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 develop innovative polymer delivery vehicles and related compositions that hold active ingredients on the skin for extended periods of time when applied topically. We designed a process for combining water soluble and insoluble polymers that is specifically formulated to carry water insoluble active ingredients in water-based
products without the use of alcohol, silicones, waxes, or other organic solvents. This enables active agents the ability to perform their intended functions for an extended period of time. Our polymer delivery vehicles, trademarked Invisicare®, allow normal skin respiration and perspiration. The polymer compositions we develop wear off as part of the natural exfoliation process of the skin's outer layer cells.
We believe Invisicare® offers the following benefits:
§ |
Displays superior skin adherence for extended time periods |
§ |
Non-occlusive yet resists water wash-off, respiration and perspiration |
§ |
Increased efficacy of active ingredients |
§ |
Allows for lower use levels of actives with increased persistence of effect |
§ |
Offers advantage of controlled and/or sustained time-release |
§ |
Highly compatible with a variety of actives and bases |
§ |
Formulates well at a cream, lotion, or spray viscosity |
§ |
Non-irritating emulsion dries quickly with no greasy after-feel |
§ |
Non-occlusive film forms protective barrier against environmental irritants |
§ |
Broad polymer selection to meet application requirements |
§ |
Offers “Life Cycle” management to core products with potential for new patent |
§ |
Simplified manufacturing process |
Products that successfully incorporate Invisicare to date include antimicrobial hand sanitizer lotions, suncare products, skincare moisturizers, sunless tanning products as well as various dermatology products for various skin disorders. On an ongoing basis, we are seeking to develop polymer formulations that can successfully be incorporated
into other products.
Our primary objective is to license Invisicare to established brand manufacturers and marketers of prescription and over-the-counter products in the dermatological, medical, cosmetic, and skincare markets. With the exception of sales to one vendor, our management’s policy is to only sell Invisicare to vendors that have
executed a license agreement with us. We conduct our research and development in-house. We engage an outside party that currently handles all of our manufacturing and distribution needs.
Recent Developments
Our core business is the research and development of products formulated with our patented technology Invisicare. This year we have added a strategic focus on the sale and marketing of these products and developing new Invisicare technologies. Our focus has allowed us to expand our reputation amongst key dermatology, consumer goods
and medical/surgical companies around the globe. It has also allowed us to branch out beyond dermatology into other medical areas that require topically delivered products.
Product Developments
We intend to expand our product offerings. Currently we have over 30 topical products formulated with Invisicare available for licensing. Our products range from acne formations to sunscreens to surgical products. A key addition to our portfolio in 2008 was our UVA/UVB sunscreen with Parsol 1789. Parsol 1789 is the most
used UVA filter in sunscreens in the US and the only ingredient approved by the US FDA that is not proprietary. Our studies show a minimum of eight hour photostability compared to the industry average of two hours. In addition, most sunscreens, even those that indicate they are water resistant, do not remain on the skin after swimming. With our Invisicare technology, sunscreens remain on the skin for 8 to 12 hours and resist wash-off and rub-off. For the international market, we have developed new
sunscreens using a proprietary sunscreen UVA filter from CIBA Specialty Chemicals called Tinasorb. While this ingredient is not yet approved for sale in the US, it is used internationally and we are working with sunscreen companies in Europe and Latin America on this new development.
On April 28th we announced that we have developed a hand sanitizing lotion that has proven effective in killing the H1N1 swine flu virus. Retroscreen Virology of London England conducted the studies with our hand sanitizer lotion called DermSafe. The
product demonstrated it had a greater than 99.99 % inactivation/kill on the H1N1 swine flu virus.
Previously on April 24th the World Health Organization (WHO) issued its first report on the H1N1 swine flu virus in the United States. Then on April 27th they raised the pandemic threat
to a phase 4 – “sustained human to human transmission”. The Center for Disease Control states that the virus spreads the same way the regular flu does; “Flu viruses are spread mainly from person to person through coughing or sneezing of people with influenza. Sometimes people may become infected by touching something with flu viruses on it and then touching their mouth or nose.” On June 11, 2009, WHO raised their pandemic threat to a Phase 6 – “the virus is contagious,
spreading easily from one person to another and from one country to another.” On the same date over 30,000 cases were confirmed in 74 countries. Less than one month later, the confirmed cases tripled in number to over 94,000, and the number continues to grow. Since that date the WHO has estimated that over 1/3 of the world’s population (over 2 billion people) will come done with the disease while the CDC in the US estimates that over 40% of the US population will come down with the disease (over 120
million people).
We have a series of studies demonstrating that DermSafe kills a host of viruses and bacteria, including several influenza viruses such as H1N1 (“swine flu”), H3N2 and H5N1 (“avian bird flu virus”). The active ingredient in DermSafe is chlorhexidine, which has been used in hospitals worldwide for over fifty years as
a pre-surgical hand scrub. DermSafe is available for licensing both commercially in healthcare and food services as well as for personal use (retail) worldwide. DermSafe has been approved for distribution by Health Canada and the company is implementing a plan to seek FDA approval in the US and worldwide.
Patent Developments
We intend to continually generate new patents (intellectual property) on our dermatology and medical products. Every product we formulate is protected by one or more patents. Patent approvals are sought (initially in the U.S. and later internationally) for all products developed. Currently there are 5 patents approved including
the US (3), Australia, India, Japan and China with 9 U.S. patents pending in addition to 34 PCT's internationally, with more to be filed. Some of these PCT patents cover up to 5 products. All patents with Invisicare are owned by Skinvisible.
Patent protection is important to our company. Pharmaceutical companies are pursuing new or improved revenue streams along with protecting their own intellectual properties. Invisicare allows companies to sell a patent-protected product that has been revitalized with new benefits, giving them a new story to help combat generic competitors.
A prescription dermatology product can generate $100 plus million per year; some even $200 plus million – and that is why we believe the investment into a license with an Invisicare formulation is a very viable option for these companies.
We continue to submit for patent protection worldwide for products formulated with Invisicare.
License Agreements
Our current licensees: JD Nelson with Safe4Hours®, DRJ Group with Stopain® and Sunless Beauty with Solerra® all remain focused on expanding their markets in the US and Solerra globally. In 2008, we added two new licensees. Our first addition was for two acne formulations made with adapalene for Panalab Internacional
S.A. for the territory of Latin America. Panalab is a multi-national dermatology company headquartered in Panama with subsidiaries and partners in most Latin American countries. Under the terms of the agreement, Panalab will be responsible for filing and obtaining marketing approval in the countries they have licensed. We received a research and development fee plus a licensing fee allocated as an upfront fee plus milestone payments. In addition, we will receive royalties based on revenues generated by the sale
of the products. According to the agreement, Panalab will have the right to manufacture, distribute, market, sell and promote the Adapalene formulations in the specified territory. Panalabs expect to receive regulatory government approval in the fall of 2009 and be selling in the spring of 2010.
In addition, two more prescription acne products (clindamycin and retinoic acid) were licensed to Embil Pharmaceuticals for Turkey, parts of Asia (Indonesia, Malaysia, and the Philippines) and Azerbaijan, Kazakhstan, Kyrgyzstan, Turkmenistan, and Uzbekistan. Embil is a multi-national dermatology company headquartered in Instanbul, Turkey with
subsidiaries and partners in S.E. Asia. Under the terms of the agreement, Embil will be responsible for filing and obtaining marketing approval in the countries they have licensed. We have received a research and development fee plus a licensing fee allocated as an upfront fee plus milestone payments. In addition, we will receive royalties based on revenues generated by the sale of the products. According to the agreement, Embil will have the right to manufacture, distribute, market, sell and promote the Clindamycin
HCL and Retinoic Acid formulations for acne in the specified territory.
In January 2009, we signed an agreement with RHEI Pharmaceuticals NV, a Belgium based pharmaceutical company that in-licenses pharmaceutical products for sale in China. This agreement gives RHEI the first option to license the exclusive rights for Skinvisible's dermatology products for the territory of China, Hong Kong and Taiwan. Specifically
the agreement is for over-the-counter and prescription dermatology products formulated with Invisicare that have been approved in a reference country. As part of the agreement, RHEI will augment its existing product lines by seeking approval and then marketing and manufacturing Skinvisible's Invisicare dermatology products in the approved territory.
The Chinese pharmaceutical market represents a huge opportunity with an estimated $22.6 billion spent on pharmaceutical drugs in 2007 and growing at an annual rate of nearly 20%. To address this huge growth, the Chinese government has implemented a more effective approval process, one that fits advantageously into the strategic plans of both
Skinvisible and RHEI.
Status of Research and Development for New Applications
We believe that the enhancement and extension of our existing products and the development of new product categories have contributed significantly to our growth to date and are necessary for our continued growth. Our management evaluates new ideas and seeks to develop new products and improvements to existing products to satisfy industry
requirements and changing consumer preferences. We seek to identify trends in consumer preferences and to generate new product ideas. Specific to the objective of generating new products, we are continuing our research and development toward developing additional applications with Invisicare. We are currently at various development stages for the following potential applications using Invisicare:
Skinvisible’s Formulas with Invisicare: |
|
|
ACTIVE INGREDIENT |
TYPE |
Availability |
Patent |
Acne |
|
|
|
Adapalene Cream & Gel (0.1% & 0.3%) |
Rx |
yes* |
pending |
Clindamycin Hydrochloride Cream (1%) |
Rx |
yes* |
pending |
Retinoic Acid Cream (0.1%) |
Rx |
yes* |
pending |
Benzoyl Peroxide (2.5%) Cream |
Rx / OTC |
In development |
pending |
Actinic Keratosis |
|
|
|
Imiquimod Lotion (2%, 3%) |
Rx |
yes |
pending |
Analgesics |
|
|
|
Topical Spray with Menthol (6% & 8%) |
OTC |
yes |
technology |
Topical Roll-On with Menthol (6% & 8%) |
OTC |
yes |
technology |
Topical Cream with Salicylate (10%) |
OTC |
yes |
technology |
Anti-Aging |
|
|
|
Retinol Cream (0.3%) |
Cosmetic |
yes |
technology |
Anti-Fungal |
|
|
|
Terbinafine Cream, Gel (1%) |
OTC |
yes |
pending |
Naftifine Cream (1%) |
Rx |
yes |
pending |
Naftifine (1%) & Hydrocortisone (1%) Cream |
Rx |
yes |
pending |
Clotrimazole Cream (1%) |
OTC |
yes |
pending |
Anti-Inflammatory |
|
|
|
Hydrocortisone Cream (1%) |
OTC |
yes |
technology |
Triamcinolone (1%) |
Rx |
yes |
technology |
Triamcinolone Acetonide (1%) |
Rx |
yes |
technology |
Clobetasole Proprionate (0.05%) |
Rx |
in-progress |
technology |
Betamethasone (1%) |
Rx |
yes |
technology |
Antimicrobial Lotions |
|
|
|
Triclosan Lotion (1%) with Nonoxynol-9 |
OTC |
yes* |
granted |
Triclosan Lotion (1%) with Tomadol 901 |
OTC |
yes* |
granted |
Benzalkonium Chloride Lotion (0.13%) |
OTC |
yes* |
granted |
Chlorhexidine Gluconate Lotion (4%) |
OTC / NDA |
yes |
pending |
Chlorhexidine Gluconate (2%) Pre-Surgical Prep |
NDA |
yes |
pending |
Atopic Dermatitis / Super Moisturizers |
|
|
|
Non-Steroidal Atopic Dermatitis Cream 1% Hyaluronic Acid |
Rx / Cosmetic |
yes |
technology |
Skin Protectant Lotion with Allantoin (1%) |
OTC |
yes |
technology |
Super Moisturizer with Ectoin |
Cosmetic |
yes |
technology |
Urea Moisturizer (25% & 30%) |
Cosmetic |
yes |
technology |
UVA / UVB Sunscreen |
|
|
|
Parsol 1789 - SPF 15 / 30 / 50 Lotion |
OTC |
yes |
pending |
Tinosorb S – SPF 15 / 30 / 50 Lotion |
OTC |
yes |
pending |
Other |
|
|
|
Scar Lotion with Onion Bulb |
Cosmetic |
yes |
technology |
Fragrance – Long Lasting Gel |
Cosmetic |
yes |
technology |
Long-lasting Sunless Tanner (2.5%, 5% & 9%) |
Cosmetic |
yes |
technology |
After Sun (Aloe) Cream |
Cosmetic |
yes |
technology |
*some territories already licensed
Results of Operations for the Three and Six Months Ended June 30, 2009 and 2008
Revenues
Our total revenue reported for the three months ended June 30, 2009 was $69,023, compared to $181,953 for the three months ended June 30, 2008. Our total revenue reported for the six months ended June 30, 2009 was $146,976, compared to $331,364 for the six months ended June 30, 2008. The decrease in revenues for the three
and six months ended June 30, 2009 from the prior periods is attributable to decreased revenue on license fees.
Cost of Revenues
Our cost of revenues for the three months ended June 30, 2009 increased to $14,139 from the prior period when cost of revenues was $10,674. Our cost of revenues for the six months ended June 30, 2009 increased to $15,560 from the prior period when cost of revenues was $5,798. The increase in our cost of revenues for the three and six months
ended June 30, 2009 from the prior periods is attributable to the revenue base being mainly polymer sales and not licence fees, which have no cost of goods to them.
Gross Profit
Gross profit for the three months ended June 30, 2009 was $54,884, or approximately 80% of sales. Gross profit for the three months ended June 30, 2008 was $171,279, or approximately 94% of sales. The decrease in total gross profit for the three and six months ended June 30, 2009 from the prior periods is attributable to the increase in cost
of revenues.
Operating Expenses
Operating expenses decreased to $454,884 for the three months ended June 30, 2009 from $565,615 for the three months ended June 30, 2008. Our operating expenses for the three months ended June 30, 2009 consisted of depreciation and amortization expenses of $4,003 and selling, general and administrative expenses of $450,881. Our operating expenses
for the three months ended June 30, 2008 consisted of depreciation and amortization expenses of $4,424, and selling, general and administrative expenses of $565,615.
Operating expenses decreased to $835,137 for the six months ended June 30, 2009 from $1,230,533 for the three months ended June 30, 2008. Our operating expenses for the six months ended June 30, 2009 consisted of depreciation and amortization expenses of $8,007 and selling, general and administrative expenses of $827,130. Our operating expenses
for the six months ended June 30, 2008 consisted of depreciation and amortization expenses of $9,779, and selling, general and administrative expenses of $1,230,533.
Other Expenses
We paid more in interest expenses for the three months ended June 30, 2009 than in the prior period ended 2008, resulting in total other expenses of $113,563 as compared with $54,321 for the prior period. We paid less in interest expenses for the six months ended June 30, 2009 than in the prior period ended 2008, resulting in total other expenses
of $175,900 as compared with $216,744 for the prior period.
Net Loss
Net loss for the three months ended June 30, 2009 was $513,563, compared to net loss of $448,657 for the three months ended June 30, 2008. Net loss for the six months ended June 30, 2009 was $879,621, compared to net loss of $1,121,711 for the six months ended June 30, 2008.
Liquidity and Capital Resources
As of June 30, 2009, we had total current assets of $115,702 and total assets in the amount of $195,938. Our total current liabilities as of June 30, 2009 were $746,484. We had a working capital deficit of $630,782 as of June 30, 2009.
Operating activities used $80,500 in cash for six months ended June 30, 2009. Our net loss of $879,621 combined with a decrease in unearned revenue of $50,000 was the primary component of our negative operating cash flow, offset mainly by stock based compensation of $354,881, decrease in prepaid royalty fees of $120,000, interest expenses
paid with common stock of $292,657, and increase in accounts payable and accrued liabilities of $91,094. There were no cash flows used or provided by investing activities during the six months ended June 30, 2009. Cash flows provided by financing activities during the six months ended June 30, 2009 amounted to $74,915 and consisted of $59,051 as proceeds from the issuance of convertible notes payable, $15,000 as proceeds from the issuance of stock, and $864 as proceeds from related party loans.
In order to preserve needed cash to operate our business, we have sought to and have been successful in converting certain of our debt into equity of our company. During the six months ended June 30, 2008, a total of $251,000 represented by loans, accrued compensation and expenses, has been converted into equity under various rates
and terms. We can provide no assurance that we will be able to convert other debt in our company under similar arrangements, or at all, in the future. If we are unable to convert our debt into equity, or raise capital to cover our liabilities, we may not be able to continue as a going concern.
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 June 30, 2009, there were no off balance sheet arrangements.
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 approximately $17,817,346 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 the 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. Our consolidated financial
statements do not include any adjustments that may result from the outcome of these aforementioned uncertainties.
Critical Accounting Policies
In December 2001, the SEC requested that all registrants list their three to five 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. We believe that the following accounting policies fit this definition.
Revenue Recognition
Revenues are recognized during the period in which the revenues are earned. Costs and expenses are recognized during the period in which they are incurred.
Product sales - Revenues from the sale of products 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 – The Company also recognizes royalty revenue from licensing its patent and trademarks, 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 – The Company also recognizes revenue from distribution and license rights 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.
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.
Fixed Assets
Fixed assets are stated at cost less accumulated depreciation. Depreciation is provided principally on the straight-line method over the estimated useful lives of the assets, which are generally 3 to 10 years. The cost of repairs and maintenance is charged to expense as incurred. Expenditures for property betterments and renewals are capitalized.
Upon sale or other disposition of a depreciable asset, cost and accumulated depreciation are removed from the accounts and any gain or loss is reflected in other income (expense).
We periodically evaluate whether events and circumstances have occurred that may warrant revision of the estimated useful life of fixed assets or whether the remaining balance of fixed assets should be evaluated for possible impairment. We use an estimate of the related undiscounted cash flows over the remaining life of the fixed assets in
measuring their recoverability.
Goodwill and Intangible Assets
Beginning January 1, 2002, we adopted Statement of Financial Accounting Standards (“SFAS”) No. 142, “Goodwill and Other Intangible Assets”. According to this statement, goodwill and 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. Fair value for goodwill is based on discounted cash flows, market multiples and/or appraised values as appropriate. Under SFAS No. 142, the carrying value of assets are calculated at the lowest level for which there are identifiable cash flows.
SFAS 142 requires us to compare the fair value of the reporting unit to its carrying amount on an annual basis to determine if there is potential impairment. If the fair value of the reporting unit is less than its carrying value, an impairment loss is recorded to the extent that the fair value of the goodwill within the reporting unit is
less than its carrying value. Upon adoption and during 2002, we completed an impairment review and did not recognize any impairment of goodwill and other intangible assets already included in the financial statements. We expect to receive future benefits from previously acquired goodwill over an indefinite period of time. Accordingly, beginning January 1, 2002, we have foregone all related amortization expense. Prior to January 1, 2002, we amortized goodwill over an estimated useful life ranging from 3 to 15
years using the straight-line method.
Recently Issued Accounting Pronouncements
In March 2008, the FASB issued SFAS No. 161, “Disclosures about Derivative Instruments and Hedging Activities – an amendment of FASB Statement No. 133,” (SFAS “161”) as amended and interpreted, which requires enhanced disclosures about an entity’s derivative and hedging activities and thereby improves
the transparency of financial reporting. Disclosing the fair values of derivative instruments and their gains and losses in a tabular format provides a more complete picture of the location in an entity’s financial statements of both the derivative positions existing at period end and the effect of using derivatives during the reporting period. Entities are required to provide enhanced disclosures about (a) how and why an entity uses derivative instruments, (b) how derivative instruments
and related hedged items are accounted for under Statement 133 and its related interpretations, and (c) how derivative instruments and related hedged items affect an entity’s financial position, financial performance, and cash flows. SFAS No. 161 is effective for financial statements issued for fiscal years and interim periods beginning after November 15, 2008. Early adoption is permitted.
At June 30, 2009, we did not have any derivative instruments or hedging activities. Management is aware of the requirements of SFAS 161 and will disclose when appropriate.
In May 2008, the FASB issued SFAS No. 162, “The Hierarchy of Generally Accepted Accounting Principles.” SFAS 162 will provide framework for selecting accounting principles to be used in preparing financial statements that are presented in conformity with U.S. generally accepted accounting principles (GAAP) for nongovernmental
entities. SFAS 162 will be effective 60 days following the Securities and Exchange Commission’s approval of the Public Company Accounting Oversight Board (“PCAOB”) amendments to AU Section 411. We do not expect the adoption of SFAS 162 will have a material impact on our financial condition or results of operation.
In May 2008, the FASB issued SFAS No. 163, “Accounting for Financial Guarantee Insurance Contracts – an interpretation of FASB Statement No. 60.” SFAS 163 requires that an insurance enterprise recognize a claim liability prior to an event of default (insured event) when there is evidence that credit deterioration
has occurred in an insured financial obligation. This Statement also clarifies how Statement 60 applies to financial guarantee insurance contracts, including the recognition and measurement to be used to account for premium revenue and claim liabilities. Those clarifications will increase comparability in financial reporting of financial guarantee insurance contracts by insurance enterprises. This Statement requires expanded disclosures about financial guarantee insurance contracts. The accounting
and disclosure requirements of the Statement will improve the quality of information provided to users of financial statements. SFAS 163 will be effective for financial statements issued for fiscal years beginning after December 15, 2008. We do not expect the adoption of SFAS 163 will have a material impact on our financial condition or results of operation.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
A smaller reporting company is not required to provide the information required by this Item.
Item 4T. 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 June 30, 2009. This evaluation was carried out under the supervision and with the participation of our Chief Executive Officer and Chief Financial
Officer, Mr. Terry Howlett. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of June 30, 2009, our disclosure controls and procedures are effective. There have been no significant changes in our internal controls over financial reporting during the quarter ended June 30, 2009 that have materially affected or are reasonably likely to materially affect such controls.
Disclosure controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act are recorded, processed, summarized and reported, within the time periods specified in the SEC's rules and forms. Disclosure controls and procedures
include, without limitation, controls and procedures designed to ensure that information required to be disclosed in our reports filed under the Exchange Act is accumulated and communicated to management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosure.
Limitations on the Effectiveness of Internal Controls
Our management does not expect that our disclosure controls and procedures or our internal control over financial reporting will necessarily prevent all fraud and material error. An internal control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system
are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can
occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the internal control. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, control may become inadequate because of
changes in conditions, or the degree of compliance with the policies or procedures may deteriorate.
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.
A smaller reporting company is not required to provide the information required by this Item.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
The information set forth below relates to our issuances of securities without registration under the Securities Act during the reporting period which were not previously included in a Current Report on Form 8-K.
During the three months ended June 30, 2009, we issued 3,000,000 restricted shares of our common stock as a result of entering into a debt conversion agreement with our officer and director, Mr. Terry Howlett, to convert total principal balances of $90,000 into equity. In connection with the debt conversion, we also issued a warrant to Mr.
Howlett to purchase 1,500,000 shares of common stock at a strike price of $0.05 per share for two years.
During the three months ended June 30, 2009, we issued 90,000 restricted shares of our common stock as a result of entering into debt conversion agreements with our directors, Messrs. Brian Piwek and Greg McCartney, to convert total principal balances of $3,600 into equity.
During the three months ended June 30, 2009, we issued 547,000 restricted shares of our common stock as a result of entering into debt conversion agreements with consultants and employees to convert total principal balances of $23,900 into equity.
During the three months ended June 30, 2009, we issued 3,337,500 restricted shares of our common stock as a result of entering into loan conversion agreements with lenders to convert total principal balances and interest of $133,500 into equity.
During the three months ended June 30, 2009, we issued 100,000 restricted shares of our common stock to an employee under the terms of an employment agreement.
During the three months ended June 30, 2009, we issued warrants to purchase 287,500 shares of our common stock at a strike price of $0.05 per share.
These securities were issued pursuant to Section 4(2) of the Securities Act. The holders represented their intention to acquire the securities for investment only and not with a view towards distribution. The investors were given adequate information about us to make an informed investment decision. We did not engage in any general solicitation
or advertising. We directed our transfer agent to issue the stock certificates with the appropriate restrictive legend affixed to the restricted stock.
Item 3. Defaults upon Senior Securities
None
Item 4. Submission of Matters to a Vote of Security Holders
No matters have been submitted to our security holders for a vote, through the solicitation of proxies or otherwise, during the quarterly period ended June 30, 2009.
Item 5. Other Information
None
Exhibit Number |
Description of Exhibit |
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SIGNATURES
In accordance with the requirements of the Securities and Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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Skinvisible, Inc. |
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Date: |
August 18, 2009 |
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By: /s/ Terry Howlett
Terry Howlett
Title: Chief Executive Officer, Chief Financial Officer, and Director |