Vivos Therapeutics, Inc. (NASDAQ:VVOS) Q1 2023 Earnings Call Transcript

Vivos Therapeutics, Inc. (NASDAQ:VVOS) Q1 2023 Earnings Call Transcript June 9, 2023

Operator: Good day, everyone. And welcome to the Vivos Therapeutics First Quarter 2023 Earnings Conference Call. At this time, participants are in a listen-only mode. A question-and-answer session will follow management’s remarks. This conference call is being recorded and a replay of today’s call will be available on the Investor Relations section of Vivos’ website and will remain posted there for the next 30 days. I will now hand the call over to Julie Gannon, Vivos’ Investor Relations Officer, for introductions and the reading of the Safe Harbor statement. Please go ahead.

Julie Gannon: Thank you, operator. Hello, everyone, and welcome to our 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 first quarter of 2023, as well as more recent developments and Vivos’ plans for the remainder of 2023. Following these formal remarks, we will be happy to take 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, goal, and variations of such words and similar expressions are intended to identify forward-looking statements. These statements involve significant known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant risks, uncertainties, and contingencies, and many of which are beyond the company’s control. Actual results, including without limitation, the results of Vivos’ growth strategies, operational plans, including sales, marketing, product acquisition and integration, research and development, regulatory initiatives, cost savings plans and plans to generate revenue as well as future potential results of operations or operating metrics such as potential for future positive cash flows 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, 2022, and our other filings with the SEC, all of which are or will be accessible on the Investor Relations section of Vivos’ website as well as the SEC’s website. Except to the extent required by law, Vivos assumes no obligation to update 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 viewed in that context.

Treatment of patients with severe OSA is performed off-label at the sole discretion — the sole clinical discretion of the treating doctor and is 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.

Kirk Huntsman: Thank you, Julie. I want to thank you all for joining us on today’s conference call. Just a moment, I’ll turn the call over to our Chief Financial Officer, Brad Amman, who will walk you through the highlights of our first quarter 2023 financial and operating results. Once Brad is finished, I’ll come back on and speak with you about the highlights of what we accomplished at Vivos’ during the first quarter and in the past few weeks following the quarter end, including our acquisition of product rights and patents from Advanced Facialdontics. This has expanded our product portfolio even further allowing Vivos’ trained providers to treat a much larger percentage of their patients, which ultimately increases the revenue potential for Vivos.

I’ll also talk about our progress with the FDA as well as ongoing R&D efforts. In more recent news, I’ll talk about some of the actions we took to improve our organizational infrastructure and highlight how we took steps to increase operational efficiencies, reduce expenses, and position us to take advantage of the growth opportunities that are available to us. I’m pleased to say that due to these initiatives, we can reiterate that we remain on target to achieve our goal of positive cash flow for the first quarter of 2024, which is a full quarter earlier than the target we provided you on our last earnings call in March. Our goal is to achieve this key target without having to raise any further equity capital if possible. Following that, I’ll talk about our plans going forward in 2023, how we intend to build upon what we’ve already done, and what we have planned for the rest of the year as well as into 2024.

After that, we’ll take your questions. Now let me turn it over to Brad to review our financials. Brad, please go ahead.

Brad Amman: Thank you, Kirk, and good afternoon, everyone. Today, I’ll review the financial highlights of our first quarter 2023 financial results. For information on our results for the three-month period ended March 31, 2023, I’ll refer you to our earnings release, which was distributed earlier today and our quarterly report on Form 10-Q, which is available on the SEC filings portion of the Investor Relations section of the Vivos website at vivos.com/investor-relations. At the outset, I want to say thank you for your patience as we switched auditors for the first quarter, which led to a delay in our 10-Q filing. I am pleased to report that our relationship with our new auditor, Moss Adams is off to a very positive start, and we are looking for a smooth and productive relationship with them.

Today, we report first quarter 2023 total revenue of $3.9 million compared to $3.6 million for the first quarter of 2022. The overall year-over-year increase was due to higher revenue from Vivos’ integrated provider or VIP enrollments, as well as increased sleep testing service revenue and increased — and conference and training related revenue. This was offset by lower revenue generated year over year from appliance sales, billing intelligence services, and central revenue. Our VIP enrollments were up in the first quarter with 38 VIPs enrolled versus 32 enrolled in the same period last year. For the first quarter of 2023, we recognized VIP revenue of approximately $1.3 million, an increase of $400,000 or 42% in enrollment revenue compared to $900,000 for the first quarter of 2022.

It should be noted that first quarter of 2022 VIP revenue was negatively affected by a $300,000 adjustment that rose from the prior year impact of our change in revenue recognition policy. We also saw an increase of approximately $200,000 in revenue recognized from our home sleep test ring lease program as well as an increase of approximately $100,000 in conference and training related revenue. The increase in total revenue was partially offset by lower product revenue. During the first quarter of 2023, we sold 2,369 oral appliance arches for a total of approximately $1.7 million compared to 2,965 during the first quarter of 2022 for approximately $1.9 million. And for the first quarter of 2023, we recognized approximately $200,000 in our billing intelligence service revenue compared to $400,000 in the same period in the prior year.

We also had approximately $100,000 in center revenue compared to approximately $200,000 during last year’s first quarter. Gross profit was $2.3 million for the first quarter of 2023 compared to gross profit of $2.6 million for the comparable period in 2022. Gross margin for the first quarter of 2023 was 61% compared to 70% during the last year’s first quarter, primarily driven by higher costs associated with VIP enrollment and training, as well as costs related to our new programs, including the sale and leasing of sleep testing rings. We continue to refine our sales, marketing, and promotional efforts with potential VIPs — not only to increase enrollment and revenue, but to improve our gross profits and margins. This includes utilizing targeted social media and digital marketing efforts, specifically designed to drive sales.

As of the first quarter, we are now starting to see the benefits of these efforts with increased VIP enrollments on a year-over-year basis. Sales and marketing expense was $600,000 for the first quarter of 2023, a decrease of approximately $200,000 compared to $800,000 for the first quarter of 2022. This year-over-year decrease was primarily due to decreased sales commissions and a reduction in associated sales related expenses. Importantly, G&A expenses decreased approximately $1.7 million or 21% to $6.5 million for the first quarter of 2023 compared to $8.3 million for the first quarter of 2022, reflecting the substantial impact our cost cutting efforts are beginning to make. We believe these important efforts will reduce our cash burn as we seek to ramp revenues and move toward cash flow-positive operations.

Operating loss was $5 million for the first quarter of 2023 compared to 6.6 million for the first quarter of 2022. This year-over-year decrease in operating loss was primarily from lower G&A expenses due to expense cuts and the factors I just discussed. Net loss was $1.7 million for the first quarter of 2023 compared to $5.3 million for the first quarter of 2022. The reduction in net loss was due in part to cost cutting, but also during the quarter, we recognized approximately $6.5 million as a one-time non-operating expense related to the difference between excess fair value from warrants issued in our January 2023 private placement and the net proceeds we received. The change in fair value of the warrant liability over the quarter was $9.6 million net of issuance costs of $600,000.

Accordingly, the net impact of the private placement warrants for the three months ended March 31, 2023, it was approximately $3.2 million of non-cash other income. Please refer to our 10-Q for further details regarding this. Turning to our statement of cash flows. Cash burn from operations for the quarter ended March 31, 2023, was $3.5 million, a decrease of approximately $2.6 million compared to approximately $6.1 million during the comparable prior-year period. This is further evidence of the positive impact of our expense reduction initiatives. For the quarter ended March 31, 2023, net cash used in investing activities consisted of capital expenditures for software of $300,000 related to the development of software for internal use, which is expected to be placed into service in mid-2023 as well as a purchase of patents and other intellectual property in February of 2023.

This compares to net cash used in investing activities of $100,000 in the comparable 2022 period arising from capital expenditures for internally developed software. As I mentioned earlier, in January of 2023, we strengthened our balance sheet by closing a private placement with a single institutional investor for net proceeds of approximately $7.4 million. The private placement consisted of shares of common stock and pre-funded warrants, together with five and half year common stock purchase warrants with an exercise price of $1.20 a share. The effective purchase price per share of common stock or pre-funded warrants in lieu thereof and associated warrant was $1.20 per share. As of March 31, 2023, we had $7 million in cash. With the financing we completed in January, as well as the strategic initiatives we have applied to reduce our expenses, we continue to anticipate having the necessary financial resources to meet our capital needs, fund our operations, and continue executing on our near-term growth strategy.

In the short-term, we expect these changes will result in relatively flat revenues sequentially for the first half of 2023. This also takes into consideration our new ASC 606 revenue recognition policy. Afterwards, we anticipate top-line quarter-over-quarter revenue growth will resume starting in the third quarter of this year. Further, as Kirk mentioned earlier. We believe these initiatives will allow us to accelerate our target time for reaching positive cash flow by a full quarter, now in the first quarter of 2024. With that, I’ll turn the call back over to Kirk.

Kirk Huntsman: Thank you, Brad. The first quarter that we are reporting on here today may seem like a distant memory. But we believe it represents a significant watershed moment for the company and our future. First, in early January, we announced FDA 510(k) clearance for our flagship DNA oral appliance product. This represented the first time in history that the FDA recognized any mechanism of action in an oral appliance other than mandibular advancement for the treatment of mild to moderate obstructive sleep apnea. No oral appliance product has ever received such a clearance. And the significance of this breakthrough should not be underestimated. We fully believe that after several years of going back and forth with the FDA, they were finally persuaded by our submission of yet another round of compelling real-world data.

This time showing a remarkable 80% of OSA patients seeing their symptoms completely resolve after treatment using the DNA appliance and the Vivos Method. Now to be clear, this data showed that clinical OSA, meeting AHI scores of five or higher was no longer present in four out of five patients after treatment and with no further intervention required. As far as we know, such clinical results are unprecedented in sleep medicine, and unparalleled by any other product or therapy. We expect the full financial impact of that regulatory clearance on our sales to be realized over time as doctors alter their treatment plans to include more DNA appliances. Second, on the heels of our announcement regarding the FDA clearance for the DNA appliance, we raised an equity tranche with net proceeds of roughly $7.4 million from a single institutional investor.

We immediately put this capital to good use and expanding our intellectual property and product suite through the acquisition of certain patents, trademarks, and trade secrets from Advanced Facialdontics. We closed on this transaction towards the end of the first quarter. That acquisition not only ensures that Vivos will maintain its technological and market-leading position at the forefront of treatments for certain conditions closely linked to obstructive sleep apnea, such as TMD pain, bruxism, nasal resistance, migraine headaches, and other conditions, but it also fills a gap in our product suite and offerings to patients — to providers and patients. Nearly 40 million people in the United States suffer from TMD pain and related issues. Another 40 million suffer from migraine headaches or have difficulty breathing through their nose.

Our new patented unilateral bite block technology has been shown to be highly effective in treating such conditions. Also, during the first quarter, we accelerated the process of rightsizing our corporate staffing levels and reorganizing our management team in order to reduce our cash burn and push the company closer to cash flow breakeven, which, as Brad mentioned, we now expect to achieve during the first quarter of 2024. As a subsequent event, early here in the second quarter, we announced a reduction in force and further reductions in overhead. Again, we think these prudent and necessary actions will serve us well as we look to improve our results of operations. On the operations side, we made important progress in our current pilot tests with certain DSO organizations known as DSOs, including the execution of new and existing pilots with eight regional and national DSOs representing over 1,000 locations nationwide.

I’d like to highlight one particular DSO, which operates in all 50 states under the name Toothpillow. Over the past 12 months, Toothpillow has been making exceptional strides forward in cultivating a direct-to-consumer channel exclusively geared towards use of our Vivos Guides products for pediatric guided growth and development. An estimated 16 million children between the ages of 3 and 12 suffer from various orofacial and developmental issues associated with ADD, ADHD, behavioral problems, scholastic challenges, chronic allergies, mouth breeding, crooked and crowded teeth, bed wetting, and breathing related sleep issues, all of which may be helped through proper oral growth and development. Toothpillow is a pioneering telehealth, commercial partner of Vivos.

And we are their exclusive oral appliance supplier. Toothpillow is set to redefine the field of pediatric dental and orthodontic treatment with a particular focus on breathing related issues. This transformational relationship leverages Vivos’ world-class pediatric oral appliances, underscoring the role of our cutting-edge products in advancing the delivery of dental and orthodontic care. Toothpillow boasts of a strong national network of 48 Vivos-trained dentists that serve as virtual trading partners and a rapidly growing referral base of over 358 in-practice providers. The synergy between Vivos’ premium pediatric oral appliances and Toothpillow’s software and highly skilled practitioners is creating a holistic, accessible, and high-quality telehealth solution for at-risk patients aged 3 to 12.

Over the past year Toothpillow has been perfecting its proprietary virtual care platform featuring a mobile app designed to facilitate seamless connections between patients and doctors. Despite not yet having launched its national marketing campaign, Toothpillow’s services have already been sought out by patients in 40 states, all through referrals with 64% of all new inquiries converting into paying patients. Vivos is excited about our relationship with Toothpillow. And we believe it not only showcases the effectiveness and versatility of our oral appliances, but also opens up a large and exciting new avenue for growth. We are confident that Toothpillow’s success will further amplify the voices reputation in the industry, bringing us one step closer to our vision of training healthcare professionals and providing them with the very best treatment tools and technology available.

Equally as important, Toothpillow is just one of several DSOs we have been speaking with and starting to do business with. And therefore, it serves as an example of similar relationships we hope to enter into in 2023 and beyond. Also today, we are announcing the execution of our first non-exclusive distribution agreement for a 90-day pilot with a nationally recognized Durable Medical Equipment company, or DME, that serves hundreds of thousands of CPAP patients nationwide, who are seeking alternatives. If this pilot is successful, a national rollout is planned to follow. And we can provide more details at that time. Other similar agreements with potential distributors are in process. We continue to believe that the financial impact on top-line revenue from these efforts will begin to show up in the third and fourth quarters of this year.

An integral part of this pilot is the Treatment Navigator program that we introduced last fall. This program was designed to effectively act as an extension of the VIP practice to help the dental office guide the patient through the many different steps of the patient journey, including coordinating diagnostic appointments, insurance pre-authorizations, further education, and generally coaching the patients through treatment under the direction of a treating doctor. Not only does the Treatment Navigator program removes significant workload from the practice, it helps to mitigate the challenges associated with employee turnover within the practice. It anticipates Vivos up to $895 per case for Treatment Navigator services, which we expect will soon become a significant revenue contributor and profit center for us.

We believe our latest rounds of cost cutting, coupled with an intense focus on creating new revenue streams, will allow us to achieve our stated goal of achieving positive cash flow by the first quarter of 2024. Our prior reliance on Vivos-trained dentists to create demand from within their practices is now being augmented by Vivos actively driving new patients into their offices through multiple distribution channels — including primary care and specialty medical doctors, medical equipment suppliers, large employers, men’s health clinics, and more. We deliver more qualified new airway patients to Vivos as we deliver more qualified new airway patients to Vivos-trained providers, our value proposition to potential new providers becomes more compelling and attractive.

It’s a virtuous cycle that creates the potential to organically fuel our growth. We expect to begin to see the impact of these strategic initiatives in the latter half of this year. With respect to our ongoing R&D efforts, the last year — this past year has produced the single largest advancement towards proving the efficacy of our technology with multiple studies and peer-reviewed papers being published in top quality journals, professional journals. We are pleased to announce today, the recent execution of an agreement with Stanford University to begin a randomized controlled trial, where our DNA appliances will be directly compared to CPAP. Additional university-based clinical trials on Vivos products are currently in process and are expected to start before year-end.

Currently, there are no less than five additional new papers showing significant clinical results that have been submitted and are pending publication. The cumulative effect of this research is to establish beyond any reasonable doubt that Vivos possesses the single most advanced and effective treatment for breathing and sleep disorders on the market today. One final note on our product development front. For some time now, we have been actively engaged in the development of a patient-driven mobile app that will assist clinicians in collecting key diagnostic data, and in monitoring patient compliance and progress, while also empowering patients to take charge of their own health and wellness. For example, patients can participate in taking periodic records, providing feedback, and actually receive coaching and interaction with their providers.

The mobile platform also allows for remote delivery of certain clinical services such as myofunctional therapy, breathing exercises, important notifications, and more. Our surveys and provider feedback leads us to believe that there is strong potential demand for such a product and that it can be commercialized and highly profitable for both Vivos and Vivos providers, while also taking a load off of dentists and their teams. We plan to have a beta version of the app ready for testing by the end of this month, and expect to have a commercial product available by the fourth quarter of this year. Now in closing. We have the evidence-based technology and products that can now address the needs of patients across the full spectrum of price points and needs.

We have the FDA clearances. We have the nationwide network of trained providers. And now we have a growing brand awareness amongst both providers and patients. Through our new distribution networks, we will soon have access to more potential new patients than ever before. We believe the combined effects of our internal cost, operating cost reductions, and the strategic revenue initiatives outlined above will yield significant top-line revenue growth and allow us to become self-sustaining in the first quarter of 2024. This concludes our prepared remarks, and now we’ll be happy to take questions. Operator?

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Q&A Session

Operator: Thank you. [Operator Instructions] Our first question comes from the line of Scott Henry with ROTH Capital Partners. Please proceed.

Scott Henry: Thank you, and good afternoon. I guess, cash flow positive in the first quarter of 2024 would be fantastic — so if you can achieve that goal. So I just wanted to drill a little bit into the assumptions. I know you expect flattish revenues in the first half of this year, but what sort of revenue run-rate do you think would allow you to achieve that goal?

Brad Amman : We believe that at $8 million run-rate per quarter, we can hit that goal, Scott.

Scott Henry: Okay. Thank you. That’s helpful. And when I look at the expense items, obviously sales and marketing was way down. And I know there was layoffs recently. I want to hone in — firstly, is that sales and marketing level of $600,000 — is that what we should think about going forward? And second of all, that G&A of $6.5 million, I imagine that’s where the bulk of the cuts are going to come to. What should we think about as G&A once all the cuts and everything has taken effect?

Brad Amman : Well, if you look at quarter over quarter, Scott, last year we were at $8.3 million. In first quarter, we were at $6.5 million in G&A expenses. In the first quarter of 2023, the marketing expenses stayed roughly flat, we were down about $100,000 quarter over quarter. As those take place, we believe on the personnel cost, we’re going to have $500,000 a quarter go against that G&A expense. So that’s roughly what we will save in terms of salaries, wages, taxes and benefits.

Scott Henry: Okay. Thank you. That’s helpful. Just a couple other small questions. Arches were down in the quarter. And if you calculate arches per doc, they were down — significantly. How should we think about that number? I mean, I know the business model is always changing and the accounting is changing as well. Just trying to get a sense of how we should think about that number as far as arches — how we should interpret the first quarter 2023 results and how we should think about that number going forward?

Kirk Huntsman : Well, first of all, I think there’s a certain element of the macroeconomic economy — other companies in the dental space have struggled with some of that and some of the results of that. So there’s that that plays into it. There is a little bit of seasonality in Q1 that that plays into it. But there was also an event that took place. It was a little bit unfortunate, towards the middle to later part of Q1 where there was some market confusion over of a product that made similar claims to some of our products out there in the marketplace. This product did not have FDA clearances, did not have research, did not have a lot of things behind it. It was a totally different type of product. But there was some market confusion over that and frankly, a lot of our providers, until we were able to wrap our minds around that and really address that directly, they — we just saw and we’ve seen a little bit of a softening in the sales of our arches from that standpoint.