SKINVISIBLE, INC. 10-K

Skinvisible, Inc. - Form 10-K - December 31, 2024 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ Annual Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2024 ☐ 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) (I.R.S. Employer Identification No.) 6320 South Sandhill Road , Unit 9 , Las Vegas , NV 89120 (Address of principal executive offices) (Zip Code) Registrant’s telephone number: 702 . 433.7154 Securities registered under Section 12(b) of the Exchange Act: Title of each class Name of each exchange on which registered None not applicable Securities registered under Section 12(g) of the Exchange Act: Title of each class Common Stock, par value $0.001 Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes [ ] No [X] Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes [ ] No [X] Indicate by checkmark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act 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 [X] 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 [X] 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. ☐ 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 has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐ Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant's executive officers during the relevant recovery period pursuant to §240.10D-1(b). State the aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the common equity was last sold, or the average bid and asked price of such common equity, as of the last business day of the registrant’s most recently completed second fiscal quarter . $ 3,524,063 Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date. 5,316,843 common shares as of April 10, 2025 1 Table of Contents TABLE OF CONTENTS Page PART I Item 1. Business 3 Item 1A. Risk Factors 7 Item 1B. Unresolved Staff Comments 14 Item 1C. Cybersecurity 14 Item 2. Properties 14 Item 3. Legal Proceedings 14 Item 4. Mine Safety Disclosures 14 PART II Item 5. Market for Registrant’s Common Equity and Related Stockholder Matters and Issuer Purchases of Equity Securities 15 Item 6. [Reserved] 17 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 17 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 20 Item 8. Financial Statements and Supplementary Data 20 Item 9. Changes In and Disagreements With Accountants on Accounting and Financial Disclosure 21 Item 9A. Controls and Procedures 21 Item 9B. Other Information 21 Item 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 21 PART III Item 10. Directors, Executive Officers and Corporate Governance 22 Item 11. Executive Compensation 24 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 25 Item 13. Certain Relationships and Related Transactions, and Director Independence 25 Item 14. Principal Accountant Fees and Services 26 PART IV Item 15. Exhibits, Financial Statement Schedules 27 Item 16. Form 10-K Summary 27 2 Table of Contents PART I Item 1. Business 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. We are also exploring new opportunities in large medical markets outside of the dermatology market such as obesity and other potential markets where a topical or transdermal solution would be a viable alternative. 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 downsizing 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. 3 Table of Contents 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 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 Quoin a license to certain patents for the development of products for commercial sale. In exchange for the license, Quoin paid us a license fee of one million USD dollars (USD $1,000,000) (the “License Fee”) and will additionally pay 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 a milestone payment of $5 million to us upon achieving the first to occur of either FDA or European Union regulatory approval for one product licensed. In addition, and upon the successful approval in the US or European Union, whichever occurs first, Skinvisible is entitled to receive a single digit royalty percentage of Quoins net sales revenues for any licensed product covered by the patent rights licensed under the License Agreement. Plus, Quoin also agreed to pay Skinvisible 25% of any revenues they receive as royalties in the event that they sublicense any licensed products to a third party. On June 6, 2022, the Company announced that its licensee Quoin and its product QRX003, was the first Invisicare delivery technology product to receive U.S. FDA Acceptance of Investigational New Drug Application and that Quoin was actively working towards obtaining necessary FDA and other regulatory approvals for marketing the product in the United States and other countries. On February 14, 2024, the Company announced that there was significant progress in Quoin's clinical trials for product formulations containing Invisicare targeting Netherton Syndrome. The trials focus on the innovative formulation "QRX003," powered by Skinvisible’s Invisicare® proprietary drug delivery technology. The updates include: • Positive Initial Data and Clean Safety Profile: The trials have demonstrated positive initial data and a clean safety profile, leading to the implementation of an optimization plan. • Optimization Plan Implementation: Quoin has increased the size of both clinical trials significantly and adjusted dosing frequency to twice-daily from once-daily for both trials. • Elimination of Lower Dose: In the blinded trial, a lower dose has been eliminated based on the positive outcomes observed. • Protocol Amendment s: Quoin's press release highlights protocol amendments aimed at enhancing the data set and potentially expediting regulatory approval. 4 Table of Contents We believe these protocol amendments could ultimately result in the generation of a highly compelling data set, which could support regulatory filings and approval for QRX003 as the first treatment for Netherton Syndrome. On March 4, 2024, Quoin announced a further milestone: it received FDA Clearance to recruit teen subjects into both ongoing Netherton Syndrome clinical studies. We believe this announcement is important as: • Clearance to include teen patients in both Quoin’s open label and placebo-controlled studies are expected to significantly expand the number of eligible subjects, potentially expedite recruitment and lead to a more robust data set. • This development represents the first ever inclusion of non-adult subjects in Netherton Syndrome clinical studies conducted under an open Investigational New Drug Application. • It is believed that the inclusion of this patient population in Quoin’s studies will be a critical component of the development of a robust data set that could result in regulatory approval with a broad label as QRX003 is being tested both as monotherapy and in conjunction with off-label treatments. On June 27, 2024, Quoin announced an International Expansion of ongoing clinical trials for Netherton Syndrome in Saudia Arabia. The site is currently treating Netherton patients who are eligible for recruitment into Quoin studies. On October 22, 2024, Quoin announced further International Expansion of ongoing clinical trials for Netherton Syndrome with two additional clinical sites to be opened in the United Kingdom where both sites are recognized Centers of Excellence for Netherton Syndrome in the UK. On November 5, 2024, Quoin Pharmaceuticals initiated clinical testing of its lead product in a pediatric Netherton Syndrome patient. This clinical assessment is being performed on a pediatric patient at children’s health Ireland in Dublin; the first evaluation of QRX003, powered by Skinvisible’s Invisicare technology, in a pediatric patient. On December 19, 2024, Quoin Pharmaceuticals announced FDA clearance to initiate a new additional Netherton Syndrome (NS) clinical study for QRX003. The company further announced that the study will be conducted by Dr. Amy Paller, of Northwestern University. It is planned that up to eight subjects will be enrolled into the study and will have QRX003 applied twice daily to greater than 80% of their entire body surface area (BSA) over a 12-week period. By comparison, in Quoin’s ongoing open-label and double-blind clinical studies, QRX003 is applied to approximately 20% of the subject’s BSA, typically the arms and lower leg. This new study, designed to mimic how NS patients will use QRX003 if approved, represents the most extensive use of QRX003 in a clinical setting to date. It is anticipated that the data generated from this study will be used to supplement the data package to support the potential regulatory approval of QRX003 as a treatment for NS. Quoin also announced other key developments, including: • Significant clinical improvements in both open label and pediatric studies including subject's disease classification improved from "severe" to "mild" after 6 weeks dosing; • No adverse events or safety concerns reported to date from each of Quoin's ongoing clinical studies in Netherton Syndrome subjects; and • License of Netherton Syndrome product QRX003 with Invisicare delivery technology in 60 countries. 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. 5 Table of Contents Patent Applications for Transdermal Delivery for Obesity and Glucose-Controlling Agents In May and June of 2024, we filed provisional patent applications covering formulations that leverage Invisicare for the transdermal administration of obesity drugs and glucose-controlling agents for diseases such as diabetes. The patents are titled "Transdermal Delivery Composition for Delivery of CB-1 Receptor Antagonists and/or GLP-1 Receptor Agonists, and Method of Delivery” and “Transdermal Delivery Composition for Delivery of at Least One Glucose Controlling Agent, and Method of Delivering at Least One Glucose Controlling Agent.” The patent applications focus on the use of Invisicare in a transdermal delivery technology designed to incorporate CB-1 receptor antagonists and/or GPL-1 receptor agonists, with drugs known for their potential in obesity management and for glucose-controlling agents, into a lotion that is applied topically to the skin using a metered applicator. Studies have demonstrated the superior transdermal penetration and controlled release of other active compounds using Invisicare's innovative technology, with certain actives exhibiting up to a tenfold increase in transdermal delivery effectiveness. By utilizing Invisicare, we aim to not only offer patients a convenient and effective alternative to traditional oral or injectable therapies but to also enhance drug efficacy and potentially significantly reduce side effects as transdermal delivery avoids first-pass metabolism. Additionally, for long-term treatment of obesity and glucose controlling agents, a transdermal delivery system could feasibly provide a convenient method for administering maintenance doses for these medications. We are actively pursuing strategic partnerships with pharmaceutical and/or biotech companies to facilitate the introduction of the first transdermal obesity therapies to market and to explore the application of its delivery platform across diverse disease domains. Competition Market research indicates there is reasonably limited direct competition for Invisicare and patented products in terms of performance capabilities for topically administered skin products. Many companies are seeking unique delivery systems to enhance their portfolio and purchasing companies that have delivery technology. Nevertheless, our current and potential competitors may have longer operating histories, significantly greater resources and name recognition, and a larger base of customers than we have. Our competitors may also be able to adopt more aggressive pricing policies and devote greater resources to the development, marketing and sale of their products and services than we can. To be competitive, we must continue to invest significant resources in sales and marketing. We may not have sufficient resources to make these investments or to develop the technological advances necessary to be competitive, which in turn will cause our business to suffer and restrict our profitability potential. Government Regulation Cosmetic and Skin Care Regulation Depending upon product claims and formulation, skin care products may be regulated as cosmetics, drugs, devices, or combination cosmetics and drugs. The FDA has authority to regulate cosmetics marketed in the United States under the FDCA and the Fair Packaging and Labeling Act (“FPLA”) and implementing regulations. The Federal Trade Commission (the “FTC”) regulates the advertising of cosmetics under the FTCA. The FDCA prohibits the marketing of adulterated and misbranded cosmetics. Cosmetic ingredients must also comply with the FDA’s ingredient, quality, and labeling requirements and the FTC’s requirements pertaining to truthful and non-misleading advertising. Cosmetic products and ingredients, except for color additives, are not required to have FDA premarket approval. Manufacturers of cosmetics are also not required to register their establishments, file data on ingredients, or report cosmetic-related injuries to the FDA. We will be responsible for substantiating the safety and product claims of the cosmetic products and ingredients before marketing. The FDA or FTC may disagree with our characterization of one or more of the skin care products as a cosmetic or the product claims. This could result in a variety of enforcement actions which could require the reformulation or relabeling of our products, the submission of information in support of the product claims or the safety and effectiveness of our products, or more punitive action, all of which could have a material adverse effect on our business. If the FDA determines we have failed to comply with applicable requirements under the FDCA or FPLA, it can impose a variety of enforcement actions from public warning letters, injunctions, consent decrees, and civil penalties to seizure of our products, total or partial shutdown of our production, and criminal prosecutions. If any of these events were to occur, it could materially adversely affect us. If the FTC determines we have failed to substantiate our claims, it can pursue a variety of actions including disgorgement of profits, injunction from further violative conduct, and consent decrees. 6 Table of Contents Domestic State and Local Government Regulation Some states and local governments in the United States regulate the labeling, operation, sale, and distribution of our skin care products. To the extent additional state or local laws apply, we intend to comply with them. Foreign Government Regulation In general, we will need to comply with the government regulations of each individual country in which our products are to be distributed and sold. These regulations vary in complexity and can be as stringent, and on occasion even more stringent, than FDA regulations in the United States. The level of complexity and stringency is not always precisely understood today for each country, creating greater uncertainty for the international regulatory process. Furthermore, government regulations can change with little to no notice and may result in up-regulation of our product(s), thereby creating a greater regulatory burden for us. We have not yet thoroughly explored the applicable laws and regulations that we will need to comply with in foreign jurisdictions. As a result, it is possible that we may not be permitted to sell our products in foreign markets or expand our business into one or more foreign jurisdictions. Environmental Laws We are not subject to any significant or material environmental regulation in the normal operation of our business. Employees Currently, we have two employees, including our Director and CEO Terry Howlett. Subsidiaries We conduct our operations through our wholly owned subsidiary, Skinvisible Pharmaceuticals, Inc. Item 1A. Risk Factors Risks Related to Our Financial Condition and our Business Our investors may lose their entire investment because our financial status creates a doubt whether we will continue as a going concern. We do not have sufficient cash nor do we have a significant source of revenues to cover our operational costs and allow us to continue as a going concern. The Company anticipates generating revenues through the licensing of its core products and if that is not sufficient we may seek to raise additional operating capital to implement our business plan in an offering of our common stock or debt. Our plan requires capital to operate for the next twelve months. However, there can be no assurance that the revenues generated or that such an offering will be successful. You may lose your entire investment 7 Table of Contents Our failure to raise additional capital or generate cash flows necessary to expand our operations could reduce our ability to compete successfully and adversely affect our results of operations. We need to raise additional funds to achieve our future strategic objectives, and we may not be able to obtain additional debt or equity financing on favorable terms, if at all. If we engage in debt financing, we may be required to accept terms that restrict our ability to incur additional indebtedness, force us to maintain specified liquidity or other ratios or restrict our ability to pay dividends or make acquisitions. If we need additional capital and cannot raise it on acceptable terms, we may not be able to, among other things: • launch, develop and enhance our existing products; • continue to expand our product base, sales and/or marketing efforts; • hire, train and retain employees; or • respond to competitive pressures or unanticipated working capital requirements. Our inability to do any of the foregoing could reduce our ability to compete successfully and adversely affect our results of operations. If we are unable to generate revenues by implementing our business plan, you will lose your entire investment in our company. We have a history of losses from inception and we had an accumulated deficit as of December 31, 2024 of $39,946,142. We have not been able to generate sufficient revenues from licensees, from the sale of our own products or otherwise to cover our expenses. If we are unsuccessful in generating revenues, you could lose your entire investment. If our products or products that are licensed by our licensees are not deemed desirable and suitable for purchase and we cannot establish a customer base, we may not be able to generate sufficient revenues, which would result in a failure of the business and a loss of any investment one makes in our company. The acceptance of our products is critically important to our success. We cannot be certain that the products that we will be offering will be appealing and as a result there may not be any demand for these products and our sales could be limited and we may never realize any significant revenues. In addition, there are no assurances that if we alter or change the products we offer in the future that the demand for these new products will develop and this could adversely affect our business and any possible revenues. If demand for the products that we offer or products that are licensed by our licensees slows, then our business would be materially affected. Demand for our products and products of our licensees, depends on many factors, including: • the economy, and in periods of rapidly declining economic conditions, customers may defer luxury purchases or may choose alternate products; • the competitive environment in the skin care sector or sectors in which products are introduced may force us to reduce prices below our desired pricing level or increase promotional spending; • our ability to anticipate changes in consumer preferences and to meet customers’ needs for skin care products in a timely cost-effective manner; • our ability to maintain efficient, timely and cost-effective production and delivery of the products and services; and, • our ability to identify and respond successfully to emerging trends in the skin care and personal care industries. 8 Table of Contents For the long term, demand for product offerings may be affected by: • the ability to establish, maintain and eventually grow market share in a competitive environment; • our ability to deliver our products in the markets we intend to service, changes in government regulations, currency fluctuations, natural disasters, pandemics and other factors beyond our control may increase the cost of items we purchase, create communication issues or render product delivery difficult which could have a material adverse effect on our sales and profitability; and • restrictions on access to North American markets and supplies. All of these factors could result in immediate and longer term declines in the demand for products that we offer as well as licensed products, which could adversely affect our sales, cash flows and overall financial condition. Because we are new in the marketplace, we may not be able to compete effectively and increase market share. Our current and potential competitors may have longer operating histories, significantly greater resources and name recognition, and a larger base of customers than we have. Our competitors may also be able to adopt more aggressive pricing policies and devote greater resources to the development, marketing and sale of their products and services than we can. To be competitive, we must continue to invest significant resources in sales and marketing. We may not have sufficient resources to make these investments or to develop the technological advances necessary to be competitive, which in turn will cause our business to suffer and restrict our profitability potential. Because we rely on third parties to manufacture our products, we are subject to factors outside of our control to meet our standards or timelines. Our products are manufactured by three third-party manufacturing companies on a purchase order basis. No contractual arrangement are currently in place, except for standard confidentiality agreements. We are dependent on the timeliness and effectiveness of our third-part manufacturers’ efforts. Failure or lack of reliability in the manufacture of our products is likely to result in loss of business. Among other risks: • Our products may fail to provide the expected results; • We may experience limited availability of quality ingredients for manufacturing; • We may experience poor quality manufacturing; • Our products may have new competition from other companies attempting to duplicate our formulas; and • Our customers could experience results different from our test results. Like other retailers, distributors and manufacturers of skin care and personal care products, we face an inherent risk of exposure to product liability claims in the event that the use of the products that we sell results in injury. We may be subjected to various product liability claims, including claims that the products we sell contain contaminants, are improperly labeled or include inadequate instructions as to use or inadequate warnings concerning side effects and interactions with other substances. In addition, we may be forced to defend lawsuits. We cannot predict whether product liability claims will be brought against us in the future or the effect of any resulting adverse publicity on the business. Moreover, we may not have adequate resources in the event of a successful claim against us. The successful assertion of product liability claim against us could result in potentially significant monetary damages. In addition, interactions of the products with other similar products, prescription medicines and over-the-counter drugs have not been fully explored. We may also be exposed to claims relating to product advertising or product quality. People may purchase our products expecting certain physical results, unique to skin care and personal care products. If they do not perceive expected results to occur, certain individuals or groups of individuals may seek monetary retribution. 9 Table of Contents If our products become contaminated, our business could be seriously harmed. We have adopted various quality, environmental, health and safety standards. However, our products may still not meet these standards or could otherwise become contaminated. A failure to meet these standards or contamination could occur in our operations or those of our bottlers, manufacturers, distributors or suppliers. Such a failure or contamination could result in expensive production interruptions, recalls and liability claims. Moreover, negative publicity could be generated even from false, unfounded or nominal liability claims or limited recalls. Any of these failures or occurrences could negatively affect our business and financial performance. Our business may be adversely affected by unfavorable publicity within the skin care markets. Management believes that the skin care market and personal care markets are significantly affected by national media attention. As with any retail provider, future scientific research or publicity may not be favorable to the industry or to any particular product, and may not be consistent with earlier favorable research or publicity. Because of our dependence on consumers’ perceptions, adverse publicity associated with illness or other adverse effects resulting from the use of our products or any similar products distributed by other companies and future reports of research that are perceived as less favorable or that question earlier research, could have a material adverse effect on our business, financial condition and results of operations. We are highly dependent upon consumers’ perceptions of the safety and quality of the products as well as similar products distributed by other companies. Thus, the mere publication of reports asserting that skin care or personal care products may be harmful or questioning their efficacy could have a material adverse effect on our business, financial condition and results of operations, regardless of whether such reports are scientifically supported or whether the claimed harmful effects would be present at the dosages recommended for such products. As we conduct international business transactions, we will be exposed to local business risks in different countries, which could have a material adverse effect on our financial condition or results of operations. We promote and sell our products internationally and our licensees do the same. International operations will be subject to risks inherent in doing business in foreign countries, including, but not necessarily limited to: • new and different legal and regulatory requirements in local jurisdictions; • potentially adverse tax consequences, including imposition or increase of taxes on transactions or withholding and other taxes on remittances and other payments by subsidiaries; • risk of nationalization of private enterprises by foreign governments; • legal restrictions on doing business in or with certain nations, certain parties and/or certain products; and, • local economic, political and social conditions, including the possibility of hyperinflationary conditions and political instability. We may not be successful in developing and implementing policies and strategies to address the foregoing factors in a timely and effective manner in the locations where we will do business. Consequently, the occurrence of one or more of the foregoing factors could have a material adverse effect on our base operations and upon our financial condition and results of operations. Since our products will be available over the Internet in foreign countries and we plan to have customers residing in foreign countries, foreign jurisdictions may require us to qualify to do business in their country. We will be required to comply with certain laws and regulations of each country in which we conduct business, including laws and regulations currently in place or which may be enacted related to Internet services available to the residents of each country from online sites located elsewhere. 10 Table of Contents Because of the nature of our products, we may be subject to government regulations or laws that increase our costs of operations or decrease our ability to generate income. Any failure by us, or by any third party that may manufacture or market our products, to comply with the law, including statutes and regulations administered by the FDA or other U.S. or foreign regulatory authorities, could result in, among other things, warning letters, fines and other civil penalties, suspension of regulatory approvals and the resulting requirement that we suspend sales of our products, refusal to approve pending applications or supplements to approved applications, export or import restrictions, interruption of production, operating restrictions, closure of the facilities used by us or third parties to manufacture our product candidates, injunctions or criminal prosecution. Any of the foregoing actions could have a material adverse effect on our business. Our commercial success depends significantly on our ability to develop and commercialize our potential products without infringing the intellectual property rights of third parties. Our commercial success will depend, in part, on operating our business without infringing the patents or proprietary rights of third parties. Third parties that believe we are infringing on their rights could bring actions against us claiming damages and seeking to enjoin the development, marketing and distribution of our products. If we become involved in any litigation, it could consume a substantial portion of our resources, regardless of the outcome of the litigation. If any of these actions are successful, we could be required to pay damages and/or to obtain a license to continue to develop or market our products, in which case we may be required to pay substantial royalties. However, any such license may not be available on terms acceptable to us or at all. Ultimately, we could be prevented from commercializing a product or forced to cease some aspect of our business operations as a result of patent infringement claims, which would harm our business. The implementation of our business plan relies on our ability to manage growth. If we are not able to manage the growth, our business plan may not be successfully implemented. We expect to expand our operations by increasing our sales and marketing efforts, research and development activities, and escalating our services. The anticipated growth could place a significant strain on our management, and operational and financial resources. Effective management of the anticipated growth shall require expanding our management and financial controls, hiring additional appropriate personnel as required, and developing additional expertise by existing management personnel. However, there can be no assurances that these or other measures we may implement shall effectively increase our capabilities to manage such anticipated growth or to do so in a timely and cost-effective manner. Moreover, management of growth is especially challenging for a company with a short revenue generating history and limited financial resources, and the failure to effectively manage growth could have a material adverse effect on our operations. Our success depends on continuing to hire and retain qualified personnel, including our director and officers and our technical personnel. If we are not successful in attracting and retaining these personnel, our business will suffer. Our success depends substantially on the performance of our management team and key personnel. Currently, we have three employees, including our Director and CEO, Terry Howlett. Due to the specialized technical nature of our business, we are particularly dependent on our technical personnel. Our future success will depend on our ability to attract, integrate, motivate and retain qualified technical, sales, operations, and managerial personnel, as well as our ability to successfully implement a plan for management succession. Competition for qualified personnel in our business areas is intense, and we may not be able to continue to attract and retain key personnel. In addition, if we lose the services of any of our management team or key personnel and are not able to find suitable replacements in a timely manner, our business could be disrupted and we may incur increased operating expenses. 11 Table of Contents If we are unable to attract new distributors and customers, or if our existing distributors and customers do not purchase additional products, the growth of our business and cash flows will be adversely affected. To increase our revenues and cash flows, we must regularly add distributors and customers and sell additional products to our existing distributors and customers. If we are unable to sell our products to customers that have been referred to us, unable to generate sufficient sales leads through our marketing programs, or if our existing or new distributors and customers do not perceive our products to be of sufficiently high value and quality, we may not be able to increase sales and our operating results would be adversely affected. In addition, if we fail to sell new products to existing distributors and customers or new distributors and customers, our operating results will suffer, and our revenue growth, cash flows and profitability may be materially and adversely affected. Key management personnel may leave us, which could adversely affect our ability to continue operations. We are entirely dependent on the efforts of our management because of the time and effort that they devote to us. They oversee all development strategies, supervise any/all future personnel, and implement our business plan. Their loss, or other key personnel in the future, could have a material adverse effect on our business, financial condition, and results of operations. We have identified a material weakness in our internal controls over financial reporting and we cannot provide assurances that this weakness will be effectively remediated or that additional material weaknesses will not occur in the future. 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. As described in Part II, Item 9A, "Controls and Procedures," management identified a material weakness as of December 31, 2024 relating to the lack of an effective risk assessment process that defined clear financial reporting objectives, that identified and evaluated risks of misstatement due to errors over certain financial reporting processes, or that developed internal controls to mitigate those risks. As part of management's evaluation of this material weakness, it has been identified that certain other deficiencies in control activities have materialized as a result of the deficiency in the Company's risk assessment. We are actively engaged in the planning for, and implementation of, remediation efforts to address this material weakness, but there can be no assurance that those efforts will be successful. A material weakness will not be considered remediated until the updated controls have operated for a sufficient period of time and management has concluded, through testing, that such controls are operating effectively. If we do not remediate this material weakness in a timely manner, or if additional material weaknesses in our internal control over financial reporting are discovered, they may adversely affect our ability to record, process, summarize and report financial information timely and accurately and our financial statements may contain material misstatements or omissions. In addition, we may experience delays or be unable to meet our reporting obligations or to comply with SEC rules and regulations, which could result in investigations and sanctions by regulatory authorities. Any of these results may, among other adverse consequences, cause investors to lose confidence in our reported financial information, incur the expense of remediation, result in regulatory scrutiny, litigation, investigations or enforcement actions, limit our ability to access the capital markets, lead to a decline in our stock price, and otherwise have a material adverse effect on our business, financial condition, results of operations and cash flows. Risks Related to Our Securities If a market for our common stock does not develop, shareholders may be unable to sell their shares. Our common stock is quoted under the symbol “SKVI” on the OTCQB operated by OTC Markets Group, Inc, an electronic inter-dealer quotation medium for equity securities. We do not currently have an active trading market. There can be no assurance that an active and liquid trading market will develop or, if developed, that it will be sustained. 12 Table of Contents Because we are quoted on the OTCQB, our securities may be less liquid, receive less coverage by security analysts and news media, and generate lower prices than might otherwise be obtained if they were listed on a national securities exchange. Our securities are very thinly traded. Accordingly, it may be difficult to sell shares of our common stock without significantly depressing the value of the stock. Unless we are successful in developing continued investor interest in our stock, sales of our stock could continue to result in major fluctuations in the price of the stock. Our common stock price may be volatile and could fluctuate widely in price, which could result in substantial losses for investors. The market price of our common stock is likely to be highly volatile and could fluctuate widely in price in response to various factors, many of which are beyond our control, including: • technological innovations or new products and services by us or our competitors; • government regulation of our products and services; • the establishment of partnerships with other technology companies; • intellectual property disputes; • additions or departures of key personnel; • sales of our common stock • our ability to integrate operations, technology, products and services; • our ability to execute our business plan; • operating results below expectations; • loss of any strategic relationship; • industry developments; • economic and other external factors; and • period to period fluctuations in our financial results. Because we have nominal revenues to date, you should consider any one of these factors to be material. Our stock price may fluctuate widely as a result of any of the above. In addition, the securities markets have from time to time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. These market fluctuations may also materially and adversely affect the market price of our common stock. We have not paid cash dividends in the past and do not expect to pay cash dividends in the future on our common stock. Any return on investment may be limited to the value of our common stock. We have never paid cash dividends on our common stock and do not anticipate paying cash dividends in the foreseeable future. The payment of cash dividends on our common stock will depend on earnings, financial condition and other business and economic factors at such time as the board of directors may consider relevant. If we do not pay cash dividends, our common stock may be less valuable because a return on your investment will only occur if its stock price appreciates. As a new investor, you will experience substantial dilution as a result of future equity issuances. In the event we are required to raise additional capital it may do so by selling additional shares of common stock thereby diluting the shares and ownership interests of existing shareholders. Because we are subject to the “Penny Stock” rules, the level of trading activity in our stock may be reduced. The Securities and Exchange Commission has adopted regulations which generally define "penny stock" to be any listed, trading equity security that has a market price less than $5.00 per share or an exercise price of less than $5.00 per share, subject to certain exemptions. The penny stock rules require a broker-dealer, prior to a transaction in a penny stock not otherwise exempt from the rules, to deliver a standardized risk disclosure document that provides information about penny stocks and the risks in the penny stock market. The broker-dealer must also provide the customer with current bid and offer quotations for the penny stock, the compensation of the broker-dealer and its salesperson in the transaction, and monthly account statements showing the market value of each penny stock held in the customer’s account. In addition, the penny stock rules generally require that prior to a transaction in a penny stock, the broker-dealer make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s written agreement to the transaction. These disclosure requirements may have the effect of reducing the level of trading activity in the secondary market for a stock that becomes subject to the penny stock rules which may increase the difficulty Purchasers may experience in attempting to liquidate such securities. 13 Table of Contents Provisions in the Nevada Revised Statutes and our Bylaws could make it very difficult for an investor to bring any legal actions against our directors or officers for violations of their fiduciary duties or could require us to pay any amounts incurred by our directors or officers in any such actions. Members of our board of directors and our officers will have no liability for breaches of their fiduciary duty of care as a director or officer, except in limited circumstances, pursuant to provisions in the Nevada Revised Statutes and our Bylaws as authorized by the Nevada Revised Statutes. Specifically, Section 78.138 of the Nevada Revised Statutes provides that a director or officer is not individually liable to the company or its shareholders or creditors for any damages as a result of any act or failure to act in his or her capacity as a director or officer unless it is proven that (1) the director’s or officer’s act or failure to act constituted a breach of his or her fiduciary duties as a director or officer and (2) his or her breach of those duties involved intentional misconduct, fraud or a knowing violation of law. This provision is intended to afford directors and officers protection against and to limit their potential liability for monetary damages resulting from suits alleging a breach of the duty of care by a director or officer. Accordingly, you may be unable to prevail in a legal action against our directors or officers even if they have breached their fiduciary duty of care. In addition, our Bylaws allow us to indemnify our directors and officers from and against any and all costs, charges and expenses resulting from their acting in such capacities with us. This means that if you were able to enforce an action against our directors or officers, in all likelihood, we would be required to pay any expenses they incurred in defending the lawsuit and any judgment or settlement they otherwise would be required to pay. Accordingly, our indemnification obligations could divert needed financial resources and may adversely affect our business, financial condition, results of operations and cash flows, and adversely affect prevailing market prices for our common stock. Item 1B. Unresolved Staff Comments This information is not required for smaller reporting companies. Item 1C. Cybersecurity We rely on our information technology to operate our business. As such, we have policies and processes designed to protect our information technology systems and resolve issues in a timely manner in the event of a cybersecurity threat or incident. We have designed our business applications and hosting services to minimize the impact that cybersecurity incidents could have on our business and have identified back-up systems where appropriate. We seek to further mitigate cybersecurity risks through a combination of monitoring and detection activities, use of anti-malware applications, quality audits and communication and reporting structures, among other processes. As of December 31, 2024, we have not identified an indication of a cybersecurity incident that would have a material impact on our business and consolidated financial statements. Item 2. Properties Currently, we do not own any or lease any real estate. Item 3. 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 4. Mine Safety Disclosures Not Applicable 14 Table of Contents PART II Item 5. Market for Registrant’s Common Equity and Related Stockholder Matters and Issuer Purchases of Equity Securities Market Information Our common stock is quoted under the symbol “SKVI” on the OTCQB operated by OTC Markets Group, Inc. The OTCQB is a quotation service that displays real-time quotes, last-sale prices, and volume information in over-the-counter equity securities. Because our stock is traded on the OTCQB, these quotations reflect inter-dealer prices, without retail markup, markdown or commission and may not represent actual transactions. Because we are quoted on the OTCQB, our securities may be less liquid, receive less coverage by security analysts and news media, and generate lower prices than might otherwise be obtained if they were listed on a national securities exchange. Trading in stocks quoted on the OTCQB is often thin and is characterized by wide fluctuations in trading prices due to many factors that may be unrelated to a company’s operations or business prospects. We cannot assure you that there will be a market in the future for our common stock. The following table sets forth, for the fiscal quarters indicated, the high and low bid information for our common stock, as reported on the OTCQB. The following quotations reflect inter-dealer prices, without retail mark-up, mark-down or commission and may not represent actual transactions. High Low Fiscal Year Ended December 31, 2024 First Quarter $ .09 $ .06 Second Quarter $ .21 $ .06 Third Quarter $ .85 $ .35 Fourth Quarter $ .82 $ .34 Fiscal Year Ended December 31, 2023 First Quarter $ .08 $ .08 Second Quarter $ .10 $ .10 Third Quarter $ .07 $ .07 Fourth Quarter $ .08 $ .08 Penny Stock The SEC has adopted rules that regulate broker-dealer practices in connection with transactions in penny stocks. Penny stocks are generally equity securities with a market price of less than $5.00, other than securities registered on certain national securities exchanges or quoted on the NASDAQ system, provided that current price and volume information with respect to transactions in such securities is provided by the exchange or system. The penny stock rules require a broker-dealer, prior to a transaction in a penny stock, to deliver a standardized risk disclosure document prepared by the SEC, that: (a) contains a description of the nature and level of risk in the market for penny stocks in both public offerings and secondary trading; (b) contains a description of the broker’s or dealer’s duties to the customer and of the rights and remedies available to the customer with respect to a violation of such duties or other requirements of the securities laws; (c) contains a brief, clear, narrative description of a dealer market, including bid and ask prices for penny stocks and the significance of the spread between the bid and ask price; (d) contains a toll-free telephone number for inquiries on disciplinary actions; (e) defines significant terms in the disclosure document or in the conduct of trading in penny stocks; and (f) contains such other information and is in such form, including language, type size and format, as the SEC shall require by rule or regulation. 15 Table of Contents The broker-dealer also must provide, prior to effecting any transaction in a penny stock, the customer with (a) bid and offer quotations for the penny stock; (b) the compensation of the broker-dealer and its salesperson in the transaction; (c) the number of shares to which such bid and ask prices apply, or other comparable information relating to the depth and liquidity of the market for such stock; and (d) a monthly account statement showing the market value of each penny stock held in the customer’s account. In addition, the penny stock rules require that prior to a transaction in a penny stock not otherwise exempt from those rules, the broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s written acknowledgment of the receipt of a risk disclosure statement, a written agreement as to transactions involving penny stocks, and a signed and dated copy of a written suitability statement. These disclosure requirements may have the effect of reducing the trading activity for our common stock. Therefore, stockholders may have difficulty selling our securities. Holders of Our Common Stock As of April 10, 2025, we had 5,316,843 shares of our common stock issued and outstanding, held by ___ shareholders of record, other than those held in street name. Dividends There are no restrictions in our articles of incorporation or bylaws that prevent us from declaring dividends. The Nevada Revised Statutes, however, do prohibit us from declaring dividends where after giving effect to the distribution of the dividend: 1. we would not be able to pay our debts as they become due in the usual course of business, or; 2. our total assets would be less than the sum of our total liabilities plus the amount that would be needed to satisfy the rights of shareholders who have preferential rights superior to those receiving the distribution. We have not declared any dividends and we do not plan to declare any dividends in the foreseeable future. Recent Sales of Unregistered Securities The Company is authorized to issue 200,000,000 shares of $0.001 par value common stock. The Company had 5,316,843 and 4,539,843 issued and outstanding shares of common stock as of December 31, 2024 and 2023, respectively. On February 5, 2024, the Company issued 300,000 units consisting of one share of common stock and one-half two-year warrant exercisable at $0.10 valued at $208,000 for the conversion of notes payable. During the year ended December 31, 2024, the Company sold 402,000 units consisting of one share of common stock and one half, one year warrant exercisable at $0.20 for $66,000, of which 25,000 shares sold for $10,000 were not issued and included in stock payable. On August 26, 2024, the Company issued 50,000 warrants valued at $26,000 for services. On October 14, 2024, the Company issued 75,000 shares valued at $42,750 for services. These securities were issued pursuant to Section 4(2) of the Securities Act and/or Rule 506 and/or Regulation S promulgated thereunder. The investor represented the intention to acquire the securities for investment only and not with a view towards distribution. The investor was 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. 16 Table of Contents Securities Authorized for Issuance under Equity Compensation Plans The following table provides information about our compensation plans under which shares of common stock may be issued upon the exercise of options as of December 31, 2024. In July 2006, we adopted the 2006 Skinvisible, Inc. Stock Option Plan, which provides for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock, performance shares and performance units, and stock awards our officers, directors or employees of, as well as advisers and consultants. This plan was confirmed by our stockholders on August 7, 2006 at the annual shareholders meeting. Under the 2006 Skinvisible, Inc. Stock Option Plan, we reserved 200,000 shares of common stock for the granting of options and rights. We currently have no shares under our Stock Option Plan. Item 6. Selected Financial Data A smaller reporting company is not required to provide the information required by this Item. Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations Forward-Looking Statements This quarterly report contains forward-looking statements. Forward-looking statements are projections of events, revenues, income, future economic performance or management’s plans and objectives for our future operations. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expects”, “plans”, “anticipates”, “believes”, “estimates”, “predicts”, “potential” or “continue” or the negative of these terms or other comparable terminology. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks in the section entitled “Risk Factors” and the risks set out below, any of which may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. These risks include, by way of example and not in limitation: • the uncertainty of profitability based upon our history of losses; • legislative or regulatory changes concerning skincare research and therapies; • risks related to failure to obtain adequate financing on a timely basis and on acceptable terms to continue as going concern; • risks related to our operations and uncertainties related to our business plan and business strategy; • changes in economic conditions; • uncertainty with respect to intellectual property rights, protecting those rights and claims of infringement of other’s intellectual property; • competition; and • cybersecurity concerns This list is not an exhaustive list of the factors that may affect any of our forward-looking statements. These and other factors should be considered carefully, including those contained in this Annual Report under “Risk Factors,” and readers should not place undue reliance on our forward-looking statements. Forward looking statements are made based on management’s beliefs, estimates and opinions on the date the statements are made, and we undertake no obligation to update forward-looking statements if these beliefs, estimates and opinions or other circumstances should change. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to actual results. Our financial statements are stated in United States dollars (US$) and are prepared in accordance with United States Generally Accepted Accounting Principles. 17 Table of Contents Results of Operations for the Years Ended December 31, 2024 and 2023 Revenues Our revenue, which we combine from product sales, royalties on patent licenses and license fees (product development fees), was $20,000 for each of the years ended December 31, 2024 and 2023. We hope to generate more revenues from our licenses with Quoin and Ovation in 2025. We also plan to enter into commercial arrangements with pharma and biotech companies to exploit our patent applications that were recently filed, and we hope to generate revenue from these efforts in the future. Gross Profit We had $0 in cost of revenues for the year ended December 31, 2024 and 2023, so our gross profit was $20,000, or 100% of sales for 2024 and 2023. Operating Expenses Operating expenses increased to $609,589 for the year ended December 31, 2024, from $510,375 for the year ended December 31, 2023. Our operating expenses for all periods consisted mainly of selling, general and administrative expenses. Our selling, general and administrative expenses for the year December 31, 2024, consisted mainly of accrued salaries and wages of $351,269 and audit and accounting of $56,857. In comparison, our selling, general and administrative expenses for the year December 31, 2023, consisted mainly of accrued salaries and wages of $356,272 and audit and accounting of $40,638. We expect our operating expenses will increase in the future as the Company begins to generate more licensing revenue. Other Income (Expenses) We had other income of $23,935 for the year ended December 31, 2024, as compared with other expenses of $1,892,065 for the year ended December 31, 2023. Our other income for the year ended December 31, 2024, consisted mainly of interest expense netted against a gain on settlement of debt. Our other expenses for the year ended December 31, 2023 consisted mainly of interest expense, netted against and gain on derivative liability changes. Net Loss We recorded a net loss of $565,654 for the year ended December 31, 2024, as compared with a net loss of $2,382,440 for the year ended December 31, 2023. 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 $39,946,142 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. 18 Table of Contents As of December 31, 2024, we had total current assets of $42,028 and total assets in the amount of $158,217. Our total current liabilities as of December 31, 2024, were $3,719,687. We had a working capital deficit of $3,677,659 as of December 31, 2024, compared with a working capital deficit of $3,476,947 as of December 31, 2023. Operating activities used $69,834 in cash for the year ended December 31, 2024, as compared with $75,969 used for the year ended December 31, 2023. Our negative operating cash flows for 2024 was the result of our net loss for the year, mainly offset by changes in operating assets and liabilities and the amortization of debt discount. Our negative operating cash flows for 2023 was the result of our net loss for the year, mainly offset by changes in operating assets and liabilities and the amortization of debt discount. We used cash of $9,218 and $10,521 in investing activities for the years ended December 31, 2024 and 2023, respectively, for the purchase of fixed and intangible assets. Cash flows provided by financing activities during the year ended December 31, 2024 amounted to $88,500, as compared with cash provided of $6,000 for the year ended December 31, 2023. Our positive financing cash flow for the year ended December 31, 2024 resulted from common stock issued for cash and proceeds from notes payable. Our positive financing cash flow for the year ended December 31, 2023 resulted from proceeds from related part notes. 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 capital. Off Balance Sheet Arrangements As of December 31, 2024, 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. 19 Table of Contents 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 December 31, 2024, we had not recorded a reserve for doubtful accounts. 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. In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The amendments in this ASU require disclosures, on an annual and interim basis, of significant segment expenses that are regularly provided to the chief operating decision maker (“CODM”), as well as the aggregate amount of other segment items included in the reported measure of segment profit or loss. This ASU requires that a public entity disclose the title and position of the CODM and an explanation of how the CODM uses the reported measure(s) of segment profit or loss in assessing segment performance and deciding how to allocate resources. This ASU is effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years, with early adoption permitted. The amendments in this ASU should be applied retrospectively to all prior periods presented in the financial statements. The Company adopted the ASU and determined that its adoption did not have a material impact on the Company’s consolidated financial statements and related disclosures. As defined in the ASU, operating segments are components of an enterprise about which discrete financial information is regularly provided to the CODM in making decisions on how to allocate resources and assess performance for the organization. The Company operates and manages its business as one reportable and operating segment. The Company’s CODM is the Chief Executive Officer. The Company’s CODM reviews consolidated operating results to make decisions about allocating resources and assessing performance for the entire Company. The Company does not believe that other standards, which have been issued but are not yet effective, will have a significant impact on its financial statements. Item 7A. Quantitative and Qualitative Disclosures About Market Risk A smaller reporting company is not required to provide the information required by this Item. Item 8. Financial Statements and Supplementary Data Index to Financial Statements Required by Article 8 of Regulation S-X: Audited Financial Statements: F-1 Reports of Independent Registered Public Accounting Firms F-3 Consolidated Balance Sheets as of December 31, 2024 and 2023 F-3 Consolidated Statements of Operations for the years ended December 31, 2024 and 2023 F-4 Consolidated Statement of Stockholders’ Deficit for the years ended December 31, 2024 and 2023 F-5 Consolidated Statements of Cash Flows for the years ended December 31, 2024 and 2023 F-6 Notes to Consolidated Financial Statements 20 Table of Contents Report of Independent Registered Public Accounting Firm To the Board of Directors and Shareholders of Skinvisible, Inc Opinion on the Financial Statements We have audited the accompanying consolidated balance sheet of Skinvisible, Inc. (the Company) as of December 31, 2024 and 2023, and the related consolidated statement of operations, stockholders’ deficit, and cash flows for the years then ended and the related notes (collectively referred to as the financial statements). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America. Going Concern Considerations The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The Company has suffered recurring losses since inception and has not achieved profitable operations, which raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are described in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. Basis for Opinion These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion. Critical Audit Matter The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of a critical audit matter does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing separate opinion on the critical audit matter or on the accounts or disclosures to which it relates. I. Accounting for Convertible Notes Critical Audit Matter Description As discussed in Note 11 to the consolidated financial statements, the Company issued a convertible note during 2024, which contained embedded features. Under ASC 815, Derivatives and Hedging , management is required to assess whether these embedded features should be bifurcated and accounted for separately as derivative liabilities. The auditing of the Company convertible note involved especially challenging auditor judgment due to the complexity of the embedded features and the application of complex accounting guidance and consideration of various terms and conditions within the convertible note agreement. Audit Response Our audit procedures to address the accounting of the convertible note included the following, among others: - We obtained and read the terms and conditions of the convertible note issued to understand the various features associated with the convertible note. - We assessed whether the embedded features met the bifurcation criteria under ASC 815, including the evaluation of whether these features were clearly and closely related to the debt host. - We evaluated management’s application of ASC 815-15 and ASC 480 to determine whether the identified embedded features should be classified as derivatives and assessed the appropriateness of their conclusions. - We evaluated the competency and objectivity of management’s expert engaged by the Company to assist in the accounting analysis of the convertible note. /s/ GreenGrowth CPAs April 14, 2025 We have served as the Company’s auditor since 2023. Los Angeles, California PCAOB ID Number 6580 F- 1 Table of Contents SKINVISIBLE, INC. CONSOLIDATED BALANCE SHEETS (AUDITED) December 31, 2024 December 31, 2023 ASSETS Current assets Cash $ 10,336 $ 888 Accounts receivable 5,000 5,000 Due from related party 17,592 21,592 Prepaid expense and other current assets 9,100 7,980 Total current assets 42,028 35,460 Patents and trademarks, net 116,189 127,409 Total assets $ 158,217 $ 162,869 LIABILITIES AND STOCKHOLDERS' DEFICIT Current liabilities Accounts payable and accrued liabilities $ 858,993 $ 438,668 Accrued interest payable 2,784,909 2,575,595 Loans from related party 13,364 6,000 Loans payable — 433,600 Convertible notes payable, net of unamortized debt discount of $ 0 and $ 63,785 , respectively — 40,000 Derivative liability 22,420 18,544 Total current liabilities 3,679,686 3,512,407 Convertible notes payable related party, net of unamortized discount of $ 0 and $ 0 respectively 5,372,403 5,372,403 Convertible notes payable 352,075 301,102 Total liabilities 9,404,164 9,185,912 Stockholders' deficit Common stock; $ 0.001 par value; 200,000,000 shares authorized; 5,316,843 and 4,539,843 shares issued and outstanding at December 31, 2024 and 2023, respectively 5,317 4,540 Shares payable 10,000 — Additional paid-in capital 30,684,878 30,352,905 Accumulated deficit ( 39,946,142 ) ( 39,380,488 ) Total stockholders' deficit ( 9,245,947 ) ( 9,023,043 ) Total liabilities and stockholders' deficit $ 158,217 $ 162,869 See Accompanying Notes to Consolidated Financial Statements. F- 2 Table of Contents SKINVISIBLE, INC. CONSOLIDATED STATEMENT OF OPERATIONS (AUDITED) Years ended December 31, 2024 December 31, 2023 Revenues $ 20,000 $ 20,000 Cost of revenues — — Gross profit 20,000 20,000 Operating expenses Depreciation and amortization 20,438 18,771 Selling general and administrative 589,151 491,604 Total operating expenses 609,589 510,375 Loss from operations ( 589,589 ) ( 490,375 ) Other income and (expense) Gain/(loss) on settlement of debt 697,249 — Interest expense ( 669,438 ) ( 1,887,150 ) Gain/(loss) on change in derivative liability ( 3,876 ) ( 4,915 ) Total other income (expense) 23,935 ( 1,892,065 ) Net loss $ ( 565,654 ) $ ( 2,382,440 ) Basic loss per common share $ ( 0.11 ) $ ( 0.52 ) Fully diluted loss per common share $ ( 0.11 ) $ ( 0.52 ) Basic weighted average common shares outstanding 5,061,350 4,539,843 Fully diluted weighted average common shares outstanding 5,061,350 4,539,843 See Accompanying Notes to Consolidated Financial Statements. F- 3 Table of Contents SKINVISIBLE, INC. CONSOLIDATED STATEMENT OF STOCKHOLDERS' DEFICIT (AUDITED) 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 — — — — ( 2,382,440 ) ( 2,382,440 ) Balance, December 31, 2023 $ 4,539,843 $ 4,540 $ 30,352,905 $ — $ ( 39,380,488 ) $ ( 9,023,043 ) Shares issued for conversion of notes payable 300,000 300 207,700 — — 208,000 Shares and warrants issued for services 75,000 75 68,675 — — 68,750 Units issued for cash 402,000 402 55,598 10,000 — 66,000 Net loss — — — — ( 565,654 ) ( 565,654 ) Balance, December 31, 2024 5,316,843 5,317 30,684,878 10,000 ( 39,946,142 ) ( 9,245,947 ) See Accompanying Notes to Consolidated Financial Statements. F- 4 Table of Contents SKINVISIBLE, INC. CONSOLIDATED STATEMENT OF CASH FLOWS (AUDITED) Years ended December 31, 2024 December 31, 2023 Cash flows from operating activities: Net loss ( 565,654 ) $ ( 2,382,440 ) Adjustments to reconcile net loss to net cash provided (used) by operating activities: — Shares issued for services 68,750 — Allowance for doubtful accounts 21,592 Depreciation and amortization 20,438 18,771 Amortization of debt discount 50,973 1,278,901 (Gain)/loss on settlement of debt ( 697,249 ) — (Gain)/loss on change in derivative liability 3,876 4,915 Changes in operating assets and liabilities: Decrease (Increase) in prepaid assets ( 1,120 ) 1,515 Decrease (Increase) in due from related party 4,000 — Increase (decrease) in accounts payable and accrued liabilities 420,325 388,926 Decrease in due to related party 7,364 ( 29,111 ) Increase in accrued interest 618,463 619,774 Net cash provided used in operating activities ( 69,834 ) ( 77,157 ) Cash flows from investing activities: Purchase of intangible assets ( 9,218 ) ( 9,333 ) Net cash used in investing activities ( 9,218 ) ( 9,333 ) Cash flows from financing activities: Common stock issued for cash 66,000 — Proceeds on related party loans — 6,000 Repayment on related party loans — — Proceeds from convertible notes payable 22,500 — Net cash provided by (used in) financing activities 88,500 6,000 Net change in cash 9,448 ( 80,490 ) Cash, beginning of period 888 81,378 Cash, end of period 10,336 $ 888 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: Accrued salary settled with Convertible notes payable related party — 1,152,194 See Accompanying Notes to Consolidated Financial Statements. F- 5 Table of Contents SKINVISIBLE, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 1. DESCRIPTION OF BUSINESS AND HISTORY Description of business Skinvisible, Inc., (referred to as the “Company”) is focused on the development, 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 including 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 audited financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America. 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 period presented have been reflected herein. 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 year ended December 31, 2024, the Company had a net loss of $ 565,654 The Company has also incurred cumulative net losses of $ 39,946,142 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. F- 6 Table of Contents 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 (See Notes 6 & 8) 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 $ 5,724,477 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. 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. 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 December 31, 2024 and 2023, the Company had determined it was not necessary to recognize 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. Income taxes The Company accounts for its income taxes in accordance with FASB Codification Topic ASC 740-10, “ Income Taxes ”, which requires recognition of deferred tax assets and liabilities for future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and tax credit carry-forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Stock-based compensation The Company follows the guidelines in FASB Codification Topic ASC 718-10 “ Compensation-Stock Compensation ”, which requires the measurement and recognition of compensation expense for all share-based payment awards made to employees and directors including employee stock options and employee stock purchases related to an Employee Stock Purchase Plan based on the estimated fair values. Earnings (loss) per share The Company reports earnings (loss) per share in accordance with FASB Codification Topic ASC 260-10 “Earnings Per Share”, Basic earnings (loss) per share is computed by dividing income (loss) available to common shareholders by the weighted average number of common shares available. Diluted earnings (loss) per share is computed similar to basic earnings (loss) per share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive. Diluted earnings (loss) per share has not been presented for the year ending December 31, 2024 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 82,346,405 additional shares issuable in connection with outstanding options, warrants, stock payable and convertible debts as of December 31, 2024 The shares issuable under each instrument is as follows; 82,346,405 shares issuable under convertible notes. F- 8 Table of Contents 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. We adopted this ASU for the year ended December 31 ,2022. This ASU had no impact on our financial statements for the years ended December 31, 2024 and 2023, respectively. In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The amendments in this ASU require disclosures, on an annual and interim basis, of significant segment expenses that are regularly provided to the chief operating decision maker (“CODM”), as well as the aggregate amount of other segment items included in the reported measure of segment profit or loss. This ASU requires that a public entity disclose the title and position of the CODM and an explanation of how the CODM uses the reported measure(s) of segment profit or loss in assessing segment performance and deciding how to allocate resources. This ASU is effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years, with early adoption permitted. The amendments in this ASU should be applied retrospectively to all prior periods presented in the financial statements. The Company adopted the ASU and determined that its adoption did not have a material impact on the Company’s consolidated financial statements and related disclosures. As defined in the ASU, operating segments are components of an enterprise about which discrete financial information is regularly provided to the CODM in making decisions on how to allocate resources and assess performance for the organization. The Company operates and manages its business as one reportable and operating segment. The Company’s CODM is the Chief Executive Officer. The Company’s CODM reviews consolidated operating results to make decisions about allocating resources and assessing performance for the entire Company. The Company does not believe that other standards, which have been issued but are not yet effective, will have a significant impact on its financial statements. 4. INTANGIBLE AND OTHER ASSETS Patents and other intangible assets are capitalized at their historical cost and are amortized over their estimated useful lives. As of December 31, 2024 intangible assets total $ 116,189 , net of $ 187,483 of accumulated amortization. As of December 31, 2023, intangible assets total $ 127,409 , net of $ 167,045 of accumulated amortization. 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 December 31, 2024. 5. RELATED PARTY TRANSACTIONS Convertible Notes Related Party Convertible Notes Payable Related Party consists of the following: December 31, 2024 December 31, 2023 On January 31, 2023, the Company negotiated 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. 5,372,403 5,372,403 — — Total, net of unamortized discount $ 5,372,403 $ 5,372,403 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.” The Company determined that all the outstanding notes had met the statue of limitations and as such the Company was no longer legally obligated to pay the notes. As such, the Company wrote the entire balance of the notes of $ 433,600 and accrued interest of $ 407,343 to gain on settlement of debt on the Statement of Operations. 7. CONVERTIBLE NOTES PAYABLE Convertible Notes Payable consists of the following: December 31, December 31, 2024 2023 $ 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 Company determined that all the outstanding notes had met the statue of limitations and as such the Company was no longer legally obligated to pay the notes. As such, the Company wrote entire balance of the notes and accrued interest to gain on settlement of debt on the Statement of Operations. — 40,000 Original issue discount — — Unamortized debt discount — — Total, net of unamortized discount — 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 $ 50,973 and $ 50,863 for the years ended December 31, 2024 and 2023, respectively. 352,075 352,075 Unamortized debt discount — ( 50,973 ) Total, net of unamortized discount 352,075 301,102 Total Convertible Notes $ 352,075 $ 341,102 Current portion: — 40,000 Total long-term convertible notes $ 352,075 $ 301,102 F- 10 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 ( $ 1,000,000 ). 9. INCOME TAXES The Company provides for income taxes under FASB ASC 740, Accounting for Income Taxes. FASB ASC 740 requires the use of an asset and liability approach in accounting for income taxes. Deferred tax assets and liabilities are recorded based on the differences between the financial statement and tax bases of assets and liabilities and the tax rates in effect currently. FASB ASC 740 requires the reduction of deferred tax assets by a valuation allowance, if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. In the Company’s opinion, it is uncertain whether they will generate sufficient taxable income in the future to fully utilize the net deferred tax asset. Accordingly, a valuation allowance equal to the deferred tax asset has been recorded. The total deferred tax asset is approximately $ 8.4 million as of December 31, 2024 which is calculated by multiplying a 21 % estimated tax rate by the cumulative net operating loss (NOL) of approximately $ 40.0 million . Due to the enactment of the Tax Reform Act of 2017, we have calculated our deferred tax assets using an estimated corporate tax rate of 21 % . US Tax codes and laws may be subject to further reform or adjustment which may have a material impact to the Company’s deferred tax assets and liabilities. The Company will recognize interest and penalties related to uncertain tax positions as a component of income tax expense. As of December 31, 2024, the Company had no accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in the Company’s statement of operations. The significant components of the Company's deferred tax assets and liabilities as of December 31, 2024 and 2023 are as follows: As of December 31, 2024 2023 Cumulative tax net operating losses (in millions) $ 40.0 $ 39.0 Deferred tax asset (in millions) $ 8.4 $ 8.3 Valuation allowance (in millions) ( 8.4 ) ( 8.3 ) Current taxes payable — — Income tax expense $ — $ — F- 11 Table of Contents As of December 31, 2024 and 2023, the Company had gross federal net operating loss carryforwards of approximately $ 39.0 million and $ 40.0 million , respectively. The Company plans to file its U.S. federal return for the year ended December 31, 2024 upon the issuance of this filing. Upon filing of the tax return for the year ended December 31, 2024 the actual deferred tax asset and associated valuation allowance available to the Company may differ from management’s estimates. The tax years 2020-2024 remained open to examination for federal income tax purposes by the major tax jurisdictions to which the Company is subject. No tax returns are currently under examination by any tax authorities. 10. STOCK WARRANTS The following is a summary of stock warrant activity during the years ended December 31, 2024 and 2023: Warrants Weighted average exercise price Outstanding December 31, 2022 — $ — Granted — $ — Outstanding December 31, 2023 — $ — Granted 452,000 $ 0.27 Outstanding December 31, 2024 452,000 $ 0.27 On February 5, 2024, the Company issued 300,000 units consisting of one share of common stock and one-half one-year warrant exercisable at $ 0.10 valued at $ 208,000 . The warrants were valued using the Binomial pricing model using the inputs stock price: $ 0.43 , discount rate 4.22 % , volatility 214.32% . During the year ended December 31, 2024, the Company sold 402,000 units consisting of one share of common stock and one half one year warrant exercisable at $ 0.20 for $ 66,000 , of which 25,000 share sold for $ 10,000 were not issued and included in stock payable. On August 26, 2024, the Company issued 50,000 warrants valued at $ 26,000 for services. The warrants were valued using the Binomial pricing model using the inputs stock price: $ 0.57 , discount rate 3.95 % , volatility 206.04 % . As of December 31, 2024, the outstanding warrants had a remaining term of 0.75 years and an intrinsic value of $ 0 . 11. STOCKHOLDERS’ DEFICIT The Company is authorized to issue 200,000,000 shares of $ 0.001 par value common stock. The Company had 5,316,843 and 4,539,843 issued and outstanding shares of common stock as of December 31, 2024 and 2023, respectively. On February 5, 2024, the Company issued 300,000 units consisting of one share of common stock and one-half one-year warrant exercisable at $ 0.10 valued at $ 208,000 for the conversion of debt. During the year ended December 31, 2024, the Company sold 402,000 units consisting of one share of common stock and one half one year warrant exercisable at $ 0.20 for $ 66,000 , of which 25,000 share sold for $ 10,000 were not issued and included in stock payable . On August 26, 2024, the Company issued 50,000 warrants valued at $ 26,000 for services. On October 14, 2024, the Company issued 75,000 shares valued at $ 42,750 for services. 12. SUBSEQUENT EVENTS In accordance with ASC Topic 855-10, the Company has analyzed its operations subsequent to December 31, 2024 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. F- 12 Table of Contents Item 9. Changes In and Disagreements with Accountants on Accounting and Financial Disclosure We (the “Company”) were informed that Gries & Associates, LLC (“Gries”) had sold its business to GreenGrowth CPAs (“GreenGrowth”). On October 17, 2023, we engaged and executed an agreement with GreenGrowth, as the Company’s new independent accountant to replace Gries. The engagement of GreenGrowth was approved by our Board of Directors. Item 9A. Controls and Procedures As required by Rule 13a-15 under the Securities Exchange Act of 1934, we have carried out an evaluation of the effectiveness of our disclosure controls and procedures as of the end of the period covered by this annual report, being December 31, 2024. This evaluation was carried out under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer. 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 Securities Exchange Act of 1934 is recorded, processed, summarized and reported, within the time periods specified in the Securities and Exchange Commission’s rules and forms. Disclosure controls and procedures include controls and procedures designed to ensure that information required to be disclosed in our company’s reports filed under the Securities Exchange Act of 1934 is accumulated and communicated to management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosure. Based upon that evaluation, including our Chief Executive Officer and Chief Financial Officer, we have concluded that our disclosure controls and procedures were ineffective as of the end of the period covered by this annual report. Management’s Annual Report on Internal Control over Financing Reporting Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) under the Securities Exchange Act of 1934). Management has assessed the effectiveness of our internal control over financial reporting as of December 31, 2024, based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. As a result of this assessment, management concluded that, as of December 31, 2024, our internal control over financial reporting was not effective. Our management identified the following material weaknesses in our internal control over financial reporting, which are indicative of many small companies with small staff: (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. We plan to take steps to enhance and improve the design of our internal control over financial reporting. During the period covered by this annual report on Form 10-K, we have not been able to remediate the material weaknesses identified above. To remediate such weaknesses, we hope to implement the following changes during our fiscal year ending December 31, 2025: (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 in (i) and (ii) 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. This annual report does not include an attestation report of our registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by our registered public accounting firm pursuant to an exemption for non-accelerated filers set forth in Section 989G of the Dodd-Frank Wall Street Reform and Consumer Protection Act. Item 9B. Other Information None . Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. None. 21 Table of Contents PART III Item 10. Directors, Executive Officers and Corporate Governance The following information sets forth the names, ages, and positions of our current directors and executive officers. Name Age Position(s) and Office(s) Held Terry Howlett 76 Chief Executive Officer, Chief Financial Officer, and Director David St. James 50 Director Set forth below is a brief description of the background and business experience of each of our current executive officers and directors. Mr. Terry H. Howlett , has been our Chief Executive Officer and Director since March 5, 1998. Mr. Howlett has a diversified background in market initialization and development, sales and venture capital financing for emerging growth companies. He has held senior management, marketing and sales positions with various companies, including the Canadian Federation of Independent Business, Family Life Insurance, and Avacare of Canada and founded Presley Laboratories, Inc., which marketed cosmetic and skin, care products on a direct sales basis. For the ten years prior to becoming President of the Company, Mr. Howlett was the President and CEO of Voice-it Solutions, Inc., a publicly traded company on the Vancouver Stock exchange that made voice response software for order entry systems. Mr. David St. James is an inventor and businessman based in Las Vegas, Nevada. He has invented and co-invented turbochargers and superchargers, some of which are in use today on production vehicles and in Formula 1. He has also been involved in other various aspects of the automotive industry, including product development, service, and repair. He has been an Officer and Director of Homeland Resources Ltd. since July of 2014 and currently serves as the President and a Director. He has been the Vice President and a Director of Nouveau Ventures Inc. since August of 2014. Mr. St. James served as the President of XLR Medical Corporation from January 2009 through January 2012. Directors Our bylaws authorize no less than one (1) and more than twelve (12) directors. We currently have two directors. Term of Office Our Directors are appointed for a one-year term to hold office until the next annual general meeting of our shareholders or until removed from office in accordance with our bylaws. Our officers are appointed by our board of directors and hold office until removed by the board. Significant Employees Ms. Doreen McMorran , is head of Business Development. Ms. McMorran brings to the Company almost 20 years of experience in the medical and pharmaceutical industry, specifically in the areas of strategic planning, sales and marketing. She has spent the last seven years selling to international dermatology and skincare focused companies like Procter and Gamble, Johnson & Johnson, Stiefel, Galderma, Novartis and Graceway, to name a few. Ms. McMorran, who holds a Bachelor of Commerce (Honors) degree, spent six years in the pharmaceutical industry with Astra Pharma. Additionally, she has held senior management level positions with a number of healthcare companies, focusing on business development, sales, marketing and operations. Family Relationships There are no family relationships between or among the directors, executive officers or persons nominated or chosen by us to become directors or executive officers. 22 Table of Contents Involvement in Certain Legal Proceedings To the best of our knowledge, during the past ten years, none of the following occurred with respect to a present or former director, executive officer, or employee: (1) any bankruptcy petition filed by or against any business of which such person was a general partner or executive officer either at the time of the bankruptcy or within two years prior to that time; (2) any conviction in a criminal proceeding or being subject to a pending criminal proceeding (excluding traffic violations and other minor offenses); (3) being subject to any order, judgment or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction, permanently or temporarily enjoining, barring, suspending or otherwise limiting his or her involvement in any type of business, securities or banking activities; and (4) being found by a court of competent jurisdiction (in a civil action), the SEC or the Commodities Futures Trading Commission to have violated a federal or state securities or commodities law, and the judgment has not been reversed, suspended or vacated. Audit Committee We do not have a separately designated standing audit committee. The entire board of directors performs the functions of an audit committee, but no written charter governs the actions of the board of directors when performing the functions of that would generally be performed by an audit committee. The board of directors approves the selection of our independent accountants and meets and interacts with the independent accountants to discuss issues related to financial reporting. In addition, the board of directors reviews the scope and results of the audit with the independent accountants, reviews with management and the independent accountants our annual operating results, considers the adequacy of our internal accounting procedures and considers other auditing and accounting matters including fees to be paid to the independent auditor and the performance of the independent auditor. We do not have an audit committee financial expert because of the size of our company and our board of directors at this time. We believe that we do not require an audit committee financial expert at this time because we retain outside consultants who possess these attributes as needed. For the fiscal year ending December 31, 2024, the board of directors: 1. Reviewed and discussed the audited financial statements with management, and 2. Reviewed and discussed the written disclosures and the letter from our independent auditors on the matters relating to the auditor’s independence. 3. Based upon the board of directors’ review and discussion of the matters above, the board of directors authorized inclusion of the audited financial statements for the year ended December 31, 2024, to be included in this Annual Report on Form 10-K and filed with the Securities and Exchange Commission. Section 16(a) Beneficial Ownership Reporting Compliance Section 16(a) of the Exchange Act requires our directors and executive officers and persons who beneficially own more than ten percent of a registered class of the Company’s equity securities to file with the SEC initial reports of ownership and reports of changes in ownership of common stock and other equity securities of the Company. Officers, directors and greater than ten percent beneficial shareholders are required by SEC regulations to furnish us with copies of all Section 16(a) forms they file. To the best of our knowledge based solely on a review of Forms 3, 4, and 5 (and any amendments thereof) received by us during or with respect to the year ended December 31, 2024, all filings were timely made. Code of Ethics We adopted a Code of Ethics for Financial Executives, which include our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions. The Code of Ethics was filed as an exhibit to the annual report on Form 10KSB for the fiscal year ended December 31, 2004 and filed with the SEC on April 14, 2005. 23 Table of Contents Item 11. Executive Compensation Compensation Discussion and Analysis Currently, the objective of the cash compensation paid by the company is to provide fair reimbursement for the time spent by our executive officer and independent directors to the extent feasible within the financial constraints faced by our developing business. The stock options granted to our executive officer and to our independent directors are intended to provide these individuals with incentives to pursue the growth and development of the company’s operations and business opportunities. Although the options awarded to our executive and directors are typically exercisable immediately, they also remain valid and exercisable for terms of several years. We believe this provides the proper balance of short-term and long-term incentives to increase the value of the company. Although an immediate increase in share price following the issuance of the options would obviously result in a profit if those options were exercised, the longer exercisable period of the options also provides an incentive to increase value over the long term and gives our executive officer and directors the opportunity to realize gains based on the sustained growth of our operations and revenues. In addition, our sole executive officer holds substantial ownership in the company and is generally motivated by a strong entrepreneurial interest in expanding our operations and revenue base to the best of his ability. Summary Compensation Table The table below summarizes all compensation awarded to, earned by, or paid to our former or current executive officers for the fiscal years ended December 31, 2024 and 2023. SUMMARY COMPENSATION TABLE Name and principal position Year Salary ($) Bonus ($) Stock Awards ($) Option Awards ($) Non-Equity Incentive Plan Compensation ($) Nonqualified Deferred Compensation Earnings ($) All Other Compensation ($) Total ($) Terry Howlett CEO & CFO 2024 2023 180,000 180,000 — — — — — — 180,000 (1) 180,000 (2) (1) Due to financial constraints, however, the total paid to Mr. Howlett during the fiscal year ended December 31, 2024 was $0. (2) Due to financial constraints, however, the total salary paid to Mr. Howlett during the fiscal year ended December 31, 2023 was $0. Narrative Disclosure to the Summary Compensation Table We granted Mr. Howlett the right to convert his accrued compensation of $180,000 and $180,000 as of December 31, 2024 and 2023 into our common stock at $0.10 per share at any time until 2028. If exercised, we also agreed to issue one three-year warrant for every two shares converted by Mr. Howlett exercisable at $0.15 per share. Outstanding Equity Awards at Fiscal Year-End There were no unexercised options, stock that has not vested, or equity incentive plan awards as of December 31, 2024. The table below summarizes all compensation of our directors as of December 31, 2024. DIRECTOR COMPENSATION Name Fees Earned or Paid in Cash ($) Stock Awards ($) Option Awards ($) Non-Equity Incentive Plan Compensation ($) Non-Qualified Deferred Compensation Earnings ($) All Other Compensation ($) Total ($) David St. James $6,000 - - - - - - 24 Table of Contents Narrative Disclosure to the Director Compensation Table All the fees earned or paid in cash and stock options awards granted to Terry Howlett were earned in connection with his service as an executive officer. Mr. Howlett received no compensation for his service as a member of our board of directors. Mr St. James was paid $6,000 for his services during the year ended December 31, 2024. Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters The following table sets forth, as of April 10, 2025, the beneficial ownership of our common stock by each executive officer and director, by each person known by us to beneficially own more than 5% of our common stock and by the executive officers and directors as a group. Title of class Name and address of beneficial owner (1) Amount of beneficial ownership (2) Percent of class (3) Executive Officers & Directors: Common Terry Howlett (4) 11,041,001 shares 68 % Common David St. James (5) 2,000 shares Less than 1 % Total of All Directors and Executive Officers: 11,043,001 shares 68 % More Than 5% Beneficial Owners: Doreen McMorran (6) 10,250,510 shares 65 % (1) Except as otherwise indicated, the address of each person named in this table is c/o Skinvisible, Inc., 6320 South Sandhill Road, Unit 9, Las Vegas, Nevada 89120. (2) As used in this table, "beneficial ownership" means the sole or shared power to vote, or to direct the voting of, a security, or the sole or shared investment power with respect to a security (i.e., the power to dispose of, or to direct the disposition of, a security). In addition, for purposes of this table, a person is deemed, as of any date, to have "beneficial ownership" of any security that such person has the right to acquire within 60 days after such date. (3) Except as otherwise indicated, all shares are owned directly and the percentage shown is based on 5,316,843 shares of common stock issued and outstanding on April 10, 2025 (4) Includes 154,466 shares held in his name as indicated on our shareholder list, and 10,886,535 shares of common stock held in derivative securities. (5) Includes an option to purchase 2,000 shares of common stock at $0.035 per share. (6) Includes 36,000 shares held in her name as indicated on our shareholder list, and 10,214,510 shares of common stock held in derivative securities. Item 13. Certain Relationships and Related Transactions, and Director Independence Aside from that which follows and in “Executive Compensation,” none of our directors or executive officers, nor any proposed nominee for election as a director, nor any person who beneficially owns, directly or indirectly, shares carrying more than 5% of the voting rights attached to all of our outstanding shares, nor any members of the immediate family (including spouse, parents, children, siblings, and in-laws) of any of the foregoing persons has any material interest, direct or indirect, in any transaction for the last two fiscal years or in any presently proposed transaction which, in either case, has or will materially affect us. On February 3, 2020, we entered into a License Agreement with Ovation Science, pursuant to which the Company 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 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. 25 Table of Contents On June 10, 2020, Ovation Science Inc. paid the Company the fee otherwise due in year 3 and in exchange the Company extended the term of Ovation’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 paid a $100,000 license fee. The Company completed the required assignments during the year ending December 31, 2021 and recognized $100,000 in revenue. The Company earned $0 and $0 in royalties under the license agreement during the years ending December 31, 2024 and 2023, respectively. The Company sold polymer products to Ovation Science Inc and earned $0 and $0 as of December 31, 2024 and 2023, respectively. Convertible Notes Related Party On January 31, 2023, the Company negotiated 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. 5,372,403 5,372,403 — — Total, net of unamortized discount $ 5,372,403 $ 5,372,403 Item 14. Principal Accounting Fees and Services Below is the table of Audit Fees (amounts in US$) billed by our auditor in connection with the audit of the Company’s annual financial statements for the years ended: Financial Statements for the Year Ended December 31 Audit Services Audit Related Fees Tax Fees Other Fees 2023 $ 19,000 $ 0 $ 0 $ 0 2024 $ 33,500 $ 0 $ 0 $ 0 26 Table of Contents PART IV Item 15. Exhibits, Financial Statements Schedules (a) Financial Statements and Schedules The following financial statements and schedules listed below are included in this Form 10-K. Financial Statements (See Item 8) (b) Exhibits Exhibit Number Description 2.1 Agreement and Plan of Merger (4) 2 .2 Termination and Release Agreement (6) 3.1 Articles of Incorporation, as amended (1) 3.2 Bylaws, as amended (1) 3.3 Certificate of Amendment (2) 3.4 Certificate of Change (5) 14.1 Code of Ethics (3) 31.1 Certification of Chief Executive Officer pursuant to Securities Exchange Act Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 31.2 Certification of Chief Financial Officer pursuant to Securities Exchange Act Rule 13a-14(a)/15d-14(a), 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 1 Incorporated by reference to the Registration Statement on Form 10SB12G filed on April; 30, 1999. 2 Incorporated by reference to the Report on Form 8-K filed on September 12, 2008. 3 Incorporated by reference to Current report on Form 10-KSB filed with the Securities and Exchange Commission on April 14, 2005. 4 Incorporated by reference to the Report on Form 8-K filed on March 29, 2018 5 Incorporated by reference to the Report on Form 8-K filed on January 22, 2019 6 Incorporated by reference to the Report on Form 8-K filed on October 22, 2019 Item 16. Form 10-K Summary None. 27 Table of Contents SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the 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. By: /s/ Terry Howlett Terry Howlett President, Chief Executive Officer, Principal Executive Officer, Chief Financial Officer, Principal Financial Officer, Principal Accounting Officer and Director April 14, 2024 Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated. By: /s/ Terry Howlett Terry Howlett President, Chief Executive Officer, Principal Executive Officer, Chief Financial Officer, Principal Financial Officer, Principal Accounting Officer and Director April 14, 2025 By: /s/ David St. James David St. James Director April 14, 2025 28