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Vivos Therapeutics Reports Third Quarter 2021 Financial Results and Operational Update Third Quarter Revenue Increased Over 38% Year-Over-Year Expects to Benefit from Increased OSA Testing, Opening

Key Takeaway: Therapeutics Reports Third Quarter 2021 Financial Results Quarter Revenue Increased Over 38% Year-Over-Year Expects to Benefit from Increased OSA Testing, Opening of Live Training Facility, Expansion of Marketing Programs, Additional FDA Approval and Positive Study to Host

Full Press Release Details

Therapeutics Reports Third Quarter 2021 Financial Results
Quarter Revenue Increased Over 38% Year-Over-Year
Expects to Benefit from Increased OSA Testing,
Opening of Live Training Facility, Expansion
of Marketing Programs,
Additional FDA Approval and Positive Study
to Host Conference Call Today at 5:00 pm ET
RANCH, Colo., November 15, 2021 - Vivos Therapeutics, Inc. ("Vivos" or the "Company") (NASDAQ: VVOS),
a medical technology company focused on developing and commercializing innovative diagnostic and treatment modalities for patients suffering
from mild to moderate obstructive sleep apnea (OSA) and snoring in adults, today reported financial results and operating highlights
for the third quarter and nine months ended September 30, 2021.
and Operating Highlights:
Revenue increased over 38% to $4.5 million for the third quarter of 2021 and was $12.5 million for the nine months ended September 30, 2021, compared to $3.3 million and $9.8 million for the three and nine months ended September 30, 2020, respectively, as Vivos benefitted from increased appliance sales and additional sources of revenue including Billing Intelligence Services and MyoCorrect myofunctional therapy;
Appliance sales increased to 2,996 total oral appliance arches, a 33% increase for the third quarter of 2021 compared to 2,245 the same period in 2020, and rose to 8,648 total oral appliance arches, a 54% increase for the nine months ended September 30, 2021 versus 5,610 for the same period in 2020;
Dentist enrollments in the Vivos Integrated Practice (VIP) program decreased somewhat in 2021 due in part to the COVID-19 Delta variant resurgence (56 and 162 enrollments, respectively and net of cancellations, for the three and nine months ended September 30, 2021, versus 64 and 194 respectively for the same periods in 2020), while VIP enrollment revenue overall increased due to enrollment revenue recognition from prior periods;
Gross profit was $3.2 million for the third quarter of 2021 and $9.5 million for the nine months ended September 30, 2021, compared to gross profit of $2.6 million and $7.7 million for the comparable periods in 2020, respectively;
Gross margin was 70% for the third quarter of 2021, compared to 78% for the third quarter of 2020, and was 76% for the first nine months of 2021, compared to 79% for the first nine months of 2020, reflecting higher costs associated with VIP enrollments;
Cash and cash equivalents were $28.5 million at September 30, 2021;
Operational highlights during the third quarter and October of 2021 included:
Vivos surpassed 22,000 total patients treated with the Vivos System, compared to just over 13,000 as of the third quarter of 2020. Vivos has also trained over 1,350 dentists in the use of the Vivos System and other related value-added services, compared to just over 1,000 as of the third quarter of 2020.
Vivos announced the U.S. Food and Drug Administration granted 510(k) market clearance to Vivos' mmRNA device for treating mild to moderate OSA, sleep-disordered breathing and snoring in adults.
Vivos announced the positive results from an independent patient survey and separate clinical study related to its proprietary Vivos treatment.
Vivos announced the opening of The Vivos Institute, an international training center in Denver, Colorado.
Vivos announced a new cooperative relationship with Empower Sleep to provide critical diagnostic and medical consultation services to people across North America who suffer from OSA.
Vivos announced the formation of the Vivos Medical Consortium, a group of renowned physicians from prominent academic institutions in the U.S. and Canada, who will collaborate to advance Vivos' OSA technology capabilities.
Vivos and Candid Care Co., a digital platform for oral healthcare, announced a new collaboration that will seek to provide patients with a comprehensive, whole-mouth solution to diagnose and treat OSA in adult patients and provide orthodontic treatment from the same provider network.
"The third quarter saw many positive
developments for Vivos," said R. Kirk Huntsman, Vivos' Chairman and CEO. "We recorded strong year-over-year growth,
reflecting what we believe is growing recognition and adoption of our Vivos System as a treatment for mild to moderate sleep apnea. Our
sales growth during the quarter, most notably in appliances, is beginning to reflect the impact of our previously announced strategic
growth initiatives, including our expanded sales and marketing activities, featuring the broad introduction of our VivoScore diagnostic
program. While we experienced a late summer decline in new VIP enrollments due in part to COVID-19, we are now generating revenue outside
of our core of VIP enrollment revenue and appliance sales, including the value-added services we offer our VIPs and their patients as
well as the beginnings of management revenue from our Medical Integration Division."
continued, "Beyond our financial results, we celebrated a number of significant milestones in the quarter. Importantly, we received
510(k) market clearance for Vivos' mmRNA device for treating mild to moderate OSA, sleep-disordered breathing and snoring in adults.
This paves the way for expanded insurance reimbursement coverage as well as reimbursement from commercial payers. Also, we announced
the opening of The Vivos Institute international training center in Denver, Colorado. This 15,000 square-foot, state-of-the-art facility
bolsters our online training programs to offer advanced post-graduate education and training to dentists, dental teams and other healthcare
professionals from around the world in a live hands-on setting. We entered into a new cooperative relationship with Empower Sleep
to provide critical diagnostic and medical consultation services to people across North America who suffer from OSA. In more recent
weeks, we entered into a strategic collaboration with Candid Care. By combining our complementary strengths, together we will provide
an all-in-one, whole-mouth diagnosis and treatment solution for adult patients suffering from OSA."
"The third quarter also brought to light
the growing acceptance of our innovative diagnostic and treatment methods amongst members of the medical and dental communities. For
example, during the third quarter and year to date, we've seen significant growth and adoption of VivoScore diagnostic technology
for OSA, as measured by the number of sleep tests being performed. Between January and October of 2021, we saw a seven fold increase
in monthly diagnostic tests for OSA using VivoScore, with approximately 45% of patients testing positive. While we don't generate
revenue directly from VivoScore, the rapid rise in testing means that a core element of our marketing effort is gaining traction and
that more patients are becoming aware of their OSA condition and engaging in dialogue with their dentists and other healthcare providers
about treatment options, including the Vivos System. We are currently working very hard to help our VIP teams to convert those OSA positive
patients into Vivos System case starts. We continue to view VivoScore, not only as an important screening and diagnostic tool to promote
increased diagnoses of sleep apnea, but also as a key strategic marketing tool to generate greater usage of the Vivos System."
the quarter, we also began to expand the first phase of our go-to-market strategy of establishing a well-trained, independent Vivos provider
network across North America by taking our model to Dental Support Organizations (DSOs), which represent thousands of general dental
and specialty practices across North America. We are in active discussions with several DSOs representing several thousand dental practices
under management, and expect to launch pilot programs for the full implementation of the Vivos System and protocols within certain target
markets beginning in the fourth quarter of 2021 and early 2022."
"Simultaneously, we are actively expanding our social media marketing
outreach to engage more directly with consumers, medical providers and large employers. Going forward, we will continue to advance our
strategic growth actions to drive increased enrollment of new dentists as VIPs, as well as productivity growth and appliance sales among
existing VIPs, while working to foster greater brand recognition and broad acceptance among both providers and the general public. By
following this path, we are hopeful that many more OSA patients can be identified and ultimately receive the care they need to improve
their overall health and lead happier, fuller lives."
information on Vivos' financial results is included on the attached condensed consolidated balance sheets and statements of operations,
and additional explanations of Vivos' financial performance are provided in the Vivos' Quarterly Report on Form 10-Q
for the nine months ended September 30, 2021, which will be filed with the Securities and Exchange Commission ("SEC"). The
full 10-Q report will be available on the SEC Filings section of the Investor Relations section of Vivos' website at https://vivoslife.com/investor-relations/.
July, Vivos unveiled new data from an independent patient survey related to its proprietary Vivos treatment. The data showed nearly
97% of patients surveyed said that they had achieved their desired outcome from Vivos System treatment for their OSA.
in July, Vivos 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, 28% of 74 adult patients treated with the Vivos' FDA Class 1 DNA appliance
for certain orofacial anomalies reported no remaining OSA symptoms, which is defined as patients having an Apnea Hypopnea Index (AHI)
score of less than five post-treatment. A more detailed summary of the national study results was released in August.
in July, Vivos announced the opening of The Vivos Institute training center in Denver, Colorado. The 15,000-square-foot facility
was established to provide advanced post-graduate education and training to dentists, dental teams and other healthcare providers from
around the world in a live and hands-on setting. The Institute's emphasis will be 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
August, Vivos announced the U.S. Food and Drug Administration (FDA) granted 510(k) market clearance to Vivos' mmRNA (modified mandibular
Repositioning Nighttime Appliance) device for treating mild to moderate OSA, sleep-disordered breathing and snoring in adults. This FDA
clearance 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.
Also in August, Vivos announced a new
cooperative relationship with Empower Sleep, a San Bernadino, Calif.-based company empowering patients with affordable, accessible and
personalized telemedicine sleep care, to provide critical diagnostic and medical consultation services to people across North America
who suffer from OSA. Together, Vivos and Empower will provide a user-friendly platform with personalized insights for patients who are
being screened for OSA by North American dentists and other healthcare providers.
September, Vivos announced the formation of the Vivos Medical Consortium. This physician working group, Drs. Clete Kushida of Stanford
University and Cecilia Wu of the University of Alberta, will collaborate to advance Vivos' OSA technology capabilities and includes
renowned physicians with specialties in sleep medicine, neurology, pediatrics, pulmonology, anesthesiology, pain medicine, otolaryngology,
obstetrics and gynecology, cardiology, and forensic pathology from prominent academic institutions in the U.S. and Canada.
to quarter end, in October Vivos announced that results from a peer-reviewed, published study by Dr. Toshi Hart, DDS, Independent
Vivos Clinical Advisor, found a significant reduction of tooth decay in pediatric patients after undergoing treatment using Vivos'
FDA Class 1 registered Vivos Guide. The Vivos Guide is an oral appliance intended to address certain malocclusions
and developmental oral tissue anomalies, and has been found to help seal the lips to convert 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 12 months after beginning Vivos Guide use was lowered by 76.4% [p = 0.0004] and 57.9% [p = 0.05] respectfully.
Later in October, Vivos and Candid Care Co., a digital platform for oral
healthcare, today announced a new collaboration that will seek to provide patients with a comprehensive, whole-mouth solution to diagnose
and treat OSA in adult patients and provide orthodontic treatment from the same provider network. At the core of this collaboration, Vivos
and Candid will market each company'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's CandidPro 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.
Vivos will conduct a conference call today,
November 15, 2021 at 5:00 p.m. (Eastern Time) to review the third quarter results as well as provide an overview of the Company's
recent milestones and growth strategy.
access the conference call, please dial (888) 394-8218, or for international callers, (720) 452-9217. A replay will be available shortly
after the call and can be accessed by dialing (844) 512-2921, or for international callers, (412) 317-6671. The passcode for the live
call and the replay is 5806322. The replay will be available until November 29, 2021.
live webcast of the conference call can be accessed on Vivos' website at https://vivoslife.com/investor-relations/. An online
Last updated: Nov 15, 2021