Kirk Huntsman
Analyst · Craig-Hallum Capital
Thanks, Ed, and thank you, everyone, for joining us today on our first quarter 2021 earnings conference call. This is our second quarterly call as a public company, and I'm excited to provide you with an update on our progress. Afterwards, our Chief Financial Officer, Brad Amman, will review the highlights of our first quarter financial results. Following that, we will be happy to take your questions. For those of you not familiar with Vivos, we are a growing revenue stage medical technology company focused on developing and commercializing innovative diagnostic products and therapeutic treatments for adult patients suffering from sleep disorder breathing, including obstructive sleep apnea or OSA. OSA is a chronic illness affecting nearly 1 billion people worldwide and over 54 million in the U.S. alone. OSA can also lead to many other debilitating and deadly health conditions such as high blood pressure, heart failure, stroke, diabetes, dementia and other debilitating or life-threatening diseases. This creates substantial societal and health care system costs, not to mention the personal toll it inflicts on people and their families. At Vivos, our mission is to rid the world of obstructive sleep apnea. We market and sell 2 primary innovative products, 1 diagnostic and the other therapeutic, each of which represents what we believe to be a best-in-class technology. Together, we believe they give us a great competitive advantage in the market for the identification and treatment of OSA, consistent with our FDA approvals. Our flagship therapeutic product is the Vivos System, a multidisciplinary set of clinical therapies and protocols featuring our patented and customized mRNA oral appliance. Studies have shown that treatment with the Vivos System can reduce OSA severity, as measured by Apnea Hypopnea Index scores, by 67.4% on average. Our VivoScore product, which we gained access to and launched in the first quarter, is a comprehensive home sleep apnea test, to which we have exclusive distribution rights to the dental sleep markets in the United States and Canada. VivoScore consists of a single-sensor ring recorder that works with a mobile phone application and proprietary cloud-based algorithms to evaluate sleep quality and clinically diagnose sleep apnea. The primary market channel for the Vivos System and VivoScore are the estimated 165,000 general dentists and dental specialists in the United States and Canada. To date, we have trained over 1,200 dentists across North America and internationally in the use and application of the Vivos System. Our dentists are enrolled in our Vivos Integrated Practice or VIP program, which offers training and other value-added services in connection with using the Vivos System. Turning now to the first quarter. We continued to advance our strategic initiatives to introduce the benefits of the Vivos System treatment to members of the medical and dental communities. This includes the finalization of our licensing, marketing and distribution agreement for and the launch of VivoScore for home sleep testing in children and adults; the opening of our first Pneusomnia Center in Del Mar, California; and the launch of a new service called MyoCorrect, where trained therapists will provide Vivos-trained providers access to orofacial myofunctional therapy, otherwise known as OMT, via telemedicine technology. Before I review our first quarter highlights, I want to talk a little about the typical kind of activity we see this time of year and perhaps, more importantly, what we've been seeing here more recently. As you may recall, during the fourth quarter, we saw an uptick in both VIP enrollment as well as higher sales of our therapeutic products and services. The fourth quarter is typically a strong quarter for us. In addition to our continued organic growth in 2020, during Q4, we usually experience some seasonal activity related to people utilizing their dental insurance benefits prior to the calendar year-end. In line with our forecasts, our revenue recognition policies, the gradual post-pandemic reopening of our economy and the timing of our sales cycle, we did not expect to realize the full impact of the capital deployed from our December 2020 IPO and accelerated growth actions in the first quarter of 2021. This is consistent with what we've shared with the analysts who cover us and why we beat the consensus revenue numbers for the quarter. Related to this, during the first quarter, we typically see a sequential slowdown in product sales activity. This reflects a slight lull that often follows the higher activity we usually see in Q4 as dental offices overall are typically slower following the year-end rush when people are trying to utilize the remainder of their dental insurance benefits to their fullest extent. As a result of these factors I've discussed, while our VIP enrollment was up quarter-over-quarter for the first quarter, the overall growth was slower than what we've seen in Q4. Having said that, I'm happy to report that following the typical seasonality of the first quarter, we have been very pleased by the strong interest in our products and services within the dental community, which has increased our VIP sales funnel. This momentum has continued throughout May to date as many dentists have reopened their offices, more Americans get vaccinated, and we all move forward from the disruptions of the COVID-19 pandemic. The second quarter has been off to a very strong start with enrollments by new VIP dentists, along with increased levels of daily appliance sales. Demand for our new VivoScore diagnostic product and MyoCorrect therapy service, available via telemedicine during Q2, have also exceeded our expectations, although any material impact on our overall revenue from those 2 products is not expected to begin to be realized until the second half of 2021. We are very pleased with this recent momentum and expect it will continue throughout the remainder of the second quarter and for the rest of 2021. With that, let me provide some highlights from our first quarter results. I'm pleased to report that for the first quarter of 2021, we generated revenue of $3.4 million, an 8% increase compared to $3.2 million for the first quarter of 2020. We achieved gross profit of $2.7 million, an 11% increase compared to gross profit of $2.4 million for the same period in 2020. We also increased gross margin to 78% compared to a gross margin of 76% for the first quarter of 2020. We surpassed 17,000 in total cases treated with the Vivos System, and we ended the first quarter of 2021 with cash and cash equivalents of $14.1 million as of March 31, 2021. Brad will review our financial results with you shortly in more detail. I am very pleased with the results we're reflecting so far, which reflect Vivos' quarter-over-quarter growth, notwithstanding the onset of the COVID-19 pandemic. More than that, I'm particularly satisfied with our more recent performance. As I noted earlier, our business began to pick up considerably in April. And this has continued to date given the drivers, which include continued adoption of the Vivos System as well as accelerated growth in VIP enrollment. And where we are now in mid-May, we expect this momentum will continue throughout the balance of the second quarter. We continue to be encouraged by our recent activity and look forward to updating you further when we have our next quarterly call. In addition to these results, during the first quarter and in the weeks that have followed, we continued making considerable progress in advancing a number of our strategic initiatives designed to both increase awareness of our therapeutic products and services and adoption of the Vivos System throughout both the medical and dental communities as well as to broaden our scope of activities and potential revenue streams. To briefly recap some first quarter achievements I discussed on our last call, in January, we commercially launched our AireO2 software, a new patient and sleep practice management software platform that will enable our VIP doctors to more effectively manage, schedule, monitor and process their patients with OSA and its related conditions. Developed in collaboration with Lyon Dental, AireO2 contains features that enhance health care professionals' medical billing services and more, including practice management systems. We believe our AireO2 patient and practice management platform represents a significant improvement in how medical and dental professionals can effectively treat sleep disorders. We look forward to continuing to market AireO2 as a key value-added component, along with our existing billing intelligence service and to actively pursue AireO2 as a revenue source from other OSA-focused health care providers that are not affiliated with Vivos. I would note that we like the Lyon Dental technology so much that this past April, for a relatively small spend, we acquired from Lyon Dental certain medical billing and practice management software licenses and contracts pertaining to the software underlying AireO2, thus eliminating all the middleman expenses to us. In February, we submitted a 510(k) Class II application to the U.S. Food and Drug Administration for our mmRNA oral appliance with indications to treat mild-to-moderate OSA, sleep-disordered breathing and snoring in adults. Our mmRNA oral appliance is a new version of our existing mRNA appliance, which is an FDA-cleared Class II oral appliance. Assuming the mmRNA receives 510(k) Class II approval, we would expect the mmRNA to be added to the Centers for Medical and -- Medicare and Medicaid Services' list of approved sleep apnea appliances. This achievement will allow our VIPs to bill Medicare and be reimbursed for their patients ages 63 and up that want the Vivos System. While the process with FDA is sometimes uncertain, we anticipate having this Class II approval later this year. This would be an important development for us, and we will keep you updated as this process continues. Later in February, as mentioned earlier, we gained access to and then launched our VivoScore diagnostic product. It is important to note that VivoScore's core technology from our partner, SleepImage, is the only FDA-cleared software as a medical device for establishing sleep quality and diagnosing and managing OSA in both children and adults. We believe this new technology will open the door for more patients to be diagnosed and eventually treated for sleep apnea. Further, we expect to generate increased revenue from VivoScore due to anticipated rise in total patients being tested for sleep apnea, which has translated into a corresponding increase in patients enrolling in the Vivos System treatment. This conclusion is based on the results of an informal pilot study conducted with independent Vivos-trained dentists and other Vivos provider feedback, which may or may not prove reliable on a broader scale. But in its public -- or in this pilot study, 12 Vivos-trained dentists performed approximately 938 sleep tests over a 3-month period using VivoScore. 56% of the patients in the pilot study tested positive for obstructive sleep apnea and received a confirming diagnosis from a physician. 50% of those patients who tested positive then entered into treatment for OSA with the Vivos System. We believe these pilot study results indicate that VivoScore may enable health care providers to more efficiently screen, diagnose and initiate treatment for OSA in their patients, which could result in more patients being treated with the Vivos System. In addition to VivoScore, during the first quarter, we continued to make advancements through our Medical Integration Division with March opening our first Pneusomnia Center. Our Medical Integration Division, or MID, was launched in 2020 with the goal of creating strategic alliances between the medical and dental communities so more medical doctors can work directly with Vivos-trained dentists for treating sleep disorders in patients. We believe this will further the diagnosis and treatment of OSA with the Vivos System. This first Pneusomnia Center is located in Del Mar, California and is owned and operated by an assorted group of local physicians led by Dr. Mimi Guarneri, a renowned cardiologist, Founder and President of The Academy of Integrative Health and Medicine and an award-winning physician and researcher. Additional Pneusomnia Centers are currently being developed in Nevada, Colorado, California and New Jersey. Later in March, we announced the launch of a new therapeutic service called MyoCorrect, where trained therapists will provide our VIP doctors and their patients with access to orofacial myofunctional therapy, or OMT, utilizing telemedicine technology as a component to OSA treatment for their patients using the Vivos System. OMT therapists work with patients to strengthen and improve function in the muscles of the lips, tongue, cheeks and face and their related roles in breathing, sucking, chewing, swallowing and some aspects of speech. Clinical research has shown OMT to be an effective component of OSA treatment. Further, Vivos-trained dentists who have actively incorporated OMT in their Vivos System treatment protocols report 4 primary benefits: one, higher case acceptance for Vivos System therapy; two, better patient compliance; three, shorter treatment times; and four, improved clinical outcomes. Despite these benefits, due to scarcity of trained OMT therapists in many areas of the country and other factors, too few dentists and patients have been able to access this important adjunctive therapy. MyoCorrect will provide every Vivos dentists and their patients with immediate and easy access via telemedicine to this valuable clinical resource at an attractive price point. Over time, we expect to see additional revenue from this new MyoCorrect service in the form of increased Vivos System case starts and direct therapeutic fees charged for the service. We expect this MyoCorrect service will become an important value-added component in the treatment of OSA as it is more fully integrated into the Vivos System. We further believe that offering a scalable and cost-effective OMT service via telemedicine will improve patient compliance, shorten overall treatment times and further improve clinical outcomes, thus providing Vivos with a further competitive advantage in the marketplace. More recently, in April, we announced the appointment of Dr. Mimi Guarneri as an independent consultant serving in the role of Medical Director of Clinical Education. As I mentioned earlier, Dr. Guarneri is one of several physician owners of Vivos' first Pneusomnia Center in Del Mar, California. In her newly created role, her duties for our company will include the promotion and expansion of our Medical Integration Division to her extensive network of medical colleagues. We are extremely excited to welcome Dr. Guarneri to Vivos. As a leading integrated cardiologist in North America, she is an incredibly valuable addition to our team. Her vast experience and expertise as an award-winning physician and researcher make her a logical choice to help inform other physicians about our breakthrough diagnostic and treatment technologies. We are happy to have her with us and look forward to her contributions to our rapidly growing organization. In summary, during the first quarter, we began to strategically deploy the capital from our IPO, laying the foundation for accelerated growth and performance throughout 2021 and beyond. At the same time, we achieved several significant milestones, including the commercial launch of AireO2; our 510(k) Class II application submission to the FDA for our mmRNA oral appliance; the finalization of our exclusive license, marketing and distribution agreement for our VivoScore sleep testing product and service; the opening of our first Pneusomnia Center; and the recent introduction of a new MyoCorrect service for orofacial myofunctional therapy. Looking ahead, as I noted earlier, in April, we began to see a substantial increase in activity throughout all facets of our business. This uptick has continued to date in May, and we believe it is further proof of the continued adoption of the Vivos System and the accelerating growth impact due to our VivoScore diagnostic product and MyoCorrect therapy services. Given this recent activity and the drivers of our business, we are hopeful that this momentum will persist throughout the remainder of the second quarter. The last month has also seen the publication of two important peer-reviewed papers, adding further validation and support to our core therapeutic technology, along with the long anticipated publication and arrival of a new textbook by our Founder and Chief Medical Officer, Dr. Dave Singh called Pneumopedics and Craniofacial Epigenetics with the foreword written by Dr. Clete Kushida, the Division Chief and Medical Director at Stanford Sleep Medicine and the Stanford Center for Human Sleep Research at Stanford University Medical Center. So with these achievements so far during our brief time as a public company and our current business momentum, we are extremely excited about our prospects. We look forward to updating you on our continued progress as we execute on our strategic initiatives to expand market share and increase awareness of our therapeutic products and services through our marketing initiatives and Medical Integration Division. This concludes my opening remarks. Now I'll pass the call on to Brad, who will review our financial results. Brad?