Full Press Release Details
Therapeutics Reports Fourth Quarter and Full Year 2021
Financial Results and Operational Update
Quarter Revenue Increased 33% Year-Over-Year
While Full Year Revenue Increased 29%
to Host Conference Call Today at 5:00 pm ET
RANCH, Colo., March 31, 2022 - Vivos Therapeutics, Inc. ("Vivos"
or the "Company'') (NASDAQ: VVOS), a medical technology company focused on developing and commercializing a suite of
innovative diagnostic and treatment modalities for patients with dentofacial abnormalities and/or mild to moderate obstructive sleep
apnea (OSA) and snoring in adults, today reported financial results and operating highlights for the fourth quarter and full year ended
and Operating Highlights
| Revenue increased 33% to $4.4 million for the fourth quarter of 2021 and was $16.9 million for the full year ended December 31, 2021, compared to $3.3 million and $13.1 million for the fourth quarter and full year 2020, respectively, as Vivos continued to benefit from increased appliance sales, VIP enrollments and additional sources of revenue including Billing Intelligence Services and MyoCorrect oral myofunctional therapy; | ||
| Appliance sales increased to 2,707 total oral appliance arches, a 7% increase for the fourth quarter of 2021 compared to 2,525 the same period in 2020, and rose to 11,355 total oral appliance arches, a 40% increase for the full year ended December 31, 2021 versus 8,135 for the full year 2020; | ||
| Vivos enrolled 35 dentists in the Vivos Integrated Practice (VIP) program (net of cancellations) during the fourth quarter of 2021, and 197 for the full year 2021, compared to 54 and 248 VIP enrollments for the fourth quarter and full year 2020, respectively. The fourth quarter 2021 decrease was due in part to COVID-19 Delta and Omicron variant resurgences, while VIP enrollment revenue for the full year 2021 increased overall due to higher enrollments that took place in June, August, and September, and enrollment revenue recognition from prior periods; | ||
| Gross profit was $3.1 million for the fourth quarter of 2021 and $12.6 million for the full year ended December 31, 2021, compared to gross profit of $2.7 million and $10.4 million for the comparable periods in 2020, respectively; |
| Gross margin was 71% for the fourth quarter of 2021, compared to 81% for the fourth quarter of 2020, and was 75% for the full year 2021, compared to 80% for the full year 2020, reflecting higher costs associated with VIP enrollments; | ||
| Cash and cash equivalents were $24.0 million at December 31, 2021; | ||
| Operational highlights during the fourth quarter of 2021 and subsequent to year end included: |
| Patients treated with The Vivos Method totaled approximately 25,000, compared to approximately 15,000 as of the fourth quarter of 2020. Vivos has also trained over 1,450 dentists in the use of The Vivos Method and Vivos' related value-added services, compared to just approximately 1,250 as of the fourth quarter of 2020. | ||
| In October 2021, 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. | ||
| In December 2021, Vivos announced the official registration of Vivos products with Health Canada, a Minister of Health department responsible for helping Canadians maintain and improve their health through services and resources. | ||
| Also in December 2021, Vivos received acceptance from a Centers for Medicare & Medicaid Services Pricing, Data Analysis and Coding ("PDAC") contractor for its mmRNA (modified mandibular Repositioning Nighttime Appliance) device for treating mild to moderate OSA and snoring in adults. | ||
| Subsequent to year end, Vivos announced significant increases across several key metrics for its SleepImage Home Sleep Apnea Tests (HST). | ||
| In January 2022, Vivos filed a U.S. patent application related to certain new and enhanced clinical methods and protocols developed within Vivos' proprietary Vivos Method treatment for OSA. |
has made substantial progress since our December 2020 initial public offering and achieved a number of key milestones," said R.
Kirk Huntsman, Vivos' Chairman and CEO. "Despite COVID-19 variant resurgences in the middle and latter part of the year,
we generated strong year-over-year revenue growth both for the fourth quarter and full year 2021. Our sales growth reflects increased
market penetration and appliance sales driven by our core of VIPs, as more people adopt The Vivos Method as a treatment for mild to moderate
sleep apnea. It also included revenue generated from new products and services we introduced in 2021, including our Billing Intelligence
Services and MyoCorrect oral myofunctional therapy. Expanding our sources of revenue remains a top priority for us in 2022, even as we
continue to grow revenue from our core business of VIP enrollment and appliances. To that end, at the beginning of this year, we were
able to renegotiate our commercial agreement with SleepImage to lower costs and convert the entire home sleep apnea diagnostic program
from a loss leader aimed primarily at stimulating new case starts with sleep apnea treatment using The Vivos Method to a potential recurring
revenue center. Under the new revenue model with SleepImage, we will lease out the SleepImage ring recorders to VIPs at a fixed price
that includes a full month's worth of diagnostic sleep test reports."
continued, "Vivos also completed a number of significant catalysts to position itself for further growth this year. As of year-end,
approximately 25,000 total patients have been treated with The Vivos Method. We also completed official registration of Vivos products
with Health Canada, providing Canadian dentists complete access to Vivos' services and products. Also of great importance, our
mmRNA oral device was placed on the PDAC list of oral appliances covered by and billable to Medicare. Adding to these developments, we
recently filed a U.S. patent application for proprietary new and enhanced clinical protocols and methods developed within our Vivos Method
for the treatment for OSA. These are all important achievements that leave us well placed for the future."
to strategic relationships, in October we announced a strategic collaboration with Candid Care, a provider of new invisible aligner technology.
Through this relationship, we will collaborate on marketing, sales, lead generation, and the joint development of potential new products.
Vivos also continued to engage with Dental Support Organizations (known as DSOs), whose memberships include thousands of general dental
and specialty practices across North America. During the fourth quarter, we launched the Vivos sleep management program for DSOs, a marketing
and sales initiative whose demand has already exceeded our expectations. We also successfully initiated pilot trials for our Vivos sleep
program involving multiple DSO practices. Further, we are in active contract discussions for additional pilots with several DSO groups
representing close to $3 billion in total annual dental revenue derived from over 1,800 locations. We see great potential in this area
as our DSO market penetration in the U.S. and Canada continues to accelerate in 2022."
what we have already achieved, we are very excited by our future prospects. Complementing these activities and our progress to date,
we will continue to expand our social media marketing outreach to engage more directly with consumers, medical providers and large employers.
By continuing to increase awareness of our products and services, we remain confident this will drive further adoption of The Vivos Method,
which in turn should generate increased VIP enrollment and appliance revenues in 2022 and beyond."
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' Annual Report on Form 10-K for the
twelve months ended December 31, 2021, which will be filed with the Securities and Exchange Commission ("SEC"). The full
10-K report will be available on the SEC Filings section of the Investor Relations section of Vivos' website at https://vivos.com/investor-relations.
December 2021, Vivos announced its official registration with Health Canada, a Minister of Health department responsible for helping
Canadians maintain and improve their health through services and resources. The official registration of Vivos products will aim to provide
patients with a comprehensive, end-to-end solution for OSA patients, which incorporates clinical screening, medical diagnosis and therapy
using Vivos products.
in December, Vivos received acceptance from a Centers for Medicare & Medicaid Services Pricing, Data Analysis and Coding ("PDAC")
contractor for its mmRNA (modified mandibular Repositioning Nighttime Appliance) device for treating mild to moderate OSA and snoring
in adults. This acceptance places the mmRNA device on the PDAC list of oral appliances covered by and billable to Medicare.
to year end, in January 2022, Vivos announced significant increases across several key metrics for its SleepImage Home Sleep Test ring
(or HST), including in particular, for the three-months ended December 31, 2021, versus the three-months ended December 31, 2020: (i)
an 18 times increase in the total number of HSTs given across the VIP network, (ii) a 5.7 times increase in the number of VIPs administering
HSTs and (iii) a 3 times increase in the average number of HSTs being administered per VIP. Vivos believes this performance gain in home
sleep testing allowed it to renegotiate its commercial agreement with SleepImage to lower costs and convert the entire diagnostic program
from a loss leader aimed primarily at stimulating new case starts with sleep apnea treatment using the Vivos Method to a potential recurring
in January, Vivos filed a U.S. patent application related to certain new and enhanced clinical methods and protocols developed within
Vivos' proprietary Vivos Method treatment for OSA. The Vivos Method, inclusive of the Vivos System, seeks to treat dentofacial
abnormalities and/or OSA through a combination of Vivos' proprietary oral appliances and devices as well as proprietary clinical
methods and protocols. This new patent application was based on early field data which revealed an additional 58% average improvement
in Apnea Hypopnea Index (AHI) score reductions in OSA patients who had received treatment with the Vivos Method where the revised clinical
protocols were implemented.
March, Vivos announced a rebranding of its proprietary offering of clinical treatment devices, modalities and protocols, now called The
Vivos Method, to better capture the multiple ways in which Vivos can help independent dentists treat their patients. Vivos also announced
the presentation of new clinical results from retrospective data in patients using The Vivos Method at the 2022 World Sleep Congress
clinical results continue to show the benefits of The Vivos Method, particularly as we enhance and further understand the use and benefits
of our multidisciplinary protocols and devices in patients," continued Mr. Huntsman. "We used to call our offering the Vivos
System, but we believe that didn't do justice to the many options and methods we provide for practitioners to treat their patients
suffering from these debilitating conditions. Our rebrand makes it clearer and easier for providers and patients to understand our offerings
and the manner in which each can contribute to addressing dentofacial and airway abnormalities in a relatable and more approachable way
and to feel secure in proactively asking their dentists or medical providers about The Vivos Method." To learn more about The Vivos
Method, patients can visit Vivos' updated website www.vivos.com to find:
| Information about OSA and its corresponding symptoms; | ||
| Testimonials from Vivos-trained dentists and their patient's success stories; and | ||
| Opportunities for Vivos partnerships, FAQs and more. |
addition to simplifying information for patients visiting the new Vivos website, Vivos now provides dentists looking to tackle OSA and
sleep therapies guidance in becoming a Vivos Integrated Provider. This turnkey program enables dentists to elevate patient services and
care, while also increasing the growth potential for practice revenue and income.
senior management will conduct a conference call today, March 31, 2022 at 5:00 p.m. (Eastern Time) to review the fourth quarter and full
year results as well as provide an overview of the Company's recent milestones and growth strategy.
access the conference call, please dial (888) 256-1007, or for international callers, (720) 543-0214. 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 5532262. The replay will be available until April 14, 2022.
live webcast of the conference call can be accessed on Vivos' website at https://vivos.com/investor-relations. An online
archive of the webcast will be available on the Company's website for 30 days following the call.
Vivos Therapeutics, Inc.
Therapeutics Inc. (NASDAQ: VVOS) is a medical technology company focused on developing and commercializing a suite of innovative diagnostic
and treatment methods for treating patients with dentofacial abnormalities and / or mild to moderate sleep apnea (OSA) and snoring in
adults. The Vivos Method represents the first clinically effective non-surgical, non-invasive, non-pharmaceutical and cost-effective
solution. The Vivos Method has proven to be effective in approximately 25,000 patients treated worldwide by more than 1,450 trained dentists.
proprietary technologies and protocols that alter the size, shape and position of the tissues that comprise a patient's upper airway,
The Vivos Method opens airway space and may significantly reduce symptoms and conditions associated with mild to moderate OSA, such as
lowering Apnea Hypopnea Index scores. Vivos also markets and distributes SleepImage diagnostic technology under its VivoScore program
for Home Sleep Testing in adults and children. The Vivos Integrated Practice (VIP) program offers dentists training and other value-added
services in connection with using the Vivos Method.
more information, visit www.vivos.com.
Note Regarding Forward-Looking Statements
press release, the management presentation referred to herein and statements of the Company's management made in connection therewith
contain "forward-looking statements" (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E