| |
Item 1. |
Financial Statements |
Our consolidated financial statements included in this Form 10-Q
are as follows:
| |
F-1 |
Consolidated Balance Sheets as of March 31, 2023 and December 31, 2022 (unaudited); |
| |
F-2 |
Consolidated Statements of Operations for the three months ended March 31, 2023 and 2022 (unaudited); |
| |
F-3 |
Consolidated Statements of Stockholders’ Equity (Deficit) for the three months ended March 31, 2023 and 2022 (unaudited); |
| |
F-4 |
Consolidated Statements of Cash Flow for the three months ended March 31, 2023 and 2022 (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 March 31, 2023 are not necessarily indicative of the results that can be expected for the full year.
SKINVISIBLE,
INC.
CONSOLIDATED
BALANCE SHEETS
(UNAUDITED)
| | |
March 31, 2023 | |
December 31, 2022 |
| ASSETS | |
| |
|
| Current assets | |
| | | |
| | |
| Cash | |
$ | 29,138 | | |
$ | 81,378 | |
| Accounts receivable | |
| 5,000 | | |
| 5,000 | |
| Due from related party | |
| 35,182 | | |
| 14,073 | |
| Prepaid expense and other current
assets | |
| 3,810 | | |
| 9,495 | |
| Total current assets | |
| 73,130 | | |
| 109,946 | |
| | |
| | | |
| | |
| Patents and trademarks, net | |
| 132,728 | | |
| 136,847 | |
| | |
| | | |
| | |
| Total assets | |
$ | 205,858 | | |
$ | 246,793 | |
| | |
| | | |
| | |
| LIABILITIES AND STOCKHOLDERS' DEFICIT | |
| | | |
| | |
| Current liabilities | |
| | | |
| | |
| Accounts payable and accrued liabilities | |
$ | 126,057 | | |
$ | 1,201,937 | |
| Accrued interest payable | |
| 2,109,989 | | |
| 1,955,820 | |
| Loans payable | |
| 433,600 | | |
| 433,600 | |
| Convertible notes payable | |
| 40,000 | | |
| 40,000 | |
| Derivative liability | |
| 16,667 | | |
| 13,629 | |
| Total current liabilities | |
| 2,726,313 | | |
| 3,644,986 | |
| | |
| | | |
| | |
| Convertible notes payable related party, net of unamortized
discount of $0 and $1,228,066 respectively | |
| 5,372,402 | | |
| 2,992,143 | |
| |
| | | |
| | |
| Convertible notes payable, net of unamortized debt
discount of $89,273 and $101,808, respectively | |
| 262,802 | | |
| 250,267 | |
| | |
| | | |
| | |
| Total liabilities | |
| 8,361,517 | | |
| 6,887,396 | |
| | |
| | | |
| | |
| Stockholders' deficit | |
| | | |
| | |
| Common stock; $0.001 par value; 200,000,000 shares authorized; 4,539,843
shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively | |
| 4,540 | | |
| 4,540 | |
| Additional paid-in capital | |
| 30,352,905 | | |
| 30,352,905 | |
| Accumulated deficit | |
| (38,513,104 | ) | |
| (36,998,048 | ) |
| Total stockholders' deficit | |
| (8,155,659 | ) | |
| (6,640,603 | ) |
| | |
| | | |
| | |
| Total liabilities and stockholders' deficit | |
$ | 205,858 | | |
$ | 246,793 | |
See Accompanying Notes to Consolidated Financial Statements.
SKINVISIBLE,
INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
| |
|
|
|
|
|
|
|
|
| | |
Three months ended |
| | |
March 31, 2023 | |
March 31, 2022 |
| | |
| |
|
| | |
| |
|
| Revenues | |
$ | 5,000 | | |
$ | 59,980 | |
| | |
| | | |
| | |
| Cost of revenues | |
| — | | |
| 1,508 | |
| | |
| | | |
| | |
| Gross profit | |
| 5,000 | | |
| 58,472 | |
| | |
| | | |
| | |
| Operating expenses | |
| | | |
| | |
| Depreciation and amortization | |
| 4,644 | | |
| 4,593 | |
| Selling general and administrative | |
| 128,260 | | |
| 133,418 | |
| Total operating expenses | |
| 132,904 | | |
| 138,011 | |
| | |
| | | |
| | |
| Loss from operations | |
| (127,904 | ) | |
| (79,539 | ) |
| | |
| | | |
| | |
| Other income and (expense) | |
| | | |
| | |
| Gain/(loss) on settlement of debt | |
| — | | |
| 135,861 | |
| Interest expense | |
| (1,384,114 | ) | |
| (289,569 | ) |
| Gain/(loss) on change in derivative
liability | |
| (3,038 | ) | |
| 18,728 | |
| Total other income (expense) | |
| (1,387,152 | ) | |
| (134,980 | ) |
| | |
| | | |
| | |
| Net income (loss) | |
$ | (1,515,056 | ) | |
$ | (214,519 | ) |
| | |
| | | |
| | |
| Basic income (loss) per common share | |
$ | (0.33 | ) | |
$ | (0.05 | ) |
| | |
| | | |
| | |
| Fully diluted income (loss) per common share | |
$ | (0.33 | ) | |
$ | (0.05 | ) |
| | |
| | | |
| | |
| Basic weighted
average common shares outstanding | |
| 4,539,843 | | |
| 4,539,843 | |
| | |
| | | |
| | |
| Fully diluted
weighted average common shares outstanding | |
| 4,539,843 | | |
| 4,539,843 | |
See Accompanying Notes to Consolidated Financial Statements.
SKINVISIBLE, INC.
CONSOLIDATED STATEMENT OF STOCKHOLDERS' DEFICIT
(UNAUDITED)
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| | |
Common
Stock | |
| |
| |
| |
|
| | |
Shares | |
Amount | |
Additional
Paid-in Capital | |
Shares
payable | |
Accumulated
Deficit | |
Total
Stockholders' Deficit |
| Balance,
December 31, 2022 | |
| 4,539,843 | | |
$ | 4,540 | | |
$ | 30,352,905 | | |
$ | — | | |
$ | (36,998,048 | ) | |
$ | (6,640,603 | ) |
| Net
loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| (1,515,056 | ) | |
| (1,515,056 | ) |
| Balance, March
31, 2023 | |
| 4,539,843 | | |
$ | 4,540 | | |
$ | 30,352,905 | | |
$ | — | | |
$ | (38,513,104 | ) | |
$ | (8,155,659 | ) |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| 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 | ) |
See Accompanying Notes to Consolidated Financial Statements.
SKINVISIBLE,
INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
| |
|
|
|
|
|
|
|
|
| | |
Three months ended |
| | |
March 31, 2023 | |
March 31, 2022 |
| | |
| |
|
| Cash flows from operating activities: | |
| | | |
| | |
| Net Income (loss) | |
$ | (1,515,056 | ) | |
$ | (214,519 | ) |
| Adjustments to reconcile net loss to net cash provided (used) by operating activities: | |
| | | |
| | |
| Depreciation and amortization | |
| 4,644 | | |
| 4,593 | |
| Amortization of debt discount | |
| 1,240,601 | | |
| 164,997 | |
| Gain/(loss) on change in derivative liability | |
| 3,038 | | |
| (18,728 | ) |
| Changes in operating assets and liabilities: | |
| | | |
| | |
| Decrease (Increase) in prepaid assets | |
| 5,685 | | |
| 3,125 | |
| Decrease (Increase) in accounts receivable | |
| — | | |
| (4,947 | ) |
| Decrease (Increase) in due from related party | |
| (21,109 | ) | |
| — | |
| Increase (decrease) in accounts payable and accrued
liabilities | |
| 76,313 | | |
| (95,032 | ) |
| Increase in accrued interest | |
| 154,169 | | |
| 119,571 | |
| Net cash provided used in operating activities | |
| (51,715 | ) | |
| (40,940 | ) |
| | |
| | | |
| | |
| Cash flows from investing activities: | |
| | | |
| | |
| Purchase of intangible assets | |
| (525 | ) | |
| — | |
| Net cash used in investing activities | |
| (525 | ) | |
| — | |
| | |
| | | |
| | |
| Cash flows from financing activities: | |
| | | |
| | |
| Net cash provided by (used in)
financing activities | |
| — | | |
| — | |
| | |
| | | |
| | |
| Net change in cash | |
| (52,240 | ) | |
| (40,940 | ) |
| | |
| | | |
| | |
| Cash, beginning of period | |
| 81,378 | | |
| 66,037 | |
| | |
| | | |
| | |
| Cash, end of period | |
$ | 29,138 | | |
$ | 25,097 | |
| | |
| | | |
| | |
| Supplemental disclosure of cash flow information: | |
| | | |
| | |
| Cash paid for interest | |
$ | — | | |
$ | 5,000 | |
| Cash paid for tax | |
$ | — | | |
$ | — | |
| | |
| | | |
| | |
| SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: | |
| | | |
| | |
| Non-cash investing and financing activities: | |
| | | |
| | |
| Accrued salary settled
with Convertible notes payable related party | |
| 1,152,193 | | |
| — |
See Accompanying Notes to
Consolidated Financial Statements.
SKINVISIBLE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2023
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 March 31, 2023. 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, 2022 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 three months ended March 31, 2023, the Company
had a net loss of $1,515,056 The Company has also incurred cumulative net losses of $38,513,104 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.
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. The carrying amount of the Company’s convertible debt is also stated at a fair value of $5,764,477 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. |
| |
• |
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. |
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 March 31, 2023 and December 31, 2022, 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 three months
ending March 31, 2023, 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 29,295,785 additional shares issuable in connection with outstanding convertible debts as
of March 31, 2023.
Recently
issued accounting pronouncements
In August 2020, the FASB issued ASU 2020-06, “Debt - Debt with Conversion and Other Options
(subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (subtopic 815-40),” which reduces the number
of accounting models in ASC 470-20 that require separate accounting for embedded conversion features. As a result, a convertible debt
instrument will be accounted for as a single liability measured at its amortized cost as long as no other features require bifurcation
and recognition as derivatives. By removing those separation models, the effective interest rate of convertible debt instruments will
be closer to the coupon interest rate. Further, the diluted net income per share calculation for convertible instruments will require
the Company to use the if-converted method. The treasury stock method should no longer be used to calculate diluted net income per share
for convertible instruments. The amendment will be effective for the Company for fiscal years beginning after December 15, 2021, including
interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15,
2020, including interim periods within those fiscal years.
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 March 31, 2023, intangible
assets total $132,728, net of $152,917 of accumulated amortization.
Amortization expense for the three months
ended March 31, 2023 and 2022 was $4,644 and $4,593, 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 March 31, 2023.
5. RELATED PARTY TRANSACTIONS
During the three months ended March 31, 2023
and 2022, the Company paid expense on behalf of an entity controlled by our CEO in the amount of $21,109. As of March 31, 2023 and December
31, 2022, the Company had amounts due from related parties of $35,182 and $4,073, respectively.
Convertible Notes Related Party
| Convertible Notes Payable Related Party consists of the following: |
March 31, 2023 | |
December 31, 2022 |
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. On January 31, 2023 the notes holders settled the Through the
issuance of a new convertible promissory note dated January 31, 2023.
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 $1,075,603
and $105,590
during the period ended March 31, 2023 and 2022, respectively. |
$ | — | | |
$ | 4,220,209 | |
| On January 31, 2023, the Company renegotiated accrued salaries, vacation, and outstanding convertible notes for its two officers. Under the terms of the agreements, all outstanding notes totaling $4,220,209, accrued salaries of $1,062,000, accrued vacation of $90,193 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 $0.10 per share along with warrants to purchase one share for every two shares issued at the exercise price of $0.15 per share for three years after the conversion date. |
| 5,372,402 | | |
| — | |
| |
| — | | |
| (1,228,066 | ) |
| Total, net of unamortized discount |
$ | 5,372,402 | | |
$ | 2,992,143 | |
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 March 31, 2023, $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: |
|
March 31, |
|
December 31, |
| |
|
2023 |
|
2022 |
| $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 $152,642 as valued under the intrinsic value method. The aggregate beneficial conversion feature has been accreted and charged to interest expenses in the amount of $12,535 and $12,535 for the years ended March 31, 2023 and 2022, respectively. |
|
|
352,075 |
|
|
|
352,075 |
| Unamortized debt discount |
|
|
(89,273 |
) |
|
|
(101,808) |
| Total, net of unamortized discount |
|
|
262,802 |
|
|
|
250,267 |
| Total Convertible Notes |
|
$ |
302,802 |
|
|
$ |
290,267 |
| Current portion: |
|
|
40,000 |
|
|
|
40,000 |
| Total long-term convertible notes |
|
$ |
262,802 |
|
|
$ |
250,267 |
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 ($1,000,000).
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.
9. 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 March 31,
2023 and December 31, 2022, respectively.
10. SUBSEQUENT EVENTS
In accordance with ASC Topic 855-10, the Company has
analyzed its operations subsequent to March 31, 2023 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.
| |
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.
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.
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.
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 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 is underway. 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. For information and updates see www.quoipharma.com.
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.
License Agreement with Ovation Science
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, Ovation Science paid us the
fee otherwise due in year 3 and in exchange we extended the term of Ovation Science’s license to 6-years and granted Ovation additional
rights to its hand sanitizer products and assigned Canadian Identification Numbers 02310589 and 02355558, all DermSafe Trademarks, DermSafe
clinical data and the right to patent DermSafe where not currently patented. In exchange for these rights, Ovation Science paid a $100,000
license fee. We completed the required assignments during the year ending December 31, 2020 and recognized $100,000 in revenue.
Results of Operations for the Three Months Ended March 31, 2023 and
2022
Revenues
Our revenue, which we combine from product sales,
royalties on patent licenses and license fees (product development fees), was $5,000 for the three months ended March 31, 2023, a decrease
from $59,980 for the same period ended March 31, 2022.
The decrease in Revenue was primarily the result of
a decrease in license fees.
Gross Profit
We had $0 in cost of revenues for the three months
ended March 31, 2023, compared with $1,508 in cost of revenues for the three months ended March 31, 2022, so our gross profit was $5,000
for the three months ended March 31, 2023, as compared with gross profit of $58,472 for the three ended March 31, 2022.
Our gross profit decreased primarily as a result of decreased
revenue during the three months ended March 31, 2023 We hope to generate more revenues from our licenses with Quoin and Ovation for the
rest of 2023.
Operating Expenses
Operating expenses decreased to $132,904 for the three months
ended March 31, 2023, from $138,011 for the same period ended March 31, 2022.
Our operating expenses for all periods consisted mainly of selling,
general and administrative expenses.
Our selling, general and administrative expenses for the three months
ended March 31, 2023, consisted mainly of accrued salaries and wages of $92,942 and audit and accounting of $17.810. In comparison, our
selling, general and administrative expenses for the three months ended March 31, 2022, consisted primarily of accrued salaries and wages
of $87,942, audit and accounting of $28,809, insurance of $6,744 and amortization of $4,251.
Other Expenses
We had other expenses of $1,387,152 for the three months ended March 31,
2023, as compared with other expenses of $134,980 for the three months ended March 31, 2022.
Our increase in other expenses is primarily a result
of the increased interest expense resulting from the amortization of debt discounts.
Net Loss
We recorded a net loss of $1,515,056 for the three months ended
March 31, 2023, as compared with a net loss of $214,519 for the three months ended March 31, 2022.
Liquidity and Capital Resources
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. The Company has incurred cumulative net losses of $38,513,104 since its inception and requires capital
for its contemplated operational and marketing activities to take place. The Company’s ability to generate the necessary funds through
licensing of its core products or the ability to 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. These factors, among others,
raises substantial doubt about the Company’s ability to continue as a going concern. The consolidated financial statements of the
Company do not include any adjustments that may result from the outcome of these aforementioned uncertainties.
As of March 31, 2023, we had total current assets
of $73,130 and total assets in the amount of $205,858. Our total current liabilities as of March 31, 2023 were $2,726,313. We had a working
capital deficit of $2,653,183 as of March 31, 2023, compared with a working capital deficit of $2,987,049 as of December 31, 2022.
Operating activities used $51,715 in cash for the
three months ended March 31, 2023, as compared with $40,940 used for the three months ended March 31, 2022. Our negative operating cash
flows for 2023 and 2022 was largely the result of our net losses for those quarters, mainly offset by changes in operating assets and
liabilities and the amortization of debt discount.
We used cash of $525 and $0 in investing activities
for the three months ended March 31, 2023 and 2022, respectively, for the purchase of intangible assets.
We had no cash flow from financing activities for
either the three months ended March 31, 2023 or 2022.
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.
Off Balance Sheet Arrangements
As of March 31, 2023, 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 March 31, 2023, 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.
