Vivos Therapeutics, Inc.

Good day, everyone, and welcome to Vivos Therapeutics' fourth quarter and full year 2023 conference call. At this time, participants are in a listen-only mode. A question-and-answer session will follow management's remarks. This conference 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 over the call to Julie Gannon, Vivos Investor Relations Officer for introductions and reading of the Safe Harbor Statement. Please go ahead.

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 of and Brad Ammon, Chief Financial Officer. Today, we'll review the highlights and financial results for the fourth quarter and full year 2023, as well as more recent developments and vivos plans for 2024. 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, goals, 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 VIVO's growth strategies, operational plans, including sales, marketing, product acquisition and integration, research and development, regulatory initiatives, cost-saving plans, and plans to generate revenue, as well as future potential results of operations or operating metrics, such as the potential for VIVO to achieve 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 Security and Exchange Commission, including the risk factors and other disclosures in our Form 10-K for the year ended December 31, 2023, which was filed with the SEC today, and our other filings with the SEC, all of which are or will be accessible on the Investor Relations section of the VVOS website, as well as the SEC's website. Except to the extent required by law, VVOS 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 510K clearance to treat mild to severe OSA. With the FDA clearance for severe last November, treatment of patients with severe OSA is no longer needed to be performed off-label at the clinical discretion of the treating doctor and is now an integral part of the treatment protocol for vivos. Now, at this time, it is my pleasure to introduce Kirk Huntsman, Chairman and CEO of Vevo. Kirk, please go ahead.

Thank you, Julie. I want to thank you all for joining us on today's conference call. In a moment, I'll turn the call over to our Chief Financial Officer, Brad Ammon, who will walk you through the highlights of our fourth quarter and full year 2023 financial and operating results. After that, we'll be happy to take your questions. But before I do that, I'll offer some brief remarks on industry events and our progress throughout the past year. 2023 began with a flurry brought on by a milestone FDA regulatory clearance in January for vivos and ended in November with an even larger and unprecedented clearance to treat severe OSA impatience. Each of these hugely important achievements garnered a higher level of visibility, respect, and overall interest in vivos, both in the public markets as well as within the sleep medicine world. Meanwhile, other separate market forces and events created challenges across the dental sleep oral appliance space, and we battled hard for every dollar of revenue throughout the year. Only after our latest FDA clearance in late Q4 did we start to see sales stabilize and begin to trend positively again. Throughout 2023, we accelerated our cost cutting and expense reduction efforts that began in 2022 and took many actions to adjust to the changing market conditions by implementing new revenue stimulating activities. Here in 2024, we are now beginning to see the benefits of these initiatives. In 2023, our full year operating expenses declined by 27% on a year over year basis. and our net operating loss was down 57% year-over-year. That is a considerable achievement, and it speaks to the tremendous efforts and dedication of our entire team here at Vivos. Also, let me be clear that these are not one-time cost reductions. Our full-year results reflect ongoing operational cost reductions and efficiencies that we have been able to implement throughout our entire organization. Complementing this, we took further steps to strengthen our regulatory approvals, enhance our liquidity position, and shore up our capital structure. For example, early last fall, shareholders approved and we effected a one-for-25 reverse stock split. In November 2023, we closed a $4 million private placement priced at the market. More recently, just this past February, the investor in the November private placement exercised 50% of the warrants issued in the November transaction at an exercise price of $4.02 per share, which generated about $4 million in gross proceeds for vivos. We believe these actions, in combination with our cost-cutting measures over the last year, have given us a much-improved financial foundation to support our revenue growth initiatives in the coming year. While we will need to raise additional capital to enhance our revenue performance and boost our stockholders' equity for NASDAQ purposes, we continue to anticipate that our revenue side initiatives will bear fruit, which could lead us to becoming cash flow positive from operations by the end of this year. When I reflect on this incredible vivos journey, I'm extremely grateful and proud of our accomplishments. Our singular vision to provide the best patient care for those experiencing breathing and sleep disorders including obstructive sleep apnea, or OSA, is being realized more and more each and every day. As I mentioned earlier, at the beginning of last year, and for the first time ever, the FDA cleared a Vivos oral medical device that does not include mandibular advancement to treat mild to moderate OSA. More recently, and in yet another unprecedented achievement, Vivos received FDA 510K clearance for our CARE line, of oral medical devices to treat severe sleep apnea in adults. These clearances not only validated our tireless work and investment, but also gave us an amazing paradigm shift that points to a bright future. Two other things happened during 2023 that are both noteworthy and potentially game changing. The first is a clinical breakthrough, and the second is an important tweak to our overarching go-to-market strategy. On the clinical front, we push the boundaries of our understanding of how to impact both the form and function of the human airway to new heights. Then we've leveraged that information to acquire, develop, and refine an entirely new set of interdisciplinary treatments and protocols. This gives vivos a full line of OSA treatment options across a range of price points for patients and represents an entire paradigm shift in the treatment of breathing and sleep disorders. When applied to patients with varied degrees of breathing and sleep disorders, we are seeing new breakthroughs and greater levels of success in achieving dramatic clinical improvements. Much work remains and further testing is already underway, but we are extremely encouraged by what we've seen thus far. The second 2023 potential game changer is that we discovered what we now believe is the key to scaling our business in a way that will allow our technology to have a broad and significant impact across the entire healthcare spectrum. This discovery came about as we looked closely at several highly successful independent BeVos VIP practices across the country and then identified the common traits behind how they'd achieved their success. These systems and best practices have been tried and tested in actual operating clinical practices across the country. In the near future, we will report on our field execution of these important and potentially game-changing tweaks to both our clinical diagnostic and treatment protocols to our business model. Suffice to say for now that coupled with our recent regulatory victories, and not to mention those that are still pending, we believe we are well-positioned operationally and competitively to deliver on the promise our technology holds. Other important and very positive market developments came about in late 2023 and early 2024. The first was the announcement by a leading CPAP manufacturer that they were suspending CPAP shipments into the U.S. pursuant to an ongoing recall and consent decree with the FDA. Since 2021, millions of CPAP units have been recalled by the FDA due to serious safety and health concerns. This caused a great deal of alarm and concern among both providers and patients that led many to seek alternative treatments, such as oral appliance therapy. The second important development came in an early 2024 announcement by UnitedHealthcare of their new policy guidelines for OSA. Effective March 1st of this year, UnitedHealthcare now mandates a regimen of oral appliance therapy as a crucial first step before considering surgical placement of neurostimulation implants for adult patients diagnosed with moderate to severe OSA. Many in the sleep medicine community believe that other insurance carriers will soon follow United's lead on this issue, thus sending many thousands of prospective implant patients to first seek treatment at their dentist. A large portion and perhaps a majority of such patients have severe OSA, for which the only FDA-cleared solution is with Vivos Care oral medical devices. We believe these two market developments will likely serve to stimulate demand for all forms of oral appliance therapy, especially now that Vivos Care oral medical devices are now an integral and prominent part of moderate to severe OSA treatment. In summary, as we move forward in 2024 and beyond, we are extremely optimistic about the future. Our expectations are bolstered by all that I have just mentioned, but most of all, by the reception and interest our products and technology are garnering throughout the medical field. Vivos is no longer a story about a novel oral appliance directed at dentists. Today, it is about the world's first real medical alternative to the treatment of severe OSA. and the only treatment that can offer all OSA patients a glimmer of hope that they may someday become free of their CPAP machines. I want to thank you all for joining us on today's conference call. Now, let me turn the call over to our Chief Financial Officer, Brad Ammon, to review our financial results.