UEEC 10-Q
United Health Products, Inc. (UEEC)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ____________ to ____________
Commission file number:
(Exact name of Company as specified in its charter) |
| ||
(State or other jurisdiction of incorporation or organization) |
| (I.R.S. Employer Identification No.) |
| ||
(Address of Company’s principal executive offices) |
| (Zip Code) |
(
(Company’s telephone number, including area code)
10624 S. Eastern Ave., Suite A209
Henderson, NV 89052
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12 (b) of the Act: None
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 checkmark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the 12 preceding months (or such shorter period that the registrant was required to submit such file).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See definition 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 | ||
| Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
The number of shares issued and outstanding of the Registrant’s Common Stock, as of August 12, 2022 was
UNITED HEALTH PRODUCTS, INC.
FORM 10-Q QUARTERLY REPORT
TABLE OF CONTENTS
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PART I. FINANCIAL INFORMATION | ||||
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Item 1. | Financial Statements (Unaudited) | |||
| Condensed Balance Sheets as of June 30, 2022 (unaudited) and December 31, 2021 | 3 | ||
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Management’s Discussion and Analysis of Financial Condition and Results of Operations | 15 | |||
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| 2 |
| Table of Contents |
UNITED HEALTH PRODUCTS, INC.
Condensed Balance Sheets
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| June 30, |
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| December 31, |
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| 2022 |
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| 2021 |
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| (Unaudited) |
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ASSETS |
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Current Assets |
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Cash and Cash Equivalents |
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Prepaid and other current assets |
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Total current assets |
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Patents, net |
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TOTAL ASSETS |
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Current Liabilities |
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Accounts payable and accrued expenses |
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Accrued liabilities - related parties |
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Accrued litigation settlement |
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Promissory note payable |
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Loans payable – related parties |
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Total current liabilities |
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TOTAL LIABILITIES |
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Commitments and Contingencies |
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Stockholders’ Equity (Deficit) |
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Series A Convertible Preferred Stock - $ |
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Common Stock - $ |
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Additional Paid-In Capital |
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Accumulated Deficit |
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Total Stockholders’ Equity (Deficit) |
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TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) |
| $ |
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| $ |
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See notes to unaudited condensed financial statements.
| 3 |
| Table of Contents |
UNITED HEALTH PRODUCTS, INC.
Condensed Statements of Operations
(Unaudited)
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| For the Three Months Ended June 30, |
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| For the Six Months Ended June 30, |
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| 2022 |
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| 2021 |
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| 2022 |
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| 2021 |
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Revenues |
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Cost of goods sold |
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Gross profit |
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Operating Costs and Expenses |
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Selling, general and administrative expenses |
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Research and development |
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Total Operating Expenses |
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Loss from Operations |
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Other Income (Expenses) |
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Interest expense |
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Interest expense – related party |
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Loss on settlement of debt |
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Other income |
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Total other income (expenses) |
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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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| $ | ( | ) |
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Weighted average number of shares outstanding |
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See notes to unaudited condensed financial statements.
| 4 |
| Table of Contents |
UNITED HEALTH PRODUCTS, INC
Condensed Statement of Stockholders’ Deficiency
Three and Six Months Ended June 30, 2022 and June 30, 2021
(Unaudited)
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| Additional |
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| Common Stock |
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| Paid-in |
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| Accumulated |
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| Shares |
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| Amount |
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| Capital |
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| Deficit |
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| Total |
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Balance at December 31, 2020 (audited) |
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| $ |
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| $ |
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| $ | ( | ) |
| $ | ( | ) | |||
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Beneficial conversion feature |
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| - |
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Issuance of common stock for services |
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Sale of common stock |
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Cancellation of common stock |
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Stock-based compensation |
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Common stock issued to settle accrued liabilities – related party |
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Common stock issued to settle related party advances |
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Common stock issued for conversion of convertible notes payable and accrued interest |
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Common stock issued for conversion of convertible notes payable and accrued interest – related party |
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Net Loss |
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| - |
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Balance at March 31, 2021 |
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Stock-based compensation |
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Common stock issued for conversion of convertible notes payable and accrued interest |
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Net Loss |
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| - |
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Balance at June 30, 2021 |
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| $ |
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| $ |
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| $ | ( | ) |
| $ | ( | ) | |||
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Balance at December 31, 2021 (audited) |
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| $ |
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| $ |
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| $ | ( | ) |
| $ | ( | ) | |||
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Issuance of common stock for services |
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Sale of common stock |
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Common stock issued to settle accounts payable and accrued liabilities |
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Net Loss |
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Balance at March 31, 2022 |
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Issuance of common stock for services |
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Issuance of common stock for services – related party |
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Common stock issued to settle accounts payable and accrued liabilities |
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Common stock issued to settle accounts payable and accrued liabilities – related party |
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Cancellation of common stock |
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Net Loss |
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| - |
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Balance at June 30, 2022 |
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| $ |
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| $ |
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| $ | ( | ) |
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See notes to unaudited condensed financial statements.
| 5 |
| Table of Contents |
UNITED HEALTH PRODUCTS, INC.
Condensed Statements of Cash Flows
(Unaudited)
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| For the Six Months Ended June 30, |
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| 2022 |
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| 2021 |
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Cash Flows from Operating Activities: |
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Net (Loss) |
| $ | ( | ) |
| $ | ( | ) |
Adjustments to Reconcile net (loss) to Net Cash Used In Operating Activities: |
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Stock for services and compensation |
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Amortization expense |
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Amortization of debt discount |
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Loss on settlement of debt |
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Changes in assets and liabilities: |
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Inventory |
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Prepaid and other current assets |
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Subscription Receivable |
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Accounts payable and accrued expenses |
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Accrued liabilities – related party |
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Accrued litigation settlement |
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Net Cash Used In Operating Activities |
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Cash Flows from Investing Activities: |
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Purchase of intangible assets |
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Net Cash Used in Investing Activities |
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Cash Flows from Financing Activities: |
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Proceeds from related party |
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Repayments on loan payable |
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Proceeds from sale of common stock |
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Proceeds from convertible notes payable |
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Cash flow provided by financing activities |
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Decrease in Cash and Cash Equivalents |
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Cash and Cash Equivalents – Beginning of period |
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CASH AND CASH EQUIVALENTS – END OF PERIOD |
| $ |
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| $ |
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Supplemental cash flow information: |
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Cash paid for interest |
| $ |
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| $ |
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Cash paid for income taxes |
| $ |
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| $ |
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Non-cash Investing & Financing Activities: |
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|
|
|
|
|
|
Cancellation of common stock |
| $ |
|
| $ |
| ||
Conversion of convertible notes payable and accrued interest – related party to convertible notes payable and accrued interest |
| $ |
|
| $ |
| ||
Common stock issued for conversion of convertible notes payable and accrued interest – related party |
| $ |
|
| $ |
| ||
Common stock issued for conversion of convertible notes payable and accrued interest |
| $ |
|
| $ |
| ||
Conversion of accounts payable to convertible notes payable |
| $ |
|
| $ |
| ||
Common stock issued to settle related party advances |
| $ |
|
| $ |
| ||
Common stock issued to settle accrued liabilities – related party |
| $ |
|
| $ |
| ||
Conversion of accrued liabilities – related party to convertible notes payable – related party |
| $ |
|
| $ |
| ||
Common stock issued to settle accrued liabilities |
| $ |
|
| $ |
| ||
Accrued litigation settlement paid with loan payable |
| $ |
|
| $ |
| ||
Debt discount related to beneficial conversion feature |
| $ |
|
| $ |
| ||
See notes to unaudited condensed financial statements.
| 6 |
| Table of Contents |
UNITED HEALTH PRODUCTS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
FOR THE QUARTERS ENDED JUNE 30, 2022 AND 2021
(Unaudited)
Note 1. Organization and Basis of Preparation
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 (“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.
The accompanying unaudited condensed financial statements of the Company have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (the “SEC”), including the instructions to Form 10-Q and Regulation S-X. Certain information and note disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”), have been condensed or omitted from these statements pursuant to such rules and regulations and, accordingly, they do not include all the information and notes necessary for comprehensive financial statements and should be read in conjunction with our audited financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on April 1, 2022.
In the opinion of management, all adjustments, which are of a normal recurring nature, considered necessary for the fair presentation of financial statements for the interim period, have been included.
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 matters, 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 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 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.
On March 11, 2020, the World Health Organization declared the outbreak of a coronavirus (COVID-19) as a pandemic. As a result, economic uncertainties have arisen which have the potential to negatively impact the Company’s ability to raise funding and to pursue is business objectives. Other factors that carry financial implications for the Company could occur although the potential impacts are unknown at this time.
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.
| 7 |
| Table of Contents |
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.
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. No discounts are currently offered by the Company. 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
We record accounts receivable at the invoiced amount and we do not charge interest. We review the accounts receivable by amounts due from customers that are past due, to identify specific customers with known disputes or collectability issues. In determining the amount of the reserve, we make judgments about the creditworthiness of significant customers based on ongoing credit evaluations. We will also maintain a sales allowance to reserve for potential credits issued to customers. We will determine the amount of the reserve based on historical credit issued.
There were no provisions for doubtful accounts recorded at June 30, 2022 and December 31, 2021. The Company recorded $0 in bad debt expense for the three and six month periods ended June 30, 2022 and 2021.
Stock Based Compensation
The Company accounts for share-based compensation under the provisions of ASC 718, Compensation-Stock Compensation. Under the fair value recognition provisions, stock-based compensation expense is measured at the fair value of the consideration received, or the fair value of the equity instruments issued, or liabilities incurred, whichever is more reliably measured. Share-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.
The Company accounts for stock compensation arrangements with non-employees in accordance with Accounting Standard Update (ASU) 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting, which requires that such equity instruments are recorded at the value on the grant date.
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 net losses for the three and six months ended June 30, 2022 and 2021 and the effect of including these potential common shares in the net loss per share calculations would be anti-dilutive.
| 8 |
| Table of Contents |
The total potential common shares as of June 30, 2022 included
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 June 30, 2022 and December 31, 2021 was $
Future Amortization Expense
Year |
| Amount |
| |
2022 (remaining) |
| $ |
| |
2023 |
|
|
| |
2024 |
|
|
| |
2025 |
|
|
| |
2026 |
|
|
| |
Thereafter |
|
|
| |
|
| $ |
| |
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 long-lived assets are sold or retired, the related cost and accumulated depreciation or amortization are removed from the accounts and any gain or loss is included in the results of operations. During the six months ended June 30, 2022 and 2021, the Company determined no impairment was required.
New Accounting Pronouncements
The Company considers all new pronouncements and management has determined that there have been no recently adopted or issued accounting standards that had or will have a material impact on its financial statements.
| 9 |
| Table of Contents |
Note 3. Related Party Transactions
Loans payable - related parties
As of December 31, 2021, Brian Thom, Chief Executive Officer had a loan payable balance of $
During the six months ended June 30, 2022, Mr. Thom loaned the Company $
As of December 31, 2021, Lou Schiliro, the former Chief Operating Officer, had a loan payable balance of $
During the six months ended June 30, 2022, Mr. Schiliro, loaned the Company $
During the six months ended June 30, 2022, Kristofer Heaton, Principal Financial Officer, loaned the Company $
Interest expense – related party on the above loans was $
Accrued liabilities – related parties
As of March 31, 2022 and December 31, 2021, $
As of March 31, 2022 and December 31, 2021, $
As of March 31, 2022 and December 31, 2021, $
Equity transactions
Per the vesting schedules of certain of the Company’s amended RSU Agreements, on January 1, 2021,
| 10 |
| 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 RSUs by issuing
During the six months ended June 30, 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
During the six months ended June 30, 2022, the Board of Directors approved an RSU Agreement with Robert Denser, Director of the Board. The agreement grants Mr. Denser
During the six months ended June 30, 2022, the Company issued
Note 4. Promissory Note Payable
During the six months ended June 30, 2022, the Company reached a settlement agreement related to Patterson’s counterclaim (see Note 6). The Company agreed to pay $
The Company paid $
The promissory note is secured by
Note 5. Issuances of Securities
Share issuances 2021
During the six months ended June 30, 2021, a total of
Share issuances 2022
During the six months ended June 30, 2022,
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 former 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 RSUs by issuing
| 11 |
| Table of Contents |
As discussed above in Note 3, during the six months ended June 30, 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. In addition, Mr. Thom’s original RSU Agreement was amended. The amendment increased the amount of RSU’s granted from
Activity related to our restricted stock units during the six months ended June 30, 2022 was as follows:
|
|
|
| Weighted |
| |||
|
|
|
| Average |
| |||
|
|
|
| Grant |
| |||
|
| Number of |
|
| Date Fair |
| ||
|
| Units |
|
| Value |
| ||
Total awards outstanding at December 31, 2021 |
|
|
|
| $ |
| ||
Units granted |
|
|
|
| $ |
| ||
Units Exercised/Released |
|
| - |
|
| $ |
| |
Units Cancelled/Forfeited |
|
| ( | ) |
| $ |
| |
Total awards outstanding at June 30, 2022 |
|
|
|
| $ |
| ||
Management is unable to predict if or when a Covered Transaction or Triggering Event which are vesting milestones under the RSU Agreements governing the restricted stock units will occur and as of June 30, 2022, there was $
Note 6. 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 schedule payment of $
Note 7. Litigation
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 2018 an action was commenced
| 12 |
| Table of Contents |
As mentioned in Note 6 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 pending 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, Haynie & Company, in Utah State Court, asserting claims related to professional negligence and breach of fiduciary duty. Haynie & Company has denied the allegations. Mediation is scheduled for the last week of August 2022.
Note 8. Other Income
The Company received payment of $
Note 9. Subsequent Events
The Company has evaluated events from June 30, 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:
The Company issued a $
The Company issued a $
The Company issued a $
The Board of Directors approved RSU Agreements with four doctors to acquire 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
| 13 |
| Table of Contents |
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations together with our condensed financial statements and related notes appearing elsewhere in this quarterly report on Form 10-Q. This discussion and analysis contains 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’ in our annual report on Form 10-K for the fiscal year ended December 31, 2021, filed with SEC on April 1, 2022.
Company Overview
UHP 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 CE Mark surgical markets.
Our HemoStyp Gauze Products
HemoStyp hemostatic gauze is a collagen-like 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 510k 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 do 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.
| 14 |
| Table of Contents |
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.
Potential Target Markets
Our HemoStyp material is currently cut to several sizes and configuration and marketed as HemoStyp Gauze. While we have paused our commercial activities to focus on our Class III PMA application, 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 510k 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. Our extensive laboratory testing and our completed human trial indicate that the HemoStyp technology can successfully compete against established Class III market participants and allow us to gain a significant market share. There can be no assurance that an FDA 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. 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 FDA 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, hemodialysis 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. 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, (ii) one or more commercial partnerships with established market participants, without any specific, associated sale or merger transaction, and (iii) a capital raising program to establish and grow our own marketing and distribution capabilities and drive revenue and profits organically.
| 15 |
| Table of Contents |
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 continue to engage in 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 largely in the United States to our specifications and using our equipment through a contract manufacturing arrangement with an FDA certified contract manufacturer that maintains stringent quality control protocols to assure the uniformity and quality of all of our gauze products. Information on our equipment, the manufacturing process and our manufacturer’s facility has been submitted as part of our PMA submission. Certain of our adhesive bandage formats designed for the 510k market are manufactured by a separate contractor based in China.
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 HemoStypo 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 |
| · | Nik Fix |
| 16 |
| Table of Contents |
Results of Operations for the three months ending June 30, 2022 and 2021
The following table sets forth a summary of certain key financial information for the three months ended June 30, 2022 and 2021:
|
| For the Three Months Ended June 30, |
| |||||
|
| 2022 |
|
| 2021 |
| ||
|
|
|
|
|
|
| ||
Revenue |
| $ | - |
|
| $ | - |
|
|
|
|
|
|
|
|
|
|
Gross profit |
| $ | - |
|
| $ | - |
|
|
|
|
|
|
|
|
|
|
Operating (expenses) |
| $ | (754,797 | ) |
| $ | (1,300,063 | ) |
|
|
|
|
|
|
|
|
|
Operating (loss) |
| $ | (754,797 | ) |
| $ | (1,300,063 | ) |
|
|
|
|
|
|
|
|
|
Other income (expense) |
| $ | (124,240 | ) |
| $ | (4,413 | ) |
|
|
|
|
|
|
|
|
|
Net (loss) |
| $ | (879,037 | ) |
| $ | (1,304,476 | ) |
|
|
|
|
|
|
|
|
|
Net loss per common share - basic and diluted |
| $ | (0.00 | ) |
| $ | (0.01 | ) |
Three Months ended June 30, 2022 versus Three Months ended June 30, 2021
During the three months ended June 30, 2022 and 2021, the Company had $0 and $0 of revenues, respectively. The Company did not generate any revenues due to the continued focus of the Company’s capital and resources towards obtaining a Class III PMA.
Total operating expenses for the three months ended June 30, 2022 and 2021 were $754,797 and $1,300,063, respectively.
The decrease in operating expenses was primarily due to the Company having a $562,000 loss on litigation settlement during the three months ended June 30, 2021 compared to $0 during the three months ended June 30, 2022.
Other income (expense) for the three months ended June 30, 2022 and 2021 was $(124,240) and $(4,413), respectively. The increase in other expense was due to an increase in total interest expense of $7,327 and an increase in loss on settlement of debt $112,500. The increase in interest expense was primarily due to the Company having a larger outstanding balance of interest bearing promissory notes. The increase in the loss on debt settlement was due to the Company issuing common stock with a fair value of $300,000 for the settlement of an aggregate of $187,500 of accrued liabilities and accrued liabilities – related parties during the three months ended June 30, 2022 compared to $0 during the three months ended June 30, 2021.
| 17 |
| Table of Contents |
Our net loss for the three months ended June 30, 2022 was $879,037 as compared to net loss of $1,304,476 for the comparable period of the prior year. The decrease in the net loss was due to the Company having a decrease in operating expenses of $545,266 and an increase in other expenses of $119,827, as explained above.
Results of Operations for the six months ending June 30, 2022 and 2021
The following table sets forth a summary of certain key financial information for the six months ended June 30, 2022 and 2021:
|
| For the Six Months Ended June 30, |
| |||||
|
| 2022 |
|
| 2021 |
| ||
|
|
|
|
|
|
| ||
Revenue |
| $ | - |
|
| $ | 59 |
|
|
|
|
|
|
|
|
|
|
Gross profit |
| $ | - |
|
| $ | 34 |
|
|
|
|
|
|
|
|
|
|
Operating (expenses) |
| $ | (1,709,298 | ) |
| $ | (28,005,288 | ) |
|
|
|
|
|
|
|
|
|
Operating (loss) |
| $ | (1,709,298 | ) |
| $ | (28,005,254 | ) |
|
|
|
|
|
|
|
|
|
Other income (expense) |
| $ | (134,003 | ) |
| $ | (346,360 | ) |
|
|
|
|
|
|
|
|
|
Net (loss) |
| $ | (1,843,301 | ) |
| $ | (28,351,614 | ) |
|
|
|
|
|
|
|
|
|
Net loss per common share - basic and diluted |
| $ | (0.01 | ) |
| $ | (0.13 | ) |
Six Months ended June 30, 2021 versus Six Months ended June 30, 2021
During the six months ended June 30, 2022 and 2021, the Company had $0 and $0 of revenues, respectively. The Company did not generate any revenues due to the continued focus of the Company’s capital and resources towards obtaining a Class III PMA.
Total operating expenses for the six months ended June 30, 2022 and 2021 were $1,709,298 and $28,005,288, respectively.
The decrease in operating expenses was due primarily to a decrease in stock-based compensation expenses of $26,201,973 and a decrease of $562,000 of litigation settlement expense. The Company recorded a total $310,200 of stock-based compensation during the six months ended June 30, 2022 compared to $26,512,173 during the six months ended June 30, 2021.
The decrease in stock-based compensation was primarily related to vesting and amortization of RSUs. During the six months ended June 30, 2021, the Company amended the RSU agreement with its former Chief Executive Officer. 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 and issued 325,000 shares of common stock valued at $230,750 due to vesting of RSUs as the result of the Company terminating services with one of its legal counsels. The Company issued 645,000 shares of common stock for services valued at $310,200 and did not have any RSU vest during the six months ended June 30, 2022.
Other income (expense) for the six months ended June 30, 2022 and 2021 was $(134,003) and $(346,360), respectively. The decrease in other expense was due to a decrease in total interest expense of $594,815 an increase in loss on debt settlement of $78,185 and decrease in other income of $304,273 during the six months ended June 30, 2022 compared to the six months ended June 30, 2021. The decrease in interest expense was primarily due to the amortization of beneficial conversion features on convertible notes payable and convertible notes payable – related party during the six months ended June 30, 2021 totaling $608,710 compared to $0 in the six months ended June 30, 2022. The increase in the loss on settlement of debt was due to the Company issuing common stock with a fair value of $304,001 for the settlement of an aggregate of $190,626 of accrued liabilities and accrued liabilities – related parties during the six months ended June 30, 2022 compared to the Company issuing shares of common stock with a fair value of $188,713 for the settlement of $153,523 of various debts and accrued liabilities – related party during the six months June 30, 2021. The decrease in other income was due to the Company receiving $304,273 as full and final payment for settlement of its December 2019 arbitration with Maxim during the six months ended June 30, 2021 compared to $0 of other income during the six months June 30, 2022.
Our net loss for the six months ended June 30, 2022 was $1,843,301 as compared to net loss of $28,351,614 for the comparable period of the prior year. The decrease in the net loss was due to the Company having a decrease in operating expenses of $26,295,956 along with a decrease in other expenses from $346,360 during the six months ended June 30, 2021 to $134,003 for the six months ended June 30, 2022 as explained above.
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Financial Condition, Liquidity and Capital Resources
As of June 30, 2022, the Company had a negative working capital of $2,334,177. The Company has not yet attained a level of operations which will allow it to meet its current overhead expense obligations. If we are not successful in our commercialization strategy, we cannot assure that we will be able to fund a standalone marketing and sale strategy, and if we do, we cannot assure we will attain profitable operations within the next year or at all. The report of our independent registered public accounting firm on our 2021 financial statements includes an explanatory paragraph expressing substantial doubt about our ability to continue as a going concern. While the Company has funded its operations with private placements, and 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.
Cash Flows
The Company’s cash on hand at June 30, 2022 and December 31, 2021 was $6,416 and $21,799, respectively.
The following table summarizes selected items from our statements of cash flows for the six months ended June 30, 2022 and 2021:
|
| For the Six Months Ended June 30, |
| |||||
|
| 2022 |
|
| 2021 |
| ||
Net cash used in operating activities |
| $ | (399,189 | ) |
| $ | (263,544 | ) |
Net cash used in investing activities |
|
| (40,500 | ) |
|
| - |
|
Net cash provided by financing activities |
|
| 424,306 |
|
|
| 235,000 |
|
|
|
|
|
|
|
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|
|
Net decrease in cash and cash equivalents |
| $ | (15,383 | ) |
| $ | (28,544 | ) |
Net Cash Provided by (Used in) Operating Activities
Net cash used in operating activities for the six months ended June 30, 2022 was $399,189. The Company had net loss of $1,843,301 offset by stock for services and compensation of $310,200, amortization expense of $2,025, a loss on debt settlement of $113,375, an increase in accounts payable and accrued expenses of $500,774, an increase in accrued liabilities - related party of $146,944 and an increase in accrued litigation settlement of $380,000 and an increase in prepaid and other current assets of $9,206.
Net cash used in operating activities for the six months ended June 30, 2021 was $263,544. The Company had net loss of $28,351,614 offset by non-cash stock-based compensation of $26,512,173, amortization of debt discount of $608,710 and a loss on settlement of debt of $35,190. The Company also had a decrease in inventory of $25, change in accounts payable and accrued expenses of $138,167, a change in accounts payable and accrued expenses related party of $236,805 and a change in accrued litigation settlement of $562,000. The Company also had an increase in prepaid and other current assets of $5,000.
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Net Cash Used by Investing Activities
The Company paid $40,500 related to the patent application fees during the six months ended June 30, 2022.
The Company did not have any investing activities during the six months ended June 30, 2021.
Net Cash Provided by (Used in) Financing Activities
Net cash provided by financing activities for the six months ended June 30, 2022 was $424,306. This was due to the result of the Company receiving $77,292 in proceeds from the sale of stock and receiving $383,275 from related party loans offset by making payments of $36,261 on loan payable.
Net cash provided by financing activities for the six months ended June 30, 2021 was $235,000. This was due to the Company receiving $20,000 in proceeds from a related party loan, $100,000 in proceeds from the sale of stock and $115,000 in proceeds from the issuance of convertible notes.
Off-Balance Sheet Arrangements
As of June 30, 2022, we have no off-balance sheet arrangements.
Critical Accounting Policies
The preparation of financial statements and related disclosures in conformity with generally accepted accounting principles in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements, and revenues and expenses during the periods reported. Actual results could materially differ from those estimates. We have identified the following items as critical accounting policies.
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. No discounts were offered by the Company. The Company does not provide an estimate for returns as there is no anticipation for any returns in the normal course of business.
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Stock Based Compensation
The Company accounts for share-based compensation under the provisions of ASC 718, Compensation-Stock Compensation. Under the fair value recognition provisions, stock-based compensation expense is measured at the fair value of the consideration received, or the fair value of the equity instruments issued, or liabilities incurred, whichever is more reliably measured. Share-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.
The Company accounts for stock compensation arrangements with non-employees in accordance with Accounting Standard Update (ASU) 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting, which requires that such equity instruments are recorded at the value on the grant date.
Item 3. Quantitative and Qualitative Disclosures about Market Risk.
Not applicable
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
The Company is in the process of implementing 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 rules and forms of the Securities and Exchange Commission, and that such information is accumulated and communicated to our Chief Executive Officer and Principal Financial Officer to allow timely decisions regarding required disclosure.
As of June 30, 2022, the Chief Executive Officer and the Principal Financial Officer carried out an assessment of the effectiveness of the design and operation of our disclosure controls and procedures and concluded that the Company’s disclosure controls and procedures were not effective.
Changes in Internal Control over Financial Reporting
During the quarter ended June 30, 2022, there were no changes in our system of internal controls over financial reporting.
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PART II – OTHER INFORMATION
Item 1. Legal Proceedings
See “Note 7” in the Notes to Condensed Financial Statements.
Item 1A. Risk Factors
Management does not believe there have been any material changes to the risk factors listed in Part I, “Item 1A, Risk Factors” in our annual report on Form 10-K for the year ended December 31, 2021. These risk factors should be carefully considered with the information provided elsewhere in this report, which could materially adversely affect our business, financial condition or results of operations.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
The following summarizes all sales of our unregistered securities from January 1, 2022 through June 30, 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 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 |
|
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
Not applicable.
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Item 6. 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.
(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-K for the year ended December 31, 2005. |
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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 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. | |||
Dated: August 15, 2022 | By: | /s/ Brian Thom | |
Brian Thom | |||
Principal Executive Officer | |||
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 | ||||
By: | /s/ Brian Thom | Chief Executive Officer, Principal Executive Officer and Director | August 15, 2022 | |||
Brian Thom |
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By: | /s/ Kristofer Heaton | Vice President, Finance and Principal Financial Officer | August 15, 2022 | |||
Kristofer Heaton |
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By: | /s/ Robert Denser | Director | August 15, 2022 | |||
Robert Denser | ||||||
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