 million compared to $13.9 for the same period in 2023. The higher SG&A expenses included $3.7 million of direct sales and marketing expenses and $1.2 million of costs related to the build-out of our PHP platform and infrastructure. Third quarter R&D expenses were $1.4 million compared to $1 million during the same period in 2023. R&D expenses included $600,000 and $800,000 attributable to our Tissue Health Plus segment for the quarters ended September 30, 2024 and 2023, respectively. Higher R&D expenses in 2024 were primarily due to new projects associated with CelerateRx. Interest expense was $900,000 for the quarter compared to $200,000 in Q3, 2023. The higher interest expense was primarily related to our term loan with CRG. Sonera had a net loss of $2.9 million for the third quarter of 2024 compared to a net loss of $1.1 million for the same period in 2023. The net loss included $2.7 million and $1.7 million attributable to our Tissue Health Plus segment for the quarters into September 30, 2024 and 2023, respectively. The higher net loss for the third quarter of 2024 was primarily due to higher SG&A costs related to the build-out of the THP platform, higher interest expense related to our CRG term loan, and higher expense related to change in fair value of earn-out liabilities. As Ron mentioned earlier, in order to better inform the investor community of our strategic rationale of the acute and post-acute comprehensive strategy investments, we have separated financial results of our two operating segments, Scenarios Surgical and Tissue Health Plus. Net of expenses we believe to be non-core to our operations, we generated consolidated positive EBITDA of $800,000 and $1.7 million during the three and nine months into September 30th, 2024, respectively. Our scenario surgical segment generated positive EBITDA of $2.6 million during the third quarter of 2024 and $5.1 million year-to-date through September 30th, 2024. Tissue Health Plus generated negative segment EBITDA of $1.7 million during Q3 and and negative 3.4 million during the nine months into September 30th. All corporate and overhead expenses are included in the scenario surgical segment as substantially all these costs relate to supporting operations and activities of the surgical segment. Scenario surgical also includes our in-house research and development team Rochelle Technologies. Our cash balance at the end of the quarter was 16.3 million. I will now turn it over to Ron for closing comments.
spk03: Thank you, Mike. We continue to execute on our strategic plan in both surgical and non-acute wound care value-based strategy. Our surgical team has generated positive adjusted EBITDA, and we expect to see continued improvement in operating results while executing on the growth plan and market expansion. As discussed, we see a significant opportunity to disrupt the non-acute wound care market with our THP value-based strategy and anticipate a mid-2025 commercial launch. Operator, I'd now like to open the line for questions.
spk02: Thank you. If you'd like to ask a question, please signal by pressing star 1 on your telephone keypad. If you're using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. And our first question today will be from Ross Osborne from Cantor Fitzgerald. Ross, your line is live.
spk01: Hey guys, congrats on the progress and thanks for taking our questions today. Starting off, would you walk us through the rationale for the investment in chemo mouthpiece and how it fits into your broader strategy?
spk03: Sure, happy to. So our strategy, Ross, has always been wound and skin care. We see, you know, many, many people think of wounds as a skin condition. We license the 18 college of peptides from Tufts. Those are all centered around wound and skin. We have a strategy moving forward on the value-based side, THP. That is a wound in skin. And the chemo mouthpiece directly impacts a skin condition that is horrific in the chemotherapy oncology space. So if you think about it, what happens is when they use chemotherapy in treating cancer, you can get these sores, oral mucositis sores, and they are really a wound that is open in your mouth. And the only way historically to be able to solve that problem is use ice cubes, which is pretty antiquated. And so a particular gentleman that had gone through cancer treatment had this horrific experience with oral mucositis. He's an engineer by background and decided he's going to come up with that. It's a de novo product, which means it's a one-of-a-kind. It's very unique, and we're bringing it to market with InfuSystem because it fits our overall strategy very well.
spk01: Got it. Makes perfect sense. And then turning to THP, if I remember correctly, you were conducting a pilot program with a podiatry group. Curious about any feedback there and how that's progressed.
spk03: Yeah, we've not started that, but I'll turn it over to Sam to talk about that.
spk00: So thank you, Ron. Ross, as we discussed last time, we were targeting pilots in the first quarter, in the first half, if you will, and we are on target to do that. And as I said on the earnings call, we have a list of people we're working with, and we are hoping to really – the early previews have been really, really good.
spk01: Okay, great. Thanks for clarifying that. And then last one on THP – How has it gone as far as attracting new operational personnel to join the team there?
spk00: That's one thing we are particularly proud of, Ross, is we've been able to attract a very skilled team with a lot of execution experience in this space. And we have actually created a team both which is in the US as well as in India to help us scale our platform development efforts. One of the things we also did was integrate it into the team external partners to kind of de-risk the execution. But in terms of being able to attract the talent, it's been a really nice journey so far, and we've been able to onboard them and make them productive really fast.
spk03: One thing we're also going to make very interesting in why it's also attractive, many people know this is a needed opportunity. strategy in this market, and people have known for decades that this strategy needs to happen. It's complex, but Sam is the perfect person to lead that charge, and he's built a team that complements him very, very well. Perfect.
spk01: And then maybe turning to OpEx, during the quarter, you demonstrated a controlled spend, particularly on the R&D line. How should we think about OpEx for the balance of this year and 2025 as you launch Tissue Health Plus in addition to the other projects you have going on?
spk03: We think through that very carefully, Ross, and we lay out exactly where we're going and how we plan to get there, and so we typically don't have a lot of surprises related to that, so it's in our budget, and so when we say that we're on that we are moving forward on our strategy to execute that strategy, we have the appropriate budget for that. And as we also said, we expect to see continued growth in our EBITDA, adjusted EBITDA. So it's all part of our overall planning, and we don't see any surprises at this moment.
spk01: Okay, perfect. And then lastly, any update on your work with POS relating to the 18 peptides you have?
spk03: I'm sorry, I didn't hear the question, Ross. Say it again.
spk01: Any update on your work with Tufts relating to the 18 peptides you have?
spk03: Yes. So if you think about the skin and wound strategy that I discussed with you just a few minutes ago, the radiation dermatitis is almost an identical same size market as the oral mucositis. And there has been no particular solution that has been developed that is a preventative and a solution for healing radiation dermatitis. And it's a horrific skin condition as a result of radiation. And both of those are the two skin conditions that really wreak havoc on keeping people on their regimen for chemotherapy and also radiation. Yes, our technical team at Rochelle, scientific team, is working on that, and we're moving that forward as quickly as we can, and we see it as a very strong complement for our JV with empty system because it will be the same call points.
spk01: Perfect. Thanks for taking our questions, and congrats again on the progress.
spk03: Thank you, Ross. Appreciate that. Thank you for the support.
spk02: Thank you, and once again, it will be star one, on your telephone keypad at this time if you wish to ask a question. We did get another question come from Ian Cassel from Microcap Club. Ian, your line is live.
spk05: Yeah, congratulations on the quarter. Can you talk generally about the types of partners that you're looking to attract for Tissue Health Plus and maybe just generally how those conversations are going?
spk03: Sure, I'll turn that over to Sam and let him do that.
spk00: Thank you, Ron. Thank you, Ian, for the question. In terms of the partners we're looking for, we're looking for two types of partners. One, financial partners, obviously, and second, execution partners. And as we laid out, we have actually filled our dancing card of execution partners. In terms of financial partners, we're really looking at some strategics who can bring execution as well. So not just money but actually smart money, if you will. So we're looking for people who have reach into the provider community. We're looking for people who have reach into the supply chain we'll be using at THP, so people like DME providers. We're looking for strategic product suppliers, product manufacturing companies who have deep science in this space as well. Outside of that, we're also looking for potential typical financial investors like venture capitalists or people who have an execution track record in the healthcare space we are targeting.
spk05: Thank you. One last question. When Tissue Health Plus launches middle of next year commercially, would you expect that segment to be immediately profitable or will there be some ramp up needed to get to profitability in that segment?
spk00: There will be a ramp up needed to get to profitability.
spk05: Okay, thank you.
spk02: Thank you. The next question will be coming from Chris Plam from Tall Pines Capital. Chris, your line is live.
spk06: Hi, guys. Good morning. Two questions. One, can we get an update on IP progress with Celerate and also just an update on Biosurge?
spk03: Yeah. Both, well, I'll let Seth talk about BioSearch and on the IP front. The IP front, as we mentioned in several calls, historically, that is a priority for us. And it is going very well and we'll be able to report by year end the success that we've had. But we continue to file provisional patents around all of our products. and the combination of our products and other things like that. So, we are making really good progress, Chris. And then, as it relates to BioSurge, Seth, maybe you could just talk about, you know, from the introduction of November through this quarter, you know, what you see.
spk07: Sure. Great question, Chris. Thank you. So, BioSurge soft launched last year at this time, formally launched at the turn of the year. We are right on pace, not only at the facility level and gaining approvals, but starting to scale that product as well. It's really a facility-level sale, not just a surgeon-level sale, and we're really happy with how that's gone through the third quarter.
spk06: Great. Thanks, guys.
spk02: Thank you, Chris. Thank you. And the next question is coming from John Seidhoff from Twin Oaks Equity. John, your line is live.
spk04: Thank you. Good morning, Ron, Mike. How are you guys doing? Congratulations on another growth quarter year to date, year over year, 47 to 60 million. Fantastic results.
spk06: Thanks, John.
spk04: You bet. I just have two quick questions. The last time I'd asked about our share price and where it's been in the mid-30s. And I was wondering, could you tell us a little bit about What Scenera has for market makers out there, just in the last, say, two years, the lows have been 28 to 30 and the highs have been 45 to $50. And so we've had people buy in at both of those levels and now we'll say we're around $35. And so at some point, you know, we do have to look out for these investors and try to get the price up a little higher with our net losses continuing on and borrowing more money for this growth. A couple of the reviews out there say that it's maybe three years until profitability. I was wondering how you guys felt about that because I know how much capital it takes to grow, of course, but I just wanted to get you guys' thoughts on The burn of cash, I know you have a lot of access to it, but what you see for profitability down the road, is it $100 million? Is it something like that? I know it's a big question. And then how will that affect our market makers out there with our share price? Thank you.
spk03: John, we're on pace exactly as we're planning. We like the progression of our adjusted EBITDA. Mike can speak to the actual cash. And so, Mike, you can talk about that now. But I would tell you, our plan is to continue to do exactly what we're doing. You know, 12 straight quarters. Last I checked, that's a lot of time frame. And we're going to continue to keep that pace. That's what we want to do. And I think the market will take care of itself. All we have to do is continue to produce results. And we don't expect to have any surprises where we would need to have a highly dilutive event. We would, we look for events that are extremely creative to us. And we've said that on many calls before from our M&A and partnering activity. And so Mike, if you want to talk a little bit about that for your projections on cashflow, that'd be, that'd be great.
spk08: Yeah. Thanks, Rod. Yeah. We had a strong cash performance in cash during the quarter. We actually generated a couple million dollars of, positive cash flow in the quarter from operating activities. And so we've been somewhat neutral through most of the year, and most of the borrowing has been for investing activities. So we don't expect to be burning cash in operating activities in the near future or even going forward.
spk04: Well, thanks, Mike. That's really good news to hear. And then, Ron, thanks also. I know that You guys are focused on growth. I know what it takes to get there. And it's great to hear that, of course, you've got our investors in mind because the money that you've raised has certainly been non-dilutive. So I appreciate that.
spk06: Thank you.
spk04: You guys have a great day. I appreciate it. Thanks.
spk02: Thank you.
spk06: Thanks, John.
spk02: Thank you. And there were no other questions from the lines. We did get some webcast questions in, so I'll go through a few of those right now. Can you give some more granularity on the timeline for THP? Will a pilot be launched in the first half of 25?
spk03: Yes, Sam, you want to take that?
spk00: Sure, yes. We are planning to launch a pilot in the first half of 25, yes. Okay.
spk02: Can you give some color on where the majority of work is that remains in order to launch THP by mid-2025, engineering partnerships, et cetera?
spk00: Sure. The majority of work, if you look at the work going on in THP, there are really three streams of work. The first stream of work, which is the locus of work, is really building the platform to scale the delivery of a care model. And that's where we have partnerships, While not naming partners, I can tell you the areas in which we are partnered. We are partnered in the area of integration with EMRs. We are partnered in the area of being able to accelerate our development efforts. And we have partnered in the area of being able to use innovative data management techniques and being able to take the data and leverage it into the rest of our techs. So what we're trying to do is to make sure that we are not rebuilding any things which are already in the marketplace, and we're really building on top of what's in the marketplace. So the partnerships have really helped with that. The second stream of work we are doing is really continuously expanding our clinical model and testing its efficacy. And the clinical model and the science behind it essentially become an input to our platform. So the work continues on that. And we've made some very good progress there. For example, we have expanded our clinical model to include atypical wounds, which constitute about 20% of the wound population out there. And that's some of the first work being done to qualify standard care for those. The third piece which your work is going on is really around the commercialization of this. That includes being able to identify network partners and working with them and creating pilots. The second piece is also really understanding pricing models, testing it in the marketplace. And we received very good feedback on that as well. So those are really the three streams of work on which we're working on right now. Hopefully that helps.
spk02: Thank you. The next question, what are your expectations regarding chemo mouthpieces contribution to top and bottom line?
spk03: We're not prepared to give that answer at this time. We obviously are very enthused and think it is a terrific opportunity in front of us and As we progress on the introduction of this product and start the launch in 2025 and get this commercially accepted in the marketplace through our partners with InfuSystem, then we'll come back and report what our expectation is. But it's a very big, wide-open market from my perspective.
spk02: Thank you. And what are some of the characteristics you're looking for in a potential M&A target for surgical?
spk03: Yeah, we'll let them know what that is when we close it.
spk02: Okay, and we are currently seeing no remaining questions at this time. That does conclude our conference for today. Thank you for your participation.
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