Company Quick10K Filing
US Stem Cell
Price0.00 EPS-0
Shares398 P/E-0
MCap0 P/FCF-0
Net Debt0 EBIT-2
TEV0 TEV/EBIT-0
TTM 2019-09-30, in MM, except price, ratios
10-Q 2019-09-30 Filed 2019-11-06
10-Q 2019-06-30 Filed 2019-08-07
10-Q 2019-03-31 Filed 2019-05-07
10-K 2018-12-31 Filed 2019-03-13
10-Q 2018-09-30 Filed 2018-11-07
10-Q 2018-06-30 Filed 2018-08-08
10-Q 2018-03-31 Filed 2018-05-09
10-K 2017-12-31 Filed 2018-04-16
10-Q 2017-09-30 Filed 2017-11-07
10-Q 2017-06-30 Filed 2017-08-08
10-Q 2017-03-31 Filed 2017-05-02
10-K 2016-12-31 Filed 2017-03-15
10-Q 2016-09-30 Filed 2016-11-08
10-Q 2016-06-30 Filed 2016-08-02
10-Q 2016-03-31 Filed 2016-05-04
10-K 2015-12-31 Filed 2016-03-08
10-Q 2015-09-30 Filed 2015-11-05
10-Q 2015-06-30 Filed 2015-08-03
10-Q 2015-03-31 Filed 2015-05-05
10-K 2014-12-31 Filed 2015-03-16
10-Q 2014-09-30 Filed 2014-11-07
10-Q 2014-06-30 Filed 2014-08-01
10-Q 2014-03-31 Filed 2014-05-09
10-K 2013-12-31 Filed 2014-03-25
10-Q 2013-09-30 Filed 2013-11-14
10-Q 2013-06-30 Filed 2013-08-14
10-Q 2013-03-31 Filed 2013-05-09
10-K 2012-12-31 Filed 2013-03-29
10-Q 2012-09-30 Filed 2012-11-14
10-Q 2012-06-30 Filed 2012-08-14
10-Q 2012-03-31 Filed 2012-05-14
10-K 2011-12-31 Filed 2012-04-12
10-Q 2011-09-30 Filed 2011-11-14
10-Q 2011-06-30 Filed 2011-08-15
10-Q 2011-03-31 Filed 2011-05-23
10-K 2010-12-31 Filed 2011-05-10
10-Q 2010-09-30 Filed 2010-11-15
10-Q 2010-06-30 Filed 2010-08-20
10-Q 2010-03-31 Filed 2010-05-14
10-K 2009-12-31 Filed 2010-03-31
8-K 2020-05-15
8-K 2020-03-31
8-K 2019-10-24
8-K 2019-10-15
8-K 2019-09-24
8-K 2019-09-01
8-K 2019-06-03
8-K 2019-06-03
8-K 2019-05-30
8-K 2019-01-31

USRM 10Q Quarterly Report

Part I - Financial Information
Item 1.
Note 1 - Significant Accounting Policies
Note 2 - Going Concern and Management's Liquidity Plans
Note 3 - Investments
Note 4 - Property and Equipment
Note 5 - Right To Use Assets and Lease Liability
Note 6 - Accrued Expenses
Note 7 - Notes and Capital Lease Payable
Note 8 - Related Party Transactions
Note 9 - Stockholders' Equity
Note 10 - Commitments and Contingencies
Note 11 - Fair Value Measurement
Note 12 - Subsequent Events
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Item 4. Controls and Procedures
Item 1. Legal Proceedings
Item 1A. Risk Factors
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Item 3. Defaults Upon Senior Securities
Item 4. Mine Safety Disclosures
Item 5. Other Information
Item 6. Exhibits
EX-31.01 ex_162374.htm
EX-32.01 ex_162376.htm

US Stem Cell Earnings 2019-09-30

Balance SheetIncome StatementCash Flow
0.10.10.0-0.0-0.1-0.12012201420172020
Assets, Equity
0.10.10.0-0.0-0.1-0.12012201420172020
Rev, G Profit, Net Income
0.10.10.0-0.0-0.1-0.12012201420172020
Ops, Inv, Fin

10-Q 1 usstem20190930_10q.htm FORM 10-Q usstem20190930_10q.htm

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

   


 

FORM 10-Q

 


 

☒      

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2019

 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: 001-33718

 

U.S. STEM CELL, INC.

(Exact name of registrant as specified in its charter)

 

Florida

65-0945967

(State or other jurisdiction of incorporation or organization

(I.R.S. Employer Identification No.)

 

1560 Sawgrass Corporate Pkwy 4th Floor, Sunrise, FL 33323

(Address of principal executive offices) (Zip Code)

 

(954) 835-1500

(Registrant’s telephone number, including area code)

 

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, or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting 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 the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

 

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

 USRM

OTC

 

As of November 5, 2019, there were 407,109,995 outstanding shares of the Registrant’s common stock, par value $0.001 per share.

 

Transitional Small Business Disclosure Format Yes ☐ No ☒

 

 

 

 

TABLE OF CONTENTS

 

PART I.

FINANCIAL INFORMATION

 

 

 

 

 

 

ITEM 1.

Financial Statements

3

 

 

 

 

 

 

Condensed balance sheets as of September 30, 2019 (unaudited) and December 31, 2018

4

 

 

 

 

 

 

Condensed statements of operations for the three and nine months ended September 30, 2019 and 2018 (unaudited)

5

 

 

 

 

 

 

Condensed statement of stockholders’ deficit for the three and nine months ended September 30, 2019 (unaudited)

6

 

 

 

 

 

 

Condensed statement of stockholders’ deficit for the three and nine months ended September 30, 2018 (unaudited)

7

 

 

 

 

 

 

Condensed statements of cash flows for the nine months ended September 30, 2019 and 2018 (unaudited)

8

 

 

 

 

 

 

Notes to condensed financial statements (unaudited)

 9-31

 

 

 

 

 

ITEM 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

32-40

 

ITEM 3.

Quantitative and Qualitative Disclosures about Market Risk

41

 

ITEM 4.

Controls and Procedures

41

 

 

 

 

PART II.

OTHER INFORMATION

 

 

 

 

 

 

ITEM 1.

Legal Proceedings

42

 

ITEM 1A.

Risk Factors

43

 

ITEM 2.

Unregistered Sales of Equity Securities and Use of Proceeds

43

 

ITEM 3.

Defaults Upon Senior Securities

43

 

ITEM 4.

Mine Safety Disclosures

43

 

ITEM 5.

Other Information

43

 

ITEM 6.

Exhibits

43

 

 

 

 

 

SIGNATURES

46

 

 

 

 

EX 31.01

Management Certification

 

 

 

 

 

EX 32.01

Sarbanes-Oxley Act

 

 

 

 

PART I — FINANCIAL INFORMATION

Item 1.

 

Interim Condensed Financial Statements and Notes to Interim Financial Statements

 

General

 

The accompanying reviewed condensed interim financial unaudited statements have been prepared in accordance with the instructions to Form 10-Q. Therefore, they do not include all information and footnotes necessary for a complete presentation of financial position, results of operations, cash flows, and stockholders’ deficit in conformity with generally accepted accounting principles. Except as disclosed herein, there has been no material change in the information disclosed in the notes to the financial statements included in the Company’s annual report on Form 10-K for the year ended December 31, 2018. In the opinion of management, all adjustments considered necessary for a fair presentation of the results of operations and financial position have been included and all such adjustments are of a normal recurring nature. Operating results for the three and nine months ended September 30, 2019 are not necessarily indicative of the results that can be expected for the year ending December 31, 2019.

 

 

 

U.S. STEM CELL, INC.

CONDENSED BALANCE SHEETS

 

 

   

September 30,

   

December 31,

 
   

2019

   

2018

 
   

(unaudited)

         

ASSETS

               

Current assets:

               

Cash and cash equivalents

  $ 78,104     $ 1,357,146  

Accounts receivable, net

    20,245       18,035  

Inventory

    46,351       93,215  

Prepaid and other

    38,128       38,128  

Total current assets

    182,828       1,506,524  
                 

Property and equipment, net

    87,659       242,615  
                 

Right to use assets

    375,593          
                 

Other assets

               

Investments

    -       57,790  

Deposits

    10,160       10,160  
                 

Total assets

  $ 656,240     $ 1,817,089  
                 

LIABILITIES AND STOCKHOLDERS' DEFICIT

               

Current liabilities:

               

Accounts payable, including $3,167 and $75,714 to related parties, respectively

  $ 1,112,280     $ 1,182,730  

Accrued expenses

    1,142,140       1,155,792  

Advances, related party

    374,901       234,901  

Deferred revenue

    183,525       293,665  

Deferred gain on sale of equipment

    53,686       128,845  

Deposits

    565,286       465,286  

Promissory note, long term portion, net of debt discount of $46,911

    1,350,851       -  

Notes payable, related party

    2,579,365       1,993,104  

Notes and capital leases payable, net of debt discount of $36,032 and $62,240, respectively

    1,512,227       462,330  

Lease liability

    59,970       -  

Total current liabilities

    8,934,231       5,916,653  
                 

Long term debt:

               

Deferred revenue

    63,250       65,500  

Deferred gain on sale of equipment

    -       21,474  

Long term deposits

    -       100,000  

Lease liability, long term portion

    316,075       -  

Promissory note, long term portion, net of debt discount of $99,183

    -       1,298,579  

Notes and capital leases payable, long term portion, net of debt discount of $0 and $12,413, respectively

    456,496       1,297,093  

Total long-term debt

    835,821       2,782,646  
                 

Total liabilities

    9,770,052       8,699,299  
                 

Stockholders' deficit:

               

Preferred stock, par value $0.001; 20,000,000 shares authorized, -0- issued and outstanding as of September 30, 2019 and December 31, 2018

    -       -  

Common stock, par value $0.001; 2,000,000,000 shares authorized, 397,743,960 and 378,076,976 shares issued and outstanding as of September 30, 2019 and December 31, 2018, respectively

    397,744       378,077  

Additional paid in capital

    123,435,415       122,528,391  

Accumulated deficit

    (132,946,971

)

    (129,788,678

)

Total stockholders' deficit

    (9,113,812

)

    (6,882,210

)

                 

Total liabilities and stockholders' deficit

  $ 656,240     $ 1,817,089  

 

See the accompanying notes to these unaudited condensed financial statements

 

 

U.S. STEM CELL, INC.

CONDENSED STATEMENTS OF OPERATIONS

(unaudited)

 

   

Three months ended September 30,

   

Nine months ended September 30,

 
   

2019

   

2018

   

2019

   

2018

 

Revenue:

                               

Products

  $ 28,160     $ 276,281     $ 299,826     $ 1,414,571  

Services

    127,456       1,227,603       2,412,808       3,622,671  

Management fees-related party

    975       -       50,751       -  

Total revenue

    156,591       1,503,884       2,763,385       5,037,242  
                                 

Cost of sales

    137,366       544,398       1,165,459       1,615,431  
                                 

Gross profit

    19,225       959,486       1,597,926       3,421,811  
                                 

Cost and operating expenses:

                               

Research and development

    -       599       263       4,527  

Marketing, general and administrative

    1,616,970       1,177,638       3,628,652       4,468,121  

Pre-litigation settlement

    -       -       500,000          

Depreciation and amortization

    -       -       -       524  

Total operating expenses

    1,616,970       1,178,237       4,128,915       4,473,172  
                                 

Loss from operations

    (1,597,745 )     (218,751 )     (2,530,989 )     (1,051,361 )
                                 

Other income (expenses):

                               

Gain on settlement of debt

    33,203       80,200       21,892       45,013  

Gain on sale of equipment

    32,211       32,211       96,634       96,634  

Miscellaneous income

    11,000       -       11,069       -  

(Loss) income from equity investment

    (33,478 )     160,216       93,778       263,322  

Interest expense

    (91,140 )     (384,813 )     (850,677 )     (1,068,238 )

Total other income (expenses)

    (48,204 )     (112,186 )     (627,304 )     (663,269 )
                                 

Net loss before income taxes

    (1,645,949 )     (330,937 )     (3,158,293 )     (1,714,630 )
                                 

Income taxes (benefit)

    -       -       -       -  
                                 

NET LOSS

  $ (1,645,949 )   $ (330,937 )   $ (3,158,293 )   $ (1,714,630 )
                                 

Net loss per common share, basic and diluted

  $ (0.00 )   $ (0.00 )   $ (0.01 )   $ (0.00 )
                                 

Weighted average number of common shares outstanding, basic and diluted

    396,637,920       368,188,089       392,029,562       362,461,973  

 

See the accompanying notes to these unaudited condensed financial statements

 

 

U.S. STEM CELL, INC.

CONDENSED STATEMENT OF STOCKHOLDERS' DEFICIT

NINE MONTHS ENDED SEPTEMBER 30, 2019

 

                                   

Additional

                 
   

Preferred stock

   

Common stock

   

Paid in

   

Accumulated

         
   

Shares

   

Amount

   

Shares

   

Amount

   

Capital

   

Deficit

   

Total

 

Balance, December 31, 2018

    -     $ -       378,076,976     $ 378,077     $ 122,528,391     $ (129,788,678 )   $ (6,882,210 )

Common stock issued in settlement of accounts payable

    -       -       8,098,929       8,099       180,862       -       188,961  

Common stock issued for services

    -       -       3,500,000       3,500       82,850       -       86,350  

Contribution to equity investment

    -       -       -       -       15,265       -       15,265  

Stock based compensation

    -       -       -       -       169,216       -       169,216  

Net loss

    -       -       -       -       -       (673,218 )     (673,218 )

Balance, March 31, 2019

    -       -       389,675,905       389,676       122,976,584       (130,461,896 )     (7,095,636 )

Common stock issued in settlement of accounts payable and accrued interest

    -       -       4,018,915       4,019       85,201       -       89,220  

Stock based compensation

    -       -       -       -       169,216       -       169,216  

Net loss

    -       -       -       -       -       (839,126 )     (839,126 )

Balance, June 30, 2019 

    -       -       393,694,820       393,695       123,231,001       (131,301,022 )     (7,676,326 )

Common stock issued in settlement of accounts payable

    -       -       4,049,140       4,049       29,964       -       34,013  

Stock based compensation

    -       -       -       -       174,450       -       174,450  

Net loss

    -       -       -       -       -       (1,645,949 )     (1,645,949 )

Balance, September 30, 2019 (unaudited)

    -     $ -       397,743,960     $ 397,744     $ 123,435,415     $ (132,946,971 )   $ (9,113,812 )

 

See the accompanying notes to these unaudited condensed financial statements

 

 

U.S. STEM CELL, INC.

CONDENSED STATEMENT OF STOCKHOLDERS' DEFICIT

NINE MONTHS ENDED SEPTEMBER 30, 2018

 

                                   

Additional

   

Common

                 
   

Preferred stock

   

Common stock

   

Paid in

   

Stock

   

Accumulated

         
   

Shares

   

Amount

   

Shares

   

Amount

   

Capital

   

Subscriptions

   

Deficit

   

Total

 

Balance, December 31, 2017

    -     $ -       342,113,098     $ 342,113     $ 120,185,821     $ -     $ (127,628,251 )   $ (7,100,317 )

Common stock issued in settlement of accounts payable

    -       -       3,817,783       3,818       143,895       -       -       147,713  

Common stock issued for services

    -       -       4,366,274       4,366       237,265       -       -       241,631  

Proceeds from issuance of common stock

    -       -       8,428,658       8,429       314,571       -       -       323,000  

Common stock subscription

    -       -       -       -       -       44,700       -       44,700  

Stock based compensation

    -       -       -       -       82,555       -       -       82,555  

Net loss

    -       -       -       -       -       -       (139,159 )     (139,159 )

Balance, March 31, 2018

    -       -       358,725,813       358,726       120,964,107       44,700       (127,767,410 )     (6,399,877 )

Common stock issued in settlement of accounts payable

    -       -       3,241,779       3,241       201,256       -       -       204,497  

Common stock issued for services

    -       -       3,500,000       3,500       154,400       -       -       157,900  

Proceeds from issuance of common stock

    -       -       921,650       922       43,778       (44,700 )     -       -  

Related party contribution to equity investment

    -       -       -       -       103,159       -       -       103,159  

Stock based compensation

    -       -       -       -       137,069       -       -       137,069  

Net loss

    -       -       -       -       -       -       (1,244,534 )     (1,244,534 )

Balance, June 30, 2018

    -       -       366,389,242       366,389       121,603,769       -       (129,011,944 )     (7,041,786 )

Common stock issued in settlement of accounts payable

    -       -       1,928,946       1,929       51,960       -       -       53,889  

Fair value of warrants issued for compensation

    -       -       -       -       24,986       -       -       24,986  

Related party contribution to equity investment

    -       -       -       -       86,750       -       -       86,750  

Stock based compensation

    -       -       -       -       168,159       -       -       168,159  

Net loss

    -       -       -       -       -       -       (330,937 )     (330,937 )

Balance, September 30, 2018 (unaudited)

    -     $ -       368,318,188     $ 368,318     $ 121,935,624     $ -     $ (129,342,881 )   $ (7,038,939 )

 

See the accompanying notes to these unaudited condensed financial statements

 

 

U.S. STEM CELL, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(unaudited)

 

                 
   

Nine months ended September 30,

 
   

2019

   

2018

 

CASH FLOWS FROM OPERATING ACTIVITIES:

               

Net loss

  $ (3,158,293 )   $ (1,714,630 )

Adjustments to reconcile net loss to net cash used in operating activities:

               

Depreciation and amortization

    154,956       155,480  

Bad debt (recoveries)

    30,869       32,546  

Amortization of discount on debt

    141,296       164,312  

Gain on settlement of debt

    (21,892 )     (45,013 )

Gain on sale of equipment

    (96,634 )     (96,634 )

Related party notes payable issued for services rendered

    800,000       800,000  

Income on equity investments

    (93,778 )     (263,322 )

Note payable issued in pre-trial settlement

    500,000       -  

Stock based compensation

    586,382       812,300  

Changes in operating assets and liabilities:

               

Receivables

    (33,079 )     (22,129 )

Inventory

    46,864       (2,284 )

Deposits

    -       -  

Prepaid and other current assets

    -       (35,000 )

Accounts payable

    269,070       332,577  

Accrued expenses

    (4,507 )     242,004  

Deferred revenue

    (112,390 )     217,038  

Net cash (used in) provided by operating activities

    (991,136 )     577,245  
                 

CASH FLOWS FROM INVESTING ACTIVITIES:

               

Proceeds from (payments to) equity investments

    166,833       214,200  

Net cash provided by investing activities

    166,833       214,200  
                 

CASH FLOWS FROM FINANCING ACTIVITIES:

               

Proceeds from notes payable

    -       126,402  

Proceeds from sale of common stock

    -       367,700  

Net proceeds from common stock subscriptions

    -       -  

Proceeds from related party advances

    140,000       100,000  

Equity contribution by related party

    -       103,159  

Repayments of related party notes

    (213,739 )     (542,971 )

Repayments of notes payable

    (381,000 )     (484,381 )

Net cash used in financing activities

    (454,739 )     (330,091 )
                 

Net (decrease) increase in cash and cash equivalents

    (1,279,042 )     461,354  
                 

Cash and cash equivalents, beginning of period

    1,357,146       986,799  

Cash and cash equivalents, end of period

  $ 78,104     $ 1,448,153  
                 

SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION

         

Interest paid

  $ 633,859     $ 808,243  

Income taxes paid

  $ -     $ -  
                 

Non cash financing activities:

               

Common stock issued in settlement of notes payable

  $ -     $ 406,099  

Equity contributed to investment

  $ 15,265     $ 86,750  

Record right-to-use assets and related lease liability

  $ 383,351     $ -  

 

See the accompanying notes to these unaudited condensed financial statements

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

SEPTEMBER 30, 2019

(unaudited)

 

NOTE 1 — SIGNIFICANT ACCOUNTING POLICIES

 

A summary of the significant accounting policies applied in the presentation of the accompanying unaudited condensed financial statements follows:

 

General

 

The accompanying unaudited condensed financial statements of U.S. Stem Cell, Inc. (the “Company”) have been prepared in accordance with the rules and regulations (Regulation S-X) of the Securities and Exchange Commission (the “SEC”) and with the instructions to Form 10-Q. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements.

 

In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. The results from operations for the three- and nine-month periods ended September 30, 2019 are not necessarily indicative of the results that may be expected for the year ended December 31, 2019. The unaudited condensed financial statements should be read in conjunction with the December 31, 2018 audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K.

 

Basis and business presentation

 

U.S. Stem Cell, Inc. was incorporated under the laws of the State of Florida in August, 1999. The Company is in the sector of the cell technology industry delivering cell therapies and biologics that help address a variety of injuries and diseases such as osteoarthritis, heart failure, lower limb ischemia, neurological conditions, autoimmune diseases and other issues. The primary business includes the development of proprietary cell therapy procedure and products as well as revenue generating physician and patient based regenerative medicine/cell therapy training services, revenues realized from an Asset Sale and Lease Agreement related to the segment of the Company business involving collecting, growing and banking cell cultures and treatment kits for humans and animals), and the operation of a cell therapy clinic (subsequently limited by the Order of Permanent Injunction, see below ). To date, the Company has not generated significant sales revenues in that they remain less than their total operating expenses, has incurred expenses, and has sustained losses. In addition, the recent Order of Permanent Injunction arising from the action brought by the Department of Justice (see Note 11), has resulting in management considering modifications to the Company business model in order to offset the loss of revenue resulting from the consequences of this Injunctive Order. Consequently, its operations are subject to all the risks inherent in the establishment of a research and development business enterprise.

 

Revenue Recognition

 

Effective January 1, 2018, the Company recognizes revenue in accordance with Accounting Standards Codification 2014-09, Revenue from Contracts with Customers (Topic 606), which supersedes the revenue recognition requirements in Topic 605, Revenue Recognition, and most industry-specific revenue recognition guidance throughout the Industry Topics of the Accounting Standards Codification. The updated guidance states that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The guidance also provides for additional disclosures with respect to revenues and cash flows arising from contracts with customers.

 

At the time of each transaction, management assesses whether the fee associated with the transaction is fixed or determinable and whether collection is reasonably assured. The assessment of whether the fee is fixed or determinable is based upon the payment terms of the transaction. Collectability is assessed based on a number of factors, including past transaction history with the client and the creditworthiness of the client.

 

The Company’s primary sources of revenue are from the sale of test kits and equipment, training services, patient treatments, laboratory services and cell banking. 

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

SEPTEMBER 30, 2019

(unaudited)

 

Revenues for kits and equipment sold are not recorded until kits and equipment are received by the customer. Revenues from in-person trainings are recognized when the training occurs and revenues from on demand online trainings are recognized when the customer purchases the rights to the training course. Any cash received as a deposit for trainings are recorded by the Company as a liability.

 

Patient treatments and laboratory services revenue are recognized when those services have been completed or satisfied.

 

Revenues for cell banking sales are accounted for as multiple performance obligations as described in ASC 606 and addresses accounting for arrangements that may involve the delivery or performance of multiple products, services and/or rights to use assets. Because the Company sells its services separately, on more than a limited basis and at a price within a narrow range, the Company was able to allocate revenue based on stand-alone pricing. The multiple performance obligations include stem cell banking, dose retrieval and yearly storage fees. Revenues for stem cell banking and dose retrieval is recognized at the point of service and revenues for the yearly storage fees is recognized over the term of the banking contract, which is typically one year with annual renewals.

 

Revenues have been adversely impacted by the Order of Permanent Injunction (see the Notes herein including Note 10).

 

At September 30, 2019 and December 31, 2018, the Company had deferred revenues of $246,775 and $293,665, respectively, which includes $63,250 and $68,500, respectively, to the Intellectual Property Licensing Agreement.

 

Use of Estimates

 

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates include the fair value of the Company’s stock, stock-based compensation, debt discounts and the valuation allowance related to deferred tax assets. Actual results may differ from these estimates.

 

Accounts Receivable

 

Trade receivables are carried at their estimated collectible amounts. Trade credit is generally extended on a short-term basis; thus, trade receivables do not bear interest. Trade accounts receivable are periodically evaluated for collectability based on past credit history with customers and their current financial condition.

 

Allowance for Doubtful Accounts

 

Any charges to the allowance for doubtful accounts on accounts receivable are charged to operations in amounts sufficient to maintain the allowance for uncollectible accounts at a level management believes is adequate to cover any probable losses. Management determines the adequacy of the allowance based on historical write-off percentages and the current status of accounts receivable. Accounts receivable are charged off against the allowance when collectability is determined to be permanently impaired. As of September 30, 2019, and December 31, 2018, allowance for doubtful accounts was $13,203 and $30,808, respectively.

 

Inventories

 

Inventories are stated at the lower of cost or market with cost being determined on a first-in, first-out (FIFO) basis. The Company writes down its inventory for estimated obsolescence or unmarketable inventory equal to the difference between the cost of inventory and the estimated market value based upon assumptions about future demand and market conditions. If actual market conditions are less favorable than those projected by management, additional inventory write-downs may be required. During the periods presented, there were no inventory write-downs.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

SEPTEMBER 30, 2019

(unaudited)

 

Investments

 

The Company follows Accounting Standards Codification subtopic 323-10, Investments-Equity Methods and Joint Ventures (“ASC 323-10) which requires the accounting for investments where the Company can exert significant influence, but not control of a joint venture or equity investment. The Company accounted for its 49.9 percent member interest ownerships of U.S. Stem Cell Clinic, LLC and Regenerative Wellness Clinic, LLC respectively and its 49 percent member interest ownership of U.S. Stem Cell Clinic of the Villages utilizing the equity method of accounting (See Note 3).

 

Property and Equipment

 

Property and equipment are stated at cost. When retired or otherwise disposed, the related carrying value and accumulated depreciation are removed from the respective accounts and the net difference less any amount realized from disposition, is reflected in earnings. For financial statement purposes, property and equipment are recorded at cost and depreciated using the straight-line method over their estimated useful lives of 3 to 15 years. Equipment under capital leases are recorded at the estimated present value of the minimum lease payments. Equipment under capital leases are amortized over the term of the lease, which is three years.

 

Stock Based Compensation

 

The Company measures the cost of services received in exchange for an award of equity instruments based on the fair value of the award. For employees and directors, the fair value of the award is measured on the grant date and for non-employees, the fair value of the award is generally re-measured on vesting dates and interim financial reporting dates until the service period is complete. The fair value amount is then recognized over the period during which services are required to be provided in exchange for the award, usually the vesting period. Stock-based compensation expense is recorded by the Company in the same expense classifications in the statements of operations, as if such amounts were paid in cash.

 

Net Loss per Common Share, basic and diluted

 

The Company computes earnings (loss) per share under Accounting Standards Codification subtopic 260-10, Earnings Per Share (“ASC 260-10”). Net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the year.  Diluted earnings per share, if presented, would include the dilution that would occur upon the exercise or conversion of all potentially dilutive securities into common stock using the “treasury stock” and/or “if converted” methods as applicable.

 

The computation of basic and diluted income (loss) per share as of September 30, 2019 and 2018 excludes potentially dilutive securities when their inclusion would be anti-dilutive, or if their exercise prices were greater than the average market price of the common stock during the period.

 

Potentially dilutive securities excluded from the computation of basic and diluted net loss per share are as follows:

 

   

September 30,

2019

   

September 30,

2018

 

Options to purchase common stock

    121,038,655       103,970,693  

Warrants to purchase common stock

    1,112,251       1,118,019  

Totals

    122,150,906       105,088,712  

 

Concentrations of Credit Risk

 

The Company’s financial instruments that are exposed to a concentration of credit risk are cash and accounts receivable. Generally, the Company’s cash and cash equivalents in interest-bearing accounts does not exceed FDIC insurance limits. The financial stability of these institutions is periodically reviewed by senior management.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

SEPTEMBER 30, 2019

(unaudited)

 

As of September 30, 2019, two customers represented 55% and 21%, respectively, representing an aggregate of 76% of the Company’s accounts receivable. As of December 31, 2018, four customers represented 41%, 10%, 16% and 10% respectively, representing an aggregate of 77% of the Company’s accounts receivable.

 

For the three months ended September 30, 2019, the Company’s revenues earned from sale of products and services were $156,591, of which three customers, one a related party (US Stem Cell Clinic LLC, a partly owned investment in which the Company holds a 49.9% interest) represented 27%, 21% and 11% (related party).  For the three months ended September 30, 2018, the Company’s revenues earned from sale of products and services were $1,503,884, of which two customers represented 12% and 10%, respectively, one of which is a related party (US Stem Cell Clinic LLC, a partly owned investment in which the Company holds a 49% interest) represented 12% of Company’s revenue.

 

For the nine months ended September 30, 2019, the Company’s revenues earned from sale of products and services were $2,763,385, of which one customer represented, a related party, (US Stem Cell Clinic LLC, a partly owned investment in with the Company holds a 49.9% interest), represents 12% of Company’s revenue.  For the nine months ended September 30, 2018, the Company’s revenues earned from sale of products and services were $5,037,242, of which two customers represented 11% and 8% respectively, of Company’s revenue, one of which is a related party (US Stem Cell Clinic LLC, a partly owned investment in which the Company held a 49.9% interest) represented 11%.    

   

Research and Development

 

The Company accounts for research and development costs in accordance with Accounting Standards Codification subtopic 730-10, Research and Development (“ASC 730-10”). Under ASC 730-10, all research and development costs must be charged to expense as incurred. Accordingly, internal research and development costs are expensed as incurred. Third-party research and development costs are expensed when the contracted work has been performed or as milestone results have been achieved as defined under the applicable agreement. Company-sponsored research and development costs related to both present and future products are expensed in the period incurred. The Company incurred research and development expenses of $0 and $263 for the three and nine months ended September 30, 2019, respectively; and $599 and $4,527 for the three and nine months ended September 30, 2018, respectively.

 

Fair Value

 

Accounting Standards Codification subtopic 825-10, Financial Instruments (“ASC 825-10”) requires disclosure of the fair value of certain financial instruments. The carrying value of cash and cash equivalents, accounts payable and accrued liabilities, and short-term borrowings, as reflected in the balance sheets, approximate fair value because of the short-term maturity of these instruments. All other significant financial assets, financial liabilities and equity instruments of the Company are either recognized or disclosed in the financial statements together with other information relevant for making a reasonable assessment of future cash flows, interest rate risk and credit risk. Where practicable the fair values of financial assets and financial liabilities have been determined and disclosed; otherwise only available information pertinent to fair value has been disclosed.

 

The Company follows Accounting Standards Codification subtopic 820-10, Fair Value Measurements and Disclosures (“ASC 820-10”) and Accounting Standards Codification subtopic 825-10, Financial Instruments (“ASC 825-10”), which permits entities to choose to measure many financial instruments and certain other items at fair value.

 

Deposits

 

Deposits are comprised of the following:

 

On March 3, 2017, the Company entered into a customer purchase agreement with General American Capital Partners (GACP), whereby the Company agreed to sell, for $50,000, the first 5,000 customers of the cell banking business after the effective date of the equipment sale/leaseback agreement with rights to purchase additional customers at a price of $20 per customer.  There is no reduction in the selling price should the new customers be fewer than 5,000.  The effective date of the sale is upon the expiry or early termination of the related equipment lease transaction (See Notes 4 and 8).

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

SEPTEMBER 30, 2019

(unaudited)

 

On March 3, 2017, the Company entered into an asset purchase agreement of intellectual property with GACP whereby the Company agreed to sell all of the Company’s worldwide rights, title or interest in certain intellectual and other property (as defined) associated with the cell banking business for $50,000. The effective date of the sale is upon the expiry or early termination of the related equipment lease transaction (See Notes 4 and 8).

 

As a consequence of the Court Order (see Note 10), the Company resolved to divest itself of certain equipment and other assets (the “Equipment Assets”) used in connection with the Company’s human tissue banking business, but consistent however with the requirements of the Court Order, and to adjust the business plan and operations to accommodate this potential divesture. To facilitate the above, the Company entered into a Termination and Release Agreement and a Letter Agreement intended to divested itself of certain equipment and other assets underlying the related equipment lease transaction (see Notes, 4, and 8).

 

Adoption of Accounting Standards

 

In February 2016, the FASB established ASC Topic 842, Leases (Topic 842), by issuing ASU No. 2016-02, which requires lessees to recognize leases on-balance sheet and disclose key information about leasing arrangements. Topic 842 was subsequently amended by ASU No. 2018-01, Land Easement Practical Expedient for Transition to Topic 842; ASU No. 2018-10, Codification Improvements to Topic 842, Leases; and ASU No. 2018-11, Targeted Improvements. The new standard establishes a right-of-use (ROU) model that requires a lessee to recognize a ROU asset and lease liability on the balance sheet. Leases will be classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the statement of operations. The Company adopted the new standard on January 1, 2019.

 

The new standard provides a number of optional practical expedients in transition. The Company has elected the ‘package of practical expedients’, which permit it not to reassess under the new standard its prior conclusions about lease identification, lease classification and initial direct costs. The Company did not elect the use-of-hindsight or the practical expedient pertaining to land easements; the latter is not applicable to the Company.

 

The new standard had a material effect on the Company’s financial statements. The most significant effects of adoption relate to (1) the recognition of new ROU assets and lease liabilities on its balance sheet for real estate operating leases; and (2) providing significant new disclosures about its leasing activities.

 

Upon adoption, the Company recognized additional operating lease liabilities, net of deferred rent, of approximately $57,000 based on the present value of the remaining minimum rental payments under current leasing standards for existing operating leases. The Company also recognized corresponding ROU assets of approximately $57,000.

 

The new standard also provides practical expedients for an entity’s ongoing accounting. The Company elected the short-term lease recognition exemption for all leases that qualify. This means, for those leases that qualify, the Company will not recognize ROU assets or lease liabilities, and this includes not recognizing ROU assets or lease liabilities for existing short-term leases of those assets in transition. Beginning in 2019, the Company changed to its disclosed lease recognition policies and practices, as well as to other related financial statement disclosures due to the adoption of this standard. See Note 5.

 

Recent Accounting Pronouncements

 

There were various updates recently issued, most of which represented technical corrections to the accounting literature or application to specific industries and are not expected to a have a material impact on the Company’s financial position, results of operations or cash flows.

 

Subsequent Events

 

The Company evaluates events that have occurred after the balance sheet date but before the consolidated financial statements are issued.  Based upon the evaluation, the Company did not identify any recognized or non-recognized subsequent events that would have required adjustment or disclosure in the consolidated financial statements, except as disclosed.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

SEPTEMBER 30, 2019

(unaudited)

 

NOTE 2 — GOING CONCERN AND MANAGEMENT’S LIQUIDITY PLANS

 

The accompanying condensed financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As shown in the accompanying financial statements for nine months ended September 30, 2019, the Company incurred net losses of $3,158,293 and has a working capital deficit (current liabilities in excess of current assets) of $8,751,403. These factors among others raise substantial doubts about the Company’s ability to continue as a going concern for a reasonable period.

 

The Company’s primary source of operating funds in the past has been from revenue generated from sales and cash proceeds from the sale of common stock and the issuance of convertible and other debt. The Company has experienced net losses and negative cash flows from operations since inception and has been hindered by the recent Order of Permanent Injunction resulting from the action brought by the Department of Justice (see Note 10). Under the current business model, the Injunction is likely to significantly reduce the Company’s future revenues. As a consequence of the Court Order (see Note 10), the Company resolved to divest itself of certain equipment and other assets (the “Equipment Assets”) used in connection with the Company’s human tissue banking business, but consistent however with the requirements of the Court Order, and to adjust the business plan and operations to accommodate this potential divesture. To facilitate the above, the Company entered into a Termination and Release Agreement and a Letter Agreement intended to divested itself of certain equipment and other assets underlying the related equipment lease transaction (see Notes, 4, and 8). Management is considering modifications to the Company business model in order to offset the loss of revenue resulting from the consequences of this Injunctive Order. As of the date herein, no specific undertakings have commenced. The Company has stockholders’ deficiencies at September 30, 2019 and requires additional financing to fund future operations.

 

The Company’s existence is dependent upon management’s ability to develop profitable operations and to obtain additional funding sources. There can be no assurance that the Company’s financing efforts or revenues realized from the Asset Sale and Lease Agreement will result in profitable operations or the resolution of the Company’s liquidity problems. The accompanying statements do not include any adjustments that might result should the Company be unable to continue as a going concern.

 

NOTE 3 — INVESTMENTS

 

U.S. Stem Cell Clinic, LLC

 

The investment in U.S. Stem Cell Clinic, LLC is comprised of a 49.9% (33.3% in 2018) member interest ownership and is accounted for using the equity method of accounting. The Company’s 49.9% (33.3% in 2018) income (loss) earned by U.S. Stem Cell Clinic, LLC member interests was $(20,637) and $51,514 for the three and nine months ended September 30, 2019 and $82,950 and $171,740 for the three and nine months ended September 30, 2018, respectively (inception to date income of $599,721) which was recorded as other income/expense in the Company’s Statement of Operations in the appropriate periods.  In addition, during the nine months ended September 30, 2019 and 2018, the Company received distributions totaling $64,870 and $154,000 from U.S. Stem Cell Clinic, LLC, respectively (inception to date of $663,870).  The carrying value of the investment at September 30, 2019 and December 31, 2018 is $0 and $8,921, respectively.

 

At September 30, 2019 and December 31, 2018, accounts receivable for sales of product and services to U.S. Stem Cell Clinic, LLC was $0; revenues earned from sales to U.S. Stem Clinic, LLC for the three and nine months ended September 30, 2019 were $33,614 and $329,003, and the three and nine months ended September 30, 2018 were $183,832 and $529,880, respectively.

 

In January 2019, a member of U.S. Stem Cell Clinic, LLC contributed 16.6% of his ownership interest to the Company increasing the Company’s member interest from 33.3% to 49.9%. The Company recorded the contribution to equity of $4,435.

 

An affiliate of one of the Company’s former officers is an investor in the U.S. Stem Cell Clinic, LLC.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

SEPTEMBER 30, 2019

(unaudited)

 

Regenerative Wellness Clinic, LLC

 

The investment in Regenerative Wellness Clinic, LLC is comprised of a 49.9% (33.3% in 2018) member interest ownership and is accounted for using the equity method of accounting. The Company has provided technical expertise, but no cash investment with Regenerative Wellness Clinic, LLC’s startup in 2017. The Company’s 49.9% (33.3% in 2018) income (loss) earned by Regenerative Wellness Clinic, LLC member interests was $(2,910) and $69,345 for the three and nine months ended September 30, 2019 and for the three and nine months ended September 30, 2018 was $58,931 and $73,247 reported, after effects of 2017 loss, of $9,695, respectively (inception to date income of $113,047) which was recorded as other income/expense in the Company’s Statement of Operations in the appropriate periods.  In addition, during the nine months ended September 30, 2019 and 2018, the Company received distributions totaling $101,963 and $21,000 from Regenerative Wellness Clinic, LLC, respectively (inception to date of $101,963).  The carrying value of the investment at September 30, 2019 and December 31, 2018 is $0 and $21,787, respectively.

 

At September 30, 2019 and December 31, 2018, accounts receivable for sales of products and services to Regenerative Wellness Clinic, LLC was $0; revenues earned from sales to Regenerative Wellness Clinic, LLC for the three and nine months ended September 30, 2019 was $16,637 and $132,984 and for the three and nine months ended September 30, 2018 was $64,945 and $149,469, respectively.

 

In January 2019, a member of Regenerative Wellness Clinic, LLC contributed 16.6% of his ownership interest to the Company increasing the Company’s member interest from 33.3% to 49.9%. The Company recorded the contribution to equity of $10,830.

 

An affiliate of one of the Company’s former officers is an investor in the Regenerative Wellness Clinic, LLC.

 

U.S. Stem Cell Clinic of the Villages LLC

 

On January 30, 2018, Greg Knutson, a director of the Company (“Knutson”) and the Company agreed to open and operate a regenerative medicine/cell therapy clinic providing cellular treatments for patients afflicted with neurological, autoimmune, orthopedic and degenerative diseases in Florida.  To that end, U.S. Stem Cell Clinic of The Villages LLC (the “LLC”) was formed on January 30, 2018. Knutson provided the Company with the sum of Three Hundred Thousand Dollars ($300,000) (the “Investment”) to be utilized for the formation and initial operation of the LLC.  Currently, Knutson holds a 51%-member interest in the LLC and the Company holds a 49%-member interest. The Company will provide operating assistance as well as management services, the latter to be compensated at fee of five percent (5%) of the LLC gross revenues.

 

As of December 31, 2018, upon completion of the LLC, the Company was credited with investment equity of $86,750 from Greg Knutson, the holder of the 51%-member interest. The Company then recorded the investment equity as contributed capital by the Company. The Company’s 49% income (loss) incurred by the LLC member interests was $(9,931) and $(27,081) for the three and nine months ended September 30, 2019 and $18,335 for three and nine months ended September 30, 2018, respectively. In addition, during the year ended December 31, 2018, the Company received distributions totaling $63,700 from the LLC. The carrying value was $0 and $27,081 at September 30, 2019 and December 31, 2018, respectively

 

At September 30, 2019 and December 31, 2018, accounts receivable for sales of products and services to the LLC was $0; revenues earned from sales to the LLC for the three and nine months ended September 30, 2019 was $9,975 and $140,328 and for the three and nine months ended September 30, 2018 was $64,074 and $143,550, respectively.

 

During the three and nine months ended September 30, 2019, the Company received $975 and $50,751 management fees from the LLC, respectively.

 

NOTE 4 — PROPERTY AND EQUIPMENT

 

Property and equipment are recorded on the basis of cost. For financial statement purposes, property, plant and equipment are depreciated using the straight-line method over their estimated useful lives. 

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

SEPTEMBER 30, 2019

(unaudited)

 

Expenditures for repair and maintenance which do not materially extend the useful lives of property and equipment are charged to operations. When property or equipment is sold or otherwise disposed of, the cost and related accumulated depreciation are removed from the respective accounts with the resulting gain or loss reflected in operations. Management periodically reviews the carrying value of its property and equipment for impairment in accordance with the guidance for impairment of long-lived assets.

 

Property and equipment as of September 30, 2019 and December 31, 2018 is summarized as follows:

 

   

September 30,

2019

   

December 31,

2018

 

Laboratory and medical equipment

  $ 5,590     $ 5,590  

Furniture, fixtures and equipment

    125,633       125,633  

Computer equipment

    49,951       49,951  

Equipment under capital lease

    624,602       624,602  

Leasehold improvements

    362,046       362,046  
      1,167,822       1,167,822  

 Less accumulated depreciation and amortization

    (1,080,163

)

    (925,207

)

    $ 87,659     $ 242,615  

 

On March 3, 2017, the Company entered into an asset sale and lease agreement (sale/leaseback transaction, the “Asset Sale and Lease Agreement”) with GACP, whereby the Company sold certain lab, medical and other equipment relating to the cell banking business for $400,000 and leased back the sold equipment over a three-year term.

 

The Company determined that the transaction was a capitalized lease and accordingly recorded the leased assets and liability based on the estimated present value of the minimum lease payments.

 

Included in net property are assets under capital leases of $624,602, less accumulated depreciation of $533,738 as of September 30, 2018 and $624,602, less accumulated depreciation of $383,559 December 31, 2018, respectively.

 

In connection with the sale of the lab, medical and other equipment, the Company realized a gain on sale of equipment of $386,535.  The gain is recognized ratably over the term of the lease to operations. During the three and nine months ended September 30, 2019, the Company recognized $32,211 and $96,634; and $32,211 and $96,634 during the three and nine months ended September 30, 2018, as the gain on sale of equipment, respectively.  As of September 30, 2019, and December 31, 2018, deferred gain on sale of equipment was $53,686 and $150,319, respectively.

 

As a consequence of the Court Order (see Note 10), the Company resolved to divest itself of certain equipment and other assets (the “Equipment Assets”) used in connection with the Company’s human tissue banking business, but consistent however with the requirements of the Court Order, and to adjust the business plan and operations to accommodate this potential divesture. To facilitate the above, the Company entered into a Termination and Release Agreement and a Letter Agreement intended to divest itself of certain equipment and other assets underlying the related equipment lease transaction (see Note 8).

 

Property and equipment are recorded based on cost. For financial statement purposes, property, plant and equipment are depreciated using the straight-line method over their estimated useful lives. 

 

Depreciation expense was $51,652 and $154,956 of which $51,652 and $154,956 were included in cost of sales for the three and nine months ended September 30, 2019, respectively.

 

Depreciation expense was $51,652 and $155,480 of which $51,652 and $154,956 were included in cost of sales for the three and nine months ended September 30, 2018, respectively.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

SEPTEMBER 30, 2019

(unaudited)

 

NOTE 5 — RIGHT TO USE ASSETS AND LEASE LIABILITY

 

The Company leases its headquarters in Sunrise, Florida which consists of 4,860 square feet of space, which it leases at a current rent of approximately $82,620 per year. In September 2013, the Company amended its facility lease to extend the term until July 31, 2016. On February 4, 2016, the Company extended its facility lease to extend the term of the lease until August 31, 2019 at a monthly base rent of $7,306 plus a pro rata share of landlord’s operating expenses.

 

Effective September 1, 2019, the Company entered into a second amendment to the above described lease to extend the premises through August 31, 2014 with base rent beginning at $87,674 per year and escalating to $98,678 per year plus a pro rata share of the landlord’s operating expenses.

 

At lease commencement date, the Company estimated the lease liability and the right of use assets at present value using the Company’s estimated incremental borrowing rate of 8% and determined their initial present values, at inception, of $383,351. In determining the length of the lease term to its long-term lease, the Company determined there was not an option to extend the lease.

 

In adopting ASC Topic 842, Leases (Topic 842), the Company has elected the ‘package of practical expedients’, which permit it not to reassess under the new standard its prior conclusions about lease identification, lease classification and initial direct costs. The Company did not elect the use-of-hindsight or the practical expedient pertaining to land easements; the latter is not applicable to the Company. In addition, the Company elected not to apply ASC Topic 842 to arrangements with lease terms of 12 months or less. In determining the length of the lease term to its long-term lease, the Company determined there was not an option to extend the lease. At lease commencement date, the Company estimated the lease liability and the right of use assets at present value using the Company’s estimated incremental borrowing rate of 8% and determined the initial present value, at inception, of $274,180. On January 1, 2019, upon adoption of ASC Topic 842, the Company recorded right to use assets of $56,734 and lease liability of $56,734.

 

Right to use assets is summarized below:

 

   

September 30,

2019

 

Sunrise Facility

  $ 383,351  

Less accumulated depreciation

    (7,758

)

Right to use assets, net

  $ 375,593  

 

During the three and nine months ended September 30, 2019, the Company recorded $34,560 and $105,885 as lease expense to current period operations, respectively.

 

Lease liability is summarized below:

 

   

September 30,

2019

 

Sunrise, FL

  $ 376,045  

Less: short term portion

    (59,970

)

Long term portion

  $ 316,075  

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

SEPTEMBER 30, 2019

(unaudited)

 

Maturity analysis under these lease agreements are as follows:

 

Three months ended December 31, 2019

  $ 21,919  

Year ended December 31, 2020

    88,551  

Year ended December 31, 2021

    91,208  

Year ended December 31, 2022

    93,944  

Year ended December 31, 2023

    96,762  

Year ended December 31, 2024

    65,786  
      458,170  

Less: Present value discount

    (82,125

)

Lease liability

  $ 376,045  

 

Lease expense for the three months ended September 30, 2019 was comprised of the following:

 

Operating lease expense

  $ 34,560  

Variable lease expense

    -  
    $ 34,560  

 

Lease expense for the nine months ended September 30, 2019 was comprised of the following:

 

Operating lease expense

  $ 105,200  

Variable lease expense

    685  
    $ 105,885  

 

NOTE 6 — ACCRUED EXPENSES

 

Accrued expenses consisted of the following as of September 30, 2019 and December 31, 2018:   

 

   

September 30,

2019

   

December 31,

2018

 

Interest and fees payable to the Guarantors of the Company’s loan agreement with Seaside Bank

  $ 422,934     $ 347,235  

Interest payable on notes payable-related party (See Note 8)

    555,571       482,784  

Vendor accruals and other

    146,420       146,420  

Payroll and related expenses

    14,837       -  

Marketing obligation

    2,378       179,353  
    $ 1,142,140     $ 1,155,792  

 

During the nine months ended September 30, 2019, the Company issued an aggregate of 16,166,984 shares of its common stock in settlement of outstanding accounts payable and accrued expenses. In connection with the issuance, the Company incurred a $23,168 net gain in settlement of debt.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

SEPTEMBER 30, 2019

(unaudited)

 

NOTE 7 — NOTES AND CAPITAL LEASE PAYABLE

 

Notes and capital lease payable were comprised of the following as of September 30, 2019 and December 31, 2018:

 

   

September 30,

2019

   

December 31,

2018

 

Seaside Bank note payable.

  $ 980,000     $ 980,000  

Hunton & Williams note(s) payable

    394,500       444,000  

Weider promissory note payable

    491,525       -  

Power Up Lending Group notes payable

    40,838       145,476  

Lab and medical equipment capitalized leases

    97,892       264,590  

Total notes payable

    2,004,785       1,834,076  

Less unamortized debt discount

    (36,032

)

    (74,653

)

Total notes payable net of unamortized debt discount

    1,968,753       1,759,423  

Less current portion

    (1,512,227

)

    (462,330

)

Long term portion

  $ 456,496     $ 1,297,093  

 

Seaside Bank

 

On October 25, 2010, the Company entered into a Loan Agreement with Seaside National Bank and Trust for a $980,000 loan at 4.25% per annum interest that was used to refinance the Company’s loan with Bank of America. The obligation is guaranteed by certain shareholders of the Company. The Company renewed the loan with Seaside National Bank and Trust during the first quarter of 2019 to extend the maturity date to May 18, 2020.

 

Hunton & Williams Notes

 

At December 31, 2016, the Company had two outstanding notes payable with interest at 8% per annum due at maturity. The two notes, $61,150 and $323,822, are payable in one balloon payment upon the date the Noteholder provides written demand, however the Company is not obligated to make payments until the Northstar Biotech Group, LLC (or successor) Loan is paid off.

 

On August 31, 2017, the Company and the note holder entered into a Note Forbearance, Modification and Repayment Agreement (“Agreement”). The two notes, $61,150 and $323,822, were payable in one balloon payment upon the date of a written demand and upon certain triggering events occurring. The total of unpaid principal and accumulated interest for both notes as of August 31, 2017 was $747,680 and an account payable of $40,596, for an aggregate total of $788,276.

 

The note holder agreed to accept full payment of their obligation of over a four (4) year period in 48 monthly installments on an adjusted debt obligation in aggregate of $624,000 (reducing the outstanding balance), with such payments staggered in amounts such that the Company will pay $10,000 monthly the first year, $12,000 monthly the second year, $14,000 monthly the third year, and $16,000 monthly the final year.  In addition, the note holder agreed to suspend accrual interest on the notes commencing September 1, 2017.

 

The Agreement remains in full force and effect provided the Company continues to make the monthly payments, there is no event of default as defined in the notes and an agreement to a subordination agreement by Northstar Biotech Group, LLC, which has been provided. During the nine-month ended September 30, 2019, the Company did not make all required payments. However, the noteholder agreed to waive their default rights under the agreement for a payment commitment of $5,000 in December 2019.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

SEPTEMBER 30, 2019

(unaudited)

 

The Company imputed an interest rate of 5% and discounted the note accordingly. The imputed debt discount of $69,700 is amortized to interest expense using the effective interest method. The imputed debt discount of $69,700 is amortized to interest expense using the effective interest method. For three and nine months ended September 30, 2019, the Company amortized $24,205 and $34,945, and for three and nine months ended September 30, 2018, the Company amortized $6,343 and $22,426 of debt discounts to current period operations as interest expense. At September 30, 2019, the Company is in default and is negotiating payment structure. The remaining unamortized debt discount at September 30, 2019 was charged to current period operations.

 

Weider Promissory Note

 

The Company, as one of the parties entered into a Settlement Agreement and General Release (the “Agreement”) dated June 3, 2019 related to certain medical procedures. Without admitting any liability, and as part of that Agreement, the Company agreed to provide a five-year 5.25% unsecured promissory note, dated June 15, 2019, in the principal amount of $500,000, payable in monthly increments of $5,000 per month, with a final balloon payment due on June 15, 2024. The Company recorded the promissory note to current period operations. Remaining outstanding balance as of September 30, 2019 was $491,525.

 

PowerUp Lending Group, Ltd

 

On November 8, 2018, the Company entered into a revenue based factoring agreement and received an aggregate of $137,200 (less origination fees of $2,800) in exchange for $187,600 of future receipts relating to monies collected from customers or other third party payors. Under the terms of the factoring agreement, the Company is required to make daily payments equal to $1,276 for 147 business days.  The Company received net proceeds of $93,809 along with cancellation of the previous revenue based factoring agreement issued in May 2018.  In connection with the cancellation of the January 2018 revenue based factoring agreement, the Company incurred a loss in settlement of debt of $37,604 in 2018.  This agreement was subsequently terminated (see below) in exchange for a new revenue based factoring agreement. 

 

On April 16, 2019, the Company entered into a revenue based factoring agreement and received an aggregate of $137,200 (less origination fees of $2,800) in exchange for $187,600 of future receipts relating to monies collected from customers or other third party payors. Under the terms of the factoring agreement, the Company is required to make daily payments equal to $1,276 for 147 business days.  The Company received net proceeds of $84,876 along with cancellation of the previous revenue based factoring agreement issued in November 2018.  In connection with the cancellation of the November 2018 revenue based factoring agreement, the Company incurred a loss in settlement of debt of $1,276 in 2019.  

 

The remaining principle balance of the PowerUp Lending Group promissory note payable at September 30, 2019 and December 31, 2018 is $40,838 and $145,486, net of unamortized discount of $36,032 and $43,452, respectively.

 

Lab and Medical Equipment Capitalized Lease

 

On March 3, 2017, the Company entered into an asset sale and lease agreement (sale/leaseback transaction; “Asset Sale and Lease Agreement”) with GACP, whereby the Company sold certain lab, medical and other equipment relating to the cell banking business for $400,000 and leased back the sold equipment over a three year term.  The Company recognized the arrangement as a capital lease.  The Company initially recorded the equipment and the capitalized lease liability at the estimated present value of the minimum lease payments of $619,825. 

 

The lease includes a base monthly rental payment of $20,000, due the first day of each calendar month plus contingent rent equal to 2.3%, 22.5%, and 31.6% of revenues collected on deposits arising from cell banking business for years 1, 2 and 3, respectively.  The contingent rent is recognized as a period expense and as interest expense at the time of collection.  At the expiration of the lease, the Company is required to return all leased equipment and along with any maintenance records, logs, etc. in the Company’s possession to the lessor with no right of repurchase.

 

The Company determined that the present value of the minimum lease payments exceeded 90% of the estimated fair value of the equipment and therefore classified the equipment sale/lease as a capitalized lease. The effective interest rate of the capitalized lease is estimated at 10.00% based on the Company estimated incremental borrowing rate.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

SEPTEMBER 30, 2019

(unaudited)

 

The following summarizes the assets under capital leases:

 

   

September 30,

2019

   

December 31,

2018

 

Classes of property

               

Lab, medical and other equipment

  $ 619,825     $ 619,825  

Office equipment

    4,777       4,777  

Less: accumulated depreciation

    (538,515

)

    (383,559

)

    $ 86,087     $ 241,043  

 

The following summarizes the current and long-term portion of capital leases:

 

   

September 30,

2019

   

December 31,

2018

 

Current leases payable

  $ 97,892     $ 225,084  

Long-term leases payable

    -       39,506  

Total

  $ 97,892     $ 264,590  

 

The following summarizes total future minimum lease payments at September 30, 2019:

 

Period ending,

       

Three months ended December 31, 2019

    60,000  

Year ended December 31, 2020

    40,000  

Total minimum lease payments

    100,000  

Amount representing interest

    (2,108

)

Present value of minimum lease payments

    97,892  

Current portion of capital lease obligations

    97,892  

Capital lease obligation, less current portion

  $ -  

 

Promissory note

 

On June 1, 2015, the Company issued an amended and restated promissory note of $1,697,762 in settlement of the $1,500,000 outstanding subordinated debt, related accrued interest of $373,469 and accumulated and unpaid guarantor fees of $624,737.

 

The note is unsecured and non-interest bearing with four semi-annual payments of $75,000 beginning on December 31, 2015 with the remaining unpaid balance due June 1, 2020.

 

The Company imputed an interest rate of 5% and discounted the promissory note accordingly. The imputed debt discount of $368,615 is amortized to interest expense using the effective interest method. For the three and nine months ended September 30, 2019, the Company amortized $17,616 and $52,273; and $17,616 and $52,273 for the three and nine months ended September 30, 2018, of debt discounts to current period operations as interest expense, respectively.  The unamortized debt discount at September 30, 2019 is $46,911.

 

As of September 30, 2019, the remaining principle due was $1,397,762.

 

NOTE 8 — RELATED PARTY TRANSACTIONS

 

Advances

 

As of September 30, 2019, and December 31, 2018, the Company’s officers and directors have provided advances in the aggregate of $374,901 and $234,901 respectively, for working capital purposes. The advances are unsecured, due on demand, and non-interest bearing.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

SEPTEMBER 30, 2019

(unaudited)

 

Notes payable-related party

 

Northstar Biotechnology Group, LLC

 

On February 29, 2012, a promissory note issued to BlueCrest Master Fund Limited was assigned to Northstar Biotechnology Group, LLC (“Northstar”), owned partly by certain directors and existing shareholders of the Company at the time, including Dr. William P. Murphy Jr., Dr. Samuel Ahn and Charles Hart. At the date of the assignment, the principal amount of the BlueCrest note was $544,267 the (“Note”).

 

On March 30, 2012, the Company and Northstar agreed to extend until May 1, 2012 the initial payment date for any and all required monthly under the Note, such that the first of the four monthly payments required under the Note will be due and payable on May, 2012 and all subsequent payments will be due on a monthly basis thereafter commencing on June 1, 2012, and to waive any and all defaults and/or events of default under the Note with respect to such payments. The Company did not make the required payment, and as a result, was in default of the revised agreement. The Company renegotiated the terms of the Note and Northstar agreed to suspend the requirement of principal payments by the Company and allow payment of interest-only in common stock.

 

On September 21, 2012, the Company issued 5,000 common stock purchase warrants to Northstar that was treated as additional interest expense upon issuance.

 

On October 1, 2012, the Company and Northstar entered into a limited waiver and forbearance agreement providing a recapitalized new note balance comprised of all sums due Northstar with a maturity date extended perpetually. The Company agreed to issue 5,000,000 shares of Series A Convertible Preferred Stock and 10,000 shares of common stock in exchange for $210,000 as payment towards outstanding debt, default interest, penalties, professional fees outstanding and due Northstar. In addition, the Company executed a security agreement granting Northstar a lien on all patents, patent applications, trademarks, service marks, copyrights and intellectual property rights of any nature, as well as the results of all clinical trials, know-how for preparing Myoblasts, old and new clinical data, existing approved trials, all right and title to Myoblasts, clinical trial protocols and other property rights.

 

In addition, the Company granted Northstar a perpetual license on products as described for resale, relicensing, and commercialization outside the United States. In connection with the granted license, Northstar shall pay the Company a royalty of up to 8% on revenues generated.

 

Effective October 1, 2012, the effective interest rate was 12.85% per annum. The parties agreed, as of February 28, 2013, to reduce the interest rate to 7% per annum.

 

In connection with the consideration paid, Northstar waived, from the effective date through the earlier of termination or expiration of the agreement, satisfaction of the obligations as described in the forbearance agreement.

 

In 2012, 5,000,000 shares of Series A Convertible Preferred Stock were approved to be issued, which was subsequently increased to 20,000,000 shares of preferred stock as Series A Convertible Preferred Stock. In addition, the Company was obligated to issue additional preferred stock equal in lieu of payment of cash of accrued and unpaid interest on each six-month anniversary of the effective date (October 1, 2012). In lieu of the initial two payments in preferred stock, the parties agreed to modify the voting rights of the subsequently cancelled Series A Convertible Preferred Stock from 20 votes per share on matters to be voted on by the common stock holders to 25 votes per share on matters to be voted on by the common stock holders and all prior and subsequent payments of interest will be in common stock. The Company is required to issue additional shares of its common stock (as amended), in lieu of cash, each six-month anniversary of the effective date for any accrued and unpaid interest.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

SEPTEMBER 30, 2019

(unaudited)

 

On March 1, 2017, Northstar and the Company entered into a settlement agreement (“Settlement Agreement “) related to then pending litigation (See Note 11). Pursuant to the terms and conditions of the Settlement Agreement, Northstar converted its outstanding Series A Convertible preferred stock, into twenty million (20,000,000) shares of common stock according to the original conversion terms. In addition, and separate and apart from the conversion, Northstar received Eleven Million (11,000,000) shares of the Company’s common stock. Northstar will receive ten percent (10%) of all Company international sales (based on a gross sales basis). There was no effect of the 10% obligation as there were no international sales in 2017 or, to date, in 2018 Furthermore, a Northstar designee, Greg Knutson, was appointed as a member of the Board of Directors of the Company and two Company directors, Michael Tomas and Kristin Comella (with Dr. Comella no longer a member of the Board of Directors after September 1, 2019), each exercised their prior Northstar options to each receive a Five percent (5%) Member Interest in Northstar.  The parties agreed to a mutual release and Northstar agreed to terminate any UCC lien on the Company assets previously filed for the benefit of Northstar. On March 9, 2017 and April 1, 2017, the Company issued 30,000,000 and 1,000,000 shares of its common stock, respectively, as described above. In connection with the settlement, the Company recorded a loss on litigation settlement of $316,800.

 

On September 30, 2013, the Company issued 8,772 shares of its common stock as payment of $100,000 towards cash advances.

 

On December 24, 2013, the Company issued 3,916 shares of its common stock as payment of accrued interest through June 30, 2013 of $85,447.

 

On April 2, 2014, the Company issued 275 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,635 due April 1, 2014 per the forbearance agreement.

 

On September 17, 2014, the limited waiver and forbearance agreement entered into on October 1, 2012 to provide that the perpetual license on products as described for resale, relicensing and commercialization outside the United States was amended as such on the condition that Northstar provide certain financing, which financing the Company, in its sole discretion, could decline and retain the license.

 

On October 3, 2014, the Company issued 515 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,705 due October 1, 2014 per the forbearance agreement.

 

On April 3, 2015, the Company issued 1,363 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,635 due April 1, 2015 per the forbearance agreement.

 

On October 2, 2015, the Company issued 4,156 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,705 due October 1, 2015 per the forbearance agreement.

 

On October 7, 2015, the Company issued 34,522 shares of its common stock in settlement of $100,000 principal payment towards the outstanding debt.

 

On April 7, 2016, the Company issued 57,778 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,705 due April 1, 2016 per the forbearance agreement.

 

On October 6, 2016, the Company issued 848,490 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,705 due October 1, 2016 per the forbearance agreement.

 

On April 1, 2017, the Company issued 286,315 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,703 due April 1, 2017 per the forbearance agreement.

 

On October 2, 2017, the Company issued 559,187 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,705 due October 1, 2017 per the forbearance agreement.

 

On October 19, 2018, the Company issued 164,523 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $9,195 due October 1, 2018 per the forbearance agreement.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

SEPTEMBER 30, 2019

(unaudited)

 

On April 19, 2018, the Company issued 379,141 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $9,145 due April 1, 2019 per the forbearance agreement.

 

As of September 30, 2019, and December 31, 2018, the principal of this note was $262,000.

 

Officer and Director Notes

 

   

September 30,

2019

   

December 31,

2018

 

Note payable, Mr. Tomas

  $ 161,786     $ 483,393  

Note payable, Mr. Tomas

    500,000       500,000  

Note payable, Mr. Tomas

    500,000       -  

Note payable, Dr. Comella*

    255,579       147,711  

Note payable, Dr. Comella*

    300,000       300,000  

Note payable, Dr. Comella*

    300,000       300,000  

Note payable, Dr. Comella*

    300,000       -  

Total

  $ 2,317,365     $ 1,731,104  

* Dr. Comella is no longer a member of the Board of Directors after September 1, 2019.

 

 

Notes payable, Mr. Tomas

 

On August 7, 2017, the Company issued a $500,000 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due one year from date of issuance. During the nine months ended September 30, 2019, the Company paid off $321,607 of the outstanding promissory note. The principal outstanding balance of this note as of September 30, 2019 and December 31, 2018 is $161,786 and $483,393, respectively.

 

On May 7, 2018, the Company issued a $500,000 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due six months from date of issuance. The principal outstanding balance of this note as of September 30, 2019 and December 31, 2018 is $500,000.

 

On July 1, 2019, the Company issued a $500,000 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due November 7, 2019. The principal outstanding balance of this note as of September 30, 2019 is $500,000.

 

At September 30, 2019 and December 31, 2018, the Company has recorded accrued interest on the outstanding and past notes to Mr. Tomas in the amount of $375,053 and $340,009, respectively, which is included in the accrued expenses on the balance sheet.

 

Notes payable, Dr. Comella

 

On September 6, 2016, the Company issued a $300,000 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and was due upon demand. During the nine months ended September 30, 2019, the Company received $107,868 of previously paid balance of the outstanding promissory note. The principal outstanding balance of this note as of September 30, 2019 and December 31, 2018 is $255,579 and $147,711, respectively.

 

On August 7, 2017, the Company issued a $300,000 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due one year from date of issuance. The principal outstanding balance of this note as of September 30, 2019 and December 31, 2018 is $300,000.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

SEPTEMBER 30, 2019

(unaudited)

 

On May 7, 2018, the Company issued a $300,000 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due six months from date of issuance. The principal outstanding balance of this note as of September 30, 2019 and December 31, 2018 is $300,000.

 

On July 1, 2019, the Company issued a $300,000 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due November 7, 2019. The principal outstanding balance of this note as of September 30, 2019 is $300,000.

 

At September 30, 2019 and December 31, 2018, the Company has recorded accrued interest on the outstanding notes to Dr. Comella in the amount of $136,144 and $102,974, respectively, which is included in the accrued expenses on the balance sheet.

 

Dr. Comella is no longer a member of the Board of Directors after September 1, 2019.

 

Transactions with Pavillion

 

On May 1, 2016, the Company entered into a consulting agreement with Pavillion, Inc., whose owner is related to an officer of the Company.  The agreement is for 12 months and renewable for 6-month periods.  Compensation is at $250 per hour or, at the Company’s discretion, in shares of the Company’s common stock. For the nine months ended September 30, 2019 and 2018, the Company has incurred $0 and $90,000 of expense under the agreement, respectively. As of September 30, 2019, and December 31, 2018, the Company had $0 and $64,909, respectively, in accounts payable owed to Pavillion. On June 1, 2018, effective June 30, 2018, the Company terminated the agreement in accordance with its terms and no further compensation was derived by Pavillion.

 

Transactions with GACP

 

On March 3, 2017, the Company entered into an asset sale and lease agreement (sale/leaseback transaction, the “Asset Sale and Lease Agreement”) with GACP, whereby the Company sold certain lab, medical and other equipment relating to the cell banking business for $400,000 and leased back the sold equipment over a three year term (See “Lab and Medical Equipment Capitalized Lease” below). The Company determined that the transaction was a capitalized lease and accordingly recorded the leased assets and liability based on the estimated present value of the minimum lease payments (see Notes 4, 8 and 12).

 

In connection with the asset sale and lease agreement, the Company is obligated to accrue 10% of banking revenue as for marketing, offset by any incurred costs of the Company.  At September 30, 2019 and December 31, 2018, the outstanding accrued marketing obligation is $2,378 and $179,353, respectively (see Note 6).

 

On March 3, 2017, the Company also entered into a customer purchase agreement with GACP, whereby the Company agreed to sell, for $50,000, the first 5,000 customers of the cell banking business after the effective date of the equipment sale/leaseback agreement with rights to purchase additional customers at a price of $20 per customer.  There is no reduction in the selling price should the new customers be fewer than 5,000.  The effective date of the sale is upon the expiry or early termination of the related equipment lease transaction.

 

On March 3, 2017, the Company also entered into an asset purchase agreement of intellectual property with GACP whereby the Company agreed to sell all of the Company’s worldwide rights, title or interest in certain intellectual and other property (as defined) associated with the cell banking business for $50,000. The effective date of the sale is upon the expiry or early termination of the related equipment lease transaction.

 

In connection with the March 3, 2017 asset purchase agreement, the CEO and CSO of U.S. Stem Cell, Inc. were also retained as CEO and CSO of American Stem Cell Centers of Excellence, which is owned by General American Capital Partners (GACP), to help with scientific and successful operational deployment of clinics. Subsequently, the CSO of U.S. Stem Cell, Inc. has vacated her position.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

SEPTEMBER 30, 2019

(unaudited)

 

On April 3, 2017, U.S. Stem Cell received a commitment to invest up to $5,000,000 from GACP with the intent for GACP to receive up to 63,873,275 shares of common stock.  To date, GACP has invested, pursuant to this commitment, $250,000 in return for 858,281 shares. Subsequent to this investment, GACP has informed the Company that they will make no further investments pursuant to this agreement and has entered into a new agreement to open their own clinics (branded American Stem Cell) using the US Stem Cell Inc. protocols, procedures, products and technologies. As of September 30, 2019 (effective May 9, 2018), pursuant to an Amendment to Asset Sale and Lease Agreement, dated June 18, 2018, GACP has suspended their obligation to open additional clinics (tolling such obligation to a mutually agreeable date in the future) and has suspended the monthly aggregate number of stem cell kits set forth for purchase in a given month arising from such clinics. As of September 30, 2019, and December 31, 2018, GACP owns 4,021,945 shares of the Company’s common stock.

 

As a consequence of the Court Order (see Note 10), the Company resolved to divest itself of certain equipment and other assets (the “Equipment Assets”) used in connection with the Company’s human tissue banking business, but consistent however with the requirements of the Court Order, and to adjust the business plan and operations to accommodate this potential divesture. To facilitate the above, the Company entered into the following agreements, which are not yet effective, as discussed below

 

 

Termination and Release Agreement by and between GACP, the Company, and Michael Tomas and Kristin Comella dated September 24, 2019 (terminating the Non-Competition and Non-Solicitation Agreement between U.S. Stem Cell, Inc. and GACP Stem Cell Bank LLC., dated March 3, 2017).

 

Letter Agreement on Stem Cell Processing and Storage by and between the Company and American Cell Technology, LLC

 

The foregoing agreements are qualified in their entirety by reference to such documents, which are attached as Exhibits hereto.

 

NOTE 9 — STOCKHOLDERS’ EQUITY

 

During the nine months ended September 30, 2019, the Company issued an aggregate of 16,166,984 shares of its common stock in settlement of outstanding accounts payable and accrued expenses. In connection with the issuance, the Company incurred a $21,892 net gain in settlement of debt.

 

During the nine months ended September 30, 2019, the Company issued 3,500,000 shares of its common stock for services.

 

Stock Options

 

On April 1, 2013, the Board of Directors approved, subject to subsequently received shareholder approval, the establishment of the Bioheart 2013 Omnibus Equity Compensation Plan, or the “2013 Omnibus Plan” (replacing the 1999 Officers and Employees Stock Option Plan, or the Employee Plan, and the 1999 Directors and Consultants Stock Option Plan). The 2013 Omnibus Plan initially reserved up to fifty thousand (50,000) shares of common stock for issuance. On August 4, 2014, the Board of Directors approved to set the reserve to one hundred thousand (100,000) shares of common stock for issuance and to close the 1999 Officers and Employees Stock Option Plan. On February 2, 2015, at the annual meeting of shareholders, the majority of shareholders approved the 2013 Omnibus Equity Compensation Plan.

 

On November 2, 2015, the Board of Directors approved the increase of the reserve under the 2013 Omnibus Plan to five hundred million (500,000,000) shares of common stock for issuance, effective September 16, 2016, approved an addition of twenty five million (25,000,000) shares of common stock to the reserve, effective April 21, 2017, approved an addition of twenty five million (25,000,000) shares of common stock to the reserve, effective August 7, 2017, approved an addition of thirty million (30,000,000) shares of common stock to the reserve and effective May 7, 2018, approved an addition of one hundred million (100,000,000) shares of common stock to reserve.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

SEPTEMBER 30, 2019

(unaudited)

 

A summary of options at September 30, 2019 and activity during the three months then ended is presented below:

 

   

Shares

   

Weighted-

Average

Exercise Price

   

Weighted-

Average

Remaining

Contractual

Term (in years)

 
                         

Options outstanding at December 31, 2018

    112,970,693     $ 0.03294       8.7  

Granted

    33,400,000     $ 0.0057       10.0  

Exercised

                     

Forfeited/Expired

    (25,332,038

)

  $ 0.02516          

Options outstanding at September 30, 2019

    121,038,655     $ 0.02663       7.2  

Options exercisable at September 30, 2019

    64,778,655     $ 0.02892       5.8  

Available for grant at September 30, 2019

    41,668,070                  

 

The following information applies to options outstanding and exercisable at September 30, 2019:

 

Exercise
Price

 

 

Number
Outstanding

 

 

Option Outstanding Options Average Remaining Contractual Life (years)

 

 

Weighted Average
Exercise price

 

 

Number
Exercisable

 

 

Options Exercisable Weighted Average

Exercise price

 

$

0.0043

 

 

 

13,600,000

 

 

 

6.05

 

 

$

0.0043

 

 

 

8,050,000

 

 

$

0.0043

 

 

0.00557

 

 

 

23,400,000

 

 

 

9.93

 

 

 

0.00557

 

 

 

-

 

 

 

0.00557

 

 

0.0196

 

 

 

21,550,000

 

 

 

5.34

 

 

 

0.0196

 

 

 

19,050,000

 

 

 

0.0196

 

 

0.02511

 

 

 

9,000,000

 

 

 

7.69

 

 

 

0.02511

 

 

 

9,000,000

 

 

 

0.02511

 

 

0.02576

 

 

 

2,220,000

 

 

 

8.86

 

 

 

0.02576

 

 

 

555,000

 

 

 

0.02576

 

 

0.03626

 

 

 

28,095,000

 

 

 

6.44

 

 

 

0.03626

 

 

 

19,985,000

 

 

 

0.03626

 

 

0.0536

 

 

 

22,500,000

 

 

 

7.68

 

 

 

0.0536

 

 

 

7,500,000

 

 

 

0.0536

 

 

0.15402

 

 

 

673,655

 

 

 

4.33

 

 

 

0.15402

 

 

 

638,655

 

 

 

0.15402

 

Total

 

 

 

121,038,655

 

 

 

6.8

 

 

$

0.02701

 

 

 

64,778,655

 

 

$

0.02964

 

 

The aggregate intrinsic value of the issued and exercisable options of $33,252 and $13,685, respectively, represents the total pretax intrinsic value, based on options with an exercise price less than the Company’s stock price of $0.006 as of September 30, 2019, which would have been received by the option holders had those option holders exercised their options as of that date.

 

On September 1, 2019, the Company granted an aggregate 33,400,000 options to purchase the Company’s common stock at $0.00557 per share to key employees, vesting over 4 years, at grant date anniversary and exercisable over 10 years. The aggregate fair value of $192,189, determined using the Black Scholes option pricing model with the following assumptions: Dividend yield: 0%; Volatility: 215.10% and Risk-free rate: 1.45%.

 

The fair value of all options vesting during the three and nine months ended September 30, 2019 of $174,450 and $512,882, respectively, was charged to current period operations.

 

As of September 30, 2019, the Company had approximately $1,594,448 of total unrecognized compensation cost related to non-vested awards granted under the 2013 Omnibus Plan, which the Company expects to recognize over a weighted average period of 1.31 years.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

SEPTEMBER 30, 2019

(unaudited)

 

Warrants

 

A summary of common stock purchase warrants at September 30, 2019 and activity during the nine months ended September 30, 2019 is presented below:

 

 

 

Shares

 

 

Weighted-

Average

Exercise

Price

 

 

Weighted-

Average

Remaining

Contractual

Term (in years)

 

Outstanding at December 31, 2018

 

 

1,114,019

 

 

$

14.735

 

 

 

9.1

 

Issued

 

 

-

 

 

 

 

 

 

 

 

 

Exercised

 

 

-

 

 

 

 

 

 

 

 

 

Expired

 

 

(1,768

)

 

$

532.10

 

 

 

 

 

Outstanding at September 30, 2019

 

 

1,112,251

 

 

$

13.91

 

 

 

8.4

 

Exercisable at September 30, 2019

 

 

1,110,706

 

 

$

3.24

 

 

 

8.4

 

 

The following information applies to common stock purchase warrants outstanding and exercisable at September 30, 2019:

 

Warrants Outstanding   

 

 

Warrants Exercisable

 

 

 

 

 

Exercise
Price

 

 

Shares

 

 

Weighted-

Average

Remaining

Contractual

Term

 

 

Weighted-

Average

Exercise

Price

 

 

Shares

 

 

Weighted-

Average

Exercise

Price

 

$

0.01 – 20.00

 

 

 

1,086,536

 

 

 

8.5

 

 

$

1.267

 

 

 

1,086,536

 

 

$

1.27

 

$

20.01 – 30.00

 

 

 

19,543

 

 

 

4.4

 

 

$

25.06

 

 

 

19,543

 

 

$

25.06

 

$

40.01 - 50.00

 

 

 

2,253

 

 

 

3.0

 

 

$

48.83

 

 

 

2,253

 

 

$

48.83

 

$

50.01 –60.00

 

 

 

543

 

 

 

1.8

 

 

$

60.00

 

 

 

543

 

 

$

60.00

 

> $60.00

 

 

 

3,376

 

 

 

3.3

 

 

$

3,988,74

 

 

 

1,831

 

 

$

865.62

 

 

 

 

 

 

1,112,251

 

 

 

8.4

 

 

$

13.91

 

 

$

1,110,706

 

 

$

3.24

 

 

The aggregate intrinsic value of the issued and exercisable warrants of $-0- represents the total pretax intrinsic value, based on warrants with an exercise price less than the Company’s stock price of $0.006 as of September 30, 2019, which would have been received by the warrant holders had those warrants holders exercised their warrants as of that date.

 

NOTE 10 — COMMITMENTS AND CONTINGENCIES

 

Litigation

 

On December 12, 2017, a product liability lawsuit was filed in Broward County, specifically Jeannine Mallard v. U.S. Stem Cell, Inc., US Stem Cell Clinics LLC., Regenestem, LLC., Regenestem Network, LLC., and Kristin C. Comella. The Company will continue to defend it vigorously.

 

On September 17, 2015, a product liability lawsuit was filed in Broward County, specifically Patsy Bade v. Bioheart, Inc. US Stem Cell Clinics LLC, Alejandro Perez, ARNP, and Shareen Greenbaum, M.D., and on November 30, 2015, a product liability lawsuit was filed in Broward County, specifically Elizabeth Noble v. Bioheart, Inc. US Stem Cell Clinics LLC, Alejandro Perez, ARNP, and Shareen Greenbaum, M.D. During the year ended December 31, 2016, both matters settled by the Company’s insurance policy with no additional cost to the Company, excluding the Company payment of the $100,000 insurance company deductible of which $11,000 was paid in fiscal 2017. As a result of the final settlement and determination of insurance coverage, the Company recognized $100,000 of expense due to litigation for the year ended December 31, 2017, of which $89,000 is included in accrued expenses at September 30, 2019 and December 31, 2018.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

SEPTEMBER 30, 2019

(unaudited)

 

The Company is subject at times to other legal proceedings and claims, which arise in the ordinary course of its business.  Although occasional adverse decisions or settlements may occur, the Company believes that the final disposition of such matters should not have a material adverse effect on its financial position, results of operations or liquidity.  There was no outstanding litigation as of September 30, 2019 other than that described above.

  

Government Claim

 

On May 9, 2018, the U.S. Department of Justice filed an injunctive action, specifically United States of America v. U.S. Stem Clinic, LLC, U.S. Stem Cell, Inc., Kristin C. Comella, and Theodore Gradel. The Complaint alleges, among other matters that the defendants manufacture “stromal vascular fraction” (SVF) products from patient adipose (fat) tissue, which the companies then market as stem cell-based treatments, and which U.S. Stem Cell Clinic, LLC administers to patients, without first obtaining what the government alleges are necessary FDA approvals. Although Theodore Gradel was initially listed as a defendant, he subsequently entered into a consent agreement and is no longer party to this case.

 

The U.S. and the defendants filed cross motions for summary judgment, each asking for a ruling in its favor. On June 3, 2019, the Court entered an order granting Summary Judgment for the government and denying the defendants’ motion for summary judgment. The order focused on the defendants’ actions in providing and marketing SVF therapy. In an order dated June 4, 2019, the Court granted the defendants’ request to allow it the opportunity to work out the language of the form of injunction with the government, and if unsuccessful, to provide a status report to the Court by June 14, 2019, outlining areas of disagreement. The Court further ordered that the defendants (U.S. Stem Clinic, LLC, U.S. Stem Cell, Inc., and Kristin C. Comella) ‘not sell, provide or otherwise engage in any SVF therapy or any other activities to be regulated by the FDA as explained in the Court’s Order on the Parties’ Motions for Summary Judgment.” On June 25, 2019, the Court entered an Order of Permanent Injunction, generally enjoining the defendants with respect to the SVF Product and requiring other actions. On – August 23, 2019, the Company has filed a notice of appeal of this judgment, and orders entered subsequent to the judgment.  In the interim, the Company has complied with the injunction requirements of the Court. The Company, in divesting certain equipment and other assets and assigning its lease, has and will continue to experience a decrease in revenues as the Company both maintains the remainder of the business and transitions into similar or unrelated business opportunities as determined by management (see Item 2 Existing Capital Resources and Future Capital Requirements and Plan of Operations below); However, management is not able to predict the duration, scope, results, or consequences of the  summary judgment and any transition of the business plan.  There can be no assurance that the Company will prevail on its appeal and obtain a reversal of the final judgment.

 

Since the Court’s issuance of the Order of Permanent Injunction, the Company has received demand letters for compensation from persons who store their SVF Product and/or other tissue product with the tissue bank (several of the persons have requested refunds of the monies paid to the tissue bank and one person has requested a full refund of monies paid to an altogether separate company due to her not receiving the full amount of treatments she requested; such requests for compensation, to date, have not been material) and requests that the Company preserve cells in the Company’s possession.  The Company sought guidance from the Court, which entered an order generally staying the requirement to destroy any SVF Product, pending a decision on the Company’s appeal.

 

Settlement Agreement and General Release

 

The Company was one of the parties to a Settlement Agreement and General Release (the “Agreement”) dated June 3, 2019 related to certain medical procedures. Without admitting any liability, and as part of that Agreement, the Company agreed to provide a five-year 5.25% Promissory Note, dated June 15, 2019, in the principal amount of Five Hundred Thousand Dollars ($500,000), payable in monthly increments of Five Thousand ($5,000) per month (see Note 7, Weider Promissory Note, above)

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

SEPTEMBER 30, 2019

(unaudited)

 

NOTE 11 — FAIR VALUE MEASUREMENT

 

The Company adopted the provisions of Accounting Standards Codification subtopic 825-10, Financial Instruments (“ASC 825-10”) on January 1, 2008. ASC 825-10 defines fair value as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining the fair value measurements for assets and liabilities required or permitted to be recorded at fair value, the Company considers the principal or most advantageous market in which it would transact and considers assumptions that market participants would use when pricing the asset or liability, such as inherent risk, transfer restrictions, and risk of nonperformance. ASC 825-10 establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 825-10 establishes three levels of inputs that may be used to measure fair value:

 

Level 1 – Quoted prices in active markets for identical assets or liabilities.

 

Level 2 – Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets with insufficient volume or infrequent transactions (less active markets); or model-derived valuations in which all significant inputs are observable or can be derived principally from or corroborated by observable market data for substantially the full term of the assets or liabilities.

 

Level 3 – Unobservable inputs to the valuation methodology that are significant to the measurement of fair value of assets or liabilities.

 

All items required to be recorded or measured on a recurring basis are based upon level 3 inputs.

 

To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, for disclosure purposes, the level in the fair value hierarchy within which the fair value measurement is disclosed and is determined based on the lowest level input that is significant to the fair value measurement.

 

Upon adoption of ASC 825-10, there was no cumulative effect adjustment to beginning retained earnings and no impact on the financial statements.

 

The carrying value of the Company’s cash and cash equivalents, accounts receivable, accounts payable, short-term borrowings (including convertible notes payable), and other current assets and liabilities approximate fair value because of their short-term maturity.

 

As of September 30, 2019, and December 31, 2018, the Company did not have any items that would be classified as level 1 or 2 disclosures.

 

As of September 30, 2019, and December 31, 2018, the Company did not have any derivative instruments that were designated as hedges.

 

There were no derivative and warrant liability as of September 30, 2019 and December 31, 2018.

 

 

U.S. STEM CELL, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

SEPTEMBER 30, 2019

(unaudited)

 

NOTE 12 — SUBSEQUENT EVENTS

 

After September 30, 2019, the Company address has changed to 1560 Sawgrass Corporate Pkwy 4th Floor, Sunrise, FL 33323 with a month to month lease at a cost of $269.54 per month.

 

On October 15, 2019, the Company, as a result of being unable to meet the $0.01 bid test, is no longer being quoted on “The OTCQB® Venture Market” but is being reported on the “pink sheets” under the symbol “USRM.PK.”

 

As a consequence of the Court Order (see Note 10), the Company resolved to divest itself of certain equipment and other assets (the “Equipment Assets”) used in connection with the Company’s human tissue banking business, but consistent however with the requirements of the Court Order, and to adjust the business plan and operations to accommodate this potential divesture. To facilitate the above, the Company entered into an Assignment and Assumption of Lease by and between the Company, American Cell Technology, LLC, and Sawgrass Business Plaza, LLC, dated October 24, 2019.

 

In October 2019, the Company issued 1,692,353 shares of common stock as payment of $9,195.12 Northstar interest.

 

In October 2019, the Company issued an aggregate of 5,011,747 shares of common stock for services rendered. 

 

In October 2019, the Company issued an aggregate of 2,661,935 shares of common stock for investment.

 

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

Unless otherwise indicated, references in this Quarterly Report on Form 10-Q to “we,” “us,” and “our” are to the Company, unless the context requires otherwise. The following discussion and analysis by our management of our financial condition and results of operations should be read in conjunction with our unaudited condensed interim financial statements and the accompanying related notes included in this quarterly report and our audited financial statements and related notes and Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2018 filed with the Securities and Exchange Commission.

 

Cautionary Statement Regarding Forward-Looking Statements

 

This report may contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act, and we intend that such forward-looking statements be subject to the safe harbors created thereby. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Any such forward-looking statements would be contained principally in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors.” Forward-looking statements include information concerning our possible or assumed future results of operations, business strategies, financing plans, competitive position, industry environment, potential growth opportunities and the effects of regulation. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as “anticipates,” “believes,” “could,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or similar expressions.

 

This report may contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act, and we intend that such forward-looking statements be subject to the safe harbors created thereby. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Any such forward-looking statements would be contained principally in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors.” Forward-looking statements include information concerning our possible or assumed future results of operations, business strategies, financing plans, competitive position, industry environment, potential growth opportunities and the effects of regulation. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as “anticipates,” “believes,” “could,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or similar expressions.

 

Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We discuss many of these risks in greater detail in “Risk Factors.” Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent our management’s beliefs and assumptions only as of the date of this report. You should read this report and the documents that we reference in this report and have filed as exhibits to the report completely and with the understanding that our actual future results may be materially different from what we expect. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

 

Additional information concerning these, and other risks and uncertainties is contained in our filings with the Securities and Exchange Commission, including the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2018.

 

Unless otherwise indicated or the context otherwise requires, all references in this Form 10-Q to “we,” “us,” “our,” “our company,” “U. S. Stem Cell, Inc.” or the “Company” refer to U.S. Stem Cell, Inc. and its subsidiaries.

 

Our Ability to Continue as a Going Concern

 

Our independent registered public accounting firm has issued its report dated March 13, 2019, in connection with the audit of our annual financial statements as of December 31, 2018, that included an explanatory paragraph describing the existence of conditions that raise substantial doubt about our ability to continue as a going concern and Note 2 to the unaudited financial statements for the period ended September 30, 2019 also describes the existence of conditions that raise substantial doubt about our ability to continue as a going concern.

 

 

Overview

 

We are an enterprise in the regenerative medicine/cellular therapy industry. Our prior focus was on the discovery, development, and commercialization of cell based therapeutics. Our business included the development of proprietary cell therapy products as well as revenue generating physician and patient based regenerative medicine/cell therapy training services, revenues realized from an Asset Sale and Lease Agreement (See Notes 4, 5,  8, and 10 of the Financial Statements and description below) related to the segment of our company business involving collecting, growing and banking cell cultures treatment kits for humans and animals, and the operation of a cell therapy clinic.

 

US Stem Cell Training, Inc. (“SCT”), an operating division of our company, is a content developer of regenerative medicine/cell therapy informational and training materials for physicians and patients. SCT also provides in-person and online training courses which are delivered through in-person presentations at SCT’s state of the art facilities and globally at university, hospital and physician’s office locations as well as through online webinars. Additionally, SCT provides hands-on clinical application training for physicians and health care professionals interested in providing regenerative medicine / cell therapy procedures.

 

Vet biologics, (“VBI”), an operating division of our company, is a veterinary regenerative medicine company committed to providing veterinarians with the ability to deliver the highest quality regenerative medicine therapies to dogs, cats and horses. VBI provides veterinarians with extensive regenerative medicine capabilities including the ability to isolate regenerative stem cells from a patient’s own adipose (fat) tissue directly on-site within their own clinic or stall-side.

 

US Stem Cell Clinic, LLC, (“SCC”), Regenerative Wellness Clinic, LLC, and US Stem Cell Clinic of the Villages, LLC are partially owned investment of our company (in which we have a 49.9%, 49.9% and 49% respectively member interests), are physician run regenerative medicine/cell therapy clinics providing cellular treatments for patients afflicted with neurological, autoimmune, orthopedic and degenerative diseases. They are operating in compliance with the FDA 1271s which allow for same day medical procedures to be considered the practice of medicine. We isolate stem cells from bone marrow and also utilize platelet rich plasma and birth tissue products.

 

Our comprehensive map of products and services:

 

 

Our mission is to advance to market novel regenerative medicine and cellular therapy products that substantially benefit humankind. Our business strategy is, to the extent possible, finance our clinical development pipeline through revenue (cash in-flows) generated through the marketing and sales of unique educational and training services, animal health products and personalized cellular therapeutic treatments.. Accordingly, we have developed a multifaceted portfolio of revenue generating products and services in our US Stem Cell Training, Vetbiologics, and US Stem Cell Clinic/Regenerative Wellness Clinic, operating divisions that will, if successful, financially support its clinical development programs. Our goal is to maximize shareholder value through the generation of short-term profits that increase cash in-flows and decrease the need for venture financings – a modern biotechnology company development strategy.

 

Today, our company is a combination of opportunistic business enterprises. What we are establishing is a foundation of value in the products and services we are and plan to sell from US Stem Cell Training, Vetbiologics, and US Stem Cell clinics. Our strategy is to expand the revenues generated from each of these operating divisions and to reinvest the profits we generate into our clinical development pipeline.

 

 

On November 9, 2016, we executed a Commercial Agency Agreement with High Rising Group Company (General Trading and Construction) and subsequently, on February 10,  2017, we authorized High Rising Group Company as an independent contractor and Licensee for our company for the territories of Kuwait and the Middle East (expressly excluding prohibited countries pursuant to the Patriot Act and The Iran Threat Reduction and Syria Human Rights Act of 2012). The intent of the agreement is for High Rising Group Company to establish clinics specializing in regenerative medicine, stem cell treatment and therapy, including stem cell bank, training, and all related stem cell machines and equipment.  To date, the first clinic in Kuwait City has been completed but has not begun operations as High Rising Group has not yet been able to secure regulatory approvals to operate. With the ongoing construction of the The Sheikha Salwa Sabah Al-Ahmad Center for Stem Cell and Umbilical Cord, a public/private partnership with the government of Kuwait, (see http://news.kuwaittimes.net/website/stem-cell-center-epitomizes-ppp which is expressly not incorporated by reference to this filing), management hopes (but cannot guarantee) that private sector stem cell centers, as described above, will get regulatory approval.

 

On March 3, 2017, we entered into an asset sale and lease agreement (sale/leaseback transaction; “Asset Sale and Lease Agreement”), with GACP (General American Capital Partners) Stem Cell Bank LLC, a Florida limited liability company (“GACP”) whereby we sold certain lab, medical and other equipment relating to the cell banking business for $400,000 and leased back the sold equipment over a three year term.  The lease includes a base monthly rental payment of $20,000, due the first day of each calendar month.  In addition, we are required to pay 2.3%, 22.5% and 31.6% of revenues collected on deposits arising from cell banking business for years 1, 2 and 3, respectively.  At the expiration of the lease, we are required to return all leased equipment and along with any maintenance records, logs, etc. in our possession to the lessor with no right of repurchase. In addition, GACP has contractually agreed to invest an additional Two and a half Million Dollars ($2,500,000) to open ten (10) stem cell clinics in the United States within 3 years--with a penalty provision to our benefit for shortfalls if less than 6 clinics are opened within 24 months.

 

As of September 30, 2019 (effective May 9, 2018), pursuant to an Amendment to Asset Sale and Lease Agreement, dated June 18, 2018, GACP has suspended their obligation to open additional clinics (tolling such obligation to a mutually agreeable date in the future) and has suspended the monthly aggregate number of stem cell kits set forth for purchase in a given month arising from such clinics. All other terms and conditions of the agreements between U.S. Stem Cell, Inc. and GACP remain in full force and effect.

 

Recently, the June 25, 2019 Order of Permanent Injunction arising from the action brought by the Department of Justice (see Note 10 of the Financial Statements and Part II, Item 1 herein), has resulting in management considering modifications to our business model in order to offset the loss of revenue resulting from the consequences of this Injunctive Order. As of the date herein, no specific undertakings have commenced. Since the Court’s issuance of the Order of Permanent Injunction, we have received demand letters for compensation from persons who store their SVF Product and/or other tissue product with the tissue bank (several of the persons have requested refunds of the monies paid to the tissue bank and one person has requested a full refund of monies paid to an altogether separate company due to her not receiving the full amount of treatments she requested; such requests for compensation, to date, have not been material) and requests that we preserve cells in our possession.

 

As a consequence of the Court Order (see Note 10), the Company resolved to divest itself of certain equipment and other assets (the “Equipment Assets”) used in connection with the Company’s human tissue banking business, but consistent however with the requirements of the Court Order, and to adjust the business plan and operations to accommodate this potential divesture. To facilitate the above, the Company entered into the following agreements, which are not yet effective, as discussed below

 

 

Termination and Release Agreement by and between GACP, the Company, and Michael Tomas and Kristin Comella dated September 24, 2019 (terminating the Non-Competition and Non-Solicitation Agreement between U.S. Stem Cell, Inc. and GACP Stem Cell Bank LLC., dated March 3, 2017 and any contractor agreement with officers of our company).

 

Letter Agreement on Stem Cell Processing and Storage by and between the Company and American Cell Technology, LLC;

 

Assignment and Assumption of Lease by and between the Company, American Cell Technology, LLC, and Sawgrass Business Plaza, LLC, dated October 24, 2019.

 

The foregoing agreements are qualified in their entirety by reference to such documents, which are attached as Exhibits hereto.

 

We will continue to evaluate and act upon opportunities to increase our top line revenue position and that correspondingly increase cash in-flows. These opportunities include but are not limited to the development and marketing of new products and services, mergers and acquisitions, joint ventures, licensing deals and more.

 

Further, if the opportunity presents itself whereby we can raise additional capital at a reasonable fair market value, our management will do so. Accordingly, we plan to continue in our efforts to restructure, equitize or eliminate legacy balance sheet issues that are obstacles to market capitalization appreciation and capital fund raising.

 

 

Results of Operations Overview

 

We are a research and development company and our product candidates have not received regulatory approval or generated any material revenues and is not expected generate revenues until commercialization  , if ever. We have generated substantial net losses and negative cash flow from operations since inception and anticipate incurring significant net losses and negative cash flows from operations for the foreseeable future as we continue clinical trials, undertake new clinical trials, apply for regulatory approvals, make capital expenditures, add information systems and personnel, make payments pursuant to our license agreements upon our achievement of certain milestones, continue development of additional product candidates using our technology, establish sales and marketing capabilities and incur the additional cost of operating as a public company. In addition, and as a result of the Court Order (see Note 10), we resolved to divest our company of certain equipment and other assets which will substantially reduce our ability to generate revenues until such time as alternative revenue producing materialize as well as assign our lease.

 

Three Months Ended September 30, 2019 as compared to the Three Months Ended September 30, 2018

 

Revenues

 

We recognized revenues of $156,591 for the three months ended September 30, 2019. These revenues were generated from the sales of kits and equipment, services, MyoCath Catheters, , and laboratory services. We recognized revenues of $1,503,884 for the three months ended September 30, 2018 from the sale of MyoCath catheters, physician training, patient studies and laboratory services. Due to the Injunction, as described in our Note 10 to our financial statements, our revenue for 2019 has been severely reduced.

 

Cost of Sales

 

Cost of sales consists of the costs associated with the production of MyoCath, laboratory supplies necessary for laboratory services, physician course materials, kits and clinic supplies required for patient studies.

 

Cost of sales were $137,366 and $544,398 in in the three-month periods ended September 30, 2019 and 2018, respectively. Associated gross margins were $19,225 (12.3%) and $959,486 (63.8%) for the three months periods ended September 30, 2019 and 2018, respectively.

 

Research and Development

 

Our research and development expenses consist of costs incurred in identifying, developing, and testing, our products and services. Research and development expenses were $0 in the three-month period ended September 30, 2019, a decrease of $599 from the research and development expenses of $599 in the three-month period ended September 30, 2018. Current management focus is towards on sales in addition to research and development and its corresponding ongoing costs. The timing and amount of our planned research and development expenditures is dependent on our ability to obtain additional financing.

 

Marketing, General and Administrative

 

Our marketing, general and administrative costs were $1,616,970 for the three-month period ended September 30, 2019 compared to $1,177,638 for the three-month period ended September 30, 2018, an increase of $439,332. The increase in costs are primarily due to annual compensation review of employees and officers in the current year, as compared to the prior year.

 

Our marketing, general and administrative expenses primarily consist of the costs associated with our general management and product and service marketing programs, including, but not limited to, salaries and related expenses for executive, administrative and marketing personnel, rent, insurance, legal and accounting fees, consulting fees, travel and entertainment expenses, conference costs and other clinical marketing and trade program expenses.

 

(Gain) Loss on settlement of debt

 

During the three months ended September 30, 2019, we incurred a net gain of $33,203 primarily related to accounts payable and debt restructured during the current period as compared to a net aggregate gain of $80,200 for the same period last year.

 

 

Gain on sale of equipment

 

In March 2017, we entered a sale/leaseback transaction whereby we sold our lab and other medical equipment and re-leased the equipment back for 36 months.  In connection with the sale/leaseback, we realized a gain on sale of equipment of $386,536, which we will recognize to operations over the term of the lease (36 months). During the three months ended September 30, 2019 and 2018, we recognized $32,211 and $32,211 in current period operations.

 

Income from equity investment

 

Our investment of a 49.9% (33.3% in 2018) member interest ownership of U.S. Stem Cell Clinic, LLC and Regenerative Wellness Clinic as well as a 49% interest in U.S. Stem Cell Clinic of the Villages LLC are accounted for using the equity method of accounting.  As such, we report our pro rata share of its income or loss for the period.  For the three months ended September 30, 2019 and 2018, our pro rata share of its income (loss) was $(33,478) and $160,216, respectively

 

Interest Expense

 

Interest expenses during the three months ended September 30, 2019 were $91,140 compared to $384,813 for the three months ended September 30, 2018. Interest expenses primarily consists of interest incurred on the principal amount of the Northstar loan, our former Bank of America loan, the Seaside National Bank loan, accrued fees and interest payable to the Guarantors, our capital lease and the amortization of debt discounts and non-cash interest incurred relating to our issued convertible notes payable. The debt discounts amortization and non-cash interest incurred during the three months ended September 30, 2019 and 2018 was $46,739 and $32,293, respectively.

 

Nine Months Ended September 30, 2019 as compared to the Nine Months Ended September 30, 2018

 

Revenues

 

We recognized revenues of $2,763,385 for the nine months ended September 30, 2019. These revenues were generated from the sales of kits and equipment, services, MyoCath Catheters, and laboratory services. We recognized revenues of $5,037,242 for the nine months ended September 30, 2018 from the sale of MyoCath catheters, physician training, patient studies and laboratory services. Due to the Injunction, as described in our Note 11 to our financial statements, our revenue for 2019 has been severely reduced.

 

Cost of Sales

 

Cost of sales consists of the costs associated with the production of MyoCath, laboratory supplies necessary for laboratory services, production of systems and materials, physician course materials, kits and clinic supplies required for patient studies.

 

Cost of sales were $1,297,926 and $1,615,431 in in the nine month periods ended September 30, 2019 and 2018, respectively. Associated gross margins were $1,597,926 (57.8%) and $3,421,811 (67.9%) for the nine months periods ended September 30, 2019 and 2018, respectively.

 

Research and Development

 

Our research and development expenses consist of costs incurred in identifying, developing, and testing, our products and services. Research and development expenses were $263 in the nine-month period ended September 30, 2019, a decrease of $4,264 from the research and development expenses of $4,527 in the nine-month period ended September 30, 2018. Current management focus is towards on sales in addition to research and development and its corresponding ongoing costs. The timing and amount of our planned research and development expenditures is dependent on our ability to obtain additional financing.

 

Marketing, General and Administrative

 

Our marketing, general and administrative costs were $3,628,652 for the nine-month period ended September 30, 2019 compared to $4,468,121 for the nine-month period ended September 30, 2018, a decrease of $839,469. The decrease in costs are primarily due to decreases in consulting and other professional fees, decrease in sales and marketing expenses and stock based and other compensation, as compared to the prior year.

 

 

Our marketing, general and administrative expenses primarily consist of the costs associated with our general management and product and service marketing programs, including, but not limited to, salaries and related expenses for executive, administrative and marketing personnel, rent, insurance, legal and accounting fees, consulting fees, travel and entertainment expenses, conference costs and other clinical marketing and trade program expenses.

 

Gain on settlement of debt

 

During the nine months ended September 30, 2019, we incurred a net gain of $21,892 primarily related to accounts payable and debt restructured during the current period as compared to a net aggregate gain of $45,013 for the same period last year.

 

Gain on sale of equipment

 

In March 2017, we entered a sale/leaseback transaction whereby we sold our lab and other medical equipment and re-leased the equipment back for 36 months.  In connection with the sale/leaseback, we realized a gain on sale of equipment of $386,536, which we will recognize to operations over the term of the lease (36 months). During the nine months ended September 30, 2019 and 2018, we recognized $96,634 and $96,634 in current period operations.

 

Income from equity investment

 

Our investment of a 49.9% (33.3% in 2018) member interest ownership of U.S. Stem Cell Clinic, LLC and Regenerative Wellness Clinic as well as a 49% interest in U.S. Stem Cell Clinic of the Villages LLC are accounted for using the equity method of accounting.  As such, we report our pro rata share of its income or loss for the period.  For the nine-months ended September 30, 2019 and 2018, our pro rata share of its income was $93,778 and $263,322, respectively

 

Interest Expense

 

Interest expenses during the nine-months ended September 30, 2019 were $850,677 compared to $1,068,238 for the nine-months ended September 30, 2018. Interest expenses primarily consists of interest incurred on the principal amount of the Northstar loan, our former Bank of America loan, the Seaside National Bank loan, accrued fees and interest payable to the Guarantors, our capital lease and the amortization of debt discounts and non-cash interest incurred relating to our issued convertible notes payable. The debt discounts amortization and non-cash interest incurred during the nine months ended September 30, 2019 and 2018 was $141,296 and $164,312, respectively.

 

Stock-Based Compensation

 

Stock-based compensation reflects our recognition as an expense of the value of stock options and other equity instruments issued to our employees and non-employees over the vesting period of the options and other equity instruments. We have granted to our employee’s options to purchase shares of common stock at exercise prices equal to the fair market value of the underlying shares of common stock at the time of each grant, as determined by our Board of Directors, with input from management.

 

We follow Accounting Standards Codification subtopic 718-10. Compensation (“ASC 718-10”) which requires that all share-based payments to both employee and non-employees be recognized in the income statement based on their fair values.

 

In awarding our common stock, our Board of Directors considered a number of factors, including, but not limited to:

 

 

our financial position and historical financial performance;

 

arm’s length sales of our common stock;

 

the development status of our product candidates;

 

the business risks we face;

 

vesting restrictions imposed upon the equity awards; and

 

an evaluation and benchmark