Overview
H-CYTE, Inc ("the Company") is a hybrid-biopharmaceutical company dedicated to developing and delivering new treatments for patients with chronic respiratory and pulmonary disorders. During the last two years, the Company has evolved into two separate divisions with its entrance into the biologics and device development space ("Biotech Division"). This division is complementary to the Company's currentLung Health Institute (LHI) autologous infusion therapy business ("Infusion Division") and is focused on underserved disease states. OnSeptember 8, 2021 , the Company announced that itsLung Health Institute facilities changed their names toCenters for Respiratory Health as the clinics continue to deliver treatments for patients with chronic respiratory and pulmonary disorders. The consolidated results forH-CYTE include the following wholly-owned subsidiaries:H-CYTE Management, LLC ,Medovex Corp ,Cognitive Health Institute, LLC , andLung Institute Tampa, LLC and the results includeLung Institute Dallas, PLLC ("LI Dallas"),Lung Institute Nashville, PLLC ("LI Nashville"),Lung Institute Pittsburgh, PLLC ("LI Pittsburgh"), andLung Institute Scottsdale, LLC ("LI Scottsdale"), as Variable Interest Entities ("VIEs"). Additionally,H-CYTE Management, LLC is the operator and manager of the variousLung Health Institute (LHI) clinics: LI Dallas, LI Nashville, LI Pittsburgh, and LI Scottsdale. The LI Dallas and LI Pittsburgh clinics did not reopen in 2020 after the temporary closure of all LI clinics due to COVID-19. These two clinics will remain permanently closed. During the first quarter of 2022, the Company decided to close the LI Tampa and LI Nashville clinics, the LI Scottsdale clinic will remain open.
OnSeptember 11, 2020 , with the closing of the Rights Offering,FWHC, LLC ,FWHC Bridge, LLC , andFWHC Bridge Friends, LLC (collectively known as "FWHC") gained control of the Company by subsequently owning approximately 61% of the fully diluted shares of the Company (for further discussion, see Notes 8 and 9-"Equity Transactions" to the consolidated financial statements in the Company's 2020 Annual Report on Form 10-K).
The Company continues its efforts related to the development and
commercialization of the DenerveX device outside of the
Impact of COVID-19 COVID-19 has adversely affected the Company's financial condition and results of operations. The impact of the COVID-19 outbreak on businesses and the economy inthe United States is expected to continue to be significant. The extent to which the COVID-19 outbreak will continue to impact businesses and the economy is highly uncertain. Accordingly, the Company cannot predict the extent to which its financial condition and results of operation will be affected. OnJanuary 30, 2020 , theWorld Health Organization ("WHO") announced a global health emergency caused by a new strain of the coronavirus and advised of the risks to the international community as the virus spread globally. InMarch 2020 , theWHO classified the COVID-19 outbreak as a pandemic based on the rapid increase in exposure globally. The spread of COVID-19 coronavirus has caused public health officials to recommend precautions to mitigate the spread of the virus, especially as to travel and congregating in large numbers. In addition, certain states and municipalities have enacted quarantining regulations which severely limit the ability of people to move and travel. In addition, the Company is uncertain of the full effect the pandemic will have on it for the longer term since the scope and duration of the pandemic is unknown, and evolving factors such as the level and timing of the distribution of efficacious vaccines across the world and the extent of any resurgences of the virus or emergence of new variants of the virus, such as the Delta variant and the Omicron variant, will impact the stability of economic recovery and growth. The Company may experience long-term disruptions to its operations resulting from changes in government policy or guidance; quarantines of employees, customers and suppliers in areas affected by the pandemic; and closures of businesses or manufacturing facilities critical to its business. RESULTS OF OPERATIONS
Year Ended
The following table sets forth certain operational data including their respective percentages of revenues for the years endedDecember 31, 2021 and 2020: H-Cyte, Inc Statement of Operations 2021 2020 Change Change % Revenues$ 1,611,518 $ 2,150,672 $ (539,154 ) -25 % Gross Profit 906,813 1,383,715 (476,902 ) -34 % Operating Expenses 6,192,417 8,476,059 (2,283,642 ) -27 % Operating Loss (5,285,604 ) (7,092,344 ) 1,806,740 25 % Other Income 486,297 633,108 (146,811 ) -23 % Net Loss$ (4,799,307 ) $ (6,459,236 ) $ 1,659,929 26 % Net Loss attributable to common stockholders$ (4,799,307 ) $ (6,781,411 ) $ 1,982,104 29 % Loss per share - Basic and diluted$ (0.03 ) $ (0.06 ) Weighted average outstanding shares - basic and diluted 145,736,785 111,491,261 9 Revenue and Gross Profit Revenue is derived predominantly from the Company's Infusion Division, which resulted in revenue, net of allowance for refunds, for the years endedDecember 31, 2021 and 2020, of approximately$1,612,000 and$2,151,000 , respectively. The decrease in revenue for the year endedDecember 31, 2021 , as compared to the prior year is attributable to the effect that COVID-19 continues to have on the Company's vulnerable patient base, sufferers of chronic lung disorders. Due to the disruption caused by COVID-19, the Company did not reopen theDallas andPittsburgh clinics after they were closed inMarch 2020 . For the years endedDecember 31, 2021 and 2020, the Company generated a gross profit totaling approximately$907,000 (56% of revenue) and$1,384,000 (64% of revenue), respectively. The gross profit percentage decreased in 2021 compared to 2020 due to the Company using higher priced part-time medical staff to treat its patients. Salaries and Related Costs For the years endedDecember 31, 2021 and 2020, the Company incurred approximately$2,214,000 and$3,199,000 , respectively, in salaries and related costs. The Company adjusted its corporate structure in 2021 in which it reduced headcount in marketing, sales, and operations. This led to lower salaries and related costs of approximately$985,000 in 2021 compared to 2020.
Other General and Administrative
For the years endedDecember 31, 2021 and 2020, the Company incurred approximately$2,698,000 and$4,125,000 , respectively, in other general and administrative costs. The decrease is attributable to cost saving measures in response to the COVID-19 pandemic. The Company made adjustments to its corporate structure by reducing expenses in marketing, sales, and operations due to decreased patient volume. The Company also closed theDallas andPittsburgh clinics permanently in 2020 and reduced theTampa and Scottsdale clinics to
part-time in 2021. Other Income (Expense) For the years endedDecember 31, 2021 and 2020, interest expense was approximately$177,000 and$1,463,000 , respectively. The decrease is related to debt and warrants attached to convertible debt outstanding during the year endedDecember 31, 2020 that were not applicable to 2021. 10
The changes in fair value of redemption put liability and fair value of the
derivative liability - warrants for the year ended
Liquidity, Sources of Liquidity, and Going Concern
The Company had approximately
The Company incurred net losses of approximately$4,799,000 and$6,459,000 for the years endedDecember 31, 2021 and 2020, respectively. The Company has historically incurred losses from operations and expects to continue to generate negative cash flows as the Company's revenue activities are curtailed and as the Company implements its business plan. The consolidated financial statements are prepared using generally accepted accounting principles inthe United States ("U.S. GAAP") as applicable to a going concern. COVID-19 has adversely affected the Company's financial condition and results of operations. The impact of the outbreak of COVID-19 on the economy in theU.S. and the rest of the world is expected to continue to be significant. The extent to which the COVID-19 outbreak will continue to impact the economy is highly uncertain and cannot be predicted. Accordingly, the Company cannot predict the extent to which its financial condition and results of operations will be affected. Although cost reduction measures have been taken, the present level of cash is insufficient to satisfy the Company's current operating requirements. The Company is seeking additional sources of funds from the sale of equity or debt securities or through a credit facility. There can be no assurance that the Company will be able to raise additional funds or that the terms and conditions of any future financings will be acceptable to the Company or its shareholders. In the event the Company is unable to fund its operations from existing cash on hand, operating cash flows, additional borrowings, or raising equity capital, there is substantial doubt about the Company's ability to continue as a going concern. The consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. InJanuary 2022 , the Company offered certain warrant holders the opportunity to receive an additional warrant to purchase the Company's Common Stock at$0.014 per share, for a period of five (5) years from issuance for the exercise of each existing warrant originally issued inApril 2020 prior toMarch 31, 2021 . As ofFebruary 23, 2022 , the Company had ten warrant holders exercise an aggregate of 75,257,511 warrants at$0.014 per share resulting in cash proceeds of$1,053,605 to the Company. The Company filed a Registration Statement on Form S-1 registering the resale of the shares of common stock issuable upon exercise of the warrants issued in theApril 2020 financing. The registration statement was declared effective on
February 14, 2022 . Convertible Notes Payable OnApril 1, 2021 , the Company, entered into a Secured Convertible Note Purchase Agreement (the "April 2021 Note Purchase Agreement") with five (5) investors (the "Holders"). Pursuant to the terms of theApril 2021 Note Purchase Agreement, the Company sold promissory notes in the aggregate principal amount of$2,575,000 maturing onMarch 31, 2022 with an annual interest rate of 8%. The Notes, plus accrued interest, are convertible into shares of Common Stock at a discount of 20% to the price paid for suchNew Securities in the next round of financing that meets the definition of Qualified Financing as defined in theApril 2021 Note Purchase Agreement. The Notes are secured by the assets of the Company under a security agreement with the Holders. The lead investor of theApril 2021 Note Purchase Agreement,FWHC Bridge, LLC , advanced$1,500,000 of the total amount to the Company.FWHC Bridge, LLC is an affiliated entity ofFWHC, LLC , which is a principal stockholder and related party of the Company. An additional affiliate ofFWHC, LLC provided an additional$25,000 as part of theApril 2021 Note Purchase Agreement. OnOctober 14, 2021 ,H-Cyte, Inc. (the "Company") entered into the Second Closing Bring Down Agreement (the "October 2021 Note Purchase Agreement") whereby the five (5) investorswho had entered into theApril 2021 Note Purchase Agreement purchased new notes in the Company in the aggregate principal amount of$750,000 . The Notes are due and payable onMarch 31, 2022 and bear interest at an annual rate of 8%. The Notes are convertible into shares of Common Stock at a discount of 20% to the price paid for suchNew Securities in the next financing that meets the definition of a Qualified Financing as defined in theApril 2021 Note Purchase Agreement. The Notes are secured by all of the assets of the Company under a security agreement with the Holders. The lead investor of theOctober 2021 Note Purchase Agreement,FWHC Bridge, LLC , advanced$437,000 of the total amount to the Company.FWHC Bridge, LLC is an affiliated entity ofFWHC, LLC , which is a principal stockholder and related party of the Company. An additional affiliate ofFWHC, LLC provided an additional$7,000 as part of theOctober 2021 Note Purchase Agreement. The Company analyzed the debt instruments and determined the embedded conversion features did not qualify as derivatives as described in Financial Accounting Standard Board's ("FASB") Accounting Standards Codification ("ASC") 815-15-25 Derivatives and Hedging, because there was no market mechanism for net settlement, and they were not readily convertible into cash. Thus, the conversion features are not required to be bifurcated from the host instruments and accounted for separately. The Company chose early adoption of ASU 2020-06 Accounting for Convertible Instruments and Contracts in an Entity's Own Equity effectiveJanuary 1, 2021 , related to theApril 2021 andOctober 2021 Note Purchase Agreements, which resulted in the Notes being accounted for solely as debt on the balance sheet.
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which we have prepared in accordance withU.S. GAAP. The preparation of these consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of revenues and expenses during the reporting periods.
On an ongoing basis, we evaluate our estimates and judgments, including those described in greater detail below.
We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. While our significant accounting policies are described in more detail in the notes to our consolidated financial statements included elsewhere in this report, we believe that the following accounting policies are the most critical to aid you in fully understanding and evaluating our financial condition and results of operations. Fair Value Measurements We measure certain non-financial assets at fair value on a non-recurring basis. These non-recurring valuations include evaluating assets such as long-lived assets and non-amortizing intangible assets for impairment; allocating value to assets in an acquired asset group; and applying accounting for business combinations and derivatives.
We use the fair value measurement framework to value these assets and report the fair values in the periods in which they are recorded or written down.
The fair value measurement framework includes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair values in their broad levels. These levels from highest to lowest priority are as follows:
? Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical assets or
liabilities;
? Level 2: Quoted prices in active markets for similar assets or liabilities or observable prices that are based on inputs not quoted on active markets, but corroborated by market data; and ? Level 3: Unobservable inputs or valuation techniques that are used when little or no market data is available. 11 The determination of fair value and the assessment of a measurement's placement within the hierarchy requires judgment. Level 3 valuations often involve a higher degree of judgment and complexity. Level 3 valuations may require the use of various cost, market, or income valuation methodologies applied to unobservable management estimates and assumptions. Management's assumptions could vary depending on the asset or liability valued and the valuation method used. Such assumptions could include estimates of prices, earnings, costs, actions of market participants, market factors, or the weighting of various valuation methods. We may also engage external advisors to assist us in determining fair value, as appropriate. Although we believe that the recorded fair value of our financial instruments is appropriate atDecember 31, 2021 , these fair values may not be indicative of net realizable value or reflective of future fair values. Revenue Recognition
The Company recognizes revenue in accordance withU.S. GAAP as outlined in the FASB ASC 606, Revenue From Contracts with Customers, which requires that five steps be completed to determine when revenue can be recognized: (i) identify the contract with the customer; (ii) identity the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price; and (v) recognize revenue when or as the entity satisfies a performance obligation. The Company records revenue under ASC 606 when control is transferred to the customer, which is consistent with past practice. The Company uses a standard pricing model for the types of cellular therapy treatments that is offered to its patients. The transaction price accounts for medical, surgical, facility, and office services rendered by LHI for consented procedures and is recorded as revenue. The Company recognizes revenue when the terms of a contract with a patient are satisfied.
The Company offers two types of cellular therapy treatments to their patients:
1) The first type of treatment includes medical services rendered typically
over a two-day period in which the patient receives cellular therapy. For
this treatment type, revenue is recognized in full at time of service.
2) The Company also offers a four-day treatment in which medical services are
rendered typically over a two-day period and then again, approximately
three months later, medical services are rendered for an additional two
days of treatment. Payment is collected in full for both service periods
at the time the first treatment is rendered. Revenue is recognized when services are performed based on the estimated stand-alone selling price for each session of treatment. The Company has deferred recognition of
revenue amounting to approximately
2021 and 2020, respectively. 12
Management performed an analysis of its customer refund history for refunds issued related to prior year's revenue. Management used the results of this historical refund analysis to record a reserve for anticipated future refunds related to recognized revenue. AtDecember 31, 2021 and 2020, the estimated allowance for refunds was approximately$9,000 and$77,000 , respectively and is recorded as a contra revenue account.
Off-Balance Sheet Arrangements
The Company does not have any off-balance sheet arrangements as defined in Regulation S-K Item 303(a)(4) during the periods presented, investments in special-purpose entities or undisclosed borrowings or debt. Additionally, we are not a party to any derivative contracts or synthetic leases.
Consulting Agreements
The Company entered into an agreement withJesse Crowne , a former Director and Co-Chairman of the Board of the Company, to provide business development consulting services for a fee of$5,000 per month. The Company incurred expense of approximately$35,000 and$10,000 for the years endedDecember 31, 2021 and 2020, respectively, related to these agreements. The Company entered into a consulting agreement withTanya Rhodes ofRhodes & Associates, Inc , effectiveJune 15, 2020 , to serve as the Chief Science Officer of the Company. The agreement has a minimum term of six months with an average fee of$21,000 per month plus expenses which increases 5% per month onJanuary 1 of each calendar year unless an alternative retainer amount is negotiated and agreed upon by both parties. The Company extended the contract onJanuary 1, 2021 , resulting in monthly expenses of$22,500 plus expenses for services rendered. The Company incurred expense of approximately$252,000 and$122,000 for the years endedDecember 31, 2021 and 2020, respectively, related to this agreement.
Departure of Directors and Certain Officers, Election of Directors, Appointment of New Board Members and Officers
OnJanuary 12, 2021 , Mr.William Horne stepped down as Chairman of the board of directors (the "Board") ofH-Cyte, Inc. (the "Company").Mr. Horne will remain a member of the Board.
On
On
On
On
On
On
Indemnification We have agreements whereby we indemnify our officers and directors for certain events or occurrences while the officer or director is or was serving, at our request, in such capacity, to the maximum extent permitted under the laws of theState of Nevada . 13 The maximum potential amount of future payments we could be required to make under these indemnification agreements is unlimited. However, we maintain directors and officers insurance coverage that may contribute, up to certain limits, a portion of any future amounts paid for indemnification of directors and officers. We believe the estimated fair value of these indemnification agreements in excess of applicable insurance coverage is minimal. Historically, we have not incurred any losses or recorded any liabilities related to performance under these types of indemnities. Additionally, in the normal course of business, we have made certain guarantees, indemnities, and commitments under which we may be required to make payments in relation to certain transactions. These indemnities include intellectual property and other indemnities to our customers and distribution network partners in connection with the sales of our products and therapies, and indemnities to various lessors in connection with facility leases for certain claims arising from such facility or lease. It is not possible to determine the maximum potential loss under these guarantees, indemnities, and commitments due to our limited history of prior indemnification claims and the unique facts and circumstances involved in each particular provision.
Recently Adopted Accounting Standards
InDecember 2019 , the FASB issued ASU 2019-12, Income Taxes (Topic 740), Simplifying the Accounting for Income Taxes, which amends the approaches and methodologies in accounting for income taxes during interim periods and makes changes to certain income tax classifications. The new standard allows exceptions to the use of the incremental approach for intra-period tax allocation, when there is a loss from continuing operations and income or a gain from other items, and to the general methodology for calculating income taxes in an interim period, when a year-to date loss exceeds the anticipated loss for the year. The standard also requires franchise or similar taxes partially based on income to be reported as income tax and the effects of enacted changes in tax laws or rates to be included in the annual effective tax rate computation from the date of enactment. Lastly, in any future acquisition, the Company would be required to evaluate when the step-up in the tax basis of goodwill is part of the business combination and when it should be considered a separate transaction. The Company adopted ASU 2019-12, as required, onJanuary 1, 2021 and the adoption did not have a material impact on our consolidated financial statements. 14 InAugust 2020 , the FASB issued ASU 2020-06. Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity's Own Equity. The ASU simplifies the accounting for certain financial instruments with characteristics of liabilities and equity. Specifically, ASU 2020-06 revises the requirements to separately account for conversion features as a derivative under ASC Topic 815 and it removes the requirement to account for beneficial conversion features on such instruments. The Company chose early adoption of ASU 2020-06 effectiveJanuary 1, 2021 , related to theApril 2021 andOctober 2021 Note Purchase Agreements. Thus, the Notes did not require consideration for a beneficial conversion feature under ASC 470-20 and the Notes were accounted for solely as debt on the balance sheet.
© Edgar Online, source