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TACTILE SYSTEMS TECHNOLOGY INC — Call Transcript 2025
Dec 2, 2025
Perfect. We're going to get going here. Welcome to the 2025 Piper Sandler Healthcare Conference. My name is Adam Maeder, and I'm one of the Med Tech analysts here at Piper Sandler. Very pleased to introduce the management team from Tactile Medical. With us, we have Sheri Dodd, CEO, and Elaine Birkemeyer, CFO. Thank you so much for joining us. Thank you, Adam. I wanted to start with a big picture question here on Q3, which was a great print all the way around, beats and raises, both for the lymphedema and airway clearance businesses. Margin performance was good too. Sheri, just high level, what's worked well since you've taken over? I guess, you know, on the other side of things, what are some areas that you're still looking to improve? Yeah, we were really pleased with our last report out, and they're expecting more. It's a nice position to be. If I think about what's working well, I just want to remind everyone that things that we have going for us is first the market. It is an under-penetrated market, both for the chronic swelling business as well as for that chronic inflammatory lung disease business, or as we think about lymphedema and our bronchiectasis airway clearance business. Bad for patients, great for us, right? It's untapped and it's been that way for a while. We also have really healthy business fundamentals. When you think about we're growing, we're profitable, we continue to expand our margin. Even though we didn't take our margins, EBITDA, up this year, we've already been able to show some leverage. As we reported out, we've got cash, we retired our debt, and we funded some stock buybacks. In a very healthy position from a business fundamental standpoint. I think where we're really seeing everything shine is just strategy and execution coming together. It's a strategy we've been talking about for the past couple of quarters. We're focusing on improving access to care, we're focused on product innovation, and we're focused on lifetime value. What we've seen is those investments are translating into business performance, and we continue, and that's going to continue, and I don't see any changes happening there. In terms of what we're working on, I mean, time to value is always something that I know the street's looking for. You made this investment, when is the return going to happen? That's not an unexpected ask. We're always looking for ways that we can show that. We're on this transformation journey, not just transformation for the purposes of transforming, we're transforming for scale, transforming for our future. That does take time. It's like laying the tracks of the railroad, and we're not going to go backwards, but we have to continue to invest so we can get to the other side to a more streamlined, seamless, scalable platform. Those aren't headwinds necessarily, they're just business things that we need to do, and I always wanted to go faster, but we also have to do it in a smart way. Sure. Great color. Maybe just a follow-up, CRM implementation, I think that was earlier this year. What is the status of that? Is that kind of fully integrated? Is that behind us? Salesforce, because you've made a lot of progress in terms of rebuilding the Salesforce. I think you're well ahead of kind of expectations at this point. Maybe just touch on those two things. Sure. For the CRM, we launched in February, and that was a hard cutover. Before, we did not really have a CRM tool, a little bit homegrown, and we moved over to Salesforce. We are embracing that not just as a documentation tool, but as a tool that the sales team uses every single day. We have added data and analytics on top of that. It actually tells them, we added market data, it tells them, in this provider group, they are diagnosing lymphedema, and yet you are not having a lot of sales coming through. Competitive potential. The teams use that, and we inspect how often they go into it, what they are documenting in terms of their visits. It is not just a checkbox, we have one. On the Salesforce, just to recall that we did, I think, the hard thing, and a lot of things companies do not like to do, which is assess your current sales organization and decide, are people where they need to be based on the business, and do you have the right types of people, role clarity for what you want to get done? We did a reset, and it was a hard reset, and it was a difficult one because it did hurt us in Q1. We did that reset, we consolidated some territories, we have a playbook and a map of exactly where do we need account management and where do we need product specialists. We did a great job of hiring. We actually filled those positions faster than we had expected. We set a Q2 target for sales rep and an end-of-year target for more than 300, and we are more than 300. It happened a little bit faster than we had originally thought, but it was great. We wanted more of those sales reps in their chair, out on the street as early as possible to drive revenue. Perfect. I know the rep productivity has been really good. Maybe we'll come back to that in the conversation. As we think about headcount for 2026, what does that look like? Will you continue to add heads, or are you at a kind of a good level? I think we're in the zip code of where we need to be. Certainly, if any of our territories split, we'll do the appropriate headcount, but we have a map of what it is that we need to do. There may be plus a few, but we've essentially done our big hiring, and we're seeing the product, the returns on that investment in terms of revenue per territory, referrals that are coming per territory. We are right in the ballpark of where we want to be. Perfect. Let's touch on reimbursement. You talked about some of the different kind of fundamentals, and I think you called them tail ends, hopefully I'm not putting words in your mouth. The LCD was retired. We now have an NCD. Feels like that's less restrictive. I think you guys talked about kind of finally having your arms wrapped around it. Is it a tailwind going forward? Is it a tailwind in Q4, or how do we think about the reimbursement change for your business? Yep. I'll share this with Elaine. It's actually been about a year now since the LCD was retired. Just as a reminder, CMS announced that they were going to retire the LCD, they were going to go to the NCD, which was already in place, and then they did not provide any training, any insight until January. Had some training in January, February, they reversed some of their decisions. It was a bit rocky in the beginning, and we learned a lesson that just because it's written one way on paper, you have to really do the inspection to make sure you understand how it'll be interpreted. We have understood a lot more now as we have gone through. I think it went from a headwind to a neutral, and then it will start to become a tailwind now that we understand that they really are going to take the position, this is what they mean by medical oversight, this is what they mean by, I'm trying to think of something else that they're so specific about. Measurement. Measurement. This is what they mean by that. Yeah, we'll see more of that as a tailwind. We only recently started to expand and lean into that policy more recently, because we wanted to not get bit. We're expecting to see that a little bit in Q4, mostly in. That tailwind is really having direct access to the advanced pump, like our Flexitouch product, which has been really difficult for those patients who need it. They had to do a trial of the basic pump for at least 30 days to show failure, that it did not resolve their symptoms before they could progress, and many patients just never made it fully through that journey. That is really, I think, the big win for patients, as well as we have got a great advanced pump product, so we are excited to have that help be a tailwind for that part of the business. Sure. And higher ASP as well. Sure. Yep. Okay. I think we've talked about Salesforce, we've talked about kind of end market and reimbursement. Maybe we can spend a little bit of time on the product portfolio. I guess Nimbl, so we're talking basic pumps here for the audience. I think you've had that for several quarters. What's the feedback been like for that product? How much more runway is there? On the advanced pump side, Flexitouch Plus, do we have an innovation kind of roadmap behind that? Just tell us maybe what's kind of in the works or coming down the pike. Sure. Nimbl has been incredibly successful. We launched originally around this time last year of the upper extremity, then we did the full launch of the lower extremity in the first quarter of this calendar year. It has been incredibly successful. It has grown faster than the market growth. We know that is both growing the market as well as taking share. Just as a reminder, in that category, it is a larger category, and while we had our Entre pump and had been there for quite a while, it was getting crowded, and certainly we had strong share, but we did not have dominant share. Since we launched Nimbl, we are now market leader in both the basic pump category as well as the advanced pump category. It is not just growing the market, but it also was in taking share. We're really pleased with that adoption. When we couple that up with Parachute ePrescribing, it was a seamless experience for the physicians as well as the patient could see themselves in it. They can travel with it. They can move around in different places in their home to do their therapy, where Entre Plus wasn't as Nimbl, and so therefore it has been really wildly successful. As it relates to Flexitouch, definitely what is going to be our next generation advanced pump, we'll be sharing more of that when we have our Q4 call, sorry, in Q1 of next year. We'll talk more about the roadmap, but we are actively working on what is the update to that product. We want to be innovating in both the basic pump category, happy with Nimbl, and we'll continue to fine-tune that. Our next big swing is to really drive innovation in the advanced pump. Perfect. Indications. Head and neck, the company's been talking about this for many years now, but we're getting closer and closer, it feels like. I think you had the six-month data in October, which was positive. Where do we go from here? What are next steps in terms of conversations with payers? How do you reach these patients? Just kind of give us some framework to kind of go off of. Sure. Just as a reminder, we've had the indication for head and neck, so indication hasn't been the problem. It's been the insurance coverage for head and neck. The garment, everything has been for a while. The data has really helped bring more awareness, the fact that the patients have an option. We have to work the reimbursement side, of course. Just update on the clinical trial. Actually, as of, I think the day before Thanksgiving, we submitted the six-month manuscript into a journal for review for publication. I'm really pleased that this year we will have submitted our two-month data as well as our six-month data, as well as we've had the poster presentations of both two and six months, which show that patients who receive Flexitouch immediately versus having to fail manual lymphatic kind of drainage, when you put them side to side, both patients do very well, but the Flexitouch population does slightly better in some areas. It is a great alternative to manual lymphatic drainage. There simply are not enough lymphatic therapists out there to see all these patients. As a reminder, the head and neck cancer patient, 90% likely after you've had head and neck cancer therapy, you are going to have lymphedema. That lymphedema is going to inhibit your ability to swallow, speak, and range of motion. It has an incredible quality of life detriment. By having the actual product, that improvement in reducing swelling is allowing people to come off of trach tubes, be able to swallow, be able to range of motion. Huge benefit. The challenge is that the NCD for the Medicare population allows this, because there is no basic pump that covers this area of the body, so they need to get it. It's the commercial payers that currently have experimental investigational designation coverage for the therapy. That's what we're working on. We've had progress with many payers, just making them aware that their current policy has E&I, and we're continuing to drive that both with the data and just with awareness that their policy is not even consistent with the NCD. Even with the absence of clinical data, they are having a more restrictive policy on NCD. Anything else? No, I would just say that we've been really happy with the reception we're getting from them, that they're listening but they're waiting for this data. We are encouraged that with that information, we'll start to see some progress for patients there. We're hoping to start to see more progress there next year. They're on their own timeline, unfortunately, when they do their coverage reviews. We're trying to ask for off-cycle reviews. In many cases, they're willing for that. We're trying to drive it with patient advocacy, clinician advocacy, and data. Sure. You talked about, Sheri, the six-month data. The manuscript was submitted just before Thanksgiving. Publication Q1, Q2 of next year? We're hoping for Q1. That's what my expectation is. You have to go back and forth on some of the revisions, but it was a very strong submission. My hope is that it will be in Q1 or early Q2 by the time it gets accepted and in publication. Is that kind of a potential impetus or something that could drive the commercial payers to adopt more quickly? Is that kind of how you're thinking about it? Yeah. I mean, definitely when you have the data and you say it's peer-reviewed and here it is published, they have a decision to do an off-cycle review or wait for their normal cycle review. Of course, we would like them to do an off-cycle review based on the strength of the data. We're not hitting them cold. We're already warming them up, letting them know that the data is coming. Many are anticipating it and waiting to hear. We're not just waiting till we have it and then running in. We're working that channel really actively. Sure. In terms of head and neck, as you think about kind of competitive dynamics, you have the data, you have a really good product for the advanced pump. Is Tactile the primary beneficiary? Are you the only beneficiary? We're the only beneficiary. We are the only pump that has coverage in the head and neck area. We have very strong IP in this area. There is no other pump out there that actually has the same coverage. It is 100% ours. That is why, while it could be a smaller population, 90% of them are going to have lymphedema, and we will capture 100% of that market. For those that choose to go to pump, some physicians may still want to use manual lymphatic drainage, or a patient may not want to use the pump. If they are going to have a pump, we would be the only pump available to them. Perfect. Wanted to also just ask about the penetration of the category. It is a very under-penetrated space. You talked about that earlier, Sheri. Maybe just help educate the audience. Where is penetration today? What is being done to drive awareness of lymphedema? How do you see the penetration of the space kind of evolving going forward? Yep. We show the iceberg slide, but if you just take lymphedema, which chronic swelling is even broader than lymphedema, but if you just look at lymphedema, there are 20 million people in the U.S. today that have lymphedema that are not yet diagnosed. Trust me, you will see them when you start looking for them. You will look at ankles, you will look at legs, you will look at individual arms and swelling in the hands, and this person will have lymphedema. Of the 20 million people with lymphedema, only 2 million of them have been diagnosed. Of the 2 million of them diagnosed, less than 10% of them are currently on medical device therapy. There is a huge opportunity here. The question is, what is getting in the way? These patients, especially if it is on the vascular side, are going through a process of elimination. Do they have DVT? Do they have heart failure? Are they just obese? Do they have lipedema? Do they have chronic venous insufficiency? They're going through this trial of trying to figure out what it is that they don't have. Then you get to a place where, okay, now you have lymphedema. From a clinician standpoint, very rarely will you have a surgical intervention. It's like, well, what can they do for you? They could put you on a pump or send you to a lymphatic therapist. It's just a really long process. A lot of patients drop out. They just get worn out. They don't have a diagnosis. They don't know what's wrong, and they just live with suffering. A little bit different on the oncology side, because at least on the oncology side, you would have had an intervention like radiation or surgery where there would be a probable cause of why you have lymphedema. Even in patients that come through the oncology channel, many of them have lymphedema and are not getting treated. They're just using garments and wraps. We have to create physician awareness. We have to create patient awareness. I would say a big aspect of this is also the diagnosis, unfortunately, is a clinical diagnosis. It's a visual diagnosis. If that patient isn't going back into the doctor, they can't do a visual diagnosis of the patient. They have to take the measurements. They have to look at the skin. There is a lot of work that needs to be done in this continuum on awareness. Diagnostic would be really helpful in bringing more awareness here. We have to create the demand, and then we have to clear the reimbursement landscape as well. By the time that someone finally gets diagnosed of the 20 million to the 2 million to that 10% that's coming through, that they don't end up with their insurance denying and saying, "I'm sorry, we don't cover this." There's just a lot of work along the way. We're a market leader. We have to do that work, but we're doing it, and I know that we're going to make it more of a clear path for patients. Okay. Perfect. I think that's a good place to stop on lymphedema. Maybe pivoting to the other part of the business, airway clearance. Your AffloVest product has been doing really well, consistently outperforming expectations this year. Maybe just talk about what's gone right this year. I think on the Q3 earnings call, you talked about bronchiectasis awareness improving. That's a hard word to say. It is. That might have been the first time I think I had heard those remarks from you all. Maybe just talk about kind of why the business is performing so well and just broader thoughts on the airway clearance category. Sure. This is also a great example of just strategy and execution. Our strategy had been to partner up with the top 10 DMEs, respiratory DMEs, secure partnerships with those individuals, and then we have a great product. How do we launch that? That had been our strategy. It's an indirect play for us, of course. What we found last year was, even though we had the strategic partnerships, there was not a full alignment between the supply chain team as well as the finance team. The finance team carries on their balance sheet as capital. They have to have a plan for the 13 months of the rental. If there is not a good tie-off, then it is going to be a shock for the finance team. We worked really closely with the finance teams as well as their operations teams. This year, all the stars were aligned. We have a great product. We have the partnerships. Many of those DMEs, we're a preferred product. Those reps have a differential compensation attached to selling AffloVest. The patients are there. Again, underserved market. That has worked incredibly well. What also has helped, I would say, is that broader awareness of the disease. There was a pharmaceutical entrant that has come in in August, launched a product for therapy for helping the inflammation aspect of bronchiectasis. There are multiple aspects of bronchiectasis: inflammation, mucus. You have to move the mucus out. That has brought more awareness. Some pharma money never hurts. Having come from pharma does not hurt. Bringing awareness of your product. That has helped just bring more disease awareness. Patients have always been there. That is just helping the lift as well. I would put it primarily against our strategy of just great product and alignment with our top 10 DMEs who are preferring our product. Fantastic. A couple of follow-ups there. It certainly sounds like you're on the offensive taking market share. Just remind us, underlying market growth. How do we think about the growth of this category? Is it healthy double digits going forward? Just any color of view there. Yeah. We recently talked about how fast the market was growing. We said that it was growing at about 10%. In the advanced pump category, kind of we are the market. It kind of does not grow in the absence of us growing it. We think that there is opportunity, especially with the NCD, of helping that aspect of the business. Of course, it is a smaller component of those that are going to advanced pump than the basic pump. Sorry. On the AffloVest side. Oh, AffloVest. I'm sorry. AffloVest. No, no problem. I switched on you. On the AffloVest side, we do believe that that is a very healthy business. It's harder to get the data in this area, but we believe that we're not going to see probably this type of growth next year, but certainly we believe that it should be in that double digit. It should be higher than a single digit growth, for sure. We don't see that changing. Maybe, I guess, tying all that together, you think both categories growing double digits? Is that lymphedema and airway clearance? Yeah, we do. There is no reason to think that if the business is growing double digits, and this is not a question you asked, but I'll offer it, then there is no reason why we should not also be growing at the rate of the market as well. In areas where we are the market, the more we can put towards growing that market, we will receive the direct benefit of that. Good color there. A couple more on AffloVest before we hit on the P&L. You have a next-generation product coming down the pike. I think you've already submitted for that with FDA. Anything you can share at this point in time regarding features, enhancements, improvements, and presumably that hits in 2026? Yes. That should hit in 2026. With the government shutdown, I do not know. I cannot say anything around the timing. The benefits of the product are we were already the lightest vest as well as the only one that is portable. It is battery. The patient can move around with it. It is even lighter. We changed some of the sizing so it is more adjustable so it could fit a bit better without having as many SKUs on the sizing. The aspect that we did not have that some of our competitors had was connectivity, the Bluetooth connectivity. Not everyone is going to use it, but certainly it is a good thing to have. When we launch this next-generation vest, we will be the lightest, still the only portable, and then Bluetooth connectivity. We definitely are in a market leadership position with that product. Perfect. Let's spend the last couple of minutes on the financials. I have to ask this, Elaine. 2026, I have consensus revenue, $347 million. That's a touch under, I think, 9% growth year-over-year. I just heard some of the commentary around end markets. Any reaction to that figure or broader comments you want to provide around 2026? I think when you think about, obviously, that number and that growth rate, it's clearly aligning with where Sheri talked about the market growth at that kind of 10%. Again, us not seeing a reason why we wouldn't grow, at least that there with the market. Obviously, can't give you any specifics at this point. We'll share much more of that next year. Hopefully, that puts a little bit of context, just connecting what Sheri said and that guidance there. Perfect. Let's talk about leverage. The company was showing really good leverage the past couple of years. 2025, strategically, was an investment year for the company. Maybe taking a little bit of a pause there from a leverage standpoint. 2026, is it another investment year, or do we kind of get back to the cadence of driving good leverage on the P&L? I would say it's a both. It is going to be investment, and we are going to have leverage. The investment doesn't come all in one. While we had big investments, the Salesforce platform was a really big investment. Now we rolled out the CRM tool. We're rolling out our order operations. We've talked about the AI work that we're doing. We're continuing to make those investments. To your first question about what are we still working on, it's that transform from a more inflexible system that was designed for the business when it was smaller, and we need to move to a system that's more flexible, designed for the future of where we want to go. We will continue to see investments, but we are expecting to see continued opportunity for leverage. Less leverage probably next year than, no, for sure. It'll be less leverage next year than we expect to have in 2027. I would definitely call next year another investment year with leverage. Good color there. Thank you. I guess just a bigger picture question around capital allocation as I see the clock winding down here. I think you've recently paid down some debt. You also have the share repurchase program. Use as a capital going forward. How do we think about that? Yeah. I think the good news is we're in a very different position than we were even when I was here a couple of years ago. It's given us a lot of good optionality here. Paying down the debt just made sense. We still have great debt capacity if needed for opportunities in the future. I think the share repurchase has been something that's been important to us as far as making sure we're getting a good ROI on our investment. We still have sufficient capital to make sure that we are able to continue to fund internal growth as well as if there is a strategically aligned external opportunity for us to take a look at as well. We remain really open to all different options to continue to grow our business. Again, very strategically focused. We're not looking, we've said before, to be a holding company and just sort of bring things in that are just to build revenue versus really being integrated in our core business. Perfect. I think that's a great place to stop. I know we're out of time here, but want to say thanks again, Sheri and Elaine, for joining us. Thank you. Thanks, Adam. Really appreciate it. All right. Why don't we get started? I'm Jason Bednar. I cover Med Tech here at Piper. Next fireside chat is with KORU Medical. Very happy to have with us today, CEO Linda Tharby and CFO Tom Adams. Thanks a lot for being here, both of you. Really appreciate it. Glad to have you back at the conference. We'll get right into Q&A. There's a lot of progress that's been made at KORU this year. You've executed on a number of strategic priorities. You made me look completely wrong with my rating. Congrats to you on that. Can you talk about what's gone right, Linda? What do you see as the major successes from 2025 that you can build upon when you look forward? Yeah. Thank you, Jason, for the compliment. We do not like proving you wrong, but in this case, I am happy with that. Talking about 2025, obviously, what we have been heading towards at KORU for several years now is a strategy that takes our growth level above that 20% level. Year-to-date, growing above 20%, driven by a few key factors. I would say the biggest one that has really propelled our growth this year has been our international expansion. We have more than doubled our international business this year. That is on the strength of prefill expansion, which is a technology where KORU was one of the first to have that device platform approved with our pump. We are able to see that. We converted our first market in Europe, and we see many more ahead of us as we move forward. Great opportunity. We took our share position from about 10 to 20, so lots of legroom there. Second has been our U.S. business, where we have a much stronger share position. We've just been outperforming the market. We've seen the market come back. The strongest patient diagnosis, primary immune deficiency, is our biggest patient population. We're seeing that population grow 8%-10%, and our U.S. business is growing about 10%-15%. That has been a huge lever for us this year. I would say, as we look ahead, what's to come? It's exciting. We're above 20% without these additional milestones. One is four new drugs that we anticipate adding to our label. More drugs flowing through our pumps, more patients using our system. We anticipate doing that over the course of early 2026 into mid-2026. Finally, we released the results of our pilot study in oncology clinics where nurses preferred our platform 97% of the time, completed our U.S. sites, and anticipate launching into the market in the second half of 2026 with a 510(k) submission expected at the end of this year. A lot of things are working really well: international expansion, U.S. patient diagnosis, and the new drugs coming onto the label. Excited for what we have built and what is to come. Yeah. You kind of preempted my next question, but I'll ask it anyways and maybe summarize what you said. I was going to ask, what's going to make for a successful 2026? You were just hitting on some of the new drugs coming on label and launching those, that moving into your U.S. business. Sounds like more international expansion and then just continuing to execute in the U.S. Is there anything that I guess I'm missing in that, or is that maybe a good summary of how you see next year unfolding? Yeah. I would say it's a good summary, those three key points that we hit. The international expansion, the U.S. expansion, the new drugs. The only other one I would say is we've got. Your participation in this conference has been terminated by the host. Goodbye.
Speaker 5: Perfect. We're going to get going here. Welcome to the 2025 Piper Sandler Healthcare Conference. My name is Adam Maeder, and I'm one of the Med Tech analysts here at Piper Sandler. Very pleased to introduce the management team from Tactile Medical. With us, we have Sheri Dodd, CEO, and Elaine Birkemeyer, CFO. Thank you so much for joining us. Perfect. perfect We're going to get going here. we're going to get going here Welcome to the 2025 Piper Sandler Healthcare Conference. welcome to the 2025 piper sandler healthcare conference My name is Adam Maeder, and I'm one of the Med Tech analysts here at Piper Sandler. my name is adam maeder and i'm one of the med tech analysts here at piper sandler Very pleased to introduce the management team from Tactile Medical. very pleased to introduce the management team from tactile medical With us, we have Sheri Dodd, CEO, and Elaine Birkemeyer, CFO. with us we have sheri dodd ceo and elaine birkemeyer cfo Thank you so much for joining us. thank you so much for joining us
Speaker 2: Thank you, Adam. Thank you, Adam. thank you adam
Speaker 5: I wanted to start with a big picture question here on Q3, which was a great print all the way around, beats and raises, both for the lymphedema and airway clearance businesses. Margin performance was good too. Sheri, just high level, what's worked well since you've taken over? I guess, you know, on the other side of things, what are some areas that you're still looking to improve? I wanted to start with a big picture question here on Q3, which was a great print all the way around, beats and raises, both for the lymphedema and airway clearance businesses. i wanted to start with a big picture question here on q3 which was a great print all the way around beats and raises both for the lymphedema and airway clearance businesses Margin performance was good too. margin performance was good too Sheri, just high level, what's worked well since you've taken over? sheri just high level what's worked well since you've taken over I guess, you know, on the other side of things, what are some areas that you're still looking to improve? i guess you know on the other side of things what are some areas that you're still looking to improve
Speaker 2: Yeah, we were really pleased with our last report out, and they're expecting more. It's a nice position to be. If I think about what's working well, I just want to remind everyone that things that we have going for us is first the market. It is an under-penetrated market, both for the chronic swelling business as well as for that chronic inflammatory lung disease business, or as we think about lymphedema and our bronchiectasis airway clearance business. Bad for patients, great for us, right? It's untapped and it's been that way for a while. We also have really healthy business fundamentals. When you think about we're growing, we're profitable, we continue to expand our margin. Even though we didn't take our margins, EBITDA, up this year, we've already been able to show some leverage. Yeah, we were really pleased with our last report out, and they're expecting more. yeah we were really pleased with our last report out and they're expecting more It's a nice position to be. it's a nice position to be If I think about what's working well, I just want to remind everyone that things that we have going for us is first the market. if i think about what's working well i just want to remind everyone that things that we have going for us is first the market It is an under-penetrated market, both for the chronic swelling business as well as for that chronic inflammatory lung disease business, or as we think about lymphedema and our bronchiectasis airway clearance business. it is an under-penetrated market both for the chronic swelling business as well as for that chronic inflammatory lung disease business or as we think about lymphedema and our bronchiectasis airway clearance business Bad for patients, great for us, right? bad for patients great for us right It's untapped and it's been that way for a while. it's untapped and it's been that way for a while We also have really healthy business fundamentals. we also have really healthy business fundamentals When you think about we're growing, we're profitable, we continue to expand our margin. when you think about we're growing we're profitable we continue to expand our margin Even though we didn't take our margins, EBITDA, up this year, we've already been able to show some leverage. even though we didn't take our margins ebitda up this year we've already been able to show some leverage As we reported out, we've got cash, we retired our debt, and we funded some stock buybacks. In a very healthy position from a business fundamental standpoint. I think where we're really seeing everything shine is just strategy and execution coming together. It's a strategy we've been talking about for the past couple of quarters. We're focusing on improving access to care, we're focused on product innovation, and we're focused on lifetime value. What we've seen is those investments are translating into business performance, and we continue, and that's going to continue, and I don't see any changes happening there. In terms of what we're working on, I mean, time to value is always something that I know the street's looking for. You made this investment, when is the return going to happen? That's not an unexpected ask. As we reported out, we've got cash, we retired our debt, and we funded some stock buybacks. as we reported out we've got cash we retired our debt and we funded some stock buybacks In a very healthy position from a business fundamental standpoint. in a very healthy position from a business fundamental standpoint I think where we're really seeing everything shine is just strategy and execution coming together. i think where we're really seeing everything shine is just strategy and execution coming together It's a strategy we've been talking about for the past couple of quarters. it's a strategy we've been talking about for the past couple of quarters We're focusing on improving access to care, we're focused on product innovation, and we're focused on lifetime value. we're focusing on improving access to care we're focused on product innovation and we're focused on lifetime value What we've seen is those investments are translating into business performance, and we continue, and that's going to continue, and I don't see any changes happening there. what we've seen is those investments are translating into business performance and we continue and that's going to continue and i don't see any changes happening there In terms of what we're working on, I mean, time to value is always something that I know the street's looking for. in terms of what we're working on i mean time to value is always something that i know the street's looking for You made this investment, when is the return going to happen? you made this investment when is the return going to happen That's not an unexpected ask. that's not an unexpected ask We're always looking for ways that we can show that. We're on this transformation journey, not just transformation for the purposes of transforming, we're transforming for scale, transforming for our future. That does take time. It's like laying the tracks of the railroad, and we're not going to go backwards, but we have to continue to invest so we can get to the other side to a more streamlined, seamless, scalable platform. Those aren't headwinds necessarily, they're just business things that we need to do, and I always wanted to go faster, but we also have to do it in a smart way. We're always looking for ways that we can show that. we're always looking for ways that we can show that We're on this transformation journey, not just transformation for the purposes of transforming, we're transforming for scale, transforming for our future. we're on this transformation journey not just transformation for the purposes of transforming we're transforming for scale transforming for our future That does take time. that does take time It's like laying the tracks of the railroad, and we're not going to go backwards, but we have to continue to invest so we can get to the other side to a more streamlined, seamless, scalable platform. it's like laying the tracks of the railroad and we're not going to go backwards but we have to continue to invest so we can get to the other side to a more streamlined seamless scalable platform Those aren't headwinds necessarily, they're just business things that we need to do, and I always wanted to go faster, but we also have to do it in a smart way. those aren't headwinds necessarily they're just business things that we need to do and i always wanted to go faster but we also have to do it in a smart way
Speaker 5: Sure. Great color. Maybe just a follow-up, CRM implementation, I think that was earlier this year. What is the status of that? Is that kind of fully integrated? Is that behind us? Salesforce, because you've made a lot of progress in terms of rebuilding the Salesforce. I think you're well ahead of kind of expectations at this point. Maybe just touch on those two things. Sure. sure Great color. great color Maybe just a follow-up, CRM implementation, I think that was earlier this year. maybe just a follow-up crm implementation i think that was earlier this year What is the status of that? what is the status of that Is that kind of fully integrated? is that kind of fully integrated Is that behind us? is that behind us Salesforce, because you've made a lot of progress in terms of rebuilding the Salesforce. salesforce because you've made a lot of progress in terms of rebuilding the salesforce I think you're well ahead of kind of expectations at this point. i think you're well ahead of kind of expectations at this point Maybe just touch on those two things. maybe just touch on those two things
Speaker 2: Sure. For the CRM, we launched in February, and that was a hard cutover. Before, we did not really have a CRM tool, a little bit homegrown, and we moved over to Salesforce. We are embracing that not just as a documentation tool, but as a tool that the sales team uses every single day. We have added data and analytics on top of that. It actually tells them, we added market data, it tells them, in this provider group, they are diagnosing lymphedema, and yet you are not having a lot of sales coming through. Competitive potential. The teams use that, and we inspect how often they go into it, what they are documenting in terms of their visits. It is not just a checkbox, we have one. Sure. sure For the CRM, we launched in February, and that was a hard cutover. for the crm we launched in february and that was a hard cutover Before, we did not really have a CRM tool, a little bit homegrown, and we moved over to Salesforce. before we did not really have a crm tool a little bit homegrown and we moved over to salesforce We are embracing that not just as a documentation tool, but as a tool that the sales team uses every single day. We have added data and analytics on top of that. we are embracing that not just as a documentation tool but as a tool that the sales team uses every single day. we have added data and analytics on top of that It actually tells them, we added market data, it tells them, in this provider group, they are diagnosing lymphedema, and yet you are not having a lot of sales coming through. it actually tells them we added market data it tells them in this provider group, they are diagnosing lymphedema and yet you are not having a lot of sales coming through Competitive potential. competitive potential The teams use that, and we inspect how often they go into it, what they are documenting in terms of their visits. the teams use that and we inspect how often they go into it what they are documenting in terms of their visits It is not just a checkbox, we have one. it is not just a checkbox we have one On the Salesforce, just to recall that we did, I think, the hard thing, and a lot of things companies do not like to do, which is assess your current sales organization and decide, are people where they need to be based on the business, and do you have the right types of people, role clarity for what you want to get done? We did a reset, and it was a hard reset, and it was a difficult one because it did hurt us in Q1. We did that reset, we consolidated some territories, we have a playbook and a map of exactly where do we need account management and where do we need product specialists. We did a great job of hiring. We actually filled those positions faster than we had expected. On the Salesforce, just to recall that we did, I think, the hard thing, and a lot of things companies do not like to do, which is assess your current sales organization and decide, are people where they need to be based on the business, and do you have the right types of people, role clarity for what you want to get done? on the salesforce just to recall that we did i think the hard thing and a lot of things companies do not like to do which is assess your current sales organization and decide are people where they need to be based on the business and do you have the right types of people role clarity for what you want to get done We did a reset, and it was a hard reset, and it was a difficult one because it did hurt us in Q1. we did a reset and it was a hard reset and it was a difficult one because it did hurt us in q1 We did that reset, we consolidated some territories, we have a playbook and a map of exactly where do we need account management and where do we need product specialists. we did that reset we consolidated some territories we have a playbook and a map of exactly where do we need account management and where do we need product specialists We did a great job of hiring. we did a great job of hiring We actually filled those positions faster than we had expected. we actually filled those positions faster than we had expected We set a Q2 target for sales rep and an end-of-year target for more than 300, and we are more than 300. It happened a little bit faster than we had originally thought, but it was great. We wanted more of those sales reps in their chair, out on the street as early as possible to drive revenue. We set a Q2 target for sales rep and an end-of-year target for more than 300, and we are more than 300. we set a q2 target for sales rep and an end-of-year target for more than 300 and we are more than 300 It happened a little bit faster than we had originally thought, but it was great. it happened a little bit faster than we had originally thought but it was great We wanted more of those sales reps in their chair, out on the street as early as possible to drive revenue. we wanted more of those sales reps in their chair out on the street as early as possible to drive revenue
Speaker 5: Perfect. I know the rep productivity has been really good. Maybe we'll come back to that in the conversation. As we think about headcount for 2026, what does that look like? Will you continue to add heads, or are you at a kind of a good level? Perfect. perfect I know the rep productivity has been really good. i know the rep productivity has been really good Maybe we'll come back to that in the conversation. maybe we'll come back to that in the conversation As we think about headcount for 2026, what does that look like? as we think about headcount for 2026 what does that look like Will you continue to add heads, or are you at a kind of a good level? will you continue to add heads or are you at a kind of a good level
Speaker 2: I think we're in the zip code of where we need to be. Certainly, if any of our territories split, we'll do the appropriate headcount, but we have a map of what it is that we need to do. There may be plus a few, but we've essentially done our big hiring, and we're seeing the product, the returns on that investment in terms of revenue per territory, referrals that are coming per territory. We are right in the ballpark of where we want to be. I think we're in the zip code of where we need to be. i think we're in the zip code of where we need to be Certainly, if any of our territories split, we'll do the appropriate headcount, but we have a map of what it is that we need to do. certainly if any of our territories split we'll do the appropriate headcount but we have a map of what it is that we need to do There may be plus a few, but we've essentially done our big hiring, and we're seeing the product, the returns on that investment in terms of revenue per territory, referrals that are coming per territory. there may be plus a few but we've essentially done our big hiring and we're seeing the product the returns on that investment in terms of revenue per territory referrals that are coming per territory We are right in the ballpark of where we want to be. we are right in the ballpark of where we want to be
Speaker 5: Perfect. Let's touch on reimbursement. You talked about some of the different kind of fundamentals, and I think you called them tail ends, hopefully I'm not putting words in your mouth. The LCD was retired. We now have an NCD. Feels like that's less restrictive. I think you guys talked about kind of finally having your arms wrapped around it. Is it a tailwind going forward? Is it a tailwind in Q4, or how do we think about the reimbursement change for your business? Perfect. perfect Let's touch on reimbursement. let's touch on reimbursement You talked about some of the different kind of fundamentals, and I think you called them tail ends, hopefully I'm not putting words in your mouth. you talked about some of the different kind of fundamentals and i think you called them tail ends hopefully i'm not putting words in your mouth The LCD was retired. the lcd was retired We now have an NCD. we now have an ncd Feels like that's less restrictive. feels like that's less restrictive I think you guys talked about kind of finally having your arms wrapped around it. i think you guys talked about kind of finally having your arms wrapped around it Is it a tailwind going forward? is it a tailwind going forward Is it a tailwind in Q4, or how do we think about the reimbursement change for your business? is it a tailwind in q4 or how do we think about the reimbursement change for your business
Speaker 2: Yep. I'll share this with Elaine. It's actually been about a year now since the LCD was retired. Just as a reminder, CMS announced that they were going to retire the LCD, they were going to go to the NCD, which was already in place, and then they did not provide any training, any insight until January. Had some training in January, February, they reversed some of their decisions. It was a bit rocky in the beginning, and we learned a lesson that just because it's written one way on paper, you have to really do the inspection to make sure you understand how it'll be interpreted. We have understood a lot more now as we have gone through. Yep. yep I'll share this with Elaine. i'll share this with elaine It's actually been about a year now since the LCD was retired. it's actually been about a year now since the lcd was retired Just as a reminder, CMS announced that they were going to retire the LCD, they were going to go to the NCD, which was already in place, and then they did not provide any training, any insight until January. just as a reminder cms announced that they were going to retire the lcd they were going to go to the ncd which was already in place and then they did not provide any training any insight until january Had some training in January, February, they reversed some of their decisions. had some training in january february they reversed some of their decisions It was a bit rocky in the beginning, and we learned a lesson that just because it's written one way on paper, you have to really do the inspection to make sure you understand how it'll be interpreted. it was a bit rocky in the beginning and we learned a lesson that just because it's written one way on paper you have to really do the inspection to make sure you understand how it'll be interpreted We have understood a lot more now as we have gone through. we have understood a lot more now as we have gone through I think it went from a headwind to a neutral, and then it will start to become a tailwind now that we understand that they really are going to take the position, this is what they mean by medical oversight, this is what they mean by, I'm trying to think of something else that they're so specific about. I think it went from a headwind to a neutral, and then it will start to become a tailwind now that we understand that they really are going to take the position, this is what they mean by medical oversight, this is what they mean by, I'm trying to think of something else that they're so specific about. i think it went from a headwind to a neutral and then it will start to become a tailwind now that we understand that they really are going to take the position this is what they mean by medical oversight this is what they mean by i'm trying to think of something else that they're so specific about
Speaker 3: Measurement. Measurement. measurement
Speaker 2: Measurement. This is what they mean by that. Yeah, we'll see more of that as a tailwind. We only recently started to expand and lean into that policy more recently, because we wanted to not get bit. We're expecting to see that a little bit in Q4, mostly in. That tailwind is really having direct access to the advanced pump, like our Flexitouch product, which has been really difficult for those patients who need it. They had to do a trial of the basic pump for at least 30 days to show failure, that it did not resolve their symptoms before they could progress, and many patients just never made it fully through that journey. Measurement. measurement This is what they mean by that. this is what they mean by that Yeah, we'll see more of that as a tailwind. yeah we'll see more of that as a tailwind We only recently started to expand and lean into that policy more recently, because we wanted to not get bit. we only recently started to expand and lean into that policy more recently because we wanted to not get bit We're expecting to see that a little bit in Q4, mostly in. we're expecting to see that a little bit in q4 mostly in That tailwind is really having direct access to the advanced pump, like our Flexitouch product, which has been really difficult for those patients who need it. that tailwind is really having direct access to the advanced pump like our flexitouch product which has been really difficult for those patients who need it They had to do a trial of the basic pump for at least 30 days to show failure, that it did not resolve their symptoms before they could progress, and many patients just never made it fully through that journey. they had to do a trial of the basic pump for at least 30 days to show failure that it did not resolve their symptoms before they could progress and many patients just never made it fully through that journey That is really, I think, the big win for patients, as well as we have got a great advanced pump product, so we are excited to have that help be a tailwind for that part of the business. That is really, I think, the big win for patients, as well as we have got a great advanced pump product, so we are excited to have that help be a tailwind for that part of the business. that is really i think the big win for patients as well as we have got a great advanced pump product so we are excited to have that help be a tailwind for that part of the business
Speaker 5: Sure. And higher ASP as well. Sure. sure And higher ASP as well. and higher asp as well
Speaker 2: Sure. Yep. Sure. sure Yep. yep
Speaker 5: Okay. I think we've talked about Salesforce, we've talked about kind of end market and reimbursement. Maybe we can spend a little bit of time on the product portfolio. I guess Nimbl, so we're talking basic pumps here for the audience. I think you've had that for several quarters. What's the feedback been like for that product? How much more runway is there? On the advanced pump side, Flexitouch Plus, do we have an innovation kind of roadmap behind that? Just tell us maybe what's kind of in the works or coming down the pike. Okay. okay I think we've talked about Salesforce, we've talked about kind of end market and reimbursement. i think we've talked about salesforce we've talked about kind of end market and reimbursement Maybe we can spend a little bit of time on the product portfolio. maybe we can spend a little bit of time on the product portfolio I guess Nimbl, so we're talking basic pumps here for the audience. i guess nimbl so we're talking basic pumps here for the audience I think you've had that for several quarters. i think you've had that for several quarters What's the feedback been like for that product? what's the feedback been like for that product How much more runway is there? how much more runway is there On the advanced pump side, Flexitouch Plus, do we have an innovation kind of roadmap behind that? on the advanced pump side flexitouch plus do we have an innovation kind of roadmap behind that Just tell us maybe what's kind of in the works or coming down the pike. just tell us maybe what's kind of in the works or coming down the pike
Speaker 2: Sure. Nimbl has been incredibly successful. We launched originally around this time last year of the upper extremity, then we did the full launch of the lower extremity in the first quarter of this calendar year. It has been incredibly successful. It has grown faster than the market growth. We know that is both growing the market as well as taking share. Just as a reminder, in that category, it is a larger category, and while we had our Entre pump and had been there for quite a while, it was getting crowded, and certainly we had strong share, but we did not have dominant share. Since we launched Nimbl, we are now market leader in both the basic pump category as well as the advanced pump category. It is not just growing the market, but it also was in taking share. Sure. sure Nimbl has been incredibly successful. nimbl has been incredibly successful We launched originally around this time last year of the upper extremity, then we did the full launch of the lower extremity in the first quarter of this calendar year. we launched originally around this time last year of the upper extremity then we did the full launch of the lower extremity in the first quarter of this calendar year It has been incredibly successful. it has been incredibly successful It has grown faster than the market growth. it has grown faster than the market growth We know that is both growing the market as well as taking share. we know that is both growing the market as well as taking share Just as a reminder, in that category, it is a larger category, and while we had our Entre pump and had been there for quite a while, it was getting crowded, and certainly we had strong share, but we did not have dominant share. just as a reminder in that category it is a larger category and while we had our entre pump and had been there for quite a while it was getting crowded and certainly we had strong share but we did not have dominant share Since we launched Nimbl, we are now market leader in both the basic pump category as well as the advanced pump category. since we launched nimbl we are now market leader in both the basic pump category as well as the advanced pump category It is not just growing the market, but it also was in taking share. it is not just growing the market but it also was in taking share We're really pleased with that adoption. When we couple that up with Parachute ePrescribing, it was a seamless experience for the physicians as well as the patient could see themselves in it. They can travel with it. They can move around in different places in their home to do their therapy, where Entre Plus wasn't as Nimbl, and so therefore it has been really wildly successful. As it relates to Flexitouch, definitely what is going to be our next generation advanced pump, we'll be sharing more of that when we have our Q4 call, sorry, in Q1 of next year. We'll talk more about the roadmap, but we are actively working on what is the update to that product. We want to be innovating in both the basic pump category, happy with Nimbl, and we'll continue to fine-tune that. We're really pleased with that adoption. we're really pleased with that adoption When we couple that up with Parachute ePrescribing, it was a seamless experience for the physicians as well as the patient could see themselves in it. when we couple that up with parachute eprescribing it was a seamless experience for the physicians as well as the patient could see themselves in it They can travel with it. they can travel with it They can move around in different places in their home to do their therapy, where Entre Plus wasn't as Nimbl, and so therefore it has been really wildly successful. they can move around in different places in their home to do their therapy where entre plus wasn't as nimbl and so therefore it has been really wildly successful As it relates to Flexitouch, definitely what is going to be our next generation advanced pump, we'll be sharing more of that when we have our Q4 call, sorry, in Q1 of next year. as it relates to flexitouch definitely what is going to be our next generation advanced pump we'll be sharing more of that when we have our q4 call sorry in q1 of next year We'll talk more about the roadmap, but we are actively working on what is the update to that product. we'll talk more about the roadmap but we are actively working on what is the update to that product We want to be innovating in both the basic pump category, happy with Nimbl, and we'll continue to fine-tune that. we want to be innovating in both the basic pump category happy with nimbl and we'll continue to fine-tune that Our next big swing is to really drive innovation in the advanced pump. Our next big swing is to really drive innovation in the advanced pump. our next big swing is to really drive innovation in the advanced pump
Speaker 5: Perfect. Indications. Head and neck, the company's been talking about this for many years now, but we're getting closer and closer, it feels like. I think you had the six-month data in October, which was positive. Where do we go from here? What are next steps in terms of conversations with payers? How do you reach these patients? Just kind of give us some framework to kind of go off of. Perfect. perfect Indications. indications Head and neck, the company's been talking about this for many years now, but we're getting closer and closer, it feels like. head and neck the company's been talking about this for many years now but we're getting closer and closer it feels like I think you had the six-month data in October, which was positive. i think you had the six-month data in october which was positive Where do we go from here? where do we go from here What are next steps in terms of conversations with payers? what are next steps in terms of conversations with payers How do you reach these patients? how do you reach these patients Just kind of give us some framework to kind of go off of. just kind of give us some framework to kind of go off of
Speaker 2: Sure. Just as a reminder, we've had the indication for head and neck, so indication hasn't been the problem. It's been the insurance coverage for head and neck. The garment, everything has been for a while. The data has really helped bring more awareness, the fact that the patients have an option. We have to work the reimbursement side, of course. Just update on the clinical trial. Actually, as of, I think the day before Thanksgiving, we submitted the six-month manuscript into a journal for review for publication. Sure. sure Just as a reminder, we've had the indication for head and neck, so indication hasn't been the problem. just as a reminder we've had the indication for head and neck so indication hasn't been the problem It's been the insurance coverage for head and neck. it's been the insurance coverage for head and neck The garment, everything has been for a while. the garment everything has been for a while The data has really helped bring more awareness, the fact that the patients have an option. the data has really helped bring more awareness the fact that the patients have an option We have to work the reimbursement side, of course. we have to work the reimbursement side of course Just update on the clinical trial. just update on the clinical trial Actually, as of, I think the day before Thanksgiving, we submitted the six-month manuscript into a journal for review for publication. actually as of i think the day before thanksgiving we submitted the six-month manuscript into a journal for review for publication I'm really pleased that this year we will have submitted our two-month data as well as our six-month data, as well as we've had the poster presentations of both two and six months, which show that patients who receive Flexitouch immediately versus having to fail manual lymphatic kind of drainage, when you put them side to side, both patients do very well, but the Flexitouch population does slightly better in some areas. It is a great alternative to manual lymphatic drainage. There simply are not enough lymphatic therapists out there to see all these patients. As a reminder, the head and neck cancer patient, 90% likely after you've had head and neck cancer therapy, you are going to have lymphedema. That lymphedema is going to inhibit your ability to swallow, speak, and range of motion. It has an incredible quality of life detriment. I'm really pleased that this year we will have submitted our two-month data as well as our six-month data, as well as we've had the poster presentations of both two and six months, which show that patients who receive Flexitouch immediately versus having to fail manual lymphatic kind of drainage, when you put them side to side, both patients do very well, but the Flexitouch population does slightly better in some areas. i'm really pleased that this year we will have submitted our two-month data as well as our six-month data as well as we've had the poster presentations of both two and six months which show that patients who receive flexitouch immediately versus having to fail manual lymphatic kind of drainage when you put them side to side both patients do very well but the flexitouch population does slightly better in some areas It is a great alternative to manual lymphatic drainage. it is a great alternative to manual lymphatic drainage There simply are not enough lymphatic therapists out there to see all these patients. there simply are not enough lymphatic therapists out there to see all these patients As a reminder, the head and neck cancer patient, 90% likely after you've had head and neck cancer therapy, you are going to have lymphedema. as a reminder the head and neck cancer patient 90% likely after you've had head and neck cancer therapy you are going to have lymphedema That lymphedema is going to inhibit your ability to swallow, speak, and range of motion. that lymphedema is going to inhibit your ability to swallow speak and range of motion It has an incredible quality of life detriment. it has an incredible quality of life detriment By having the actual product, that improvement in reducing swelling is allowing people to come off of trach tubes, be able to swallow, be able to range of motion. Huge benefit. The challenge is that the NCD for the Medicare population allows this, because there is no basic pump that covers this area of the body, so they need to get it. It's the commercial payers that currently have experimental investigational designation coverage for the therapy. That's what we're working on. We've had progress with many payers, just making them aware that their current policy has E&I, and we're continuing to drive that both with the data and just with awareness that their policy is not even consistent with the NCD. Even with the absence of clinical data, they are having a more restrictive policy on NCD. Anything else? By having the actual product, that improvement in reducing swelling is allowing people to come off of trach tubes, be able to swallow, be able to range of motion. by having the actual product that improvement in reducing swelling is allowing people to come off of trach tubes be able to swallow be able to range of motion Huge benefit. huge benefit The challenge is that the NCD for the Medicare population allows this, because there is no basic pump that covers this area of the body, so they need to get it. the challenge is that the ncd for the medicare population allows this because there is no basic pump that covers this area of the body so they need to get it It's the commercial payers that currently have experimental investigational designation coverage for the therapy. it's the commercial payers that currently have experimental investigational designation coverage for the therapy That's what we're working on. that's what we're working on We've had progress with many payers, just making them aware that their current policy has E&I, and we're continuing to drive that both with the data and just with awareness that their policy is not even consistent with the NCD. we've had progress with many payers just making them aware that their current policy has e&i and we're continuing to drive that both with the data and just with awareness that their policy is not even consistent with the ncd Even with the absence of clinical data, they are having a more restrictive policy on NCD. even with the absence of clinical data they are having a more restrictive policy on ncd Anything else? anything else
Speaker 3: No, I would just say that we've been really happy with the reception we're getting from them, that they're listening but they're waiting for this data. We are encouraged that with that information, we'll start to see some progress for patients there. We're hoping to start to see more progress there next year. No, I would just say that we've been really happy with the reception we're getting from them, that they're listening but they're waiting for this data. no i would just say that we've been really happy with the reception we're getting from them that they're listening but they're waiting for this data We are encouraged that with that information, we'll start to see some progress for patients there. we are encouraged that with that information we'll start to see some progress for patients there We're hoping to start to see more progress there next year. we're hoping to start to see more progress there next year
Speaker 2: They're on their own timeline, unfortunately, when they do their coverage reviews. We're trying to ask for off-cycle reviews. In many cases, they're willing for that. We're trying to drive it with patient advocacy, clinician advocacy, and data. They're on their own timeline, unfortunately, when they do their coverage reviews. they're on their own timeline unfortunately when they do their coverage reviews We're trying to ask for off-cycle reviews. we're trying to ask for off-cycle reviews In many cases, they're willing for that. in many cases they're willing for that We're trying to drive it with patient advocacy, clinician advocacy, and data. we're trying to drive it with patient advocacy clinician advocacy and data
Speaker 5: Sure. You talked about, Sheri, the six-month data. The manuscript was submitted just before Thanksgiving. Publication Q1, Q2 of next year? Sure. sure You talked about, Sheri, the six-month data. you talked about sheri the six-month data The manuscript was submitted just before Thanksgiving. the manuscript was submitted just before thanksgiving Publication Q1, Q2 of next year? publication q1 q2 of next year
Speaker 2: We're hoping for Q1. That's what my expectation is. You have to go back and forth on some of the revisions, but it was a very strong submission. My hope is that it will be in Q1 or early Q2 by the time it gets accepted and in publication. We're hoping for Q1. we're hoping for q1 That's what my expectation is. that's what my expectation is You have to go back and forth on some of the revisions, but it was a very strong submission. you have to go back and forth on some of the revisions but it was a very strong submission My hope is that it will be in Q1 or early Q2 by the time it gets accepted and in publication. my hope is that it will be in q1 or early q2 by the time it gets accepted and in publication
Speaker 5: Is that kind of a potential impetus or something that could drive the commercial payers to adopt more quickly? Is that kind of how you're thinking about it? Is that kind of a potential impetus or something that could drive the commercial payers to adopt more quickly? is that kind of a potential impetus or something that could drive the commercial payers to adopt more quickly Is that kind of how you're thinking about it? is that kind of how you're thinking about it
Speaker 2: Yeah. I mean, definitely when you have the data and you say it's peer-reviewed and here it is published, they have a decision to do an off-cycle review or wait for their normal cycle review. Of course, we would like them to do an off-cycle review based on the strength of the data. We're not hitting them cold. We're already warming them up, letting them know that the data is coming. Many are anticipating it and waiting to hear. We're not just waiting till we have it and then running in. We're working that channel really actively. Yeah. yeah I mean, definitely when you have the data and you say it's peer-reviewed and here it is published, they have a decision to do an off-cycle review or wait for their normal cycle review. i mean definitely when you have the data and you say it's peer-reviewed and here it is published they have a decision to do an off-cycle review or wait for their normal cycle review Of course, we would like them to do an off-cycle review based on the strength of the data. of course we would like them to do an off-cycle review based on the strength of the data We're not hitting them cold. we're not hitting them cold We're already warming them up, letting them know that the data is coming. we're already warming them up letting them know that the data is coming Many are anticipating it and waiting to hear. many are anticipating it and waiting to hear We're not just waiting till we have it and then running in. we're not just waiting till we have it and then running in We're working that channel really actively. we're working that channel really actively
Speaker 5: Sure. In terms of head and neck, as you think about kind of competitive dynamics, you have the data, you have a really good product for the advanced pump. Is Tactile the primary beneficiary? Are you the only beneficiary? Sure. sure In terms of head and neck, as you think about kind of competitive dynamics, you have the data, you have a really good product for the advanced pump. in terms of head and neck as you think about kind of competitive dynamics you have the data you have a really good product for the advanced pump Is Tactile the primary beneficiary? is tactile the primary beneficiary Are you the only beneficiary? are you the only beneficiary
Speaker 2: We're the only beneficiary. We are the only pump that has coverage in the head and neck area. We have very strong IP in this area. There is no other pump out there that actually has the same coverage. It is 100% ours. That is why, while it could be a smaller population, 90% of them are going to have lymphedema, and we will capture 100% of that market. For those that choose to go to pump, some physicians may still want to use manual lymphatic drainage, or a patient may not want to use the pump. If they are going to have a pump, we would be the only pump available to them. We're the only beneficiary. we're the only beneficiary We are the only pump that has coverage in the head and neck area. we are the only pump that has coverage in the head and neck area We have very strong IP in this area. we have very strong ip in this area There is no other pump out there that actually has the same coverage. there is no other pump out there that actually has the same coverage It is 100% ours. it is 100% ours That is why, while it could be a smaller population, 90% of them are going to have lymphedema, and we will capture 100% of that market. that is why while it could be a smaller population 90% of them are going to have lymphedema and we will capture 100% of that market For those that choose to go to pump, some physicians may still want to use manual lymphatic drainage, or a patient may not want to use the pump. for those that choose to go to pump some physicians may still want to use manual lymphatic drainage or a patient may not want to use the pump If they are going to have a pump, we would be the only pump available to them. if they are going to have a pump we would be the only pump available to them
Speaker 5: Perfect. Wanted to also just ask about the penetration of the category. It is a very under-penetrated space. You talked about that earlier, Sheri. Maybe just help educate the audience. Where is penetration today? What is being done to drive awareness of lymphedema? How do you see the penetration of the space kind of evolving going forward? Perfect. perfect Wanted to also just ask about the penetration of the category. wanted to also just ask about the penetration of the category It is a very under-penetrated space. it is a very under-penetrated space You talked about that earlier, Sheri. you talked about that earlier sheri Maybe just help educate the audience. maybe just help educate the audience Where is penetration today? What is being done to drive awareness of lymphedema? where is penetration today? what is being done to drive awareness of lymphedema How do you see the penetration of the space kind of evolving going forward? how do you see the penetration of the space kind of evolving going forward
Speaker 2: Yep. We show the iceberg slide, but if you just take lymphedema, which chronic swelling is even broader than lymphedema, but if you just look at lymphedema, there are 20 million people in the U.S. today that have lymphedema that are not yet diagnosed. Trust me, you will see them when you start looking for them. You will look at ankles, you will look at legs, you will look at individual arms and swelling in the hands, and this person will have lymphedema. Of the 20 million people with lymphedema, only 2 million of them have been diagnosed. Of the 2 million of them diagnosed, less than 10% of them are currently on medical device therapy. There is a huge opportunity here. The question is, what is getting in the way? These patients, especially if it is on the vascular side, are going through a process of elimination. Yep. yep We show the iceberg slide, but if you just take lymphedema, which chronic swelling is even broader than lymphedema, but if you just look at lymphedema, there are 20 million people in the U.S. today that have lymphedema that are not yet diagnosed. we show the iceberg slide but if you just take lymphedema which chronic swelling is even broader than lymphedema but if you just look at lymphedema, there are 20 million people in the u.s today that have lymphedema that are not yet diagnosed Trust me, you will see them when you start looking for them. You will look at ankles, you will look at legs, you will look at individual arms and swelling in the hands, and this person will have lymphedema. trust me you will see them when you start looking for them. you will look at ankles, you will look at legs, you will look at individual arms and swelling in the hands and this person will have lymphedema Of the 20 million people with lymphedema, only 2 million of them have been diagnosed. of the 20 million people with lymphedema only 2 million of them have been diagnosed Of the 2 million of them diagnosed, less than 10% of them are currently on medical device therapy. of the 2 million of them diagnosed less than 10% of them are currently on medical device therapy There is a huge opportunity here. there is a huge opportunity here The question is, what is getting in the way? the question is what is getting in the way These patients, especially if it is on the vascular side, are going through a process of elimination. these patients especially if it is on the vascular side are going through a process of elimination Do they have DVT? Do they have heart failure? Are they just obese? Do they have lipedema? Do they have chronic venous insufficiency? They're going through this trial of trying to figure out what it is that they don't have. Then you get to a place where, okay, now you have lymphedema. From a clinician standpoint, very rarely will you have a surgical intervention. It's like, well, what can they do for you? They could put you on a pump or send you to a lymphatic therapist. It's just a really long process. A lot of patients drop out. They just get worn out. They don't have a diagnosis. They don't know what's wrong, and they just live with suffering. Do they have DVT? do they have dvt Do they have heart failure? do they have heart failure Are they just obese? are they just obese Do they have lipedema? do they have lipedema Do they have chronic venous insufficiency? do they have chronic venous insufficiency They're going through this trial of trying to figure out what it is that they don't have. they're going through this trial of trying to figure out what it is that they don't have Then you get to a place where, okay, now you have lymphedema. then you get to a place where okay now you have lymphedema From a clinician standpoint, very rarely will you have a surgical intervention. from a clinician standpoint very rarely will you have a surgical intervention It's like, well, what can they do for you? it's like well what can they do for you They could put you on a pump or send you to a lymphatic therapist. they could put you on a pump or send you to a lymphatic therapist It's just a really long process. it's just a really long process A lot of patients drop out. a lot of patients drop out They just get worn out. they just get worn out They don't have a diagnosis. they don't have a diagnosis They don't know what's wrong, and they just live with suffering. they don't know what's wrong and they just live with suffering A little bit different on the oncology side, because at least on the oncology side, you would have had an intervention like radiation or surgery where there would be a probable cause of why you have lymphedema. Even in patients that come through the oncology channel, many of them have lymphedema and are not getting treated. They're just using garments and wraps. We have to create physician awareness. We have to create patient awareness. I would say a big aspect of this is also the diagnosis, unfortunately, is a clinical diagnosis. It's a visual diagnosis. If that patient isn't going back into the doctor, they can't do a visual diagnosis of the patient. They have to take the measurements. They have to look at the skin. There is a lot of work that needs to be done in this continuum on awareness. A little bit different on the oncology side, because at least on the oncology side, you would have had an intervention like radiation or surgery where there would be a probable cause of why you have lymphedema. a little bit different on the oncology side because at least on the oncology side you would have had an intervention like radiation or surgery where there would be a probable cause of why you have lymphedema Even in patients that come through the oncology channel, many of them have lymphedema and are not getting treated. even in patients that come through the oncology channel many of them have lymphedema and are not getting treated They're just using garments and wraps. they're just using garments and wraps We have to create physician awareness. we have to create physician awareness We have to create patient awareness. we have to create patient awareness I would say a big aspect of this is also the diagnosis, unfortunately, is a clinical diagnosis. i would say a big aspect of this is also the diagnosis unfortunately is a clinical diagnosis It's a visual diagnosis. it's a visual diagnosis If that patient isn't going back into the doctor, they can't do a visual diagnosis of the patient. if that patient isn't going back into the doctor they can't do a visual diagnosis of the patient They have to take the measurements. they have to take the measurements They have to look at the skin. they have to look at the skin There is a lot of work that needs to be done in this continuum on awareness. there is a lot of work that needs to be done in this continuum on awareness Diagnostic would be really helpful in bringing more awareness here. We have to create the demand, and then we have to clear the reimbursement landscape as well. By the time that someone finally gets diagnosed of the 20 million to the 2 million to that 10% that's coming through, that they don't end up with their insurance denying and saying, "I'm sorry, we don't cover this." There's just a lot of work along the way. We're a market leader. We have to do that work, but we're doing it, and I know that we're going to make it more of a clear path for patients. Diagnostic would be really helpful in bringing more awareness here. diagnostic would be really helpful in bringing more awareness here We have to create the demand, and then we have to clear the reimbursement landscape as well. we have to create the demand and then we have to clear the reimbursement landscape as well By the time that someone finally gets diagnosed of the 20 million to the 2 million to that 10% that's coming through, that they don't end up with their insurance denying and saying, "I'm sorry, we don't cover this." There's just a lot of work along the way. by the time that someone finally gets diagnosed of the 20 million to the 2 million to that 10% that's coming through that they don't end up with their insurance denying and saying "i'm sorry we don't cover this." there's just a lot of work along the way We're a market leader. we're a market leader We have to do that work, but we're doing it, and I know that we're going to make it more of a clear path for patients. we have to do that work but we're doing it and i know that we're going to make it more of a clear path for patients
Speaker 5: Okay. Perfect. I think that's a good place to stop on lymphedema. Maybe pivoting to the other part of the business, airway clearance. Your AffloVest product has been doing really well, consistently outperforming expectations this year. Maybe just talk about what's gone right this year. I think on the Q3 earnings call, you talked about bronchiectasis awareness improving. That's a hard word to say. Okay. okay Perfect. perfect I think that's a good place to stop on lymphedema. i think that's a good place to stop on lymphedema Maybe pivoting to the other part of the business, airway clearance. maybe pivoting to the other part of the business airway clearance Your AffloVest product has been doing really well, consistently outperforming expectations this year. your afflovest product has been doing really well consistently outperforming expectations this year Maybe just talk about what's gone right this year. maybe just talk about what's gone right this year I think on the Q3 earnings call, you talked about bronchiectasis awareness improving. i think on the q3 earnings call you talked about bronchiectasis awareness improving That's a hard word to say. that's a hard word to say
Speaker 2: It is. It is. it is
Speaker 5: That might have been the first time I think I had heard those remarks from you all. Maybe just talk about kind of why the business is performing so well and just broader thoughts on the airway clearance category. That might have been the first time I think I had heard those remarks from you all. that might have been the first time i think i had heard those remarks from you all Maybe just talk about kind of why the business is performing so well and just broader thoughts on the airway clearance category. maybe just talk about kind of why the business is performing so well and just broader thoughts on the airway clearance category
Speaker 2: Sure. This is also a great example of just strategy and execution. Our strategy had been to partner up with the top 10 DMEs, respiratory DMEs, secure partnerships with those individuals, and then we have a great product. How do we launch that? That had been our strategy. It's an indirect play for us, of course. What we found last year was, even though we had the strategic partnerships, there was not a full alignment between the supply chain team as well as the finance team. The finance team carries on their balance sheet as capital. They have to have a plan for the 13 months of the rental. If there is not a good tie-off, then it is going to be a shock for the finance team. We worked really closely with the finance teams as well as their operations teams. Sure. sure This is also a great example of just strategy and execution. this is also a great example of just strategy and execution Our strategy had been to partner up with the top 10 DMEs, respiratory DMEs, secure partnerships with those individuals, and then we have a great product. our strategy had been to partner up with the top 10 dmes respiratory dmes secure partnerships with those individuals and then we have a great product How do we launch that? how do we launch that That had been our strategy. that had been our strategy It's an indirect play for us, of course. it's an indirect play for us of course What we found last year was, even though we had the strategic partnerships, there was not a full alignment between the supply chain team as well as the finance team. what we found last year was even though we had the strategic partnerships there was not a full alignment between the supply chain team as well as the finance team The finance team carries on their balance sheet as capital. the finance team carries on their balance sheet as capital They have to have a plan for the 13 months of the rental. they have to have a plan for the 13 months of the rental If there is not a good tie-off, then it is going to be a shock for the finance team. if there is not a good tie-off then it is going to be a shock for the finance team We worked really closely with the finance teams as well as their operations teams. we worked really closely with the finance teams as well as their operations teams This year, all the stars were aligned. We have a great product. We have the partnerships. Many of those DMEs, we're a preferred product. Those reps have a differential compensation attached to selling AffloVest. The patients are there. Again, underserved market. That has worked incredibly well. What also has helped, I would say, is that broader awareness of the disease. There was a pharmaceutical entrant that has come in in August, launched a product for therapy for helping the inflammation aspect of bronchiectasis. There are multiple aspects of bronchiectasis: inflammation, mucus. You have to move the mucus out. That has brought more awareness. Some pharma money never hurts. Having come from pharma does not hurt. Bringing awareness of your product. That has helped just bring more disease awareness. Patients have always been there. That is just helping the lift as well. This year, all the stars were aligned. this year all the stars were aligned We have a great product. we have a great product We have the partnerships. we have the partnerships Many of those DMEs, we're a preferred product. many of those dmes we're a preferred product Those reps have a differential compensation attached to selling AffloVest. those reps have a differential compensation attached to selling afflovest The patients are there. the patients are there Again, underserved market. again underserved market That has worked incredibly well. that has worked incredibly well What also has helped, I would say, is that broader awareness of the disease. what also has helped i would say is that broader awareness of the disease There was a pharmaceutical entrant that has come in in August, launched a product for therapy for helping the inflammation aspect of bronchiectasis. there was a pharmaceutical entrant that has come in in august launched a product for therapy for helping the inflammation aspect of bronchiectasis There are multiple aspects of bronchiectasis: inflammation, mucus. there are multiple aspects of bronchiectasis inflammation mucus You have to move the mucus out. you have to move the mucus out That has brought more awareness. that has brought more awareness Some pharma money never hurts. some pharma money never hurts Having come from pharma does not hurt. having come from pharma does not hurt Bringing awareness of your product. bringing awareness of your product That has helped just bring more disease awareness. that has helped just bring more disease awareness Patients have always been there. patients have always been there That is just helping the lift as well. that is just helping the lift as well I would put it primarily against our strategy of just great product and alignment with our top 10 DMEs who are preferring our product. I would put it primarily against our strategy of just great product and alignment with our top 10 DMEs who are preferring our product. i would put it primarily against our strategy of just great product and alignment with our top 10 dmes who are preferring our product
Speaker 5: Fantastic. A couple of follow-ups there. It certainly sounds like you're on the offensive taking market share. Just remind us, underlying market growth. How do we think about the growth of this category? Is it healthy double digits going forward? Just any color of view there. Fantastic. fantastic A couple of follow-ups there. a couple of follow-ups there It certainly sounds like you're on the offensive taking market share. it certainly sounds like you're on the offensive taking market share Just remind us, underlying market growth. just remind us underlying market growth How do we think about the growth of this category? how do we think about the growth of this category Is it healthy double digits going forward? is it healthy double digits going forward Just any color of view there. just any color of view there
Speaker 2: Yeah. We recently talked about how fast the market was growing. We said that it was growing at about 10%. In the advanced pump category, kind of we are the market. It kind of does not grow in the absence of us growing it. We think that there is opportunity, especially with the NCD, of helping that aspect of the business. Of course, it is a smaller component of those that are going to advanced pump than the basic pump. Yeah. yeah We recently talked about how fast the market was growing. we recently talked about how fast the market was growing We said that it was growing at about 10%. we said that it was growing at about 10% In the advanced pump category, kind of we are the market. in the advanced pump category kind of we are the market It kind of does not grow in the absence of us growing it. it kind of does not grow in the absence of us growing it We think that there is opportunity, especially with the NCD, of helping that aspect of the business. we think that there is opportunity especially with the ncd of helping that aspect of the business Of course, it is a smaller component of those that are going to advanced pump than the basic pump. of course it is a smaller component of those that are going to advanced pump than the basic pump
Speaker 5: Sorry. On the AffloVest side. Sorry. sorry On the AffloVest side. on the afflovest side
Speaker 2: Oh, AffloVest. I'm sorry. AffloVest. Oh, AffloVest. oh afflovest I'm sorry. i'm sorry AffloVest. afflovest
Speaker 5: No, no problem. No, no problem. no no problem
Speaker 2: I switched on you. On the AffloVest side, we do believe that that is a very healthy business. It's harder to get the data in this area, but we believe that we're not going to see probably this type of growth next year, but certainly we believe that it should be in that double digit. It should be higher than a single digit growth, for sure. We don't see that changing. I switched on you. i switched on you On the AffloVest side, we do believe that that is a very healthy business. on the afflovest side we do believe that that is a very healthy business It's harder to get the data in this area, but we believe that we're not going to see probably this type of growth next year, but certainly we believe that it should be in that double digit. it's harder to get the data in this area but we believe that we're not going to see probably this type of growth next year but certainly we believe that it should be in that double digit It should be higher than a single digit growth, for sure. it should be higher than a single digit growth for sure We don't see that changing. we don't see that changing
Speaker 5: Maybe, I guess, tying all that together, you think both categories growing double digits? Is that lymphedema and airway clearance? Maybe, I guess, tying all that together, you think both categories growing double digits? maybe i guess tying all that together you think both categories growing double digits Is that lymphedema and airway clearance? is that lymphedema and airway clearance
Speaker 2: Yeah, we do. There is no reason to think that if the business is growing double digits, and this is not a question you asked, but I'll offer it, then there is no reason why we should not also be growing at the rate of the market as well. In areas where we are the market, the more we can put towards growing that market, we will receive the direct benefit of that. Yeah, we do. yeah we do There is no reason to think that if the business is growing double digits, and this is not a question you asked, but I'll offer it, then there is no reason why we should not also be growing at the rate of the market as well. there is no reason to think that if the business is growing double digits and this is not a question you asked but i'll offer it then there is no reason why we should not also be growing at the rate of the market as well In areas where we are the market, the more we can put towards growing that market, we will receive the direct benefit of that. in areas where we are the market the more we can put towards growing that market we will receive the direct benefit of that
Speaker 5: Good color there. A couple more on AffloVest before we hit on the P&L. You have a next-generation product coming down the pike. I think you've already submitted for that with FDA. Anything you can share at this point in time regarding features, enhancements, improvements, and presumably that hits in 2026? Good color there. good color there A couple more on AffloVest before we hit on the P&L. a couple more on afflovest before we hit on the p&l You have a next-generation product coming down the pike. you have a next-generation product coming down the pike I think you've already submitted for that with FDA. i think you've already submitted for that with fda Anything you can share at this point in time regarding features, enhancements, improvements, and presumably that hits in 2026? anything you can share at this point in time regarding features enhancements improvements and presumably that hits in 2026
Speaker 2: Yes. That should hit in 2026. With the government shutdown, I do not know. I cannot say anything around the timing. The benefits of the product are we were already the lightest vest as well as the only one that is portable. It is battery. The patient can move around with it. It is even lighter. We changed some of the sizing so it is more adjustable so it could fit a bit better without having as many SKUs on the sizing. The aspect that we did not have that some of our competitors had was connectivity, the Bluetooth connectivity. Not everyone is going to use it, but certainly it is a good thing to have. When we launch this next-generation vest, we will be the lightest, still the only portable, and then Bluetooth connectivity. We definitely are in a market leadership position with that product. Yes. yes That should hit in 2026. that should hit in 2026 With the government shutdown, I do not know. with the government shutdown i do not know I cannot say anything around the timing. i cannot say anything around the timing The benefits of the product are we were already the lightest vest as well as the only one that is portable. the benefits of the product are we were already the lightest vest as well as the only one that is portable It is battery. it is battery The patient can move around with it. the patient can move around with it It is even lighter. it is even lighter We changed some of the sizing so it is more adjustable so it could fit a bit better without having as many SKUs on the sizing. we changed some of the sizing so it is more adjustable so it could fit a bit better without having as many skus on the sizing The aspect that we did not have that some of our competitors had was connectivity, the Bluetooth connectivity. the aspect that we did not have that some of our competitors had was connectivity the bluetooth connectivity Not everyone is going to use it, but certainly it is a good thing to have. not everyone is going to use it but certainly it is a good thing to have When we launch this next-generation vest, we will be the lightest, still the only portable, and then Bluetooth connectivity. when we launch this next-generation vest we will be the lightest still the only portable and then bluetooth connectivity We definitely are in a market leadership position with that product. we definitely are in a market leadership position with that product
Speaker 5: Perfect. Let's spend the last couple of minutes on the financials. I have to ask this, Elaine. 2026, I have consensus revenue, $347 million. That's a touch under, I think, 9% growth year-over-year. I just heard some of the commentary around end markets. Any reaction to that figure or broader comments you want to provide around 2026? Perfect. perfect Let's spend the last couple of minutes on the financials. let's spend the last couple of minutes on the financials I have to ask this, Elaine. 2026, I have consensus revenue, $347 million. i have to ask this elaine 2026 i have consensus revenue $347 million That's a touch under, I think, 9% growth year- over- year. that's a touch under i think 9% growth year- over- year I just heard some of the commentary around end markets. i just heard some of the commentary around end markets Any reaction to that figure or broader comments you want to provide around 2026? any reaction to that figure or broader comments you want to provide around 2026
Speaker 3: I think when you think about, obviously, that number and that growth rate, it's clearly aligning with where Sheri talked about the market growth at that kind of 10%. Again, us not seeing a reason why we wouldn't grow, at least that there with the market. Obviously, can't give you any specifics at this point. We'll share much more of that next year. Hopefully, that puts a little bit of context, just connecting what Sheri said and that guidance there. I think when you think about, obviously, that number and that growth rate, it's clearly aligning with where Sheri talked about the market growth at that kind of 10%. i think when you think about obviously that number and that growth rate it's clearly aligning with where sheri talked about the market growth at that kind of 10% Again, us not seeing a reason why we wouldn't grow, at least that there with the market. again us not seeing a reason why we wouldn't grow at least that there with the market Obviously, can't give you any specifics at this point. obviously can't give you any specifics at this point We'll share much more of that next year. we'll share much more of that next year Hopefully, that puts a little bit of context, just connecting what Sheri said and that guidance there. hopefully that puts a little bit of context just connecting what sheri said and that guidance there
Speaker 5: Perfect. Let's talk about leverage. The company was showing really good leverage the past couple of years. 2025, strategically, was an investment year for the company. Maybe taking a little bit of a pause there from a leverage standpoint. 2026, is it another investment year, or do we kind of get back to the cadence of driving good leverage on the P&L? Perfect. perfect Let's talk about leverage. let's talk about leverage The company was showing really good leverage the past couple of years. 2025, strategically, was an investment year for the company. the company was showing really good leverage the past couple of years 2025 strategically was an investment year for the company Maybe taking a little bit of a pause there from a leverage standpoint. 2026, is it another investment year, or do we kind of get back to the cadence of driving good leverage on the P&L? maybe taking a little bit of a pause there from a leverage standpoint 2026 is it another investment year or do we kind of get back to the cadence of driving good leverage on the p&l
Speaker 2: I would say it's a both. It is going to be investment, and we are going to have leverage. The investment doesn't come all in one. While we had big investments, the Salesforce platform was a really big investment. Now we rolled out the CRM tool. We're rolling out our order operations. We've talked about the AI work that we're doing. We're continuing to make those investments. To your first question about what are we still working on, it's that transform from a more inflexible system that was designed for the business when it was smaller, and we need to move to a system that's more flexible, designed for the future of where we want to go. We will continue to see investments, but we are expecting to see continued opportunity for leverage. Less leverage probably next year than, no, for sure. I would say it's a both. i would say it's a both It is going to be investment, and we are going to have leverage. it is going to be investment and we are going to have leverage The investment doesn't come all in one. the investment doesn't come all in one While we had big investments, the Salesforce platform was a really big investment. while we had big investments the salesforce platform was a really big investment Now we rolled out the CRM tool. now we rolled out the crm tool We're rolling out our order operations. we're rolling out our order operations We've talked about the AI work that we're doing. we've talked about the ai work that we're doing We're continuing to make those investments. we're continuing to make those investments To your first question about what are we still working on, it's that transform from a more inflexible system that was designed for the business when it was smaller, and we need to move to a system that's more flexible, designed for the future of where we want to go. to your first question about what are we still working on it's that transform from a more inflexible system that was designed for the business when it was smaller and we need to move to a system that's more flexible designed for the future of where we want to go We will continue to see investments, but we are expecting to see continued opportunity for leverage. we will continue to see investments but we are expecting to see continued opportunity for leverage Less leverage probably next year than, no, for sure. less leverage probably next year than no for sure It'll be less leverage next year than we expect to have in 2027. I would definitely call next year another investment year with leverage. It'll be less leverage next year than we expect to have in 2027. it'll be less leverage next year than we expect to have in 2027 I would definitely call next year another investment year with leverage. i would definitely call next year another investment year with leverage
Speaker 5: Good color there. Thank you. I guess just a bigger picture question around capital allocation as I see the clock winding down here. I think you've recently paid down some debt. You also have the share repurchase program. Use as a capital going forward. How do we think about that? Good color there. good color there Thank you. thank you I guess just a bigger picture question around capital allocation as I see the clock winding down here. i guess just a bigger picture question around capital allocation as i see the clock winding down here I think you've recently paid down some debt. i think you've recently paid down some debt You also have the share repurchase program. you also have the share repurchase program Use as a capital going forward. use as a capital going forward How do we think about that? how do we think about that
Speaker 3: Yeah. I think the good news is we're in a very different position than we were even when I was here a couple of years ago. It's given us a lot of good optionality here. Paying down the debt just made sense. We still have great debt capacity if needed for opportunities in the future. I think the share repurchase has been something that's been important to us as far as making sure we're getting a good ROI on our investment. We still have sufficient capital to make sure that we are able to continue to fund internal growth as well as if there is a strategically aligned external opportunity for us to take a look at as well. We remain really open to all different options to continue to grow our business. Again, very strategically focused. Yeah. yeah I think the good news is we're in a very different position than we were even when I was here a couple of years ago. i think the good news is we're in a very different position than we were even when i was here a couple of years ago It's given us a lot of good optionality here. it's given us a lot of good optionality here Paying down the debt just made sense. paying down the debt just made sense We still have great debt capacity if needed for opportunities in the future. we still have great debt capacity if needed for opportunities in the future I think the share repurchase has been something that's been important to us as far as making sure we're getting a good ROI on our investment. i think the share repurchase has been something that's been important to us as far as making sure we're getting a good roi on our investment We still have sufficient capital to make sure that we are able to continue to fund internal growth as well as if there is a strategically aligned external opportunity for us to take a look at as well. we still have sufficient capital to make sure that we are able to continue to fund internal growth as well as if there is a strategically aligned external opportunity for us to take a look at as well We remain really open to all different options to continue to grow our business. we remain really open to all different options to continue to grow our business Again, very strategically focused. again very strategically focused We're not looking, we've said before, to be a holding company and just sort of bring things in that are just to build revenue versus really being integrated in our core business. We're not looking, we've said before, to be a holding company and just sort of bring things in that are just to build revenue versus really being integrated in our core business. we're not looking we've said before to be a holding company and just sort of bring things in that are just to build revenue versus really being integrated in our core business
Speaker 5: Perfect. I think that's a great place to stop. I know we're out of time here, but want to say thanks again, Sheri and Elaine, for joining us. Perfect. perfect I think that's a great place to stop. i think that's a great place to stop I know we're out of time here, but want to say thanks again, Sheri and Elaine, for joining us. i know we're out of time here but want to say thanks again sheri and elaine for joining us
Speaker 2: Thank you. Thanks, Adam. Really appreciate it. Thank you. thank you Thanks, Adam. thanks adam Really appreciate it. really appreciate it
Speaker 6: All right. Why don't we get started? I'm Jason Bednar. I cover Med Tech here at Piper. Next fireside chat is with KORU Medical. Very happy to have with us today, CEO Linda Tharby and CFO Tom Adams. Thanks a lot for being here, both of you. Really appreciate it. Glad to have you back at the conference. We'll get right into Q&A. There's a lot of progress that's been made at KORU this year. You've executed on a number of strategic priorities. You made me look completely wrong with my rating. Congrats to you on that. Can you talk about what's gone right, Linda? What do you see as the major successes from 2025 that you can build upon when you look forward? All right. all right Why don't we get started? why don't we get started I'm Jason Bednar. i'm jason bednar I cover Med Tech here at Piper. i cover med tech here at piper Next fireside chat is with KORU Medical. next fireside chat is with koru medical Very happy to have with us today, CEO Linda Tharby and CFO Tom Adams. very happy to have with us today ceo linda tharby and cfo tom adams Thanks a lot for being here, both of you. thanks a lot for being here both of you Really appreciate it. really appreciate it Glad to have you back at the conference. glad to have you back at the conference We'll get right into Q&A. we'll get right into q&a There's a lot of progress that's been made at KORU this year. there's a lot of progress that's been made at koru this year You've executed on a number of strategic priorities. you've executed on a number of strategic priorities You made me look completely wrong with my rating. you made me look completely wrong with my rating Congrats to you on that. congrats to you on that Can you talk about what's gone right, Linda? can you talk about what's gone right linda What do you see as the major successes from 2025 that you can build upon when you look forward? what do you see as the major successes from 2025 that you can build upon when you look forward
Speaker 1: Yeah. Thank you, Jason, for the compliment. Yeah. yeah Thank you, Jason, for the compliment. thank you jason for the compliment We do not like proving you wrong, but in this case, I am happy with that. Talking about 2025, obviously, what we have been heading towards at KORU for several years now is a strategy that takes our growth level above that 20% level. Year-to-date, growing above 20%, driven by a few key factors. I would say the biggest one that has really propelled our growth this year has been our international expansion. We have more than doubled our international business this year. That is on the strength of prefill expansion, which is a technology where KORU was one of the first to have that device platform approved with our pump. We are able to see that. We converted our first market in Europe, and we see many more ahead of us as we move forward. Great opportunity. We do not like proving you wrong, but in this case, I am happy with that. we do not like proving you wrong but in this case, i am happy with that Talking about 2025, obviously, what we have been heading towards at KORU for several years now is a strategy that takes our growth level above that 20% level. talking about 2025 obviously what we have been heading towards at koru for several years now is a strategy that takes our growth level above that 20% level Year- to- date, growing above 20%, driven by a few key factors. year- to- date growing above 20% driven by a few key factors I would say the biggest one that has really propelled our growth this year has been our international expansion. i would say the biggest one that has really propelled our growth this year has been our international expansion We have more than doubled our international business this year. we have more than doubled our international business this year That is on the strength of prefill expansion, which is a technology where KORU was one of the first to have that device platform approved with our pump. that is on the strength of prefill expansion which is a technology where koru was one of the first to have that device platform approved with our pump We are able to see that. we are able to see that We converted our first market in Europe, and we see many more ahead of us as we move forward. we converted our first market in europe and we see many more ahead of us as we move forward Great opportunity. great opportunity We took our share position from about 10 to 20, so lots of legroom there. Second has been our U.S. business, where we have a much stronger share position. We've just been outperforming the market. We've seen the market come back. The strongest patient diagnosis, primary immune deficiency, is our biggest patient population. We're seeing that population grow 8%-10%, and our U.S. business is growing about 10%-15%. That has been a huge lever for us this year. I would say, as we look ahead, what's to come? It's exciting. We're above 20% without these additional milestones. One is four new drugs that we anticipate adding to our label. More drugs flowing through our pumps, more patients using our system. We anticipate doing that over the course of early 2026 into mid-2026. We took our share position from about 10 to 20, so lots of legroom there. we took our share position from about 10 to 20 so lots of legroom there Second has been our U.S. business, where we have a much stronger share position. second has been our u.s business where we have a much stronger share position We've just been outperforming the market. we've just been outperforming the market We've seen the market come back. we've seen the market come back The strongest patient diagnosis, primary immune deficiency, is our biggest patient population. the strongest patient diagnosis primary immune deficiency is our biggest patient population We're seeing that population grow 8%-10%, and our U.S. business is growing about 10%-15%. we're seeing that population grow 8%-10% and our u.s business is growing about 10%-15% That has been a huge lever for us this year. that has been a huge lever for us this year I would say, as we look ahead, what's to come? i would say as we look ahead what's to come It's exciting. it's exciting We're above 20% without these additional milestones. we're above 20% without these additional milestones One is four new drugs that we anticipate adding to our label. one is four new drugs that we anticipate adding to our label More drugs flowing through our pumps, more patients using our system. more drugs flowing through our pumps more patients using our system We anticipate doing that over the course of early 2026 into mid-2026. we anticipate doing that over the course of early 2026 into mid-2026 Finally, we released the results of our pilot study in oncology clinics where nurses preferred our platform 97% of the time, completed our U.S. sites, and anticipate launching into the market in the second half of 2026 with a 510(k) submission expected at the end of this year. A lot of things are working really well: international expansion, U.S. patient diagnosis, and the new drugs coming onto the label. Excited for what we have built and what is to come. Finally, we released the results of our pilot study in oncology clinics where nurses preferred our platform 97% of the time, completed our U.S. sites, and anticipate launching into the market in the second half of 2026 with a 510(k) submission expected at the end of this year. finally we released the results of our pilot study in oncology clinics where nurses preferred our platform 97% of the time completed our u.s sites and anticipate launching into the market in the second half of 2026 with a 510(k) submission expected at the end of this year A lot of things are working really well: international expansion, U.S. patient diagnosis, and the new drugs coming onto the label. a lot of things are working really well international expansion u.s patient diagnosis and the new drugs coming onto the label Excited for what we have built and what is to come. excited for what we have built and what is to come
Speaker 6: Yeah. You kind of preempted my next question, but I'll ask it anyways and maybe summarize what you said. I was going to ask, what's going to make for a successful 2026? You were just hitting on some of the new drugs coming on label and launching those, that moving into your U.S. business. Sounds like more international expansion and then just continuing to execute in the U.S. Is there anything that I guess I'm missing in that, or is that maybe a good summary of how you see next year unfolding? Yeah. yeah You kind of preempted my next question, but I'll ask it anyways and maybe summarize what you said. you kind of preempted my next question but i'll ask it anyways and maybe summarize what you said I was going to ask, what's going to make for a successful 2026? i was going to ask what's going to make for a successful 2026 You were just hitting on some of the new drugs coming on label and launching those, that moving into your U.S. business. you were just hitting on some of the new drugs coming on label and launching those that moving into your u.s business Sounds like more international expansion and then just continuing to execute in the U.S. sounds like more international expansion and then just continuing to execute in the u.s Is there anything that I guess I'm missing in that, or is that maybe a good summary of how you see next year unfolding? is there anything that i guess i'm missing in that or is that maybe a good summary of how you see next year unfolding
Speaker 1: Yeah. I would say it's a good summary, those three key points that we hit. The international expansion, the U.S. expansion, the new drugs. The only other one I would say is we've got. Yeah. yeah I would say it's a good summary, those three key points that we hit. i would say it's a good summary those three key points that we hit The international expansion, the U.S. expansion, the new drugs. the international expansion the u.s expansion the new drugs The only other one I would say is we've got. the only other one i would say is we've got
Speaker 4: Your participation in this conference has been terminated by the host. Goodbye. Your participation in this conference has been terminated by the host. your participation in this conference has been terminated by the host Goodbye. goodbye