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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

FORM 10-Q

 

Quarterly Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
   
  For the quarterly period ended September 30, 2022
   
Transition Report pursuant to 13 or 15(d) of the Securities Exchange Act of 1934
   
  For the transition period from __________  to __________
   
  Commission File Number: 000-25911

 

Skinvisible, Inc.

(Exact name of Registrant as specified in its charter)

 

Nevada 88-0344219
(State or other jurisdiction of incorporation or organization)  (IRS Employer Identification No.)

 

6320 South Sandhill Road, Suite 10, Las Vegas, NV 89120
(Address of principal executive offices)

 

702.433.7154
(Registrant’s telephone number)
 
 _______________________________________________________________
(Former name, former address and former fiscal year, if changed since last report)

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days Yes  No

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes No

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and "emerging growth company" in Rule 12b-2 of the Exchange Act.

 

☐   Large accelerated filer ☐   Accelerated filer
  Non-accelerated Filer Smaller reporting company
    Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.   

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes   No   

 

State the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: 4,539,843 common shares as of November 1, 2022.

 

 1 
Table of Contents 

  

 

  TABLE OF CONTENTS

 

Page

 

PART I – FINANCIAL INFORMATION

 

Item 1: Financial Statements 3
Item 2: Management’s Discussion and Analysis of Financial Condition and Results of Operations 4
Item 3: Quantitative and Qualitative Disclosures About Market Risk 8
Item 4: Controls and Procedures 9

 

PART II – OTHER INFORMATION

 

Item 1: Legal Proceedings 10
Item 1A: Risk Factors 10
Item 2: Unregistered Sales of Equity Securities and Use of Proceeds 10
Item 3: Defaults Upon Senior Securities 10
Item 4: Mine Safety Disclosure 10
Item 5: Other Information 10
Item 6: Exhibits 10

 

 2 
Table of Contents 

 

PART I - FINANCIAL INFORMATION

 

  Item 1. Financial Statements

 

Our consolidated financial statements included in this Form 10-Q are as follows:

 

  F-1 Consolidated Balance Sheets as of September 30, 2022 and December 31, 2021 (unaudited);
 
  F-2 Consolidated Statements of Operations for the three and nine months ended September 30, 2022 and 2021 (unaudited);
     
  F-3 Consolidated Statements of Stockholders’ Equity (Deficit) for the nine months ended September 30, 2022 and 2021 (unaudited);
     
  F-4 Consolidated Statements of Cash Flow for the nine months ended September 30, 2022 and 2021 (unaudited);
     
  F-5 Notes to Consolidated Financial Statements.

 

These consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and the SEC instructions to Form 10-Q. In the opinion of management, all adjustments considered necessary for a fair presentation have been included. Operating results for the interim period ended September 30, 2022 are not necessarily indicative of the results that can be expected for the full year.

 

 3 
Table of Contents 

SKINVISIBLE, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

       
   September 30, 2022  December 31, 2021
ASSETS      
Current assets          
Cash  $127,413   $66,037 
Accounts receivable   5,000    82 
Prepaid expense and other current assets   5,685    8,125 
Total current assets   138,098    74,244 
           
Patents and trademarks, net   141,060    153,055 
           
Total assets  $279,158   $227,299 
          .  
LIABILITIES AND STOCKHOLDERS' DEFICIT          
Current liabilities          
Accounts payable and accrued liabilities  $1,110,931   $1,039,661 
Accrued interest payable   1,835,574    1,475,067 
Loans from related party         27,299 
Loans payable   433,600    433,600 
Convertible notes payable   220,000    40,000 
Derivative liability   21,945    45,664 
Total current liabilities   3,622,050    3,061,291 
           
Convertible notes payable related party, net of unamortized discount of $1,380,529 and $1,837,918 respectively   2,839,680    2,382,291 
        
Convertible notes payable, net of unamortized debt discount of $114,621 and $152,642, respectively   57,454    199,433 
           
Total liabilities   6,519,184    5,643,015 
           
Stockholders' deficit          
Common stock; $0.001 par value; 200,000,000 shares authorized; 4,539,843 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively   4,540    4,540 
Additional paid-in capital   30,352,905    30,352,905 
Accumulated deficit   (36,597,471)   (35,773,161)
Total stockholders' deficit   (6,240,026)   (5,415,716)
           
Total liabilities and stockholders' deficit  $279,158   $227,299 

See Accompanying Notes to Condensed Consolidated Financial Statements.

 

 F-1 
Table of Contents 

SKINVISIBLE, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

                                 
   Three months ended  Nine months ended
   September 30, 2022  September 30, 2021  September 30, 2022  September 30, 2021
             
             
Revenues  $9,316   $111,421   $274,296   $410,571 
                     
Cost of revenues   3,300          4,808    3,300 
                     
Gross profit   6,016    111,421    269,488    407,271 
                     
Operating expenses                    
Depreciation and amortization   4,729    4,696    14,000    13,244 
Selling general and administrative   128,454    114,578    376,204    353,487 
Total operating expenses   133,183    119,274    390,204    366,731 
                     
Loss from operations   (127,167)   (7,853)   (120,716)   40,540 
                     
Other income and (expense)                    
Gain/(loss) on settlement of debt         19,272    144,379    102,825 
Interest expense   (291,178)   (294,216)   (871,692)   (886,207)
Gain/(loss) on change in derivative liability   277    79,445    23,719    (164,529)
Total other income (expense)   (290,901)   (195,499)   (703,594)   (947,911)
                     
Net income (loss)  $(418,068)  $(203,352)  $(824,310)  $(907,371)
                     
Basic income (loss) per common share  $(0.09)  $(0.04)  $(0.18)  $(0.20)
                     
Fully diluted income (loss) per common share  $(0.09)  $(0.04)  $(0.18)  $(0.20)
                     
Basic weighted average common  shares outstanding   4,539,843    4,539,843    4,539,843    4,539,843 
                     
Fully diluted weighted average common  shares outstanding   4,539,843    4,539,843    4,539,843    4,539,843 

 

 

See Accompanying Notes to Condensed Consolidated Financial Statements 

 

 F-2 
Table of Contents 

SKINVISIBLE, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT

(UNAUDITED)

                                               
     Common Stock                     
     Shares      Amount      Additional Paid-in Capital     Shares payable    Accumulated Deficit    Total Stockholders' Deficit
 Balance, December 31, 2021   4,539,843   $4,540   $30,352,905   $     $(35,773,161)  $(5,415,716)
 Net loss                           (214,519)   (214,519)
 Balance, March 31, 2022   4,539,843   $4,540   $30,352,905   $     $(35,987,680)  $(5,630,235)
 Net loss                           (191,723)   (191,723)
 Balance, June 30, 2022   4,539,843   $4,540   $30,352,905   $     $(36,179,403)  $(5,821,958)
 Net loss                           (418,068)   (418,068)
 Balance, September 30, 2022   4,539,843   $4,540   $30,352,905   $     $(36,597,471)  $(6,240,026)
                              
 Balance, December 31, 2020   4,539,843   $4,540   $30,241,089   $     $(34,700,408)  $(4,454,779)
 Net loss                           (435,505)   (435,505)
 Balance, March 31, 2021   4,539,843    4,540    30,241,089          (35,135,913)   (4,890,284)
 Derivative liability reclassified to APIC               53,305                53,305
 Net loss                           (268,514)   (268,514)
 Balance, June 30, 2021   4,539,843    4,540    30,294,394          (35,404,427)   (5,105,493)
 Net loss                           (203,352)   (203,352)
 Balance, September 30, 2021   4,539,843    4,540    30,294,394          (35,607,779)   (5,308,845)

 

See Accompanying Notes to Condensed Consolidated Financial Statements 

 F-3 
Table of Contents 

SKINVISIBLE, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

                 
   Nine months ended
   September 30, 2022  September 30, 2021
       
Cash flows from operating activities:          
Net Income (loss)  $(824,310)  $(907,371)
Adjustments to reconcile net loss to net cash provided (used) by operating activities:          
Non-cash interest expense         102,825 
Depreciation and amortization   14,000    13,244 
Amortization of debt discount   495,410    495,410 
Gain/(loss) on settlement of debt   (144,379)   (102,825)
Gain/(loss) on change in derivative liability   (23,719)   164,529 
Changes in operating assets and liabilities:          
Decrease (Increase) in prepaid assets   2,440    2,750 
Decrease (Increase) in accounts receivable   (4,918)   2,670 
Increase in accounts payable and accrued liabilities   215,649    168,403 
Decrease in due from related party         (7,616)
Increase in accrued interest   360,507    288,772 
Net cash provided used in operating activities   90,680    220,791 
           
Cash flows from investing activities:          
Purchase of fixed and intangible assets   (2,005)   (20,864)
Net cash used in investing activities   (2,005)   (20,864)
           
Cash flows from financing activities:          
Payments on related party loans         (200)
Proceeds from related party loans   (27,299)      
Payments on loans payable         (106,400)
Payments on convertible notes payable         (65,000)
Payments on convertible notes payable - related party         (15,000)
Net cash provided by (used in) financing activities   (27,299)   (186,600)
           
Net change in cash   61,376    13,327 
           
Cash, beginning of period   66,037    35,896 
           
Cash, end of period  $127,413   $49,223 
           
Supplemental disclosure of cash flow information:          
Cash paid for interest  $5,000   $   
Cash paid for tax  $     $   

See Accompanying Notes to Condensed Consolidated Financial Statements

 F-4 
Table of Contents 

 

SKINVISIBLE, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2022

 

1.       DESCRIPTION OF BUSINESS AND HISTORY

 

Description of business

Skinvisible, Inc., (referred to as the “Company”) is focused on the development and manufacture and sales of innovative topical, transdermal and mucosal polymer-based delivery system technologies and formulations incorporating its patent-pending formula/process for combining hydrophilic and hydrophobic polymer emulsions. The technologies and formulations have broad industry applications within the pharmaceutical, over-the-counter, personal skincare and cosmetic arenas. Additionally, the Company’s non-dermatological formulations, offer solutions for a broad spectrum of markets women’s health, pain management, and others. The Company maintains executive and sales offices in Las Vegas, Nevada.

 

History

The Company was incorporated in Nevada on March 6, 1998, under the name of Microbial Solutions, Inc. The Company underwent a name change on February 26, 1999, when it changed its name to Skinvisible, Inc. The Company’s subsidiary’s name of Manloe Labs, Inc. was also changed to Skinvisible Pharmaceuticals, Inc.

  

Skinvisible, Inc., together with its subsidiaries, shall herein be collectively referred to as the “Company.”

 

2.       BASIS OF PRESENTATION AND GOING CONCERN

 

Basis of presentation

The accompanying unaudited interim financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and with the instructions to Quarterly Report on Form 10-Q and Article 10 of Regulation S-X , and should be read in conjunction with the audited financial statements and notes thereto contained in the Company’s most recent Annual Financial Statements on Form 10-K filed with the SEC on April 15, 2021. In the opinion of management, all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of financial position and the results of operations for the interim period presented have been reflected herein. The results of operations for the interim period are not necessarily indicative of the results to be expected for the full year. Notes to the financial statements which would substantially duplicate the disclosures contained in the audited financial statements for the most recent fiscal period, as reported in the Form 10-K, have been omitted.

 

The condensed consolidated balance sheet at December 31, 2021 has been derived from the audited financial statements at that date, but does not include all of the information and footnotes required by generally accepted accounting principles in the U.S. for complete financial statements.

 

Going concern

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. For the nine months ended September 30, 2022, the Company had a net loss of $824,310. The Company has also incurred cumulative net losses of $36,597,471 since its inception and requires capital for its contemplated operational and marketing activities to take place. These factors, among others, raises substantial doubt about the Company’s ability to continue as a going concern within one year from the date of filing.

 

Managements plans for the Company are to generate the necessary funding through licensing of its core products and to seek additional debt and equity funding. However, the Company’s ability to generate the necessary funds through licensing or raise additional capital through the future issuances of common stock or debt is unknown. The obtainment of additional financing, the successful development of the Company’s contemplated plan of operations, and its transition, ultimately, to the attainment of profitable operations are necessary for the Company to continue operations. The consolidated financial statements of the Company do not include any adjustments that may result from the outcome of these aforementioned uncertainties.

  

 F-5 
Table of Contents 

 

3.       SUMMARY OF SIGNIFICANT POLICIES

 

This summary of significant accounting policies of Skinvisible Inc. is presented to assist in understanding the Company’s consolidated financial statements. The consolidated financial statements and notes are representations of the Company’s management, who are responsible for their integrity and objectivity. These accounting policies conform to accounting principles generally accepted in the United States of America and have been consistently applied in the preparation of the consolidated financial statements.  

 

Principles of consolidation

The consolidated financial statements include the accounts of the Company and its subsidiary Skinvisible Pharmaceuticals Inc. All significant intercompany balances and transactions have been eliminated.

 

Use of estimates

The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates include estimates used to review the Company’s, impairments and estimations of long-lived assets, allowances for uncollectible accounts, inventory valuation, and the valuations of non-cash capital stock issuances. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable in the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

 

Cash and cash equivalents

For purposes of the statement of cash flows, the Company considers all highly liquid investments and short-term instruments with original maturities of three months or less to be cash equivalents.

 

Fair Value of financial instruments

The carrying value of cash, accounts payable and accrued expenses, and debt approximate their fair values because of the short-term nature of these instruments. Management believes the Company is not exposed to significant interest or credit risks arising from these financial instruments

 

Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value maximize the use of observable inputs and minimize the use of unobservable inputs. The Company utilizes a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable.

 

  Level 1 Quoted prices in active markets for identical assets or liabilities. These are typically obtained from real-time quotes for transactions in active exchange markets involving identical assets. The Company uses Level 1 measurements to value the transactions when it issues shares, warrants, options and debt with beneficial conversion features.

 

  Level 2 Quoted prices for similar assets and liabilities in active markets; quoted prices included for identical or similar assets and liabilities that are not active; and model-derived valuations in which all significant inputs and significant value drivers are observable in active markets. These are typically obtained from readily available pricing sources for comparable instruments. The Company did not rely on any Level 2 measurements for any of its transactions in the periods included in these financial statements.

 

  Level 3 Unobservable inputs, where there is little or no market activity for the asset or liability. These inputs reflect the reporting entity’s own beliefs about the assumptions that market participants would use in pricing the asset or liability, based on the best information available in the circumstances. The Company did not rely on any Level 3 measurements for any of its transactions in the periods included in these financial statements.

 

 F-6 
Table of Contents 

 

Revenue recognition

We recognize revenue in accordance with generally accepted accounting principles as outlined in the Financial Accounting Standard Board's (“FASB”) Accounting Standards Codification (“ASC”) 606, Revenue From Contracts with Customers, which requires that five steps be followed in evaluating revenue recognition: (i) identify the contract with the customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price; and (v) recognize revenue when or as the entity satisfied a performance obligation.

 

Product sales – Revenues from the sale of products (Invisicare® polymers) are recognized when title to the products are transferred to the customer and only when no further contingencies or material performance obligations are warranted, and thereby have earned the right to receive reasonably assured payments for products sold and delivered.

 

Royalty sales – We also recognize royalty revenue from licensing our patented product formulations only when earned, with no further contingencies or material performance obligations are warranted, and thereby have earned the right to receive and retain reasonably assured payments.

 

Distribution and license rights sales – We also recognize revenue from distribution and license rights when no further contingencies or material performance obligations are warranted, and thereby have earned the right to receive and retain reasonably assured payments.

 

The Company has made an accounting policy election to exclude from the measurement of the transaction price all taxes assessed by governmental authorities that are collected by the Company from its customers (sales and use taxes, value added taxes, some excise taxes).

 

Accounts Receivable

Accounts receivable is comprised of uncollateralized customer obligations due under normal trade terms requiring payment within 30 days from the invoice date. The carrying amount of accounts receivable is reviewed periodically for collectability. If management determines that collection is unlikely, an allowance that reflects management’s best estimate of the amounts that will not be collected is recorded. Management reviews each accounts receivable balance that exceeds 30 days from the invoice date and, based on an assessment of creditworthiness, estimates the portion, if any, of the balance that will not be collected. As of September 30, 2022 and December 31, 2021, the Company had not recorded a reserve for doubtful accounts.

 

Intangible assets

The Company follows Financial Accounting Standard Board’s (FASB) Codification Topic 350-10 (“ASC 350-10”), “Intangibles – Goodwill and Other”. According to this statement, intangible assets with indefinite lives are no longer subject to amortization, but rather an annual assessment of impairment by applying a fair-value based test.  Under ASC 350-10, the carrying value of assets are calculated at the lowest level for which there are identifiable cash flows.

 

Stock-based compensation

The Company follows the guidelines in FASB Codification Topic ASC 718-10 “Compensation-Stock Compensation”, which requires the measurement and recognition of compensation expense for all share-based payment awards made to employees and directors including employee stock options and employee stock purchases related to an Employee Stock Purchase Plan based on the estimated fair values.

  

Earnings (loss) per share

The Company reports earnings (loss) per share in accordance with FASB Codification Topic ASC 260-10 “Earnings Per Share”, Basic earnings (loss) per share is computed by dividing income (loss) available to common shareholders by the weighted average number of common shares available. Diluted earnings (loss) per share is computed similar to basic earnings (loss) per share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive. Diluted earnings (loss) per share has not been presented for the year ending December 31, 2021, since the effect of the assumed exercise of options and warrants to purchase common shares (common stock equivalents) would have an anti-dilutive effect. There are 23,609,820 additional shares issuable in connection with outstanding options, warrants, stock payable and convertible debts as of September 30, 2022. The shares issuable under each instrument is as follows; 0 shares issuable for options, 0 shares issuable for warrants, and 23,609,820 shares issuable under convertible notes.

  

Recently issued accounting pronouncements

The Company has evaluated all other recent accounting pronouncements and believes that none of them will have a material effect on the Company's financial position, results of operations or cash flows.

  

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4.       INTANGIBLE AND OTHER ASSETS

 

Patents and trademarks and other intangible assets are capitalized at their historical cost and are amortized over their estimated useful lives. As of September 30, 2022, intangible assets total $141,060, net of $143,535 of accumulated amortization. As of December 31, 2021, intangible assets total $153,055, net of $129,536 of accumulated amortization.

 

Amortization expense for the nine months ended September, 2022 and 2021 was $14,000 and $13,244, respectively. License and distributor rights were acquired by the Company in January 1999 and provide exclusive use distribution of polymers and polymer based products. The Company has a non-expiring term on the license and distribution rights. Accordingly, the Company annually assesses this license and distribution rights for impairment and has determined that no impairment write-down is considered necessary as of September 30, 2022.

 

5.        RELATED PARTY TRANSACTIONS

 

During the nine months ended September 30, 2022 and 2021, $0 and $0 was advanced by an officer and $27,299 and $200 was repaid, respectively .

 

As of September 30, 2022 and December 31, 2021, $0 and $27,299 in advances remained due to officers of the company, respectively. All other related party notes have been extinguished or re-negotiated as convertible notes. (See note 9 for additional details.)

 

Convertible Notes Related Party

 

Convertible Notes Payable Related Party consists of the following:   September 30, 2022   December 31, 2021
On June 30, 2019, the Company renegotiated accrued salaries, accrued interest, unpaid reimbursements, cash advances, and outstanding convertible notes for its two officers. Under the terms of the agreements, all outstanding notes totaling $2,464,480, accrued interest of $966,203, accrued salaries of $617,915, accrued vacation of $64,423, unpaid reimbursements of $11,942 and cash advances of $110,245 were converted to promissory notes convertible into common stock with a warrant feature. The convertible promissory notes are unsecured, due five years from issuance, and bear an interest rate of 10%. At the investor’s option until the repayment date, the note may be converted to shares of the Company’s common stock at a fixed price of $0.20 per share along with warrants to purchase one share for every two shares issued at the exercise price of $0.30 per share for three years after the conversion date.
 
The Company has determined the value associated with the beneficial conversion feature in connection with the notes to be $3,369,244. The aggregate beneficial conversion feature associated with these notes has been accreted and charged to interest expenses as a financing expense in the amount of $457,389 and $457,389 during the nine months ended September 30, 2022 and 2021, respectively.
  $ 4,220,209     $ 4,220,209
Unamortized debt discount     (1,380,529 )     (1,837,918)
Total, net of unamortized discount   $ 2,839,680     $ 2,382,291

 

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6.       NOTES PAYABLE

 

Secured debt offering

During the period from May 22, 2013 and December 31, 2018, the Company entered into a 9% notes payable to nineteen investors and received proceeds of $552,000. The notes were due two years from the anniversary date of execution. The Notes are secured by the US Patent rights granted for the Company's Sunscreen Products: US patent number #8,128,913: "Sunscreen Composition with Enhanced UV-A Absorber Stability and Methods.”

 

As of September 30, 2022, $433,600 of the outstanding notes payable are past due and in default and have been classified as current notes payable.

 

7.       CONVERTIBLE NOTES PAYABLE

 

Convertible Notes Payable consists of the following:   September 30,   December 31,
    2022   2021
$40,000 face value 9% secured notes payable to investors, due in 2015. At the investor’s option until the repayment date, the note and related interest may be converted to shares of the Company’s common stock a discount of 90% of the current share price after the first anniversary of the note. The notes are secured by the accounts receivable of a license agreement the Company has with Womens Choice Pharmaceuticals, LLC on its proprietary prescription product, ProCort®. The notes have reached maturity and are now in default, under the notes default provisions the entire balance is now due upon demand.     40,000       40,000
Original issue discount                
Unamortized debt discount                
Total, net of unamortized discount     40,000       40,000
               

 

 

             
On June 30, 2019, the Company renegotiated accrued salaries and interest and outstanding convertible notes for a former employee. Under the terms of the agreements, all outstanding notes totaling $224,064, accrued interest of $119,278, accrued salaries of $7,260 and accrued vacation of $1,473 were converted to a promissory note convertible into common stock with a warrant feature. The convertible promissory note is unsecured, due five years from issuance, and bears an interest rate of 10%. At the noteholder’s option until the repayment date, the note may be converted to shares of the Company’s common stock at a fixed price of $0.20 per share along with warrants to purchase one share for every two shares issued at the exercise price of $0.30 per share for three years after the conversion date.
 
The Company has determined the value associated with the beneficial conversion feature in connection with the notes to be $280,076 as valued under the intrinsic value method. The aggregate beneficial conversion feature has been accreted and charged to interest expenses in the amount of $38,021 and $38,201 for the nine months ended September 30, 2022 and 2021, respectively.
    352,075       352,075
Unamortized debt discount     (114,621 )     (152,642)
Total, net of unamortized discount     277,454       239,433
Current portion:     220,000       40,000
Total long-term convertible notes   $ 57,454     $ 199,433

 

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8.       STOCK OPTIONS AND WARRANTS

 

The following is a summary of option activity during the nine months ended September 30, 2022.

 

   Number of Shares  Weighted Average Exercise Price
Balance, December 31, 2021   30,000    1.51 
           
Options granted and assumed            
Options expired   (30,000)   1.51 
Options canceled            
Options exercised            
           
Balance, September 30, 2022            

 

As of September 30, 2022, there are no stock options outstanding.

 

9.    COMMITMENTS AND CONTINGENCIES

 

License Agreement

 

On October 17, 2019, Skinvisible entered an Exclusive License Agreement with Quoin pursuant to which Skinvisible granted to Quoin a license to certain patents for the development of products for commercial sale. In exchange for the license, Quoin agreed to pay to Skinvisible a license fee of $1,000,000 and a royalty percentage on all net sales on the licensed products subject to adjustment in certain situations. The agreement also requires that Quoin make certain milestone payments to Skinvisible upon achieving regulatory approval milestones for certain drug products.

 

The agreement is subject to termination, if among other things, 50% of the license fee is not paid by December 31, 2019 and if the full License Fee is not paid by March 31, 2020. No payments were made by Quoin and the agreement was terminated on December 31, 2019. Both Parties subsequently determined that they continue to see the value in a partnership and therefore on May 8, 2020 and again on July 31, 2020 the companies agreed to extend the Exclusive License Agreement, as amended under the same terms to expire on September 30, 2020   and on January 27, 2021 the companies agreed to revise the milestone payments due under the agreement and to extend the agreement indefinitely.

 

On June 14, 2021, the Company entered into an amendment to change the terms of the license Fee as shown below.

 

As partial consideration for the rights conveyed by Skinvisible under this Agreement, Licensee agrees to pay to Skinvisible a one-time, non-refundable, non-creditable license issue fee of one million USD dollars (USO $1,000,000) (''License Fee'').

 

As of September 30, 2022, the Company has recognized $1,000,000 under the agreement including $250,000 during the nine months ended September 30, 2022.

 

On February 3, 2020, we entered into a License Agreement with Ovation Science Inc. pursuant to which Skinvisible granted to Ovation Science Inc. a license for the manufacture and distribution rights to its hand sanitizer product, DermSafe. In exchange for the license, Ovation Science Inc. agreed to pay to Skinvisible a royalty percentage on all net sales on the licensed products subject to adjustment in certain situations plus a license fee payable in year 3 of the agreement if it chooses to continue the license. On June 10, 2020, the agreement was further amended to provide additional assignment rights for its hand sanitizer products in exchange for $100,000

  

 10.       STOCKHOLDERS’ DEFICIT

 

The Company is authorized to issue 200,000,000 shares of $0.001 par value common stock. The Company had 4,539,843 and 4,539,843 issued and outstanding shares of common stock as of September 30, 2022 and December 31, 2021, respectively.

 

11.       SUBSEQUENT EVENTS

 

In accordance with ASC Topic 855-10, the Company has analyzed its operations subsequent to September 30, 2022 to the date these financial statements were available to be issued and has determined that it does not have any material subsequent events to disclose in these financial statements.  

 

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  Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations Forward-Looking Statements

 

Certain statements, other than purely historical information, including estimates, projections, statements relating to our business plans, objectives, and expected operating results, and the assumptions upon which those statements are based, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements generally are identified by the words “believes,” “project,” “expects,” “anticipates,” “estimates,” “intends,” “strategy,” “plan,” “may,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. We intend such forward-looking statements to be covered by the safe-harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995, and are including this statement for purposes of complying with those safe-harbor provisions. Forward-looking statements are based on current expectations and assumptions that are subject to risks and uncertainties which may cause actual results to differ materially from the forward-looking statements. Our ability to predict results or the actual effect of future plans or strategies is inherently uncertain. Factors which could have a material adverse affect on our operations and future prospects on a consolidated basis include, but are not limited to: changes in economic conditions, legislative/regulatory changes, availability of capital, interest rates, competition, and generally accepted accounting principles. These risks and uncertainties should also be considered in evaluating forward-looking statements and undue reliance should not be placed on such statements. We undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Further information concerning our business, including additional factors that could materially affect our financial results, is included herein and in our other filings with the SEC.

 

Company Overview

 

We, through our wholly owned subsidiary Skinvisible Pharmaceuticals Inc., are a pharmaceutical research and development (“R&D”) company that has developed and patented an innovative polymer delivery system, Invisicare® and formulated over forty topical skin products, which we out-license globally. We were incorporated in 1998, and target an estimated $80 billion global skincare and dermatology market and a $30 billion global over-the-counter market as well as other healthcare / medical and consumer goods markets.

 

With the research and development complete on forty products and numerous patents issued (technology and product patents), we are ready to monetize our investment. Our business model will continue to be to out-license our patented prescription and over-the-counter (“OTC”) products featuring Invisicare to established manufacturers and marketers of brands internationally and to maximize profits from the products we have already out-licensed.

 

The opportunity for us to license our products continues to be a viable model as the need for pharmaceutical companies to access external R&D companies for new products due to their own down-sizing or elimination of internal R&D departments. The demand for our products is enhanced due to the granting of key US and international patents and the completed development of a number of unique products. 

 

  

Our Flagship Product

 

Pivotal to our success is our patented polymer delivery system technology Invisicare. Invisicare is a patented polymer delivery system that enhances the delivery of active ingredients for topically applied skin care products. Its patented technology has a unique formula and process for combining active ingredients with a delivery system that extends the duration of time the product remains on the skin and active.

  

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Invisicare is specifically formulated to carry water insoluble active and certain cationic active ingredients in water-based products without the use of alcohol, silicones, waxes, or other organic solvents. Products utilizing Invisicare have the proven ability to bond active ingredients to the skin for up to four hours and longer. They are non-occlusive and allow normal skin respiration and perspiration while moisturizing and protecting against exposure from a wide variety of environmental irritants.

When topically applied, these formulated products adhere to the skin's outer layers, forming a protective bond, resisting wash-off, and delivering targeted levels of therapeutic or cosmetic skincare agents to the skin. They allow enhanced delivery performance for a variety of skincare agents resulting in improved efficacy, longer duration of action, reduced irritation and lower dosage of active agent required. The "invisible" polymer compositions wear off as part of the natural exfoliation process of the skin's outer layer cells.

 

The advantage of products formulated with Invisicare is (1) Invisicare’s ability to bind active ingredients (the drug) to the skin, forming a protective bond on the skin, for extended periods of time; (2) Invisicare can deliver targeted levels (high or low) of therapeutic or cosmetic ingredients to the skin in a controlled release; (3) Invisicare can help to reduce the irritation of some active ingredients due to how it controls the slower release of that active ingredient; and (4) Invisicare science proves that it provides a protective skin barrier which helps retain the natural moisture content of the skin, while still allowing it to breathe. These benefits present an excellent opportunity for clear scientific advantages and marketing messages which resonate with physicians and consumers.

 

What We Do

 

We have positioned ourselves in the $80 billion worldwide prescription and over-the-counter dermatology and skincare market. We generate revenue by:

 

   • LICENSING: We develop topical prescription and over-the-counter products enhanced with Invisicare to license to pharmaceutical and consumer goods companies around the world for an upfront fee and ongoing royalties;
     
    • CO-DEVELOPMENT: We assist pharmaceutical clients in the early development of the most optimal formulation, which they then take forward into clinical testing;
     
    • LIFE CYCLE MANAGEMENT: We provide cost-effective solutions to global pharmaceutical companies by reformulating their products coming off patent with a new Invisicare patent and new product benefits and line extensions. Pharmaceutical companies are under a lot of pressure to develop innovative strategies to counteract the revenue loss from their drugs coming off patent.

 

License Agreement with Quoin

 

On October 17, 2019, we entered an Exclusive License Agreement with Quoin Pharmaceuticals, Inc., a Delaware corporation (“Quoin”) pursuant to which we granted to Quoin a license to certain patents for the development of products for commercial sale. In exchange for the license, Quoin agreed to pay to us a license fee of $1,000,000 (the “License Fee”) and a single digit royalty interest of all net sales on the licensed products subject to adjustment in certain situations. The agreement also requires that Quoin make certain milestone payments to us upon achieving regulatory approval milestones for certain drug products.

 

The agreement was subject to termination, if among other things, 50% of the license fee is not paid by December 31, 2019 and if the full License Fee is not paid by March 31, 2020. No payments were made by Quoin and the agreement was terminated. Both Parties subsequently determined that they continue to see the value in a partnership and therefore on May 8, 2020 and again on July 31, 2020 the companies agreed to extend the Exclusive License Agreement under the same terms to expire on December 31, 2020, and on January 27, 2021 the companies agreed to revise the milestone payments due under the agreement and to extend the agreement indefinitely.

 

On June 14, 2021, the Company entered into an amendment to change the terms of the license Fee as shown below.

 

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As partial consideration for the rights conveyed by Skinvisible under this Agreement, Licensee agrees to pay to Skinvisible a one-time, non-refundable, non-creditable license issue fee of one million USD dollars (USD $1,000,000) (''License Fee''). To date, Licensee has paid one million US dollars (USD $1,000,000)

  

Additionally, the milestones in the initial agreement were changed as shown below:

 

  (i)     Successful completion of Phase 2 testing: $0
  (ii)     Successful completion of Phase 3 testing: $0
  (iii)    Regulatory approval in either 1· the US or EU, whichever happens first: $5,000,000

 

On June 6, 2022 we announced that Quoin has received U.S. FDA acceptance of its Investigational New Drug (IND) application for its licensed formulation which uses our Invisicare proprietary drug delivery technology. The topical formulation "QRX003" was developed to treat Nethertons Syndrome, a debilitating hereditary disorder that affects the skin, hair and the immune system. There currently is no cure or approved treatment for Netherton Syndrome.

 

With the IND approved, the clinical trial will be underway shortly. We look forward to assisting Quoin in their success and potential FDA approval as well as potentially bringing a treatment to patients suffering from Nethertons Syndrome.

 

Quoin is responsible for obtaining all FDA and other regulatory body approvals necessary to market the products in the US and other countries. Upon the successful completion of various clinical and regulatory milestones, Skinvisible is entitled to receive a milestone payment of $5 million and ongoing royalties from sales.

 

Results of Operations for the Three and Nine Months Ended September 30, 2022 and 2021

 

Revenues

 

Our revenue, which we combine from product sales, royalties on patent licenses and license fees (product development fees), was $9,316 for the three months ended September 30, 2022, a decrease from $111,421 for the same period ended September 30, 2021. Our revenue was $274,296 for the nine months ended September 30, 2022, a decrease from $410,571 for the same period ended September 30, 2021.

 

The revenue for 2022 was mainly from license fees with Quoin and the revenue for 2021 was mainly from license fees with Quoin and Ovation. We hope to generate more revenues from our licenses with Quoin and Ovation for the rest of 2022.

 

Gross Profit

 

We had $3,300 and $4,808 in cost of revenues for the three and nine months ended September 30, 2022, compared with no cost of revenues for the three months ended September 30, 2021 and $3,300 in cost of revenues for the nine months ended September 30, 2021, so our gross profit was $6,016 and $269,488 for the three and nine months ended September 30, 2022, respectively, as compared with gross profit of $111,421 and $407,271 for the three and nine months ended September 30, 2021, respectively.

 

Our gross profit decreased in 2022 due to less revenues from our license with Quoin, and we hope to generate more revenues from our licenses with Quoin and Ovation for the rest of 2022.

 

Operating Expenses

 

Operating expenses increased to $133,183 for the three months ended September 30, 2022 from $119,274 for the same period ended September 30, 2021. Operating expenses increased to $390,204 for the nine months ended September 30, 2022 from $366,731 for the same period ended September 30, 2021. 

 

Our operating expenses for all periods consisted mainly of selling, general and administrative expenses.

 

Our selling, general and administrative expenses for the nine months ended September 30, 2022 consisted mainly of accrued salaries and wages of $245,827 and audit and accounting of $46,528. In comparison, our selling, general and administrative expenses for the nine months ended September 30, 2021 consisted mainly of accrued salaries and wages of $243,826, audit and accounting of $43,102.

 

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Other Expenses

 

We had other expenses of $290,901 for the three months ended September 30, 2022, as compared with other expenses of $195,499 for the three months ended September 30, 2021. We had other expenses of $703,594 for the nine months ended September 30, 2022, as compared with other expenses of $947,911 for the nine months ended September 30, 2021.

 

Our other expenses for the nine months ended September 30, 2022 consisted mainly of interest expense, netted against a gain on settlement of debt and gain on derivative liability changes. Our other expenses for the nine months ended September 30, 2021 consisted mainly of interest expense and a loss on the changes in derivative liability, offset by a gain on the settlement of debt.

 

Net Loss

 

We recorded a net loss of $418,068 for the three months ended September 30, 2022, as compared with a net loss of $203,352 for the three months ended September 30, 2021. We recorded a net loss of $824,310 for the nine months ended September 30, 2022, as compared with a net loss of $907,371 for the nine months ended September 30, 2021. 

 

Liquidity and Capital Resources

 

As of September 30, 2022, we had total current assets of $138,098 and total assets in the amount of $279,158. Our total current liabilities as of September 30, 2022 were $3,622,050. We had a working capital deficit of $3,483,952 as of September 30, 2022, compared with a working capital deficit of $2,987,049 as of December 31, 2021.

 

Operating activities provided $90,680 in cash for the nine months ended September 30, 2022, as compared with $220,791 provided for the nine months ended September 30, 2021. Our positive operating cash flows for 2022 and 2021 was largely the result of changes in operating assets and liabilities, amortization of debt discount offset mainly by the net loss for the periods.

 

We used cash of $2,005 and $20,864 in investing activities for the nine months ended September 30, 2022 and 2021, respectively, for the purchase of fixed and intangible assets.

 

Cash flows used by financing activities during the nine months ended September 30, 2022 amounted to $27,299, as compared with cash used of $186,600 for the nine months ended September 30, 2021. Our negative financing cash flow for the nine months ended September 30, 2022 resulted from payments on related party loans. Our negative financing cash flow for the nine months ended September 30, 2021 resulted from the repayments of debt.

 

The features of the debt instruments and payables concerning our financing activities are detailed in the footnotes to our financial statements.

 

Based upon our current financial condition, we do not have sufficient cash to operate our business at the current level for the next twelve months. We intend to fund operations through increased sales and debt and/or equity financing arrangements, which may be insufficient to fund expenditures or other cash requirements. We plan to seek additional financing in a private equity offering to secure funding for operations. There can be no assurance that we will be successful in raising additional funding. If we are not able to secure additional funding, the implementation of our business plan will be impaired. There can be no assurance that such additional financing will be available to us on acceptable terms or at all.

 

Going concern – The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. We have incurred cumulative net losses of $36,597,471 since our inception and require capital for our contemplated operational and marketing activities to take place. Our ability to raise additional capital through the future issuances of common stock is unknown. The obtainment of additional financing, the successful development of our contemplated plan of operations, and our transition, ultimately, to the attainment of profitable operations are necessary for us to continue operations. The ability to successfully resolve these factors raise substantial doubt about our ability to continue as a going concern. These consolidated financial statements do not include any adjustments that may result from the outcome of these aforementioned uncertainties.

 

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Off Balance Sheet Arrangements

 

As of September 30, 2022, there were no off balance sheet arrangements.

 

Critical Accounting Policies

 

In December 2001, the SEC requested that all registrants list their most “critical accounting polices” in the Management Discussion and Analysis. The SEC indicated that a “critical accounting policy” is one which is both important to the portrayal of a company’s financial condition and results, and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain.

 

Product sales – Revenues from the sale of products (Invisicare® polymers) are recognized when title to the products are transferred to the customer and only when no further contingencies or material performance obligations are warranted, and thereby have earned the right to receive reasonably assured payments for products sold and delivered.

 

Royalty sales – We also recognize royalty revenue from licensing our patented product formulations only when earned, with no further contingencies or material performance obligations are warranted, and thereby have earned the right to receive and retain reasonably assured payments.

 

Distribution and license rights sales – We also recognize revenue from distribution and license rights only when earned (and are amortized over a five-year period), with no further contingencies or material performance obligations are warranted, and thereby have earned the right to receive and retain reasonably assured payments.

 

Costs of Revenue – Cost of revenue includes raw materials, component parts, and shipping supplies. Shipping and handling costs is not a significant portion of the cost of revenue.

  

Accounts Receivable – Accounts receivable is comprised of uncollateralized customer obligations due under normal trade terms requiring payment within 30 days from the invoice date. The carrying amount of accounts receivable is reviewed periodically for collectability. If management determines that collection is unlikely, an allowance that reflects management’s best estimate of the amounts that will not be collected is recorded. Management reviews each accounts receivable balance that exceeds 30 days from the invoice date and, based on an assessment of creditworthiness, estimates the portion, if any, of the balance that will not be collected. As of September 30, 2022, we had not recorded a reserve for doubtful accounts.

 

Recently Issued Accounting Pronouncements

 

We do not expect the adoption of recently issued accounting pronouncements to have a significant impact on our results of operations, financial position or cash flow.

 

  Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

A smaller reporting company is not required to provide the information required by this Item.

 

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  Item 4. Controls and Procedures

 

Disclosure Controls and Procedures

 

We carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of September 30, 2022. This evaluation was carried out under the supervision and with the participation of our Chief Executive Officer and our Chief Financial Officer. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of September 30, 2022, our disclosure controls and procedures were not effective due to the presence of material weaknesses in internal control over financial reporting.

 

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the company’s annual or interim financial statements will not be prevented or detected on a timely basis. Management has identified the following material weaknesses which have caused management to conclude that, as of September 30, 2022, our disclosure controls and procedures were not effective: (i) inadequate segregation of duties and effective risk assessment; and (ii) insufficient written policies and procedures for accounting and financial reporting with respect to the requirements and application of both US GAAP and SEC guidelines.

 

Remediation Plan to Address the Material Weaknesses in Internal Control over Financial Reporting

 

Our company plans to take steps to enhance and improve the design of our internal controls over financial reporting. During the period covered by this quarterly report on Form 10-Q, we have not been able to remediate the material weaknesses identified above. To remediate such weaknesses, we plan to implement the following changes during our fiscal year ending December 31, 2022: (i) appoint additional qualified personnel to address inadequate segregation of duties and ineffective risk management; and (ii) adopt sufficient written policies and procedures for accounting and financial reporting. The remediation efforts set out are largely dependent upon our securing additional financing to cover the costs of implementing the changes required. If we are unsuccessful in securing such funds, remediation efforts may be adversely affected in a material manner.

 

Changes in Internal Control over Financial Reporting

 

There were no changes in our internal control over financial reporting during the nine months ended September 30, 2022 that have materially affected, or are reasonable likely to materially affect, our internal control over financial reporting.

 

 

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PART II – OTHER INFORMATION

 

  Item 1. Legal Proceedings

 

We are not a party to any pending legal proceeding. We are not aware of any pending legal proceeding to which any of our officers, directors, or any beneficial holders of 5% or more of our voting securities are adverse to us or have a material interest adverse to us.

 

  Item 1A. Risk Factors

 

See risk factors included in our Annual Report on Form 10-K for the year ended December 31, 2021 filed on March 31, 2022.

 

  Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

None

 

  Item 3. Defaults upon Senior Securities

 

None

 

  Item 4. Mine Safety Disclosures

 

Not applicable.

 

  Item 5. Other Information

 

None

 

  Item 6. Exhibits

 

Exhibit Number Description of Exhibit

  31.1 Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

  31.2 Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

  32.1 Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

  101** The following materials from the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2022 formatted in Extensible Business Reporting Language (XBRL).

**Provided herewith

 

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Table of Contents 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

Skinvisible, Inc.

 

Date: November 14, 2022

 

By: /s/ Terry Howlett

Terry Howlett

Title: Chief Executive Officer, Chief Financial Officer and Director

 

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