Great. Good afternoon, everyone. Thank you for joining the conference over the next couple of days. I'm Richard Close. I lead Research at Canaccord for Digital and Tech-Enabled Health. I have a very interesting company with us today in the airway management area, growing and profitable, with their differentiated SmartVest system. From the company, we have CEO Jim Cunniff to tell the story and CFO Brad Nagel as well. With that, Jim, thanks for coming and turning it over to you.
Outstanding. Thank you, Richard. Thank you all for joining today. Good afternoon. Hope you're enjoying your lunch. As Richard had mentioned, I'm Jim Cunniff. I'm the CEO of Electromed, and Brad is my partner in crime over here, who's our CFO. I'm here to talk to you today about SmartVest. We are an innovative company in the airway clearance space. I'm going to get the disclosures over with, not go through that, but a little bit about our company. We're based in New Prague, Minnesota, which is about an hour southwest of the Twin Cities. All of our manufacturing is done in the United States. I was listening to the previous speaker, and one of the questions was talking about tariffs. We are basically immune from those.
All of our manufacturing is done domestically, and all of our componentry that we use in the assembly of our product is also sourced domestically in the United States. We've been around for a little while. We're about a $62 million company, and we're a single product company. I'm going to talk more about that in a minute. A couple of financial highlights, and I'm not going to go through every bullet that's on here, but the short story is pretty compelling. That short story is that we are growing, we're profitable, we're generating cash, and we have no debt. For a company our size, that's pretty unusual. The other thing that's unique about us is we're in a space, which you're going to see in a minute here, that has got fantastic tailwinds. Those tailwinds are really predicated on the disease state that we serve, which is called bronchiectasis.
I'll talk more about that as well. What is bronchiectasis? Bronchiectasis is the primary disease that our technology serves. It's one of several, including cystic fibrosis and ALS. This is the primary disease state that we serve. If you're not familiar with bronchiectasis, it's kind of a unique respiratory disease, in that it's chronic and it's irreversible. Once you have bronchiectasis, you're not going to get cured for it. Essentially what our device does is it improves the patient's quality of life and helps them breathe easier. The disease is misdiagnosed. It is also underdiagnosed. The mechanism of action of our device, which is called HFCWO, or high-frequency chest wall oscillation, is underprescribed. We feel like that's the big opportunity that we have. This disease is really a function of mucus that is pooling within a patient's lungs that causes infection.
Because of that mucus pooling, the patient has a hard time breathing. We're in a really, really large, growing and underpenetrated market. I want to unpack this iceberg for you. In the United States, there's 824,000 patients that have been diagnosed with bronchiectasis. Of that, only 127,000 of those patients have actually been prescribed our technology or one of our competitors. The remaining 700,000 patients, and that's just above the waterline in that iceberg, 35% of them are actually seen by a pulmonologist. We have a direct sales team, and that's their primary call point is pulmonologists. That's about 230,000 patients. If each and every one of those patients was put on our technology, that represents a $2.3 billion, with a B, revenue opportunity. That doesn't even include the 4.1 million people, population in the United States that has COPD, bronchiectasis overlap that could benefit from our technology.
The prevalence rate is growing by about 12% annually. There are, again, some fantastic tailwinds to continue that trend. How is it treated? First and foremost, you need to clear the airways first. That's really where our product comes into play. I'm going to share with you the mechanism of action of that. Then you want to treat the infection. Typically that's done with antibiotics. You also want to do everything that you can to minimize the inflammation because it's the inflammation of the large airways within the patient population that causes that mucus to build up and the infection to occur in the first place. That cycle, that kind of roller coaster of having an infection, clearing your lungs out, treating with antibiotics, we're really the first mode of defense for that. If you can clear out the mucus, then you're clearing out the fuel for future infections.
How does our device work? On the left-hand side, there's a bit of a cartoon depiction. We have a generator that's attached to a hose that's then attached to a vest. The vest is very lightweight. Most of our patients are over 65 years of age or older. They typically get on this technology later within their disease state. Essentially what our garment does is it inflates and deflates. That mechanism of action, where you have the air pulsing technology, forces the mucus from the large airways so that the patient can either cough it up or swallow it, to breathe easier. A lot of times we get questions, well, how often does somebody need to use this device? The reality is, since this is a chronic irreversible condition, they need to use this device twice a day.
It's usually for a therapy session of 30 minutes at a time, forever, for the rest of their lives. It doesn't cure the disease. What it basically does is it improves their quality of life. When you wonder, okay, is there anybody else that's in this market? It is a competitive market space. We're one of four companies that has an HFCWO type product, but we really have the newest technology on the market. Our vest is the lightest weight. Most of our patients are frail. Many of them have arthritis, and you want to have something that's comfortable so that you get patient compliance. We're also the only company in the market with a single hose. You want this to be ergonomic. All of our competitors have two hoses. We feel like the industrial design on the product is pretty nice.
That's really important because this is a product that is used in the patient's home. It will be sitting in their living room or in their bedroom, and we want to make sure that it's something that is attractive. Actually, it's incredibly intuitive. There's no on-off button on this device. There are only a few buttons that they need to activate in order for them to get the therapy. The other thing that we do that's unique is, with this type of device, you want to make sure that there's patient compliance. We have respiratory therapists that we basically contract with. When we get a prescription for this product, we deliver it to the patient's home. We actually will train the patient on the product, and a respiratory therapist is actually the one who does the training.
At that point in time, what we'll do is we'll do a baseline assessment of how that patient is doing. We'll then come back five days later, do another assessment, and then we'll come back an additional 30 days later and do a final assessment. Then what we do is we compile all that information and we provide, actually, to the provider, or in this case, the pulmonologist, what's called a SmartNote. That does a couple of things. It shows them that not only did we get the prescription, we delivered the product, the patient is progressing as hoped. We will also then compile SmartNotes not only for single patients, but we'll put together a mosaic for the clinic as well so that they can see all the different patients that they have in our technology and the benefit it's providing to them. It's improving their quality of life.
It's not curing them. We also have great clinical evidence for this product. On the left-hand side of the slide, basically our customer testimonials, most of them would recommend this to others. 97% of patients report feeling better or the same after SmartVest, and 98%, I know this is right after lunch, of patients report an increase in sputum production. That's really important because really what we're trying to do is get the mucus out of the airways. As you can see on the right-hand side of this slide, one of the key things that we are trying to do with this technology, because the patient is getting treated in the home, is we want to keep them out of the emergency department. We want to minimize their use of antibiotics. We want to reduce the amount of hospitalizations that they have.
As you can see from our clinical evidence, the device has been very successful in doing that. The other thing that's really unique about us is we are not only a manufacturer, but we're also a durable medical equipment distributor. What that means is we not only make the product, but we actually deliver the product to the patient's home, as I mentioned before. The other thing that we do is we have payer contracts. We have Medicare, you know, a Medicare contract. We have contracts with most, if not all, of the commercial payers. In fact, we have over 275 million lives that we have covered. What that enables us to do is, you know, the top end of this slide, I think it's important if you're not familiar with the home space, the home care space. Most manufacturers, what they'll do is they'll make the device.
What they do is they sell and market that product to a durable medical equipment distributor. That distributor is really the one with the feet on the street. They're the ones who have all the payer contracts. They're the ones who are getting prescriptions for the product and then delivering it to the patient's home. Our model is different because we're not only the manufacturer, but we're also a DME. When we do get a prescription, we deliver it directly to the patient's home. We do all the billing to the payers, and a consequence of that is we get to maintain more of that margin. As a medical device company within the space, we've been successful in having, you know, mid-70% margins on our product. Where's our revenue coming from?
Most of our revenue comes from the home, although we do have a nascent international as well as a hospital business. A hospital business is a little bit different because it's more of a capital equipment sell, and that is an area where we see potential to grow even further because we believe that the hospital is a gateway to the home. If you get the patient on the product in the hospital, they transition to the home. We want to put them on our technology. From a payer standpoint, about half of our revenue comes from Medicare. The other half is from commercial payers. As I mentioned before, the majority of the disease state that we serve with our product is called bronchiectasis, and, again, just fantastic tailwinds with that symptomology. How are we going to grow? We continue to invest in feet on the street.
We believe that one of the big opportunities in this space, most of the pulmonologists are used to seeing COPD and asthma patients, but more and more, they're getting enlightened to their patient population that has bronchiectasis. There's a big investment that we make in driving commercialization and market development. We also have a fantastic direct-to-consumer team because, as you can imagine, if you have this disease state and you're having a hard time breathing, people are looking for solutions. They go online, they contact us directly. We can't prescribe our technology, but we can refer them to pulmonologists who can. The people who are taking the calls on our end and responding to patients directly are all respiratory therapists, so they're clinicians and can provide great feedback to those patients.
The last thing that I'll mention on this is, in the home space, the clinics that are out there mostly will send their prescriptions through fax, which I know is kind of the dark ages. In the last 12 months, we've been bringing them along to what we believe is the light and having them send us their prescriptions through our e-prescribed solution. What that does is when we get an e-prescribed prescription, it mitigates us having to review all the documentation. We can send that documentation directly to the payer and make sure that we get paid for it, that the patient, they get paid as, or the technology gets reimbursed, and they don't have a large out-of-pocket expense. It's a real big efficiency benefit for us and the clinics.
We don't give guidance, but I will tell you that we've been successful in growing our top-line revenue double digits. We're expecting to continue that. I'm seeing Brad smile. One of the things that I think has been really differentiated about us in the last two years is we've always been growing and we've always been profitable, but we haven't been growing our profitability. Really in the last two years, we've been successful in leveraging our P&L, and we're going to continue to do that. Why invest? Large expanding market that I talked about. We've got fantastic clinically proven technology, which we're continuing to innovate on. We've got outstanding payer coverage. In fact, last year, one of the big investments that we made is expanding our footprint in that area, because there's a couple of areas, most notably in California, where we have gaps and we want to fill those.
We've got a great growth story. As I mentioned at the onset of the presentation, we're growing, we're profitable, we're generating cash, and we have no debt. The last thing I would mention to you is that my incentives, Brad's incentives, all of management team's incentives are really aligned with our investor community. If we don't grow and we don't do so profitably, Brad and I, we don't get paid our incentive compensation. We feel like that lines up well with the investors. We just recently were entered at the end of June into the Russell 2000. When you take a look at Electromed's financial metrics versus the averages within the Russell 2000 Medical Index, whether it's sales growth, gross profit margin, or operating margin, we feel like our metrics are head and shoulders above the averages. Those are my prepared comments.
I'm going to now invite Richard to come up and, in the time remaining, ask some questions of Brad and I.
Great. Maybe we could start off with the iceberg slide, which I think is really interesting. I'm really more curious, the $4.1 million below the waterline, you know, how do you guys go about attacking that and getting awareness up?
No, that's a great question. If you may recall on that slide that I showed with the iceberg, that 4.1 million patients, those are patients that have COPD, but they have bronchiectasis overlap, and that's about 54% of the total COPD population. A lot of it, Richard, as I mentioned in my comments, is awareness related. Most of these physicians, when they're seeing the patient, unless when they look at their CT scan that most of the pulmonologists have done on their patients, that it's actually being identified that they have bronchiectasis, they'll treat them as a COPD patient. Part of what we have invested quite a bit in is there's a couple of foundations, the Bronchiectasis NTM Foundation being one of them, that has a registry of patients that have bronchiectasis and COPD.
You mine that, but also, you know, they work with a cohort of key opinion leaders that we then can help educate, and then they can spread the gospel on our behalf as well. Really the most notable investment that we make is in our sales team. They're calling on these pulmonologists every day and helping them identify patients that would fit this technology.
Okay. I cover some DME companies, so interested in that area. How did you come to the direct-to-patient model?
I think it predates me. We're not a flash in the pan. We've been around since 1992, and that really predates me. I think there was a couple of catalysts for that, one of which is, as you saw in our slides, it helps us retain more of the margin. I think when you, you know, this is still largely a clinical sale, so you need to have salespeople that are calling on these pulmonologists who can help identify patients who could use this, help educate them on HFCWO, which is our mechanism of action, help them adjudicate the reimbursement landscape because it's not like we just get a prescription and then we can fulfill this technology. For somebody to get a SmartVest, they have to have been diagnosed with bronchiectasis as an example.
The guidelines for CMS reimbursement are CT scan that confirms you have bronchiectasis, you have to have tried and failed something else, and that could be manual chest percussion, and you have to have had a productive cough for six months. We need to see that in the patient's notes. Once we see all that, then we know that we're going to get reimbursed for the technology and the patient won't have an out-of-pocket expense. That's a big deal, so you want to have a sales team who can actually articulate that and walk the clinic through that process.
That's helpful. I am curious, you had mentioned or you had the pie charts in there and the hospital is a small sliver and you said it'd be nice to get in there and identify the patients and whatnot, getting them using it in the hospitals. Can you talk a little bit about any partnerships you have or how you're addressing that market?
Yeah, it's an awesome question. A couple of things, number one of which is, you know, the hospital market is very different than the home market because every time a hospital buys a unit from us, it's really a capital sale. In the home, it's a capitated rental. We're actually billing CMS or we're billing a commercial payer anywhere from 10 - 13 months. In a hospital, they're buying capital equipment from us. The trailing consumables that we have are the hoses and the vests and our wraps that we sell. That process in the hospital takes a lot longer. You're not just dealing with one decision maker, which is a pulmonologist, as you know, you're dealing with a hospital and their capital committee, their new product committee. They will keep our technology or one of our competitors much longer. They'll carry, you know, could be seven to 10 years.
We have made investments. We've got several folks on our team that wake up every day calling on health systems. We have a contract with Vizient, which is the largest group purchasing organization in the country. That represents, you know, half the hospitals across the country. We have a contract with them, so a bit of a captive with that. There's also a niche within that market, which is the VA hospitals. When we get a prescription from a VA, it's kind of like a capital order to us. We have a lot of veterans who can benefit from this technology. We have a partnership with a company called Marathon Medical that is owned by, it's a small, veteran-owned business that has inroads into that market. We think that's a neat place for us to be mining.
Helpful there. Maybe Brad, maybe a question for you since we put you up here. I'm curious, Jim had mentioned or had the slide up there versus the Russell Medical , and mentioned the improving profitability. What was the driver of that over the last couple of years? It'd be helpful to know.
Yeah, as Jim mentioned in his prepared remarks, the company has been profitable for a long time, but not necessarily growing its profitability. A lot of that has to do with the fact that as a small company, historically, when we made an investment in our sales team, we were also having to make investments into back office functions like reimbursement. Frankly, probably didn't have the best technology or process to support those groups to become more efficient. Really what's happened over the last couple of years, even up until kind of where we are right now, we've made some investments in systems, like a reimbursement system for billing, like an ERP for better understanding our operations and gross margin. Finally here, we're just in the process of implementing a CRM.
What those allow us to do is to gain efficiency so that as we continue to grow our sales force, we're getting a lot more leverage out of the back office functions and systems, better people, process, and technology to allow us to drop more of that revenue through to operating income.
Great. I know you're in a quiet period, so I won't ask about the future, but I am curious in terms of how you guys prioritize use of capital. You are profitable, generating cash. I'm just curious, what are the main priorities there?
Absolutely. As we've been able to grow our operating income, dropping more cash through to the balance sheet, a top priority has remained for us to continue to invest in the business. We have made those capital investments in systems, and we continue to invest in growing our sales channel. Beyond investment into the business, we want to make sure that we're finding ways to give value back to shareholders. We don't want to accumulate an oversized pile of cash. How we've done that most recently is over the past fiscal year, which we are just closing up to your point, we've authorized two $5 million share repurchases. As of our last reporting, the finish of our Q3, we had completely closed out the first $5 million and done about 2/3 of the second $5 million.
To the extent that we can, we'll find ways to give value back to shareholders. The primary way to do that has been through repurchases.
Okay. We have a minute left. I have to ask this question. Obviously, it's been a tough month for a lot of healthcare companies, a tough couple of years, but a tough month as well. I'm curious your thoughts on the one big beautiful bill, you know, how you're impacted or any thoughts regarding it.
What a great closing question. The big beautiful bill really has had no impact, and we don't anticipate it's going to have impact on our business. As it relates to, and probably the biggest component of that is Medicare. Thankfully, touch wood, one of the benefits we've had is our Medicare reimbursement is typically, we get increases every year, and it's tied to the urban CPI, and we expect that to continue. When you take a look at healthcare spend in general and how small home care is as a percent of total, it's minute. There are much bigger fish to fry with other specialties, and we're just not on the radar screen for that. I think the only watch out would potentially be Medicaid, but that's only 2% of our total revenue, and so it's really a nascent piece of our business.
Okay, great. Thanks for being here and telling us the story.
Hey, it's a pleasure. Thanks for having us. Thanks for your time and attention, everyone. Appreciate it.
Take care .