SKINVISIBLE, INC. 10-Q

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, 2021 ☐ 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 17, 2021. 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 7 Item 4: Controls and Procedures 8 PART II – OTHER INFORMATION Item 1: Legal Proceedings 9 Item 1A: Risk Factors 9 Item 2: Unregistered Sales of Equity Securities and Use of Proceeds 9 Item 3: Defaults Upon Senior Securities 9 Item 4: Mine Safety Disclosure 9 Item 5: Other Information 9 Item 6: Exhibits 9 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 Condensed Consolidated Balance Sheets as of September 30, 2021 and December 31, 2020 (unaudited); F-2 Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2021 and 2020 (unaudited); F-3 Condensed Consolidated Statements of Stockholders’ Equity ( Deficit) for the nine months ended September 30, 2021 and 2020 (unaudited); F-4 Condensed Consolidated Statements of Cash Flow for the nine months ended September 30, 2021 and 2020 (unaudited); F-5 Notes to Condensed Consolidated Financial Statements (unaudited). These condensed 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, 2021 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 (UNAUDITED) September 30, 2021 December 31, 2020 ASSETS Current assets Cash $ 49,223 $ 35,896 Accounts receivable 5,048 7,718 Prepaid expense and other current assets 3,750 6,500 Total current assets 58,021 50,114 Patents and trademarks, net 157,750 150,130 Total assets $ 215,771 $ 200,244 LIABILITIES AND STOCKHOLDERS' DEFICIT Current liabilities Accounts payable and accrued liabilities $ 1,033,900 $ 865,497 Accounts payable related party — 7,616 Accrued interest payable 1,310,145 1,021,373 Loans from related party 52,299 52,499 Loans payable 445,600 552,000 Convertible notes payable 155,000 220,000 Derivative liability 111,224 — Total current liabilities 3,108,168 2,718,985 Convertible notes payable related party, net of unamortized discount of $ 1,990,381 and $ 2,447,770 respectively 2,229,828 1,787,439 Convertible notes payable, net of unamortized debt discount of $ 165,455 and $ 203,476 , respectively 186,620 148,599 Total liabilities 5,524,616 4,655,023 Stockholders' deficit Common stock; $ 0.001 par value; 200,000,000 shares authorized; 4,539,843 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively 4,540 4,540 Additional paid-in capital 30,294,394 30,241,089 Accumulated deficit ( 35,607,779 ) ( 34,700,408 ) Total stockholders' deficit ( 5,308,845 ) ( 4,454,779 ) Total liabilities and stockholders' deficit $ 215,771 $ 200,244 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, 2021 September 30, 2020 September 30, 2021 September 30, 2020 Revenue: Product revenue $ — $ — $ 4,316 $ 7,132 Royalty revenues 3,921 4,183 31,255 14,460 License revenues 107,500 — 375,000 — Revenues related party — 2,633 — 121,246 Cost of revenues — — 3,300 — Gross profit 111,421 6,816 407,271 142,838 Operating expenses Depreciation and amortization 4,696 4,292 13,244 23,973 Selling general and administrative 114,578 121,146 353,487 380,241 Total operating expenses 119,274 125,438 366,731 404,214 Loss from operations ( 7,853 ) ( 118,622 ) 40,540 ( 261,376 ) Other income and (expense) Interest expense ( 294,216 ) ( 291,137 ) ( 886,207 ) ( 891,260 ) Change in fair value of derivative liability 79,445 — ( 164,529 ) — Gain on settlement of debt 19,272 — 102,825 — Total other income (expense) ( 195,499 ) ( 291,137 ) ( 947,911 ) ( 891,260 ) Loss from operations before income taxes ( 203,352 ) ( 409,759 ) ( 907,371 ) ( 1,152,636 ) Provision for income taxes — — — — Net loss $ ( 203,352 ) $ ( 409,759 ) $ ( 907,371 ) $ ( 1,152,636 ) Basic loss per common share $ ( 0.04 ) $ ( 0.09 ) $ ( 0.20 ) $ ( 0.26 ) Fully diluted loss per common share $ ( 0.04 ) $ ( 0.09 ) $ ( 0.20 ) $ ( 0.26 ) Basic weighted average common shares outstanding 4,539,843 4,471,746 4,539,843 4,476,468 Fully diluted weighted average common shares outstanding 4,539,843 4,471,746 4,539,843 4,476,468 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, 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 ) Balance, December 31, 2019 4,471,746 $ 4,472 $ 30,181,555 $ 59,602 $ ( 33,252,796 ) $ ( 3,007,167 ) Net loss — — — — ( 430,084 ) ( 430,084 ) Balance, March 31, 2020 4,471,746 4,472 30,181,555 59,602 ( 33,682,880 ) ( 3,437,251 ) Net loss — — — — ( 312,793 ) ( 312,793 ) Balance, June 30, 2020 4,471,746 4,472 30,181,555 59,602 ( 33,995,673 ) ( 3,750,044 ) Shares issued for shares payable 68,097 68 59,534 ( 59,602 ) — — Net loss — — — — ( 409,759 ) ( 409,759 ) Balance, September 30, 2020 4,539,843 4,540 30,241,089 — ( 34,405,432 ) ( 4,159,803 ) 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, 2021 September 30, 2020 Cash flows from operating activities: Net loss $ ( 907,371 ) $ ( 1,152,636 ) Adjustments to reconcile net loss to net cash provided (used) by operating activities: Non-cash interest expense 102,825 — Amortization of patents and trademarks 13,244 23,973 Amortization of debt discount 495,410 495,550 Gain on settlement of debt ( 102,825 ) — Loss on change in derivative liability 164,529 — Changes in operating assets and liabilities: Decrease in prepaid assets 2,750 1,625 Decrease (Increase) in accounts receivable 2,670 ( 644 ) Increase in accounts payable and accrued liabilities 168,403 249,011 Decrease in due from related party ( 7,616 ) — Increase in accrued interest 288,772 398,709 Net cash provided used in operating activities 220,791 15,588 Cash flows from investing activities: Purchase of fixed and intangible assets ( 20,864 ) ( 16,767 ) Net cash used in investing activities ( 20,864 ) ( 16,767 ) Cash flows from financing activities: Payments on related party loans ( 200 ) ( 15,300 ) Proceeds from related party loans — 27,000 Payments on convertible notes payable ( 65,000 ) — Payments on loans payable ( 106,400 ) — Payments on convertible notes payable - related party ( 15,000 ) Net cash provided by (used in) financing activities ( 186,600 ) 11,700 Net change in cash 13,327 10,521 Cash, beginning of period 35,896 1,298 Cash, end of period $ 49,223 $ 11,819 Supplemental disclosure of cash flow information: Cash paid for interest $ — $ — Cash paid for tax $ — $ — SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: Non-cash investing and financing activities: Common stock payable on extinguishment of debts $ — $ 59,602 See Accompanying Notes to Condensed Consolidated Financial Statements F- 4 Table of Contents SKINVISIBLE, INC. NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS SEPTEMBER 30, 2021 (UNAUDITED) 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, 2020 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, 2021, the Company had a net loss of $ 907,371 . The Company has also incurred cumulative net losses of $ 35,607,779 since its inception and requires capital for its contemplated operational and marketing activities to take place. These factors, among others, raise 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 COVID-19 Pandemic In December 2019, an outbreak of a novel strain of coronavirus originated in Wuhan, China (“COVID-19”) and has since spread worldwide, including to the Unites States, posing public health risks that have reached pandemic proportions (the “COVID-19 Pandemic”). The COVID-19 Pandemic poses a threat to the health and economic wellbeing of our employees, customers and vendors. Like most businesses world-wide, the COVID-19 Pandemic has impacted the Company financially; however, management cannot presently predict the scope and severity with which COVID-19 will impact our business, financial condition, results of operations and cash flows. 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. As of September 30, 2021 and December 31, 2020 the Company had no 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. The carrying amount of the Company’s convertible debt is also stated at a fair value of $ 4,727,284 since the stated rate of interest approximates market rates. 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. F- 6 Table of Contents • 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. Financial assets and liabilities measured at fair value on a recurring basis are summarized below as of September 30, 2021: Level 1 Level 2 Level 3 Total Liabilities Derivative Financial Instruments $ — $ — $ 111,224 $ 111,224 As of September 30, 2021, the Company’s used the following assumptions to value the derivative liabilities using the for Binomial-Lattice valuation model. Stock price was $ 0.11 , term 0.25 years, risk-free discount rate of 0.05 % and volatility of 344.11 % The following table provides a summary of the changes in fair value, including net transfers in and/or out, of the derivative financial instruments, measured at fair value on a recurring basis using significant unobservable inputs: Amount Balance December 31, 2020 $ — Derivative reclassified to additional paid in capital ( 53,305 ) Change in fair market value of derivative liabilities 164,529 Balance September 30, 2021 $ 111,224 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. Revenue from royalty sales is recognized at the point of time in which sales occur which is determined by the receipt of royalty statements. F- 7 Table of Contents 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. Revenue from distribution and license rights is recognized immediately meeting milestones and once collection is substantially probable. 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, 2021 and December 31, 2020, 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 nine months ending September 30, 2021 and 2020, 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 30,689,400 additional shares issuable in connection with outstanding options, warrants, stock payable and convertible debts as of September 30, 2021. The shares issuable under each instrument is as follows; 30,000 shares issuable for options, 40,000 shares issuable for warrants, and 30,619,400 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. In August 2020, FASB issued ASU 2020-06, Accounting for Convertible Instruments and Contracts in an Entity; Own Equity (“ASU 2020-06”), as part of its overall simplification initiative to reduce costs and complexity of applying accounting standards while maintaining or improving the usefulness of the information provided to users of financial statements. Among other changes, the new guidance removes from GAAP separation models for convertible debt that require the convertible debt to be separated into a debt and equity component, unless the conversion feature is required to be bifurcated and accounted for as a derivative or the debt is issued at a substantial premium. As a result, after adopting the guidance, entities will no longer separately present such embedded conversion features in equity, and will instead account for the convertible debt wholly as debt. The new guidance also requires use of the “if-converted” method when calculating the dilutive impact of convertible debt on earnings per share, which is consistent with the Company’s current accounting treatment under the current guidance. The guidance is effective for financial statements issued for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years, with early adoption permitted, but only at the beginning of the fiscal year. The Company is currently evaluating the impact the adoption of ASU 2020-06 will have on the Company’s financial statements F- 8 Table of Contents 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, 2021, intangible assets total $ 157,750 , net of $ 124,840 of accumulated amortization. As of December 31, 2020, intangible assets total $ 150,130 , net of $ 111,596 of accumulated amortization. Amortization expense for the nine months ended September 30, 2021 and 2020 was $ 13,244 and $ 23,973 , 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, 2021. 5. RELATED PARTY TRANSACTIONS Loans From Related Party During the nine months ended September 30, 2021 and 2020, $ 0 and $ 27,000 was advanced by an officer and $ 200 and $ 15,300 was repaid, respectively . As of September 30, 2021 and December 31, 2020, $ 52,299 and $ 52,499 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, 2021 December 31, 2020 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. During the three months ended September 30, 2021, the Company made a $ 15,000 payment toward the principal balance of the note. 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, 2021 and 2020, respectively. $ 4,220,209 $ 4,235,209 Unamortized debt discount ( 1,990,381 ) ( 2,447,770 ) Total, net of unamortized discount $ 2,229,828 $ 1,787,439 F- 9 Table of Contents 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.” During the nine months ended September 30, 2021, the Company entered to settlement agreements to settle various notes. As part of the settlement the principal balance of the note was settled for cash and all interest due through the date of settlement was forgiven. As of September 30, 2021, the Company has recorded a gain on settlement of the debt of $ 64,673 associated with the settlement of $ 41,400 of principal. As of September 30, 2021, $ 445,600 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, 2021 2020 $ 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. The Company evaluated the conversion feature of the note and concluded that it represents an embedded derivative. As of September 30, 2021, the fair value of the derivative is $ 28,703 . The Company determined the derivative was immaterial as of December 31, 2020. 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 October 26, 2015 the Company issued a $ 135,000 face value 9% unsecured notes payable to investors, due October 26, 2017 . After the first anniversary of the note, 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 at a variable conversion price of 90 % of the average trading price of the common stock during the five (5) trading day period ending on the latest complete trading day prior to the conversion date.. 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 note has reached maturity and is in default. The Company evaluated the conversion feature of the note and concluded that it represents an embedded derivative. During the three months ended June 30, 2021, the Company made payments of $ 50,000 on the balance of the note. The fair value of the embedded derivative associated with the payments was $ 43,305 and was recorded to additional paid in capital. As of September 30, 2021, the fair value of the derivative is $ 60,994 . The Company determined the derivative was immaterial as of December 31, 2020. The note has reached maturity and is now in default, under the notes default provisions the entire balance is now due upon demand. During the nine months ended September 30, 2021, the Company entered into a settlement agreements to settle the note. As part of the settlement an initial payment of $ 50,000 was made on the principal balance of the note and all interest due through the date of settlement was forgiven. As of September 30, 2021, the Company has recorded a gain on settlement of the debt of $ 34,320 associated with the settlement and the note had a balance of $ 85,000 as of September 30, 2021. 85,000 135,000 Unamortized debt discount — — Total, net of unamortized discount 85,000 135,000 On February 17, 2016, the Company entered into a convertible promissory note pursuant to which it borrowed $ 20,000 . Interest under the convertible promissory note is 9 % per annum, and the principal and all accrued but unpaid interest was due on February 17, 2018 . The note is convertible at any time following 90 days after the issuance date at noteholders option into shares of our common stock at a variable conversion price of 90 % of the average five day market price of our common stock during the 5 trading days prior to the notice of conversion, subject to adjustment as described in the note. The holder’s ability to convert the note, however, is limited in that it will not be permitted to convert any portion of the note if the number of shares of our common stock beneficially owned by the holder and its affiliates, together with the number of shares of our common stock issuable upon any full or partial conversion, would exceed 4.99% of the Company’s outstanding shares of common stock. The Company evaluated the conversion feature of the note and concluded that it represents an embedded derivative. As of September 30, 2021, the fair value of the derivative is $ 14,351 . The Company determined the derivative was immaterial as of December 31, 2020. The notes have reached maturity and are now in default, under the notes default provisions the entire balance is now due upon demand. 20,000 20,000 Unamortized debt discount — — Total, net of unamortized discount 20,000 20,000 F- 10 Table of Contents On August 11, 2016, the Company entered into a convertible promissory note pursuant to which it borrowed $ 15,000 . Interest under the convertible promissory note is 9 % per annum, and the principal and all accrued but unpaid interest was due on August 11, 2018. The note is convertible into shares of our common stock at a variable conversion price of 90 % of the average market price of our common stock during the 5 trading days prior to the notice of conversion, subject to adjustment as described in the note . The Company evaluated the conversion feature of the note and concluded that it represents an embedded derivative. The fair value of the embedded derivative associated with the payments was $ 10,000 and was recorded to additional paid in capital. On April 15, 2021, the Company entered into a settlement agreements to settle the note. As part of the settlement an initial payment of $ 15,000 was made on the principal balance of the note and all interest due through the date of settlement was forgiven. As of September 30, 2021, the Company has recorded a gain on settlement of the debt of $ 3,832 associated with the settlement of the note. — 15,000 Unamortized debt discount — — Total, net of unamortized discount — 15,000 On January 27, 2017, the Company entered into a convertible promissory note pursuant to which it borrowed $ 10,000 . Interest under the convertible promissory note is 9 % per annum, and the principal and all accrued but unpaid interest is due on January 27, 2019 . The note is convertible into shares of our common stock at a variable conversion price of 90 % of the average market price of our common stock during the 5 trading days prior to the notice of conversion, subject to adjustment as described in the note . The note has reached maturity and is in default. The Company evaluated the conversion feature of the note and concluded that it represents an embedded derivative. As of September 30, 2021, the fair value of the derivative is $ 7,176 . The Company determined the derivative was immaterial as of December 31, 2020. The notes have reached maturity and are now in default, under the notes default provisions the entire balance is now due upon demand. 10,000 10,000 Unamortized debt discount — — Total, net of unamortized discount 10,000 10,000 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 $ 38,201 and $ 12,731 for the nine months ended September 30, 2021 and 2020, respectively. 352,075 352,075 Unamortized debt discount ( 165,455 ) ( 203,476 ) Total, net of unamortized discount 186,620 148,599 Total Convertible Notes $ 341,620 $ 368,599 Current portion: 155,000 220,000 Total long-term convertible notes $ 186,620 $ 148,599 F- 11 Table of Contents 8. 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''). To date, Licensee has paid three hundred ninety-two thousand five hundred US dollars (USD $392,500) of this fee as part of the First Half Payment of the License Fee, $125,000 of which was paid in the year ending December 31, 2020 and $375,000 in the nine months ended September 30, 2021. The balance due of the First Half Payment is one hundred seven thousand five hundred US dollars (USD $107,500) which was received on July 7, 2021. A further payment of two hundred and fifty thousand dollars ($250,000) is due no later than ten (10) business days after receipt by Licensee of additional funding from Altium Capital which coincides with the approval from the SEC on Quoin’s merger with a NASDAQ listed company. On October 28, 2021 Quoin completed a merger with Cellect Biotechnology, Ltd. and completed a securities purchase agreement with Altium Capital. The remaining balance of two hundred and fifty thousand dollars ($250,000) will be paid on December 31, 2021. As of September 30, 2021 the Company has recognized $ 510,800 under the agreement including $ 385,800 during the nine months ended September 30, 2021. 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 . F- 12 Table of Contents 9. STOCK OPTIONS AND WARRANTS The following is a summary of option activity during the nine months ended September 30, 2021. Number of Shares Weighted Average Exercise Price Balance, December 31, 2020 100,000 1.51 Options granted and assumed — — Options expired ( 70,000 ) — Options canceled — — Options exercised — — Balance, September 30, 2021 30,000 1.51 As of September 30, 2021, all stock options outstanding are exercisable. Stock warrants - The following is a summary of warrants activity during the nine months ended September 30, 2021. Number of Shares Weighted Average Exercise Price Balance, December 31, 2020 60,000 $ 1.11 Warrants granted and assumed — — Warrants expired ( 20,000 ) — Warrants canceled — — Warrants exercised — — Balance, September 30, 2021 40,000 $ 1.17 As of September 30, 2021, all stock warrants outstanding are exercisable. 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, 2021 and December 31, 2020, respectively. 11. SUBSEQUENT EVENTS In accordance with ASC Topic 855-10, the Company has analyzed its operations subsequent to September 30, 2021 to the date these financial statements were issued and has determined that it does not have any material subsequent events to disclose in these financial statements. F- 13 Table of Contents 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. Overview COVID-19 The full extent of the impact of the COVID-19 pandemic on our business, operations and financial results will depend on numerous evolving factors that we may not be able to accurately predict at the present time. In an effort to contain COVID-19 or slow its spread, governments around the world have enacted various measures, including orders to close all businesses not deemed “essential,” isolate residents to their homes or places of residence, and practice social distancing when engaging in essential activities. We anticipate that these actions and the global health crisis caused by COVID-19 will negatively impact business activity across the globe. While we have not observed any noticeable impact on our revenue related to these conditions in the past fiscal year, or through the date of this filing, we cannot estimate the impact COVID-19 will have in the future as business and consumer activity decelerates across the globe. We will continue to actively monitor the situation and may take further actions that alter our business operations as may be required by federal, state, local or foreign authorities, or that we determine are in the best interests of our employees, customers, partners and stockholders. It is not clear what the potential effects any such alterations or modifications may have on our business, including the effects on our customers, partners, or vendors, or on our financial results. Recent Developments 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 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. 4 Table of Contents 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''). To date, Licensee has paid three hundred ninety-two thousand five hundred US dollars (USD $392,500) of this fee as part of the First Half Payment of the License Fee. The balance due of the First Half Payment is one hundred seven thousand five hundred US dollars (USD $107,500) which was received on July 7. A further payment of two hundred and fifty thousand dollars ($250,000) is due no later than ten (10) business days after receipt by Licensee of additional funding from Altium Capital which coincides with the approval from the SEC on Quoin’s merger with a NASDAQ listed company, which closed in October. The remaining balance of two hundred and fifty thousand dollars ($250,000) will be paid on December 31, 2021. 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 Results of Operations for the Three and Nine Months Ended September 30, 2021 and 2020 Revenues Our revenue, which we combine from product sales, royalties on patent licenses and license fees (product development fees), was $111,421 for the three months ended September 30, 2021, an increase from $6,816 for the same period ended September 30, 2020. Our revenue was $410,571 for the nine months ended September 30, 2021, an increase from $142,838 for the same period ended September 30, 2020. The revenue for both periods in 2021 was mainly from license fees with Quoin and the revenue for both periods in 2020 was mainly from license fees with Ovation. We hope to generate more revenues from our licenses with Quoin and Ovation for the rest of the year. Gross Profit We had $3,300 in cost of revenues for the nine months ended September 30, 2021, no cost of revenues for the three months ended September 30, 2021, and no cost of revenues for the three and nine months ended September 30, 2020, so our gross profit was $111,421 and $407,271 for the three and nine months ended September 30, 2021, respectively, as compared with gross profit of $6,816 and $142,838 for the three and nine months ended September 30, 2020, respectively. We had some product sales resulting in a reduced gross profit for 2021 as compared with 2020. Our gross profit increased in 2021 due to more revenues from our licenses with Quoin and Ovation expected for the rest of the year, which do not have a cost of revenue component. Operating Expenses Operating expenses increased to $119,274 for the three months ended September 30, 2021 from $125,438 for the same period ended September 30, 2020. Operating expenses decreased to $366,731 for the nine months ended September 30, 2021 from $404,214 for the same period ended September 30, 2020. Our operating expenses for all periods consisted mainly of selling, general and administrative expenses. 5 Table of Contents 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. In comparison, our selling general and administrative expenses for the nine months ended September 30, 2020 consisted mainly of accrued salaries and wages of $263,827 and audit and accounting of $55,089. Other Expenses We had other expenses of $195,499 for the three months ended September 30, 2021, as compared with other expenses of $291,137 for the three months ended September 30, 2020. We had other expenses of $947,911 for the nine months ended September 30, 2021, as compared with other expenses of $891,260 for the nine months ended September 30, 2020. Our other expenses for the three 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. 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. Our other expenses for the nine months ended September 30, 2020 consisted mainly of a loss on the settlement of debt and interest expense. Net Loss We recorded a net loss of $203,352 for the three months ended September 30, 2021, as compared with a net loss of $409,759 for the three months ended September 30, 2020. We recorded a net loss of $907,371 for the nine months ended September 30, 2021, as compared with a net loss of $1,152,636 for the nine months ended September 30, 2020. Liquidity and Capital Resources As of September 30, 2021, we had total current assets of $58,021 and total assets in the amount of $215,771. Our total current liabilities as of September 30, 2021 were $3,108,168. We had a working capital deficit of $3,050,147 as of September 30, 2021, compared with a working capital deficit of $2,668,871 as of December 31, 2020. Operating activities provided $220,791 in cash for the nine months ended September 30, 2021, as compared with $15,588 provided for the nine months ended September 30, 2020. Our positive operating cash flow for each period was largely the result of the amortization of debt discount and changes in accounts payable and accrued liabilities and accrued interest. We used cash of $20,864 and $16,767 in investing activities for the nine months ended September 30, 2021 and 2020, respectively, for the purchase of fixed and intangible assets. Cash flows used by financing activities during the nine months ended September 30, 2021 amounted to $186,600, as compared with cash provided of $11,700 for the nine months ended September 30, 2020. Our negative financing cash flow for the nine months ended September 30, 2021 resulted from the repayments of debt. Our positive financing cash flow for the nine months ended September 30, 2020 consisted of proceeds from related party loans, offset by repayments on the same. 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. 6 Table of Contents 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 $35,607,779 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. Off Balance Sheet Arrangements As of September 30, 2021, there were no off balance sheet arrangements. Critical Accounting Policies The discussion and analysis of our financial condition and results of operations is based upon the accompanying financial statements, which have been prepared in accordance with the accounting principles generally accepted in the United States of America and are expressed in United States dollars. Preparing financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, and expenses. These estimates and assumptions are affected by management’s application of accounting policies. We believe that understanding the basis and nature of the estimates and assumptions involved with the following aspects of our financial statements is critical to an understanding of our financial statements. Recently Issued Accounting Pronouncements In August 2020, FASB issued ASU 2020-06, Accounting for Convertible Instruments and Contracts in an Entity; Own Equity (“ASU 2020-06”), as part of its overall simplification initiative to reduce costs and complexity of applying accounting standards while maintaining or improving the usefulness of the information provided to users of financial statements. Among other changes, the new guidance removes from GAAP separation models for convertible debt that require the convertible debt to be separated into a debt and equity component, unless the conversion feature is required to be bifurcated and accounted for as a derivative or the debt is issued at a substantial premium. As a result, after adopting the guidance, entities will no longer separately present such embedded conversion features in equity, and will instead account for the convertible debt wholly as debt. The new guidance also requires use of the “if-converted” method when calculating the dilutive impact of convertible debt on earnings per share, which is consistent with the Company’s current accounting treatment under the current guidance. The guidance is effective for financial statements issued for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years, with early adoption permitted, but only at the beginning of the fiscal year. The Company is currently evaluating the impact the adoption of ASU 2020-06 will have on the Company’s financial statements. Item 3. Quantitative and Qualitative Disclosures About Market Risk A smaller reporting company is not required to provide the information required by this Item. 7 Table of Contents 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, 2021. 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, 2021, 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, 2021, 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, 2021: (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, 2021 that have materially affected, or are reasonable likely to materially affect, our internal control over financial reporting. 8 Table of Contents 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, 2020 filed on April 15, 2021. 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, 2021 formatted in Extensible Business Reporting Language (XBRL). **Provided herewith 9 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 19, 2021 By: /s/ Terry Howlett Terry Howlett Title: Chief Executive Officer, Chief Financial Officer and Director 10