Sanara MedTech Inc. - Quarter Report: 2022 March (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2022
or
☐ 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 001-39678
SANARA MEDTECH INC.
(Exact name of Registrant as specified in its charter)
Texas | 59-2219994 | |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
1200 Summit Ave, Suite 414, Fort Worth, Texas 76102 |
(Address of principal executive offices)
(817) 529-2300 (Registrant’s telephone number, including area code) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
Common Stock, $0.001 par value | SMTI | The Nasdaq Capital Market |
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. ☒ Yes ☐ No
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒ Yes ☐ No
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 | ☐ | |
Non-accelerated filer | ☒ | Smaller reporting company | ☒ | |
Emerging growth company | ☐ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of May 16, 2022, shares of the Issuer’s $0.001 par value common stock were issued and outstanding.
SANARA MEDTECH INC.
Form 10-Q
Quarter Ended March 31, 2022
Sanara, Sanara MedTech, our logo and our other trademarks or service marks appearing in this report are the property of Sanara MedTech Inc. Trade names, trademarks and service marks of other companies appearing in this report are the property of their respective owners. Solely for convenience, the trademarks, service marks and trade names included in this report are without the ®, ™ or other applicable symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensors to these trademarks, service marks and trade names.
Unless otherwise indicated, “Sanara,” “we,” “us,” “our,” and “the Company,” refer to Sanara MedTech Inc. and its consolidated subsidiaries.
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Part I – Financial Information
Item 1. Financial Statements
SANARA MEDTECH INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(Unaudited) | ||||||||
March 31, | December 31, | |||||||
2022 | 2021 | |||||||
Assets | ||||||||
Current assets | ||||||||
Cash | $ | 16,143,080 | $ | 18,652,841 | ||||
Accounts receivable, net of allowances of $88,310 and $99,278 | 3,409,048 | 2,861,014 | ||||||
Accounts receivable - related party | 96,278 | 79,787 | ||||||
Royalty receivable | 49,344 | 49,344 | ||||||
Inventory, net of allowance for obsolescence of $359,577 and $333,850 | 2,171,328 | 2,048,191 | ||||||
Prepaid and other assets | 624,923 | 917,318 | ||||||
Total current assets | 22,494,001 | 24,608,495 | ||||||
Long-term assets | ||||||||
Property and equipment, net | 1,578,973 | 1,629,845 | ||||||
Right of use assets – operating leases | 355,081 | 412,770 | ||||||
Intangible assets, net | 4,617,947 | 4,727,970 | ||||||
Investment in equity securities | 4,887,718 | 5,017,351 | ||||||
Total long-term assets | 11,439,719 | 11,787,936 | ||||||
Total assets | $ | 33,933,720 | $ | 36,396,431 | ||||
Liabilities and shareholders’ equity | ||||||||
Current liabilities | ||||||||
Accounts payable | $ | 929,374 | $ | 438,154 | ||||
Accounts payable – related parties | 51,847 | 155,817 | ||||||
Accrued royalties and expenses | 940,337 | 706,196 | ||||||
Accrued bonus and commissions | 3,129,203 | 4,518,817 | ||||||
Operating lease liability - current | 180,233 | 203,292 | ||||||
Total current liabilities | 5,230,994 | 6,022,276 | ||||||
Long-term liabilities | ||||||||
Operating lease liability – long term | 187,040 | 222,151 | ||||||
Total long-term liabilities | 187,040 | 222,151 | ||||||
Total liabilities | 5,418,034 | 6,244,427 | ||||||
Commitments and contingencies (Note 6) | ||||||||
Shareholders’ equity | ||||||||
Common Stock: $ par value, shares authorized; issued and outstanding as of March 31, 2022 and issued and outstanding as of December 31, 2021 | 7,810 | 7,677 | ||||||
Additional paid-in capital | 47,438,466 | 45,867,768 | ||||||
Accumulated deficit | (18,415,012 | ) | (15,235,044 | ) | ||||
Total Sanara MedTech shareholders’ equity | 29,031,264 | 30,640,401 | ||||||
Equity attributable to noncontrolling interest | (515,578 | ) | (488,397 | ) | ||||
Total shareholders’ equity | 28,515,686 | 30,152,004 | ||||||
Total liabilities and shareholders’ equity | $ | 33,933,720 | $ | 36,396,431 |
The accompanying notes are an integral part of these unaudited consolidated financial statements.
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SANARA MEDTECH INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
Three Months Ended | ||||||||
March 31, | ||||||||
2022 | 2021 | |||||||
Net Revenue | $ | 7,811,223 | $ | 5,009,436 | ||||
Cost of goods sold | 805,081 | 474,433 | ||||||
Gross profit | 7,006,142 | 4,535,003 | ||||||
Operating expenses | ||||||||
Selling, general and administrative expenses | 9,375,630 | 5,409,730 | ||||||
Research and development | 204,637 | 118,212 | ||||||
Depreciation and amortization | 202,747 | 90,591 | ||||||
Total operating expenses | 9,783,014 | 5,618,533 | ||||||
Operating loss | (2,776,872 | ) | (1,083,530 | ) | ||||
Other expense | ||||||||
Interest expense | - | (711 | ) | |||||
Share of losses from equity method investment | (379,633 | ) | (99,135 | ) | ||||
Total other expense | (379,633 | ) | (99,846 | ) | ||||
Net loss | (3,156,505 | ) | (1,183,376 | ) | ||||
Less: Net loss attributable to noncontrolling interest | (27,181 | ) | (1,632 | ) | ||||
Net loss attributable to Sanara MedTech common shareholders | $ | (3,129,324 | ) | $ | (1,181,744 | ) | ||
Net loss per share of common stock, basic and diluted | $ | (0.41 | ) | $ | (0.17 | ) | ||
Weighted average number of common shares outstanding, basic and diluted | 7,606,450 | 6,816,646 |
The accompanying notes are an integral part of these unaudited consolidated financial statements.
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SANARA MEDTECH INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (UNAUDITED)
Common Stock | Additional | Accumulated | Total | |||||||||||||||||||||
$0.001 par value | Paid-In | Income/ | Noncontrolling | Shareholders’ | ||||||||||||||||||||
Shares | Amount | Capital | (Deficit) | Interest | Equity | |||||||||||||||||||
Balance at December 31, 2020 | 6,297,008 | $ | 6,297 | $ | 13,176,576 | $ | (7,032,242 | ) | $ | (310,395 | ) | $ | 5,840,236 | |||||||||||
Issuance of common stock for asset acquisitions | 50,370 | 50 | 1,749,950 | - | - | 1,750,000 | ||||||||||||||||||
Issuance of common stock in equity offering | 1,265,000 | 1,265 | 28,937,992 | - | - | 28,939,257 | ||||||||||||||||||
Share-based compensation | 4,744 | 5 | 325,513 | - | - | 325,518 | ||||||||||||||||||
Distribution to noncontrolling interest member | - | - | - | - | (200,000 | ) | (200,000 | ) | ||||||||||||||||
Net loss | - | - | (1,181,744 | ) | (1,632 | ) | (1,183,376 | ) | ||||||||||||||||
Balance at March 31, 2021 | 7,617,122 | $ | 7,617 | $ | 44,190,031 | $ | (8,213,986 | ) | $ | (512,027 | ) | $ | 35,471,635 |
Common Stock | Additional | Accumulate | Total | |||||||||||||||||||||
$0.001 par value | Paid-In | Income/ | Noncontrolling | Shareholders’ | ||||||||||||||||||||
Shares | Amount | Capital | (Deficit) | Interest | Equity | |||||||||||||||||||
Balance at December 31, 2021 | 7,676,662 | $ | 7,677 | $ | 45,867,768 | $ | (15,235,044 | ) | $ | (488,397 | ) | $ | 30,152,004 | |||||||||||
Share-based compensation | 137,076 | 136 | 1,622,982 | - | - | 1,623,118 | ||||||||||||||||||
Net settlement and retirement of equity-based awards | (3,343 | ) | (3 | ) | (52,284 | ) | (50,644 | ) | - | (102,931 | ) | |||||||||||||
Net loss | - | - | (3,129,324 | ) | (27,181 | ) | (3,156,505 | ) | ||||||||||||||||
Balance at March 31, 2022 | 7,810,395 | $ | 7,810 | $ | 47,438,466 | $ | (18,415,012 | ) | $ | (515,578 | ) | $ | 28,515,686 |
The accompanying notes are an integral part of these unaudited consolidated financial statements.
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SANARA MEDTECH INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
Three Months Ended | ||||||||
March 31, | ||||||||
2022 | 2021 | |||||||
Cash flows from operating activities: | ||||||||
Net loss | $ | (3,156,505 | ) | $ | (1,183,376 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities | ||||||||
Depreciation and amortization | 202,747 | 90,591 | ||||||
Loss on disposal of asset | 2,501 | - | ||||||
Bad debt expense | 15,000 | - | ||||||
Inventory obsolescence | 71,819 | 7,312 | ||||||
Share-based compensation | 584,935 | 325,518 | ||||||
Noncash lease expense | 57,688 | 30,572 | ||||||
Loss on equity method investment | 379,633 | 99,135 | ||||||
Changes in operating assets and liabilities: | ||||||||
Accounts receivable | (563,034 | ) | (245,550 | ) | ||||
Accounts receivable - related party | (16,492 | ) | - | |||||
Inventory | (194,956 | ) | (37,953 | ) | ||||
Prepaid and other assets | 292,394 | 91,757 | ||||||
Accounts payable | 491,220 | 9,071 | ||||||
Accounts payable - related parties | (103,970 | ) | (136,997 | ) | ||||
Accrued royalties and expenses | 234,141 | (70,654 | ) | |||||
Accrued bonus and commissions | (409,599 | ) | (241,030 | ) | ||||
Net cash used in operating activities | (2,112,478 | ) | (1,261,604 | ) | ||||
Cash flows from investing activities: | ||||||||
Purchase of property and equipment | (44,697 | ) | (4,391 | ) | ||||
Proceeds from disposal of assets | 345 | - | ||||||
Investment in equity securities | (250,000 | ) | (600,000 | ) | ||||
Net cash used in investing activities | (294,352 | ) | (604,391 | ) | ||||
Cash flows from financing activities: | ||||||||
Draw on line of credit | - | 800,000 | ||||||
Pay off line of credit | - | (800,000 | ) | |||||
Public offering net proceeds | - | 28,939,257 | ||||||
Net settlement of equity-based awards | (102,931 | ) | - | |||||
Distribution to noncontrolling interest member | - | (200,000 | ) | |||||
Net cash flows provided by (used in) financing activities | (102,931 | ) | 28,739,257 | |||||
Net increase (decrease) in cash | (2,509,761 | ) | 26,873,262 | |||||
Cash, beginning of period | 18,652,841 | 455,366 | ||||||
Cash, end of period | $ | 16,143,080 | $ | 27,328,628 | ||||
Cash paid during the period for: | ||||||||
Interest | $ | $ | 711 | |||||
Income taxes | - | - | ||||||
Supplemental noncash investing and financing activities: | ||||||||
Common stock issued for asset acquisitions | - | 1,750,000 |
The accompanying notes are an integral part of these unaudited consolidated financial statements.
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SANARA MEDTECH INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 – NATURE OF BUSINESS AND BACKGROUND
Sanara MedTech Inc. (“we”, “our”, the “Company”) is a medical technology company focused on developing and commercializing transformative technologies to improve clinical outcomes and reduce healthcare expenditures in the surgical and chronic wound and skin care markets. The Company’s portfolio of products and services is designed to allow the Company to deliver comprehensive wound and skin care solutions for patients in all care settings, including acute (hospitals and long-term acute care hospitals) and post-acute (wound care clinics, physician offices, skilled nursing facilities (“SNFs”), home health, hospice, and retail). Each of the Company’s products, services, and technologies contributes to the Company’s overall goal of achieving better clinical outcomes at a lower overall cost for patients regardless of where they receive care. The Company strives to be one of the most innovative and comprehensive providers of effective wound and skin care products and technologies.
NOTE 2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Principles of Consolidation and Basis of Presentation
The accompanying unaudited consolidated financial statements include the accounts of Sanara MedTech Inc., its wholly owned and majority-owned subsidiaries, as well as other entities in which the Company has a controlling financial interest. Intercompany profits, losses, transactions and balances have been eliminated in consolidation.
The accompanying unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. generally accepted accounting principles for complete financial statements. In the opinion of management of the Company, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three-month period ended March 31, 2022, are not necessarily indicative of the results that may be expected for the year ending December 31, 2022, or any other period. These financial statements and notes should be read in conjunction with the financial statements for each of the two years ended December 31, 2021 and 2020, which are included in the Company’s most recent Annual Report on Form 10-K.
Use of Estimates
The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect amounts reported in the financial statements and accompanying notes. The extent to which the COVID-19 pandemic may directly or indirectly impact our business, financial condition, and results of operations is highly uncertain and subject to change. The Company considered the potential impact of the COVID-19 pandemic on its estimates and assumptions and determined there was not a material impact on the Company’s estimates and assumptions used in preparing the unaudited consolidated financial statements as of and for the three months ended March 31, 2022. However, actual results could differ from those estimates and there may be changes to the Company’s estimates in future periods.
Cash and Cash Equivalents
The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents.
The Company computes income per share in accordance with Accounting Standards Codification (“ASC”) Topic 260, Earnings per Share, which requires the Company to present basic and dilutive income per share when the effect is dilutive. Basic income per share is computed by dividing income available to common shareholders by the weighted average number of shares of common stock outstanding. Diluted income per share is computed similar to basic income per share except that the denominator is increased to include the number of additional shares of common stock that would have been outstanding if the potential shares of common stock had been issued and if the additional shares of common stock were dilutive. All common stock equivalents were excluded from the current and prior period calculations, as their inclusion would have been anti-dilutive during the three months ended March 31, 2022 and 2021 due to the Company’s net loss.
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Three Months Ended | ||||||||
March 31, | ||||||||
2022 | 2021 | |||||||
Stock options | 11,500 | 11,500 | ||||||
Unvested restricted stock | 179,180 | 121,691 |
Revenue Recognition
The Company recognizes revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). Revenues are recognized when control of the promised goods or services is transferred to the customer in an amount that reflects the consideration the Company expects to be entitled to receive in exchange for transferring those goods or services. Revenue is recognized based on the following five step model:
- Identification of the contract with a customer
- Identification of the performance obligations in the contract
- Determination of the transaction price
- Allocation of the transaction price to the performance obligations in the contract
- Recognition of revenue when, or as, the Company satisfies a performance obligation
Details of this five-step process are as follows:
Identification of the contract with a customer
Customer purchase orders are generally considered to be contracts under ASC 606. Purchase orders typically identify specific terms of products to be delivered, create the enforceable rights and obligations of both parties, and result in commercial substance. No other forms of contract revenue recognition, such as the completed contract or percentage of completion methods, were utilized by the Company in either 2022 or 2021.
Performance obligations
The Company’s performance obligation is generally limited to delivery of the requested items to its customers at the agreed upon quantities and prices.
Determination and allocation of the transaction price
The Company has established prices for its products. These prices are effectively agreed to when customers place purchase orders with the Company. Rebates and discounts, if any, are recognized in full at the time of sale as a reduction of net revenue. Allocation of transaction prices is not necessary where one performance obligation exists.
Recognition of revenue as performance obligations are satisfied
Product revenues are recognized when the products are delivered, and control of the goods and services passes to the customer.
Disaggregation of Revenue
Revenue streams from product sales and royalties are summarized below for the three months ended March 31, 2022 and 2021. All revenue was generated in the United States; therefore, no geographical disaggregation was necessary.
Three Months Ended | ||||||||
March 31, | ||||||||
2022 | 2021 | |||||||
Product sales revenue | $ | 7,760,973 | $ | 4,959,186 | ||||
Royalty revenue | 50,250 | 50,250 | ||||||
Total Revenue | $ | 7,811,223 | $ | 5,009,436 |
The Company recognizes royalty revenue from a development and license agreement between BioStructures, LLC and the Company. The Company records revenue each calendar quarter as earned per the terms of the agreement, which stipulates that the Company will receive quarterly royalty payments of at least $50,250. Under the terms of the development and license agreement, royalties of 2.0% are recognized on sales of products containing the Company’s patented resorbable bone hemostasis. The minimum annual royalty due to the Company is $201,000 per year throughout the life of the patent which expires in 2023. These royalties are payable in quarterly installments of $50,250. To date, royalties related to this development and license agreement have not exceeded the annual minimum of $201,000 ($50,250 per quarter).
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Contract Assets and Liabilities
The Company does not have any contract assets or contract liabilities.
Allowance for Doubtful Accounts
The Company establishes an allowance for doubtful accounts to ensure accounts receivable are not overstated due to uncollectible accounts. The Company recorded bad debt expense of $15,000 and $ during the three months ended March 31, 2022 and 2021, respectively. The allowance for doubtful accounts was $79,899 at March 31, 2022 and $64,899 at December 31, 2021. Bad debt reserves are maintained based on a variety of factors, including the length of time receivables are past due and a detailed review of certain individual customer accounts. The Company also establishes other allowances to ensure accounts receivable are not overstated due to customer rebates and certain customer allowances. These allowances totaled $8,411 at March 31, 2022 and $34,379 at December 31, 2021. If circumstances related to customers change, estimates of the recoverability of receivables would be further adjusted.
Inventories
Inventories are stated at the lower of cost or net realizable value, with cost computed on a first-in, first-out basis. Inventories consist of finished goods and related packaging components. The Company recorded inventory obsolescence expense of $71,819 for the three months ended March 31, 2022 and $7,312 for the three months ended March 31, 2021. The allowance for obsolete and slow-moving inventory had a balance of $359,577 at March 31, 2022, and $333,850 at December 31, 2021.
Property and Equipment
Property and equipment are stated at cost, less accumulated depreciation. Depreciation is recorded using the straight-line method over the estimated useful lives of the related assets, ranging from three to ten years. Below is a summary of property and equipment for the periods presented:
March 31, | December 31, | |||||||
2022 | 2021 | |||||||
Computers | $ | 112,703 | $ | 104,568 | ||||
Office equipment | 22,637 | 21,731 | ||||||
Furniture and fixtures | 232,076 | 221,565 | ||||||
Leasehold improvements | 18,331 | 2,030 | ||||||
Internal use software | 1,618,998 | 1,622,525 | ||||||
2,004,745 | 1,972,419 | |||||||
Less accumulated depreciation | (425,772 | ) | (342,574 | ) | ||||
Property and equipment, net | $ | 1,578,973 | $ | 1,629,845 |
Depreciation expense related to property and equipment was $92,724 for the three months ended March 31, 2022, and $17,488 for the three months ended March 31, 2021.
Internal Use Software
The Company accounts for costs incurred to develop computer software for internal use in accordance with ASC Topic 350-40, Intangibles – Goodwill and Other. The Company capitalizes the costs incurred during the application development stage, which generally includes third-party developer fees to design the software configuration and interfaces, coding, installation, and testing.
The Company begins capitalization of qualifying costs when both the preliminary project stage is completed, and management has authorized further funding for the completion of the project. Costs incurred during the preliminary project stage along with post implementation stages of internal-use computer software are expensed as incurred. The Company also capitalizes costs related to specific upgrades and enhancements when it is probable the expenditures will result in additional functionality. Capitalized development costs are classified as “property and equipment, net” in the consolidated balance sheets and are amortized over the estimated useful life of the software, which is generally five to seven years.
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Intangible Assets
Intangible assets are stated at cost of acquisition less accumulated amortization and impairment loss, if any. Cost of acquisition includes purchase price and any cost directly attributable to bringing the asset to its working condition for the intended use. The Company amortizes its intangible assets on a straight-line basis over the useful life of the respective assets which is generally the life of the related patents (if applicable).
See Note 3 for more information on intangible assets.
Impairment of Long-Lived Assets
Long-lived assets, including certain identifiable intangibles held and to be used by the Company, are reviewed for impairment whenever events or changes in circumstances, including the COVID-19 pandemic, indicate that the carrying amount of such assets may not be recoverable. The Company continuously evaluates the recoverability of its long-lived assets based on estimated future cash flows and the estimated liquidation value of such long-lived assets and provides for impairment if such undiscounted cash flows are insufficient to recover the carrying amount of the long-lived assets. If impairment exists, an adjustment is made to write the asset down to its fair value, and a loss is recorded as the difference between the carrying value and fair value. Fair values are determined based on quoted market values, undiscounted cash flows or internal and external appraisals, as applicable. Assets to be disposed of are carried at the lower of carrying value or estimated net realizable value. No impairment was recorded during the three months ended March 31, 2022 or 2021.
Investments in Equity Securities
The Company’s equity investments consist of non-marketable equity securities in privately held companies without readily determinable fair values. Unless accounted for under the equity method of accounting, the investments are reported at cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or similar investment of the same issuer.
The Company applies the equity method of accounting to investments when it has significant influence, but not controlling interest, in the investee. Judgment regarding the level of influence over each equity method investment includes considering key factors such as ownership interest, representation on the board of directors, participation in policy-making decisions and material intercompany transactions. The Company’s proportionate share of the net income (loss) resulting from these investments is reported under the line item captioned “Share of losses from equity method investment” in our consolidated statements of operations. The Company’s equity method investments are adjusted each period for the Company’s share of the investee’s income or loss and dividend paid, if any. The Company classifies distributions received from equity method investments using the cumulative earnings approach on the consolidated statements of cash flows.
The Company has reviewed the carrying value of its investments and has determined there was no impairment or observable price changes as of and for the three months ended March 31, 2022 and 2021.
Fair Value Measurement
As defined in ASC Topic 820, Fair Value Measurement (“ASC 820”), fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). The Company utilizes market data or assumptions that market participants would use in pricing the asset or liability, including assumptions about risk and the risks inherent in the inputs to the valuation technique. These inputs can be readily observable, market corroborated, or generally unobservable. ASC 820 establishes a fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). This fair value measurement framework applies at both initial and subsequent measurement.
The three levels of the fair value hierarchy defined by ASC 820 are as follows:
Level 1 – Quoted prices are available in active markets for identical assets or liabilities as of the reporting date. Active markets are those in which transactions for the asset or liability occur in sufficient frequency and volume to provide pricing information on an ongoing basis. Level 1 primarily consists of financial instruments such as exchange-traded derivatives, marketable securities and listed equities.
Level 2 – Pricing inputs are other than quoted prices in active markets included in Level 1, which are either directly or indirectly observable as of the reported date. Level 2 includes those financial instruments that are valued using models or other valuation methodologies. These models are primarily industry-standard models that consider various assumptions, including quoted forward prices for commodities, time value, volatility factors, and current market and contractual prices for the underlying instruments, as well as other relevant economic measures. Substantially all of these assumptions are observable in the marketplace throughout the full term of the instrument, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. Instruments in this category generally include non-exchange-traded derivatives such as commodity swaps, interest rate swaps, options and collars.
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Level 3 – Pricing inputs include significant inputs that are generally less observable from objective sources. These inputs may be used with internally developed methodologies that result in management’s best estimate of fair value. The carrying amounts of cash, accounts receivable, accounts payable and accrued expenses approximate fair value because of the short-term nature of these instruments. The Company does not have any assets or liabilities that are required to be measured and recorded at fair value on a recurring basis.
Income Taxes
Income taxes are accounted for under the asset and liability method, whereby deferred income taxes are recorded for temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities. Deferred tax assets and liabilities reflect the tax rates expected to be in effect for the years in which the differences are expected to reverse. A valuation allowance is provided if it is more likely than not that some or all of the deferred tax asset will not be realized.
Advertising Expense
In accordance with ASC Topic No. 720-35-25-1, the Company recognizes advertising expenses the first time the advertising takes place. Advertising expenses are expensed as incurred.
The Company accounts for stock-based compensation to employees and nonemployees in accordance with Accounting Standards Update (“ASU”) 2018-07, Compensation – Stock Compensation (Topic 718). Stock-based compensation is measured at the grant date, based on the fair value of the award, and is recognized as expense over the stipulated vesting period, if any. The Company estimates the fair value of stock-based payments using the Black-Scholes option-pricing model for common stock options and warrants, and the closing price of the Company’s common stock for common stock issuances.
Research and Development Costs
Research and development (“R&D”) expenses consist of personnel-related expenses, including salaries and benefits for all personnel directly engaged in R&D activities, contracted services, materials, prototype expenses and allocated overhead which is comprised of lease expense and other facilities-related costs. R&D expenses include costs related to enhancements to the Company’s currently available products, and additional investments in the product and platform development pipeline. The Company expenses R&D costs as incurred.
Recent Accounting Pronouncements
There are no recently issued accounting pronouncements that have not yet been adopted that are expected to have a material effect on the Company’s consolidated results of operations, financial condition or cash flows.
NOTE 3 – INTANGIBLE ASSETS
The carrying values of the Company’s finite-lived intangible assets were as follows:
March 31, 2022 | December 31, 2021 | |||||||||||||||||||||||
Accumulated | Accumulated | |||||||||||||||||||||||
Cost | Amortization | Net | Cost | Amortization | Net | |||||||||||||||||||
Product Licenses | $ | 4,193,879 | $ | (671,051 | ) | $ | 3,522,828 | $ | 4,193,879 | $ | (586,541 | ) | $ | 3,607,338 | ||||||||||
Patents and Other IP | 1,610,111 | (571,772 | ) | 1,038,339 | 1,610,111 | (551,285 | ) | 1,058,826 | ||||||||||||||||
Software and Other | 127,492 | (70,712 | ) | 56,780 | 127,492 | (65,686 | ) | 61,806 | ||||||||||||||||
Total | $ | 5,931,482 | $ | (1,313,535 | ) | $ | 4,617,947 | $ | 5,931,482 | $ | (1,203,512 | ) | $ | 4,727,970 |
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In March 2021, the Company issued 750,000 milestone payment required per the terms of a licensing agreement with Rochal. The payment became due upon the Company’s public offering of common stock in February 2021. The milestone payment was recorded as an addition to intangible assets. shares of its common stock to Rochal Industries, LLC (“Rochal”) for a $
As of March 31, 2022, the weighted-average amortization period for all intangible assets was 12.7 years. Amortization expense related to intangible assets was $110,023 for the three months ended March 31, 2022 and $73,103 for the three months ended March 31, 2021. The estimated remaining amortization expense as of March 31, 2022 is as follows:
Remainder of 2022 | $ | 327,655 | ||
2023 | 432,598 | |||
2024 | 432,598 | |||
2025 | 432,598 | |||
2026 | 415,342 | |||
2027 | 415,342 | |||
Thereafter | 2,161,814 | |||
Total | $ | 4,617,947 |
The Company has reviewed the carrying value of intangible assets and has determined there was no impairment on the Company’s intangible assets during either of the three months ended March 31, 2022 or 2021.
NOTE 4 - COMMITMENTS AND CONTINGENCIES
License Agreements and Royalties
CellerateRX® Activated Collagen®
On August 27, 2018, the Company entered into an exclusive, world-wide sublicense agreement with CGI Cellerate RX, LLC (“CGI Cellerate RX”) to distribute CellerateRX Surgical and HYCOL products into the wound care and surgical markets. Pursuant to the sublicense agreement, the Company pays royalties of 3-5% of annual collected net sales of CellerateRX Surgical and HYCOL. As amended on January 26, 2021, the term of the sublicense extends through May 2050, with automatic successive year-to-year renewal terms thereafter so long as the Company’s Net Sales (as defined in the sublicense agreement) each year are equal to or in excess of $1,000,000. If the Company’s Net Sales fall below $1,000,000 for any year after the initial expiration date, CGI Cellerate RX will have the right to terminate the sublicense agreement upon written notice. Minimum royalties of $400,000 per year are payable for the first five years of the sublicense agreement.
For the three months ended March 31, 2022 and 2021, royalty expense, which is recorded in cost of goods sold in the accompanying consolidated statements of operations, was $369,233 and $187,875, respectively, under the terms of this agreement.
BIAKOS Antimicrobial Wound Gel and BIAKOS Antimicrobial Skin and Wound Cleanser
On July 7, 2019, the Company executed a license agreement with Rochal, a related party, whereby the Company acquired an exclusive world-wide license to market, sell and further develop antimicrobial products for the prevention and treatment of microbes on the human body utilizing certain Rochal patents and pending patent applications (the “BIAKOS License Agreement”). Currently, the products covered by the BIAKŌS License Agreement are BIAKOS Antimicrobial Wound Gel and BIAKOS Antimicrobial Skin and Wound Cleanser. Both products are 510(k) approved. The Company’s Executive Chairman is a director of Rochal, and indirectly a significant shareholder of Rochal, and through the potential exercise of warrants, a majority shareholder of Rochal. Another one of the Company’s directors is also a director and significant shareholder of Rochal.
Future commitments under the terms of the BIAKOS License Agreement include:
● | The Company pays Rochal a royalty of 2-4% of net sales. The minimum annual royalty due to Rochal is $120,000 for 2022 and will increase by $10,000 each subsequent calendar year up to a maximum amount of $150,000. |
● | The Company pays additional royalty annually based on specific net profit targets from sales of the licensed products, subject to a maximum of $1,000,000 during any calendar year. |
Unless previously terminated by the parties, the BIAKOS License Agreement expires with the related patents in December 2031.
For the three months ended March 31, 2022 and 2021, royalty expense, which is recorded in cost of goods sold in the accompanying consolidated statements of operations, was $30,000 and $27,500, respectively, under this agreement.
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CuraShield Antimicrobial Barrier Film and No Sting Skin Protectant
On October 1, 2019, the Company executed a license agreement with Rochal pursuant to which the Company acquired an exclusive world-wide license to market, sell and further develop certain antimicrobial barrier film and skin protectant products for use in the human health care market utilizing certain Rochal patents and pending patent applications (the “ABF License Agreement”). Currently, the products covered by the ABF License Agreement are CuraShield Antimicrobial Barrier Film and a no sting skin protectant product.
Future commitments under the terms of the ABF License Agreement include:
● | The Company will pay Rochal a royalty of 2-4% of net sales. The minimum annual royalty due to Rochal will be $50,000 beginning with the first full calendar year following the year in which first commercial sales of the products occur. The annual minimum royalty will increase by 10% each subsequent calendar year up to a maximum amount of $75,000. |
● | The Company will pay additional royalties annually based on specific net profit targets from sales of the licensed products, subject to a maximum of $500,000 during any calendar year. |
Unless previously terminated or extended by the parties, the ABF License Agreement will terminate upon expiration of the last U.S. patent in October 2033.
No commercial sales or royalties have been recognized under this agreement as of March 31, 2022.
Debrider License Agreement
On May 4, 2020, the Company executed a product license agreement with Rochal, pursuant to which the Company acquired an exclusive world-wide license to market, sell and further develop a debrider for human medical use to enhance skin condition or treat or relieve skin disorders, excluding uses primarily for beauty, cosmetic, or toiletry purposes (the “Debrider License Agreement”).
Future commitments under the terms of the Debrider License Agreement include:
● | At the time Rochal issues a purchase order to its contract manufacturer for the first good manufacturing practice run of the licensed products, the Company will pay Rochal $600,000 in cash. |
● | Upon FDA clearance of the licensed products, the Company will pay Rochal $500,000 in cash and $1,000,000, which at the Company’s option may be paid in any combination of cash and its common stock. |
● | The Company will pay Rochal a royalty of 2-4% of net sales. The minimum annual royalty due to Rochal will be $100,000 beginning with the first full calendar year following the year in which first commercial sales of the licensed products occur and increase by 10% each subsequent calendar year up to a maximum amount of $150,000. |
● | The Company will pay additional royalty annually based on specific net profit targets from sales of the licensed products, subject to a maximum of $1,000,000 during any calendar year. |
Unless previously terminated or extended by the parties, the Debrider License Agreement will expire in October 2034.
No commercial sales or royalties have been recognized under this agreement as of March 31, 2022.
Resorbable Bone Hemostat
The Company acquired a patent in 2009 for a resorbable bone hemostat and delivery system for orthopedic bone void fillers. This patent is not part of the Company’s long-term strategic focus. The Company subsequently licensed the patent to a third party to market a bone void filler product for which the Company receives a 3% royalty on product sales over the life of the patent, which expires in 2023, with annual minimum royalties of $201,000. The Company pays two unrelated third parties a combined royalty equal to 8% of the Company’s net revenues or minimum royalties generated from products that utilize the Company’s acquired patented bone hemostat and delivery system. To date, royalties received by the Company related to this licensing agreement have not exceeded the annual minimum of $201,000 ($50,250 per quarter). Therefore, the Company’s annual royalty obligation under the terms of the license agreement has been $16,080 ($4,020 per quarter), with the expense being reported in cost of goods sold in the accompanying consolidated statements of operations.
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Other Commitments
At the time of the formation of Sanara Pulsar, it and Wound Care Solutions, Limited (“WCS”), entered into a supply agreement whereby Sanara Pulsar became the exclusive distributor in the United States of certain wound care products that utilize intellectual property developed and owned by WCS. In the event WCS’s annual Form K-l from Sanara Pulsar does not allocate to WCS net income of at least $200,000 (the “Target Net Income”), the Company will, within 30 days after such determination, pay WCS the amount of funds representing the difference between the Target Net Income and the actual amount of net income shown on WCS’s Form K-1, as a distribution from Sanara Pulsar to WCS. In April 2022, the Company paid WCS $220,000 related to the fiscal 2021 Form K-1. For each of the years 2022 through 2024 the Target Net Income will increase by $20,000 and in the event WCS’s Form K-1 for any of those years does not allocate to WCS net income in an amount at least equal to the Target Net Income for such year, then the Company will, within 30 days after such determination, pay WCS the amount of funds representing the difference between the Target Net Income and the actual amount of net income shown on WCS’s Form K-1 for the applicable year. All other distributions made by Sanara Pulsar to its members, not including tax distributions, will be made exclusively to the Company until such time as the Company has received an amount of distributions equal to all such advances to WCS.
NOTE 5 - OPERATING LEASES
The Company periodically enters into operating lease contracts for office space and equipment. Arrangements are evaluated at inception to determine whether such arrangements constitute a lease.
Right of use assets, which we refer to as “ROU assets,” represent the right to use an underlying asset for the lease term, and lease liabilities represent the obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities were recognized on the transition date based on the present value of lease payments over the respective lease term, with the office space ROU asset adjusted for deferred rent liability.
The Company has two active operating leases: an office space lease with a remaining lease term of 27 months and a facility lease with a remaining term of 5 months as of March 31, 2022. All other leases are short-term leases, which for practical expediency, the Company has elected to not recognize as ROU assets and lease liabilities.
Effective July 1, 2021, the Company assumed an office lease pursuant to the Rochal asset purchase agreement. This lease expires August 31, 2022. The base monthly rent was $8,504 through August 31, 2021, then increased to $8,808 for the remainder of the lease. As the implicit rate in the lease was not determinable, the discount rate applied to determine the present value of lease payments was the 4% borrowing rate on the Company’s line of credit as of the assumption date. The office space lease agreement contains no renewal terms; therefore, no lease liability was recorded beyond the termination date. Additionally, the Company assumed the subleasing of a portion of the office space to a subtenant at a monthly rate of $975. Sublease income was recognized on a straight-line basis over the term of the sublease agreement, whose expiration corresponds to that of the master lease agreement and is presented as a reduction of general and administrative expense in the Company’s consolidated statement of operations. The sublease was terminated on April 20, 2022 due to the Company’s need for additional office space. Sublease income totaled $2,925 during the three months ended March 31, 2022 and $0 for the three months ended March 31, 2021.
In accordance with ASC Topic 842, Leases, the Company has recorded ROU assets of $355,081 and a related lease liability of $367,273 as of March 31, 2022. The Company recorded lease expense of $63,407 for the three months ended March 31, 2022 for its leased assets and $37,738 for the three months ended March 31, 2021. Cash paid for amounts included in the measurement of operating lease liabilities was $63,889 for the three months ended March 31, 2022 and $38,089 for the three months ended March 31, 2021. The present value of our operating lease liabilities is shown below.
Maturity of Operating Lease Liabilities
March 31, 2022 | ||||
Remainder of 2022 | 157,905 | |||
2023 | 154,271 | |||
2024 | 77,870 | |||
2025 | - | |||
2026 | - | |||
Thereafter | - | |||
Total lease payments | 390,046 | |||
Less imputed interest | (22,773 | ) | ||
Present Value of Lease Liabilities | $ | 367,273 | ||
Operating lease liability - current | 180,233 | |||
Operating lease liability – long term | 187,040 |
As of March 31, 2022, the Company’s operating leases have a weighted average remaining lease term of 2.0 years and a weighted average discount rate of 6%.
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NOTE 6 – SHAREHOLDERS’ EQUITY
Common Stock
At the Company’s Annual Meeting of Shareholders held on July 9, 2020, the Company approved the Restated 2014 Omnibus Long-Term Incentive Plan (the “LTIP Plan”) in which the Company’s directors, officers, employees and consultants are eligible to participate. A total of shares had been issued under the LTIP Plan and were available for issuance as of March 31, 2022.
On January 18, 2021, the Company entered into an Equity Exchange Agreement (the “Exchange Agreement”), effective as of January 14, 2021, with two individuals who each owned 50% of the outstanding equity interests in Woundyne Medical, LLC (“Woundyne”). Pursuant to the Exchange Agreement, the Company acquired 100% of the issued and outstanding equity interests of Woundyne in exchange for the issuance of an aggregate of shares of the Company’s common stock with a fair value of $1,000,000. The acquisition of the outstanding equity interests of Woundyne was accounted for as an asset acquisition. The primary asset acquired by the Company is the Woundyne software platform which allows data related to chronic and surgical wounds to be tracked, monitored, and interfaced with the software user’s electronic medical records. Woundyne has no other material assets, liabilities, or revenues. The issuance of these shares was capitalized as internal use software. The Company subsequently changed the name of Woundyne Medical, LLC to WounDerm, LLC.
On February 12, 2021, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Cantor Fitzgerald & Co. as representative of several underwriters named therein (collectively, the “Underwriters”), pursuant to which the Company agreed to issue and sell an aggregate of shares of the Company’s common stock to the Underwriters at a price to the public of $ per share, less underwriting discounts and commissions (the “Offering”). Pursuant to the Underwriting Agreement, the Company granted the Underwriters a 30-day option to purchase up to an additional shares of common stock at the public offering price, less underwriting discounts and commissions, which the Underwriters exercised in full. The Offering, including the purchase of the additional shares of common stock, closed on February 17, 2021.
The net proceeds to the Company from the Offering were $28.9 million, after (i) giving effect to the Underwriter’s full exercise of its option to purchase additional shares of common stock, and (ii) deducting the underwriting discounts and commissions and offering expenses payable by the Company. Through an insured cash sweep service, the net proceeds have been deposited in accounts insured by the Federal Deposit Insurance Corporation.
Following the closing of the Offering in February 2021, the Company made the $750,000 Post Capital Raise Payment (as defined in the BIAKŌS License Agreement) to Rochal in the form of shares of the Company’s common stock (see Notes 3 and 4).
On July 14, 2021, the Company entered into an asset purchase agreement with Rochal, effective July 1, 2021, pursuant to which the Company purchased certain assets of Rochal, including, among others, certain of Rochal’s intellectual property, furniture and equipment, supplies, rights and claims, other than certain excluded assets, all as more specifically set forth in the asset purchase agreement. In exchange for the acquired assets, the Company paid to Rochal (i) $496,100 in cash and (ii) shares of the Company’s common stock, and assumed certain net liabilities of $3,900. Based on the trading price of the Company’s common stock on July 14, 2021, the fair value of the equity consideration transferred was determined to be $584,244.
Restricted Stock Awards
During the three months ended March 31, 2022, the Company issued restricted stock awards under the LTIP Plan which are subject to certain vesting provisions and other terms and conditions set forth in each recipient’s respective restricted stock agreement. The Company granted and issued 3,474,575 based on the closing price of the Company’s common stock on the respective grant dates, which will be recognized as compensation expense on a straight-line basis over the vesting period of the awards. shares, net of forfeitures, of restricted common stock to Company employees and directors of the Company. The fair value of these awards was $
Share-based compensation expense of $ was recognized in selling, general and administrative expenses during the three months ended March 31, 2022, compared to $recognized during the three months ended March 31, 2021. Equity awards totaling $1,038,183, which were accrued as a liability as of December 31, 2021, were reclassed to equity in 2022 upon settlement of these awards.
At March 31, 2022, there was $ of total unrecognized share-based compensation expense related to unvested share-based equity awards. Unrecognized share-based compensation expense is expected to be recognized over a weighted-average period of years.
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For the Three Months Ended March 31, 2022 | ||||||||
Weighted Average | ||||||||
Shares |
Grant Date Fair Value | |||||||
Non-vested at beginning of period | 161,450 | $ | 18.13 | |||||
Granted | 137,467 | 25.35 | ||||||
Vested | (119,346 | ) | 18.84 | |||||
Forfeited | (391 | ) | 26.79 | |||||
Non-vested at March 31, 2022 | 179,180 | $ | 23.18 |
Stock Options
For
the Three Months Ended March 31, 2022 | ||||||||||||
Weighted | Weighted Average | |||||||||||
Options | Average
Exercise Price | Remaining Contract Life | ||||||||||
Outstanding at beginning of period | 11,500 | $ | 6.00 | |||||||||
Granted | ||||||||||||
Exercised | ||||||||||||
Forfeited | ||||||||||||
Expired | ||||||||||||
Outstanding at March 31, 2022 | 11,500 | $ | 6.00 | |||||||||
Exercisable at March 31, 2022 | 11,500 | $ | 6.00 |
NOTE 7 – DEBT AND CREDIT FACILITIES
Revolving Line of Credit
On January 15, 2021, the Company entered into a loan agreement (the “Loan Agreement”) with Cadence Bank, N.A. (“Cadence”) providing for a $2.5 million revolving line of credit. Pursuant to the terms of the Loan Agreement, the revolving line of credit was set to mature on January 13, 2023, and was secured by substantially all of the Company’s assets.
On February 11, 2021, the Company made an $800,000 draw on the revolving line of credit. On February 19, 2021, the Company paid down the entire balance of the revolving line of credit. As of December 31, 2021, there were no outstanding amounts owed by the Company under the Loan Agreement. Effective March 25, 2022, the Company terminated the Loan Agreement and released Cadence from any obligation to make advances under the Loan Agreement. No amounts of principal, interest or other fees and expenses were owed by the Company as of the termination date.
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NOTE 8 – INVESTMENT IN EQUITY SECURITIES
The Company’s equity investments consist of non-marketable equity securities in privately held companies without readily determinable fair values. Unless accounted for under the equity method of accounting, the investments are reported at cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or similar investment of the same issuer.
The Company made a $ long-term investment in July 2020 to purchase certain non-marketable securities consisting of Series B-2 Preferred Shares of Direct Dermatology Inc. (“DirectDerm”), representing % ownership of DirectDerm at that time. Through this investment, the Company received exclusive rights to utilize DirectDerm’s technology in all acute and post-acute care settings such as skilled nursing facilities, home health, and wound clinics. The Company does not have the ability to exercise significant influence over DirectDerm’s operating and financial activities. In 2021, the Company purchased an additional shares of DirectDerm’s Series B-2 Preferred for $ . On March 7, 2022, the Company purchased an additional shares of DirectDerm’s Series B-2 Preferred for $ . The Company’s ownership of DirectDerm was % as of March 31, 2022.
On November 9, 2020, the Company entered into agreements to purchase certain non-marketable securities consisting of 600,000. The Series A Stock is convertible into shares of common stock of Precision Healing and has a senior liquidation preference relative to the common shareholders. This initial investment represented 12.6% ownership of Precision Healing’s outstanding voting securities. In February 2021, the Company invested $600,000 to purchase additional shares of Series A Stock which is convertible into shares of common stock of Precision Healing. This resulted in ownership of 22.4% of Precision Healing’s outstanding voting securities. With this level of significant influence, the Company transitioned to the equity method of accounting for this investment. On June 17, 2021, the Company invested $500,000 for additional shares of Series A Stock which increased the Company’s ownership of Precision Healing’s outstanding voting securities to 29.0%. In October and in December of 2021, and more shares of Series A Stock were purchased for $500,000 and $600,000, respectively. The Company’s ownership of Precision Healing was 40.3% at March 31, 2022. For the three months ended March 31, 2022, the Company recorded $379,633 as its share of the loss from this equity method investment. shares of Series A Convertible Preferred Stock (the “Series A Stock”) of Precision Healing Inc. (“Precision Healing”) for an aggregate purchase price of $
On June 3, 2021, the Company invested $ to purchase Class A Preferred Shares (the “Shares”) of Pixalere Healthcare, Inc. (“Pixalere”). The Shares are convertible into % of the outstanding equity of Pixalere. Pixalere provides a cloud-based wound care software tool that empowers nurses, specialists and administrators to deliver better care for patients. In connection with the Company’s purchase of the Shares, Pixalere granted Pixalere Healthcare USA, LLC (“Pixalere USA”), a subsidiary of the Company, a royalty-free exclusive license to use the Pixalere software and platform in the United States. In conjunction with the grant of the license, the Company issued Pixalere a % equity ownership interest in Pixalere USA valued at $ .
The Company has reviewed the characteristics of the Shares in accordance with ASC Topic 323, Investments – Equity Method and Joint Ventures. Due to the substantive liquidation preferences of the Shares over Pixalere’s common stock, the Shares are not “in-substance” common stock, and therefore, the Company will not utilize the equity method of accounting for this investment. In accordance with ASC Topic 321, Investments - Equity Securities, this investment was reported at cost as of March 31, 2022.
The following summarizes the Company’s investments:
March 31, 2022 | December 31, 2021 | |||||||||||||||
Carrying Amount | Economic Interest | Carrying Amount | Economic Interest | |||||||||||||
Equity Method Investment | ||||||||||||||||
Precision Healing Inc. | $ | 1,803,440 | 40.3 | % | $ | 2,183,073 | 40.3 | % | ||||||||
Cost Method Investments | ||||||||||||||||
Direct Dermatology, Inc. | 1,000,000 | 750,000 | ||||||||||||||
Pixalere Healthcare, Inc. | 2,084,278 | 2,084,278 | ||||||||||||||
Total Cost Method Investments | 3,084,278 | 2,834,278 | ||||||||||||||
Total Investments | $ | 4,887,718 | $ | 5,017,351 |
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The following summarizes the loss from the equity method investment reflected in the consolidated statements of operations:
Three Months ended March 31, | ||||||||
2022 | 2021 | |||||||
Investment | ||||||||
Precision Healing Inc. | $ | (379,633 | ) | $ | (99,135 | ) | ||
Total | $ | (379,633 | ) | $ | (99,135 | ) |
NOTE 9 – ROCHAL ASSET ACQUISITION
On July 14, 2021, the Company entered into an asset purchase agreement with Rochal, effective July 1, 2021, pursuant to which the Company purchased certain assets of Rochal, including, among others, certain of Rochal’s intellectual property, furniture and equipment, supplies, rights and claims, other than certain excluded assets, all as more specifically set forth in the asset purchase agreement, and assume certain liabilities upon the terms and subject to the conditions set forth in the asset purchase agreement. In exchange for the acquired assets, the Company paid to Rochal (i) $496,100 in cash and (ii) shares of the Company’s common stock, and assumed certain net liabilities of $3,900. Based on the trading price of the Company’s common stock on July 14, 2021, the fair value of the equity consideration transferred was determined to be $584,244. The total purchase price as determined by the Company is as follows:
Description | Amount | |||
Net cash consideration | $ | 496,100 | ||
Equity consideration (fair value) | 584,244 | |||
Net liabilities assumed | 3,900 | |||
Transaction costs | 78,586 | |||
Total purchase consideration | $ | 1,162,830 |
Prior to the transaction, the Company entered into product license agreements with Rochal, pursuant to which the Company acquired exclusive world-wide licenses to market, sell and further develop certain antimicrobial barrier film and skin protectant products, antimicrobial products for the prevention and treatment of microbes on the human body utilizing certain of Rochal’s patents and a debrider for human medical use to enhance skin condition or treat or relieve skin disorders. Pursuant to the asset purchase agreement, each of the foregoing licenses were retained by Rochal and were excluded from the purchased assets.
Pursuant to the asset purchase agreement, for the three-year period after the effective date, Rochal is entitled to receive consideration for any new product relating to the business that is directly and primarily based on an invention conceived and reduced to practice by a member or members of Rochal’s science team. For the three-year period after the effective date, Rochal is also entitled to receive an amount in cash equal to twenty-five percent of the proceeds actually received for any Grant (as defined in the asset purchase agreement) by either the Company or Rochal. In addition, the Company agreed to use commercially reasonable efforts to perform Minimum Development Efforts (as defined in the asset purchase agreement) with respect to certain products under development, which if obtained, will entitle the Company to intellectual property rights from Rochal in respect of such products.
In connection with the asset purchase agreement, the Company hired certain employees of Rochal on an “at will” basis, with the terms of such employment being consistent with the Company’s current employment agreements.
Concurrent with the asset purchase, on July 14, 2021, the Company entered into a consulting agreement with Ann Beal Salamone pursuant to which Ms. Salamone agreed to provide the Company with consulting services with respect to, among other things, writing new patents, conducting patent intelligence, and participating in certain grant and contract reporting. In consideration for the consulting services to be provided to the Company, Ms. Salamone is entitled to receive an annual consulting fee of $177,697, with payments to be paid once per month. The consulting agreement has an initial term of three years, unless earlier terminated by the Company, and is subject to renewal. Ms. Salamone is a director of the Company and is the current Chair of the board of directors of Rochal.
Based on guidance provided by ASC Topic 805, Business Combinations (“ASC 805”), the Company recorded the Rochal asset purchase as an asset acquisition due to the determination that substantially all of the fair value of the assets acquired was concentrated in a group of similar identifiable assets. The Company believes the “substantially all” criterion was met with respect to the acquired intellectual property (i.e., patents, patent applications, and patent applications to be written) based on the Company’s internal valuation models. These models assigned value to the acquired intellectual property based on estimated future cash flows over the life of the respective patents and patent applications. Accordingly, the Company accounted for the acquisition of the purchased net assets as an asset acquisition.
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The purchase consideration, plus transaction costs, was allocated to the individual assets according to their fair values as a percentage of the total fair value of the assets purchased, with no goodwill recognized. Based on the Company’s internal valuation performed, the total fair value of the net assets acquired was attributable to the intellectual property (i.e., patents) and assembled workforce. Due to the de minimis estimated fair value of furniture and equipment acquired, the Company did not allocate any amounts to such assets. The total purchase consideration was allocated based on the relative estimated fair value of such assets as follows:
Description | Amount | Percent of Total | ||||||
Patents and Intellectual Property | $ | 1,099,801 | 94.6 | % | ||||
Assembled Workforce | 63,029 | 5.4 | % | |||||
Total purchase consideration | $ | 1,162,830 | 100.0 | % |
The Company did not recognize any gain on the purchase of the net assets.
NOTE 10 - RELATED PARTIES
Payables and Receivables with Related Parties
The Company had outstanding payables to related parties totaling $51,847 at March 31, 2022, and $155,817 at December 31, 2021. The Company had outstanding receivables from related parties totaling $96,278 at March 31, 2022, and $79,787 at December 31, 2021.
CellerateRX Sublicense Agreement
We have an exclusive, world-wide sublicense to distribute CellerateRX products into the wound care and surgical markets from an affiliate of Catalyst, CGI Cellerate RX, which licenses the rights to CellerateRX from Applied Nutritionals. Sales of CellerateRX have comprised the majority of our sales during 2018, 2019 and 2020. On January 26, 2021, we amended the term of the sublicense agreement to extend the term to May 17, 2050, with automatic successive one-year renewals so long as annual net sales of CellerateRX exceed $1,000,000. We pay royalties based on our annual Net Sales of CellerateRX (as defined in the sublicense agreement) consisting of 3% of all collected Net Sales each year up to $12,000,000, 4% of all collected Net Sales each year that exceed $12,000,000 up to $20,000,000, and 5% of all collected Net Sales each year that exceed $20,000,000. Minimum royalties of $400,000 per year are payable for the first five years of the sublicense agreement, which was entered on August 27, 2018. For the three months ended March 31, 2022 and 2021, royalties accrued under the terms of this agreement totaled $369,233and $187,875, respectively.
Ronald T. Nixon, our Executive Chairman, is the founder and managing partner of Catalyst. Mr. Nixon and Catalyst, collectively with their affiliates, including CGI Cellerate RX, beneficially owned shares of our common stock as of March 31, 2022.
Product License Agreements
On July 7, 2019, the Company executed a license agreement with Rochal, a related party, whereby the Company acquired an exclusive world-wide license to market, sell and further develop antimicrobial products for the prevention and treatment of microbes on the human body utilizing certain Rochal patents and pending patent applications. Currently, the products covered by the BIAKŌS License Agreement are BIAKŌS Antimicrobial Wound Gel and BIAKŌS Antimicrobial Skin and Wound Cleanser. Both products are 510(k) approved. The Company’s Executive Chairman is a director of Rochal, and indirectly a significant shareholder of Rochal, and through the potential exercise of warrants, a majority shareholder of Rochal. Another one of the Company’s directors is also a director and significant shareholder of Rochal.
On October 1, 2019, the Company executed the ABF License Agreement with Rochal whereby the Company acquired an exclusive world-wide license to market, sell and further develop certain antimicrobial barrier film and skin protectant products for use in the human health care market utilizing certain Rochal patents and pending patent applications. Currently, the products covered by the ABF License Agreement are CuraShield Antimicrobial Barrier Film and a no sting skin protectant product.
On May 4, 2020, The Company executed a product license agreement with Rochal, whereby the Company acquired an exclusive world-wide license to market, sell and further develop a debrider for human medical use to enhance skin condition or treat or relieve skin disorders, excluding uses primarily for beauty, cosmetic, or toiletry purposes.
See Note 4 for more information on these product license agreements.
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Rochal Asset Purchase
As noted above, on July 14, 2021, the Company entered into an asset purchase agreement with Rochal, effective July 1, 2021, pursuant to which we purchased certain assets of Rochal, including, among others, certain of Rochal’s intellectual property, furniture and equipment, supplies, rights and claims, other than certain excluded assets, and assumed certain liabilities upon the terms and subject to the conditions set forth in the asset purchase agreement. In exchange for the acquired assets, the Company paid Rochal (i) $496,100 in cash and (ii) shares of the Company’s common stock (see Note 9 for more information).
Consulting Agreement
Concurrent with the Rochal asset purchase, on July 14, 2021, we entered into a consulting agreement with Ann Beal Salamone pursuant to which Ms. Salamone agreed to provide the Company with consulting services with respect to, among other things, writing new patents, conducting patent intelligence, and participating in certain grant and contract reporting. In consideration for the consulting services to be provided, Ms. Salamone is entitled to receive an annual consulting fee of $177,697, with payments to be paid once per month. The consulting agreement has an initial term of three years, unless earlier terminated by the Company, and is subject to renewal.
Ronald T. Nixon is also a director of Rochal, and indirectly a significant shareholder of Rochal, and through the potential exercise of warrants a majority shareholder of Rochal. Ann Beal Salamone, a director, is a significant shareholder, the former president and current Chairman of the Board of Rochal.
NOTE 11 – SUBSEQUENT EVENTS
On April 1, 2022, the Company, entered into a merger agreement by and among the Company, United Wound and Skin Solutions, LLC, a Delaware limited liability company and wholly owned subsidiary of the Company (“UWSS”), Precision Healing, PH Merger Sub I, Inc., a Delaware corporation, PH Merger Sub II, LLC, a Delaware limited liability company, and Furneaux Capital Holdco, LLC (d/b/a BlueIO), solely in its capacity as the representative of the securityholders of Precision Healing. On April 4, 2022, the merger parties closed the transactions contemplated by the merger agreement and effected a business combination wherein Precision Healing became a wholly owned subsidiary of the Company.
As further described in Note 8, the Company’s investment in Precision Healing had been accounted for as an equity method investment as of and for the three months ended March 31, 2022.
Pursuant to the merger agreement, among other things, the Company agreed to (i) pay the holders of Precision Healing common stock and preferred stock an aggregate of approximately $4.6 million, which is payable in cash or equity, (ii) pay approximately $0.6 million of transaction expenses on behalf of the equity holders of Precision Healing, (iii) assume all outstanding options and warrants of Precision Healing and (iv) pay, subject to the achievement of certain performance thresholds, earnout consideration, each as described in further detail below.
We have not yet completed our purchase accounting for this acquisition, including determining the preliminary fair value of the assets acquired, liabilities assumed and the fair value of contingent consideration. During the three months ended March 31, 2022, we incurred approximately $450,000 of transaction costs related to this acquisition, which are recorded in selling, general and administrative expenses in the accompanying consolidated statements of operations.
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Closing Consideration to Precision Healing Equity Holders
Pursuant to the terms of the merger agreement, holders of Precision Healing common stock and preferred stock, other than UWSS, were entitled to receive approximately $5.2 million as aggregate closing consideration, which consisted of $125,965 in cash consideration payable to stockholders who were not accredited investors, shares of the Company’s common stock paid only to “accredited investors” as such term is defined in Rule 501(a) of Regulation D promulgated under the Securities Act of 1933, as amended, and the payment in cash of approximately $0.6 million of transaction expenses of Precision Healing.
Assumption of Precision Healing Options and Warrants
On the closing date, the Precision Healing outstanding options previously granted under the Precision Healing 2020 Stock Option and Grant Plan (the “Precision Healing Plan”), converted pursuant to their terms into options to acquire an aggregate of 4,421 shares of Company common stock with an initial exercise price of $7.32 per share and an expiration date of April 22, 2031 and (ii) 12,301 shares of the Company’s common stock with an initial exercise price of $12.05 per share and an expiration date of August 10, 2030. shares of Company common stock with a weighted exercise price of $ per share. In addition, outstanding and unexercised Precision Healing warrants converted into rights to receive warrants to purchase (i)
Assumption of the Precision Healing Plan
Pursuant to the merger agreement, the Company assumed sponsorship of the Precision Healing Plan, effective as of the closing date, as well as the outstanding awards granted thereunder, the award agreements evidencing the grants of such awards and the remaining shares available under the Precision Healing Plan, in each case adjusted in the manner set forth in the merger agreement to such awards. Concurrent with the assumption of the Precision Healing Plan, the Company terminated the ability to offer future awards under the Precision Healing Plan.
Earnout Consideration
Pursuant to the merger agreement, upon the achievement of certain performance thresholds, the securityholders of Precision Healing, including the holders of options and warrants to purchase Precision Healing common stock and certain persons promised options to purchase Precision Healing common stock, are also entitled to receive payments of up to $10.0 million (the “Earnout Consideration”), which will be accounted for as contingent consideration pursuant to ASC 805. The Earnout Consideration is payable in cash or, at the Company’s election, is payable to accredited investors in shares of Company common stock at a price per share equal to the greater of (i) $ and (ii) the average closing price of Company common stock for the 20 trading days prior to the date such Earnout Consideration is due and payable. Pursuant to the merger agreement, a minimum percentage of the Earnout Consideration may be required to be issued to accredited investors in shares of Company common stock for tax purposes. The amount and composition of the portion of Earnout Consideration payable is subject to adjustment and offsets as set forth in the merger agreement.
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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion of the financial condition and results of operations of Sanara MedTech Inc. (collectively with its consolidated subsidiaries, the “Company,” “Sanara MedTech,” “Sanara,” “SMTI,” “we,” “our,” or “us”) should be read in conjunction with the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section and audited consolidated financial statements and related notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2021 and with the unaudited consolidated financial statements and related notes thereto presented in this Quarterly Report on Form 10-Q.
Cautionary Statement Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may discuss expectations as to future trends, plans, events, results of operations or financial condition, or state other information relating to the Company, including, without limitation, statements concerning the impact of the COVID-19 pandemic and our expectations for selling, general and administrative expenses. Statements, other than statements of historical fact, included in this Quarterly Report on Form 10-Q are forward-looking statements and generally may be identified by words such as “anticipate,” “believe,” “continue,” “contemplate,” “could,” “estimate,” “expect,” “forecast,” “guidance,” “intend,” “may,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” or other similar words, phrases or expressions. These statements should be viewed with caution and are subject to various risks and uncertainties, many of which are outside of the Company’s control. The following factors, among others, could cause actual results to differ materially from those in the forward-looking statements:
● | the impact of the COVID-19 pandemic on our business, financial condition and results of operations; |
● | shortfalls in forecasted revenue growth; |
● | our ability to implement our comprehensive wound and skin care strategy through acquisitions and investments and our ability to realize the anticipated benefits of such acquisitions and investments; |
● | our ability to meet our future capital requirements; |
● | our ability to retain and recruit key personnel; |
● | the intense competition in the markets in which we operate and our ability to compete within our markets; |
● | the failure of our products to obtain market acceptance; |
● | the effect of security breaches and other disruptions; |
● | our ability to maintain effective internal controls over financial reporting; |
● | our ability to develop and commercialize new products and products under development, including the manufacturing, distribution, marketing and sale of such products; |
● | our ability to maintain and further grow clinical acceptance and adoption of our products; |
● | the impact of competitors inventing products that are superior to ours; |
● | disruptions of, or changes in, our distribution model, consumer base or the supply of our products; |
● | our ability to manage product inventory in an effective and efficient manner; |
● | the failure of third-party assessments to demonstrate desired outcomes in proposed endpoints; |
● | our ability to successfully expand into wound and skin care virtual consult and other services; |
● | our ability and the ability of our research and development partners to protect the proprietary rights to technologies used in certain of our products and the impact of any claim that we have infringed on intellectual property rights of others; |
● | our dependence on technologies and products that we license from third parties; |
● | the effects of current and future laws, rules, regulations and reimbursement policies relating the labeling, marketing and sale of our products and our planned expansion into wound and skin care virtual consult and other services and our ability to comply with the various laws, rules and regulations applicable to our business; and |
● | the effect of defects, failures or quality issues associated with our products. |
For a more detailed discussion of these and other factors that may affect our business and that could cause the actual results to differ materially from those anticipated in these forward-looking statements, see “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2021, Part II, Item 1A, “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Forward-looking statements speak only as of the date on which they are made, and the Company does not assume any obligation to update these forward-looking statements.
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Overview
We are a medical technology company focused on developing and commercializing transformative technologies to improve clinical outcomes and reduce healthcare expenditures in the surgical and chronic wound and skin care markets. Our portfolio of products and services is designed to allow us to deliver comprehensive wound and skin care solutions for patients in all care settings, including acute (hospitals and long-term acute care hospitals (“LTACHs”)) and post-acute (wound care clinics, physician offices, skilled nursing facilities (“SNFs”), home health, hospice, and retail). Each of our products, services, and technologies contributes to our overall goal of achieving better clinical outcomes at a lower overall cost for patients regardless of where they receive care. We strive to be one of the most innovative and comprehensive providers of effective wound and skin care products and technologies and are continually seeking to expand our offerings for patients requiring wound and skin care treatments across the entire continuum of care in the United States.
We currently market several products across chronic and surgical wound care applications and have multiple products in our pipeline. We currently license our products from research and development partners Applied Nutritionals, LLC (“AN”) (through a sublicense with CGI Cellerate RX, LLC (“CGI Cellerate RX”), an affiliate of The Catalyst Group, Inc. (“Catalyst”)) and Rochal Industries, LLC (“Rochal”) and have the right to exclusively distribute certain products under development by Cook Biotech Inc. (“Cook Biotech”). We are also developing additional products in our own product pipeline.
In June 2020, we formed a subsidiary, United Wound and Skin Solutions LLC (“UWSS”, or “WounDerm”), to hold certain investments and operations in wound and skin care virtual consult services. We anticipate that our various service offerings will allow clinicians/physicians utilizing our technologies to collect and analyze large amounts of data on patient conditions and outcomes that will improve treatment protocols and ultimately lead to more evidence-based formulary to improve patient outcomes. We intend to fully launch virtual consult services through WounDerm for both virtual wound and virtual skin (dermatology) consultations. Through a combination of our WounDerm services and our Sanara products, we believe we will be able to offer patient care solutions at every step in the continuum of wound and skin care from diagnosis through healing.
Effective July 1, 2021, we acquired certain assets from Rochal, including, among others, intellectual property, four FDA 510(k) clearances, rights to license certain products and technologies currently under development, equipment and supplies. As a result of the asset purchase, our pipeline now contains product candidates for mitigation of opportunistic pathogens and biofilm, wound re-epithelialization and closure, necrotic tissue debridement and cell compatible substrates.
Recent Developments
Update on the COVID-19 Pandemic
During the second half of 2021, the United States experienced a surge of COVID-19 cases as the Delta and Omicron variants of the virus impacted much of the country and negatively impacted our sales in Texas, the northeastern United States, and other markets. The duration and effects of the pandemic remain uncertain; however, management believes that elective surgical procedures will continue to be performed with the exception of certain geographic hotspots. During the first quarter of 2022, we do not believe our business was materially affected by COVID-19 restrictions on elective surgeries. We will continue to closely monitor the pandemic in order to ensure the safety of our people and our ability to serve our customers and patients.
Precision Healing Merger
As previously disclosed, on April 1, 2022, we entered into a merger agreement by and among the Company, UWSS, Precision Healing, PH Merger Sub I, Inc., a Delaware corporation, PH Merger Sub II, LLC, a Delaware limited liability company, and Furneaux Capital Holdco, LLC (d/b/a BlueIO), solely in its capacity as the representative of the securityholders of Precision Healing. On April 4, 2022, the merger parties closed the transactions contemplated by the merger agreement and effected a business combination wherein Precision Healing became a wholly owned subsidiary of the Company.
Pursuant to the merger agreement, among other things, we agreed to (i) pay the holders of Precision Healing common stock and preferred stock an aggregate of approximately $4.6 million, which is payable in cash or equity, (ii) pay approximately $0.6 million of transaction expenses on behalf of the equity holders of Precision Healing, (iii) assume all outstanding options and warrants of Precision Healing and (iv) pay, subject to the achievement of certain performance thresholds, earnout consideration, each as described in further detail below.
Closing Consideration to Precision Healing Equity Holders
Pursuant to the terms of the merger agreement, holders of Precision Healing common stock and preferred stock, other than UWSS, were entitled to receive approximately $5.2 million as aggregate closing consideration, which consisted of $125,965 in cash consideration payable to stockholders who were not accredited investors, 165,738 shares of our common stock paid only to “accredited investors” as such term is defined in Rule 501(a) of Regulation D promulgated under the Securities Act of 1933, as amended, and the payment in cash of approximately $0.6 million of transaction expenses of Precision Healing.
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Assumption of Precision Healing Options and Warrants
On the closing date, the Precision Healing outstanding options previously granted under the Precision Healing 2020 Stock Option and Grant Plan (the “Precision Healing Plan”), converted pursuant to their terms into options to acquire an aggregate of 144,191 shares of our common stock with a weighted exercise price of $10.71 per share. In addition, outstanding and unexercised Precision Healing warrants converted into rights to receive warrants to purchase (i) 4,421 shares of our common stock with an initial exercise price of $7.32 per share and an expiration date of April 22, 2031 and (ii) 12,301 shares of our common stock with an initial exercise price of $12.05 per share and an expiration date of August 10, 2030.
Assumption of the Precision Healing Plan
Pursuant to the merger agreement, we assumed sponsorship of the Precision Healing Plan, effective as of the closing date, as well as the outstanding awards granted thereunder, the award agreements evidencing the grants of such awards and the remaining shares available under the Precision Healing Plan, in each case adjusted in the manner set forth in the merger agreement to such awards. Concurrent with the assumption of the Precision Healing Plan, we terminated the ability to offer future awards under the Precision Healing Plan.
Earnout Consideration
Pursuant to the merger agreement, upon the achievement of certain performance thresholds, the securityholders of Precision Healing, including the holders of options and warrants to purchase Precision Healing common stock and certain persons promised options to purchase Precision Healing common stock, are also entitled to receive payments of up to $10.0 million (the “Earnout Consideration”), which will be accounted for as contingent consideration pursuant to ASC 805. The Earnout Consideration is payable in cash or, at our election, is payable to accredited investors in shares of our common stock at a price per share equal to the greater of (i) $27.13 and (ii) the average closing price of our common stock for the 20 trading days prior to the date such Earnout Consideration is due and payable. Pursuant to the merger agreement, a minimum percentage of the Earnout Consideration may be required to be issued to accredited investors in shares of our common stock for tax purposes. The amount and composition of the portion of Earnout Consideration payable is subject to adjustment and offsets as set forth in the merger agreement.
Components of Results of Operations
Sources of Revenues
Our revenue is derived primarily from sales of our surgical products to hospitals and other acute care facilities, and sales of our chronic wound care products to customers across the post-acute continuum of care. Our revenue is driven by direct orders shipped by us to our customers, and to a lesser extent, direct sales to customers through delivery at the time of procedure by one of our sales representatives. We generally recognize revenue when our product is received by the customer.
The vast majority of our product sales revenue is derived from sales of CellerateRX surgical powder. Revenue streams from product sales and royalties are summarized below for the three months ended March 31, 2022 and March 31, 2021. All revenue was generated in the United States.
Three Months Ended | ||||||||
March 31, | ||||||||
2022 | 2021 | |||||||
Product sales revenue | $ | 7,760,973 | $ | 4,959,186 | ||||
Royalty revenue | 50,250 | 50,250 | ||||||
Total Revenue | $ | 7,811,223 | $ | 5,009,436 |
We recognize royalty revenue from a development and license agreement with BioStructures, LLC. We record revenue each calendar quarter as earned per the terms of the agreement which stipulates that we will receive quarterly royalty payments of at least $50,250. Under the terms of the development and license agreement, royalties of 2.0% are recognized on sales of products containing our patented resorbable bone hemostasis. The minimum annual royalty due to us is $201,000 per year throughout the life of the patent which expires in 2023. These royalties are payable in quarterly installments of $50,250. To date, royalties related to this development and license agreement have not exceeded the annual minimum of $201,000 ($50,250 per quarter).
Cost of Goods Sold
Cost of goods sold consists of the acquisition costs from the manufacturers of our licensed products, raw material costs for certain components sourced directly by us, and all related royalties due as a result of the sale of our products. Our gross profit represents total revenue less the cost of goods sold, and gross margin is gross profit expressed as a percentage of total revenue.
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Operating Expenses
Selling, general and administrative expenses (“SG&A”) consist primarily of salaries, sales commissions, benefits, bonuses, and stock-based compensation. SG&A also includes outside legal counsel, audit fees, insurance premiums, rent, and other corporate expenses. We expense all SG&A expenses as incurred.
Research and development expenses (“R&D”) include costs related to enhancements to our currently available products and additional investments in our product and platform development pipeline. This includes personnel-related expenses, including salaries and benefits for all personnel directly engaged in R&D activities, contracted services, materials, prototype expenses and allocated overhead, which is comprised of lease expense and other facilities-related costs. We expense R&D costs as incurred. We generally expect that R&D expenses will increase as we continue to support product enhancements as well as to bring new products to market.
Other Income (Expense)
Other income (expense) is primarily comprised of gains or losses on equity method investments, interest income, interest expense and other non-operating activities.
Results of Operations
Revenues. For the three months ended March 31, 2022, revenues totaled $7,811,223 compared to revenues of $5,009,436 for the three months ended March 31, 2021, representing a 56% increase from the prior year period. The higher revenues in 2022 were primarily due to increased sales of surgical wound care products as a result of our sales force expansion and our continuing strategy to expand our independent distribution network in both new and existing U.S. markets.
Cost of goods sold. Cost of goods sold for the three months ended March 31, 2022 was $805,081, compared to cost of goods sold of $474,433 for the three months ended March 31, 2021. The increase over the prior year period was primarily due to higher sales volume in 2022. Gross margins were approximately 90% and 91% for the three months ended March 31, 2022 and 2021, respectively.
Selling, general and administrative expenses. SG&A expenses for the three months ended March 31, 2022, were $9,375,630 compared to SG&A expenses of $5,409,730 for the three months ended March 31, 2021. The higher SG&A expenses in 2022 were primarily due to increased selling costs resulting from sales force expansion and operational support, higher sales commission expense as a result of higher product sales, higher non-cash equity compensation costs, and higher payroll costs related to the mid-year addition of the Rochal workforce in July 2021. Costs related to travel and in-person promotional activities also increased in 2022 compared to 2021 as many in-person activities were cancelled or postponed in 2021 as a result of the COVID-19 pandemic. In addition, SG&A expenses in 2022 included $450,000 of transaction costs associated with the Precision Healing merger which closed on April 4, 2022. As part of our strategy to expand our sales reach in new and existing markets, we employed thirteen additional field sales managers since March 31, 2021. As of March 31, 2022, we had a total of 31 field sales managers.
Research and development expenses. R&D expenses for the three months ended March 31, 2022, were $204,637 compared to $118,212 for the three months ended March 31, 2021. The higher R&D expenses in 2022 were due to several new development projects for our currently licensed products.
Depreciation and amortization expense. Depreciation and amortization expense for the three months ended March 31, 2022 was $202,747 compared to $90,951 for the three months ended March 31, 2021. The higher depreciation and amortization expense in 2022 was due to the amortization of internal use software placed into service in 2021, and due to additional amortization related to the patents acquired from Rochal.
Other expense. Other expense for the three months ended March 31, 2022 was $379,633 compared to $99,846 for the three months ended March 31, 2021. The higher Other expense in 2022 was due to increased ownership in Precision Healing, resulting in recognition of a non-cash loss of $379,633 from our equity method investment, compared to $99,135 for the three months ended March 31, 2021. Interest expense was $0 for the three months ended March 31, 2022, as compared to $711 for the three months ended March 31, 2021. The higher Interest expense in 2021 was due to a draw on our former line of credit with Cadence Bank, N.A. (“Cadence”) in early 2021.
Net income / loss. For the three months ended March 31, 2022, we had a net loss of $3,156,505, compared to net loss of $1,183,376 for the three months ended March 31, 2021. The higher net loss in 2022 was due to increased SG&A costs described above, higher R&D expenses, and the recognition of losses on our equity method investment in Precision Healing.
Liquidity and Capital Resources
Cash on hand at March 31, 2022 was $16,143,080, compared to $18,652,841 at December 31, 2021. Historically, we have financed our operations primarily from the sale of equity securities. On February 12, 2021, we closed an underwritten public offering of 1,265,000 shares of our common stock at a public offering price of $25.00 per share resulting in gross proceeds of $31,625,000, before deducting underwriting discounts and commissions and offering expenses. We expect our future needs for cash to include expanding our salesforce, further development of our products, services and technologies pipeline, clinical studies and general corporate purposes, including working capital and acquisitions. Based on our current plan of operations, including acquisitions, we believe our cash on hand, when combined with expected cash flows from operations, will be sufficient to fund our growth strategy and to meet our anticipated operating expenses and capital expenditures for at least the next twelve months.
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On January 15, 2021, we entered into a loan agreement (the “Loan Agreement”) with Cadence providing for a $2.5 million revolving line of credit. Pursuant to the terms of the Loan Agreement, the revolving line of credit was set to mature on January 13, 2023 and was secured by substantially all of our assets.
On February 11, 2021, we made an $800,000 draw on the revolving line of credit. On February 19, 2021, we paid down the entire balance of the revolving line of credit. Effective March 25, 2022, we terminated Loan Agreement and released Cadence from any obligation to make advances under the Loan Agreement. No amounts of principal, interest or other fees and expenses were owed by the Company as of the termination date. There is no assurance that we will enter into an additional loan agreement with Cadence or with another bank on similar terms, or at all.
At the time of the formation of Sanara Pulsar, it and Wound Care Solutions, Limited (“WCS”), entered into a supply agreement whereby Sanara Pulsar became the exclusive distributor in the United States of certain wound care products that utilize intellectual property developed and owned by WCS. In the event WCS’s annual Form K-l from Sanara Pulsar does not allocate to WCS net income of at least $200,000 (the “Target Net Income”), the Company will, within 30 days after such determination, pay WCS the amount of funds representing the difference between the Target Net Income and the actual amount of net income shown on WCS’s Form K-1, as a distribution from Sanara Pulsar to WCS. In April 2022, the Company paid WCS $220,000 related to the fiscal 2021 Form K-1. For each of the years 2022 through 2024 the Target Net Income will increase by $20,000 and in the event WCS’s Form K-1 for any of those years does not allocate to WCS net income in an amount at least equal to the Target Net Income for such year, then the Company will, within 30 days after such determination, pay WCS the amount of funds representing the difference between the Target Net Income and the actual amount of net income shown on WCS’s Form K-1 for the applicable year. All other distributions made by Sanara Pulsar to its members, not including tax distributions, will be made exclusively to the Company until such time as the Company has received an amount of distributions equal to all such advances to WCS.
On November 9, 2020, we entered into agreements to purchase shares of Series A Convertible Preferred Stock (the “Series A Stock”) of Precision Healing for an aggregate purchase price of $600,000. In 2021, we made additional purchases of Series A Stock as follows: $600,000 in February, $500,000 in June, $500,000 in October, and $600,000 in December of 2021.
On July 7, 2019, we executed a license agreement with Rochal whereby we acquired an exclusive world-wide license to market, sell and further develop antimicrobial products for the prevention and treatment of microbes on the human body utilizing certain Rochal patents and pending patent applications (the “BIAKŌS License Agreement”). Under the terms of the BIAKŌS License Agreement, we agreed to pay Rochal $750,000 upon the completion of a capital raise, on or before December 31, 2022, of at least $10,000,000 through the sale of our common stock or assets. In March 2021, we issued 20,834 shares of our common stock to Rochal as full payment of the $750,000, which became due upon the completion of our capital raise in February 2021.
On June 3, 2021, we invested $2,084,278 for 278,587 Class A Preferred Shares (the “Shares”) of Canada based Pixalere Healthcare, Inc. (“Pixalere”). The Shares are convertible into 28.6% of the outstanding equity of Pixalere. Pixalere provides a cloud-based wound care software tool that empowers nurses, specialists and administrators to deliver better care for patients. In connection with our purchase of the Shares, Pixalere granted Pixalere Healthcare USA, LLC (“Pixalere USA”), our subsidiary, a royalty-free exclusive license to use the Pixalere software and platform in the United States. In conjunction with the grant of the license, we issued Pixalere a 27.3% equity ownership interest in Pixalere USA valued at $93,879.
On July 14, 2021, we entered into an asset purchase agreement with Rochal, effective July 1, 2021, pursuant to which we purchased certain assets of Rochal, including, among others, certain of Rochal’s intellectual property, furniture and equipment, supplies, rights and claims, other than certain excluded assets, and assumed certain liabilities upon the terms and subject to the conditions set forth in the asset purchase agreement. In exchange for the acquired assets, we paid Rochal (i) $496,100 in cash and (ii) 14,369 shares of our common stock, and assumed certain liabilities of $3,900.
On April 1, 2022, we entered into a merger agreement by and among the Company, UWSS, Precision Healing, PH Merger Sub I, Inc., a Delaware corporation, PH Merger Sub II, LLC, a Delaware limited liability company, and Furneaux Capital Holdco, LLC (d/b/a BlueIO), solely in its capacity as the representative of the securityholders of Precision Healing. On April 4, 2022, the merger parties closed the transactions contemplated by the merger agreement and effected a business combination wherein Precision Healing became a wholly owned subsidiary of the Company.
Pursuant to the terms of the merger agreement, holders of Precision Healing common stock and preferred stock, other than UWSS, were entitled to receive approximately $5.2 million as aggregate closing consideration, which consisted of $125,965 in cash consideration payable to stockholders who were not accredited investors, 165,738 shares of our common stock paid only to “accredited investors” as such term is defined in Rule 501(a) of Regulation D promulgated under the Securities Act of 1933, as amended, and the payment in cash of approximately $0.6 million of transaction expenses of Precision Healing.
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In addition, upon the achievement of certain performance thresholds related to revenue from the sale of wound care products and skin care products, which performance shall be calculated during measurement periods generally consisting of one calendar year, the securityholders of Precision Healing, including the holders of options and warrants to purchase Precision Healing common stock and certain persons promised options to purchase Precision Healing common stock, are also entitled to receive Earnout Consideration consisting of two payments of up to $5.0 million each, provided that the aggregate Earnout Consideration not exceed $10.0 million.
The Earnout Consideration is payable in cash or, at our election, is payable to accredited investors in shares of our common stock at a price per share equal to the greater of (i) $27.13 and (ii) the average closing price of our common stock for the 20 trading days prior to the date such Earnout Consideration is due and payable. Pursuant to the merger agreement, a minimum percentage of the Earnout Consideration may be required to be issued to accredited investors in shares of our common stock for tax purposes. The amount and composition of the portion of Earnout Consideration payable is subject to adjustment and offsets as set forth in the merger agreement.
Cash Flow Analysis
For the three months ended March 31, 2022, net cash used in operating activities was $2,112,478 compared to $1,261,604 used in operating activities for the three months ended March 31, 2021. The higher use of cash in 2022 was primarily due to higher SG&A expenses related to sales force expansion, the addition of the Rochal workforce in mid-2021, and the resumption of certain travel and promotional activities in 2022 which were cancelled or postponed in 2021 as a result of the COVID-19 pandemic.
For the three months ended March 31, 2022, net cash used in investing activities was $294,352 compared to $604,391 used in investing activities during the three months ended March 31, 2021. The lower use of cash used in investing activities in 2022 was primarily due to fewer investments in equity securities during the first quarter of 2022.
For the three months ended March 31, 2022, net cash used in financing activities was $102,931 as compared to $28,739,257 provided by financing activities for the three months ended March 31, 2021. The cash provided by financing activities in 2021 was due to proceeds received pursuant to an underwritten public offering of 1,265,000 shares of our common stock at a public offering price of $25.00 per share resulting in gross proceeds of $31,625,000, before deducting underwriting discounts and commissions and offering expenses.
Material Transactions with Related Parties
CellerateRX Sublicense Agreement
We have an exclusive, world-wide sublicense to distribute CellerateRX products into the wound care and surgical markets from an affiliate of Catalyst, CGI Cellerate RX, which licenses the rights to CellerateRX from Applied Nutritionals. Sales of CellerateRX have comprised the majority of our sales during 2018, 2019 and 2020. On January 26, 2021, we amended the term of the sublicense agreement to extend the term to May 17, 2050, with automatic successive one-year renewals so long as annual net sales of CellerateRX exceed $1,000,000. We pay royalties based on our annual Net Sales of CellerateRX (as defined in the sublicense agreement) consisting of 3% of all collected Net Sales each year up to $12,000,000, 4% of all collected Net Sales each year that exceed $12,000,000 up to $20,000,000, and 5% of all collected Net Sales each year that exceed $20,000,000. Minimum royalties of $400,000 per year are payable for the first five years of the sublicense agreement, which was entered on August 27, 2018. For the three months ended March 31, 2022 and 2021, royalties accrued under the terms of this agreement totaled $369,233and $187,875, respectively.
Ronald T. Nixon, our Executive Chairman, is the founder and managing partner of Catalyst. Mr. Nixon and Catalyst, collectively with their affiliates, including CGI Cellerate RX, beneficially owned 3,534,956 shares of our common stock as of March 31, 2022.
Rochal Asset Purchase
On July 14, 2021, we entered into an asset purchase agreement with Rochal, effective July 1, 2021, pursuant to which we purchased certain assets of Rochal, including, among others, certain of Rochal’s intellectual property, furniture and equipment, supplies, rights and claims, other than certain excluded assets, and assumed certain liabilities upon the terms and subject to the conditions set forth in the asset purchase agreement. In exchange for the acquired assets, we paid Rochal (i) $496,100 in cash and (ii) 14,369 shares of common stock.
After the asset purchase, Rochal owned 95,203 shares of our common stock. Ronald T. Nixon, the Company’s Executive Chairman, is, with respect to Rochal, a director, a significant shareholder indirectly and a majority shareholder with the exercise of certain warrants. Additionally, Ann Beal Salamone, a director of the Company, is a significant shareholder, former president and current Chair of the board of directors of Rochal. See Note 9 for more information regarding this transaction.
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Consulting Agreement
Concurrent with the Rochal asset purchase, on July 14, 2021, we entered into a consulting agreement with Ann Beal Salamone pursuant to which Ms. Salamone agreed to provide the Company with consulting services with respect to, among other things, writing new patents, conducting patent intelligence, and participating in certain grant and contract reporting. In consideration for the consulting services to be provided, Ms. Salamone is entitled to receive an annual consulting fee of $177,697, with payments to be paid once per month. The consulting agreement has an initial term of three years, unless earlier terminated by the Company, and is subject to renewal.
Critical Accounting Estimates
Our unaudited consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles. Our discussion and analysis of our financial condition and operating results require the Company’s management to make judgments, assumptions and estimates that affect the amounts reported. Significant accounting policies and methods used in the preparation of our consolidated financial statements are summarized in Note 1, “Summary of Significant Accounting Policies” of the Notes to the consolidated Financial Statements in Part I, Item 1 of this Form 10-Q, and in the Notes to Consolidated Financial Statements in Part II, Item 8 of our 2021 Form 10-K. Historically, our critical accounting estimates have not differed materially from actual results. However, if our assumptions change, we may need to revise our estimates or take other corrective actions, either of which may also have a material adverse effect on our consolidated statements of operations, liquidity and financial condition.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
As a smaller reporting company, we are not required to provide this information.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed by us in the reports that we file or submit to the Securities and Exchange Commission (“SEC”) under the Exchange Act, is recorded, processed, summarized and reported within the time periods specified by the SEC’s rules and forms, and that information is accumulated and communicated to our management, including our principal executive and principal financial officers (whom we refer to in this periodic report as our Certifying Officers), as appropriate to allow timely decisions regarding required disclosure. Our management evaluated, with the participation of our Certifying Officers, the effectiveness of our disclosure controls and procedures as of March 31, 2022, pursuant to Rule 13a-15(b) under the Exchange Act. Based upon that evaluation, our Certifying Officers concluded that, as of March 31, 2022, our disclosure controls and procedures were effective.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting that occurred during the quarter ended March 31, 2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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Part II — Other Information
Item 1. Legal Proceedings
From time to time, we may be involved in claims and legal actions that arise in the ordinary course of business. To our knowledge, there are no material pending legal proceedings to which we are a party or of which any of our property is the subject.
Item 1A. Risk Factors
There were no material changes to the Risk Factors disclosed in “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2021. For more information concerning our risk factors, please see “Item 1A. Risk Factors” in the Annual Report on Form 10-K for the year ended December 31, 2021.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
There were no sales of unregistered securities during the quarter ended March 31, 2022 that were not previously reported on a Current Report on Form 8-K.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosure
This item is not applicable.
Item 5. Other Information
None.
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Item 6. Exhibits
The following documents are filed as part of this Report or incorporated herein by reference:
* Filed herewith
# Schedules have been omitted pursuant to Item 601(b)(2) of Regulation S-K. Sanara MedTech Inc. hereby undertakes to furnish supplementally copies of any of the omitted schedules upon request by the Securities and Exchange Commission.
** The certifications attached as Exhibit 32.1 and Exhibit 32.2 are not deemed “filed” with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of Sanara MedTech Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Annual Report on Form 10-K, irrespective of any general incorporation language contained in such filing.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
SANARA MEDTECH INC. | ||
May 16, 2022 | By: | /s/ Michael McNeil |
Michael McNeil | ||
Chief Financial Officer (Principal Financial Officer and duly authorized officer) |
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