Move on to the next presentation. My name is Shawn Severson, CEO and founding partner of Water Tower Research. Next, we have up Vivos Therapeutics. That's on the NASDAQ, VVOS. Kirk, I'll let you give an introduction of the company and to yourself to begin with, then we'll run through some questions, if that works for you. Let's do that. Thank you very much. Welcome. Glad you have everybody here. My name is Kirk Huntsman. I'm the co-founder, CEO, and chairman of Vivos Therapeutics. We have a very interesting product that I'll just go through and show you the product first. Let me see if I can get this to work here. The market for our technology, the total addressable market, is just continuing to explode on us. As we go further down the road, we're seeing more and more different applications come to bear. One that we didn't anticipate is coming out of the cardiology profession. There's over 2,500 cardiology group practices in the United States. These cardiologists, interestingly enough, sleep apnea is wreaking havoc with all the interventions that these cardiologists are doing. As a result, what's happening is that they're looking for people to come and diagnose and treat the sleep apnea that exists in their patient populations. We have large cardiology groups around the country that we're now entering into collaboration agreements with to diagnose and treat their sleep apnea for them. The applications for our technology continue to grow. Over 85% of CVD patients test positive for OSA, so it's rampant in that patient cohort. There's over 2,600 total accredited sleep testing centers. This is where our patients come from. This is where we garner the raw patient population that we address with our technology for sleep apnea. We have just a greenfield opportunity here with lots and lots of runway. Three and a half million new sleep tests being done each year. In a latest report that I just read last night, somebody sent it to me, is that this is exploding with the wearables. You have the Oura rings, you have the Apple Watches, you have the WHOOPs, the Fitbits, all those kinds of wearable technologies creating just an explosion in people learning that they have obstructive sleep apnea or some type of breathing and sleep disorder. Cardiology patients need sleep testing and treatment. Sleep centers are profitable. They need profitable new services. Let's talk about how this works. Just the growth drivers for our business. Sleep center. We have a Sleep Center of Nevada operation that we acquired last year. That thing is just exploding in its growth. Sleep and Airway Medicine Centers of Nevada is where we do the treatment. The testing is done at the sleep center. The therapy is done over at the Sleep and Airway Medicine Centers. Cardiology partnerships are opening up in Florida and Arizona for us. We have multi-market pediatric program that we're rolling out because there's 10 million children in the United States that have obstructive sleep apnea. We do some EEG testing. This is for insomnia. We do the insomnia side of it as well as the obstructive sleep apnea. We are using IT technology driven by AI to be able to capture all the different codes that are necessary when you get these patients. Revenue and profits are growing rapidly at both SCN, that's The Sleep Center of Nevada, and SAMC, which is Sleep and Airway Medicine Centers in Nevada. The pivot that we made away from dentistry and towards medicine is working. Significant opportunities exist to expand and scale from affiliations and highly accretive new programs. Let's get into it. Let me show you exactly what we've got here. If somebody's diagnosed with obstructive sleep apnea today, they have three choices. The first is to wear CPAP every night for the rest of their life. Nobody wants to do that. You have 50% of abandonment rate in the first year and 25% use at the three-year mark. If you fail CPAP, fortunately, you get to have an implant device in your chest. This part right here goes in between your breast and your clavicle right in here. They actually slit your throat. They fish a wire up, one of these leads. There's two leads. One lead goes down to your diaphragm, so when you're gasping for air at night, it fires and your tongue jets out. That's exactly what this thing does. When your tongue jets out, it clears your airway. $45,000, $1,500, over here you have Vivos. This is the only other cleared device oral appliance to treat sleep apnea in the world that's FDA cleared to treat severe. What you have here is you have this oral appliance device, lasting results, a limited treatment duration. It's only nine to 12 months. You wear this at night, you wear it overnight for nine to 12 months, and you're done. It's a one and done treatment. These things, you have to have this implanted for life. You can't get it back out unless it's very expensive, very difficult surgery. All right. Here we go with this woman. Let me just show you this woman here because I want to show you. An AHI is apnea-hypopnea index score. This woman is having a near-death experience every night with that level of severity. After she goes into treatment for seven months, she's mild. After 11 months, she's done. No more sleep apnea. She'll have that the rest of her life. She came to work for me right here four months after her husband passed away from severe sleep apnea. Here, she marries a multimillionaire guy from Dallas, quits her job with me to go work for him. One of my best testimonials walked out the door. This is her airway. I want to just show you this little video because this is her airway before. Non-surgically remodeled her airway through Vivos technology. In 11 months, she went from that to that. You can see the difference in her airway size and the patency. You can see the volume changes. No device in the mouth for either one of these photos, either one of these radiographs here. You can see the difference in size. Which set of pipes would you rather breathe through, right? It's the one that's open and patent. You can see looking down the chute, this is what it looks like. All right. I'm just going to go here quickly because I want to keep that progressing. Yes, you guys are definitely a blessing in disguise. I did. I really thought I was going to be stuck with our stupid CPAP machine for like the rest of my life. She's one of our patients out in Can you give me volume on that or not? I called it my necessary evil. No. Sorry about that. No. Sorry about that. Okay, no problem. I hated it, but I needed it. I'm just accepting of it, but I really deep down was like, "I wish I could have something else. She's another one of our patients out there in Nevada. She had in two weeks she went from an She's another one of our patients out there in Nevada. She had in two weeks she went from an AHI of 24 to four. I promise you, I literally, I was like- She was just thrilled about it. I think that's enough. I think what I want to do is get into sort of why Vivos and why now and what all the things I've talked about. Yes, you guys are definitely a blessing in disguise. I did. I really thought I was going to be stuck with that stupid CPAP machine. Obviously bringing the technology like this to market has a fair set of challenges and hurdles to get over. Yeah. Can you walk through the process, what you've learned, how that process has gone? Because I think it's important for investors to understand the history to get you there. Yeah. We had an oral appliance device. We went to dentists because it made the most sense, right? When we went to the dentist with this, at first, they were very enthusiastic about it. Then as they got into it more and they realized they had to deal with very sick patients in a medical kind of an environment, they actually got a little bit scared about it. They just said, "You know what? We really would rather do dental things." When we have to deal with medical doctors and airway conditions and complicated comorbidities, it's just not our thing." We said, "Okay, fine." We've pivoted now, and you read about this in our SEC filings, we pivoted to the medical community. We hire the dentists in an MSO/DSO model, which is a proven way to have providers work for you, all regulatorily compliant. We do that, and we hire the dentists when we need them. We work through the medical community, and we get the patients at the site of either their cardiology office, where we get them tested and then we put them into therapy, or we do it at a sleep testing center. How does it get to Is this something that, you think of device sales, right? Somebody's going around knocking on doors. Yeah. How does that process work for you in getting to those that can- Yeah. The beauty of this is when you have patients being delivered at your doorstep, we have 3,000 patients a month, new patients a month in Nevada. It's like drinking from a fire hydrant. We barely have enough dentists, and we still don't. We're still growing into being able to have the capacity to meet the demand in that market. If you think about it, the cardiology offices are the same. They've got tens of thousands of patients in these cardiology offices that 90% of them have OSA. They don't have anybody to treat and deal with it, so they need somebody to do that. Our cost of patient acquisition is effectively zero. Explain, when you say that you have hired dentists, what are they actually doing? Why would the- The dentists have to take the. They do the oral exams. Okay. They actually do head and neck exams. They actually place the devices in the mouth, make sure they fit properly. That's required of a dentist. We're actually changing the bite, the occlusion of a patient. The MDs really don't want to touch that. They want to leave that to the dentist, and the dentists do it. They do a great job with that. The cardiologist becomes a referral network. Exactly. They go back to one of your sleep centers. Yep. The dentists do the fitting, device fit for them. What we do is we basically sell them a 20% stake in our management company. They have an economic interest that's all regulatorily compliant. That's how they do it. That's where they get the economics out of doing it. They refer. The sleep centers are not independently operated, but they have an economic interest. Yes. The dentists have an economic interest. That's right. Okay. How does that rollout work then, as far as the sleep centers and acquiring dentists, let's say? The first way that we did this, to be able to prove the model, is we went out and bought the sleep centers, right? Okay. I had to have full control over every step of the process. Now that I understand basically all the dynamics along the way, I can go out and do a collaboration deal with independent cardiology groups, neurology groups, primary care, and I can now stamp this out across the country. This is the beauty of where we're at, because where we've been is nowhere near where we're at right now. We now have figured out how to monetize. What you just saw is a technology. When I show the medical doctors what we just showed you here, their jaws drop. They're like, "How do you do that? How do you non-surgically remodel a part of the human body?" They have no idea how we do that. In dentistry, it's been done for years in certain respects. Now we're showing the medical community for the first time, and they are just stunned by what we're able to do. Their only product that they've had has been either CPAP, which everybody hates, or this radical implant surgery, which nobody wants, and it's $45,000. How is this different from like GLP weight loss induced sleep apnea? How does this compare? Yeah, it's great. It's all part of the same process. Right. If you lose weight, about one-third of sleep apnea is attributable to people who are overweight. Right. Okay. You got two-thirds of people that are out there that have sleep apnea that it's not about your weight. It could be, I don't know who's a skinny guy in this room, but you or you, right? You guys are thin, right? You could still have sleep apnea. You could still have sleep apnea. You don't have to be overweight to do that. There's a cohort of the population where GLPs are going to work great. There's a large portion of the population where that's not going to do anything at all. Wouldn't it be a dual treatment? Yeah, you can do a dual treat. We do dual treatments all the time. Yeah. One of the big markets for us is to take people out of their CPAP, because if those of you in this room, if you have sleep apnea and we were to survey you, we say, "How many of you would, if tomorrow you could get out of your CPAP?" Every hand would go up, right? Nobody wants to wear that thing. That little girl, the little African American gal that was on there, couldn't hear, she was wearing a CPAP. 28 years old and wearing a CPAP. Well, she's going to wear that the rest of her life. Except for now, we're actually remodeling her, giving her a new set of pipes to breathe through, and in two weeks' time, her AHI dropped from 24 to four. It's like, okay, how are we doing this? What is the market with 25, 30 million CPAP wearers around the country who want out of their CPAP, plus all the new ones every year? That's our market. Let's go back to the sleep center and the success of it. Yeah. Obviously you're looking for inflection points in the business. Yeah. I address that more as like a proof of concept, right? Sure. You needed to get one of these done. Yeah. You've executed, it's working. Should become cookie cutter kind of process. Is that? Yep. That's exactly right. The model that we've established in Nevada is replicable in Arizona and scalable to Florida and wherever else we want to go. I've got inquiries around the country. I've mentioned those markets because those are the two next most immediate collaboration deals that we're working on. We can do that anywhere. The model that we've got in Nevada is our prototype for everything that we've got to do. All we need is to have a facility and to hire the doctors and the support personnel and the nurse practitioners, and we're good to go. That's really how we're going to scale this up to be a national presence. If you go back again to the history, so through the dentist, this pivoted. I know you've used capital and had to grow and basically established this as a proof of concept. Right. That's been accomplished now. Yeah. The growth path forward is what and how? Well, the growth path forward is further collaborations. Right. See, one of the problems that I had with the acquisition model is that it chews up capital. Right. I mean, it just, oh my gosh, it chews up capital. With a collaboration, it reduces my CapEx per additional location by 95%. I have very little capital outlay versus substantial if I have to go acquire it. The integration of an acquisition is always complicated and full of risk. If I just set up and I collaborate. I've got lots of additional economics. I give away about 20% of the net, but I keep 80% of it, and I save all that CapEx. It's a capital efficient way to grow the business. The collaboration, what's the 20% of? Let's say there's a sleep center and they're interested in becoming- Yeah. Let me give you an idea for the economics and why this is so exciting. Earlier on in my career, I ran what's called a dental service organization or a DSO. That's a roll-up of dental practices. If you get a 20% EBITDA margin out of your dental offices, you're excited about that. In the sleep business, we're getting 50 and 55% EBITDA margins at the practice level. Today in Nevada, we're at about 35%, but we're trending towards 50, where we've projected these things to be. I think on a steady state run rate basis, basically out in the hinterlands, wherever we go with this model, we can consistently get to this 50, 55% EBITDA margin. That's huge margins. We give 20% of the net margin away to the referring providers, and that's where I was going with that. It's very profitable, but we give part of that away to the doctors that are referring. Our cost of patient acquisition is next to nothing. Did you want to ask a question? Absolutely. Yes. I'm assuming you're FDA approved? Yes. Oh, yeah. Did I show you the devices? There's a picture. Oh, no. Yeah. Our devices are the only FDA cleared devices for severe in adults to treat severe sleep apnea, and in children, the only ones to treat moderate to severe. There's no other oral appliance devices that have that clearance. The second question is, do you have intentions of commercializing beyond North America? Oh, yes. I have providers all around the world today, but I don't have scale around the world. I have a guy here. I have one in Dubai. I have one in South Africa. I have a couple in South America and Central America, but I don't have scale. I have a couple in Australia. We have exposure on a global scale, but not density. Okay. There's a huge market. There's 1 billion people worldwide with sleep apnea. 1 billion. Wow. Yeah. We have the total— When you talk about the total addressable market, I can't even calculate it, right? Let's go back to the economics then. If there's a facility, how would you go about this with pick one? Pick an example of the next one. What will the model look like and how this goes? Yeah. Let's take Arizona. I've got a four office large cardiology group that has like 40,000 patients in it. They see 25,000 a month. Okay. These guys are active. They have 27 providers. I'm going to go out down there. I'm going to set up shop with about 5,000 to 6,000 square feet. I'm going to hire two dentists to start. I'm going to hire 16 staff personnel. I'm going to hire a couple of nurse practitioners, and then I'm going to say, "We're ready to rock and roll." They'll start sending me their adults. I'll go out in the community, and I'll get the parents and the kids, because there's 10 million kids with sleep apnea in America. We'll get the pediatric program rolling, I'll have multiple revenue lines coming into this facility. With a very modest footprint, I can generate about $6 million a year with a 50% margin. That's my target. That's my model. Yeah. Okay? You had a question back there. Yeah. How much time does it take to put the device in a person? If you have one person, how many patients can they handle a day? I'm trying to. You still got me caught on the revenue model. Yeah How you're going to be logistically putting it together to get the revenue coming in so you can be cash flow positive and get those big margins. I'll give you a little bit more detail around that. Each team, we call it a sleep optimization team. Each team, which I just described a minute ago, a couple of dentists, a couple nurse practitioners, and staff personnel, can do $500,000-$600,000 a month in revenue with about $150,000 of staffing and doctor overhead. Payroll and that sort of thing is about $135,000-$150,000 a month. I have no patient acquisition costs. There's no marketing. None of the things you would typically see in a business, you don't have it here because these patients are just showing up. You open your doors every day and these patients are flowing in. Out in Nevada, interestingly, this Sleep Center of Nevada group, since 2019, has actually tested 10% of the entire population of the city of Las Vegas. 10% of the people who live in Las Vegas have been sleep tested at Sleep Center of Nevada. That's how pervasive this whole thing is. 250,000 patients over the last, what, six years. How much time does it take? How much time does it take? The answer to that is the doctor time is probably less than an hour per patient, but there's other staff members that are doing certain things, taking records, doing certain things. There's other adjunctive procedures we put. We do a multidisciplinary approach to this. It's not just a plug and play with our device. There's actually some laser surgery. It's not really surgery, but it's laser procedures. There's some myofunctional therapy, which is training the jaw muscles to work right. There's other things that go on here that are part of it. All in all, though, you can tell by the bottom line it's very profitable. Per patient, probably a couple hours to get them started. A couple hours of services. Not all by the doctor, though. Is it multiple visits back to the- It is process? Yeah. Yeah. They'll come in. We have a visit one, visit two, visit three. Visit one, they get the head and neck exam. They get evaluation. We take records. Visit two, we call that the money shot. That's where we're actually getting the patient in to say, "Here's what we found in our records. This is our evaluation. Here's your option A, B, C, and D." We give them choices and let them pick what they want to do. Every one of those options, we have plenty of money and margin in. We suit it to the needs of that individual patient. How much will their insurance pay? How much can they afford to come out of pocket with? Do they want to rehabilitate or just monitor this or manage it for the rest of their life? We have lots of options, and each patient picks their path. You touched on something, insurance. Insurance coverage eligible? Mostly, yes. We're still working on getting in-network with certain payers out there in Nevada. The way we solve that nationwide to scale up is we found a group that's called iSleep Physicians out of California. They're licensed and in insurance programs in every state in the nation. In Nevada, where it took us 10 months to get in-network with some of these guys, the iSleep guys already have it. They already have the contracts. They're already in-network. We give them 3% or 4%, and they're happy. By being in-network, they're qualified Yes to prescribe this device and get coverage. We immediately get coverage. Yeah. The patients get covered, and we get payment without having to fight for it. You restructured some debt. You talked about that. Yeah wanted to spend a little bit of time about the growth. Yeah. We used a group out of Chicago called Streeterville Capital to actually fund this first venture out there, this first group of practices that we bought, it was expensive debt. It was just bleeding us. Last week we announced, last Friday, we've restructured a lot of that. Streeterville Capital's been very cooperative with us in doing that, our stock traded 70 million shares in one day. Everybody's like, "Oh, finally. Everybody knows. Yeah. Everybody knows, Yeah. Everybody knows, right? Going forward, I don't have to do that again. Yeah. That's the beauty of it is now we've got a highly cash flow, cash generating machine, and I don't have to incur that kind of debt every time. Right. Capital-light model, essentially. Yes going forward. Exactly. Great. Any questions? We got about five minutes. Yeah. Yeah, Paul. Yeah. How about Medicare? Oh, yeah. Have you gone there? They're looking to save money, and there's a lot of patients there, and it's a good base load. Yeah If you can get in there. We announced in March, I believe, that we have Medicare coverage now, that you have to get on a certain list. In the oral appliances, you have to get on this list called a PDAC list. CMS, once you get on the PDAC list, that means you pass the engineering inspection and you've met the criteria, and then you get admitted to the CMS listing, and you can get eligible for Medicare coverage. We have all that. We have all that, we're ready. Yeah. What is the relative to the other two options you illustrated before? What is the relative cost of- Ours? I realize that insurance and everything else- Sure distorts the classic- Yeah treatment, but- Yeah. Relative economics. Yeah. Relative economics in a CPAP, $1,500. In the Inspire device, $45,000-$50,000. Our device, $8,000-$10,000, depending on how much adjunctive things. I mentioned laser and myofunctional therapy. Depending on how much adjunctive therapy you add onto it. That little gal, that little black gal that you saw there, her cost of treatment was around $10,000 or $11,000. She's paying $200 a month. Right? We help them get the financing, and so her insurance paid, I don't remember. Preferential within the existing framework. Yeah. Here's the other thing about that, because there is an economic part of this, right? No doubt about it. There's also a key differential in the fact that we are one and done. Quality of life. Quality of life, absolutely. I see people walking in the airport, I can tell now they're schlepping around their CPAP machines through the airport and on the airplanes. It's everywhere, right? Once you know what their bags are or what they look like, I could pick them out everywhere. You never have to deal with that. Once you fix this, you never have to deal with it again. A lot of people like that. They'll pay a little more just to not have to manage it and fuss with it the rest of their life. Kirk, you have visit one, visit two, visit three. You're generating revenue and margin across all three? All three visits. No, all three visits. Yeah, bring me back to that. Visit 1, they get some records, but we also make money on the radiographs. We make money on the visit, the office visit. We make money on some of the procedures. The visit 2 is where they choose which oral appliance pathway they want to go down. Are they going to manage it? Are they going to rehabilitate? We call it rehabilitation, where they actually. That's the most expensive one, but it takes, it's only this nine to 12 month thing. Visit 3 is where we actually deliver the appliance. That's their third visit. They have to come back a couple, three times throughout the year just to have adjustments and make sure everything's working and fitting as it's supposed to. Last, Shawn asked about the partnership model. When it comes to a cardiologist, what is the incentive for a cardiologist, other than to do no harm, let's say? Yeah. You also mentioned setting up a management company. Yeah. You set up sort of like a project finance approach where each practice is its own company. Healthcare, as you know, is a complicated mess, right? Federally, we have these Anti-Kickback Statute, and then each state has their own set of kickback statutes. Within the confines of each state, we have to comply with certain regulatory structures. Within these regulations, there are what they call safe harbors. These safe harbors allow for exemptions for certain structures to be compliant. One of them is a management services company. We've selected that so we can hire the doctor, pay them, and they can work for us without any conflict. The cardiologists who are referring patients, they can actually own a piece of the management company, and then they can safely refer to that company without any kickback issues. We have that structure. We worked that out with, believe me, a lot of legal fees to figure that out. Yeah. Great. Any last questions? We're up on the top of the hour. Anybody else? I'll turn it over to you for closing remarks, Kirk. Listen, Vivos has always had the technology to be a unicorn in the healthcare space. There is so much opportunity here. The problem has been that we never could figure out how to monetize this. Now that we've pivoted to the medical community, our ability to monetize it is now showing up in everything we do. We are on a growth trajectory like no other, and it's only going to get better, I think, as we begin to execute. I think I was talking, maybe it was you, Paul, you said to me, "It's all about execution from here on out." That's right. It is. My team, by the way, this management team that I have, we built from scratch a several hundred million dollar DSO back in the early 2000s, sold it off to a private equity group, and cashed out. It's the same management team. We know how to build, we know how to operate, we know how to do this. The only reason we haven't so far is we picked the wrong horse to go to market with, we went to the dental community, and it proved to be a mistake. We still use dentists, but we use them in the way that we can control them, now it's the right way to go. I would just say thank you for your attention today, and happy to stick around if you have any questions afterwards. Thank you. Great. Thank you, Kirk. Thanks, everyone.
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