−Removed: Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
−Removed: common stock began trading on Nasdaq under the symbol “VVOS”
−Removed: on December 11, 2020.
−Removed: Prior to that date, there was no
−Removed: established public trading market for our common stock.
+Added: Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
+Added: common stock began trading on Nasdaq under the symbol “VVOS” on December 11, 2020.
+Added: Prior to that date, there was no established
+Added: public trading market for our common stock.
of March 23, 2022, there were approximately 5,400 holders of record of our common stock.
−Removed: This number does not include stockholders
−Removed: who are beneficial owners, but whose shares are held in street name by brokers and other nominees.
−Removed: This number of holders of record
−Removed: also does not include stockholders whose shares may be held in trust by other entities.
+Added: This number does not include stockholders who
+Added: are beneficial owners, but whose shares are held in street name by brokers and other nominees.
+Added: This number of holders of record also
+Added: does not include stockholders whose shares may be held in trust by other entities.
Sales of Unregistered Securities
Authorized for Issuance under Equity Compensation Plans
−Removed: following table provides information as of December 31, 2020, regarding our common stock that may be issued under the Company’s
−Removed: 2017 stock and option award plan (the “2017 Plan”), and the 2019 stock and option award plan (the “2019 Plan”).
+Added: following table provides information as of December 31, 2021, regarding our common stock that may be issued under our 2017 stock
+Added: and option award plan (the “2017 Plan”), and our 2019 stock and option award plan (the “2019 Plan”).
+Added: be Issued Upon
+Added: Weighted Average
Plan Category:
−Removed: Number of Securities to be issued Upon Exercise of Outstanding Options, Warrants, and Rights (a)
−Removed: Weighted Average Exercise Price of Outstanding Options (b)
−Removed: Number of Securities Remaining Available for Future Issuance Under Equity Compensation Plans (Excluding Securities Reflected in column (a)) (c)
−Removed: Equity compensation plans approved by stockholders
−Removed: 2017 Plan (1)
−Removed: 2019 Plan (2)
−Removed: Equity compensation plans not approved by stockholders (3)
−Removed: 2017 Plan permits grants of equity awards to employees, directors, consultants and other independent contractors.
−Removed: of directors and shareholders have approved a total reserve of 1,333,333 shares for issuance under the 2017 Plan.
−Removed: 2019 Plan permits grants of equity awards to employees, directors, consultants and other independent contractors.
−Removed: of directors and shareholders have approved a total reserve of 333,334 shares for issuance under the 2019 Plan.
−Removed: 2020, our shareholders approved an amendment and restatement of the 2019 Plan to increase the number shares or our common
−Removed: stock available for issuance thereunder by 833,333 share of common stock such that, after amendment and restatement of the
−Removed: 2019 Plan, and prior to any grants, 1,166,667 shares of common stock were available under the 2019 Plan.
−Removed: options granted to officers and employees prior to the approval by our stockholders of the 2017 Plan.
−Removed: of the date of this Annual Report on Form 10-K, we have not paid any cash dividends to stockholders.
−Removed: The declaration of any future
−Removed: cash dividend will be at the discretion of our board of directors and will depend upon our earnings, if any, our capital requirements
−Removed: and financial position, the general economic conditions, and other pertinent conditions.
−Removed: It is our present intention not to pay
−Removed: any cash dividends in the foreseeable future, but rather to reinvest earnings, if any, in our business operations.
−Removed: of Proceeds from Initial Public Offering
−Removed: December 11, 2020, we completed our initial public offering by issuing 4,025,000 common shares at a price of $6.00 per share,
−Removed: for net proceeds of approximately $21.6 million, after deducting underwriter discounts and commissions and offering expenses payable
−Removed: Following our initial public offering, we made payments of $2.0 million to our founder and Chief Medical Officer, Dr.
−Removed: Singh to redeem a portion of our then outstanding Series A Preferred Stock held by Dr.
−Removed: In early January 2021, we paid an additional
−Removed: $1.5 million to Dr.
−Removed: Singh to redeem all remaining outstanding shares of Series A Preferred Stock.
−Removed: Additionally, we plan to spend approximately
−Removed: $3.95 million for working capital and general corporate purposes, $3.3 million on settlement expense (see “October 2020 Derivative
−Removed: Demand and Settlement”), $0.9 million for sales and support staff, $0.3 for sales and marketing expenses and $0.1 million for
−Removed: software development including enterprise resource planning implementation.
−Removed: proceeds used in working capital and general corporate purposes, include payments to investment banking firms we previously had
−Removed: engagements with, comprised of $175,000 to Weild & Co., a FINRA member broker-dealer and $30,000 to Maxim Group, LLC, a FINRA
−Removed: member broker-dealer.
−Removed: foregoing expected use of net proceeds from our initial public offering represents our intentions based upon our current plans
−Removed: and business conditions.
−Removed: However, the nature, amounts and timing of our actual expenditures may vary significantly depending on
−Removed: numerous factors.
−Removed: For example, we may also elect to use proceeds from this offering to acquire complimentary technologies, products
−Removed: or businesses, although we are not a party to any letters of intent or definitive agreements for any such acquisition.
−Removed: our management has and will retain broad discretion over the allocation of the net proceeds.
−Removed: We may find it necessary or advisable
−Removed: to use the net proceeds for other purposes, and we will have broad discretion in the application of net proceeds.
−Removed: Additionally,
−Removed: we intend to invest the net proceeds in a variety of capital preservation investments, including short-term, investment-grade,
−Removed: interest-bearing instruments and U.S.
−Removed: government securities.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations.
−Removed: following discussion and analysis of our financial condition and results of operations should be read in conjunction with our
−Removed: financial statements and the related notes to those statements included elsewhere in this Annual Report on Form 10-K.
−Removed: to historical financial information, the following discussion and analysis contains forward-looking statements that involve risks,
−Removed: uncertainties, and assumptions.
−Removed: Some of the numbers included herein have been rounded for the convenience of presentation.
−Removed: actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors, including
−Removed: those discussed under Part I.
−Removed: “Item 1A.
−Removed: Risk Factors’’
−Removed: and elsewhere in this Annual Report on Form 10-K.
−Removed: are a revenue stage medical technology company focused on the development and commercialization of a highly differentiated technology
−Removed: offering a clinically effective non-surgical, non-invasive, non-pharmaceutical, and low-cost solution for patients with SDB, including
−Removed: mild-to-moderate OSA.
−Removed: We offer novel and proprietary alternatives for treating mild-to-moderate OSA as well as certain craniofacial
−Removed: and anatomical anomalies known to be associated with OSA.
−Removed: We believe our products and technology represent a significant improvement
−Removed: in the treatment of mild-to-moderate OSA versus other treatments such as CPAP.
−Removed: treatment for mild-to-moderate OSA involves specially designed and customized oral appliances and treatment protocols that we
−Removed: call the Vivos System .
−Removed: We believe the Vivos System technology represents the first non-surgical, non-invasive and
−Removed: cost-effective solution that normally does not require lifetime use of intervention for the hundreds of millions of people globally
−Removed: who suffer from mild-to-moderate OSA.
−Removed: We intend to more rapidly expand the use of the Vivos System by actively recruiting dentists
−Removed: and training them about OSA and the use and application of our products and technology to treat mild-to-moderate OSA.
−Removed: appliances have proven effective (within the scope of the U.S.
−Removed: Food and Drug Administration (or FDA) cleared uses as described
−Removed: below) in over 15,000 patients treated worldwide by more than 1,200 trained dentists.
−Removed: December 11, 2020, we completed our initial public offering by issuing 4,025,000 shares of common stock, at a public offering price of
−Removed: $6.00 per share, for net proceeds of approximately $21.6 million after deducting underwriting discounts and commissions and offering
−Removed: expenses payable by us.
−Removed: early 2020 outbreak of COVID-19 and its development into a pandemic in March 2020 has resulted in significant economic disruption
−Removed: Actions taken by various governmental authorities, individuals and companies around the world to prevent the spread
−Removed: of COVID-19 through social distancing have restricted travel, many business operations, public gatherings and the overall level
−Removed: of individual movement and in-person interaction across the globe.
−Removed: This has significantly reduced global economic activity and
−Removed: resulted in a decline in demand across many industries.
−Removed: of our VIPs and potential VIPs closed their offices for periods of time during 2020 as a result of COVID-19, although some remained
−Removed: open to specifically provide patients with our appliances and VIPs were deemed an essential business for health considerations
−Removed: in many jurisdictions.
−Removed: In the face of the pandemic and the potential for revenue reduction, we worked diligently to reduce expenses
−Removed: and maintain revenues during 2020.
−Removed: While revenue growth flattened in March and April 2020, expenses were reduced, and we aggressively
−Removed: expanded our network of healthcare providers familiar with our products by offering online continuing education courses which
−Removed: introduced many in the medical and dental communities to our product line.
−Removed: As a result, we determined no triggering events had
−Removed: occurred indicating no impairment needed as of December 31, 2020.
−Removed: However, even as we take action to face the challenges of the
−Removed: pandemic, since the situation with COVID-19 remains uncertain, we cannot predict with certainty the impact of the pandemic or
−Removed: local outbreaks thereof will have on our near- and longer-term results of operations.
−Removed: of Operations
−Removed: Ended December 31, 2020 Compared to Year Ended December 31, 2019
−Removed: Product revenue
−Removed: Service revenue
−Removed: Total revenue
−Removed: Cost of sales
−Removed: Gross profit %
−Removed: Operating expenses
−Removed: General and administrative
−Removed: (16,090,049 )
−Removed: (16,172,505 )
−Removed: Sales and marketing
−Removed: Settlement expense
−Removed: Depreciation and amortization
−Removed: Operating loss
−Removed: (12,039,808 )
−Removed: (10,577,233 )
−Removed: Interest expense
−Removed: Interest income
−Removed: Loss on sale of business
−Removed: $ (12,056,877 )
−Removed: $ (10,754,319 )
−Removed: $ (1,302,558 )
−Removed: increased $1.7 million, or 15%, to $13.1 million for the year ended December 31, 2020 compared to the year ended December 31,
−Removed: This increase was related to revenue from our VIP program along with the increase in the number of oral appliances sold.
−Removed: During the year ended December 31, 2020, we enrolled 248 VIPs for a total of $7,540,718.
−Removed: During the year ended December 31, 2019,
−Removed: we enrolled 204 VIPs for a total of $6,742,283.
−Removed: Additionally, BIS service revenues increased from $256,415 for the year ended
−Removed: December 31, 2019 to $620,094 for the year ended December 31, 2020.
−Removed: During the year ended December 31, 2020 we sold 8,135 total
−Removed: oral appliance arches for a total of $4,547,883 and for the year ended December 31, 2019 we sold 4,696 total oral appliance arches
−Removed: for a total of $2,917,095.
−Removed: The increase in appliance revenue is due to both volume and price increases.
−Removed: of Goods Sold and Gross Margin
−Removed: of goods sold decreased $0.1 million, on increased sales of $1.7 million.
−Removed: COVID-19 impacted our sales mix as many dental offices
−Removed: were closed for a good portion of April and May, resulting in having higher margin service revenues represent a larger portion
−Removed: of our overall revenues than our product revenues for the year ended December 31, 2020 as compared to the year ended December
−Removed: and Administrative Expenses
−Removed: and administrative expenses decreased $0.1 million, for the year ended December 31, 2020 as compared to the year ended December
−Removed: As a percentage of revenues, general and administrative expenses decreased to 123% of revenues for the year ended December
−Removed: 31, 2020 from 143% of revenues for the year ended December 31, 2019.
−Removed: This decrease as a percent of revenues was achieved as a
−Removed: result of scaling operations as our revenues grew and reducing payroll and travel expenses during the COVID-19 outbreak.
−Removed: and Marketing
−Removed: and marketing expense was flat for the year ended December 31, 2020 as compared to the year ended December 31, 2019.
−Removed: reason for this decrease was the postponement until 2021 of our annual conference for VIPs due to the COVID-19 outbreak combined
−Removed: with the increase in revenues that drives sales and marketing expenses.
−Removed: expense in 2020 resulted from the settlement of a shareholder demand in the fourth quarter of 2020.
−Removed: We issued 300,000 shares of
−Removed: common stock and 325,000 warrants to purchase common shares as a result of this settlement.
−Removed: and Amortization
−Removed: and amortization expense decreased approximately $33,000 for the year ended December 31, 2020 as compared to the year ended December
−Removed: 31, 2019, due primarily to the sale of one of our Vivos Centers in the fourth quarter of 2019.
−Removed: expense decreased by approximately $41,000, for the year ended December 31, 2020 as compared to the year ended December 31, 2019
−Removed: as a result of the convertible notes being exchanged into Series B Preferred Stock throughout 2020.
−Removed: income increased by approximately $58,000 for the year ended December 31, 2020 as compared to the year ended December 31, 2019
−Removed: primarily due to interest on our note receivable related to the sale of one of our Vivos Centers in the fourth quarter of 2019.
−Removed: incurred a net loss of $12.1 million during the year ended December 31, 2020 as compared to a net loss of $10.8 million for the
−Removed: year ended December 31, 2019.
−Removed: The $1.3 million additional loss was primarily due to the settlement expense of $3.3 million offset
−Removed: by $1.8 million higher gross margin in 2020.
−Removed: Ended December 31, 2019 Compared to the Year Ended December 31, 2018
−Removed: Product revenue
−Removed: Service revenue
−Removed: Total revenue
−Removed: Cost of sales
−Removed: Gross profit %
−Removed: Operating expenses
−Removed: General and administrative
−Removed: (16,172,505 )
−Removed: Sales and marketing
−Removed: Depreciation and amortization
−Removed: Operating loss
−Removed: (10,577,233 )
−Removed: Interest expense
−Removed: Interest income
−Removed: Loss on sale of business
−Removed: $ (10,754,319 )
−Removed: $ (8,439,156 )
−Removed: $ (2,315,163 )
−Removed: revenue for the year ended December 31, 2019 increased $7,601,016, or 200%, to $11,393,277 from $3,792,261 for the year ended
−Removed: December 31, 2018.
−Removed: This increase was related to revenue from our VIP program that began during 2019 along with the increase in
−Removed: the number of oral appliances sold.
−Removed: During the year ended December 31, 2019, we enrolled 204 VIPs for a total of $6,742,283.
−Removed: the year ended December 31, 2018, we enrolled 67 VIPs for a total of $1,251,679.
−Removed: During the year ended December 31, 2019 we sold
−Removed: 4,696 total oral appliance arches for a total of $2,917,095 and for the year ended December 31, 2018 we sold 2,201 total oral
−Removed: appliance arches for a total of $695,250.
−Removed: The increase in appliance revenue is due to both volume and price increases.
−Removed: of sales for the year ended December 31, 2019 increased $1,654,393, or 153%, to $2,736,034 from $1,081,641 for the year ended
−Removed: December 31, 2018 due to the relative increase in revenue.
−Removed: As a percentage of revenue, cost of sales was 24% for the year ended
−Removed: December 31, 2019 and 29% for the year ended December 31, 2018.
−Removed: The decrease in cost as percentage of revenue was due to a greater
−Removed: mix of higher margin VIP program revenue during the year ended December 31, 2019 over year ended December 31, 2018.
−Removed: and Administrative
−Removed: and administrative expenses increased $6,899,615, or 74%, for the year ended December 31, 2019 as compared to the year ended December
−Removed: This increase relates primarily to payroll and benefits, consultants, travel and other costs associated with the growth
−Removed: of our business.
−Removed: and Marketing
−Removed: and marketing increased $1,147,504, or 99%, for the year ended December 31, 2019 as compared to the year ended December 31, 2018.
−Removed: The primary reason for this increase were additional commissions related to the increased service and product revenues, which
−Removed: increased 200%.
−Removed: and Amortization
−Removed: and amortization expense increased $140,555 for the year ended December 31, 2019 as compared to the year ended December 31, 2018,
−Removed: due almost entirely to the full year’s depreciation on furniture and equipment and leasehold improvements at the Vivos Centers
−Removed: in 2019 versus a partial year in 2018.
−Removed: expense increased $34,902 for the year ended December 31, 2019 compared to the year ended December 31, 2018, primarily as a result
−Removed: of a convertible note offering that commenced in April 2019.
−Removed: incurred a net loss of $10,754,319 during the year ended December 31, 2019 as compared to $8,439,156 of net loss for the year
−Removed: ended December 31, 2018.
−Removed: A higher gross margin of $5,946,623 was offset by higher sales and marketing expenses and general and
−Removed: administrative expenses.
−Removed: and Capital Resources
−Removed: of December 31, 2020, we had cash and cash equivalents of $18,205,860 compared to cash and cash equivalents of $469,353 at December 31,
−Removed: In January 2020, we commenced a private placement offering that authorized the issuance of up to $15,000,000 of newly designated
−Removed: Series B Preferred Stock to accredited investors.
−Removed: As of October 1, 2020, we closed our Series B Preferred Stock offering after having
−Removed: received approximately $2,450,000 from the issuance of Series B Preferred Stock and exchanging approximately $2,944,000 in accrued
−Removed: principal and interest from our 2019 convertible notes into Series B Preferred Stock, whereas other 2019 convertible note holders elected
−Removed: to convert their notes into common stock.
−Removed: All Series B Preferred Stock converted into common stock in December 2020 in connection with
−Removed: the initial public offering.
−Removed: May 2020, we secured funding of $1,265,067 under the Paycheck Protection Program that was signed into law as part of the Coronavirus
−Removed: Aid, Relief and Economic Security (CARES) Act as a result of the COVID-19 pandemic.
−Removed: The promissory note contains an interest rate
−Removed: of 1.0% per year.
−Removed: Payments will be deferred for the first six months of the loan, then we must pay principal and interest monthly
−Removed: based on the unforgiven portion of the loan balance plus all accrued interest, beginning seven months from the month the note
−Removed: We anticipate seeking forgiveness of a significant portion of the loan amount under the provisions of the program as
−Removed: the amount borrowed has been used to pay compensation, rent and utilities.
−Removed: While we believe that our use of the loan proceeds
−Removed: will meet the conditions for forgiveness of the loan, there is a risk that the loan will not be forgiven or that we will take
−Removed: actions that could cause us to be ineligible for forgiveness of the loan, in whole or in part.
−Removed: December 11, 2020, we completed our initial public offering by issuing 4,025,000 common shares at a price of $6.00 per share, for net
−Removed: proceeds of approximately $21.6 million, after deducting underwriter discounts and commissions and offering expenses payable by
−Removed: Following our initial public offering, we made payments of $2.0 million to our founder and chief medical officer to redeem a portion
−Removed: of the outstanding Series A Preferred Stock.
−Removed: In early January, we paid an additional $1.5 million to our founder and chief medical officer
−Removed: to redeem all outstanding remaining Series A Preferred Stock.
−Removed: believe that our existing cash resources will be sufficient to meet our capital requirements and fund our operations for at least
−Removed: the next 12 months.
−Removed: We may also seek liquidity through additional securities offerings or through borrowings under a new credit
−Removed: following table presents a summary of our cash flow for the periods indicated:
−Removed: Net cash provided by (used in):
−Removed: Operating activities
+Added: Equity compensation plans approved by security
1,333,333 (1)
1,018,000 (2)
−Removed: Investing activities
−Removed: Financing activities
−Removed: Increase (Decrease) in cash and cash equivalents
−Removed: cash used in operations was $5,680,294 for the year ended December 31, 2020 compared to net cash used of $5,340,480 for the year
−Removed: ended December 31, 2019.
−Removed: The increase in cash used from operating activities was primarily driven by the increase in our net loss
−Removed: of $1.2 million.
−Removed: Net cash used in investing activities
−Removed: consists of capital expenditures for property, plant and equipment and increased by approximately $206,000 from the year ended
−Removed: December 31, 2020 compared to cash provided by investing activities for the year ended December 31, 2019.
−Removed: For the year ended December
−Removed: 31, 2019, $250,000 in proceeds from the sale of a business were included in investing activities.
−Removed: cash provided by financing activities for the year ended December 31, 2020 consisted of the more than $22.3 million in net proceeds
−Removed: from our initial public offering plus $2.5 million in proceeds from the sale of Series B Preferred Stock and $1.3 million in proceeds
−Removed: from the PPP loan offset by $2.2 million in redemptions on the Series A Preferred Stock.
−Removed: For the year ended December 31, 2019,
−Removed: $1.2 million was received from the issuance of common stock and $3.8 million was received from the proceeds of our convertible
−Removed: debt offering that was offset by $0.4 million in redemptions on Series A Preferred Stock.
−Removed: Sheet Arrangements
−Removed: do not have any off-balance sheet arrangements, as defined by applicable regulations of the SEC, that are reasonably likely to
−Removed: have a current or future material effect on our financial condition, results of operations, liquidity, capital expenditures or
−Removed: capital resources.
−Removed: Accounting Policies Involving Management Estimates and Assumptions
−Removed: of Presentation and Consolidation
−Removed: consolidated financial statements included as part of this Annual Report on Form 10-K, which include the accounts of our company
−Removed: and our wholly owned subsidiaries (BMS and First Vivos), are prepared in conformity with U.S.
−Removed: GAAP and the rules and regulations
−Removed: of the SEC related to annual and quarterly reports.
−Removed: All significant intercompany balances and transactions have been eliminated
−Removed: in consolidation.
−Removed: Certain information and note disclosures normally included in annual financial statements prepared in accordance
−Removed: GAAP have been condensed or omitted pursuant to those rules and regulations.
−Removed: The consolidated balance sheet as of December
−Removed: 31, 2019 included in this report has been derived from our audited consolidated financial statements.
−Removed: The unaudited interim condensed
−Removed: consolidated financial statements have been prepared on the same basis as the annual audited consolidated financial statements
−Removed: and, in the opinion of management, reflect all material adjustments (consisting of normal recurring accruals) necessary for a
−Removed: fair presentation of the unaudited interim condensed consolidated financial statements.
−Removed: The information presented throughout this
−Removed: report, as of and for the periods ended December 31, 2020 and 2019, is unaudited.
−Removed: prepare financial statements in conformity with U.S.
−Removed: GAAP, management must make estimates and assumptions that affect the amounts
−Removed: reported in the financial statements and accompanying notes.
−Removed: Actual results could differ from those estimates.
−Removed: Concentration
−Removed: of Credit Risk and Significant Customers
−Removed: instruments, which potentially subject us to concentrations of credit risk, consist primarily of cash and cash equivalents and
−Removed: accounts receivable.
−Removed: We limit our exposure to credit loss by placing our cash with high credit quality financial institutions.
−Removed: Additionally, we have a diverse customer base and no single customer represented greater than ten percent of sales or accounts
−Removed: receivable for the years ended December 31, 2020 and December 31, 2019.
−Removed: Receivable, Net
−Removed: accounts receivable in the accompanying consolidated financial statements are stated at the amounts management expects to collect.
−Removed: We perform credit evaluations of our customers’
−Removed: financial condition and may require a prepayment for a portion of the services
−Removed: to be performed.
−Removed: We reduce accounts receivable by estimating an allowance that may become uncollectible in the future.
−Removed: determines the estimated allowance for uncollectible amounts based on its judgements in evaluating the aging of the receivables
−Removed: and the financial condition of our clients.
−Removed: Allowance for uncollectible receivables was $507,347 and $180,852 as of December 31,
−Removed: 2020 and 2019, respectively.
−Removed: assets consist of assets acquired from First Vivos and costs paid to third parties for work related to our patents.
−Removed: The identified
−Removed: intangible assets acquired from First Vivos are amortized using the straight-line method over the estimated life of the assets,
−Removed: which approximates 5 years.
−Removed: The costs paid to third parties for our assets are amortized using the straight-line method over the
−Removed: life of the underlying patents, which approximates 15 years commencing at which time the patent has been granted.
−Removed: We determined
−Removed: the fair value of the intangible assets using a discounted cash flow approach.
−Removed: is the excess of acquisition cost of an acquired entity over the fair value of the identifiable net assets acquired.
−Removed: is not amortized, but tested for impairment annually or whenever indicators of impairment exist.
−Removed: These indicators may include
−Removed: a significant change in the business climate, legal factors, operating performance indicators, competition, sale or disposition
−Removed: of a significant portion of the business or other factors.
−Removed: We test for impairment annually after the close of the year.
−Removed: was no impairment of goodwill recognized at December 31, 2020 or 2019.
−Removed: review and evaluate the recoverability of long-lived assets whenever events or changes in circumstances indicate that an asset’s
−Removed: carrying amount may not be recoverable.
−Removed: Such circumstances could include, but are not limited to (1) a significant decrease in
−Removed: the market value of an asset, (2) a significant adverse change in the extent or manner in which an asset is used, or (3) an adverse
−Removed: action or assessment by a regulator.
−Removed: We measure the carrying amount of the asset against the estimated undiscounted future cash
−Removed: flows associated with it.
−Removed: Should the sum of the expected future net cash flows be less than the carrying value of the asset being
−Removed: evaluated, an impairment loss would be recognized.
−Removed: The impairment loss would be calculated as the amount by which the carrying
−Removed: value of the asset exceeds its fair value.
−Removed: The fair value is measured based on quoted market prices, if available.
−Removed: If quoted market
−Removed: prices are not available, the estimate of fair value is based on various valuation techniques, including the discounted value
−Removed: of estimated future cash flows.
−Removed: The evaluation of asset impairment requires us to make assumptions about future cash flows over
−Removed: the life of the asset being evaluated.
−Removed: These assumptions require significant judgment and actual results may differ from assumed
−Removed: and estimated amounts.
−Removed: Our evaluation of long-lived assets completed for the years ended December 31, 2020 and 2019 resulted in
−Removed: no impairment loss.
−Removed: Receivable, Net
−Removed: notes receivable in the accompanying financial statements are stated at the amount management expects to collect.
−Removed: portion is what the Company expects to collect in the next twelve months and the long-term portion consists of the portion the
−Removed: Company expects to collect beyond twelve months.
−Removed: Periodically throughout the year, management evaluates the collectability of
−Removed: the note receivable based on its judgements of the operations and financial strength of underlying practice.
−Removed: The Company reduced
−Removed: notes receivable by estimating a discount based on market rates.
−Removed: The discount on notes receivable was $68,101 and $93,421 as of
−Removed: December 31, 2020 and 2019, respectively.
−Removed: Accretion on the discount and interest on the note is recorded in interest income.
−Removed: adopted Accounting Standards Update No.
−Removed: 2014-09 (Topic 606) titled, “Revenue from Contracts with Customers”
−Removed: January 1, 2019 and relied upon transitional guidance provided for in 606-10- 65-1(f)(3) and do not disclose the transaction price
−Removed: allocated to the remaining performance obligations or an explanation of when we expect to recognize that amount as revenue.
−Removed: generate revenue from the sale of products and services.
−Removed: Revenue is recognized when control of the products or services is transferred
−Removed: to our customers in a way that reflects the consideration we expect to be entitled to in exchange for those products and services.
−Removed: determine revenue recognition through the following five-step model, which entails:
−Removed: identification
−Removed: of the promised goods or services in the contract;
−Removed: determination
−Removed: of whether the promised goods or services are performance obligations, including whether they are distinct in the context
−Removed: of the contract;
−Removed: of the transaction price, including the constraint on variable consideration;
−Removed: of the transaction price to the performance obligations;
−Removed: of revenue when, or as the Company satisfies each performance obligation.
−Removed: revenue is recognized when the underlying training or other services are performed.
−Removed: Unearned revenue reported on the balance sheet
−Removed: as contract liability represents the portion of fees paid by customers for services that have not yet been performed as of the
−Removed: reporting date and are recorded as the service is rendered.
−Removed: We recognize this revenue over the twelve-month life of the contract.
−Removed: Provisions for discounts are provided in the same period that the related revenue from the products and/or services is recorded.
−Removed: enter into programs that may provide for multiple element deliverables.
−Removed: Commencing in 2018, we began enrolling medical and dental
−Removed: professionals in a one-year program which includes training in a highly personalized, deep immersion workshop format which provides
−Removed: the dentist access to an onboarding team who is dedicated to creating a successful integrated practice.
−Removed: The key topics covered
−Removed: in training include case selection, clinical diagnosis, appliance design, adjunctive therapies, instructions on ordering our products,
−Removed: guidance on pricing, instruction on insurance reimbursement protocols and interacting with our proprietary software system and
−Removed: the many features on our website.
−Removed: The initial training and educational workshop is typically provided in the first month that
−Removed: a VIP enrolls.
−Removed: Since VIPs are able to begin generating revenue after the first training workshop, we recognize 50% of the service
−Removed: revenue in the second month of enrollment and the remaining 50% pro-rata throughout the following eleven months of the service
−Removed: Ongoing support and additional training are provided throughout the year and include access to our proprietary Airway
−Removed: Intelligence Service (or AIS) which provides VIPs with resources to help simplify the diagnostic and treatment planning process.
−Removed: AIS is provided as part of the price of each appliance and is not a separate revenue stream.
−Removed: Following the year of training and
−Removed: support, a VIP may pay for seminars and training courses that meet the VIP’s needs on a subscription or a course by course
−Removed: In addition to enrollment service revenue, we have more recently launched an additional service on a monthly subscription
−Removed: Billing Intelligence Service (or BIS).
−Removed: Revenue for this service is recognized monthly during the month the service is rendered.
−Removed: identify all goods and services that are delivered separately under a sales arrangement and allocates revenue to each deliverable
−Removed: based on relative fair values.
−Removed: Fair values are generally established based on the relevant service period which approximates the
−Removed: prices for relevant training that would be charged if those services were sold separately.
−Removed: In general, revenues are separated
−Removed: between durable medical equipment (product revenue) and education and training services (service revenue).
−Removed: The allocated revenue
−Removed: for each deliverable is then recognized ratably based on relative fair values of the components of the sale.
−Removed: Revenue from training
−Removed: is recognized over the relevant service period (i.e., as we satisfy our performance obligations and creates value for the VIP).
−Removed: We also evaluate the impact of undelivered items on the functionality of delivered items for each sales transaction and, where
−Removed: appropriate, defer revenue on delivered items when that functionality has been affected.
−Removed: Functionality is determined to be met
−Removed: if the delivered products or services represent a separate earnings process.
−Removed: time to time we offer various discounts to our customers.
−Removed: These include the following:
−Removed: for cash pay in full
−Removed: or trade show incentives
−Removed: concessions on annual enrollment fee
−Removed: amount of the discount is determined up front prior to the sale.
−Removed: Accordingly, measurement is determined before the sale occurs
−Removed: and revenue is recognized based on the terms agreed upon between us and the VIP over the performance period.
−Removed: In rare circumstances,
−Removed: a discount has been given after the sale during a conference which is offering a discount to full price.
−Removed: In this situation revenue
−Removed: is measured and the change in transaction price is allocated over the remaining performance obligation.
−Removed: amount of consideration can vary by customer due to promotions and discounts authorized to incentivize a sale.
−Removed: Prior to the sale,
−Removed: the customer and us agree upon the amount of consideration that the customer will pay in exchange for the services we provide.
−Removed: The net consideration that the customer has agreed to pay is the expected value that is recognized as revenue over the service
−Removed: Any overpayments are refunded during the reporting period so that no refund liability is recognized.
−Removed: At the end of each
−Removed: reporting period, we update the transaction price to represent the circumstances present at the end of the reporting period and
−Removed: any changes in circumstances during the reporting period.
−Removed: addition to revenue from services, we also generate revenue from the sale of our patented oral devices and preformed guides, known
−Removed: as appliances or systems to our customer, the VIP.
−Removed: Revenue from the appliance sale is recognized when control of product is transferred
−Removed: to the VIP in an amount that reflects the consideration we expect to be entitled to in exchange for those products.
−Removed: turn charges the VIP’s patient and/or patient’s insurance a fee for the appliance and for his or her professional
−Removed: services in measuring, fitting, installing the appliance and educating the patient as to its use.
−Removed: We are contracted with the VIP
−Removed: for the sale of the appliance and are not involved in the sale of the products and services from the VIP to the VIP’s patient.
−Removed: appliances are visually similar to a retainer that is worn after braces are removed.
−Removed: Each appliance is specifically fitted to
−Removed: each patient.
−Removed: We utilize our network of certified VIPs throughout the country to sell the appliances to their customers as well
−Removed: as in two centers that we operate.
−Removed: We utilize third party contract manufacturers or labs to produce each appliance and preformed
−Removed: The manufacturer designated by us (of which there are several) produces the appliance in strict adherence to our patents,
−Removed: design files, protocols, processes and procedures and under the direction and specific instruction of us.
−Removed: The manufacturer then
−Removed: ships the appliance to the VIP who ordered the appliance from us.
−Removed: All of our contract manufacturers are required to follow our
−Removed: master design files in production of appliances or the lab will be in violation of the FDA’s rules and regulations.
−Removed: an analysis under ASC Topic 606-10-55-36 through 55-40 and concluded it is the principal in the transaction and is reporting revenue
−Removed: We bill the VIP provider the contracted price for the appliance which is recorded as product revenue.
−Removed: Product revenue is
−Removed: recognized once the appliance ships to the VIP provider under our direction.
−Removed: in 2018, we operated three centers in Colorado and Utah.
−Removed: Effective October 1, 2019, we sold our center in Utah (see Note 4 to
−Removed: the financial statements included as part of this Annual Report on Form 10-K).
−Removed: Within each center, we utilize a team of medical
−Removed: professionals to measure, order and fit each appliance.
−Removed: Upon scheduling the patient (which is our customer in this case), the
−Removed: center takes a deposit and reviews the patient’s insurance coverage.
−Removed: Revenue is recognized differently for our owned centers
−Removed: than for our VIPs.
−Removed: We recognize revenue in the centers after the appliance is received from the manufacturer and once the appliance
−Removed: is fitted and provided to the patient.
−Removed: offer our clinical advisors (who help our VIPs with technical aspects of our products) discounts from our standard VIP pricing.
−Removed: This is done to help encourage our clinical advisors to purchase our products for their own practices.
−Removed: In addition, from time
−Removed: to time, we offer buy one, get one offers and other credits to incentivize our VIPs to embrace our products and increase volume
−Removed: within their practices.
−Removed: board of directors (or the compensation committee thereof) grants share-based payments to employees under our equity incentive
−Removed: plans described below.
−Removed: Historically, this is has come in the form of options to purchase shares of our common stock.
−Removed: Since November
−Removed: 2018, all stock options have been granted with an exercise price of $7.50 per share on post-reverse split basis.
−Removed: Exercise price
−Removed: of such stock options has been consistent with the price offered to private investors in the Company’s private placements
−Removed: during this period, which our board of directors or its compensation committee deemed to be the fair value of the underlying common
−Removed: an accounting perspective, we account for share-based payments to employees by recognizing compensation expense based upon the
−Removed: estimated fair value of the awards on the date of grant.
−Removed: Absent a publicly traded market for our stock, we use the price paid
−Removed: for our stock in the most recent sales to third parties as the stock price input into our valuation model as of the date of grant.
−Removed: We determine the estimated grant fair value using the Black-Scholes option pricing model and recognize compensation costs ratably
−Removed: over the requisite service period which approximates the vesting period using the straight-line method.
−Removed: options issued to consultants, we recognize the estimated fair value of options issued using the Black-Scholes option pricing
−Removed: model at the time the services are rendered.
−Removed: Black-Scholes model requires the input of certain subjective assumptions and the application of judgment in determining the fair
−Removed: value of the awards.
−Removed: The most significant assumptions and judgments include the expected volatility, risk-free interest rate,
−Removed: the expected dividend yield, and the expected term of the awards.
−Removed: The Company accounts for forfeitures as they occur.
−Removed: assumptions used in our option pricing model represent management’s best estimates.
−Removed: If factors change and different assumptions
−Removed: are used, our equity-based compensation expense could be materially different in the future.
−Removed: The key assumptions included in the
−Removed: model are as follows:
−Removed: Price –
−Removed: We use the price of our stock sold to third parties in our offerings as the most available representation of
−Removed: fair value per share of common stock on date of grant.
−Removed: volatility —
−Removed: We determine the expected price volatility based on the historical volatilities of our peer group as we
−Removed: do not have a sufficient trading history for our common stock.
−Removed: Industry peers consist of several public companies in the bio-tech
−Removed: industry similar to us in size, stage of life cycle and financial leverage.
−Removed: We intend to continue to consistently apply this
−Removed: process using the same or similar public companies until a sufficient amount of historical information regarding the volatility
−Removed: of our own stock price becomes available, or unless circumstances change such that the identified companies are no longer
−Removed: similar to us, in which case, more suitable companies whose share prices are publicly available would be utilized in the calculation.
−Removed: interest rate —
−Removed: The risk free rate was determined based on yields of U.S.
−Removed: Treasury Bonds of comparable terms.
−Removed: The volatility
−Removed: is based on analyzing the stock price and implied volatility of guideline companies.
−Removed: dividend yield —
−Removed: We have not previously issued dividends and do not anticipate paying dividends in the foreseeable future.
−Removed: Therefore, we used a dividend rate of zero based on our expectation of additional dividends.
−Removed: We estimate the expected term using the simplified method which is the average of the vesting term and the contractual
−Removed: term of the options.
−Removed: 2017, our board of directors and shareholders approved the adoption of a stock and option award plan (the “2017 Plan”),
−Removed: under which shares were reserved for future issuance for options, restricted stock awards and other equity awards.
−Removed: The 2017 Plan
−Removed: permits grants of equity awards to employees, directors, consultants and other independent contractors.
+Added: Equity compensation
+Added: plans not approved by stockholders:
+Added: 2017 Plan permits grants of equity awards to employees, directors, consultants and other independent contractors.
Our board of directors
and shareholders have approved a total reserve of 1,333,333 shares for issuance under the 2017 Plan.
−Removed: 2019, our board of directors and shareholders approved the adoption of a stock and option award plan (the “2019 Plan”),
−Removed: under which shares were reserved for future issuance for options, restricted stock awards and other equity awards.
−Removed: The 2019 Plan
−Removed: permits grants of equity awards to employees, directors, consultants and other independent contractors.
+Added: 2019 Plan permits grants of equity awards to employees, directors, consultants and other independent contractors.
Our board of directors
−Removed: and shareholders have approved a total reserve of 333,334 shares for issuance under the 2019 Plan.
−Removed: On June 18, 2020, our shareholders
−Removed: approved an amendment and restatement of the 2019 Plan to increase the number shares or our common stock available for issuance
−Removed: thereunder by 833,333 share of common stock such that, after amendment and restatement of the 2019 Plan, and prior to any grants,
−Removed: 1,166,667 shares of common stock were available under the 2019 Plan.
−Removed: and Diluted Net Loss Per Share
−Removed: net loss per share is computed using the weighted average number of common shares outstanding during the period.
−Removed: Diluted net loss
−Removed: per common share is computed using the weighted average number of common shares outstanding and the weighted average dilutive
−Removed: potential common shares outstanding using the treasury stock method.
−Removed: However, for the years ended December 31, 2020 and 2019,
−Removed: diluted net loss per share is the same as basic net loss per share as the inclusion of weighted average shares of common stock
−Removed: issuable upon the exercise of outstanding warrants and stock options would be anti-dilutive.
−Removed: The numerator in the basic and diluted
−Removed: net loss per share calculation is the net loss attributable to common stockholders, which is the net loss for the year increased
−Removed: by the current year preferred stock dividends accrued.
−Removed: holder of our outstanding Series A Preferred Stock (Dr.
−Removed: Dave Singh, our founder and Chief Medical Officer) was entitled to
−Removed: participate in common stock dividends, if and when declared, on a one-to-one per-share basis.
−Removed: Accordingly, in periods in which
−Removed: we have net income, earnings per share will be computed using the two-class method whereby the pro rata dividends distributable
−Removed: to the holder of our Series A Preferred Stock will be deducted from earnings applicable to common stockholders, regardless of
−Removed: whether a dividend is declared for such undistributed earnings.
−Removed: For the years ended December 31, 2020 and 2019, we incurred a
−Removed: net loss and, accordingly, there were no undistributed earnings to allocate under the two-class method.
−Removed: following table summarizes outstanding common stock securities not included in the computation of diluted net loss per common
−Removed: share as their inclusion would be anti-dilutive:
−Removed: Common stock warrants
−Removed: Common stock options
+Added: and shareholders have approved a total reserve of 2,366,667 shares for issuance out of which 250,000 shares have been exercised under
+Added: the 2019 Plan.
+Added: options granted to officers and employees prior to the approval by our stockholders of the 2017 Plan.
+Added: of the date of this Annual Report on Form 10-K, we have not paid any cash dividends to stockholders.
+Added: The declaration of any future cash
+Added: dividend will be at the discretion of our board of directors and will depend upon our earnings, if any, our capital requirements and
+Added: financial position, the general economic conditions, and other pertinent conditions.
+Added: It is our present intention not to pay any cash
+Added: dividends in the foreseeable future, but rather to reinvest earnings, if any, in our business operations.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.