United Health Products, Inc 10-K for FY2022
United Health Products, Inc. (UEEC)
About this 10-K
United Health Products, Inc filed this 10-K on March 28, 2023, covering the fiscal year ended December 31, 2022 (FY2022).
Headline figures
Fiscal year ended December 31, 2022, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $37.5K
- up 63459.3% from $59 a year earlier
- Net loss
- $1.69M
- compared with a net loss of $30.55M a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
FOR THE FISCAL YEAR ENDED
COMMISSION FILE NUMBER:
(Exact name of Registrant as specified in its charter) |
(State of jurisdiction of incorporation or organization) | (I.R.S. Employee Identification Number) | |
(Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12 (b) of the Act:
Title of each class | Trading Symbol | Name of each exchange on which registered | ||
None | None | None |
Securities registered pursuant to Section 12 (g) of the Act: Common Stock, $.001 Par Value
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐
Check whether the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Exchange Act. Yes ☐
Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days.
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).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☐ |
☒ | Smaller reporting company | ||
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| 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. Yes ☐ No ☐
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.
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
As of June 30, 2022, the number of shares held by non-affiliates was approximately 226,241,797 shares. The approximate market value based on the last sale (i.e. $0.42 per share as of June 30, 2022, the last business day of the second quarter) of the Company’s Common Stock was approximately $
The number of shares issued and outstanding of the Registrant’s Common Stock, as of March 27, 2023 was
Forward-looking Statements
Statements in this annual report on Form 10-K that are not historical facts constitute forward-looking statements which are made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that 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. Those factors include, among other things, those listed under “Risk Factors” and elsewhere in this annual report. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “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. Actual events or results may differ materially. Moreover, neither we nor any other person assumes responsibility.
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PART I
ITEM 1. BUSINESS
Company Overview
United Health Products, Inc. (“UHP or the “Company”) develops, manufactures, and markets a patented hemostatic gauze for the healthcare and wound care sectors. Our gauze product, HemoStyp®, is a neutralized, oxidized, regenerated cellulose (“NORC”) derived from cotton and designed to absorb exudate/drainage from superficial wounds and help control bleeding. We are in the process of seeking regulatory approval to sell our Hemostyp product line into the U.S. Class III and European Union CE Mark surgical markets.
Recent Developments
The following developments in the Company’s business have occurred during 2022 and prior to the filing of this report:
| · | During 2022, the Company worked to address certain deficiencies in its Premarket Approval (PMA) application that were identified by the FDA in 2021. These were largely related to the need for standardized procedures for our manufacturing process, and quality assurance procedures for finished, customer ready products. As of the date of this report we have implemented procedures and Good Manufacturing Practices that are responsive to the deficiencies identified by the FDA. We are currently conducting testing of finished HemoStyp product to ensure consistent and uniform production and to confirm our packaging procedures, which we outsource to an ISO 14385 certified partner, meet the FDA requirements for Class III products. Upon completion of this testing, we will submit a revised PMA application to the FDA for their review. |
Our HemoStyp Gauze Products
HemoStyp hemostatic gauze is a natural substance created from chemically treated cellulose derived from cotton. It is an effective hemostatic agent registered with the FDA for superficial use under a 510(k) approval obtained in 2012 to help control bleeding from open wounds and body cavities. The HemoStyp hemostatic material contains no chemical additives, thrombin, collagen or animal-derived products, and is hypoallergenic. When the product comes in contact with blood it expands slightly and quickly converts to a translucent gel that subsequently breaks down into glucose and salts. Because of its benign impact on body tissue and the fact that it degrades to non-toxic end products, HemoStyp does not impede the healing of body tissue as compared to certain competing hemostatic products. Laboratory testing has shown HemoStyp to be 100% absorbable in the human body within 24 hours, compared to days or weeks with competing organic regenerated cellulose products. A human trial conducted in 2019 and 2020 demonstrated the effectiveness of HemoStyp in vascular, thoracic and abdominal surgical procedures.
HemoStyp hemostatic gauze is a flexible, silk-like material that is applied by placing the gauze onto the bleeding tissue. The supple material can be easily folded and manipulated as needed to fit the size of the wound or incision. In surface bleeding and surgical situations, the product quickly converts to a translucent gel that allows the physician or surgeon to monitor the coagulation process. The gel maintains a neutral pH level, which avoids damaging the surrounding tissue. In superficial bleeding situations, HemoStyp can be bonded to an adhesive plastic bandage or integrated into a traditional gauze component to address a broad range of needs, including traumatic bleeding injuries and prolonged bleeding following hemodialysis.
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Potential Target Markets
Our HemoStyp material is currently cut to several sizes and configuration and marketed as HemoStyp Gauze. Our potential customer base includes, without limitation, the following:
| • | Hospitals and Surgery Centers for all Internal Surgical usage (in the event we obtain FDA Class III approval) |
| • | Hospitals, Clinics and Physicians for external trauma |
| • | EMS, Fire Departments and other First Responders |
| • | Military Medical Care Providers |
| • | Hemodialysis centers |
| • | Nursing Homes and Assisted Living Facilities |
| • | Dental and Oral & Maxillofacial Surgery Offices |
| • | Veterinary hospitals |
Primary Strategy
Our HemoStyp technology received an FDA 510(k) approval in 2012 for use in external or superficial bleeding situations and we believe there is an opportunity for HemoStyp products to address unmet needs in several medical applications that represent attractive commercial opportunities. However, the Class III surgical markets, both domestic and international, represent the most attractive market for our products due to the smaller number of competitors offering Class III approved hemostatic agents and the resulting premium pricing for products that can meet the demanding requirements of the human surgical environment. We believe that our extensive laboratory testing and our completed human trial indicate that the HemoStyp technology could successfully compete against established Class III market participants, and could gain a significant market share. There can be no assurance that an FDA Premarket Approval (PMA) will be granted.
In 2018, we made the decision to focus our efforts and resources on accessing these Class III markets to maximize the value potential of our HemoStyp products. The Class III PMA process required a substantial investment of time and resources so we made the strategic determination to pause our sales and marketing to non-Class III markets in order to devote our full attention to the PMA process. In the fourth quarter of 2021, with our PMA application largely complete and under review by the FDA, we re-engaged with certain consumers and distributors of 510(k) hemostatic products with the objective of developing a revenue channel in this market going forward. Our primary market focus for this initiative includes the first-aid, dental surgery and emergency medicine sectors.
In anticipation of receiving a Class III PMA (which cannot be assured), we are evaluating paths to rapidly grow our revenue and profits in all potential market segments, with the objective of maximizing shareholder value. We do not intend to pursue the full commercialization of our products independently nor to remain an independent company in the long term. Options under consideration include (i) a sale or merger of the Company with an industry leader in the wound care and surgical device sectors, which may include a pre-sale collaboration on commercialization and distribution and (ii) one or more commercial partnerships with established market participants, without any specific, associated sale or merger transaction.
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The Company has been contacted by several medical technology companies that are active in the surgical equipment and hemostatic products sectors, and who have expressed an interest in the Company’s products and business strategy. In response to these inbound contacts, we have held discussions to evaluate the potential commercial partnerships in anticipation of an FDA decision on our Class III PMA application. There can be no assurances that any specific transaction will occur as a result of these discussions. No assurances can be given that the Company will identify any commercialization candidate(s) or complete a transaction.
Manufacturing and Packaging of our Products
The Company’s NORC products will be manufactured to our specifications and using our equipment through a contract manufacturing arrangement with an FDA certified supplier that maintains stringent quality control protocols to assure the uniformity and quality of all of our gauze products. Information on the manufacturing process and our manufacturer’s facility has been submitted as part of our PMA submission. Our gauze products are cut to size, packaged and sterilized by service providers in the United States.
Patents and Trademarks
Our NORC technology is protected through patents filed with the U.S. Patent and Trademark Office, which protection currently runs through 2029. In 2020 and 2021, we filed additional U.S. and International patents that protect the use of our NORC technology in a gel or hydrocolloid formulation.
On January 21, 2021, the U.S. Patent Office provided notification of publication of the Company’s patent application for the method of forming and using a hemostatic hydrocolloid. This publication does not imply any assurance of the receipt of the patent but establishes an obligation of any party that seeks to use the applicable method to pay royalties for the right to do so. The patent application for this process remains pending as of the date of this filing.
On February 11, 2021, the Company was notified that its application to establish global patent protection for the process of creating and deploying a hydrocolloid (or gel) format of its HemoStyp technology was accepted for publication under the procedures of the Patent Cooperation Treaty (“PCT”), an international patent law treaty which provides a unified procedure for filing a patent application in most foreign countries. We previously filed provisional patent applications for our HemoStyp hydrocolloid process in 2020. In January 2022, the Company initiated steps to register its hydrocolloid patent in the European common market and in additional foreign countries where we intend to commercialize any future HemoStyp gel formats. We can give no assurance that foreign registration of our patents will be granted in any of these jurisdictions.
The Company has registered trademarks for the following product formats:
| • | Boo Boo Strips |
| • | The Ultimate Bandage |
| • | Hemostrips |
| • | CelluSTAT |
| • | Nik Fix |
Competition
The wound care products market in the United States is concentrated among large and established companies such as Baxter International, Becton Dickinson & Company, Bristol-Myers Squibb Company, Johnson & Johnson and 3M Company, each of which have greater capital and operational resources than us. Our hemostatic gauze product will directly compete in the gauze markets served by these companies. In this market, competitive factors include product performance, price, breadth of product offerings, value-added service programs, service and delivery, credit terms, and customer support.
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Government Regulation
We are subject to oversight by various federal and state governmental entities and we are subject to, and affected by, a variety of federal and state laws, regulations and policies generally applicable to the healthcare and medical device industries.
Environmental Matters
The Company may be subject to, or affected by, environmental legislation including, among others, the Toxic Substances Control Act, the Clean Air Act, the Clean Water Act, Compensation and Liability Act (CERCLA or Superfund) and the Resource Conservation and Recovery Act. There may be laws and regulations that exist or that may come to pass that may also have an impact on the Company in ways that we cannot foresee. Compliance with the multitude of regulations issued by federal, state, provincial and local administrative agencies that may apply to the Company can be burdensome and costly. To date, the Company has not been impacted by these laws and regulations.
Research and Development Expenditures
In the years ending December 31, 2022 and 2021 we incurred research and development expenditures of $624,564 and $237,458, respectively.
Personnel
As of March 27, 2023, we have seven full-time personnel working under consulting agreements. Additionally, we have four Medical Advisory Board members.
ITEM 1A. RISK FACTORS
We are engaged in the development, sale and distribution of hemostatic gauze products to stop superficial bleeding. As we develop our business, there are numerous and varied risks, known and unknown, that may prevent us from achieving our goals. If any of these risks actually occur, our business, financial condition or results of operation may be materially adversely affected. In such case, the trading price of our common stock could decline, and investors could lose all or part of their investment.
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RISKS RELATED TO OUR BUSINESS
We have a history of operating losses and we may continue to lose money in the future
For the years ended December 31, 2022 and 2021, the Company had a net loss of $1,687,501 and $30,549,183, respectively. We may continue to lose money in the future, and we will rely on financing to fund our business strategy for the foreseeable future as discussed in the Risk Factor “We will need additional financing to execute our business plan and fund operations, which may not be available”.
We can provide no assurances that our Class III application for internal surgical procedures in the U.S. market will be approved by the FDA.
In response to the FDA’s comments and questions to our 2021 and 2022 PMA submissions, we have developed and incorporated several product design, manufacturing and quality assurance procedures into our production process. Upon completion of certain finished product testing that is being conducts by outside laboratories we will submit a revised application to the FDA. There can be no assurance that our revised application, once resubmitted, will lead to a successful FDA decision regarding a PMA.
No assurances can be given that our Management plans to penetrate all market segments will be successful.
We continue to believe that the Class III surgical markets, both domestic and international, represent the most attractive market for our products due to the limited competition from other Class III approved ORC (Oxidized Regenerated Cellulose) products and the resulting premium pricing for hemostatic agents that can meet the demanding requirements of the human surgical environment. As of the filing date of this Form 10-K, the FDA review process is ongoing and we are preparing to submit an application for CE Mark approval in order to access the European and other markets. In the event we receive Class III and CE Mark approvals, which cannot be assured, we are evaluating the best paths grow our revenue and profits in all potential markets, which could include one or more commercial partnerships and licensing agreements with established market participants or an acquisition/merger agreement with any such participants, each as an alternative to raising the necessary capital to establish and grow our own marketing and distribution capabilities via organic growth. We will carefully evaluate the returns on investment to create shareholder value of each of these strategies. No assurances can be given that our plans to penetrate all market segments or be acquired/merged with an established market participant will be successful on terms satisfactory to us, if at all.
We can provide no assurances that ongoing discussions with potential commercial partners and acquirers will result in the occurrence of a specific transaction.
The Company has been contacted by several medical technology companies that are active in the surgical equipment and hemostatic products sectors, and who have expressed an interest in the Company’s products and business strategy. In response to these inbound contacts, and to maximize shareholder value, the Company continues to consider a range of strategic alternatives, which include, without limitation, entering into one or more commercial and distribution partnerships, a sale of the Company or a standalone growth plan. There can be no assurances that any specific transaction will occur as a result of these discussions. No assurances can be given that the Company will identify a suitable acquisition or commercialization partnership candidate(s) or complete any transaction on terms that are in the best interests of shareholders.
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We will need additional financing to execute our business plan and fund operations, which may not be available.
We currently have a working capital deficit, minimal cash and limited sales of our products. As result of the Company’s financial position, we may not be able to execute our current business plan and fund business operations long enough to achieve profitability. Our ultimate success will depend upon our ability to raise additional capital. There can be no assurance that additional funds will be available when needed from any source or, if available, will be available on terms that are acceptable to us.
We will pursue required additional capital through various means, including commercial collaborations and debt or equity financings. Future financings through equity investments are likely to be dilutive to existing stockholders. Also, the terms of securities we may issue in future capital transactions may be more favorable for our new investors. Newly issued securities may include preferences, superior voting rights, the issuance of warrants or other derivative securities. The issuances of incentive awards under existing and future employee incentive plans, may have additional dilutive effects. Further, we may incur substantial costs in pursuing future capital and/or financing, including investment banking fees, legal fees, accounting fees, printing and distribution expenses and other costs. We may also be required to recognize non-cash expenses in connection with certain securities we may issue, such as convertible notes and warrants, which may adversely impact our financial condition.
Our ability to obtain needed financing may be impaired by such factors as capital markets disruptions, both generally and specifically relating to the healthcare industry, and events that have a negative impact on existing and potential investors or funding sources. If the amount of capital we are able to raise from financing activities, together with our revenues from operations, is not sufficient to satisfy our capital needs we may be required to cease operations.
No guarantee of market acceptance.
Our success is dependent on market acceptance of our hemostatic gauze products. We cannot be certain that healthcare professionals and purchasing decision makers will conclude that our products offer a superior performance or value proposition, in any or all of the target markets we have identified, or that we will attain the level of market acceptance necessary to generate adequate revenues to cover our business costs and generate a return for investors.
We may be dependent upon commercial relationships to conduct our operations and implement our strategy.
Our proposed strategy includes the use of distribution and commercial partnerships to market and sell our hemostatic gauze products. We currently do not have any such commercial relationships. We may not be able to establish these relationships, or if established, we may not be able to maintain them. In addition, the dynamics of our relationships with strategic partners may require us to incur expenses or undertake activities we would not otherwise be inclined to in order to fulfill our obligations to these partners or maintain our relationships. If these relationships are not established or maintained, our business prospects may be limited, which could diminish our ability to conduct our operations. We can provide no assurances that distribution agreements will be entered into on terms satisfactory to us, if at all, or that our operations will be profitable as a result of these distribution agreements.
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We could experience difficulties in our supply chain.
Our NORC products are manufactured in Asia and the United States to our specifications. Unforeseen events at any manufacturing or packaging location may result in a disruption of production that could negatively impact our ability to supply our customers and generate revenues. We own certain specialized production equipment which is installed at our own manufacturing location which is not readily available should we need to replace it. While we intend to maintain significant supplies of finished product inventory, any prolonged disruption this facility could have a material adverse impact on our operations and business.
We are currently dependent on one hemostatic gauze product to generate income in the future.
The Company’s hemostatic gauze products are currently our sole source of potential revenue in the future. While we have multiple formats of this product and hope to access new markets upon receipt of a Class III PMA, we cannot provide assurance that our product will be accepted by potential customers or that new, superior hemostatic technologies will not be introduced that negatively impact the market perceptions of our own products. Unless we are able to develop or acquire additional product lines, the failure to develop a commercial market for this product line will materially adversely affect our operations.
Our business may suffer if we do not attract and retain talented personnel.
Our success will depend in large measure on the abilities, expertise, judgment, discretion, integrity and good faith of our management and other personnel in conducting our intended business. In addition, we depend on management and employees to correctly interpret and respond to market data, economic and other conditions to locate and adopt appropriate business opportunities. We presently have a small management team, which we intend to expand in conjunction with our planned operations and growth. We intend to ensure that management and any key employees are appropriately compensated; however, their continued service to the Company cannot be guaranteed. If we are unable to attract and retain additional key management personnel and enter into satisfactory employment and other agreements, our business may be adversely affected.
We may not be able to adequately protect our technologies or intellectual property rights.
Our ability to achieve commercial or strategic success will depend in part on maintaining patent protection and trade secret protection of our technologies as well as successfully defending our intellectual property against third-party challenges. We will only be able to protect our technologies from unauthorized use by third parties to the extent that valid and enforceable patents or trade secrets cover them. Furthermore, the degree of future protection of our proprietary rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage. Additionally, legal enforcement of intellectual property rights is costly and we may not have the financial resources to take the necessary legal action to protect our rights.
If our intellectual property positions are challenged, invalidated, circumvented, or expire, or if we fail to prevail in future intellectual property litigation, our business could be adversely affected. We have created multiple variations of our gauze product and will protect each of these new generation platforms and product with additional intellectual property. Our success depends in part on our ability to defend our intellectual property rights. The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and often involve complex legal, scientific, and factual questions. Third parties may seek to challenge, invalidate, or circumvent our intellectual property rights. In addition, our patent positions might not protect us against competitors with similar products or technologies because competing products or technologies may not infringe our patents. Also, there are third parties who have patents or pending patent applications that they may claim necessitate payment of a royalty or prevent us from commercializing our patent in certain territories. Patent disputes are frequent, costly and can preclude, delay, or increase the cost of commercialization of products.
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We have identified various material weaknesses in our internal control over financial reporting which could affect our ability to timely and accurately report our results of operations and financial condition. These material weaknesses may not have been fully remediated as of the filing date of this report and we cannot assure you that other material weaknesses will not be identified in the future.
Our Chief Executive Officer and Principal Financial Officer have concluded that, as of December 31, 2022, we had material weaknesses in our internal controls over financial reporting and that, as a result, our disclosure controls and procedures and our internal controls over financial reporting were not effective at such date. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting that creates a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.
In addition, we believe that we continued to have material weaknesses in our internal control over financial reporting subsequent to December 31, 2022. See “Controls and Procedures” under Item 9A for a detailed discussion of the material weaknesses identified as of December 31, 2022 and possible material weaknesses as of subsequent periods. Although we are in the process of implementing remedial measures to address all of the identified material weaknesses, our assessment of the impact of these measures has not been completed as of the filing date of this report, and we cannot assure you that these measures will be adequate. Moreover, we cannot assure you that additional material weaknesses in our internal control over financial reporting will not arise or be identified in the future.
As a result, we must continue to improve our operational, information technology, and financial systems, infrastructure, procedures, and controls, as well as continue to expand, train, retain, and manage our employee base. Any failure to do so, or any difficulties we encounter during implementation, could result in additional material weaknesses or in material misstatements in our financial statements. These misstatements could result in a future restatement of our financial statements, could cause us to fail to meet our reporting obligations, or could cause investors to lose confidence in our reported financial information, leading to a decline in our stock price.
Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern. This could make it more difficult for us to raise funds and adversely affect our relationships with creditors, investors and suppliers.
Our auditors believe that substantial doubt exists regarding our ability to remain in business. We cannot provide any assurance that we will in fact operate our business profitably or obtain sufficient financing to sustain our business in the event we are not successful in our efforts to generate sufficient revenue and operating cash flow. The expression of such doubt by our independent registered public accounting firm or our inability to overcome the factors leading to such doubt could have a material adverse effect on our relationships with prospective customers, creditors, investors and suppliers, and therefore could have a material adverse effect on our business.
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The healthcare industry is subject to extensive government regulation, which can result in increased costs, delays, limits on its operating flexibility and competitive disadvantages.
The healthcare industry is generally subject to extensive regulatory requirements. Adhering to these requirements generally carries significant costs to industry participants, including our Company. Given our limited financial resources these significant costs may adversely affect our business and financial results. If we are unable to pass on these costs through our product pricing they would negatively impact our profit margin.
Healthcare insurance legislation may lead to unintended adverse effects for businesses involved in our industry. New legislation that gives the Federal government greater regulatory powers may lead to negative consequences for certain aspects of our business. The full scope of the ongoing uncertainty in healthcare related legislation may not be known for several years, making it difficult to predict the future consequences that would create challenges to our Company, or if we can overcome them.
Failure to comply with laws or government regulations could result in penalties.
Certain government requirements for technologies in the healthcare market may require licensure or mandatory minimum standards relating to the provision of products and services. Failure to comply with these requirements could materially affect our ability to expand into new or existing markets. Future regulatory developments may also cause disruptions to our operations.
GENERAL RISK FACTORS
We are subject to the reporting requirements of the federal securities laws, which can be expensive.
We are a public reporting company and, accordingly, subject to the information and reporting requirements of the Exchange Act and other federal and state securities laws, including compliance with the Sarbanes-Oxley Act of 2002. The costs of preparing and filing annual and quarterly reports, proxy statements and other information with the SEC and furnishing audited reports to stockholders increase our operating costs.
It is time consuming, difficult and costly for us to develop and implement the internal controls and reporting procedures required by the Sarbanes-Oxley Act. We may need to hire additional financial reporting, internal controls and other finance personnel in order to develop and implement appropriate internal controls and reporting procedures. If we are unable to comply with the internal control’s requirements of the Sarbanes-Oxley Act, we may not be able to obtain the independent accountant certifications required by that Act.
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Public company compliance requirements may make it more difficult to attract and retain officers and directors.
The Sarbanes-Oxley Act and rules subsequently implemented by the SEC have required changes in corporate governance practices of public companies. Compliance with the new rules and regulations increases our operating costs and makes certain activities more time consuming and costly than if we were not a public company. As a public company, these new rules and regulations make it more difficult and expensive for us to obtain director and officer liability insurance. As a result, it may be more difficult for us to attract and retain qualified persons to serve on our Board of Directors or as executive officers.
There exist risks to stockholders relating to dilution: authorization of additional securities and reduction of percentage share ownership following investment.
To the extent that additional shares of common stock are issued, our existing stockholders would experience dilution of their respective ownership interests in the Company. Additionally, if the Company issues a substantial number of shares of common stock in connection with or following an investment, a change in control of the Company may occur which may affect, among other things, the Company’s ability to utilize net operating loss carry forwards, if any. Furthermore, the issuance of a substantial number of shares of common stock may adversely affect prevailing market prices for our common stock and could impair the Company’s ability to raise additional capital through the sale of its equity securities. The Company has in the past and may in the future compensate certain consultants and other service providers using our shares of common stock, which would result in further dilution for our existing stockholders.
Our stock price may be volatile.
The market price of our common stock is likely to be highly volatile and could fluctuate widely in response to various factors, many of which are beyond our control, including the following:
| • | changes in the healthcare industry; |
| • | competitive pricing pressures; |
| • | our ability to obtain working capital financing; |
| • | additions or departures of key personnel; |
| • | our ability to execute our business plan; |
| • | operating results that fall short of expectations; |
| • | loss of certain material strategic relationships; |
| • | regulatory developments; |
| • | economic and other external factors, including among others, effects on the markets stemming from the COVID-19 pandemic; and |
| • | period-to-period fluctuations in our financial results. |
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 dividends in the past and do not expect to pay dividends in the future. Any return on investment may be limited to changes in the value of our common stock.
We have never paid cash dividends on our common stock and do not anticipate doing so 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 affecting us at such time as our board of directors may consider relevant. If we do not pay dividends, return on investment will only occur if our stock price appreciates.
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There is currently no established market for our common stock, and we cannot ensure that one will ever develop or be sustained.
The Company’s common stock is available for trading on the OTC Pink. Management considers the market for our common stock to be limited. We can provide no assurances that an established trading market for our common stock will exist in the future.
Our common stock is deemed a “penny stock”, which may make it more difficult for our investors to sell their shares.
Our common stock is subject to the “penny stock” rules adopted under Section 15(g) of the Securities Exchange Act of 1934. The penny stock rules apply to companies whose common stock is not listed on a national securities exchange and trades at less than $5.00 per share or that have tangible net worth of less than $5,000,000 ($2,000,000 if the company has been operating for three or more years). These rules require, among other things, that brokers who trade penny stock to persons other than “established customers” complete certain documentation, make suitability inquiries of investors and provide investors with certain information concerning trading in the security, including a risk disclosure document and quote information under certain circumstances. Many brokers have decided not to trade penny stocks because of the requirements of the penny stock rules and, as a result, the number of broker-dealers willing to act as market makers in such securities is limited. If we remain subject to the penny stock rules for any significant period, it could have an adverse effect on the market, if any, for our securities. In as much as our securities are subject to the penny stock rules, investors may find it more difficult to dispose of our securities.
Offers or availability for sale of a substantial number of shares of our common stock may cause the price of our common stock to decline.
If certain of our stockholders seek to sell substantial amounts of our common stock in the public market upon the expiration of any holding period under Rule 144, or expiration of lock-up periods applicable to outstanding shares, or issued upon the exercise of outstanding options or warrants, it could create a circumstance commonly referred to as an “overhang” and in anticipation of which the market price of our common stock could fall. The existence of an overhang, whether or not sales have occurred or are occurring, also could impair our ability to raise additional financing through the sale of equity or equity-related securities in the future at a time and price that we deem reasonable or appropriate.
ITEM 1B. UNRESOLVED STAFF COMMENTS
None
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ITEM 2. DESCRIPTION OF PROPERTY
The Company is utilizing on a temporary basis, rent free, a central mailing address as its principal executive office, located at 526 Commerce Circle, Ste. #120, Mesquite, NV 89027. On October 31, 2022, the Company signed a 120-day lease for 600 square feet of space in Hammonton, New Jersey to install, commission and test its medical device equipment. The Company is a virtual company with personnel in Nevada and five other states working remotely.
ITEM 3. LEGAL PROCEEDINGS
Philip Forman, who served as Chairman, a director, Chief Executive Officer and Chief Medical Advisor of the Company at various times between 2011 and October 2015, filed a lawsuit against the Company and our then-Chief Executive Officer, Douglas Beplate, in the United States District Court of the District of Nevada. The plaintiff has claimed, among other things: that the June 25, 2015 Amendment to his November 10, 2014 Employment Agreement with the Company, which terminated the Employment Agreement on October 1, 2015, is not enforceable due to lack of consideration; that a July 22, 2015 Stock Purchase Agreement pursuant to which the plaintiff sold Company shares issued to him under the Amendment to a third a party is unenforceable (despite the fact that all payment for the shares under the Stock Purchase Agreement was made); that the plaintiff’s 2014 Employment Agreement remains valid and that he is entitled to cash and stock compensation under that Employment Agreement (without giving regard to the Amendment); and that the Company and Mr. Beplate defrauded the plaintiff relating to the foregoing. The plaintiff is seeking declaratory judgment regarding the parties’ relative rights under the Employment Agreement, the Amendment and the Stock Purchase Agreement; money damages of no less than $2,795,000; and punitive damages of $8,280,000. The Company filed a motion to dismiss the plaintiff’s claims which was denied on March 19, 2020. On May 5, 2021, the plaintiff provided a deposition as instructed by the Court, subsequent to which the Company filed a motion for dismissal of this proceeding. On February 14, 2022, the Court issued an Order which declared the Amendment to be unenforceable and thus the terms of the original Employment Agreement to remain in effect. The Order also noted that the Company is not a party to the Stock Purchase Agreement, and the Employment Agreement does not constitute a prior agreement that could have been superseded by the Stock Purchase Agreement.
In July 2022, United Health Products filed a motion to reopen discovery for the purpose of developing additional issues it wished to raise at trial. At the beginning of August 2022, the court denied United Health Products’ request to reopen discovery. The court instructed counsel for both parties to meet and confer regarding a Joint Trial Order to be filed with the court. The Joint Trial Order generally details the parties’ position on which issues are to be addressed at trial. The parties are currently seeking to reach agreement on what issues should be addressed at trial. Once the issues have been agreed upon, the Joint Trial Order will be filed with the court and the court will set a trial date. Concurrently with the completion of the Joint Trial Order, the parties are engaged in various settlement negotiations.
In August 2020, United Health Products filed suit against its former auditors, in Utah State Court, asserting claims related to professional negligence and breach of fiduciary duty. The Company and the defendant through mediation reached an agreement on settlement in which the defendant paid the Company $392,000 in September 2022.
Due to uncertainties inherent in litigation, we cannot predict the outcome of the legal proceedings described herein.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
| 14 |
PART II
ITEM 5. MARKET FOR COMMON EQUITY, RELATED STOCKHOLDER MATTERS, AND ISSUER PURCHASES OF EQUITY SECURITIES.
(a) Market information
The common shares of the Company trade on the OTC Pink under the symbol UEEC. There is no established trading market for our common shares and there has been only limited trading activity to date. The following table sets forth the high and low sales price of the common stock on a quarterly basis for the periods presented, rounded to the nearest penny.
|
| High |
|
| Low |
| ||
For Year Ended 2022 |
|
|
|
|
|
| ||
First Quarter |
| $ | 0.70 |
|
| $ | 0.42 |
|
Second Quarter |
| $ | 0.79 |
|
| $ | 0.35 |
|
Third Quarter |
| $ | 0.50 |
|
| $ | 0.29 |
|
Fourth Quarter |
| $ | 0.33 |
|
| $ | 0.21 |
|
|
|
|
|
|
|
|
|
|
For Year Ended 2021 |
|
|
|
|
|
|
|
|
First Quarter |
| $ | 1.18 |
|
| $ | 1.00 |
|
Second Quarter |
| $ | 1.19 |
|
| $ | 0.83 |
|
Third Quarter |
| $ | 1.08 |
|
| $ | 0.94 |
|
Fourth Quarter |
| $ | 0.99 |
|
| $ | 0.53 |
|
(b) Holders
As of March 27, 2023, there were approximately 404 holders of record of the Company’s issued and outstanding shares of common stock.
(c) Dividends
The Company has not paid any dividends to date, has not yet generated earnings sufficient to pay dividends, and currently does not intend to pay dividends in the foreseeable future.
| 15 |
(d) Stock Issuances and Repurchases
The following table summarizes all sales and issuances by the Company of unregistered securities during the year ended December 31, 2022. The securities in the below-referenced transactions were (i) issued without registration and (ii) were subject to restrictions under the Securities Act and the securities laws of certain states, in reliance on the private offering exemptions contained in Sections 4(a)(2), 4(a)(6) and/or 3(b) of the Securities Act and on Regulation D promulgated under the Securities Act, and in reliance on similar exemptions under applicable state laws as transactions not involving a public offering. No placement or underwriting fees were paid in connection with these transactions. All cash proceeds from the sale of securities were used for working capital and general corporate purposes.
Date of Sale |
| Title of Security |
| Number Sold |
|
| Consideration Received | ||
January 2022 |
| Common Stock |
|
| 6,252 |
|
| $3,126 of accrued liabilities | |
February 2022 |
| Common Stock |
|
| 184,028 |
|
| $77,292 in cash at $0.42 per share | |
February 2022 |
| Common Stock |
|
| 20,000 |
|
| $10,200 in services provided | |
April 2022 |
| Common Stock |
|
| 625,000 |
|
| $187,500 of accrued liabilities | |
April 2022 |
| Common Stock |
|
| 625,000 |
|
| $300,000 in services provided | |
September 2022 |
| Common Stock |
|
| 525,000 |
|
| $173,250 in services provided | |
September 2022 |
| Common Stock |
|
| 466,667 |
|
| $140,000 of accrued liabilities | |
September 2022 |
| Common Stock |
|
| 75,000 |
|
| $9,856 in cash, net of legal expenses | |
September 2022 |
| Common Stock |
|
| 757,576 |
|
| $250,000 for commitment fee | |
November 2022 |
| Common Stock |
|
| 827,397 |
|
| $200,000 in convertible debt and $6,849 of accrued interest | |
December 2022 |
| Common Stock |
|
| 570,000 |
|
| $113,089, in cash, net of legal expenses | |
ISSUER PURCHASES OF EQUITY SECURITIES
Period |
| Total Number of Shares Purchased |
|
| Average Price Paid Per Share |
|
| Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs |
|
| Approximate Dollar Value of Shares that May Yet be Purchased under the Plans or Programs |
| ||||
August 1, 2022 - August 31, 2022 |
|
| 142,857 |
|
| $ | 0.35 |
|
|
| - |
|
| $ | - |
|
Total |
|
| 142,857 |
|
| $ | 0.35 |
|
|
| - |
|
| $ | - |
|
(e) Description of Our Capital Stock
The following description of our capital stock is a summary only and is qualified by reference to our Certificate of Incorporation and Bylaws, which are included as Exhibits 3.1, 3.2, 3.3 and 3.4 to this report.
General
Our authorized capital stock consists of 300,000,000 shares of common stock, with a par value of $0.001 per share. As of March 27, 2023, there were 234,343,534 shares of common stock issued and outstanding.
Common Stock
Each holder of Common Stock will be entitled to one vote for each share of Common Stock held of record by such holder with respect to all matters to be voted on or consented to by our stockholders, except as may otherwise be required by applicable Nevada law. The stockholders will not have pre-emptive rights under our Certificate of Incorporation to acquire additional shares of Common Stock or other securities. The Common Stock will not be subject to redemption rights and will carry no subscription or conversion rights. In the event of liquidation of the Company, the stockholders will be entitled to share in corporate assets on a pro rata basis after the Company satisfies all liabilities and after provision is made for each class of capital stock having preference over the Common Stock (if any). Subject to the laws of the State of Nevada, and the rights of the holders of any outstanding series of preferred stock (if any), the Board of Directors will determine, in their discretion, to declare dividends advisable and payable to the holders of outstanding shares of Common Stock.
| 16 |
Transfer Agent and Registrar
Pacific Stock Transfer Company is the registrar and transfer agent for our shares of common stock. Its address is 6725 Via Austi Pkwy, Suite 300, Las Vegas, NV 89119, United States; Telephone: (800) 785-7782.
ITEM 6. [RESERVED]
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION
You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and related notes appearing elsewhere in this annual report on Form 10-K. This discussion and analysis contain forward-looking statements that involve risks, uncertainties and assumptions. The actual results may differ materially from those anticipated in these forward-looking statements as a result of certain factors, including, but not limited to, those set forth under ‘Risk Factors’ and elsewhere in this annual report on Form 10-K.
Results of Operations years ending December 31, 2022 and 2021
The following table sets forth a summary of certain key financial information for the years ended December 31, 2022 and 2021:
|
| 2022 |
|
| 2021 |
| ||
|
|
|
|
|
|
| ||
Revenue |
| $ | 37,500 |
|
| $ | 59 |
|
|
|
|
|
|
|
|
|
|
Gross profit |
| $ | 18,856 |
|
| $ | 34 |
|
|
|
|
|
|
|
|
|
|
Operating (expenses) |
| $ | (2,820,895 | ) |
| $ | (29,800,669 | ) |
|
|
|
|
|
|
|
|
|
Operating (loss) |
| $ | (2,802,039 | ) |
| $ | (29,800,635 | ) |
|
|
|
|
|
|
|
|
|
Other income (expense) |
| $ | 1,114,538 |
|
| $ | (748,548 | ) |
|
|
|
|
|
|
|
|
|
Net (loss) |
| $ | (1,687,501 | ) |
| $ | (30,549,183 | ) |
|
|
|
|
|
|
|
|
|
Basic and diluted |
| $ | (0.01 | ) |
| $ | (0.14 | ) |
| 17 |
Year ended December 31, 2022 versus year ended December 31, 2021
During the year ended December 31, 2022 and 2021, the Company had $37,500 and $59 of revenues, respectively. The Company fulfilled an order to one customer, which accounted for all the revenue during the year ended December 31, 2022. The Company generated minimal revenues during the years ended December 31, 2022 and 2021 due to focusing its capital and resources towards seeking a Class III PMA.
Total operating expenses for the year ended December 31, 2022 and 2021 were $2,820,895 and $29,800,669, respectively. The decrease in operating expenses is due primarily to a $26,377,647 decrease in stock-based compensation expense, a decrease of $224,972 in loss on settlement of debt and a decrease of $232,000 of litigation settlement expense (see Note 7 to the financial statements) compared to 2021.
The decrease in stock-based compensation is primarily related to vesting and amortization of RSUs. During the year ended December 31, 2021, the Company amended the RSU agreement with its former Chief Executive Officer and Chairman. The amendment resulted in the vesting of 21,970,000 RSUs along with the issuance of an additional 2,000,000 shares of restricted stock as a bonus. The change in vesting and issuance of the bonus shares of common stock resulted in the immediate recognition of $26,127,300 in stock-based compensation expense. The Company also recognized $43,121 of stock-based compensation due to the amortization of the RSUs that vested on January 1, 2021, issued 100,000 shares of common stock for settlement of a consulting agreement valued at $111,000, issued 125,000 shares of common stock for services valued at $102,500 and issued 560,000 shares of common stock valued at $477,175 due to vesting of RSUs.
During the year ended December 31, 2022, the Company recorded $483,450 of stock-based compensation. The Company issued 1,170,000 shares of common stock for services valued at $483,450 and did not have any RSUs vest during the year ended December 31, 2022.
Other income (expense) for the year ended December 31, 2022 and 2021 was $1,114,538 and $(748,548), respectively. The increase in other income was due to other income of $1,402,981 offset by total interest expense of $78,845 and loss on settlement of debt of $209,598. The increase in other income was due to the Company receiving $392,000 as a settlement payment from its former auditor related to litigation and the receipt of $202,200 in cash and 2,085,258 shares of common stock as payment of $808,781 from its former Chief Executive Officer to satisfy a disgorgement obligation during the year ended December 31, 2022 compared with the Company receiving $304,273 for settlement of its December 2019 arbitration with Maxim during the year ended December 31, 2021.
The decrease in interest expense is primarily due to the amortization of beneficial conversion features on convertible notes payable and convertible notes payable – related party during the year ended December 31, 2022 totaling $16,533 compared to $608,710 in the year ended December 31, 2021. The decrease in the loss on settlement of debt is due to the Company issuing common stock with a fair value of $458,001 for the settlement of an aggregate of $330,626 of accrued liabilities and accrued liabilities – related parties and recording $82,223 in loss on settlement of debt related to lowering the conversion price of a convertible note as an inducement for conversion during the year ended December 31, 2022 compared to issuing shares of common stock with a fair value of $1,205,718 for the settlement of $771,148 of various debts and accrued liabilities – related party during the year ended December 31, 2021.
Our net loss for the year ended December 31, 2022 was $1,687,501 as compared to a net loss of $30,549,183 for the prior year. The decrease in the net loss was due to the Company having a decrease in operating expenses of $26,979,774 along with an increase in other income (expense) from $(748,548) during the year ended December 31, 2021 to $1,114,538 for the year ended December 31, 2022, as explained above.
| 18 |
Financial Condition, Liquidity and Capital Resources
As of December 31, 2022, the Company had a negative working capital of $2,344,416. The Company has not yet attained a level of operations, and for the foreseeable future will not be pursuing commercial operations, which will allow it to meet its current overhead expense obligations. The report of our independent registered public accounting firm on our 2022 and 2021 financial statements includes an explanatory paragraph expressing substantial doubt about our ability to continue as a going concern. The Company generated minimal revenues during the years ended December 31, 2022 and 2021 due to focusing its capital and resources towards seeking a Class III PMA for its HemoStyp technology, and has funded its initial operations with private placements, and unsecured loans from related parties. There can be no assurance that adequate financing will continue to be available to the Company and, if available, on terms that are favorable to the Company. Our ability to continue as a going concern is also dependent on many events outside of our direct control, including, among other things, our ability to achieve our business goals and objectives, as well as improvement in the economic climate.
As discussed in Note 6 of the financial statements, the Company entered into a common stock purchase agreement (“CSPA”) with White Lion, which gives the Company the right, but not the obligation, to require White Lion to purchase up to $10,000,000 of the Company’s common stock, subject to certain limitations and conditions set forth in the CSPA. As of the date of this filing, the Company has received $577,855 in proceeds from White Lion to pay for its operations and finalization of its Class III PMA application. The sale of additional equity or convertible debt securities would be dilutive to our shareholders. In addition, economic conditions and actions by policymaking bodies are contributing to rising interest rates and significant capital market volatility, which, along with increases in our borrowing levels, could increase our future borrowing costs.
Cash Flows
The Company’s cash on hand as of December 31, 2022 and 2021 was $13,377 and $21,799, respectively.
The following table summarizes selected items from our statements of cash flows for the years ended December 31, 2022 and 2021:
|
| 2022 |
|
| 2021 |
| ||
Net cash used in operating activities |
| $ | (619,720 | ) |
| $ | (828,079 | ) |
Net cash used in investing activities |
|
| (40,500 | ) |
|
| - |
|
Net cash provided by financing activities |
|
| 651,798 |
|
|
| 803,802 |
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
| $ | (8,422 | ) |
| $ | (24,277 | ) |
Net Cash Provided by (Used in) Operating Activities
Net cash used in operating activities for the year ended December 31, 2022 was $619,720. The Company had net loss of $1,687,501 and $808,781 as stock received as other income offset by stock for services and compensation of $483,450, amortization expense of $4,050, amortization of debt discount of $16,533 and a loss on debt settlement of $209,598. The Company had an increase in accounts payable and accrued expenses of $638,721, an increase in accrued liabilities - related party of $296,872, an increase in accrued litigation settlement of $280,000, an increase in prepaid expenses of $17,932 and an increase in inventory of $34,730.
Net cash used in operating activities for the year ended December 31, 2021 was $828,079. The Company had net loss of $30,549,183 offset by non-cash stock-based compensation of $26,861,097, amortization of debt discount of $608,710, stock issued for litigation settlement of $312,000, write-off of inventory of $69,649, write-off of property and equipment of $101,350 and a loss on settlement of debt of $434,570. The Company also had a decrease in inventory of $26, change in accounts payable and accrued expenses of $693,692, a change in accounts payable and accrued expenses related party of $525,011 and a change in accrued litigation settlement of $120,000. The Company also had an increase in prepaid and other current assets of $5,000.
Net Cash Used by Investing Activities
The Company paid $40,500 related to the patent application fees during the year ended December 31, 2022.
The Company did not have any investing activities during the year ended December 31, 2021.
| 19 |
Net Cash Provided by (Used in) Financing Activities
Net cash provided by financing activities for the year ended December 31, 2022 was $651,798. This was due to the Company receiving $383,275 in proceeds from related parties, $175,887 in proceeds from the sale of stock, $93,000 in proceeds from convertible notes – related party and $392,975 in proceeds from convertible notes payable offset by making payments of $226,275 on loans payable – related party, $90,864 on a promissory note payable, $26,200 of offering costs and repurchasing $50,000 of common stock.
Net cash provided by financing activities for the year ended December 31, 2021 was $803,802 consisting of $245,500 in proceeds from related party loans, $479,802 in proceeds from the sale of stock and $115,000 in proceeds from the issuance of convertible notes offset by $36,500 of repayments to related parties.
Off-Balance Sheet Arrangements
As of December 31, 2022 and 2021, we had no off-balance sheet arrangements.
Related Parties
Information concerning related party transactions is included in the financial statements and related notes, appearing elsewhere in this annual report on Form 10-K.
Critical Accounting Estimates
The preparation of financial statements in conformity with generally accepted accounting principles of the United States (“GAAP”) requires estimates and assumptions that affect the reported amounts of assets and liabilities, revenues and expenses in the financial statements and accompanying notes. Critical accounting estimates are those estimates made in accordance with GAAP that involve a significant level of estimation uncertainty and have had or are reasonably likely to have a material impact on the financial condition or results of operations of the Company. Based on this definition, we have the critical accounting estimates identified below. We also have other key accounting policies, which involve the use of estimates, judgments, and assumptions that are significant to understanding our results which are found in Note 2 – Significant Accounting Policies of the accompanying financial statements. Although we believe that our estimates, assumptions, and judgments are reasonable, they are based upon information presently available. Actual results may differ significantly from these estimates under different assumptions, judgments, or conditions.
Stock-Based Compensation
The Company accounts for stock-based compensation under the provisions of ASC 718, Compensation-Stock Compensation. Stock-based compensation expense for employees and non-employees is measured at the grant date fair value. Stock-based compensation for all stock-based awards to employees and directors is recognized as an expense over the requisite service period, which is generally the vesting period.
| 20 |
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The financial statements required by Item 8 can be found beginning on Page F-2 of this report.
INDEX TO FINANCIAL STATEMENTS AND SUPPLEMENTAL DATA
|
| Page | |
|
|
|
|
Report of Independent Registered Public Accounting Firms (Firm ID |
| F-2 |
|
|
|
| |
Financial Statements of United Health Products, Inc. |
|
| |
| F-3 |
| |
Statements of Operations for the years ended December 31, 2022 and 2021 |
| F-4 |
|
Statements of Stockholders’ Deficiency for the years ended December 31, 2022 and 2021 |
| F-5 |
|
Statements of Cash Flows for the years ended December 31, 2022 and 2021 |
| F-6 |
|
| F-7 |
|
| F-1 |
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders
United Health Products, Inc.
Opinion on the Financial Statements
We have audited the accompanying balance sheets of United Health Products, Inc. as of December 31, 2022 and 2021, and the related statement of operations, stockholders’ deficiency, and cash flows for each of the two years in the period ended December 31, 2022, 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 Untied Health Products, Inc. as of December 31, 2022 and 2021, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2022, in conformity with accounting principles generally accepted in the United States of America.
Going Concern
The accompanying financial statements have been prepared assuming that the entity will continue as a going concern. As discussed in Note 2 to the financial statements, the entity has suffered recurring losses from operations and has a net capital deficiency that raise substantial doubt about its ability to continue as a going concern. Management's plans in regard to these matters are also 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 entity’s management. Our responsibility is to express an opinion on these 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 United Health Products, Inc. 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. United Health Products, Inc. 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 entity'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 Matters
Critical audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters.
/s/
We have served as United Health Products, Inc.'s auditor since 2019.
March 28, 2023
| F-2 |
| Table of Contents |
UNITED HEALTH PRODUCTS, INC.
Balance Sheets
|
| December 31, |
|
| December 31, |
| ||
|
| 2022 |
|
| 2021 |
| ||
|
|
|
|
| ||||
ASSETS | ||||||||
Current Assets |
|
|
|
|
|
| ||
Cash and Cash Equivalents |
| $ |
|
| $ |
| ||
Inventory |
|
|
|
|
|
| ||
Prepaid and other current assets |
|
|
|
|
|
| ||
Total current assets |
|
|
|
|
|
| ||
|
|
|
|
|
|
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|
|
Deferred offering costs |
|
|
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|
| ||
Patents, net |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
TOTAL ASSETS |
| $ |
|
| $ |
| ||
|
|
|
|
|
|
|
|
|
Current Liabilities |
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
| $ |
|
| $ |
| ||
Accrued liabilities - related parties |
|
|
|
|
|
| ||
Accrued litigation settlement |
|
|
|
|
|
| ||
Promissory note payable |
|
|
|
|
|
| ||
Loans payable – related parties |
|
|
|
|
|
| ||
Convertible notes payable, net of debt discount |
|
|
|
|
|
| ||
Convertible notes payable – related party, net of debt discount |
|
|
|
|
|
| ||
Total current liabilities |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
Commitments and Contingencies |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
Stockholders' Deficit |
|
|
|
|
|
|
|
|
Series A Convertible Preferred Stock - $ |
|
|
|
|
|
| ||
Common Stock - $ |
|
|
|
|
|
| ||
Subscription Receivable |
|
| ( | ) |
|
|
| |
Additional Paid-In Capital |
|
|
|
|
|
| ||
Accumulated Deficit |
|
| ( | ) |
|
| ( | ) |
Total Stockholders' Deficit |
|
| ( | ) |
|
| ( | ) |
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT |
| $ |
|
| $ |
| ||
See notes to financial statements.
| F-3 |
| Table of Contents |
UNITED HEALTH PRODUCTS, INC
Statements of Operations
|
| 2022 |
|
| 2021 |
| ||
|
|
|
|
|
|
| ||
Revenues |
| $ |
|
| $ |
| ||
Cost of sales |
|
|
|
|
|
| ||
Gross profit |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
Operating Costs and Expenses |
|
|
|
|
|
|
|
|
Selling, general and administrative expenses |
|
|
|
|
|
| ||
Research and development expenses |
|
|
|
|
|
| ||
Total Operating Expenses |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
Loss from Operations |
|
| ( | ) |
|
| ( | ) |
|
|
|
|
|
|
|
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|
Other income (expenses) |
|
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|
Interest expense |
|
| ( | ) |
|
| ( | ) |
Interest expense – related party |
|
| ( | ) |
|
| ( | ) |
Loss on settlement of debt |
|
| ( | ) |
|
| ( | ) |
Other income |
|
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|
| ||
Total other income (expense) |
|
|
|
|
| ( | ) | |
|
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Income tax expense |
|
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| ||
|
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Net Loss |
| $ | ( | ) |
| $ | ( | ) |
|
|
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Net Loss per common share: |
|
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Basic and diluted |
| $ | ( | ) |
| $ | ( | ) |
|
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Weighted average number of shares outstanding |
|
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|
| ||
See notes to financial statements.
| F-4 |
| Table of Contents |
UNITED HEALTH PRODUCTS, INC
Statement of Stockholders’ Deficiency
For the Years Ended December 31, 2022 and 2021
|
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| Additional |
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| Common Stock |
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| Paid-in |
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| Subscription |
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| Accumulated |
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| ||||||||||
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| Shares |
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| Amount |
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| Capital |
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| Receivable |
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| Deficit |
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| Total |
| ||||||
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| ||||||
Balance at December 31, 2020 |
|
|
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| $ |
|
| $ |
|
| $ |
|
| $ | ( | ) |
| $ | ( | ) | ||||
|
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Beneficial conversion feature |
|
| - |
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Issuance of common stock for services and compensation |
|
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Sale of common stock |
|
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| ||||||
|
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|
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|
|
|
|
|
|
|
|
|
|
Cancelled shares |
|
| ( | ) |
|
| ( | ) |
|
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|
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|
| ||||
|
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|
Common stock issued for litigation settlement |
|
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| ||||||
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|
Common stock issued to settle accrued liabilities – related party |
|
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| ||||||
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|
|
|
|
|
|
|
Common stock issued to settle related party advances |
|
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| ||||||
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|
|
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|
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|
Common stock issued to settle accrued liabilities |
|
|
|
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| ||||||
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|
|
|
|
|
|
|
Common stock issued for conversion of convertible notes payable and accrued interest |
|
|
|
|
|
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|
|
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| ||||||
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|
|
|
|
|
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|
|
|
Common stock issued for conversion of convertible notes payable and accrued interest – related party |
|
|
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| ||||||
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) | ||
|
|
|
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|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2021 |
|
|
|
| $ |
|
| $ |
|
| $ |
|
| $ | ( | ) |
| $ | ( | ) | ||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock for services and compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sale of common stock, net of $26,200 of offering costs |
|
|
|
|
|
|
|
|
|
|
|
|
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| ||||||
|
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|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock repurchased and cancelled |
|
| ( | ) |
|
| ( | ) |
|
| ( | ) |
|
|
|
|
|
|
|
| ( | ) | ||
|
|
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|
|
|
|
|
|
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|
|
|
|
|
|
|
|
Common stock issued for commitment fee |
|
|
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|
|
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|
|
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|
| ||||||
|
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock issued to settle accrued liabilities – related party |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock issued to settle accrued liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
|
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|
|
|
|
|
|
|
|
|
|
Common stock issued for conversion of convertible notes payable and accrued interest |
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
| ||||||
|
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|
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|
|
|
|
|
|
|
|
|
Common stock issued for a stock subscription receivable |
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
|
|
|
|
| |||||
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of deferred offering costs |
|
| - |
|
|
|
|
|
| ( | ) |
|
|
|
|
|
|
|
| ( | ) | |||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
| - |
|
|
|
|
|
|
|
|
|
|
|
| ( | ) |
|
| ( | ) | |||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2022 |
|
|
|
| $ |
|
| $ |
|
| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) | |||
See notes to financial statements.
| F-5 |
| Table of Contents |
UNITED HEALTH PRODUCTS, INC
Statements of Cash Flows
|
| 2022 |
|
| 2021 |
| ||
|
|
|
|
|
|
| ||
Cash Flows from Operating Activities: |
|
|
|
|
|
| ||
Net Loss |
| $ | ( | ) |
| $ | ( | ) |
Adjustments to Reconcile Net Loss to Net Cash Used in Operating Activities: |
|
|
|
|
|
|
|
|
Stock for services and compensation |
|
|
|
|
|
| ||
Loss on settlement of debt |
|
|
|
|
|
| ||
Write-off of inventory |
|
|
|
|
|
| ||
Write-off of property and equipment |
|
|
|
|
|
| ||
Stock issued for litigation settlement |
|
|
|
|
|
| ||
Amortization of debt discount |
|
|
|
|
|
| ||
Amortization expense |
|
|
|
|
|
| ||
Stock received as other income |
|
| ( | ) |
|
|
| |
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
Inventory |
|
| ( | ) |
|
|
| |
Prepaid and other current assets |
|
| ( | ) |
|
| ( | ) |
Accounts payable and accrued expenses |
|
|
|
|
|
| ||
Accrued litigation settlement |
|
|
|
|
|
| ||
Accrued liabilities – related party |
|
|
|
|
|
| ||
Net Cash Used In Operating Activities |
|
| ( | ) |
|
| ( | ) |
|
|
|
|
|
|
|
|
|
Cash Flows from Investing Activities: |
|
|
|
|
|
|
|
|
Purchase of patents |
|
| ( | ) |
|
|
| |
Net Cash Used In Investing Activities |
|
| ( | ) |
|
|
| |
|
|
|
|
|
|
|
|
|
Cash Flows from Financing Activities: |
|
|
|
|
|
|
|
|
Repayment to on loan payable - related parties |
|
| ( | ) |
|
| ( | ) |
Proceeds from loan payable - related parties |
|
|
|
|
|
| ||
Repayments on promissory note payable |
|
| ( | ) |
|
|
| |
Repurchase of common stock |
|
| ( | ) |
|
|
| |
Proceeds from convertible notes payable – related party |
|
|
|
|
|
| ||
Proceeds from convertible notes payable |
|
|
|
|
|
| ||
Payment of offering costs |
|
| ( | ) |
|
| - |
|
Proceeds from issuance of common stock |
|
|
|
|
|
| ||
Net Cash Provided By Financing Activities |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
Increase (decrease) in Cash and Cash Equivalents |
|
| ( | ) |
|
| ( | ) |
Cash and Cash Equivalents - Beginning of period |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS - END OF PERIOD |
| $ |
|
| $ |
| ||
|
|
|
|
|
|
|
|
|
Supplemental cash flow information: |
|
|
|
|
|
|
|
|
Cash paid for interest |
| $ |
|
| $ |
| ||
Cash paid for income taxes |
| $ |
|
| $ |
| ||
|
|
|
|
|
|
|
|
|
Schedule of Non-Cash Financing Activities: |
|
|
|
|
|
|
|
|
Cancellation of common stock |
| $ |
|
| $ |
| ||
Common stock issued for commitment fee |
| $ |
|
| $ |
| ||
Common stock issued to settle accrued liabilities – related party |
| $ |
|
| $ |
| ||
Common stock issued to settle accounts payable and accrued liabilities |
| $ |
|
| $ |
| ||
Accrued litigation settlement paid with loan payable |
| $ |
|
| $ |
| ||
Debt discount related to beneficial conversion feature |
| $ |
|
| $ |
| ||
Conversion of accounts payable and accrued liabilities to convertible notes payable |
| $ |
|
| $ |
| ||
Accrued liabilities – related party converted to convertible notes payable – related party |
| $ |
|
| $ |
| ||
Loans payable – related party converted to convertible notes payable – related party |
| $ |
|
| $ |
| ||
Conversion of accrued liabilities – related party to loans payable – related parties |
| $ |
|
| $ |
| ||
Common stock issued to settle related party advances |
| $ | - |
|
| $ |
| |
Common stock issued for conversion of convertible notes payable and accrued interest |
| $ |
|
| $ |
| ||
Common stock issued for conversion of convertible notes payable and accrued interest – related party |
| $ |
|
| $ |
| ||
Convertible notes payable and accrued interest– related party converted to convertible notes payable and accrued interest |
| $ |
|
| $ |
| ||
Common stock issued for subscription receivable |
| $ |
|
| $ | - |
| |
Debt discount related to original issue discount |
| $ |
|
| $ | - |
| |
Amortization of deferred offering costs |
| $ |
|
| $ | - |
| |
See notes to financial statements.
| F-6 |
| Table of Contents |
UNITED HEALTH PRODUCTS, INC.
NOTES TO FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021
Note 1. Description of the Business
United Health Products, Inc. (the “Company”) develops, manufactures, and markets a patented hemostatic gauze for the healthcare and wound care sectors. Our gauze product, HemoStyp®, is a neutralized, oxidized, regenerated cellulose derived from cotton and designed to absorb exudate/drainage from superficial wounds and help control bleeding. The Company in the process of seeking regulatory approval to sell our HemoStyp product line into the U.S. Class III and European Union CE Mark surgical markets.
Note 2. Significant Accounting Policies
Going Concern
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The Company has incurred recurring net losses, negative working capital and operations have not provided cash flows. Additionally, the Company does not currently have sufficient revenue producing operations to cover its operating expenses and meet its current obligations. In view of these factors, there is substantial doubt about the Company's ability to continue as a going concern. The Company intends to finance its future development activities and its working capital needs largely from the sale of public equity securities with some additional funding from other traditional financing sources, including term notes, until such time that funds provided by operations are sufficient to fund working capital and other business requirements. The financial statements of the Company do not include any adjustments relating to the recoverability and classification of recorded assets, or the amounts and classifications of liabilities that might be necessary should the Company be unable to continue as a going concern.
Basis of Presentation
The Company prepares its financial statements on the accrual basis of accounting in accordance with accounting principles generally accepted in the United States of America.
Use of Estimates
The preparation of financial statements in conformity with generally accepted accounting principles requires the Company’s management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of income and expenses during the reported period. Changes in the economic environment, financial markets, as well as in the healthcare industry, and any other parameters used in determining these estimates, could cause actual results to differ.
Cash and Cash Equivalents
The Company considers all highly liquid debt investments purchased with a maturity of three months or less to be cash equivalents.
| F-7 |
| Table of Contents |
Fair Value Measurements
Accounting principles generally accepted in the United States define fair value 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 at the measurement date. Additionally, the inputs used to measure fair value are prioritized based on a three-level hierarchy. This hierarchy requires entities to maximize the use of observable inputs and minimize the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows:
Level 1 — Quoted prices in active markets for identical assets or liabilities.
Level 2 — Observable inputs other than quoted prices included in Level 1. We value assets and liabilities included in this level using dealer and broker quotations, bid prices, quoted prices for similar assets and liabilities in active markets, or other inputs that are observable or can be corroborated by observable market data.
Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. This includes certain pricing models, discounted cash flow methodologies and similar techniques that use significant unobservable inputs.
Fair value estimates discussed herein are based upon certain market assumptions and pertinent information available to management as of December 31, 2022 and 2021. The respective carrying value of certain on-balance-sheet financial instruments approximated their fair values due to the short-term nature of these instruments.
Income Taxes
The Company accounts for income taxes using a method that requires recognition of deferred tax assets and liabilities for expected future tax consequences of temporary differences that currently exist between tax bases and financial reporting bases of the Company’s assets and liabilities which is commonly known as the asset and liability method. In assessing the ability to realize deferred tax assets, the Company considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized.
The Company evaluates its tax positions taken or expected to be taken in the course of preparing the Company’s tax returns to determine whether the tax positions are ‘‘more-likely-than-not’’ of being sustained by the applicable tax authority. Tax positions not deemed to meet the “more-likely-than-not” threshold are recorded as an expense in the applicable year. The Company does not have a liability for any unrecognized tax benefits. Management’s evaluation of uncertain tax positions may be subject to review and adjustment at a later date based upon factors including, but not limited to, an on-going analysis of tax laws, regulations and interpretations thereof, with due consideration given to the fact that tax periods are open to examination by tax authorities.
As of December 31, 2022 and 2021, the Company has approximately $
| F-8 |
| Table of Contents |
Revenue Recognition
The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers. Under ASC 606, the Company recognizes revenue from the sale of its HemoStyp product by applying the following steps: (1) identify the contract with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to each performance obligation in the contract; and (5) recognize revenue when each performance obligation is satisfied.
The Company receives orders for its HemoStyp products directly from its customers. Revenues are recognized based on the agreed upon sales or transaction price with the customer when control of the promised goods are transferred to the customer. The transfer of goods to the customer and satisfaction of the Company’s performance obligation will occur either at the time when products are shipped or when the products arrive and are received by the customer depending on the shipping terms. No discounts are offered by the Company as part of payment terms. The Company does not provide an estimate for returns as there is no anticipation for any returns in the normal course of business.
Trade Accounts Receivable and Concentration Risk
The Company records accounts receivable at the invoiced amount and does not charge interest. The Company reviews the accounts receivable by amounts due from customers which are past due to identify specific customers with known disputes or collectability issues. In determining the amount of the reserve, the Company makes judgments about the creditworthiness of significant customers based on ongoing credit evaluations. The Company will also maintain a sales allowance to reserve for potential credits issued to customers. The Company will determine the amount of the reserve based on historical credits issued.
There was no provision for doubtful accounts recorded at December 31, 2022 and 2021. The Company recorded $
For the year ended December 31, 2022, one customer accounted for
For the year ended December 31, 2021, one customer accounted for
Inventory
Inventory is valued at the lower of cost or net realizable value using the first-in, first-out (FIFO) method. Inventory on the balance sheet consists of raw materials purchased by the Company and finished goods.
|
| December 31, 2022 |
|
| December 31, 2021 |
| ||
Raw materials |
| $ |
|
| $ |
| ||
Finished goods |
|
|
|
|
|
| ||
|
| $ |
|
| $ |
| ||
During the years ended December 31, 2022 and 2021, the Company determined that $
| F-9 |
| Table of Contents |
Patents
Patents are stated on the balance sheet at cost. Costs, such as filing fees with patent granting agencies and legal fees directly relating to those filings, incurred to file patent applications were capitalized when the Company believed that there was a high likelihood that the patent would be issued and there would be future economic benefit associated with the patent. These costs were amortized from the date of the patent application on a
Accumulated amortization as of December 31, 2022 and December 31, 2021 was $
Future Amortization Expense
Year |
| Amount |
| |
2023 |
| $ |
| |
2024 |
|
|
| |
2025 |
|
|
| |
2026 |
|
|
| |
2027 |
|
|
| |
Thereafter |
|
|
| |
|
| $ |
| |
Deferred Offering Costs
Deferred offering costs represent specific incremental costs directly attributable to the offering of securities. The deferred offering costs are recorded as an offset to additional paid-in capital and charged against the proceeds received.
Advertising and Marketing Costs
Advertising and marketing costs are expensed as incurred. The Company incurred $
Shipping and Handling Costs
The Company includes shipping and handling cost as part of cost of goods sold.
Research and Development
The Company charges research and development costs to expense when incurred. The Company incurred $
Stock-Based Compensation
The Company accounts for stock-based compensation under the provisions of ASC 718, Compensation-Stock Compensation. Stock-based compensation expense for employees and non-employees is measured at the grant date fair value. Stock-based compensation for all stock-based awards to employees and directors is recognized as an expense over the requisite service period, which is generally the vesting period.
Per Share Information
Basic earnings per share are calculated using the weighted average number of common shares outstanding for the period presented. Diluted earnings per share is computed using the weighted-average number of common shares and, if dilutive, potential common shares outstanding during the period. The dilutive effect of potential common shares is not reflected in diluted earnings per share because the Company incurred a net loss for the years ended December 31, 2022 and 2021 and the effect of including these potential common shares in the net loss per share calculations would be anti-dilutive.
The total potential common shares as of December 31, 2022 include
| F-10 |
| Table of Contents |
Impairment of Long-lived Assets
The Company applies the provisions of ASC 360, Property, Plant and Equipment, where applicable to all long-lived assets. ASC 360 addresses accounting and reporting for impairment and disposal of long-lived assets. The Company periodically evaluates the carrying value of long-lived assets to be held and used in accordance with ASC 360. ASC 360 requires impairment losses to be recorded on long-lived assets used in operations when indicators of impairment are present and the undiscounted cash flows estimated to be generated by those assets are less than the assets’ carrying amounts. In that event, a loss is recognized based on the amount by which the carrying amount exceeds the fair market value of the long-lived assets. Loss on long-lived assets to be disposed of is determined in a similar manner, except that fair market values are reduced for the cost of disposal.
When equipment is sold or retired, the related cost and accumulated depreciation are removed from the accounts and any gain or loss is included in the results of operations. During the years ended December 31, 2022 and 2021 the Company determined its property and equipment should be impaired and $
Leases
The Company has elected not to recognize right-of-use assets and lease liabilities that arise from short-term leases for any class of assets.
New and Recently Adopted Accounting Pronouncements
In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (ASU) No. 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): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity.
Under current GAAP, there are five accounting models for convertible debt instruments. ASU 2020-06 removes from U.S. GAAP the separation models for (1) convertible debt with a cash conversion feature and (2) convertible instruments with a beneficial conversion feature. As a result, after adopting the ASU’s guidance, entities will not separately present in equity an embedded conversion feature in such debt. Instead, they will account for a convertible debt instrument wholly as debt, and for convertible preferred stock wholly as preferred stock (i.e., as a single unit of account), unless (1) a convertible instrument contains features that require bifurcation as a derivative under ASC 815 or (2) a convertible debt instrument was issued at a substantial premium. Additionally, for convertible debt instruments with substantial premiums accounted for as paid-in capital, the FASB decided to add disclosures about (1) the fair value amount and the level of fair value hierarchy of the entire instrument for public business entities and (2) the premium amount recorded as paid-in capital.
ASU 2020-06 will be effective for public business entities that meet the definition of a Securities and Exchange Commission (SEC) filer, excluding entities eligible to be smaller reporting companies as defined by the SEC, for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. For all other entities, the amendments are effective for fiscal years beginning after December 15, 2023, 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. The Company adopted this accounting pronouncement on January 1, 2022 and it did not have any impact to its financial statements.
The Company considers all new pronouncements and management has determined that there have been no other recently adopted or issued accounting standards that had or will have a material impact on its financial statements.
| F-11 |
| Table of Contents |
Note 3. Related Party Transactions
Convertible notes payable - related parties
As of December 31, 2022 and 2021, convertible notes payable – related parties totaled $
As of December 31, 2020, Brian Thom, the Chief Executive Officer had a total outstanding convertible note payable balance of $
During the year ended December 31, 2021, Mr. Thom converted $
During the year ended December 31, 2021, Mr. Thom, converted the total outstanding convertible note balance of $
During the year ended December 31, 2022, Mr. Thom, converted $
As of December 31, 2020, Louis Schiliro, the former Chief Operating Officer, had a total outstanding convertible note payable balance of $
During the year ended December 31, 2021, Mr. Schiliro converted $
During the year ended December 31, 2021, $
| F-12 |
| Table of Contents |
As of December 31, 2020, Kristofer Heaton, the Principal Financial Officer, has a convertible notes payable balance of $
During the year ended December 31, 2021, Mr. Heaton, converted $
The total outstanding principal balance of $
During the year ended December 31, 2022, Robert Denser, Director of the Company, loaned the Company $
Interest expense – related party on the above convertible notes payable was $
Loans payable/Advances - related parties
As of December 31, 2022 and 2021, loans payable – related parties totaled $
During the year ended December 31, 2021, Mr. Thom loaned the Company a total of $
During the year ended December 31, 2022, Mr. Thom loaned the Company $
During the year ended December 31, 2021, Mr. Schiliro advanced the Company $
During the year ended December 31, 2022, Mr. Schiliro, loaned the Company $
During the year ended December 31, Mr. Heaton, loaned the Company $
Interest expense – related party on the above loans was $
| F-13 |
| Table of Contents |
Accrued liabilities – related parties
As of December 31, 2020, $
As of December 31, 2021, $
During the year ended December 31, 2022, the Company had accrued Mr. Thom’s 2022 first quarter compensation of $
As of December 31, 2020, $
During the year ended December 31, 2022, the Company had accrued Mr. Schiliro’s 2022 first quarter compensation of $
As of December 31, 2020, $
During the year ended December 31, 2022, the Company had accrued Mr. Heaton’s 2022 first quarter compensation of $
As of December 31, 2022, $
Equity transactions
Per the vesting schedules of certain of the Company’s amended RSU Agreements, on January 1, 2021,
| F-14 |
| Table of Contents |
On January 6, 2021, the Board of Directors approved the second amendment to the RSU Agreement between the Company and Mr. Beplate in conjunction with Mr. Beplate’s retirement from his day-to-day management role with the Company. The amendment accelerated the vesting and immediately settled his remaining RSU’s by issuing
In December 2020, the Company entered into a second restricted stock unit agreement with Mr. Heaton. The second agreement issued an additional
During the year ended December 31, 2021, 200,000 of Mr. Heaton’s RSU’s mentioned above vested due to achievement of certain Company objectives. The Company recorded stock-based compensation expense of $
During the year ended December 31, 2021, the Company issued
During the year ended December 31, 2022, the Board of Directors approved an amendment to Mr. Thom’s RSU Agreement dated November 24, 2020. The amendment increased the number of RSU’s granted
During the year ended December 31, 2022, the Board of Directors approved an RSU Agreement with Robert Denser, Director of the Board. The agreement grants Mr. Denser
During the year ended December 31, 2022, the Company acquired
During the year ended December 31, 2022, the Company issued
Note 4. Promissory Note Payable
During the year ended December 31, 2022, the Company reached a settlement agreement related to Patterson’s counterclaim (see Note 8). The Company agreed to pay $
The Company paid $
The promissory note is secured by
Note 5. Convertible Notes
Convertible notes 2021
During the year ended December 31, 2021, the service providers and medical advisor converted $
The total outstanding principal balance of $
| F-15 |
| Table of Contents |
During the year ended December 31, 2021, one of the Company’s legal counsel was assigned $
During the year ended December 31, 2021, the Company issued a total of $
During the year ended December 31, 2021, the $
Convertible notes 2022
During the year ended December 31, 2022, the Company issued a $
In November 2022, the Company amended the conversion terms of the convertible promissory note from a conversion price of $
During the year ended December 31, 2022, the Company issued a $
Interest expense on the above convertible notes payable was $
| F-16 |
| Table of Contents |
Note 6. Issuances of Securities
Share issuances 2021
During the year ended December 31, 2021, the Company had the following common stock transactions:
| · | A total of |
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Triton Purchase Agreement
On June 25, 2021, the Company entered into a common stock purchase agreement (the “Triton Purchase Agreement”) with Triton Funds LP (“Triton”) to sell
| F-17 |
| Table of Contents |
Share issuances 2022
During the year ended December 31, 2022, the Company had the following common stock transactions:
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On September 1, 2022, the Company entered into a common stock purchase agreement (the “CSPA”) with White Lion Capital, LLC (“White Lion”). Pursuant to the CSPA, the Company has the right, but not the obligation, to require White Lion to purchase up to $
The Company’s right to sell shares to White Lion commenced on the effective date of the resale registration statement and extends for a period of three years. During this term, the Company may exercise its right to sell shares to White Lion, subject to limitations on the amount of shares that are permitted to be sold with each exercise. The purchase price to be paid by White Lion for such shares will equal 93% the lower of: (i) the volume-weighted average price of the Company’s common stock during a period of five consecutive trading days following the Company’s exercise of its right to sell shares, or (ii) the closing price of the common stock on the day the Company exercises its right to sell shares, subject to a minimum price of $
In consideration for White Lion’s commitment to purchase shares under the CSPA when requested, the Company issued
The Company will have the right to terminate the CSPA at any time, at no cost or penalty, upon ten trading days prior written notice. Additionally, White Lion will have the right to terminate the CSPA in accordance with its terms for certain breaches of the CSPA by the Company, a Company bankruptcy filing, or the Company’s CEO, Principal Financial Officer or Director of Operations terminating their respective employment with the Company.
During the year ended December 31, 2022, the Company sold
See Note 12 “Subsequent Events” to our financial statement include in this report for additional information.
Share repurchases 2022
During the year ended December 31, 2022, the Company paid $
Share cancellations 2022
During the year ended December 31, 2022, 250,000 shares of common stock were returned to the Company for no consideration, therefore the Company cancelled the shares, reducing common stock by $250 and increasing additional paid-in capital by the same.
Restricted stock units
During the year ended December 31, 2020 the Board of Directors approved amendments to its March 25, 2019 RSU Agreement for certain management and consultants to the Company.
The amendment resulted in
On January 6, 2021, the Board of Directors approved the second amendment to the Restricted Stock Unit Agreement between the Company and Mr. Beplate, former Chief Executive Officer and current Chairman of the Board, in conjunction with Mr. Beplate’s retirement from his day-to-day management role with the Company.
| F-18 |
| Table of Contents |
In April 2021,
During the year ended December 31, 2021, the Company terminated the services of one of its legal counsels who had an RSU agreement in place. Per the RSU agreement, all of the unvested RSU’s owed to the legal counsel vested immediately upon termination of services. This resulted in
During the year ended December 31, 2021, the Company recorded the grant of
As discussed in Note 3, Mr. Heaton was granted
As described above in Note 3, during the year ended December 31, 2022, the Board of Directors approved an RSU Agreement in which Robert Denser, Director was granted
During the year ended December 31, 2022, the Board of Directors approved RSU Agreements with four physicians as consideration to acquire their rights to the patent application and related intellectual property rights in the “Method of Forming and Using a Hemostatic Hydrocolloid”, U.S. Patent Office Serial No. 62/875,798, filed July 18, 2019, in which a total of
During the year ended December 31, 2022, the Board of Directors approved an amendment to the original terms of an RSU Agreement with a consultant. The amendment increased the amount of RSU’s granted from
Management is unable to determine if and when FDA approval of a PMA Class III will be awarded to the Company or when a change of control will occur, if at all, and as of December 31, 2022, there was a total of $
Activity related to our restricted stock units during the year ended December 31, 2021 was as follows:
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Total awards outstanding at December 31, 2020 |
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Units granted |
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Units Exercised/Released |
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Units Cancelled/Forfeited |
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Total awards outstanding at December 31, 2021 |
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Activity related to our restricted stock units during the year ended December 31, 2022 was as follows:
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Total awards outstanding at December 31, 2021 |
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Units granted |
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Units Exercised/Released |
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Units Cancelled/Forfeited |
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Total awards outstanding at December 31, 2022 |
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| F-19 |
| Table of Contents |
Note 7. Accrued Litigation Settlement
On June 15, 2022, the Security and Exchange Commission’s (SEC) investigation of the Company, initially reported in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, was settled through the filing of a consent judgment without the Company admitting or denying the SEC’s allegations. As part of the settlement, the Company is required to pay a civil penalty of $
| · | $ |
| · | $ |
| · | $ |
| · | $ |
The Company made the initial scheduled payment of $
Note 8. Litigation
A Complaint was filed with the United States District Court, Southern District of New York by Steven Safran as Plaintiff against the Company and Douglas Beplate, its CEO, as Defendant. This case was transferred to the United States District Court in Las Vegas, Nevada. Mr. Safran sought damages and monies allegedly owed pursuant to an employment agreement of approximately $
In March 2021, the Company received payment of $
Philip Forman, who served as Chairman, a director, Chief Executive Officer and Chief Medical Advisor of the Company at various times between 2011 and October 2015, filed a lawsuit against the Company and our then-Chief Executive Officer, Douglas Beplate, in the United States District Court of the District of Nevada. The plaintiff has claimed, among other things: that the June 25, 2015 Amendment to his November 10, 2014 Employment Agreement with the Company, which terminated the Employment Agreement on October 1, 2015, is not enforceable due to lack of consideration; that a July 22, 2015 Stock Purchase Agreement pursuant to which the plaintiff sold Company shares issued to him under the Amendment to a third a party is unenforceable (despite the fact that all payment for the shares under the Stock Purchase Agreement was made); that the plaintiff’s 2014 Employment Agreement remains valid and that he is entitled to cash and stock compensation under that Employment Agreement (without giving regard to the Amendment); and that the Company and Mr. Beplate defrauded the plaintiff relating to the foregoing. The plaintiff is seeking declaratory judgment regarding the parties’ relative rights under the Employment Agreement, the Amendment and the Stock Purchase Agreement; money damages of no less than $
In July 2022, United Health Products filed a motion to reopen discovery for the purpose of developing additional issues it wished to raise at trial. At the beginning of August 2022, the court denied United Health Products’ request to reopen discovery. The court instructed counsel for both parties to meet and confer regarding a Joint Trial Order to be filed with the court. The Joint Trial Order generally details the parties’ position on which issues are to be addressed at trial. The parties are currently seeking to reach agreement on what issues should be addressed at trial. Once the issues have been agreed upon, the Joint Trial Order will be filed with the court and the court will set a trial date. Concurrently with the completion of the Joint Trial Order, the parties are engaged in various settlement negotiations.
In 2018, an action was commenced
| F-20 |
| Table of Contents |
As mentioned in Note 7 above, the Company settled the SEC’s investigation through the filing of a consent judgment on the terms described in the Company’s Form 8-K filed on April 29, 2022, without the Company admitting or denying the SEC’s allegations.
Due to uncertainties inherent in litigation, we cannot predict the outcome of the above legal proceedings.
The Company is or was also a party to the following legal proceedings:
On February 7, 2020, the Company filed the Original Petition for Fraud and Breach of Contract in the Texas District Court for the 215th Judicial District of Harris County against defendants Patterson Companies Inc., Patterson Management, L.P., Patterson Veterinary, Inc. and Patterson Logistics Services, Inc., and Animal Health International, Inc. On March 5, 2020, the defendants removed the case to U.S. District Court for Southern District of Texas. The defendants filed their answer in federal court on March 12, 2020. The original August 25, 2020 pretrial deadlines were extended. On January 18, 2022, the Company’s claims were dismissed, with prejudice, by the court. On February 9, 2022, the Company and Patterson reached an agreement on settlement of Patterson’s counterclaim. The Company agreed to pay $
In August 2020, United Health Products filed suit against its former auditors, in Utah State Court, asserting claims related to professional negligence and breach of fiduciary duty. The Company and the defendant, through mediation reached an agreement on settlement in which the defendant agreed to pay $
Note 9. Income Tax
The Company accounts for income taxes under the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) No. 740, Income Taxes (“ASC 740”). Under ASC 740, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. 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. Under ASC 740, 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.
The Company did not take any uncertain tax positions and had no adjustments to its income tax liabilities or benefits pursuant to the provisions of Section 740-10-25 for the years ended December 31, 2022 and 2021. The Company recognizes interest accrued related to unrecognized tax benefits in interest expense and penalties in operating expenses. No such interest or penalties were recognized during the period presented. The Company had no accruals for interest and penalties at December 31, 2022 or 2021.
The Company’s federal income tax returns for the years ended December 31, 2019 through December 31, 2022 remain subject to examination by the Internal Revenue Service as of December 31, 2022.
During 2022 and 2021, the Company incurred net losses and, therefore, has no tax liability. The net deferred tax asset generated by the loss carry-forward has been fully reserved.
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Net deferred tax assets consist of the following components as of December 31, 2022 and 2021
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Net operating loss carryover |
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Valuation allowance |
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Net deferred tax asset |
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The income tax provision differs from the amount of income tax determined by applying the U.S federal income tax rate (21%) for the years ended December 31, 2022 and 2021 due to the following:
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Book income |
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Interest amortization |
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Valuation allowance |
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Income tax expense |
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As of December 31, 2022 and 2021, the Company has taxable net loss carryovers of approximately $
Note 10. Other Income
As described in Note 8 above, during the year ended December 31, 2021, the Company received payment of $
During the year ended December 31, 2022, as described in Note 8 above, the Company received $
Note 11. Leases
On October 31, 2022,
Note 12. Subsequent Events
The Company has evaluated events from December 31, 2022, through the date whereupon the financial statements were issued and has determined that there are no material events that need to be disclosed, except as follows:
On January 25, 2023, the Company and White Lion amended the CSPA to provide that if the Company issues a share price purchase notice at a time that the Company’s
The Company issued
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| F-22 |
| Table of Contents |
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
None
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
The Company needs to implement disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934 (the ‘‘Exchange Act’’), that are designed to ensure that information required to be disclosed in the Company’s Exchange Act reports are recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission, and that such information is accumulated and communicated to our Chief Executive Officer and Chief Financial Officer to allow timely decisions regarding required disclosure.
As of December 31, 2022, the Chief Executive Officer and Chief Financial Officer carried out an assessment, of the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Exchange Act Rules 13a-15(b) and 15d-15(b). As of the date of this assessment, the Chief Executive Officer and Chief Financial Officer concluded that the Company’s disclosure controls and procedures were not effective as of December 31, 2022.
Management’s Report on Internal Control over Financial Reporting
Management of the Company is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. The Company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external reporting purposes in accordance with accounting principles generally accepted in the United States of America. Internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the Company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the Company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the Company’s assets that could have a material effect on the interim or annual financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with policies or procedures may deteriorate.
The Chief Executive Officer and Principal Financial Officer assessed the effectiveness of the Company’s internal control over financial reporting as of December 31, 2022. In performing its assessment of the effectiveness of the Company’s internal control over financial reporting, management applied the criteria described in the Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (‘‘COSO - 2013’’).
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.
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The material weaknesses identified during management’s assessment were the following:
| • | Inadequate corporate governance |
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| • | Inadequate internal control structure and control environment |
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| • | Lack of information technology controls |
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| • | Lack of segregation of duties |
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| • | Limited accounting resources with SEC experience, US generally accepted accounting principles knowledge and tax accounting expertise |
These material weaknesses could result in a material misstatement of significant accounts or disclosures that would result in a material misstatement to the Company’s interim or annual financial statements that would not be prevented or detected.
Because of the material weaknesses, management concluded that the Company did not maintain effective internal control over financial reporting as of December 31, 2022, based on the criteria in Internal Control-Integrated Framework issued by COSO -2013.
Changes in Internal Control over Financial Reporting
There were no reported changes in internal control over financial reporting for the year ended December 31, 2022.
ITEM 9B. OTHER INFORMATION
None.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTION
None.
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PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE
Directors and Executive Officers
Our directors and executive officers as of the filing date of this Annual Report on Form 10-K are as follows:
Name |
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Brian Thom |
| 57 |
| Chief Executive Officer, and Director |
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Kristofer Heaton |
| 44 |
| Vice President of Finance and Principal Financial Officer |
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Robert Denser |
| 51 |
| Director |
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Our directors hold office for one-year terms and until their successors have been elected and qualified. Our officers are appointed annually and serve at the discretion of the Board.
Brian Thom was appointed as Chief Executive Officer effective December 1, 2020 and joined our Board as a Director on January 1, 2021. Mr. Thom has served as a consultant to the Company since April 2020 overseeing finance and business development activities and has served as external financial advisor to the Company since 2018. He brings over 20 years of corporate finance experience and a successful track record of helping fast growing companies across a broad range of industries to raise capital and create shareholder value. Over the course of his career he spent a decade with JPMorgan’s global Mergers and Acquisitions group and five years leading the Americas Corporate Finance group with Société Générale, a multi-national European investment bank, among other entrepreneurial pursuits.
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Kristofer Heaton was brought on as the Vice President of Finance and Principal Financial Officer in December 2020. Mr. Heaton is a CPA designation and began his career in commercial banking with a bank in Salt Lake City in 2004. In 2006, he moved to public accounting and gained experience in various industries while working for various firms. Mr. Heaton founded his own accounting firm in 2015 which specializes in audits of public companies and has provided non-audit accounting and administrative services to the Company since 2017.
Robert J. Denser has served as a Director of the Company since November 2014. Over the past 10 years his main focus has been to assist federal and state agencies, first responders, EMS agencies and hospitals with their planning and procurement of the necessary medical equipment needed to be adequately prepared for any type of natural or man-made disaster. This includes working with the Medical Directors and their teams from the State of California and Los Angeles County with the development and fulfillment of a $60 million project that will give hospitals the caches of medical equipment needed to properly respond to the surge of patients that will result from a disaster. For the past five years Mr. Denser has been a member of ETL Response, LLC and has been in the role of Director of Sales and Finance. In this role he coordinates all ETL projects as needed. ETL Response. Mr. Denser’s background experience also includes direct access to key decision makers within the VA hospital system, as well as federal and private disaster response agencies, like FEMA and the Red Cross, that are on the front lines of any disaster.
Directors’ and Officers’ Liability Insurance
We are currently seeking to obtain directors’ and officers’ liability insurance against any liability for acts or omissions in their capacities as directors or officers, subject to certain exclusions. Such insurance also would insure us against losses which we may incur in indemnifying our officers and directors. In addition, we may enter into indemnification agreements with key officers and directors and such persons shall also have indemnification rights under applicable laws, and our certificate of incorporation and bylaws.
Corporate Governance
Our business, property and affairs are managed by, or under the direction of, our Board, in accordance with the General Corporation Law of the State of Nevada and our By-Laws. Members of the Board are kept informed of our business through discussions with the Chief Executive Officer and other key members of management, by reviewing materials provided to them by management.
We continue to review our corporate governance policies and practices by comparing our policies and practices with those suggested by various groups or authorities active in evaluating or setting best practices for corporate governance of public companies. Based on this review, we have adopted, and will continue to adopt, changes that the Board believes are the appropriate corporate governance policies and practices for our Company. We have adopted changes and will continue to adopt changes, as appropriate, to comply with the Sarbanes-Oxley Act of 2002 and subsequent rule changes made by the SEC and any applicable securities exchange.
Director Qualifications and Diversity
The Board seeks independent directors who represent a diversity of backgrounds and experiences that will enhance the quality of the board’s deliberations and decisions. Candidates shall have substantial experience with one or more publicly traded companies or shall have achieved a high level of distinction in their chosen fields. The Board is particularly interested in maintaining a mix that includes individuals who are active or retired executive officers and senior executives, particularly those with experience in the medical device and health care industries.
In evaluating Director candidates, our Board also looks for certain personal attributes, such as integrity, ability and willingness to apply sound and independent business judgment, comprehensive understanding of a director’s role in corporate governance, availability for meetings and consultation on Company matters, and the willingness to assume and carry out fiduciary responsibilities. Qualified candidates for membership on the Board will be considered without regard to race, color, religion, sex, ancestry, national origin or disability.
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Risk Oversight
Enterprise risks are identified and prioritized by management and each prioritized risk is assigned to the full board for oversight. These risks include, without limitation, the following:
| • | Risks and exposures associated with strategic, financial and execution risks and other current matters that may present material risk to our operations, plans, prospects or reputation. |
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| • | Risks and exposures associated with financial matters, particularly financial reporting, tax, accounting, disclosure, internal control over financial reporting, financial policies, investment guidelines and credit and liquidity matters. |
|
|
|
| • | Risks and exposures relating to corporate governance; and management and director succession planning. |
|
|
|
| • | Risks and exposures associated with leadership assessment, and compensation programs and arrangements, including incentive plans. |
Board Leadership Structure
In accordance with the Company’s By-Laws, the Chairman of the Board presides at all meetings of the Board. The position of Chairman of the Board of the Company was held by Douglas Beplate until his resignation as a director effective on February 28, 2022. Mr. Thom holds the position of Chief Executive Officer and currently is serving as Chairman [Pro Tem]. The Company has no fixed policy with respect to the separation of the offices of the Chairman of the Board and Chief Executive Officer.
Code of Ethics
We have adopted a Code of Ethics within the meaning of Item 406(b) of Regulation S-K of the Exchange Act. This Code of Ethics applies to our directors and senior officers, such as the principal executive officer, principal financial officer and persons performing similar functions. Our Code of Ethics is available as Exhibit 14 to our Annual Report on Form 10-K filed April 16, 2010.
Committees
As of the filing date of this Form 10-K, the Board of Directors has no committees. Robert Denser may be deemed an independent director of the Company as that term is defined under the Exchange Act of 1934, as amended. Mr. Denser is not deemed to be a financial expert. The term “Financial Expert” is defined under the Sarbanes-Oxley Act of 2002, as amended, as a person who has the following attributes: an understanding of generally accepted accounting principles and financial statements; has the ability to assess the general application of such principles in connection with the accounting for estimates, accruals and reserves; experience preparing, auditing, analyzing or evaluating financial statements that present a breadth and level of complexity of accounting issues that are generally comparable to the breadth and complexity of issues that can reasonably be expected to be raised by the company’s financial statements, or experience actively supervising one or more persons engaged in such activities; an understanding of internal controls and procedures for financial reporting; and an understanding of audit committee functions.
| 25 |
Delinquent Section 16(a) Reports
The rules of the Securities and Exchange Commission require us to disclose late filings of reports of stock ownership and changes in stock ownership by our directors, officers and ten percent shareholders. To our knowledge, based solely on our review of (a) the copies of such reports and amendments thereto furnished to us and (b) written representations that no other reports were required, during our fiscal year ended December 31, 2022, all of the filings for our officers, directors and ten percent shareholders were made on a timely basis, except for two Form 4s for Mr. Thom that were inadvertently filed late detailing one transaction and three transactions, respectively.
Communications with the Board of Directors
Stockholders may communicate with the Board of Directors by sending a letter to United Health Products, Inc. Board of Directors, c/o our securities counsel, Ruskin Moscou Faltischek, PC, East Tower 15th Floor, 1425 RXR Plaza, Uniondale, New York 11556. Our securities counsel will receive the correspondence and forward it to the Chairman or to any individual director or directors to whom the communication is directed, unless the communication is unduly hostile, threatening or illegal, does not reasonably relate to the Company or its business, or is similarly inappropriate. The Chairman of the Board has the authority to discard or disregard any inappropriate communications or to take other appropriate actions with respect to any such inappropriate communications.
Medical Advisory Board
As the Company continues to pursue its FDA application to have HemoStyp approved for Class III surgical uses in the United States and abroad, it has formed a Medical Advisory Board which consists of the following persons as of the date of this filing:
Gerard Abate, MD Former Executive Director, Medical Affairs for Fortune 500 company Quest Diagnostics, where he directed 80+ Medical Affairs group that includes 8 clinical franchise medical directors, (oncology, genetics, women’s health, cardiovascular-metabolism, neurology, infectious disease/inflammation), HEOR team, publications group, MSLs, genetic counselors and project management.
Michael Erik Jessen MDProfessor and Chairman, and Frank M. Ryburn, Jr. Distinguished Chair in Cardiothoracic Surgery and Transplantation, Department of Cardiovascular and Thoracic Surgery, University of Texas Southwestern Medical Center.
Richard Massoth, DDS, MSD received his specialty training in Endodontics and his Master of Science in Dentistry from Boston University in 1982. He has been an Adjunct Professor at the UCLA School of Dentistry and has been in clinical practice for 36 years. Dr. Massoth has been a published author and a symposium speaker on “Endodontic Microsurgery” and “The Use of Cone Beam CT Scans in Endodontic Diagnosis.”
David Ramey, DVM brings thirty-five years of clinical experience as a full-time veterinarian, specializing in the care of performance and pleasure horses. He has written and published thirteen books, five book chapters, and over seventy papers in professional journals. Dr. Ramey is a frequent speaker on various veterinary topics at universities, conventions, and continuing education seminars around the United States, as well as Canada, Australia, and the UK.
| 26 |
ITEM 11. EXECUTIVE COMPENSATION
The following table sets forth the overall compensation earned over the fiscal years ended December 31, 2022 and 2021 by (1) each person who served as the principal executive officer of the Company during fiscal year 2022; (2) our most highly compensated (up to a maximum of two) executive officers as of December 31, 2022 with compensation during fiscal year ended 2022 of $100,000 or more; and (3) those individuals, if any, who would have otherwise been included in section (2) above but for the fact that they were not serving as an executive as of December 31, 2022.
|
| Fiscal Year |
| Salary ($)(7) |
|
| Bonus ($) |
|
| Stock Awards ($)(1) (4) |
|
| Options Awards ($)(1) |
|
| Non-Equity Incentive Plan Compensation ($) |
|
| Non-qualified Deferred Compensation Earnings ($) |
|
| All Other Compensation ($)(2)(3) |
|
| Total ($) |
| ||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||||
Douglas Beplate |
| 2022 |
| $ | -0- |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | -0- |
|
Former Chief Executive Officer (5) |
| 2021 |
| $ | -0- |
|
| $ | -0- |
|
| $ | 26,156,566 |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | 26,156,566 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Brian Thom |
| 2022 |
| $ | 238,500 |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | 238,500 |
|
Chief Executive Officer |
| 2021 |
| $ | 180,000 |
|
| $ | -0- |
|
| $ | 24,600 |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | 204,600 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Kristofer Heaton |
| 2022 |
| $ | 198,750 |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | 198,750 |
|
Principal Financial Officer |
| 2021 |
| $ | 127,500 |
|
| $ | -0- |
|
| $ | 240,933 |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | 368,433 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Louis Schiliro |
| 2022 |
| $ | 238,500 |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | 238,500 |
|
Former Chief Operating Officer (6) |
| 2021 |
| $ | 180,000 |
|
| $ | -0- |
|
| $ | 33,259 |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | -0- |
|
| $ | 213,259 |
|
_____________
(1) | FASB ASC Topic 718 requires the company to determine the overall full grant date fair value of the restricted stock awards and options as of the date of grant based upon the Black-Scholes method of valuation which total amounts are set forth in the table above under the year of grant, and to then expense that value over the service period over which the restricted stock awards and options become vested. As a general rule, for time-in-service-based restricted stock awards and options, the company will immediately expense any restricted stock awards and option or portion thereof which is vested upon grant, while expensing the balance on a pro rata basis over the remaining vesting term of the restricted stock awards and options. For a description FASB ASC Topic 718 and the assumptions used in determining the value of the restricted stock awards and options under the Black-Scholes model of valuation, see the notes to the financial statements included with this Form 10-K. |
(2) | Includes all other compensation not reported in the preceding columns, including (i) perquisites and other personal benefits, or property, unless the aggregate amount of such compensation is less than $10,000; (ii) any “gross-ups” or other amounts reimbursed during the fiscal year for the payment of taxes; (iii) discounts from market price with respect to securities purchased from the company except to the extent available generally to all security holders or to all salaried employees; (iv) any amounts paid or accrued in connection with any termination (including without limitation through retirement, resignation, severance or constructive termination, including change of responsibilities) or change in control; (v) contributions to vested and unvested defined contribution plans; (vi) any insurance premiums paid by, or on behalf of, the company relating to life insurance for the benefit of the named executive officer; and (vii) any dividends or other earnings paid on stock or option awards that are not factored into the grant date fair value required to be reported in a preceding column. | ||
|
| ||
(3) | Includes compensation for service as a director described under Director Compensation, below. | ||
|
| ||
(4) | The Company issued RSU’s which vest according to certain performance conditions as discussed in the financial statements. The grant date fair value of the RSU’s granted assuming all performance conditions are met would be; $5,686,750 for Brian Thom; $4,615,000 for Lou Schiliro and $1,110,750 for Kristofer Heaton. | ||
|
| ||
(5) | Resigned as Chief Executive Officer effective on December 1, 2020. Resigned as director effective on February 28, 2022. | ||
|
| ||
(6) | Resigned as Chief Operating Officer and a director effective on February 28, 2022. Mr. Schiliro continues in a non-officer position with the Company with a focus on the Company’s FDA PMA application, new product and format development, R&D and manufacturing. | ||
|
| ||
(7) | The amounts include the grant date fair value of $193,500 of stock compensation received in lieu of cash and $45,000 of accrued compensation to Mr. Thom and Mr. Schiliro and the grant date fair value of $161,250 of stock compensation received in lieu of cash and $37,500 of accrued compensation for Mr. Heaton. | ||
| 27 |
For a description of the material terms of each named executive officers’ compensation arrangements, including the terms of any contract, agreement, plan or other arrangement that provides for any payment to a named executive officer in connection with his or her resignation, retirement or other termination, or a change in control of the company see section below entitled “Compensation Arrangements.”
No outstanding common share purchase option or other equity-based award granted to or held by any named executive officer were repriced or otherwise materially modified, including extension of exercise periods, the change of vesting or forfeiture conditions, the change or elimination of applicable performance criteria, or the change of the bases upon which returns are determined, nor was there any waiver or modification of any specified performance target, goal or condition to payout, other than as described below.
Stock Awards – Restricted Stock Units
During the year ended December 31, 2020 the Board of Directors approved amendments to its March 25, 2019 RSU Agreement for certain management and consultants to the Company.
The amendment resulted in 9,960,000 of the RSU’s vesting on January 1, 2021. The fair value of the 9,960,000 RSU’s was $7,071,600. The compensation expense was being amortized on a straight-line basis from the date of the amendment through January 1, 2021 which is the vesting date. Stock-based compensation of $43,121 was recognized as expense during the year ended December 31, 2021.
On January 6, 2021, the Board of Directors approved the second amendment to the Restricted Stock Unit Agreement between the Company and Mr. Beplate, former Chief Executive Officer and current Chairman of the Board, in conjunction with Mr. Beplate’s retirement from his day-to-day management role with the Company. The amendment accelerated the vesting and immediately settled his remaining RSU’s by issuing 21,970,000 shares of common stock. Per ASC 718-20-35, the change in vesting conditions resulted in a modification of the stock-based compensation awards. The modification is considered a Type III modification as described in ASC 718-20-55 and resulted in recording $23,947,300 of stock-based compensation expense which was the fair value of the shares on the date of the modification.
Mr. Heaton was granted 500,000 RSU’s in December of 2020 and an additional 500,000 RSU’s in May of 2021. The vesting conditions are contingent upon the achievement of certain Company objectives and milestones. During the year ended December 31, 2021, certain objectives were achieved which resulted in the vesting of 200,000 of RSU’s granted to Mr. Heaton. The 200,000 RSU’s had a grant date fair value of $220,000 which was recorded as stock-based compensation expense.
During the year ended December 31, 2022, Mr. Thom’s original RSU Agreement was amended. The amendment increased the amount of RSU’s granted from 11,500,000 to 13,225,000. The RSU’s are subject to certain conditions and shall vest upon the achievement of certain Company objectives and milestones.
Compensation Agreements
Messrs. Thom and Heaton are being compensated at the monthly rate of $15,000 and $12,500 respectively, pursuant to services agreements entered with each of them. Mr. Schiliro was being compensated at the monthly rate of $15,000 pursuant to services agreement in his capacity as Chief Operating Officer until his resignation from that position effective on February 28, 2022. Mr. Schiliro remains in a non-officer position with the Company at the same rate of compensation.
| 28 |
OUTSTANDING EQUITY AWARDS AT FISCAL YEAR END
The following table sets forth all outstanding equity awards held by our named executive officers as of December 31, 2022.
|
| Option Awards |
|
| Stock Awards |
| ||||||||||||||||||
Name |
| Number of Securities Underlying Unexercised Options (#) Exercisable |
|
| Number of Securities Underlying Unexercised Options (#) Unexercisable |
|
| Option Exercise Price ($) |
|
| Option Expiration Date |
|
| Number of Shares or Units That Have Not Vested (#) |
|
| Market Value of Shares or Units of Stock That Have Not Vested(1) ($) |
| ||||||
Brian Thom, |
|
| — |
|
|
| — |
|
| $ | — |
|
|
| — |
|
|
| 13,225,000 |
|
| $ | 0.43 |
|
CEO |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
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|
Kristofer Heaton, |
|
| — |
|
|
| — |
|
| $ | — |
|
|
| — |
|
|
|
|
|
|
|
|
|
Principal Financial Officer |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| 325,000 |
|
| $ | 0.71 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| 400,000 |
|
| $ | 1.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| 400,000 |
|
| $ | 1.20 |
|
_____________
(1) | Market value is based on the stock price on the day the Restricted Stock Unit agreement or amendment was entered into. |
DIRECTOR COMPENSATION
The following table sets forth certain information concerning the compensation paid to our directors not named as an executive officer in this Item 11 above for services rendered to us during the fiscal year ended December 31, 2022.
Name |
| Fees Earned or Paid in Cash ($) |
|
| Stock Awards (1) (2) |
|
| Option Awards |
|
| Total |
| ||||
Robert Denser |
| $ | — |
|
| $ | — |
|
| $ | — |
|
| $ | — |
|
(1) | FASB ASC Topic 718 requires the company to determine the overall full grant date fair value of the restricted stock awards and options as of the date of grant based upon the Black-Scholes method of valuation which total amounts are set forth in the table above under the year of grant, and to then expense that value over the service period over which the restricted stock awards and options become vested. As a general rule, for time-in-service-based restricted stock awards and options, the company will immediately expense any restricted stock awards and option or portion thereof which is vested upon grant, while expensing the balance on a pro rata basis over the remaining vesting term of the restricted stock awards and options. For a description FASB ASC Topic 718 and the assumptions used in determining the value of the restricted stock awards and options under the Black-Scholes model of valuation, see the notes to the financial statements included with this Form 10-K. |
|
|
(2) | During the year ended December 31, 2022, the Board of Directors approved an RSU Agreement to grant 1,000,000 RSU’s to Mr. Denser which vest according to certain performance conditions as discussed in the financial statements. The grant date fair value of the RSU’s granted assuming all performance conditions are met would be $430,000. |
Cash Fees and Options
Currently the Company has no audit, compensation, corporate governance, nominating or other committee of the Board of Directors, although it intends to establish an audit, compensation and corporate governance committee in the future as part of the process to achieve a full exchange listing. No cash fees have been paid to board members for serving on the board.
During the year ended December 31, 2022, the Board of Directors approved an RSU Agreement in which Robert Denser, Director was granted 1,000,000 RSU’s which are subject to certain conditions and shall vest upon the achievement of certain Company objectives and milestones.
| 29 |
Travel Expenses
All directors are entitled to be reimbursed for their reasonable out-of-pocket expenses associated with attending director and shareholder meetings in person.
Review of Risks Arising from Compensation Policies and Practices
We have reviewed our compensation policies and practices for all employees and concluded that any risks arising from our policies and practices are not reasonably likely to have a material adverse effect on the Company.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.
As of March 27, 2023, the Company had 234,343,534 shares of Common Stock outstanding. The only persons of record who presently hold or are known to own (or believed by the Company to own) beneficially more than 5% of the outstanding shares of such class of stock are listed below. The following table also sets forth certain information as to holdings of the Company’s Common Stock of all officers and directors individually, and all officers and directors as a group.
Name and Address of Beneficial Owner (1) |
| Number of Common Shares |
|
| Percentage |
| ||
Officers and Directors |
|
|
|
|
|
| ||
Brian Thom |
|
| 920,296 |
|
| * |
| |
Robert Denser |
|
| 1,550,000 |
|
| * |
| |
Kristofer Heaton |
|
| 1,555,916 |
|
| * |
| |
All directors and officers as a group (three persons) |
|
| 4,026,212 |
|
|
| 1.7 | % |
Stockholders |
|
|
|
|
|
|
|
|
Wendy Beplate TTEE (Trust) (2) |
|
| 18,000,000 |
|
|
| 7.7 | % |
___________
* | Represents less than 1% |
(1)
| Beneficial ownership is determined in accordance with Rule 13d-3 under the Securities Exchange Act of 1934, as amended, and is generally determined by voting powers and/or investment powers with respect to securities. Unless otherwise noted, all of such shares of common stock listed above are owned of record by each individual named as beneficial owner and such individual has sole voting and dispositive power with respect to the shares of common stock owned by each of them. Such person or entity’s percentage of ownership is determined by assuming that any options or convertible securities held by such person or entity, which are exercisable within sixty (60) days from the date hereof, have been exercised or converted as the case may be, but not for the purposes of determining the number of outstanding shares held by any other named beneficial owner. All addresses for officers and directors are c/o United Health Products, Inc., 526 Commerce Circle, Suite 120, Mesquite, NV 89027. |
(2) | Wendy Beplate and Douglas Beplate are beneficiaries of the Wendy Beplate TTEE (Trust) (the “Beplate Trust”). Pursuant to the terms of the Beplate Trust, an independent trustee exercises the sole voting and dipositive control over the holdings therein. The address of the Beplate Trust is 12481 Persons Road, Bow, Washington 98232. |
Stock Bonuses
None during the fiscal years ending December 31, 2022 and 2021.
| 30 |
Securities Authorized for Issuance under Equity Compensation Plans.
On August 8, 2013, the Board of Directors approved the 2013 Employee Benefit and Consulting Services Compensation Plan (the “2013 Plan”) which had 15,000,000 shares that may be issued under said Plan. The 2013 Plan provides for the direct issuance of shares of common stock and the granting of non-statutory stock options on terms established by the Board of Directors or committee thereof. While the Plan provides for incentive stock options, no incentive stock options may be granted under the Plan since no stockholder approval was obtained on or before August 8, 2014. In September 2013, the Company issued 6,000,000 shares of stock under the 2013 Plan to the Company’s former CEO Douglas Beplate pursuant to his consulting agreement then in effect. No other shares or options have been granted under the 2013 Plan. There are currently 9,000,000 shares available for issuance under this 2013 Plan.
On October 30, 2019, the Board of Directors approved the 2019 Employee Benefit and Consulting Services Compensation Plan (the “2019 Plan”) which has 2,000,000 shares that may be issued under said Plan. The 2019 Plan provides for the direct issuance of shares of common stock and the granting of non-statutory stock options or incentive stock options on terms established by the Board of Directors or committee thereof. The Plan has not been approved by the Company’s stockholders. The Company approved the issuance of 1,525,000 shares in November 2019 to certain persons who were then consultants, officers and directors. The Company has not issued any options under this 2019 Plan.
Separate from the 2013 Plan and 2019 Plan, the Board of Directors has approved individual Restricted Stock Unit Agreements with certain consultants, officers and directors (including now former officers and directors) which represent an unvested aggregate amount of 47,665,000 and 28,190,000 as of December 31, 2022 and 2021, respectively, which upon vesting will result in the issuance of common shares. These include RSUs issued to officers and directors (including now former officers and directors) as described in Item 13 under the section “Equity Transactions” below.
| 31 |
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
Convertible notes payable - related parties
As of December 31, 2022 and 2021, convertible notes payable – related parties totaled $478,331 and $0, respectively.
As of December 31, 2020, Brian Thom, the Chief Executive Officer had a total outstanding convertible note payable balance of $555,000 and unamortized debt discount of $199,314.
During the year ended December 31, 2021, Mr. Thom converted $45,000 of accrued compensation into a convertible note. The note was convertible at $0.50 per share at the discretion of Mr. Thom, had a maturity date of March 31, 2021 and carried an interest rate of 3%. The note resulted in a beneficial conversion feature of $45,000 which was recorded as a debt discount.
During the year ended December 31, 2021, Mr. Thom, converted the total outstanding convertible note balance of $600,000, which was related to $450,000 of loans to the Company and $150,000 of accrued compensation along with accrued interest of $10,135 into 1,220,272 shares of common stock leaving $0 owed to Mr. Thom as of December 31, 2021. The debt discount on the convertible notes was amortized during the year and a total of $244,314 for all of Mr. Thom’s notes was amortized to interest expense – related party, which included the unamortized debt discount of $199,314 as of December 31, 2020 and the debt discount of $45,000 recorded during 2021. As of December 31, 2021, the remaining unamortized debt discount was $0.
During the year ended December 31, 2022, Mr. Thom, converted $372,000 of a loan payable balance to a convertible note payable. The unpaid accrued interest on the loan payable was transferred to the convertible note payable. The note has an interest rate of 10%, an original issue discount (“OID”) of 7% and has a maturity date of December 31, 2023. The note is convertible into common stock of the Company at $0.35 per share. In the event the Company issues any shares of common stock before the maturity date at a price that is lower than $0.35 per share, the conversion price shall be reduced to equal such lower issue price per share. The Company recorded $28,000 of a debt discount related to the OID. As of December 31, 2022, the remaining unamortized debt discount was $16,998 and accrued interest associated with the note was $33,897.
As of December 31, 2020, Louis Schiliro, the former Chief Operating Officer, had a total outstanding convertible note payable balance of $170,000 and an unamortized debt discount of $69,564.
During the year ended December 31, 2021, Mr. Schiliro converted $45,000 of accrued compensation into a convertible note. The note was convertible at $0.50 per share at the discretion of Mr. Schiliro, had a maturity date of March 31, 2021 and carried an interest rate of 3%. The note resulted in a beneficial conversion feature of $45,000 which was recorded as a debt discount.
During the year ended December 31, 2021, $175,000 of the convertible note payable along with $1,502 of accrued interest was assigned to one of the Company’s legal counsel leaving a total outstanding balance of $40,000. The remaining balance of $40,000 along with accrued interest was converted into 80,173 shares of common stock leaving $0 owed to Mr. Schiliro as of December 31, 2021. The debt discount on the convertible notes payable was amortized during the year and a total of $114,654 for all of Mr. Schiliro’s notes was amortized to interest expense – related party during the year ended December 31, 2021, which included the unamortized debt discount of $69,654 as of December 31, 2020 and the debt discount of $45,000 recorded during 2021. As of December 31, 2021, the remaining unamortized debt discount was $0.
| 32 |
As of December 31, 2020, Kristofer Heaton, the Principal Financial Officer, has a convertible notes payable balance of $3,750 and an unamortized debt discount of $3,750.
During the year ended December 31, 2021, Mr. Heaton, converted $22,500 of accrued compensation into a convertible note. The note was convertible at $0.50 per share at the discretion of Mr. Heaton, had a maturity date of March 31, 2021 and carried an interest rate of 3%. The note resulted in a beneficial conversion feature totaling $22,500 which was recorded as a debt discount.
The total outstanding principal balance of $26,250 along with accrued interest was converted into 52,666 shares of common stock leaving $0 owed to Mr. Heaton as of December 31, 2021. The debt discount on the convertible notes payable was amortized during the year and a total of $26,250 for all of Mr. Heaton’s convertible notes payable was amortized to interest expense – related party during the year ended December 31, 2021, which included the unamortized debt discount of $3,750 as of December 31, 2020 and the debt discount of $22,500 recorded during the 2021. As of December 31, 2021, the remaining unamortized debt discount was $0.
During the year ended December 31, 2022, Robert Denser, Director of the Company, loaned the Company $93,000 through a convertible note. The note has an interest rate of 10%, an OID of 7% and has a maturity date of December 31, 2023. The note is convertible into common stock of the Company at $0.35 per share. In the event the Company issues any shares of common stock before the maturity date at a price that is lower than $0.35 per share, the conversion price shall be reduced to equal such lower issue price per share. The Company recorded $7,000 of a debt discount related to the OID. As of December 31, 2022, the remaining unamortized debt discount was $4,671 and accrued interest associated with the note was $4,034.
Interest expense – related party on the above convertible notes payable was $36,531 (including $13,331 of debt discount amortization related to the OID) and $389,804 (including $385,218 of debt discount amortization) during the year ended December 31, 2022 and 2021, respectively. Accrued interest – related party due to these convertible notes was $37,931 and $0, as of December 31, 2022 and 2021, respectively.
Loans payable/Advances - related parties
As of December 31, 2022 and 2021, loans payable – related parties totaled $4,000 and $219,000, respectively.
During the year ended December 31, 2021, Mr. Thom loaned the Company a total of $175,000 to pay for operating expenses. The loans had an interest rate of 10% and had a maturity date of December 31, 2022.
During the year ended December 31, 2022, Mr. Thom loaned the Company $315,000 to pay for operating expenses. The loans had an interest rate of 10% and was due on demand. The Company repaid $118,000 in principal and $6,569 of accrued interest and $372,000 of principal was converted to a convertible note payable and any unpaid accrued interest was transferred to the convertible note payable as mentioned above. The outstanding balance owed to Mr. Thom on the loan payable was $0 and $175,000 as of December 31, 2022 and 2021, respectively. Accrued interest on the loan payable was $0 and $2,125 as of December 31, 2022 and 2021, respectively.
During the year ended December 31, 2021, Mr. Schiliro advanced the Company $34,000 to pay for operating expenses and paid $30,000 of expenses on behalf of the Company. During the year ended December 31, 2021, the Company issued 25,000 shares of common stock to settle $20,000 of the outstanding balance leaving a balance of $44,000 as of December 31, 2021. The shares of common stock had a fair market value of $26,750 and the Company recorded a loss on debt settlement of $6,750.
During the year ended December 31, 2022, Mr. Schiliro, loaned the Company $64,275 to pay for operating expenses. The loans had an interest rate of 10% and was due on demand. The Company repaid $108,275 in principal and $5,802 of accrued interest leaving a balance of $0 on the loan payable and accrued interest owed to Mr. Schiliro as of December 31, 2022.
During the year ended December 31, Mr. Heaton, loaned the Company $4,000 to pay for operating expenses. As of December 31, 2022, $4,000 in principal and $224 in accrued interest is owed to Mr. Heaton . The loan has an interest rate of 10% and is due on demand. .
Interest expense – related party on the above loans was $25,292 and $2,308 during the years ended December 31, 2022 and 2021, respectively. Accrued interest – related party as of December 31, 2022 and 2021 was $224 and $2,308, respectively.
| 33 |
Accrued liabilities – related parties
As of December 31, 2020, $74,056 was owed to Nate Knight, who was the Company’s Chief Financial Officer until November 2020, for accrued compensation and reimbursable expenses. During the year ended December 31, 2021, the Company issued 78,500 shares of common stock to settle the total balance owed of $74,056. The shares of common stock had a fair market value of $82,425 and the Company recorded a loss on debt settlement of $8,368.
As of December 31, 2021, $899 was owed to Mr. Thom, for reimbursable expenses. During the year ended December 2021, $45,000 of compensation was converted into convertible loans as mentioned above and $135,000 of accrued compensation was settled with the issuance of 270,000 shares of common stock. The stock had a fair market value of $221,400 which resulted in a $86,400 loss on settlement of debt (see Note 6).
During the year ended December 31, 2022, the Company had accrued Mr. Thom’s 2022 first quarter compensation of $45,000 and during the second quarter of 2022, the Company issued 150,000 shares of common stock to Mr. Thom to settle the accrued compensation. The common stock had a fair value of $72,000 and the Company recorded $27,000 as a loss on settlement of debt. The Company also paid him $899 for reimbursable expenses leaving a balance of $0 owed for reimbursable expenses.
As of December 31, 2020, $59,467 was owed to Mr. Schiliro, for accrued salary and reimbursable expenses, respectively. During the year ended December 31, 2021, $45,000 of accrued compensation was converted into a convertible note as mentioned above, 74,335 shares of common stock were issued to settle the total prior year balance owed of $59,467 and 270,000 shares of common stock were issued to settle $135,000 of accrued compensation. The shares of common stock had a total fair market value of $300,938 and the Company recorded a loss on settlement of debt in the amount of $106,471 (see Note 6).
During the year ended December 31, 2022, the Company had accrued Mr. Schiliro’s 2022 first quarter compensation of $45,000 and during the second quarter of 2022, the Company issued 150,000 shares of common stock to Mr. Schiliro for the accrued compensation. The common stock had a fair value of $72,000 and the Company recorded $27,000 as a loss on settlement of debt. As of December 31, 2022, $6,923 was owed to Mr. Schiliro, for reimbursable expenses.
As of December 31, 2020, $52,625 was owed to Mr. Heaton, for accrued compensation and services provided. During the year ended December 31, 2021, $22,500 of compensation was converted into a convertible note as described above and 320,250 shares of common shares of stock were issued to settle $105,000 of accrued compensation and $52,625 of prior accruals. The shares of common stock had a total fair market value of $262,605 and the Company recorded a loss on settlement of debt in the amount of $104,980 (see Note 6).
During the year ended December 31, 2022, the Company had accrued Mr. Heaton’s 2022 first quarter compensation of $37,500 and during the second quarter of 2022, the Company issued 125,000 shares of common stock to Mr. Heaton for the accrued compensation. The common stock had a fair value of $60,000 and the Company recorded $22,500 as a loss on settlement of debt.
As of December 31, 2022, $45,000, $45,000 and $37,500 of accrued compensation was due to Mr. Thom, Mr. Schiliro, and Mr. Heaton, respectively.
Equity transactions
Per the vesting schedules of certain of the Company’s amended RSU Agreements, on January 1, 2021, 6,760,000 shares of common stock were issued to Mr. Douglas Beplate, former Chairman of the Board, 2,000,000 shares of common stock were issued to Mr. Schiliro and 100,000 shares of common stock were issued to Mr. Heaton.
| 34 |
On January 6, 2021, the Board of Directors approved the second amendment to the RSU Agreement between the Company and Mr. Beplate in conjunction with Mr. Beplate’s retirement from his day-to-day management role with the Company. The amendment accelerated the vesting and immediately settled his remaining RSU’s by issuing 21,970,000 shares of common stock. Further, as a bonus in recognition of Mr. Beplate’s service to the Company and in recruitment of new executive management, the Company issued to Mr. Beplate an additional 2,000,000 shares of common stock. The Company recorded $26,127,300 of stock-based compensation expense during the year ended December 31, 2021 related to the accelerated vesting of these RSU’s and issuance of common stock.
In December 2020, the Company entered into a second restricted stock unit agreement with Mr. Heaton. The second agreement issued an additional 1,000,000 RSU’s, 500,000 of which were granted on the award date and 500,000 of which would be granted on May 15, 2021 provided his professional services agreement was in effect on that date. The 500,000 RSU’s were granted during 2021 per the agreement. The RSU’s, subject to certain conditions, shall vest upon the achievement of certain Company objectives and milestones.
During the year ended December 31, 2021, 200,000 of Mr. Heaton’s RSU’s mentioned above vested due to achievement of certain Company objectives. The Company recorded stock-based compensation expense of $220,000 related to the vesting of these RSU’s which was the grant date fair value.
During the year ended December 31, 2021, the Company issued 30,000 shares of common stock to Mr. Thom, 30,000 shares of common stock to Mr. Schiliro and 25,000 shares of common stock to Mr. Heaton for services rendered. The 85,000 shares of common stock had a total fair market value of $69,700.
During the year ended December 31, 2022, the Board of Directors approved an amendment to Mr. Thom’s RSU Agreement dated November 24, 2020. The amendment increased the number of RSU’s granted from 11,500,000 to 13,225,000. The RSU’s are subject to certain conditions and shall vest upon the achievement of certain Company objectives and milestones.
During the year ended December 31, 2022, the Board of Directors approved an RSU Agreement with Robert Denser, Director of the Board. The agreement grants Mr. Denser 1,000,000 RSU’s which are subject to certain conditions and shall vest upon the achievement of certain Company objectives and milestones.
During the year ended December 31, 2022, the Company acquired 2,228,115 shares of common stock from its former Chief Executive Officer as described in Note 6.
During the year ended December 31, 2022, the Company issued 300,000 shares of common stock each to Mr. Thom and Mr. Schiliro and 250,000 shares of common stock to Mr. Heaton for compensation in lieu of cash. The common stock had a total fair value of $344,250.
Director Independence
Robert Denser is deemed by management to be an independent director of the Company as that term is defined under Section 10 of the Securities Exchange Act of 1934, as amended.
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ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The following table sets forth the aggregate fees for professional audit services rendered by MAC Accounting Group, LLP (“MAC”) for the audit of the Company’s annual financial statements for the fiscal year ended December 31, 2022 and 2021, and fees billed for other services provided by MAC in the fiscal year ended December 31, 2022 and 2021.
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| 2022 |
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| 2021 |
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Audit fees |
| $ | 50,000 |
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| $ | 49,500 |
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Audit-related fees |
| $ | - |
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| $ | - |
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Tax fees |
| $ | - |
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| $ | - |
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All other fees |
| $ | 7,500 |
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| $ | 8,250 |
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_________
Audit Fees consist of the aggregate fees billed for professional services rendered for the audit of our annual financial statements and the reviews of the financial statements included in our Forms 10-Q and for any other services that were normally provided in connection with our statutory and regulatory filings or engagements.
Audit Related Fees consist of the aggregate fees billed for professional services rendered for assurance and related services that were reasonably related to the performance of the audit or review of our financial statements and were not otherwise included in Audit Fees.
Tax Fees consist of the aggregate fees billed for professional services rendered for tax compliance, tax advice and tax planning. Included in such Tax Fees are fees for preparation of our tax returns and consultancy and advice on other tax planning matters.
All Other Fees consist of the aggregate fees billed for products and services provided and not otherwise included in Audit Fees, Audit Related Fees or Tax Fees. Included in such Other Fees are fees for services rendered in connection with any private and public offerings or registration statements conducted during such periods.
Audit Committee Pre-Approval Policy
The Company does not have an audit committee. Audit committee functions are conducted by the Board of Directors. We understand the need for the accounting firm to maintain objectivity and independence in its audit of our financial statements. To minimize relationships that could appear to impair their objectivity, our Board has restricted the non-audit services that they may provide to us.
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ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
(1) | Financial Statements |
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| The financial statements of United Health Products, Inc., supplemental information and report of independent registered public accounting firm are included in this Form 10-K. |
(2) | Financial Statement Schedules |
Schedules have been omitted because of the absence of conditions under which they are required or because the required information is included in the financial statements or notes thereto.
(3) | Exhibits | |
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| (a) | Exhibits |
The following exhibits are filed with this report, or incorporated by reference as noted:
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101.INS |
| Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document). |
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101.SCH |
| Inline XBRL Taxonomy Extension Schema Document. |
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101.CAL |
| Inline XBRL Taxonomy Extension Calculation Linkbase Document. |
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101.DEF |
| Inline XBRL Taxonomy Extension Definition Linkbase Document. |
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101.LAB |
| Inline XBRL Taxonomy Extension Labels Linkbase Document. |
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101.PRE |
| Inline XBRL Taxonomy Extension Presentation Linkbase Document. |
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104 |
| Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101). |
___________
* | Filed herewith. |
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(1) | Incorporated by reference to the Company’s Form 10-Q for the quarter ended September 30, 2014. |
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(2) | Incorporated by reference to the Company’s Form 10-Q for the quarter ended June 30, 2022. |
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(3) | Incorporated by reference to Form 8-K dated August 7, 2015 – date of earliest event filed on August 10, 2015. |
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(4) | Incorporated by reference to the Company’s Form 10-Q for the quarter ended June 30, 2018. |
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(5) | Incorporated by reference to the Company’s Form 10-K for the year ended December 31, 2018. |
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(6) | Incorporated by reference to the Form 8-K dated December 2, 2020 |
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(7) | Incorporated by reference to the Form 8-K dated January 11, 2021 |
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(8) | Incorporated by reference to the Form 8-K dated June 23, 2022 |
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(9) | Incorporated by reference to the Form 8-K dated September 1, 2022 |
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(10) | Incorporated by reference to Form S-8 dated November 1, 2019 |
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SIGNATURES
Pursuant to the requirements Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.
| UNITED HEALTH PRODUCTS, INC. |
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Dated: March 28, 2023 | By: | /s/ Brian Thom |
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| Brian Thom |
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| Chief Executive Officer, Principal Executive Officer and Director |
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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:
Signatures |
| Title |
| Date | |
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By: | /s/ Brian Thom |
| Chief Executive Officer, Principal |
| March 28, 2023 |
| Brian Thom |
| Executive Officer and Director |
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By: | /s/ Kristofer Heaton |
| Principal Financial Officer |
| March 28, 2023 |
| Kristofer Heaton |
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By: | /s/ Robert Denser |
| Director |
| March 28, 2023 |
| Robert Denser |
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| 39 |
EXHIBIT 31.1
CERTIFICATION PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
| I, Brian Thom certifies that: | ||
| 1. | I have reviewed this annual report on Form 10-K of United Health Products, Inc.; | |
| 2 | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; | |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; | |
| 4. | The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: | |
| a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | |
| b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | |
| c) | Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | |
| d) | Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and | |
| 5. | The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions): | |
| a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and | |
| b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting. | |
| Date: March 28, 2023 | By: | /s/ Brian Thom |
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| Brian Thom |
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| Principal Executive Officer |
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EXHIBIT 31.2
CERTIFICATION PURSUANT TO
RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
| I, Kristofer Heaton certifies that: | ||
| 1. | I have reviewed this annual report on Form 10-K of United Health Products, Inc.; | |
| 2 | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; | |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; | |
| 4. | The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: | |
| a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | |
| b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | |
| c) | Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | |
| d) | Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and | |
| 5. | The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions): | |
| a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and | |
| b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting. | |
| Date: March 28, 2023 | By | /s/ Kristofer Heaton |
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| Kristofer Heaton |
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| Principal Financial Officer |
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EXHIBIT 32.1
CERTIFICATION
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. Section 1350), Brian Thom, Principal Executive Officer of United Health Products, Inc. (the "Company") of the Company, hereby certifies that, to the best of his knowledge:
| 1. | The Company's Annual Report on Form 10-K for the year ended December 31, 2022, to which this Certification is attached as Exhibit 32.1 (the "Annual Report"), fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, and | |
| 2. | The information contained in the Annual Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
In witness whereof, the undersigned have set their hands hereto as of the March 28, 2023.
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| By: | /s/ Brian Thom |
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| Brian Thom |
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| Principal Executive Officer |
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EXHIBIT 32.2
CERTIFICATION
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. Section 1350), Kristofer Heaton, Principal Financial Officer of United Health Products, Inc. (the "Company") of the Company, hereby certifies that, to the best of his knowledge:
| 1. | The Company's Annual Report on Form 10-K for the year ended December 31, 2022, to which this Certification is attached as Exhibit 32.2 (the "Annual Report"), fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, and | |
| 2. | The information contained in the Annual Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
In witness whereof, the undersigned have set their hands hereto as of the March 28, 2023.
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| By: | /s/ Kristofer Heaton |
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| Kristofer Heaton |
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| Principal Financial Officer |
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EXHIBIT 10.11
AMENDMENT TO COMMON STOCK PURCHASE AGREEMENT
Reference is made to that certain Common Stock Purchase Agreement (the “Agreement”) dated September 1, 2022 by and between United Health Products, Inc., a Nevada corporation (the “Company”), and White Lion Capital, LLC, a Nevada limited liability company (the “Investor”). The Company and the Investor hereby agree to amend the Agreement as set forth herein (the “Amendment”.) All capitalized terms not defined herein shall carry the meaning ascribed to them in the Agreement.
1. The definition of “Purchase Price” shall be amended in its entirety to read as follows:
“Purchase Price” shall mean 93% multiplied by the lower of the (i) average daily VWAP of the Common Stock during the Valuation Period or (ii) the most recent closing price of the Company’s Common Stock prior to receipt of Purchase Notice; provided, however, if the Common Stock is trading on any National Exchange, the Purchase Price shall mean 95% multiplied by the lower of the (i) average daily VWAP of the Common Stock during the Valuation Period or (ii) the most recent closing price of the Company’s Common Stock prior to receipt of Purchase Notice, provided that, in the event the Investor agrees to waive the Floor Price restriction set forth in Section 2.1 for any Purchase Notice, the 93% and 95% multiplicands referenced above shall be reduced to 90% and 92%, respectively, for the associated Purchase Notice Shares.”
All other terms of the Agreement shall remain unchanged.
In witness hereof, the parties have caused this Amendment to be executed by their respective officers thereunto duly authorized effective as of January 25, 2023.
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| UNITED HEALTH PRODUCTS, INC. |
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| By: | /s/ Brian Thom | ||
| Name: | Brian Thom | ||
| Title: | Chief Executive Officer | ||
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| WHITE LION CAPITAL, LLC |
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| By: | /s/ Nathan Yee |
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| Name: | Nathan Yee |
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| Title: | Managing Partner |
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