Suraj Kalia, a Senior Medical Device Analyst at Oppenheimer. Pleased to have with us this afternoon, Sheri Dodd, CEO, and Elaine Birkemeyer, CFO of Tactile Medical. I know a lot of you guys on the call and those who will be listening to the replay, you know, Tactile comes up in a lot of conversations in terms of how new management is shaping the company, given everything from the past and current macro level. It is a timely conversation. Sheri, I'll let you take the floor. I'll resurface like five minutes towards the end and, you know, present any client questions. I certainly have a question or two. Thank you so much, ladies.
Thank you. Thank you very much, Suraj. Looking forward to being here. I'm going to start with probably one of our favorite starting places to really kind of talk about the business. The basis of this really is, if you think about any business at all, what are the business fundamentals and what gets you most excited? A question that I've been getting a lot since joining as CEO. I think what boils down to an external assessment of a healthy business is, are you able to address unmet needs? Do you actually have innovative solutions? Is there a specific patient population that is particularly attractive to you? What is the commercial viability of the business? I think this as a dashboard really highlights all of those.
When we think about the population, over 25 million patients are currently not diagnosed with the very condition of which we can help patients improve their quality of life. This would include both lymphedema and bronchiectasis. Twenty-five million patients are currently undiagnosed. We are just talking about the U.S. alone. Of those, about 2.5 million patients are diagnosed, and yet a smaller proportion of those actually currently have access to therapy. An amazing opportunity in terms of a market that clearly has an unmet need. Current TAM, $10 billion. We served over 79,000 patients in 2024. We do this on a basis in that commercial viability standpoint of, you know, are you able to generate revenue? Indeed. About $293 million was our 2024. Are you able to do it profitably? Absolutely. 74% on our gross margins, our adjusted EBITDA at $37.1 million.
A cash flow at $40 million is where we ended the year, and it's growing. Really, really healthy business fundamentals in terms of the unmet need. We'll talk about the innovative products that we have. Certainly, this commercial viability is very clear for us. Again, it's a great market to be in. We think about where we've been investing. Knowing that this is a great market, this is what makes it attractive for us to win. It really comes in this unique assets area. We have a very rich body of clinical evidence that supports the value of our therapy in this underserved population. We have an incredibly large distribution reach. Not only in our sales force, but these patients show up in different channels.
They are going to be in the oncology channel, or they're going to be in a therapist channel, or they're going to be in the vein clinic channel or in vascular channel, and they're in the VA. We have an opportunity of finding the patients where they are and have a sales force that can support that. We have an incredible and very scalable revenue cycle management team and tools. It is not just the bodies we're able to put on this, but we're investing in the technology that helps make the revenue cycle management scalable and simplified. This shows up when you look actually at our balance sheet and long AR. Over the past several years, we've been able to demonstrate that not only do we have a great product that's in demand and being used by patients, but we're able to get paid.
That revenue cycle management is ensuring that the claims can be submitted, accepted, and processed for revenue and collections on our side. Multi-pronged product development. We just launched Nimbl. I'll talk about that. We just launched a new product at the end of last year and this year, completely reimagining what a basic pump could look like for our patients. It has been incredibly well received by both patients and providers. We will continue to look at the way digital strategies are going to play out, not only in our marketing campaigns, but in our patient engagement and provider value. All of this is underpinned by this value creation.
Being a profitable market leader, poised for scale, gross margins over 70%, and being in a really strong cash position, again, makes not just this year, but our future years incredibly bright. Here is a graphic of what I talked about on the very first slide, where you have this underdiagnosed population and this diagnosed population. What is interesting is both in the lymphedema category as well as the bronchiectasis, it is the same story. From a market standpoint of being in large and underpenetrated populations, as well as this care journey for these patients, it is extremely protracted, and it is very complicated from the point where they have symptoms to getting diagnosed to getting on appropriate therapy. There are a lot of similarities between the lymphedema and the bronchiectasis patients. This is where we believe we have got core capabilities and competencies to help support them.
Let me, because these are underdiagnosed populations, there's many that are confused in terms of, well, actually, what is this condition? I think part of our job is not just to sell on the product innovation that we have, which certainly is an easy sell. The harder sell is actually on the diagnosis because it is not entirely clear when a patient has lymphedema and when they don't. One of the challenges is, is because it's hard to see. Although I guarantee you, if you were to go to a grocery store, a church, an airport, a shopping mall, or in any place where you're going to have people and you start looking at people's limbs, you will see someone that has lymphedema.
You may not know, and you may think that maybe it's an obesity issue or something else is going on, but it's quite likely these patients have lymphedema. While I don't encourage you to ask them if they do, there's a strong likelihood that they may or may not have even been diagnosed yet. What is it? The lymphatic system enables the transportation of fluids that have these white blood cells, and they help get rid of toxins and waste throughout the body. When the lymphatic system is damaged, either from cancer treatment, surgical or radiation, or if you have chronic vein insufficiency and you're overloading your limbs, this system is going to be damaged. Once it's damaged, it cannot be repaired. It's a chronic progressive disease, and it causes swelling and infection and discomfort.
It gets to a point where some of you have seen more of these extreme cases of elephantiasis, or we actually have weeping wounds. This is because the skin degradation has happened with all this buildup of fluid that has actually changed the skin and its ability to keep the fluid inside and starts weeping out. It is typically a secondary condition. It is caused, again, as I said, by the various conditions here, but it can also be caused by trauma or surgery or overall infection. 90% of patients with head and neck cancer are going to have lymphedema. 90%. More than likely, if you have a head and neck cancer and you are a survivor, you are going to then be living with a condition of lymphedema, which may impact your ability to swallow, speak, and range of motion.
We have a therapy that can help you. Breast cancer patients, 40% of survivors are going to have lymphedema. If you've survived the cancer, now you have this secondary condition that is causing you impact on quality of life. We have a treatment that can help you. The populations are there, and there definitely is a need. Here's a bit of a patient view of the patients that end up with lymphedema. As I said, you're likely to know someone or to have seen someone that likely has this condition. A lot of patients, and why this journey is so complicated, is because they have the symptoms, but they don't actually know what's happening to them. They have to typically go through seeing a primary care physician who doesn't necessarily know, may prescribe a diuretic.
They are going to potentially want to rule out heart failure and what this edema is coming from. It takes a while for them to finally get to a physician that can say, you have lymphedema. From there, how do you go about getting the appropriate therapy? For bronchiectasis, it is also common in that you have a large proportion of populations that are having symptoms, but not necessarily have a diagnosis yet. Bronchiectasis is this respiratory disease that causes the airways to become widened, inflamed, and scarred, which is a permanent damage, also not reversible, and can be very progressive. When you have a damaged airway, you can no longer clear mucus. You get bacteria. You have a cough. You have mucus, but then you are unable to actually move that mucus out.
It stays in this progressive cycle of infection and mucus and inflammation. This bronchiectasis is often in, in fact, 42% of patients with COPD and in 1%-4% of overall smokers. Again, it's a bit of a rule out what's going on with the patient. They've had multiple admissions. They're having chronic pneumonia. They're coming back in. Also, typically a secondary condition to something else. Although some patients, like with cystic fibrosis, it'd be more of a primary therapy for them. The majority of these patients do have bronchiectasis. Similar to lymphedema, bronchiectasis is routinely misdiagnosed and left untreated. These patients also suffer with a lot of hospitalization visits. Again, maybe trying other therapies like huff coughing and PEP devices. The challenge is with bronchiectasis, typically they can't get enough of the push through their diaphragm to actually cough.
You can try to cough, but you don't have enough of the dysfunctional diaphragm could actually be preventing you from having a full cough. There are way too many patients with this condition that are not receiving access to our product, which is an airway clearance vest. I'll talk about that. Again, really disappointing and not a great position to be in as patients, but as a business, clearly unmet need where innovative solutions are going to make an impact. When we think about the build of the lymphedema patient, you know, potential of $5 billion of addressable market and a $5 billion on bronchiectasis gets us to the math that I showed you earlier for a $10 billion TAM for this population.
When we think about parts of the body, we're covering it all from the lower body to the upper body, which is both lymphedema and chest, as well as the head and neck, which would be exclusive to the lymphedema and head and neck cancer patients. When we think about what needs to happen then to unlock this TAM, it isn't magic. In fact, many businesses before have been in this very same situation where you had unmet needs and you had a technology, but you had this, you know, big opportunity, this addressable TAM that really starts with getting the undiagnosed to a diagnosed state. For us, when we think about how we go addressing this access to care, it really is going to require pretty bread and butter type of market development activities. It's the patient and provider education.
It's going to be making sure you have a favorable reimbursement environment, of which we do for coding and for payment. The coverage is one that we're continuing to work on. That you have evidence that actually supports the value of the technology, that you can process the identification from patient being identified with diagnosis to them getting the product in a way that is simplified, and then having solutions on those innovative solutions and that connectivity that really allow the patient to get the benefit of the therapy. Again, it's not magic what needs to happen here. It can't go fast enough from my standpoint about how we go after addressing these barriers, but we have very solid plans on how to do this.
We are seeing the benefit of our place in the market as well as our technology and our core capabilities to be able to go after and unlock this huge market. Let's think about how we do this with our product standpoint. First of all, we have in the lymphedema space, there are two types of technologies that we have. One is called a basic device or a basic pump. We also call it by its reimbursement code name of an E0651. Then we have an advanced device, an E0652. These are different devices meant for different patient types. There is a segmentation that happens for these patients. The first in that basic pump was called the Entre Plus. It is a very convenient at-home treatment for patients that have limb swelling, so upper body or lower limb swelling.
In the advanced pump, it has different features and functionality that uses an intermittent compression, but it also has coverage for chest and trunk as well as head and neck for those patients that have swelling in areas that the basic pump does not cover. This has been areas where we participate in the market for these two types of populations that have different needs. We recently launched a new technology called Nimbl, which is our next generation platform. We launched the upper extremity in October of last year and the lower extremity in February of this year. Now we have a full system for upper limbs as well as lower. This technology and the controller is smaller, it's lighter, it's portable, and a huge decrease in the amount of hosing that goes from the garments into the controller. We're very excited.
We've seen amazing adoption by both providers as well as patients really appreciating the smaller, lighter, portable aspect of the Nimbl platform. This very platform of having the smaller, lighter, and portable will be the thinking as we go into developing what is our next generation advanced pump. Again, meeting the patients where they are in their care continuum and make sure that they have a product that is very patient-centric. Speaking of patient-centric, I don't know anyone who launches a product anymore that doesn't have an app. Apps are everywhere and largely undifferentiated. What I want to call out about ours, and I don't even like calling it an app, I think about it as a patient engagement product. The nice thing about Kylee is that it's not even specific to our product.
We're finding that therapists are asking patients, massage therapists, lymphatic therapists, and are asking patients to download Kylee as they're starting their manual therapy. It's a great tool that allows the patient to take pictures of their limb, they can put in their symptoms, and they can track their therapy. When patients have a way of doing this and have their own engagement, it makes that connection with their provider or their clinician, like a therapist, much tighter because now you're looking at shared goals and you're looking at progress. The Kylee app truly is for us a patient engagement platform. It allows for that learning education. The patient can learn more about their conditions, they can track what's going on, and then they can share that information with their care team. It also allows us to push messages into the app for patients.
It's a great one and two-way and actually kind of three-way with the provider-patient, as well as if we want to provide updates, engagement with the patient. We're continuing to invest in that platform and see that as key to our longer-term strategies. I talked before around evidence. How do you differentiate your product and what creates a compelling value proposition? Evidence does. You see here a number of data points that support the value of our therapy in terms of clinical symptom reduction as well as patient satisfaction as well as compliance. We don't have a problem with therapy benefit. Therapy benefit is very clear. It's supported by the evidence, and it's supported by patients continuing to use the therapy in home because they're getting that immediate benefit.
When we look at where we're going and how overall, you know, this is placed, we're feeling very positive and very confident that we have an opportunity of really owning the space in lymphedema solutions that can improve patients' lives. Again, a $5 billion addressable market. We're number one in the market share total between the basic and the advanced pumps, and patients are being served and benefited from the therapy. It's a great business to be in and it's one that we're feeling very, very confident we have an ability to grow. In our bronchiectasis treatment plan, again, a lot of evidence that supports our product.
As we sit as number two in market share, patients prefer our product to bladder- style vest, that 90% of patients say that they would be compliant with the therapy once a day and that the product actually fits their lifestyle. You can see it's portable. It's not tethered. The patient can use it as they're going about their day. They typically wear it for about an hour, but it allows for a lot of patient fit to the patient's lifestyle. Again, a great product and one that we're really proud of. As we think about this market, total $5 billion TAM, this portable design, the fact that we are currently indirect. For us, it makes a lot of sense. We partner directly with the respiratory DME reps that are in the hospitals working directly with the physicians that see these patients.
They have a portfolio of products. They can help identify the patient that is currently failing on oxygen or on nebulizer or non-invasive vents and help identify what is the right patient potentially for the vest. We believe that this is, again, a great category for us, again, with very strong reimbursement and a great value proposition, not just to patients, but also to our DME channels. Recent milestones of when we look at both of these, you can see a building base of evidence and kind of value over time from 2022 onto 2024, showing the evidence, showing the innovation, showing the way we're simplifying our business and super proud of the direction that was set in previous years with the leadership before me and very excited about the direction that we're going ourselves.
When we look at our overall CAGR, a 16% CAGR over time, you see where our 2025 guidance is. In some ways, I feel we're just getting started in this area. We've been at this for quite a while, but I believe that our current strategies and the focus that we have in improving access to care and in looking at that expanded treatment options and that lifetime value are going to be the formula that will help us unlock value again for the external market as well as helping us think about it from a scale and leverage standpoint. These are our three strategies. We set these out on our last earning calls. They may seem kind of big and unwieldy, but for us, they're incredibly clear. Increasing access to care really is around removing barriers.
That is, again, in the education, making sure that the evidence supports the value, making sure we've got appropriate and favorable policies for both commercial and government payers and how do we just make the process easier so we don't end up with that patient leakage and fallout. You can't be a business without having innovation. For us, innovation is key to where we're going. When we look at Nimbl as a platform and how we're going to be advancing that patient-centric design to patients in the advanced pump, as well as we're looking even more broadly across what is the portfolio of products and services and offerings to help support patients, very much part of our strategy.
As much as I talked about the long journey of patients finally coming to a place of diagnosis, once they get our pump, there's a bit of a dropout and we don't necessarily have a means of bringing value or following that patients. When I think about unlocking pure opportunity for value for all shareholders and stakeholders, it truly is elongating that value proposition from not just at the time when they're looking for a diagnosis, but even after they're starting to get therapy, how can we continue to provide value? That's going to be both with our Kylee app as well as it might be with further product innovation. I am very excited. We outlined these as strategies. These are our key strategies. We're aligning our resources to these and excited about the direction that we're going.
Let me end there and turn it over to you, Suraj. Oh, you're on mute, Suraj.
Sorry about that. Sheri, a bunch of questions came in. I don't know if I'll be able to make all of them, but I'll just kind of rattle through quickly. What are the impacts of VA cuts from the current administration, if at all, on Tactile?
You know, we definitely know that the VA has been nervous about, you know, the cuts. Anytime you're having cuts in staff, you potentially have some impact. We're not seeing it directly in our business in a profound way right now. We do benefit from the fact that our product sits on the prosthesis list. From a funding perspective, when they talked about the credit cards being frozen, they're not frozen for those products that are on the prosthetic list. That's positive for us.
I think, you know, anytime you're not having headcount to do jobs, it could have an impact. I'm not saying it won't have an impact, but for right now, we're watching it carefully and we're helping to support the patients and the physicians that are looking to, you know, help the patients get diagnosed and on to the best therapy.
Got it. Sheri, Elaine, I'm abbreviating this question. Essentially, it's same store, new store dynamics on the lymphedema side.
Sorry, same store, same story?
Same store, new store, like new, you know, existing customers within a practice versus new customer. I have abbreviated the question, but that's what they're asking.
Got it. Do you want to take it, Elaine?
Yeah. I think, you know, we're like many businesses, we've got high prescribers and we've got those that, you know, are kind of less frequent.
You know, we continue just given the size of the TAM to have the opportunity to, you know, continue to cultivate, find more patients within our existing prescriber base, so kind of get those lower prescribers to be high prescribers, as well as continue to engage with new prescribers. I think our growth, we continue to have that opportunity just given these patients are kind of, you know, coming through different channels there. That is both, I would say both the same store and new store are both continued growth drivers for us.
Fair enough. Guys, sorry, I'm just trying to squeeze as many in. Challenges in how do you unlock undiagnosed patients?
It definitely comes from awareness. It is both patient awareness and physician awareness. You know, we've thought, you know, you could do a huge campaign on patient awareness.
You know, pharmaceutical companies have done this with, you know, diseases that aren't necessarily super common. You have a bunch of patients that are flooding to physicians, but if the physicians aren't aware of the disease, you're not really helping. You're creating another kind of bottleneck and barrier. We need to do both at the same time. We are looking at the patient campaigns and we'll continue to do that. We're very committed and happen to the physician education. We continue to do that. That's maybe same store, new store. How do you get more physicians aware? Literally, the slide that I showed you on lymphedema, you know more now about lymphedema than many physicians get in medical school. There is a lot of work to be done.
We continue to have the training and education through professional societies as well as our own programs. We'll continue to do that. We're expanding those education footprints this year and we'll continue to.
Fair enough. Medicare cuts, anybody's from that? Again, folks, sorry, I'm just abbreviating. Yeah, trying to please as much.
I think on the Medicare cuts, certainly we are not, we have not seen and don't expect to see cuts in the actual reimbursement. We are benefiting from, remember, a congressional act passed for the Lymphedema Treatment Act. It's hard to imagine that they're going to overturn a congressional act and go after lymphedema right now. I don't think that that's going to be the administration's priority. Certainly, if there's less staff, that could slow down the administrative reviews on MACs and these types of things.
The good news, you know, for us is that the patients are there. The easier we make the process and the better we make sure that the physicians are putting in the right documentation and we're able to streamline that, we expect that that will, you know, we'll weather that, we'll weather that storm through both people, knowledge as well as technology.
Sheri, rapid fire. How do you capitalize on your large distribution reach? Any additional color on head and neck adoption? Guys, I fit everything in.
Yeah. On the head and neck, just quick, our two-month data has been reviewed, submitted for manuscript or submitted for publication as well as some meeting abstracts at some cancer meetings.
We have not yet heard if those have been accepted, but I definitely expect to see, we'll be able to share more of the data both two months and hopefully six months by the end of the year. Those data are going to be very impactful in helping us, particularly with commercial payers that see the, that see head and neck as being experimental. The good news is with the new NCD, that unique characteristics could definitely include head and neck. We believe that that's not going to be a huge barrier on the coverage standpoint. We're working on the coding specifically for head and neck, and we have a good strategy here. Again, great IP. I'm feeling very bullish on our head and neck.
It's just going to take some, it's going to take some time to have all of the access to care pieces in place. Your other question was on leverage of our sales organization, was that right?
Distribution reach, that's what they.
Yeah, distribution reach. You know, as we shared in our Q4 Earnings Call, we are investing this year in our, in more in our sales organization. We specifically called out more of those specialists that are helping to get the documentation. Top of license, our reps are out in the field selling to the clinicians, helping with identification, product awareness. We are making those investments.
As we see technology coming on that helps either eliminate the documentation or make it more streamlined, we can throttle those resources up and down that are on the specialists, and that will be our leverage as technology takes hold and makes it our ability to scale on the back of technology, not just on adding people. I hope that met the question.
We're up on time, Sheri. You managed to fit all the answers and try to help, Sheri Dodd. My apologies for squeezing in as much as I could.
It's all good. Those were great questions and glad we were able to answer it. Appreciate the opportunity, Suraj.
Thank you. And congrats on all the progress.
I appreciate it. Thank you very much. Bye-bye.