Vivos Therapeutics, Inc.

good day everyone and welcome to the vivos therapeutics inc third quarter 2021 earnings 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 the vivos website and will remain posted there for the next 30 days i will now hand the call over to mr edward low

vivos investor relations officer for introductions in the reading of the safe harbor statement please go ahead sir thank you operator hello everyone and welcome to vivos therapeutics third quarter 2021 earnings conference call a copy of the company's earnings press release is available on the investor relations section of our website at www.vivoslife.com with us on today's call are kirk huntsman Vivos Chairman and Chief Executive Officer, and Brad Ammon, Chief Financial Officer. Today, we'll review the highlights and financial results for the third quarter of 2021, as well as more recent developments. 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 in Section 21E of the Securities and Exchange Act of 1934 as amended concerning future results. Words such as may, should, projects, expects, intends, plans, believes, anticipates, hopes, estimates, and variations of such words in 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 uncertainties and contingencies, many of which are beyond the company's control. Actual results, including the results of Vivos' growth strategies, operational plans, future potential results of operations or operating metrics, and other matters to be addressed by Vivos management in this conference call may differ materially 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 in other disclosures contained in VIVOS's filings with the Securities and Exchange Commission, including our third quarter 2021 10Q, which is being filed today, as well as in our most recent Form 10-K, which can also be accessed on the VIVOS Investor Relations website. Except to the extent required by law, Vivos assumes no obligation to update statements as circumstances change. Now at this time, it is my pleasure to introduce Kirk Huntsman, Chairman and CEO of Vivos. Kirk, please go ahead, sir.

Thank you, Ed, and thank you everyone for joining us today on our third quarter 2021 earnings conference call. I'm eager to review our quarterly results and provide you with an update on our progress. Afterwards, our Chief Financial Officer, Brad Ammon, will review the highlights of our third quarter financial results. Following that, we'll be happy to take your questions. The third quarter was an exciting period for Vivos. We recorded strong year-over-year quarterly revenue growth of over 38%, a substantial increase from the prior year, and also a 28% increase for the nine months ended September 30, 2021, versus the same period last year. During the quarter, we benefited from a material increase in appliance sales driven by our core of VIPs. And we also generated revenue from additional sources like our billing intelligence services and myocorrect myofunctional therapy, which we didn't have last year. While we experienced a late summer dip in VIP enrollments due in part to the COVID-19 Delta variant resurgence, enrollment revenue was actually up due to a recognition of revenue from prior periods. Overall, we believe this growth demonstrates the increasing recognition and adoption of our vivo system and related products and services by dentists as a treatment for patients suffering from sleep disorder breathing, including obstructive sleep apnea, known as OSA. We also believe our sales growth also highlights the benefits of our strategic growth initiatives, including our expanded sales and marketing activities and collaborations with third parties, which I will discuss in further detail in a moment. In addition to our revenue results, I'm pleased to report that for the third quarter of 2021, we reported gross profit of approximately $3.2 million, up 23% compared to gross profit of approximately $2.6 million for the same period in 2020. We recorded gross margin of 70% compared to 78% for the third quarter of 2020. The year-over-year decrease reflects higher costs associated with VIP enrollments. We ended the quarter with cash and cash equivalents of $28.5 million. During the third quarter, we surpassed $22,000 in total patients treated with Avivo system, compared to just over $13,000 as of the third quarter of 2020. And as of September 30, 2021, we have trained over 1,350 dentists globally in the use and application of the VIVO system, providing our VIPs with training and other related value-added services, compared to just over 1,000 as of the third quarter of 2020. We are very pleased with these results. Brad will review our financial highlights with you in more detail later on. Digging a little deeper here, in addition to the revenue from our core business of VIP enrollment revenue and appliances, We also saw growing activity and brand development as well as revenue contributions from the value added services we offer dentists that are enrolled in our vivos integrated practice or VIP program and their patients, including our vivos score diagnostic product and mild correct therapy service as well as some management revenue from our medical integration division or MID. As for vivos score, our home sleep apnea test that we introduced earlier this year, we have continued to see increased usage of this product throughout our VIP members. We consider VivoScore, powered by sleep image technology, to be a breakthrough screening and diagnostic tool to promote increased diagnoses of sleep apnea. Strategically, VivoScore has taken center stage as a powerful marketing tool to generate greater awareness and usage of the Vivo system. So seeing vivos scores increase usage not only indicates greater awareness of OSA, it also helps to promote specific recognition for vivos products and services. Complementing this, we have continued our efforts to expand dentist awareness of vivos and potential VIP enrollment by engaging with dental support organizations, also known as DSOs. For those of you less familiar with DSOs, DSOs acquire and operate multiple dental practices to provide critical business management and support. These DSOs control thousands of general dental and specialty practices across North America, and their recommendations to their affiliated providers carry substantial weight. As more people become aware of the health issues associated with sleep disorder breathing, DSOs are anxious to provide more support and education for their affiliated dentists who wish to treat OSA. In addition, DSOs are constantly looking for new and profitable services they can offer to patients. We believe our vivos sleep treatment program represents the largest single profit opportunity for DSOs since the introduction of implants over 20 years ago. Given these prevailing trends and our extensive industry relationships, we see great benefits and accelerated growth potential in engaging with these organizations and educating them on the benefits of the vivo system. We continue to have active discussions with several leading DSOs representing nearly 4,000 affiliated dental offices and expect to launch pilot programs within target markets beginning here in the fourth quarter and even more as we move into 2022. Concurrently with our engagement with DSOs, we are also actively expanding our social media marketing outreach to engage more directly with consumers, medical providers, and large employers. Beyond our financial results and our success with these strategic initiatives, we also celebrated a number of significant milestones in the quarter. Since we spoke with you on our last earnings call and partially in response to discussions we have on a regular basis with the investment community, we reported more detailed survey and study data highlighting certain rather striking clinical benefits of our products. For example, in July, we announced results from a national study commissioned by Vivos to assess patients' airway function and OSA symptoms after undergoing the Vivos treatment. In the study, one in four, or 28%, of the 74 adult patients treated with our FDA Class I DNA appliance for certain oral facial anomalies reported no remaining OSA symptoms, which is defined as patients having an apnea hypopnea index, or AHI score, of less than five post-treatment. Now, there are some doctors out there who would say that patients who have their AHI scores reduced to less than five are effectively cured of their sleep apnea. Regardless, to the best of our knowledge and belief, no one has ever before reported eliminating or reducing OSA symptoms down to within normal limits non-surgically and without ongoing intervention. We believe this data furthers the case we've been making that our products are both highly effective and highly differentiated, and that our technology represents a significant breakthrough in the battle against OSA and its related health conditions. In August, we announced more detailed data from this study, which reported that prior to treatment, 20 patients had severe OSA. which from an AHI perspective improved post-treatment or is improving mid-treatment by 53%. Of these 20 patients, none have reported worsening of their OSA symptoms, while three patients still have severe OSA, 12 have moderate OSA, four have mild OSA, and one has no OSA. The study data also showed that for the 18 patients who began the study with moderate OSA, the average percent improvement in HI scores were 64%. Although future results may differ from this study data, we think these positive results are quite impressive, and we are extremely happy to provide our investors with this real-world data about our devices. For those of you interested in reviewing the more detailed summary of these national study results, This is available on our company website at www.vivoslife.com under the investor relations section. In addition to these national study results, during the quarter we officially opened our Vivos Institute International Training Center in Denver, Colorado. This 15,000 square foot state-of-the-art facility complements our online training programs and was established to offer advanced postgraduate education and training to dentists, dental teams, and other healthcare professionals from around the world in a live, hands-on setting. The Institute focuses on educating healthcare providers about OSA and vivos' treatments for OSA within their practice areas, along with training on vivos' related practice management tools for dentists. While we pivoted and had success last year and this year with online training, We continually hear that live, hands-on training is preferable to many practitioners, and we agree. Creating and opening the Vivos Institute was a major strategic objective for our company in 2021, which we were pleased to have completed and opened with a great kickoff, notwithstanding the COVID-related challenges. Moreover, we are extremely excited about the future of this facility and believe this dedicated, state-of-the-art forum will be a core hub where we can train independent dentists with patients suffering from dental facial malformations that may be associated with OSA and introduce them to the VEVO system as a treatment option. In August, we achieved another important business milestone with the US FDA granting VEVO's 510K market clearance for our MMRNA device for treating mild to moderate OSA, sleep disorder breathing, and snoring in adults. This is quite a boon for us and for those suffering from OSA. Today, more than 1 billion people worldwide and 54 million in the United States suffer from sleep apnea. What's more disturbing is that over 80% of these people still remain undiagnosed and continue to suffer in silence. This 510 market clearance is extremely important as it opens the door for patients to have a viable, patient-friendly, and most often permanent treatment option to the current standard of care. Also, it paves the way for expanded insurance reimbursement coverage for the MMRNA device, including Medicare, as well as for potential future government contracts and reimbursement from commercial payers that follow Medicare guidelines. This opens up the vivo system to a much wider audience of potential patients. Also, in August, we announced a new cooperative relationship with Empower Sleep, Once again, the importance of this relationship cannot be overstated as it helps our vivos dentists overcome an important barrier to getting patients properly diagnosed and into treatment. Empower is a San Bernardino, California-based company that provides patients with affordable, accessible, and personalized telemedicine sleep care and supplies critical diagnostic and medical consultation services to people across North America who suffer from OSA. By leveraging our VivoScore diagnostic technology and combining it with Empower Sleep's telemedicine model, providers and patients now have easy access to confirming diagnoses of their sleep disorders in an easily accessible and affordable manner. This relieves dentists from having to seek out and cultivate local sleep specialists who may not be as easy to work with or as convenient for patients. Most importantly, patients will be able to receive the appropriate treatment for any sleep-related breathing disorder they may be experiencing, including mild to moderate OSA. Towards the end of the quarter, in September, we announced the formation of the Vivos Medical Consortium. This physician working group, led by Drs. Clete Kushida of Stanford University and Cecilia Wu of the University of Alberta, will collaborate to advance Vivos' OSA technology capabilities. Together they lead a team of multidisciplinary physicians from prominent academic institutions across the U.S. and Canada with specialties including sleep medicine, neurology, pediatrics, pulmonology, anesthesiology, pain medicine, otolaryngology, obstetrics and gynecology, cardiology, and forensic pathology. The key reason for taking such a multidisciplinary approach in constituting the medical consortium is that sleep apnea affects the clinical care and treatment of patients across many medical specialties. The Vivos Medical Consortium will assist us with the planning, dissemination, and conduct of key research initiatives, enhancing physician-dental collaborations, and expanding novel applications of the Vivos technology for additional medical conditions. We are optimistic that our medical consortium will enhance our scientific progress and research endeavors, as well as raise further awareness of our technology within the medical community. Subject to quarter end, in October, we announced that results from a peer-reviewed published study by Dr. Toshi Hart, an independent Bevos clinical advisor, found that found a significant reduction of tooth decay in pediatric patients after undergoing treatment using our FDA Class I registered VivosGuide, a flexible BPA-free base polymer intraoral device. The VivosGuide is a preformed oral appliance intended to prevent a child's teeth from shifting position and has been shown to be helpful in converting mouth-breathing children to nose-breathing. Data from the study demonstrated that the risk reduction of tooth decay per child in the treatment group versus the control group at six months and at 12 months after beginning vivos guide use was lowered by 76.4% and 57.9% respectively. Both of those figures, by the way, were statistically significant. The vivos guide was well tolerated by the children in the study with no reported complaints from children or their caregivers. We are extremely happy with the results from this study, which helps to show how the DivosGuide internal device may promote nasal breathing and reduce tooth decay. And more recently, in October, we announced a strategic collaboration with CandidCare, a digital platform for oral healthcare, primarily focused in orthodontics. Through this relationship, we will look to provide patients with a comprehensive, whole-mouth solution to diagnose and treat obstructive sleep apnea in adult patients, and provide orthodontic treatment from the same provider network. At the core of this collaboration, Vivos and Candid will market each other's products and areas of expertise to deliver a comprehensive sleep and oral health solution to patients in the United States and Canada. The focus of the collaboration will be Candid Pro Clear Aligner for straightening teeth and the Vivos system for treating OSA. The two companies will also share educational resources, training, and key opinion leaders to bridge the gap between airway health and orthodontic therapy. Additionally, under the terms of the agreement, Vivos and Candid will join forces to explore new research and development opportunities for device development and other alliances related to orthodontics, OSA, and snoring. Candid will also conduct specialized training sessions at our Vivos Institute. We are thrilled to be working with Candid, and our companies look forward to combining our dual strengths to offer a full-service solution for patients suffering from OSA. So all in all, the third quarter was an exciting and productive period for Vivos. We delivered solid financial results despite some COVID-related headwinds. While seeing increased usage of our VivoScore sleep apnea test, we also continued to actively engage with DSOs, and expect to share further developments with you on this front by the end of this calendar year. Additionally, we celebrated a number of significant milestones as our strategic initiatives come online and begin to reap benefits for our company. With our progress and achievements to date, we believe we have established a strong foundation for our continued and future growth. Going forward, we will continue to advance our strategic growth actions to drive VIP enrollment growth and appliance sales. while working to foster greater recognition and adoption of the vivo system as well as our expanded product offerings. By following this path, we will enable many more patients to receive the care they need for their OSA so they can improve their overall health and lead happier, fuller lives. We are very proud of what we've already achieved so far and look forward to updating you on our continued progress. This concludes my opening remarks. Now I'll pass the call on to Brad, who will review our financial results. Brad? Thank you, Kirk, and good afternoon, everyone.