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Earnings call · FY2022 Q3
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Good day, everyone, and welcome to the Vivos Therapeutics Second and Third Quarter 2022 Earnings Conference Call. This conference call is being recorded, and a replay of today's call will be available on the Investor Relations section of Vivos' website for the next 30 days.
Thank you, operator. Hello, everyone, and welcome to Vivos Therapeutics Second and Third Quarter 2022 Earnings Conference Call. A copy of our earnings press release is available on the Investor Relations section of our website at www.vivos.com. With us on today's call are Kirk Huntsman, Vivos Chairman and Chief Executive Officer; and Brad Amman, Chief Financial Officer. Today, we'll review the highlights and financial results for the second and third quarters of 2022 as well as the more recent developments and Vivos plans for 2023. Following these formal remarks, we will be prepared to answer your questions. I would also like to remind everyone that today's call will contain certain forward-looking statements from our management made within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, concerning future events. Words such as aim, may, could, should, projects, expects, intends, plans, believes, anticipates, hopes, estimates and variations of such words and similar expressions are intended to identify forward-looking statements. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant risks, uncertainties and contingencies, many of which are beyond the company's control. Actual results, including without limitation, the results of Vivos growth strategies, operational plans, including cost-saving plans and plans to generate revenue, future potential results of operations or operating metrics and other matters to be addressed by Vivos management in this conference call, may differ materially and adversely from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the risk factors described and other disclosures contained in Vivos filings with the Securities and Exchange Commission, including the risk factors and other disclosures in our Form 10-K for the year ended December 31, 2021, and our first, second and third quarter 2022 Form 10-Q, all of which are accessible on the Investor Relations section of the Vivos website as well as the SEC's website. Except to the extent required by law, Vivos assumes no obligation to update these statements as circumstances change. Finally, please be aware that the U.S. Food and Drug Administration has given certain Vivos appliances 510(k) clearance to treat mild to moderate OSA. Any reference herein regarding Vivos treatment or the Vivos Method should be reviewed in that context. Treatment of patients with severe OSA are performed off-label at the sole discretion of the treating doctor and are not part of the Vivos treatment protocol. Now at this time, it is my pleasure to introduce Kirk Huntsman, Chairman and CEO of Vivos. Kirk, please go ahead.
Thank you, Julie. Before we begin, I want to thank you all for joining us today and for your patience as we work through the revenue recognition review that delayed the filings of our second and third quarter financial results. Given the nature of that process, we were unfortunately limited in what we were able to say publicly, which was as frustrating for us as I'm sure it was for most of you. However, we can now report that the upshot of our ASC 606 review is that our prior and current results of operations have only minimally been impacted. No revenue was lost, and we will now be recognizing revenue, particularly VIP enrollment revenue, over a slightly longer period of time. Additionally, we believe that our controls and procedures will be stronger for having gone through this process. In a moment, I'll turn the call over to our Chief Financial Officer, Brad Amman, who will spend some time talking a bit more about this and walk you through the highlights of our financial results for the second and third quarters. After that, my goal today is to tell you about some of the exciting things that are happening at Vivos and to discuss the steps we've been taking in order to ensure our company's continuing development and, most of all, to give everyone on today's call some more insight as to why we're so optimistic about our future. Then we'll be happy to take your questions. When we're finished, I hope you will all leave today's call with a better sense of why we believe Vivos is succeeding far beyond what is currently being recognized by our valuation in the capital markets and why this company has a very bright future with the potential to lead the market for sleep apnea treatment.
Thank you, Kirk, and good afternoon, everyone. Today, I will go over the financial highlights from our second and third quarter 2022 results. For details on our results for the six months ending June 30, 2022, and nine months ending September 30, 2022, please refer to our earnings release distributed earlier today and our 10-Q reports available on the SEC filings section of the Investor Relations part of the Vivos website. Today, we announced total revenue of $4.2 million for the second quarter of 2022, down from $4.5 million in the same period last year. The decline is attributed to lower revenue from VIP enrollments due to the ongoing effects of COVID-19 variant resurgences and typical seasonal trends in the dental industry, though this was somewhat offset by a notable increase in appliance revenue during the quarter. In the second quarter of 2022, we enrolled 58 VIPs and achieved approximately $1.2 million in revenue, compared to 73 VIP enrollments and $2.4 million in revenue during the same quarter of the previous year. The year-over-year enrollments were influenced by the resurgence of COVID-19 variants that started towards the end of 2021, affecting dentists’ offices that were operating with reduced capacity and staff. We began to notice a decline in these impacts in June. Additionally, regarding our revenue recognition policies under ASC Topic 606, we reassessed our existing approach for VIP enrollments, and with guidance from our Audit Committee, we concluded that our previous policy was not in alignment with ASC 606. After reviewing our VIP contracts using the 5-step process of ASC 606, we found that for VIP enrollment contracts, we need to identify performance obligations separately and recognize revenue as these obligations are fulfilled or over the customer life as relevant. We now assess each contract separately for factors that meet the definition under ASC Topic 606. However, as Kirk mentioned, the actual impact on our company and results of operations, both historically and moving forward, has been relatively limited, and no prior audited financial statements will require restatement. In the second quarter of 2022, appliance revenue rose by 28% due to increased pricing and volume, as we sold 3,321 total oral appliance arches generating approximately $2.1 million, compared to 3,082 arches and about $1.6 million in revenue during the second quarter of 2021. We also saw approximately $200,000 in incentive revenue this quarter, up from $100,000 last year, and around $200,000 in oral myofunctional therapy revenue compared to virtually none the prior year, following the introduction of these services late in Q1 2021. Our gross revenue for Q2 2022 was $2.6 million, down from approximately $3.6 million in Q2 2021. The gross margin for this quarter was 62%, compared to 81% in the same quarter last year, primarily due to increased costs related to appliances and incentives for VIP enrollments. We have been refining our sales, marketing, and promotional activities to increase revenue as well as improve our gross profit and margins, which includes expanded efforts in social media and digital marketing that Kirk will discuss in detail later. Sales and marketing expenses were $1.7 million for Q2 2022, up from $1.4 million in the same quarter last year, mainly due to new marketing campaigns and website enhancements, partially offset by lower sales commissions from decreased VIP enrollments. General and administrative expenses were around $7.7 million in Q2 2022, compared to $6.1 million in Q2 2021, largely due to higher headcount and costs related to being a public company, along with increased travel and event expenses as conditions regarding COVID-19 improved. We reported a net loss of approximately $7 million in Q2 2022, compared to about $4 million in Q2 2021, with the increase primarily stemming from higher G&A and sales and marketing expenses. Moving on to our third-quarter results, we reported total revenue of $4.2 million, down from $4.5 million in the third quarter of 2021. This decrease was a result of reduced revenue from VIP enrollments and lower management revenue from the MID clinics, although this was partially offset by increased appliance revenue we had recognized earlier in the quarter. In Q3 2022, we enrolled 56 VIPs and acknowledged approximately $1.6 million in revenue, compared to the same number of enrollments and approximately $2.3 million in revenue last year. The difference in revenue despite the same number of VIPs is due to our new revenue recognition policy, which spreads some VIP enrollment revenue over a longer timeframe. Year-over-year enrollments were again affected by the COVID-19 variant resurgences and the changes in our revenue recognition methodology. Applianced revenue in Q3 2022 rose by 20% due to volume increases, with 3,057 oral appliance arches sold generating about $1.9 million, compared to 2,996 arches and approximately $1.6 million in revenue during the same quarter last year. We reported around $100,000 in center revenue, consistent with the same quarter of last year, and approximately $400,000 in our orofacial myofunctional therapy revenue, compared to $200,000 in the third quarter of 2021, as those services were introduced in Q1 2021. Gross profit for Q3 2022 was $2.5 million, down from $3.2 million for the comparable period in 2021, with a gross margin of 59% compared to 70% last year, reflecting higher costs associated with appliances and VIP enrollments, as well as the extended recognition period for enrollment revenue. Sales and marketing expenses decreased by $900,000 to $1.1 million in Q3 2022, down from $2 million in the same quarter of 2021. This drop was due to a reduction in spending on digital campaigns and materials, offset by expenses related to improving our website and increased sales commissions. General and administrative expenses were approximately $6.6 million for Q3 2022, compared to $6.5 million for Q3 2021. The slight increase year-over-year is mainly attributed to growth in the company, additional headcount, and costs associated with being a public entity, alongside increased travel and event expenses as conditions improved for COVID-19. Our net loss for Q3 2022 was approximately $5.4 million, which is relatively unchanged from the same quarter last year, attributed to the factors previously mentioned. Now, regarding our balance sheet and cash flows, cash burn from operations for the nine months ending September 30, 2022, increased by roughly $5 million compared to the same period last year. This rise was primarily due to the increased net loss, along with higher accounts payable and accrued expenses related to consulting, legal, and lab fees associated with growing production of our Vivos appliances, and a $0.5 million increase in prepaid expenses, partially offset by a decrease in accounts receivable and a return of about $0.5 million in tenant improvement allowances for our Vivos Institute training facility in Denver. For the nine months ending September 30, 2022, cash used in investing activities involved about $700,000 in capital expenditures for software development, aimed at internal use and expected to be operational by 2023. As of September 30, 2022, we had approximately $6.7 million in cash and cash equivalents, which may not sufficiently support our operations and strategic objectives for the next 12 months. Therefore, we have been looking for additional financing options to replenish our capital and support our business in 2023. We believe that with extra financing and the cost-saving measures we've initiated in the latter half of 2022 to manage cash burn, we can meet our financial needs, sustain operations, and continue growing. Additionally, these cost-saving initiatives are expected to result in permanent reductions in SG&A expenses moving forward. We are also focused on increasing revenues, which Kirk will discuss further shortly. Moreover, we continue to explore various financing strategies to support growth and extend our cash runway, including potential debt financing in light of our recent stock performance. In summary, we are optimistic about the recent momentum shown in our business, as well as increased contributions from new revenue avenues such as our strategic collaboration with Nexus. That concludes the financial overview, and I will now turn the call back to Kirk for some recent updates and insights on long-term growth prospects.
Thank you, Brad. Today marks the end of a long and arduous journey over the past 6 months. As almost all of you know and are keenly aware, the net result of our recently completed revenue recognition review was essentially a first quarter revenue adjustment of less than $200,000 in our favor. That's it. No restatement of prior years, no findings of managerial misconduct, no revelations of wrongdoing, just a minor revenue adjustment and a new formula for pushing the recognition of a portion of revenue further out into the future. So let me be clear about this without going into all the details. In order to satisfy certain highly technical provisions of an accounting standard that even the experts themselves couldn't always agree upon and which require management to make certain highly subjective estimates, in the end, we spent 6 long months and significant financial and time resources only to end up pretty much where we began. While we are grateful that the outcome was a relatively minor adjustment and that our policies and procedures were improved, which will serve us well going forward, it is cold comfort viewed against the time, resources and capital markets credibility, which we lost along the way. Having said all that, this long and arduous process is now behind us. We do not expect to have any further issues related to this topic. So if nothing else, that is cause for celebration. Now let me briefly review why we believe our core proprietary technology and services platform will continue to disrupt and eventually dominate the global market for breathing and sleep disorders such as obstructive sleep apnea or OSA. There is broad acceptance of the ultimate potential to address OSA globally. Conservative estimates placed the market at over 1 billion OSA sufferers worldwide or about 1 out of every 8 people. Ironically, as diagnostic technologies improve and become more ubiquitous, those estimates continue to rise. In our own rather extensive sleep testing here in the U.S. and Canada, we see nearly 1 out of 2 of all patients testing positive for the condition. Today, an estimated 90% of OSA patients are prescribed CPAP as the medical gold standard treatment. When used, it can work well, but no one wants to use it every night for the rest of their lives. And most patients eventually stop using it after several months. For patients who are CPAP intolerant or noncompliant, the next step options are even more limited and less appealing. So there can be no doubt that for whoever puts forward a clinically effective product or treatment solution at an attractive price point that patients actually want, the payday could be substantial. In short, we have that very thing here today at Vivos. Our products and services meet all the key criteria. They work. They are cost effective. And when patients are given all the options, we find they are preferred over alternative treatments. In the past, we haven't been able to prove that to the satisfaction of some. But just this year, we've moved beyond small or limited studies published in low-impact journals to larger studies in top-tier medical journals, such as Sleep Medicine, where statistically significant results were achieved. In the past year, Vivos also presented original research on our flagship CARE, C-A-R-E, oral appliance devices at the top 3 academic sleep medicine meetings in the world, the World Sleep Congress by the World Sleep Society, SLEEP 2022 by the American Academy of Sleep Medicine and SLEEP Europe 2022 by the European Sleep Research Society as well as at the Greater New York Dental Meeting. At these conferences, Vivos presented 2 database reviews, demonstrating significant benefits of CARE device used in treating adult OSA and regarding use in the management of pediatric OSA and promoting healthy nasal breathing in children. We also presented some of our latest data regarding the use of our CARE devices in the treatment of adult headaches. Seven additional papers with similarly supporting data showing statistically significant results have either been published or submitted and are pending publication in other peer-reviewed journals. Vivos created and has begun enrollment in an academic integrated provider program, providing access to academic researchers to study Vivos' proprietary products in an open-source format. Vivos has also continued its aggressive pursuit of clinical trials, and several potential teams and sites have been identified and are in the planning phases. One noteworthy and very practical application that has come about through our research and ongoing development has been the introduction of a key diagnostic technology called rhinomanometry. You may recall that Vivos is the exclusive dental market distributor in the United States and Canada for the only FDA-cleared rhinomanometer available. So we have highly differentiated products and technologies that actually work and have been working for over a decade in over 31,000 patients. We have broad out-of-network insurance coverage for medical payers as well. What we haven't had is a therapeutic product line that could address the needs of patients at lower price points. To address that need, we recently announced several exciting new additions to our product line and services to allow far more patients to receive treatment through our provider network. These new products allow us entry into several new product and equipment categories where we've never before had a presence. We now have a broader range of price point offerings that are being rolled out that significantly decreases the friction per patient and makes it easier for dentists to get patients into the Vivos ecosystem and that stimulates our growth. With product lines now ranging from diagnostics to CPAP, to mandibular advancement and treatment with all the devices and the Vivos Method, we now have a product and path for treatment for the vast majority of patients. We often hear the question, if Vivos treatment is so great, why haven't many more dentists integrated Vivos into their practice? That's a great question. We often ask ourselves the same. So it's important to note that our Vivos integrated practice or VIP enrollment efforts to date have been focused on attracting only the very best dentists available, those who had the clinical confidence and success to adopt and integrate something like Vivos into their practice. They are typically the ones who get the overall picture of what this can mean for their practice and their patients and who see the value in our initial training and enrollment fees that can be as high as $50,000. Now that we've established a broad core network of over 1,650 Vivos-trained dentists across North America, we can now begin bringing in more dentists at lower introductory prices for limited programs that will attract many more doctors and allow them to test the waters with our company and our products. As a direct result of creating many more lower cost points of entry, in 2023, we expect to see more dentists than ever before becoming customers of Vivos and purchasing products and services. Keep in mind also that Vivos is still relatively new to dentistry. We are roughly where aligned technology was in their early days as they rolled out Invisalign. And recall that their stock likewise dropped nearly 90% from their IPO price before rebounding and eventually peaking out at over $600 a share. Adoption of any new medical technology takes time and perseverance. Inspire Medical was first spun out of Medtronic back in 2007. And while both companies currently enjoy much greater valuations than we have, we believe our overall market opportunity, our products and our technology are superior and will ultimately prevail in the market. Keep in mind that important growth pivots for each of these companies came when they began driving patients who are asking specifically for their products to train providers. We are continuing to get our name out so that more and more patients specifically ask for our products. In that regard, we recently successfully piloted and rolled out a new program called Treatment Navigator, which is already showing great promise. This program supports dental offices and provides each new patient and advocate who assists them in navigating the many different steps involved in the patient journey, coordinating medical and dental diagnostic appointments, insurance pre-authorizations, furthering education and treatment planning and generally coaching the patients through treatment. The Treatment Navigator's role is effectively to act as an extension of the VIP practice, taking a significant load off the provider's team. Under the guidance of the appropriate healthcare professional, Treatment Navigators assist and motivate patients to obtain the right treatment for them. Treatment Navigators also leverage the power of our Vivos AireO2 EHR, which is electronic health record software platform, to facilitate communication and collaboration amongst providers to file medical and dental insurance claims and to record patient progress throughout. You may recall that our Vivos AireO2 EHR software program is the only full-featured medical dental practice management system on the market today, configured specifically to accommodate the treatment of breathing and sleep disorders. Doctors pay additional fees to Vivos for our Treatment Navigator service. Over the course of 2023, we expect to see this program evolve into a significant revenue and profit source for the company. Currently, we have taken over 70 applications from VIPs to join this program, and we are systematically rolling this program out across the country. Our initial results from our Treatment Navigator pilot tests demonstrate that we can deliver a valuable service to our VIP offices, solving one of their primary issues of staff shortages and turnover. Now all they have to do is screen patients coming through their hygiene departments and then allow the Treatment Navigator to manage the logistics and get the patient ready for treatment. In addition, our Treatment Navigators assist patients who come through our social media website or other marketing campaigns to find answers and get into the Vivos ecosystem. Now I'd like to focus on our Q2 and Q3 results, starting with our key metrics of VIP enrollments and appliances sold. During the second and third quarters of 2022, macroeconomic factors, including rising inflation and interest rates, continued to impact our business and the practices we serve. These factors, along with the ongoing effects of COVID, caused dentists to delay their enrollment with Vivos and resulted in fewer patients visiting our VIP offices. This issue has not been exclusive to Vivos; it has affected the entire dental industry, with other companies also facing similar obstacles. For instance, Align Technology reported a significant 8% drop in their aligner revenue quarter-over-quarter in Q3 and a 13% decline from the previous year. At Vivos, we saw our appliance sales reach a record high in June, but they fell back somewhat in Q3. Despite these challenges, we are not content with our relatively flat performance in 2022 and have taken important steps to return to a growth trajectory. We have reorganized and reduced staffing at all levels, made cuts or renegotiated vendor relationships, and wherever possible, turned expense categories into new revenue opportunities. I will elaborate on these initiatives shortly. Looking deeper into our performance beyond the income statement, there are several significant achievements. In terms of new provider enrollments, we added 58 and 56 new providers in Q2 and Q3, respectively, which is a 12% year-over-year decrease due to the previously mentioned factors. However, enrollments in the second quarter rose by 81% over the first quarter. Although total enrollments remained relatively flat in Q3, we have improved our sales conversion rate and expect to continue this trend. One contributing factor to our improved closing rate is a new zero-interest financing program for new VIPs, which now allows qualified dentists to become Vivos integrated providers for as low as $750 a month. Additionally, preregistrations for our sleep medicine revolution events in January, February, and March of next year are nearly sold out, which is unprecedented for us and indicative of a positive trend. Next, let's discuss home sleep tests and case starts, which are key performance metrics. The VivoScore home sleep test we provide to our VIPs from Sleep Image is a significant advantage because it offers a simple and affordable way for patients to obtain a clinically accurate assessment of their breathing and sleep. Our VivoScore home sleep tests for Q2 and Q3 of 2022 were twice the rate compared to the same periods in 2021. This indicates that thousands of patients each month are discovering some form of obstructive sleep apnea and will need to address this condition. Our main goal is to help our VIPs facilitate meaningful discussions with these patients about their condition to ultimately close more cases and increase treatment. This motivation led to the creation of our Treatment Navigator program. MyoCorrect enrollments for Q2 and Q3 rose 2.5 times compared to the same period last year, contributing to a consistent and growing revenue stream for the company while enhancing patients' overall treatment experience. Overall, new appliance case starts have declined slightly from the previous year. To date, our VIPs have treated over 31,000 patients with the Vivos Method. Vivos is making significant strides in the dental service organization channel, with active pilots in three DSO organizations, encompassing over 457 practices. We are also initiating pilot programs with four additional DSOs, representing another 519 locations, and are in advanced contract discussions with 17 more DSOs, which equates to an additional 5,500 locations. In total, this means we are engaging with 24 distinct DSOs and nearing 7,000 practices. As many of you know, I founded one of the first dental service organizations and helped establish the DSO model that provides business and clinical support to independent dentists. This past summer, I had the honor of speaking at one of the largest DSO conferences, where I discussed why Vivos represents a significant opportunity for the DSO community. The DSO market is crucial, so I'll emphasize this again along with its positive impact on Vivos. Firstly, the DSO corporate model aims to acquire practices, boost EBITDA, and sell for a higher multiple. Secondly, sleep dentistry presents the greatest opportunity to enhance EBITDA, following aligners and implants. Thirdly, a typical DSO practice that screens just two patients each day, four days a week would test around 32 patients monthly. Half of those will test positive, and half of the positive group should begin treatment, leading to top-line revenue of nearly $1 million per practice. To grasp the significance of this, it's essential to understand that dentistry has largely turned into a commodity market with few opportunities for new revenue or margin growth. Under these conditions, there is no comparable opportunity in dentistry that matches Vivos. Fourthly, the estimated net EBITDA margins of 30% for the DSO per practice would yield the practice approximately $300,000 each year. Given that DSO multiples typically hover around 10 times EBITDA, just one practice could elevate the overall DSO valuation by $3 million. For a relatively small DSO with 35 locations, incorporating Vivos into their workflow could enhance their firm valuation by $100 million. Now let's consider Vivos' impact. Each DSO practice performing according to these metrics would generate about $192,000 in annual revenue for our company. I previously mentioned the three DSO practices currently in pilot testing, which together manage 897 total practices. If just 20% of those practices became Vivos' providers, it would add approximately $34 million in annual revenue to Vivos. We believe there is significant potential beyond just 20%. The economics outlined above suggest that we can expect much greater penetration over time. From our pilot test, it's increasingly clear that the opportunity for Vivos with respect to DSOs is exactly what we anticipated, if not even more significant. When combined with our Treatment Navigator program, the return on investment for both DSOs and Vivos is unmatched. Now on the regulatory front, earlier this year, Vivos was cleared through the Canadian Ministry of Health and Health Canada to sell devices in Canada with even broader specifications. And as our research and clinical data becomes more widely accepted, more regulatory doors are opening for us. In the second quarter of 2022, Therapeutic Goods Administration or TGA in Australia issued clearances for our devices to treat adults and children for all indications inclusive of OSA regardless of severity. For those of you not familiar with the TGA, it is Australia's equivalent to the U.S. Food and Drug Administration. This is a significant development for us. Not only does this pave the way in many international markets, but this also provides further validation of our technology. We continue to move forward seeking clearance here in the U.S. as well as international regulatory agencies. We are optimistic that our clinical data will continue to be well received and that the necessary regulatory approvals going forward will not be a barrier. Speaking of international markets, we are in late-stage negotiations to take our technology into Dubai and the Middle East and are in the early stages of going into India and Southeast Asia. Our penetration into the Australian market is also going well now that we have full regulatory approval. We note that these opportunities have come to us by way of dentists and others who have come to the U.S. for training at our institute and have now desired to take this life-changing technology back to their home countries and regions. So there, you have just a glimpse of why we believe the future of Vivos has never been brighter. From the latest research that continues to elevate and substantiate our technology, to our revised and streamlined new business model and product lines, which will accelerate our scale-up to new and exciting regulatory approvals in worldwide markets, we continue to make strides and progress. Now obviously, we will need additional capital to achieve those objectives and realize the potential I've just outlined. Along the same lines, our primary focus throughout this year has been to ensure we position ourselves to achieve positive cash flow as soon as possible. To accomplish this, we have taken a series of steps to streamline expenses while also creating new revenue opportunities. Our internal structures and processes have been significantly revamped with a focus on near-term ROI. On the cost-cutting front, we disassembled the company and reorganized in new ways that we believe will be more efficient and cost-effective going forward. Vendor relationships have been reassessed and/or renegotiated. What were once expense line items have now been turned into revenue opportunities wherever possible. The net effect of all these efforts has been a reduction approaching $1 million per month in our cash burn from its peak in the first quarter to where we are today. Also, we expect to see the impact of our new revenue streams gradually take shape throughout 2023 and contribute significantly to our profitability. As previously mentioned, our goal is to achieve cash flow breakeven in the next 12 to 18 months. Meanwhile, we are doing everything we know how to be great stewards of the capital we have available. And as Brad mentioned, we have been exploring additional financing options. We believe we have a good solution available, and we hope to announce something in the near future. Another important result of the reorganizing our business from the ground up has been a general simplification in what we do and how we do it. Our training is more streamlined and intently focused on the essentials so that ramp-up times for new providers are as brief as possible. Our messaging to the world at large is crisper and clearer. Patients in search of real solutions are finding us and being directed into Vivos-trained practices. Over the past several months, we have been aggressively pursuing additional capital financing options. And as I said, we hope to have something to announce on that front very soon. The company has been actively exploring options for suitable additional financing that will replenish our capital resources and help drive our business plan forward in 2023. In prior earnings calls, we highlighted our strategic pivot towards direct-to-consumer marketing efforts that began in the latter part of 2021. Today, I am pleased to announce that we're working in close collaboration with our marketing partners. We have successfully piloted a marketing initiative to drive more new patients into Vivos training provider practices and to generate more case starts. This program has exceeded our forecast and is consistently delivering between 30 and 50 qualified new sleep apnea patients per month into each participating office. To put that into perspective, that number of total new patients would be above average for a typical general dental office. We are beginning to roll this new consumer marketing program out to our entire VIP provider network. From a company standpoint, we could see a significant financial impact across the board with almost no incremental investment. Also along the direct-to-consumer front, we are announcing the formation of an independent firm called Tooth Pillar that seeks to leverage social media influencers to generate awareness of the many benefits from the use of our highly effective Vivos guides in guiding the craniofacial growth and development of pediatric patients. Their stated goal is to put 25,000 children into treatment using Vivos products. This company is led by some of our most prolific and supportive Vivos doctors and former company executives who have witnessed firsthand over several years just how impactful and life-changing our products can be. Vivos is the exclusive supplier of products to Tooth Pillar. Finally, more of our VIPs should begin to receive greater reimbursements going forward because more patients will now be eligible to have coverage for their Vivos treatment. This is due in part to a strategic alliance Vivos recently entered into with a company called Nexus Dental Systems to create what is expected to be one of the most comprehensive medical billing services in the dental industry. This collaboration is expected to provide both companies' provider networks with greater access to both in-or-out-of-network billing with all major medical insurance companies, facilitating case acceptances, insurance billing procedures and reimbursement. Again, this creates additional important revenue stream for Vivos. We believe that these combined efforts will create additional awareness with dentists, improve VIP enrollments, case starts and revenue. In closing, we believe our future at Vivos remains bright for the reasons I just outlined above. We continue to grow despite a challenging environment. We have a number of initiatives underway to drive additional revenue growth, increase VIP enrollment, expand our offerings and open up new revenue streams for Vivos, including our recent collaboration with Nexus. At the same time, we are conscious of costs and have taken the necessary steps to generate permanent cost savings while shortening our path to cash flow profitability. We intend to stay the course and look forward to updating you on our progress. Again, we want to thank our shareholders for their patience as we work through our recent revenue recognition challenges. This is now behind us with a positive outcome, and our eyes are squarely focused on the future.
And our first question comes from the line of Scott Henry with ROTH Capital.
I will review the 10-Q, so my questions will be quite general. The revenues for the second and third quarters were around $4 million, indicating an annual rate of approximately $16 million. My first question is regarding your expectations for organic growth in the fourth quarter of this year and the first half of next year. What kind of growth range should we anticipate?
Thank you for your question, Scott. Throughout this year, we've faced some challenges, as we mentioned earlier, but those seem to be easing up. We're observing a rebound in this fourth quarter, and we're hopeful that this trend continues into next year. The staffing issues that arose during COVID are still affecting dental offices. However, we believe that our Treatment Navigator program will help address some of these challenges. We're still uncertain about how quickly these new revenue streams will develop, but I expect that we will experience organic growth over the next year, surpassing the $4 million mark by this time next year. I understand that's what we achieved this past year, but I anticipate that these additional revenue streams will start to contribute significantly.
Okay. And maybe another way to ask a similar question. You talked about cash flow breakeven in 12 to 18 months. What rate of revenue do you think gets you there? If you think about your first breakeven quarter and annualize that revenue number, what do you think that is?
Well, I think the run rate number is probably in the neighborhood of $25 million, perhaps $30 million. I think as we look at our forecast internally, that's probably what it's going to take to get to cash flow breakeven for us. And so again, we've trimmed out a lot of costs. We think we can run pretty lean and still grow revenue. And we'll continue to evaluate this literally on a month-to-month basis as we go forward.
Okay. So would you say gross margins are trending around 60% right now? That used to be higher than that. What do you think is more reflective going forward, the 60% range, or do you think it will go back to 70%?
My guess would be somewhere in the 60% range going forward. We have some opportunities to improve that. But I think to be safe and conservative, I would say right now that I don't see where the margins will experience a lot of further erosion, but I think 60% is probably a conservative gross margin forecast.
I'm calculating in my head that with a 70% gross margin and $7 million each quarter, reaching breakeven would likely require cutting an additional $2 million from expenses. Does that sound accurate? Do you believe there's capacity to make these cuts, or would the alternative be to grow into it through leveraging? To achieve breakeven at $7 million a quarter, I think some reductions will be necessary. Would you agree?
I think that's fair on the back of the napkin. And so let's see what happens. We have some pretty high-margin revenue streams coming online, which we hope will improve our margins a little bit further. So let's see what happens. We've got room yet to go to cut expenses if we need to, and we're prepared to do that as we evaluate month by month going forward.
And our next question comes from the line of Alex Nowak with Craig-Hallum Capital Group.
Maybe to continue there. Can you expand a little bit more on the cost cuts that you do want to take place, the ones that you have planned, the ones that you take if you absolutely need to? And just the thoughts around those cost cuts and how it would or would not impact revenue growth on the go forward.
We have completely reorganized our operations from the ground up. We assessed where we could reduce positions or personnel and made those adjustments. Our practice advisory model was a significant source of overhead, and in the first quarter, we focused on enhancing our practice advisory services to retrain staff lost in the dental profession. Many of our top providers had lost their teams and were not producing. To address this, we initially increased our overhead, but we found a more efficient approach through our Treatment Navigator program. We transformed that expense into a profit center. After the initial surge, we let go some of the practice advisers and converted the remaining ones into Treatment Navigators. These navigators facilitate the patient journey into treatment, which has become profitable for us. While this initiative is still in its early stages and the impact isn't reflected in our third quarter results, we expect it to show a promising margin in the fourth quarter and beyond. We have strong interest in this service and believe it will be beneficial moving forward.
Alex, this is Brad. I would like to add to what Kirk said regarding our VivoScore rings. In 2021, we used VivoScore as a loss leader to assist VIPs in starting their patient screenings. In 2022, we introduced a six-month no-cost lease with the VIP enrollment program. After the six months, we began charging $79.95 per month for each ring. This transition allows us to turn that loss leader model into a revenue generator, and we are beginning to see growth in revenue from those ring leases in the latter half of the year.
Okay. Understood. And then maybe refresh us on the big studies to watch here going forward. I know there was a Stanford head-to-head study going against CPAP. Just any update around the big studies? Any other head-to-head studies we should be watching?
We have been extremely frustrated with the progress of the Stanford trial. Navigating the bureaucratic processes has been a challenge, and we don’t have clarity on the current status because we still lack information. We are doing our best to encourage progress and tackle the administrative hurdles with their internal review board. Unfortunately, it feels like we encounter one obstacle after another. We continue to engage in the competitive landscape against alternative treatments on a daily basis, working to transition patients away from CPAP machines. We face competition from Inspire and other therapies each day. In terms of research, we are in the process of creating a university-based research network that will allow university researchers to conduct open-source studies using Vivos products. Researchers can design projects comparing our treatments with CPAP or other alternatives. We have strong confidence in the effectiveness of our treatments and protocols, which is why we are adopting this open-source approach. We have received positive feedback from various universities and dental departments interested in conducting this research, and we are excited about the potential outcomes. I wish I had better news regarding Stanford, especially as we've been discussing it for the past two years. It feels like progress has stalled in their bureaucracy. We had to revise the protocol six to eight months ago, but it still seems to be stagnant. In the meantime, we are exploring other options and have received interest from different institutions for similar studies. Research is a crucial part of our mission. With seven pending papers, we're eager to share findings that we believe will enhance our regulatory standing and strengthen our credibility with payers, ultimately resulting in positive developments for our company.
And we have reached the end of the question-and-answer session. I'll now turn the call back over to management for closing remarks.
Well, we would just like to thank everyone for being here this afternoon. I apologize for my voice. I'm a little under the weather today, and I appreciate you bearing with me as I cough through some of these things. Look, we believe that our future of Vivos remains bright for all the reasons that we've just outlined. We continue to grow. We continue to navigate a challenging environment. We look forward to sharing our continued progress with each of you in the future. So thank you, and have a great day, and happy holidays.
And this concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.
SEC filing · Item 2.02
Filed Nov 22, 2022 · complete as-filed document
SEC periodic report
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