R. Huntsman
Analyst · ROTH Capital
Thank you, Brad. It should come as no surprise to those of you who follow Vivos closely that this company has always held the promise of doing great things, the things that could change the world. After all, no company has ever come to market with a technology that has been proven time and time again in both clinical studies and in actual practice to reverse or eliminate sleep apnea in a majority of patients without lifelong nightly intervention. And because sleep apnea either causes or contributes to virtually every major chronic health condition out there, we believe that what we're doing here at Vivos is and will continue to be a very big deal.
By practically any measure, our sleep apnea solutions are superior to everything else on the market. Generally speaking, Vivos treatment is less expensive, less invasive, more effective, more comfortable, longer lasting, as safe as CPAP and safer than neurostimulation implants. Yet those technologies, despite being undesirable last resorts, continue to dominate the marketplace, and the companies behind them command multibillion dollar market caps. But we didn't come this far to take second or third place. We're playing to win. We have to win. There are far too many patients counting on us to prevail.
So I'm sure the question on everybody's mind is how do you explain the results? With a virtually unlimited blue ocean type of market to work with and tens of millions of suffering patients yearning for an alternative solution to CPAP and surgery, why hasn't Vivos garnered more market share? And what's going to be different this time around? I'd like to take a moment and make the case that the issue is not and never has been our technology or the science behind it or anything of the sort. It has never been our strategy or the effectiveness of management in executing the strategy. Disruptive innovation and new technologies simply take time to dislodge old technologies and old paradigms of thought and practice. But here's why we believe the time has finally come for Vivos.
First, we finally have a true national network of Vivos providers armed with a comprehensive suite of products and services that will enable them to serve larger numbers of new patients. It takes lots of dentists who are specially trained and confident who are conveniently located to where the patients really are. It also takes a comprehensive product offering to address a wide range of diverse patient needs from disease prevention to disease management and even rehabilitation.
Developing and growing that national dental provider network and the suite of product offerings aimed at treating OSA is what we have spent the last 5 years creating. This was always Phase 1 of our go-to-market strategy because without a national network of competent, committed Vivos oral appliance providers armed with an assortment of evidence-based, highly effective products that patients need and want, nothing else really matters.
But dentists cannot do this alone or in isolation from other health care providers, such as primary care physicians, ENTs, neurologists, pulmonologists, pediatricians, cardiologists, functional medicine doctors, chiropractors and physical therapists, all of whom see patients suffering from breathing and sleep disorders such as OSA every single day. And what do all these patients have in common? They dislike or are unable to tolerate their CPAP treatment and are looking for something better. So one way or another, patients must come from and through those other health care providers while making their way into specially trained dental offices such as Vivos' VIP offices to receive treatment.
Facilitating the referral of medical patients with sleep apnea into our network of trained Vivos offices thus becomes Phase 2 of our go-to-market strategy. Fortunately, we've been finding new and creative ways to drive failed or disgruntled CPAP patients into Vivos treatment. Our recently executed national distribution agreement with a major durable medical equipment company, or DME company, is a prime example.
On June 1, 2023, we entered into a nonexclusive distribution agreement with a leading supplier in the United States of home health and respiratory products such as CPAP equipment. Our new distributor currently provides respiratory products to approximately 1.8 million patients nationwide. Pursuant to this agreement, our distributor has begun to distribute certain of our products in the United States, including the Vida, Vida Sleep and Versa, all of which we acquired earlier this year. The agreement called for an initial 90-day trial period in Colorado and Florida, which made the contract subject to potential cancellation. However, within weeks of starting the trial, our distributor reported an initial 36% positive patient response along with other positive feedback and requested a modification to our agreement that would make it exclusive for a period of 1 year.
We are currently negotiating the potential terms of exclusivity. Plans are already underway to extend the scope of the distribution territory beyond the initial 2 markets into Texas, Virginia, North Carolina, New Jersey and at least one other major market. A nationwide rollout is expected to follow soon thereafter. Our hope is to be able to share with the market even more definitive information about this exciting development in the near future.
Regardless of the outcome of our present negotiations for exclusivity, we are confident that this new form of arrangement with DME companies will help us increase our product revenues during the second half of 2023 and beyond. There are many more such DME companies out there, some of which are substantial public companies serving millions of patients in the United States and Canada. With widely recognized CPAP adherence rates of just 30% to 60%, every DME company, depending on its size, has the records of thousands or tens of thousands and perhaps hundreds of thousands of known OSA patients who have failed CPAP. Often, these patients have nowhere to go and do nothing further to treat their OSA until they get desperate enough to try neurostimulation implants or surgery. As an authorized Vivos distributor, DME companies can now offer their OSA patients a much more attractive, nonsurgical alternative therapy.
Launching our distribution model in the DME space is a milestone achievement. We now have the model, the infrastructure, the product line and the provider network to service large numbers of patients. We believe this model will appeal to many other DME companies as it gives them an easy way to monetize and reengage patients who are not currently receiving treatment for their OSA. Each month in the United States, DME companies distribute roughly 500,000 new CPAP units to freshly diagnosed OSA patients. And every month, about half of that number stop using their CPAP units. If the current rate of 36% of such patients expressing interest in oral appliance treatment holds true over time, then the number of new prospects flowing into Vivos' VIP offices could be substantial. With roughly just 2,500 new case starts per month from DMEs, or about 1% of the total monthly failures -- CPAP failures, Vivos' revenues could easily double, advancing us toward our goal of becoming cash flow positive.
In our current DME distribution effort, we don't yet know the final conversion rate of these patients. But what we do know so far is that 36% of the CPAP failed patients contacted by our current DME partners are saying yes to seeking oral appliance therapy at a Vivos provider. Historically, our experience suggests that conversion rates for such patients are around 80%. Within a few weeks, we should have reliable data on conversion rates, which should then allow for more accurate forecasts.
In addition to our DME distribution model, a select few Vivos-trained dentists, or VIPs, have seen great success by actively seeking patient referrals from a wide variety of local medical doctors, such as cardiologists, primary care physicians, ENTs, neurologists, pediatricians and other health care providers who see patients with OSA every day. Some of these Vivos-trained dentists, known as VIPs, are generating millions of dollars per year in oral appliance airway treatments from their independent practices. It is a model that we believe is working across multiple offices, and we believe it is therefore replicable and scalable.
As a second key part of our Phase 2 go-to-market strategy, we are more sharply focused on establishing medical referrals into our VIP doctor practices on a much broader scale. Along with DME company referrals, we believe these initiatives will bring significant new growth opportunities to Vivos in the months and years ahead. We see them augmenting and accelerating our other VIP and DSO enrollment efforts because as we are able to deliver more and more new patients to Vivos-trained VIPs, the intrinsic value proposition for becoming a VIP or DSO affiliate increases significantly. In the long run, that is how we see our business unfolding over the next 18 to 24 months.
Now earlier in this call, we alluded to an unforeseen market event that occurred during the second quarter that had an adverse impact on our revenue. In early March, a televised CBS News story broke about a widely publicized lawsuit and ensuing governmental, including criminal, investigations into an unrelated, non-Vivos, non-FDA-cleared oral appliance called the AGGA, A-G-G-A, purporting to treat sleep apnea. Although Vivos was not named in either the lawsuit or any of the initial publicity, rumors, speculation and viral misinformation created significant confusion and concern among both dentists and patients. This occurred despite our best efforts to counter such misinformation by reminding our customers that all Vivos appliances are duly registered or cleared by the FDA and have been proven both safe and effective in numerous studies as well as in treating over 40,000 patients.
Not long after reports of this matter began to circulate, Vivos began to experience declines in both new VIP enrollments and CARE appliance sales. Our CARE devices are the oral appliances most likely to be confused with the AGGA oral appliance noted above. These declines may also have been impacted by certain second quarter personnel cuts to our practice advisor support teams.
Regardless, the decline in CARE appliance sales continued throughout the second quarter. Importantly, through the end of the second quarter, units of our Guide appliances for pediatric growth and development rose 89% year-to-date compared to the same period in 2022. Guide appliances are high-margin products but priced much lower than CARE devices. So it takes larger unit growth of Guides to be able to overcome the decrease in CARE unit sales. In addition, our non-Guide, non-CARE devices which we began to introduce in the second quarter also showed tremendous growth. These product lines have continued to grow rapidly here in the third quarter, and we remain very optimistic about the continued growth going forward.
During previous calls and filings, we stated that our goal was to decrease costs and increase revenues during 2023 with the aim of becoming cash flow positive from operations by the first quarter of 2024 without the need for additional financing, if possible. As Brad stated earlier, Vivos has successfully implemented cost-savings measures and significantly reduced cash used in operations. However, sales have not grown during 2023 as anticipated due to the external factors just mentioned. As such, Vivos now anticipates that it will likely be required to obtain additional financing to satisfy cash needs as Vivos works towards increasing revenue and achieving cash flow positive operations in the foreseeable future. We are presently working to determine the best path forward to ensure Vivos has the necessary resources to meet the opportunities before us.
As previously highlighted throughout this year, we significantly reduced our cash burn, which was aided greatly by the 31% quarter-over-quarter and 25% year-over-year reduction in operating expenses we achieved in the second quarter. At the same time, we strategically expanded our product offerings to address a broader spectrum of patient needs and price points to drive long-term growth -- long-term revenue growth. This included our acquisition of certain key patents, trademarks, product rights and trade secrets earlier in 2023, which filled certain gaps in our product offerings to providers and patients.
This strategic move has already shown great promise as these new products prove critical to Vivos' landing this national distribution agreement with the large DME company during the second quarter and which will add significantly to our revenue over time. As we just highlighted, those new product lines have also been growing at a significantly faster rate than our CARE products, which is fully in line with our expectations as those products filled some important gaps in our product line offerings. We believe that we'll continue to see solid revenue improvement here in the second half of 2023.
We continue to look at opportunities to expand our product offerings and partnerships and just recently signed an agreement with DEKA to offer DEKA digital lasers to Vivos' clients through The Vivos Institute. DEKA recently introduced new advanced technology that can be used to effectively treat snoring as well as swollen tonsils and other soft tissues that can obstruct the human airway. DEKA is the dental laser subsidiary of the world's largest laser manufacturer, El.En. Group, an $800 million Italian public company. Other product distribution and collaboration agreements are in advanced discussions and will be announced if and as they are consummated. Management believes that such product representation and collaboration agreements will continue to build revenue and growth lines for Vivos in the months and years ahead.
So while we face some headwinds in the market on the revenue side, we also see new revenue opportunities emerging as marketplace momentum and sales build across our entire suite of products. The second quarter also saw continued progress in our pilot tests with DSOs, including the execution of new and existing pilots during the quarter with 8 regional and national DSOs, representing over 1,000 locations nationwide. As an indicator of our momentum in the DSO space, since the close of the second quarter, we have progressed to having advanced discussions, including on-site meetings, with an additional 5 DSO groups, with another 12 groups being added to our sales funnel after expressing high levels of interest.
We are also pleased to report significant progress from our ongoing efforts to obtain additional FDA clearances and indications of use for our products. We now have submitted several rounds of what we believe to be compelling data to the FDA, pursuant to our applications to expand the scope of authorization for use of our medical devices. We believe such applications and requests are in the latter stages of consideration. If and as any such new clearances are received, we will publish those milestones immediately.
In addition, our Clinical Advisory Board led by Dr. Clete Kushida of Stanford University, along with certain independent clinicians and researchers, have continued to work diligently to publish new data and peer-reviewed papers providing further scientific validation of the efficacy and safety of our technology. Currently, 5 new papers have been submitted and accepted for publication and presentation at medical professional conferences over the next few months. At least 2 additional papers have also been submitted and are currently under peer review. Through the combination of our strategic revenue initiatives, internal operating cost reductions and new capital raising initiatives, we believe we have positioned Vivos to achieve revenue growth and ultimately, cash flow positive operations and profitability in the foreseeable future.
In summary, while the larger economic and market environment is creating challenges for both medical and dental communities, Vivos has taken steps to address those challenges, and our long-term growth drivers remain in place. With our innovative, evidence-based technology and network of trained providers, we remain committed to our core mission of addressing the crisis of sleep apnea and breathing-related sleep issues. For all of those reasons and more, we are undaunted by the current challenges, and we remain fully committed to our core mission and purpose. We believe Vivos is positioned now better than ever to do great things and to begin to realize its full potential. We thank you for your patience and support. We know it has taken longer to get here than we had expected, but we see a very bright future ahead.
This concludes our prepared remarks. Now we'll be happy to take questions.