U.S. Stem Cell, Inc. - Quarter Report: 2014 June (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
___________________________________
FORM 10-Q
x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2014
OR
o | 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
________________________
BIOHEART, INC.
(Exact name of registrant as specified in its charter)
________________________
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Florida | 65-0945967 |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
13794 NW 4th Street, Suite 212, Sunrise, Florida 33325
(Address of principal executive offices) (Zip Code)
(954) 835-1500
(Registrants telephone number, including area code)
______________
Securities registered under Section 12(b) of the Exchange Act:
None
Securities registered under Section 12(g) of the Exchange Act:
Common Stock, $0.001 par value per share
(Title of Class)
_____________
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 x No o
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.045 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No o
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 x |
(Do not check if a smaller reporting company) |
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x.
As of August 1, 2014, there were 517,272,472 outstanding shares of the Registrant’s common stock, par value $0.001 per share.
Transitional Small Business Disclosure Format Yes o No x
BIOHEART, INC.
INDEX TO FORM 10-Q FILING
JUNE 30, 2014
TABLE OF CONTENTS
PART I | Financial Information | Page Number | |
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| Item 1. | Financial Information | 3 |
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| Condensed Balance Sheets June 30, 2014 (Unaudited) and December 31, 2013 | 4 |
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| Unaudited Condensed Statements of Operations (Unaudited) Three and Six Months Ended June 30, 2014 and 2013 | 5 |
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| Unaudited Condensed Statements of Stockholders Deficit (Unaudited) Six Months Ended June 30, 2014 | 6 |
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| Unaudited Condensed Statements of Cash Flows (Unaudited) Six Months Ended June 30, 2014 and 2013 | 7 |
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| Notes to Unaudited Condensed Financial Statements | 8 |
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| Item 2. | Managements Discussion and Analysis of Financial Condition and Results of Operations | 26 |
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| Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 33 |
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| Item 4. | Controls and Procedures | 33 |
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PART II | Other Information |
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| Item 1. | Legal Proceedings | 34 |
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| Item 1A. | Risk Factors | 34 |
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| Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 34 |
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| Item 3. | Defaults Upon Senior Securities | 34 |
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| Item 4. | Mine Safety Disclosures | 34 |
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| Item 5. | Other Information | 35 |
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| Item 6. | Exhibits | 35 |
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SIGNATURES |
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EX-31.1 | Management Certification |
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EX-32.1 | Sarbanes-Oxley Act |
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PART I FINANCIAL INFORMATION
Item 1.
Interim Financial Statements and Notes to Interim Financial Statements
General
The accompanying reviewed 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' equity 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, 2013. 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 six months ended June 30, 2014 are not necessarily indicative of the results that can be expected for the year ending December 31, 2014.
3
BIOHEART, INC. | ||||||||
CONDENSED BALANCE SHEETS | ||||||||
June 30, | December 31, | |||||||
2014 | 2013 | |||||||
(unaudited) | ||||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 91,221 | $ | 46,227 | ||||
Accounts receivable, net | 105,572 | 19,913 | ||||||
Prepaid and other | 3,980 | 784 | ||||||
Total current assets | 200,773 | 66,924 | ||||||
Property and equipment, net | 13,435 | 9,055 | ||||||
Other assets | 10,012 | 10,160 | ||||||
Total assets | $ | 224,220 | $ | 86,139 | ||||
LIABILITIES AND STOCKHOLDERS' DEFICIT | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 2,183,285 | $ | 2,382,267 | ||||
Accrued expenses | 2,300,700 | 4,480,335 | ||||||
Advances, related party | 247,657 | 416,198 | ||||||
Deposits | 478,286 | 478,286 | ||||||
Subordinated debt, related party | 1,500,000 | 1,500,000 | ||||||
Notes payable, related party | 1,594,752 | 2,241,477 | ||||||
Notes payable, net of debt discount | 1,454,457 | 1,930,841 | ||||||
Total current liabilities | 9,759,137 | 13,429,404 | ||||||
Long term debt: | ||||||||
Derivative liability | 874,153 | 403,811 | ||||||
Stockholders' deficit: | ||||||||
Preferred stock, par value $0.001; 20,000,000 shares authorized, 20,000,000 issued and outstanding | 20,000 | 20,000 | ||||||
Common stock, par value $0.001; 2,000,000,000 and 950,000,000 shares authorized, respectively; 506,639,901 and 379,787,745 shares issued and outstanding as of June 30, 2014 and December 31, 2013, respectively | 506,640 | 379,788 | ||||||
Additional paid in capital | 106,859,239 | 103,819,119 | ||||||
Common stock subscription | 160,000 | 215,000 | ||||||
Accumulated deficit | (117,954,949 | ) | (118,180,983 | ) | ||||
Total stockholders' deficit | (10,409,070 | ) | (13,747,076 | ) | ||||
Total liabilities and stockholders' deficit | $ | 224,220 | $ | 86,139 | ||||
See the accompanying notes to these financial statements |
4
BIOHEART, INC. | ||||||||||||||||
CONDENSED STATEMENTS OF OPERATIONS | ||||||||||||||||
(unaudited) | ||||||||||||||||
Three months ended June 30, | Six months ended June 30, | |||||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||||
Revenue | $ | 497,034 | $ | 20,129 | $ | 819,606 | $ | 24,321 | ||||||||
Cost and operating expenses: | ||||||||||||||||
Cost of sales | 107,119 | — | 201,565 | — | ||||||||||||
Research and development | 15,478 | 172,407 | 25,335 | 336,381 | ||||||||||||
Marketing, general and administrative | 831,362 | 439,389 | 1,669,691 | 809,922 | ||||||||||||
Depreciation and amortization | 1,123 | 481 | 1,986 | 1,250 | ||||||||||||
Total operating expenses | 955,082 | 612,277 | 1,898,577 | 1,147,553 | ||||||||||||
Net loss from operations | (458,048 | ) | (592,148 | ) | (1,078,971 | ) | (1,123,232 | ) | ||||||||
Other income (expenses): | ||||||||||||||||
Development revenues | — | — | — | — | ||||||||||||
Net gain on settlement of debt | 93,422 | — | 2,187,054 | 1,004,224 | ||||||||||||
Net gain (loss) on change of fair value of derivative liability | 311,414 | 551,176 | (177,957 | ) | (89,413 | ) | ||||||||||
Other income | — | — | — | 939 | ||||||||||||
Interest expense | (398,194 | ) | (709,366 | ) | (704,092 | ) | (1,061,749 | ) | ||||||||
Total other income (expenses) | 6,642 | (158,190 | ) | 1,305,005 | (145,999 | ) | ||||||||||
Net (loss) income before income taxes | (451,406 | ) | (750,338 | ) | 226,034 | (1,269,231 | ) | |||||||||
Income taxes (benefit) | — | — | — | — | ||||||||||||
NET (LOSS) INCOME | $ | (451,406 | ) | $ | (750,338 | ) | $ | 226,034 | $ | (1,269,231 | ) | |||||
Net (loss) income per common share, basic | $ | (0.001 | ) | $ | (0.003 | ) | $ | 0.001 | $ | (0.006 | ) | |||||
Net (loss) income per common share, diluted | $ | (0.001 | ) | $ | (0.003 | ) | $ | 0.000 | $ | (0.006 | ) | |||||
Weighted average number of common shares outstanding, basic | 471,842,494 | 218,057,409 | 436,892,204 | 202,735,064 | ||||||||||||
Weighted average number of common shares outstanding, diluted | 471,842,494 | 218,057,409 | 553,719,873 | 202,735,064 | ||||||||||||
See the accompanying notes to these financial statements |
5
BIOHEART, INC. | ||||||||||||||||||||||||||||||||
CONDENSED STATEMENT OF STOCKHOLDERS' DEFICIT | ||||||||||||||||||||||||||||||||
SIX MONTHS ENDED JUNE 30, 2014 | ||||||||||||||||||||||||||||||||
(unaudited) | ||||||||||||||||||||||||||||||||
Additional | ||||||||||||||||||||||||||||||||
Preferred stock | Common stock | Paid in | Subscription | Accumulated | ||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Capital | Receivable | Deficit | Total | |||||||||||||||||||||||||
Balance, December 31, 2013 | 20,000,000 | $ | 20,000 | 379,787,745 | $ | 379,788 | $ | 103,819,119 | $ | 215,000 | $ | (118,180,983 | ) | $ | (13,747,076 | ) | ||||||||||||||||
Common stock issued in settlement of accounts payable | — | — | 31,052,689 | 31,053 | 518,395 | — | — | 549,448 | ||||||||||||||||||||||||
Common stock issued in connection with settlement of other debt | — | — | 51,823,229 | 51,823 | 1,464,272 | — | — | 1,516,095 | ||||||||||||||||||||||||
Common stock issued for services | — | — | 3,839,832 | 3,840 | 180,151 | — | — | 183,991 | ||||||||||||||||||||||||
Common stock issued upon exercise of warrants | — | — | 11,918,181 | 11,918 | 124,082 | — | — | 136,000 | ||||||||||||||||||||||||
Proceeds from issuance of common stock | — | — | 28,218,225 | 28,218 | 397,782 | (55,000 | ) | — | 371,000 | |||||||||||||||||||||||
Fair value of vesting warrants issued in connection with joint venture and intellectual property | — | — | — | — | 112,070 | — | — | 112,070 | ||||||||||||||||||||||||
Stock based compensation | — | — | — | — | 243,368 | — | — | 243,368 | ||||||||||||||||||||||||
Net income | — | — | — | — | — | — | 226,034 | 226,034 | ||||||||||||||||||||||||
Balance, June 30, 2014 | 20,000,000 | $ | 20,000 | 506,639,901 | $ | 506,640 | $ | 106,859,239 | $ | 160,000 | $ | (117,954,949 | ) | $ | (10,409,070 | ) | ||||||||||||||||
See the accompanying notes to these financial statements |
6
BIOHEART, INC. | ||||||||
CONDENSED STATEMENTS OF CASH FLOWS | ||||||||
(unaudited) | ||||||||
Six months ended June 30, | ||||||||
2014 | 2013 | |||||||
CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
Net income (loss) | $ | 226,034 | $ | (1,269,231 | ) | |||
Adjustments to reconcile net income (loss) to net cash used in operating activities: | ||||||||
Depreciation and amortization | 1,986 | 1,250 | ||||||
Bad debt expense | 28,732 | — | ||||||
Discount on convertible debt | 201,615 | 242,635 | ||||||
Loss on change in fair value of derivative liability | 177,957 | 89,413 | ||||||
Net gain on settlement of debt | (2,187,054 | ) | (1,004,224 | ) | ||||
Non cash payment of interest | 280,876 | 221,395 | ||||||
Warrants issued in connection with joint venture agreement and intellectual property | 112,070 | — | ||||||
Common stock issued in connection with accounts payable | — | 2,500 | ||||||
Preferred stock issued in settlement of debt and forbearance agreement | — | 274,050 | ||||||
Stock based compensation | 282,119 | 38,380 | ||||||
(Increase) decrease in: | ||||||||
Receivables | (114,391 | ) | 1,122 | |||||
Inventory | — | 62,953 | ||||||
Prepaid and other current assets | (3,048 | ) | 38,442 | |||||
Increase (decrease) in: | ||||||||
Accounts payable | 255,392 | (71,135 | ) | |||||
Accrued expenses | 230,653 | 277,294 | ||||||
Net cash used in operating activities | (507,059 | ) | (1,095,156 | ) | ||||
CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
Acquisitions of property and equipment | (6,366 | ) | — | |||||
Net cash used by investing activities | (6,366 | ) | — | |||||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
Bank overdraft | — | (89 | ) | |||||
Proceeds from issuance of common stock, net | 371,000 | 850,000 | ||||||
(Repayments) proceeds from related party advances | (13,241 | ) | 180,500 | |||||
Proceeds from exercise of stock options and warrants | 136,000 | — | ||||||
Proceeds from notes payable | 288,000 | 237,500 | ||||||
Repayments of notes payable | (223,340 | ) | — | |||||
Net cash provided in financing activities | 558,419 | 1,267,911 | ||||||
Net increase in cash and cash equivalents | 44,994 | 172,755 | ||||||
Cash and cash equivalents, beginning of period | 46,227 | — | ||||||
Cash and cash equivalents, end of period | $ | 91,221 | $ | 172,755 | ||||
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION | ||||||||
Interest paid | $ | 161,532 | $ | 277,683 | ||||
Income taxes paid | $ | — | $ | — | ||||
Non cash financing activities: | ||||||||
Common stock issued in settlement of notes payable | $ | 787,289 | $ | 140,000 | ||||
Common stock issued in settlement of accounts payable | $ | 549,448 | $ | 149,239 | ||||
Common stock issued in settlement of related party notes and advances payable | $ | 728,806 | $ | — | ||||
Preferred stock issued in settlement of notes payable | $ | — | $ | 70,000 | ||||
See the accompanying notes to these financial statements |
7
BIOHEART, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
JUNE 30, 2014
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 Bioheart, Inc., (the Company), have been prepared in accordance with the rules and regulations (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 six month period ended June 30, 2014 are not necessarily indicative of the results that may be expected for the year ended December 31, 2014. The unaudited condensed financial statements should be read in conjunction with the December 31, 2013 financial statements and footnotes thereto included in the Companys Annual Report on Form 10-K.
Basis and business presentation
Bioheart, Inc. (the Company) was incorporated under the laws of the State of Florida in August, 1999. The Company is in the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. To date, the Company has not generated significant sales revenues, has incurred expenses, and has sustained losses. Consequently, its operations are subject to all the risks inherent in the establishment of a research and development business enterprise. For the period from inception through June 30, 2014, the Company has accumulated a deficit of $117,954,949.
Revenue Recognition
The Company recognizes revenue in accordance with Accounting Standards Codification subtopic 605-10, Revenue Recognition (ASC 605-10) which requires that four basic criteria must be met before revenue can be recognized: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred; (3) the selling price is fixed and determinable; and (4) collectability is reasonably assured. Determination of criteria (3) and (4) are based on managements judgments regarding the fixed nature of the selling prices of the products delivered and the collectability of those amounts. Provisions for discounts and rebates to customers, estimated returns and allowances, and other adjustments are provided for in the same period the related sales are recorded.
At the time of each transaction, management assesses whether the fee associated with the transaction is fixed or determinable and whether or not collection is reasonably assured. The assessment of whether the fee is fixed or determinable is based upon the payment terms of the transaction. If a significant portion of a fee is due after our normal payment terms or upon implementation or client acceptance, the fee is accounted for as not being fixed or determinable and revenue is recognized as the fees become due or after implementation or client acceptance has occurred. Collectability is assessed based on a number of factors, including past transaction history with the client and the creditworthiness of the client.
8
BIOHEART, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
JUNE 30, 2014
Revenues for test kits and equipment sold are not recorded until test kits are delivered. The Company has revenue sharing arrangements for the sale of goods whereby the Company is the primary obligor, sets pricing with the customers and bears all associated credit risks with the customers. Sales under revenue share arrangements are recorded as gross sales and any portion shared with third parties under such arrangements are recorded as cost of sales. Revenues from trainings are not recorded until the completion of the training. Any cash received as a deposit for trainings are recorded by the company as a liability.
Unbilled revenue is revenue that is recognized but is not currently billable to the customer pursuant to contractual terms. In general, such amounts become billable in accordance with predetermined payment schedules, but recognized as revenue as services are performed. Amounts included in unbilled revenue are expected to be collected within one year and are included within current assets.
Comprehensive Income
The Company does not have any items of comprehensive income in any of the periods presented.
Net Income (loss) per Common Share, basic and diluted
The Company has adopted Accounting Standards Codification subtopic 260-10, Earnings Per Share (ASC 260-10) specifying the computation, presentation and disclosure requirements of earnings per share information. Basic loss per share has been calculated based upon the weighted average number of common shares outstanding. Stock options, warrants and shares issuable upon conversion of notes payable have been excluded as common stock equivalents in the diluted loss per share because their effect is anti-dilutive on the computation for the three months ended June 30, 2014 and for the three and six months ended June 30, 2014. Fully diluted shares outstanding were 588,670,163 and 290,900,920 for the three months ended June 30, 2014 and 2013, respectively and 553,719,873 and 264,534,723 for the six months ended June 30, 2014 and 2013, respectively.
Stock Based Compensation
The Company follows Accounting Standards Codification subtopic 718-10, Compensation (ASC 718-10) which requires that all share-based payments to both employees and non-employees be recognized in the income statement based on their fair values. (See note 10).
As of June 30, 2014, there were outstanding stock options to purchase 48,499,343 shares of common stock, 16,775,856 shares of which were vested.
Concentrations of Credit Risk
The Companys financial instruments that are exposed to a concentration of credit risk are cash and accounts receivable. The financial stability of these institutions is periodically reviewed by senior management.
As of June 30, 2014, one customer represented 45% of the Companys accounts receivable.
As of December 31, 2013, three customers represented 20%, 20% and 36% (total 76%) of the Companys accounts receivable.
For the three months ended June 30, 2014, the Companys revenues earned from the sale of products and services were $497,034, of which two customers represented 11% and 12% of the Companys revenues.
For the six months ended June 30, 2014, the Companys revenues earned from the sale of products and services were $819,606, of which one customer represented 13% of the Companys revenues.
9
BIOHEART, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
JUNE 30, 2014
For the three and six month period ended June 30, 2013, the Companys revenues earned from the sale of products and services were $20,129 and $24,321 from two (2) customers, respectively.
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 $15,478 and $25,335 for the three and six months ended June 30, 2014, respectively; and $172,407 and $336,381 for the three and six months ended June 30, 2013, 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. Neither of these statements had an impact on the Companys financial position, results of operations nor cash flows.
Reliance on Key Personnel and Consultants
The Company has 4 full-time employees and 1 part-time employee. The Company is heavily dependent on the continued active participation of these current executive officers, employees and key consultants. The loss of any of the senior management or key consultants could significantly and negatively impact the business until adequate replacements can be identified and put in place.
Derivative Instrument Liability
The Company accounts for derivative instruments in accordance with ASC 815, which establishes accounting and reporting standards for derivative instruments and hedging activities, including certain derivative instruments embedded in other financial instruments or contracts and requires recognition of all derivatives on the balance sheet at fair value, regardless of hedging relationship designation. Accounting for changes in fair value of the derivative instruments depends on whether the derivatives qualify as hedge relationships and the types of relationships designated are based on the exposures hedged. At June 30, 2014 and December 31, 2013, the Company did not have any derivative instruments that were designated as hedges.
10
BIOHEART, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
JUNE 30, 2014
Recent Accounting Pronouncements
The Company has adopted Accounting Standards Update (ASU) No. 2014-10, Development Stage Entities (Topic 915): Elimination of Certain Financial Reporting Requirements, Including an Amendment to Variable Interest Entities Guidance in Topic 810, Consolidation. The amendments in this ASU remove all incremental financial reporting requirements from U.S. GAAP for development stage entities, including the removal of Topic 915, Development Stage Entities, from the FASB Accounting Standards Codification™. Other than the elimination of the inception to date information, there were no other changes to the financial statements.
A development stage entity is one that devotes substantially all of its efforts to establishing a new business and for which: (a) planned principal operations have not commenced; or (b) planned principal operations have commenced, but have produced no significant revenue. For example, many start-ups or even long-lived organizations that have not yet begun their principal operations or do not have significant revenue would be identified as development stage entities.
For public business entities, the presentation and disclosure requirements in Topic 915 will no longer be required for the first annual period beginning after December 15, 2014. The revised consolidation standards are effective one year later, in annual periods beginning after December 15, 2015. Early adoption is permitted.
There are various other 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
NOTE 2 GOING CONCERN MATTERS
The accompanying unaudited 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 unaudited condensed financial statements, during six months ended June 30, 2014, the Company incurred an operating loss of $1,078,971 and used $507,059 in cash for operating activities. As of June 30, 2014, the Company had a working capital deficit (current liabilities in excess of current assets) of approximately $9.6 million. These factors among others may indicate that the Company will be unable to continue as a going concern for a reasonable period of time.
The Companys existence is dependent upon managements ability to develop profitable operations and to obtain additional funding sources. There can be no assurance that the Companys financing efforts will result in profitable operations or the resolution of the Companys 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 PROPERTY AND EQUIPMENT
Property and equipment as of June 30, 2014 and December 31, 2013 is summarized as follows:
11
BIOHEART, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
JUNE 30, 2014
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| June 30, 2014 |
| December 31, 2013 | ||||
Laboratory and medical equipment |
| $ | 352,358 |
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| $ | 352,358 |
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Furniture, fixtures and equipment |
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| 125,634 |
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| 125,634 |
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Computer equipment |
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| 45,892 |
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| 39,525 |
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Leasehold improvements |
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| 362,046 |
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| 362,046 |
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| 885,930 |
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| 879,563 |
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Less accumulated depreciation and amortization |
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| (872,495 | ) |
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| (870,508 | ) |
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| $ | 13,435 |
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| $ | 9,055 |
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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.
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.
NOTE 4 ACCRUED EXPENSES
Accrued expenses consisted of the following as of June 30, 2014 and December 31, 2013:
| June 30, 2014 |
| December 31, 2013 | ||||
License and royalty fees | $ | |
|
| $ | 2,122,130 |
|
Amounts payable to the Guarantors of the Companys loan agreement with Bank of America and Seaside Bank, including fees and interest |
| 1,454,772 |
|
|
| 1,373,775 |
|
Interest payable on notes payable |
| 600,132 |
|
|
| 714,180 |
|
Vendor accruals and other |
| 136,385 |
|
|
| 120,692 |
|
Employee commissions, compensation, etc. |
| 109,411 |
|
|
| 149,558 |
|
| $ | 2,300,700 |
|
| $ | 4,480,335 |
|
In June 2000, the Company had entered into an agreement with William Beaumont Hospital, or WBH, pursuant to which WBH granted the Company a worldwide, exclusive, non-sublicenseable license to two U.S. method patents covering the inducement of human adult myocardial cell proliferation in vitro, or the WBH IP. The term of the agreement was for the life of the patents, which expire in 2015. The Company did not use this license in any of their technologies or made any payments to WBH other than the initial payment to acquire the license. On April 2, 2014, the Company received confirmation from WBH that it has no obligation under the patent license agreement and WBH agreed to terminate the patent license agreement pursuant to a termination letter dated March 3, 2014.
Accordingly, the Company recognized approximately $2,122,130 in settlement of debt which represents the accumulative accrual and related interest from past years under the 2000 patent license agreement.
12
BIOHEART, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
JUNE 30, 2014
During the six months ended June 30, 2014, the Company issued an aggregate of 31,052,689 shares of its common stock in settlement of outstanding accounts payable and accrued expenses. In connection with the issuance, the Company incurred $190,966 loss in settlement of debt.
NOTE 5 STANDBY EQUITY DISTRIBUTION AGREEMENT
On November 2, 2011, the Company and Greystone Capital Partners (Greystone) had entered into a Standby Equity Distribution Agreement (the Agreement). Pursuant to the Agreement, Greystone had agreed to provide the Company with up to $1.0 million of funding for the 24-month period following the date a registration statement of the Companys common stock is declared effective by the SEC (the Equity Line). The registration statement went effective on February 10, 2012. The Agreement automatically terminated on the first of April, 2014 (the first day of the month next following the second (2nd) anniversary of the Effective Date).
NOTE 6 NOTES PAYABLE
Notes payable were comprised of the following as of June 30, 2014 and December 31, 2013:
| June 30, 2014 |
| December 31, 2013 | ||||
Seaside Bank note payable. | $ | 980,000 |
|
| $ | 980,000 |
|
August 2008 Unsecured Promissory Note |
| - |
|
|
| 500,000 |
|
Hunton & Williams notes payable |
| 384,972 |
|
|
| 384,972 |
|
Asher notes payable |
| 183,000 |
|
|
| 143,000 |
|
Daniel James Management note payable |
| 60,000 |
|
|
| - |
|
Fourth Man, LLC note payable |
| 50,000 |
|
|
| 35,000 |
|
Total notes payable |
| 1,657,972 |
|
|
| 2,042,972 |
|
Less unamortized debt discount |
| (203,515 | ) |
|
| (112,131 | ) |
Total notes payable net of unamortized debt discount | $ | 1,454,457 |
|
| $ | 1,930,841 |
|
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 Companys 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 2014 to extend the maturity date to December 23, 2015.
August 2008 Unsecured Promissory Note
On August 20, 2008, the Company borrowed $1.0 million from a third party pursuant to the terms of an unsecured Promissory Note and Agreement. Outstanding principal and interest on the loan, which accrues at the rate of 13.5% per annum, would be payable in one balloon payment upon the Companys repayment of the BlueCrest Loan, which was scheduled to mature in May 2010, however the Company was not obligated to make payments until BlueCrest Loan is paid off. In the event the Company completes a private placement of its common stock and/or securities exercisable for or convertible into its common stock which generates at least $19.0 million of gross proceeds, the Company may prepay, without penalty, all outstanding principal and interest due under the loan using the same type of securities issued in the subject private placement. Because repayment of the loan could occur within 12 months from the date of the balance sheet, the Company has classified this loan as short term.
13
BIOHEART, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
JUNE 30, 2014
Subject to certain conditions, at the end of each calendar quarter during the time the loan is outstanding, the Company may, but is not required to, pay all or any portion of the interest accrued but unpaid as of such date with shares of its common stock. In April 2009, as consideration for the authorization to amend certain documents related to the Note, the Company issued to the Note holder a warrant to purchase 451,053 shares of common stock at an exercise price of $0.5321 per share.
The warrant, which became exercisable immediately upon issuance, has a ten year term. This warrant had a fair value of $195,694, which was accounted for as additional paid in capital and reflected as a component of debt discount and has been fully amortized as interest expense ratably over the term of the loan.
In 2013, 1,000,000 shares of common stock were issued to the debt holder, in exchange for $500,000 in principal and $598,125 of accrued interest relating to a previously issued note resulting in a gain of $1,078,625. A gain of $1,078,625 was included in the net gain on settlement of debt and trade payables on the statement of operations for the year ended December 31, 2013.
On June 16, 2014, 14,539,191 shares of common stock were issued to the debt holder, in exchange for the remaining $500,000 principal and $81,568 of accrued interest resulting in a gain of $255,890. A gain of $255,890 was included in the net gain on settlement of debt and trade payable on the statement of operations for the three and six months ended June 30, 2014.
Hunton & Williams Notes
At June 30, 2014 and December 31, 2013, the Company has 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 (or successor) Loan is paid off.
Asher Notes (During this year)
During the six months ended June 30, 2014, the Company entered into a Securities Purchase Agreements with Asher Enterprises, Inc. (Asher) or affiliates, for the sale of 8% convertible notes in aggregate principal amount of $183,000 (the Asher Notes).
The Asher Notes bear interest at the rate of 8% per annum. As of the quarter ended June 30, 2014 all interest and principal must be repaid nine months from the issuance date, with the last note being due February 16, 2015. The Notes are convertible into common stock, at Ashers option, at a 45% discount to the average of the three lowest closing bid prices of the common stock during the 10 trading day period prior to conversion. The Company has identified the embedded derivatives related to the Asher Notes.
These embedded derivatives included certain conversion features and reset provision. The accounting treatment of derivative financial instruments requires that the Company record fair value of the derivatives as of the inception date of Asher Notes and to fair value as of each subsequent reporting date, which at June 30, 2014 was $278,495. At the inception of the Asher Notes, the Company determined the aggregate fair value of $355,447 of the embedded derivatives.
14
BIOHEART, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
JUNE 30, 2014
Daniel James Management
During the six months ended June 30, 2014, the Company entered into a Securities Purchase Agreements with Daniel James Management (Daniel) for the sale of 8% to 9.5% convertible note in aggregate principal amount of $60,000 (the Daniel Notes).
The Daniel Notes bear interest at the rate of 8% to 9.5% per annum. As of the quarter ended June 30, 2014, all interest and principal must be repaid one year from the issuance dated, with the last note being due May 29, 2015. The Daniel Notes are convertible into common stock, at holders option, at a 47% discount to the average of the three lowest closing bid prices of the common stock during the 10 trading day period prior to conversion. The Company has identified the embedded derivatives related to the Daniel Note. These embedded derivatives included certain conversion features and reset provision.
The accounting treatment of derivative financial instruments requires that the Company record fair value of the derivatives as of the inception date of Daniel Notes and to fair value as of each subsequent reporting date which at June 30, 2014 was $105,778. At the inception of the Daniel Note, the Company determined the aggregate fair value of $126,337 of the embedded derivatives.
Fourth Man, LLC
During the six months ended June 30, 2014, the Company entered into a Securities Purchase Agreements with Fourth Man, LLC. (Fourth Man), for the sale of an 8% to 9.5% convertible note in the aggregate principal amount of $50,000 (the Note).
The Notes bears interest at the rate of 8% to 9.5% per annum. As of the quarter ended June 30, 2014, all interest and principal must be repaid one year from the issuance dated, with the last note being due June 26, 2015. The Notes are convertible into common stock, at Fourth Mans option, at a 47% discount to the average of the three lowest closing bid prices of the common stock during the 10 trading day period prior to conversion. The Company has identified the embedded derivatives related to the Fourth Man Notes. These embedded derivatives included certain conversion features and reset provision.
The accounting treatment of derivative financial instruments requires that the Company record fair value of the derivatives as of the inception date of Fourth Man Notes and to fair value as of each subsequent reporting date which at June 30, 2014 was $89,051. At the inception of the Fourth Man Notes, the Company determined the aggregate fair value of $87,090 of the embedded derivatives.
The fair value of the embedded derivatives of the Asher, Daniel and Fourth Man Notes, was determined using the Binomial Option Pricing Model based on the following assumptions: (1) dividend yield of 0%; (2) expected volatility of 169.92% to 171.91%, (3) weighted average risk-free interest rate of 0.10% to 0.11%, (4) expected lives of 0.76 to 1.00 years, and (5) estimated fair value of the Companys common stock from $0.024 to $0.0486 per share. The initial fair value of the embedded debt derivative of $568,876 was allocated as a debt discount up to the proceeds of the note ($288,000) with the remainder ($280,876) charged to current period operations as interest expense. For the three and six months ended June 30, 2014, the Company amortized an aggregate of $108,011 and $201,615 of debt discounts to current period operations as interest expense, respectively. For the three and six months ended June 30, 2013 , the Company amortized $52,485 and $242,635 of debt discount to operations as interest expense, respectively.
15
BIOHEART, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
JUNE 30, 2014
NOTE 7 RELATED PARTY TRANSACTIONS
Advances
As of June 30, 2014 and December 31, 2013, the Company officers and directors have provided advances in the aggregate of $247,657 and $416,198 respectively, for working capital purposes. The advances are unsecured, due on demand and non-interest bearing.
During the six months ended June 30, 2014, the Company issued an aggregate of 6,604,177 shares of common stock in settlement of $153,635 of related party advances and outstanding accounts payable.
Notes payable-related party
Northstar Biotechnology Group, LLC
On February 29, 2012, a 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, 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.
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. As of September 30, 2012, the Company was in default, however, subsequent to September 30, 2012, the Company renegotiated the terms of the Note, Northstar has 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 5,000,000 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 10,000,000 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.
16
BIOHEART, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
JUNE 30, 2014
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 is 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 have determined to modify the voting rights of the 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.
On April 2, 2014, the Company issued 274,681 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.
As of June 30, 2014 and December 31, 2013, the principle of this note was $362,000.
Officer and Director Notes
At June 30, 2014 and December 31, 2013, the Company has outstanding notes payable to officers and directors with interest at 8% per annum due at maturity in aggregate $240,000 and $365,000, respectively. The remaining subordinated notes $100,000 and $140,000 were previously due on November 30, 2012 and June 4, 2011 respectively, and are unsecured. The Company is not obligated to make payment until Northstar loan is paid off.
On September 30, 2013, the Company issued an aggregate of 15,350,876 shares of its common stock in settlement of $175,000 of these related party notes payable.
On June 20, 2014, the Company issued 4,045,796 shares of its common stock in settlement of $125,000 of related party note payable and accrued interest of $36,832.
On August 1, 2013, the Company issued an aggregate of $500,000 promissory notes due on demand to officers and employee in settlement of accrued compensation. The promissory notes bear interest of 5% per annum and due at various maturity dates. During the six months ended June 30, 2014, the Company paid off $223,340 of the outstanding promissory notes. The principle outstanding balance of these notes as of June 30, 2014 is $206,124.
Subordinated debt, related party
As of June 30, 2014 and December 31, 2013, the Company officers and directors have outstanding notes in aggregate of $786,628 and $1,500,000, respectively. The notes are at from 4.75% to 8% per annum and are due upon payoff of the Northstar note payable described above.
On June 20, 2014, the Company issued 10,333,475 shares of its common stock in settlement of $300,385 of related party note payable and accrued interest of $112,954.
17
BIOHEART, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
JUNE 30, 2014
NOTE 8 DERIVATIVE LIABILITIES
Reset warrants
On October 1, 2012, in connection with the forbearance agreement with Northstar as discussed in Note 7 above, the Company issued an aggregate of 15,000,000 common stock purchase warrants to purchase the Companys common stock with an exercise price of $0.014 per share for ten years with anti-dilutive (reset) provisions.
The Company has identified embedded derivatives related to the issued warrants. These embedded derivatives included certain and anti-dilutive (reset) provisions. The accounting treatment of derivative financial instruments requires that the Company record fair value of the derivatives as of the inception date and to fair value as of each subsequent reporting date.
At June 30, 2014, the fair value of the reset provision of $400,829 was determined using the Binomial Option Pricing model with the following assumptions: dividend yield: 0%; volatility: 170.55%; risk free rate: 2.13%; and expected life: 8.26 years. The Company recorded a gain (loss) on change in derivative liabilities of $265,657 and $(253,974) during the three and six months ended June 30, 2014.
Convertible notes
In 2013 and the six months ended June 30, 2014, the Company issued convertible notes (see Note 6 above).
These notes are convertible into common stock, at holders option, at a discount to the market price of the Companys common stock. The Company has identified the embedded derivatives related to these notes relating to certain anti-dilutive (reset) provisions. These embedded derivatives included certain conversion features. The accounting treatment of derivative financial instruments requires that the Company record fair value of the derivatives as of the inception date of Asher Note and to fair value as of each subsequent reporting date.
The fair value of the embedded derivatives at June 30, 2014, in the amount of $473,324, was determined using the Binomial Option Pricing Model based on the following assumptions: (1) dividend yield of 0%; (2) expected volatility of 170.55%, (3) weighted average risk-free interest rate of 0.04 to 0.11%, (4) expected lives of 0.30 to 0.99 years, and (5) estimated fair value of the Companys common stock of $0.027 per share. The Company recorded a gain on change in derivative liabilities of $45,757 and $76,017 during the three and six months ended June 30, 2014.
Based upon ASC 840-15-25 (EITF Issue 00-19, paragraph 11) the Company has adopted a sequencing approach regarding the application of ASC 815-40 to its outstanding convertible notes. Pursuant to the sequencing approach, the Company evaluates its contracts based upon earliest issuance date.
At June 30, 2014, the aggregate derivative liabilities was valued at $874,153, the Company believes an event under the contract that would create an obligation to settle in cash or other current assets is remote and has classified the obligation as a long term liability.
18
BIOHEART, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
JUNE 30, 2014
NOTE 9 STOCKHOLDERS EQUITY
Preferred stock
On August 17, 2012, the board of directors designated 5,000,000 shares of preferred stock as Series A Convertible Preferred Stock which was increased to 20,000,000 shares of preferred stock as Series A Convertible Preferred Stock (currently held by Northstar Biotechnology Group, LLC). Each share of preferred stock is convertible into equal number of common shares at the option of the holder; entitled to 20 votes on all matters presented to be voted by the holders of common stock; upon event of liquidation, entitled to amount equal to stated value plus any accrued and unpaid dividends or other fees before distribution to junior securities. In lieu of the initial two payments due to Northstar on April 1, 2013 and October 1, 2013, the parties have determined to modify the voting rights of the 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 (see Note 7 above).
Common stock
Effective May 19, 2014, the Company amended its articles of incorporation to increased the authorized shares of capital stock of the Company from nine hundred and fifty million (950,000,000) shares of common stock and twenty million (20,000,000) shares of preferred stock, both $.001 par value respectively, to two billion (2,000,000,000) shares of shares of common stock and twenty million (20,000,000) shares of preferred stock, both $.001 par value respectively.
During the six months ended June 30, 2014, the Company issued an aggregate of 31,052,689 shares of its common stock in settlement of outstanding accounts payable and accrued expenses. In connection with the issuance, the Company incurred $190,966 loss in settlement of debt.
During the six months ended June 30, 2014, the Company issued an aggregate of 51,823,229 shares of its common stock for the conversion of $1,516,095 of notes payable and related accrued interest of $88,688. In connection with the issuance, the Company incurred $255,890 gain in settlement of debt.
During the six months ended June 30, 2014, the Company issued an aggregate of 3,839,832 shares of its common stock for services provided to the Company.
NOTE 10 STOCK OPTIONS AND WARRANTS
Stock Options
In December 1999, the Board of Directors and shareholders adopted the 1999 Officers and Employees Stock Option Plan, or the Employee Plan, and the 1999 Directors and Consultants Stock Option Plan, or the Director Plan. The Employee Plan and the Director Plan are collectively referred to herein as the Plans. The Plans are administered by the Board of Directors and the Compensation Committee. The objectives of the Plans include attracting and retaining key personnel by encouraging stock ownership in the Company by such persons. In February 2010, the Directors & Consultants Plan was amended to extend the termination date of the Plan to December 1, 2011.
In April 1, 2013, the Board of Directors approved, subject to shareholder approval, the establishment of the Bioheart 2013 Omnibus Equity Compensation Plan, or the 2013 Omnibus Plan. The 2013 Omnibus Plan reserves up to fifty million shares of common stock for issuance.
A summary of options at June 30, 2014 and activity during the three months then ended is presented below:
19
BIOHEART, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
JUNE 30, 2014
|
|
| Shares |
|
| Weighted- Average Exercise Price |
| Weighted- Average Remaining Contractual Term (in years) | ||||
|
|
|
|
| ||||||||
Options outstanding at January 1, 2013 |
|
| 7,853,376 |
|
| $ | 0.67 |
| 8.2 | |||
Granted |
|
| 17,400,000 |
|
| $ | 0.016 |
| 9.9 | |||
Exercised |
|
| |
|
| $ |
|
|
| |||
Forfeited/Expired |
|
| (1,340,433 | ) |
| $ | 1.08 |
|
| |||
Options outstanding at December 31, 2013 |
|
| 23,912,943 |
|
| $ | 0.15 |
| 9.0 | |||
Granted |
|
| 24,648,487 |
|
| $ | 0.021 |
| 10.0 | |||
Exercised |
|
| |
|
|
|
|
|
| |||
Forfeited/Expired |
|
| (62,087 | ) |
| $ | 1.08 |
|
| |||
Options outstanding at June 30, 2014 |
|
| 48,499,343 |
|
| $ | 0.075 |
| 9.1 | |||
Options exercisable at June 30, 2014 |
|
| 16,775,856 |
|
| $ | 0.18 |
| 8.7 | |||
Available for grant at June 30, 2014 |
|
| 1,500,657 |
|
|
|
|
|
|
|
The following information applies to options outstanding and exercisable at June 30, 2014:
|
| Options Outstanding |
| Options Exercisable | |||||||||
|
| Shares |
| Weighted- Average Remaining Contractual Term |
| Weighted- Average Exercise Price |
| Shares |
| Weighted- Average Exercise Price | |||
|
|
|
|
|
|
|
|
|
|
|
|
| |
$0.00 $0.70 |
| 47,938,487 |
| 9.2 |
| $ | 0.03 |
| 16,215,000 |
| $ | 0.04 | |
$0.71 $1.28 |
| 162,286 |
| 3.9 |
| $ | 0.80 |
| 162,286 |
| $ | 0.80 | |
$5.25 $5.67 |
| 373,858 |
| 1.8 |
| $ | 5.55 |
| 373,858 |
| $ | 5.55 | |
$7.69 |
| 24,712 |
| 2.1 |
| $ | 7.69 |
| 24,712 |
| $ | 7.69 | |
|
| 48,499,343 |
| 9.1 |
| $ | 0.075 |
| 16,775,856 |
| $ | 0.18 |
On February 24, 2014, the Company issued an aggregate 15,000,000 options to purchase the Companys common stock at $0.019 per share to officers, vesting at 25% immediately and the remainder over approximately 42 months, exercisable over 10 years. The aggregate fair value of $282,597, determined using the Black Scholes option pricing model with the following assumptions: Dividend yield: 0%; Volatility: 163.63% and Risk free rate: 2.75%.
On February 24, 2014, the Company issued an aggregate 4,800,000 options to purchase the Companys common stock at $0.019 per share to officers, vesting immediately and exercisable over 10 years. The aggregate fair value of $90,431, determined using the Black Scholes option pricing model with the following assumptions: Dividend yield: 0%; Volatility: 163.63% and Risk free rate: 2.75%.
20
BIOHEART, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
JUNE 30, 2014
On May 12, 2014, the Company issued an aggregate 4,848,487 options to purchase the Companys common stock at $0.0272 per share to officers and employees, vesting over four years at anniversary and exercisable over 10 years. The aggregate fair value of $130,135, determined using the Black Scholes option pricing model with the following assumptions: Dividend yield: 0%; Volatility: 161.36% and Risk free rate: 2.66%.
The fair value of all options vesting during the three and six months ended June 30, 2014 of $48,805 and $243,370, respectively, was charged to current period operations.
Warrants
A summary of common stock purchase warrants at June 30, 2014 and activity during the three months then ended is presented below:
| Shares |
| Weighted- Average Exercise Price |
| Weighted- Average Remaining Contractual Term (in years) | |
|
|
|
|
|
|
|
Outstanding at January 1, 2013 | 74,073,322 |
| $ | 0.37 |
| 4.5 |
Issued | 50,350,536 |
| $ | 0.16 |
| 9.2 |
Exercised | |
| $ | 0.00 |
|
|
Forfeited | (6,345,002) |
| $ | 0.38 |
|
|
Outstanding at December 31, 2013 | 118,078,856 |
| $ | 0.22 |
| 6.3 |
Issued | 36,292,783 |
| $ | 0.02 |
| 7.7 |
Exercised | (11,918,181 | ) | $ | 0.01 |
|
|
Expired | (2,314,575 | ) | $ | 0.18 |
|
|
Outstanding at June 30, 2014 | 140,138,883 |
| $ | 0.18 |
| 6.1 |
Exercisable at June 30, 2014 | 105,301,650 |
| $ | 0.12 |
| 5.4 |
The following information applies to common stock purchase warrants outstanding and exercisable at June 30, 2014:
|
| Warrants Outstanding |
| Warrants Exercisable | ||||||||||
|
| Shares |
| Weighted- Average Remaining Contractual Term |
| Weighted- Average Exercise Price |
| Shares |
| Weighted- Average Exercise Price | ||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||
$0.01 $0.50 |
| 133,889,750 |
| 6.1 |
| $ | 0.02 |
| 100,596,967 |
| $ | 0.02 | ||
$0.52 $0.68 |
| 2,699,675 |
| 4.8 |
| $ | 0.58 |
| 2,699,675 |
| $ | 0.58 | ||
$0.70 $1.62 |
| 848,176 |
| 5.5 |
| $ | 0.71 |
| 848,176 |
| $ | 0.71 | ||
$5.67 $7.69 |
| 2,701,282 |
| 8.4 |
| $ | 7.55 |
| 1,156,832 |
| $ | 7.35 | ||
|
| 140,138,883 |
| 6.1 |
| $ | 0.18 |
| 105,301,650 |
| $ | 0.12 |
21
BIOHEART, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
JUNE 30, 2014
In conjunction with the authorized issuance of common stock, the Company granted 24,292,783 common stock purchase warrants during the six months ended June 30, 2014.
During the six months ended June 30, 2014, the Company issued an aggregate of 8,000,000 warrants in connection with a joint venture agreement dated March 10, 2014. The warrants are exercisable at $0.0217 for four years vesting from June 8, 2014 through March 10, 2016. During the three and six months ended June 30, 2014, the Company charged $56,710 and $79,256 to current period operations for the vesting portion.
During the six months ended June 30, 2014, the Company issued an aggregate of 4,000,000 warrants in connection with use of certain intellectual property. The warrants are exercisable at $0.0481 for four years vesting from July 6, 2014 through April 6, 2017. During the three and six months ended June 30, 2014, the Company charged $32,814 to current period operations for the vesting portion.
NOTE 11 COMMITMENTS AND CONTINGENCIES
Joint Venture Agreement
On March 10, 2014, the Company entered into a profits sharing agreement (the Agreement) with Global Stem Cells, Group, LLC and its subsidiaries whereby both parties will participate in marketing for obtaining patients and provide physician training for stem cell treatments under the names of Regenestem and Stem Cell Training, respectively. In addition, each party will be responsible for selling equipment and kit to existing and previous customers. Profits are divided on a fifty/fifty basis with distribution within 10 days of the accounting for patients and physician training and 30 day with sales of equipment and kits.
In consideration of Global Stem Cell Group, LLCs participation, the Company issued an aggregate of 8,000,000 warrants to purchase the Companys common stock for four years at $0.0217 per share with 2,000,000 warrants vesting 90 days from the effective date, 2,000,000 vesting on each anniversary date for three years. During the three and six months ended June 30, 2014, the Company charged $71,532 and $94,078 to current period operations for the vesting portion.
William Beaumont Hospital
In June 2000, the Company entered into an agreement with William Beaumont Hospital, or WBH, pursuant to which WBH granted to the Company worldwide, exclusive, non-sublicenseable license to two U.S. method patents covering the inducement of human adult myocardial cell proliferation in vitro, or the WBH IP. The term of the agreement is for the life of the patents, which expire in 2015. The Company did not use this license in any of our technologies. The Company had not made any payments to WBH other than the initial payment to acquire the license. The Company has received confirmation from WBH that it has no obligation under the patent license agreement and WBH agreed to terminate the patent license agreement. (See Note 4)
Accordingly, the Company has recognized approximately $2,122,130 in settlement of debt which represents the accumulative accrual and related interest from past years under the 2000 patent license agreement.
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BIOHEART, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
JUNE 30, 2014
Litigation
The Company is subject to other legal proceedings that arise in the ordinary course of business. In the opinion of management, as of June 30, 2014, the amount of ultimate liability with respect to such matters, if any, in excess of applicable insurance coverage, is not likely to have a material impact on the Companys business, financial position, results of operations or liquidity. However, as the outcome of litigation and other claims is difficult to predict significant changes in the estimated exposures could exist.
Consulting agreements
On November 20, 2013, the Company entered into an investment banking agreement with Cassel Salpeter & Co. (CSC), who will act as exclusive third party financial advisor in connection with investment banking matters. The term of the Investment Banking Agreement shall be for a period of twenty four months unless terminated or extended in accordance with its terms. For these services, CSC will receive a one-time $25,000 fee, $5,000 monthly fees and 5,207,630 ten year common stock purchase warrants, exercisable at $.0113 and applicable consideration in the event the closing of a Mezzanine Financing consisting of non-convertible subordinated debt and/or sale of equity securities. The Company will also reimburse CSC for its reasonable out-of-pocket expenses associated with the services provided pursuant to the Investment Banking Agreement. As of June 30, 2014 and December 31, 2013, the Company accrued $36,964 and $32,424 under the agreement, respectively.
NOTE 12 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.
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BIOHEART, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
JUNE 30, 2014
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 Companys 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 June 30, 2014 or December 31, 2013, the Company did not have any items that would be classified as level 1 or 2 disclosures.
The Company recognizes its derivative liabilities as level 3 and values its derivatives using the methods discussed in notes 7 and 9. While the Company believes that its valuation methods are appropriate and consistent with other market participants, it recognizes that the use of different methodologies or assumptions to determine the fair value of certain financial instruments could result in a different estimate of fair value at the reporting date. The primary assumptions that would significantly affect the fair values using the methods discussed in Notes 7 and 9 are that of volatility and market price of the underlying common stock of the Company.
As of June 30, 2013 and December 31, 2013, the Company did not have any derivative instruments that were designated as hedges.
The derivative liability as of June 30, 2014, in the amount of $874,153 has a level 3 classification.
The following table provides a summary of changes in fair value of the Companys Level 3 financial liabilities as of June 30, 2014:
Excess Share Derivative | Warrant Liability | Debt Derivative | ||||||||||
Balance, December 31, 2012 | $ | 390,048 | 221,179 | $ | — | |||||||
Total (gains) losses | ||||||||||||
Initial fair value of debt derivative at note issuance | — | 673,219 | ||||||||||
Initial fair value of derivative relating to reset warrants | — | — | — | |||||||||
Mark-to-market at December 31, 2013: | 84.906 | (74,324 | ) | (39,761 | ) | |||||||
Transfers out of Level 3 upon increase in authorized shares | (474,954 | ) | — | — | ||||||||
Transfers out of Level 3 upon conversion and settlement of notes | (376,502 | ) | ||||||||||
Balance, December 31, 2013 | $ | — | $ | 146,855 | $ | 256,956 | ||||||
Total (gains) losses | ||||||||||||
Initial fair value of debt derivative at note issuance | — | — | 568,876 | |||||||||
Mark-to-market at June 30, 2014: | — | 253,974 | (76,017 | ) | ||||||||
Transfers out of Level 3 upon conversion of notes payable | — | — | (276,491 | ) | ||||||||
Balance, June 30, 2014 | $ | — | $ | 400,829 | $ | 473,324 | ||||||
Net (Loss) Gain for the period included in earnings relating to the liabilities held at June 30, 2014 | $ | — | $ | (253,974 | ) | $ | 76,017 |
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BIOHEART, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
JUNE 30, 2014
Fluctuations in the Companys stock price are a primary driver for the changes in the derivative valuations during each reporting period. The Companys stock price increased approximately 170% from December 31, 2013 to June 30, 2014. As the stock price increases for each of the related derivative instruments, the value to the holder of the instrument generally increases, therefore increasing the liability on the Companys balance sheet. Additionally, stock price volatility is one of the significant unobservable inputs used in the fair value measurement of each of the Companys derivative instruments. The simulated fair value of these liabilities is sensitive to changes in the Companys expected volatility. Increases in expected volatility would generally result in a higher fair value measurement.
NOTE 13 SUBSEQUENT EVENTS
Officer compensation
On July 28, 2014, the Companys Board of Directors approved the 2014/2015 salary for Mike Tomas, Chief Executive Officer, at $525,000 per year, beginning July 1, 2014 with an incentive bonus ranging from $150,000 to $500,000. In addition, the Board of Directors will grant Mr. Tomas options to be determined on or before June 30, 2015. The Companys Board of Directors approved a bonus of $500,000 and options to acquire 10,000,000 shares of the Companys common stock for ten years with four year vesting and a cashless exercise provision at an exercise price equal to the five day average closing price of the Companys common stock as of August 1, 2014. The cash bonus may be paid in the form a six month promissory note.
On July 28, 2014, the Companys Board of Directors approved the 2014/2015 salary for Kristin Comella, Chief Scientific Officer, at $250,000 per year, beginning July 1, 2014 with an incentive bonus ranging from $100,000 to $300,000. In addition, the Board of Directors will grant Ms. Comella options to be determined on or before June 30, 2015. The Companys Board of Directors approved a bonus of $300,000 and options to acquire 5,000,000 shares of the Companys common stock for ten years with four year vesting and a cashless exercise provision at an exercise price equal to the five day average closing price of the Companys common stock as of August 1, 2014. The cash bonus may be paid in the form a six month promissory note.
Subsequent issuances
In July 2014, the Company issued an aggregate of 1,006,451 shares of its common stock for services provided.
In July 2014, the Company issued 155,677 shares of its common stock in settlement of accounts payable of $6,227.
In July 2014, the Company issued an aggregate of 6,985,495 shares of its common stock in settlement of related party notes payable, accrued interest and other obligations in aggregate of $279,419.
In July 2014, the Company issued an aggregate of 2,640,625 shares of its common stock in settlement of notes payable of $32,500.
Subsequent financing
On July 30, 2014, the Company entered into a Securities Purchase Agreement with Daniel James Management, Inc., for the sale of an 9.5% convertible note in the principal amount of $25,000 (the Note).
The Note bears interest at the rate of 9.5% per annum. All interest and principal must be repaid on July 29, 2015, 2015. The Note is convertible into common stock, at holders option, at a 47% discount to the lowest daily trading price of the common stock during the 10 trading day period prior to conversion. In the event the Company prepays the Note in full, the Company is required to pay off all principal and accrued interest at 150%, and any other amounts.
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Item 2. | Managements 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 Managements 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, 2013 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 managements beliefs and assumptions and on information currently available to our management. Any such forward-looking statements would be contained principally in Managements 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 managements 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, 2013.
In this Quarterly Report on Form 10-Q, Company, our company, us, and our refer to Bioheart, Inc., unless the context requires otherwise.
Our Ability to Continue as a Going Concern
Our independent registered public accounting firm has issued its report dated March 24, 2014, in connection with the audit of our financial statements as of December 31, 2013, 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 June 30, 2014 also describes the existence of conditions that raise substantial doubt about our ability to continue as a going concern.
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Overview
We are a biotechnology company focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage. Our lead product candidate is MyoCell, an innovative clinical therapy designed to populate regions of scar tissue within a patients heart with autologous muscle cells, or cells from a patients body, for the purpose of improving cardiac function in chronic heart failure patients.
Biotechnology Product Candidates
We are focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage. In our pipeline, we have multiple product candidates for the treatment of heart damage, including MyoCell, Myocell SDF-1 and AdipoCell. MyoCell and MyoCell SDF-1 are clinical muscle-derived cell therapies designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients.
MyoCell SDF-1 is intended to be an improvement to MyoCell. MyoCell SDF-1 is similar to MyoCell except that the myoblast cells to be injected for use in MyoCell SDF-1 will be modified prior to injection by an adenovirus vector or non-viral vector so that they will release extra quantities of the SDF-1 protein, which expresses angiogenic factors. AdipoCell is a patient-derived cell therapy proposed for the treatment of acute myocardial infarction, chronic heart ischemia, and lower limb ischemia. We hope to demonstrate that these product candidates are safe and effective complements to existing therapies for chronic and acute heart damage.
Our most recent completed clinical trials of MyoCell are the SEISMIC Trial, a 40-patient, randomized, multicenter, controlled, Phase II-a study conducted in Europe and the MYOHEART Trial, a 20-patient, multicenter, Phase I dose-escalation trial conducted in the United States. We were approved by the FDA, to proceed with a 330-patient, multicenter Phase II/III trial of MyoCell in North America and Europe, or the MARVEL Trial. We completed the MyoCell implantation procedure on the first patient in the MARVEL Trial on October 24, 2007. Thus far, 20 patients, including 6 control patients, have been treated. Initial results for the 20 patients were released at the Heart Failure Society of American meeting in September, 2009, showing a significant (35%) improvement in the 6 minute walk for those patients who were treated, and no improvement for those who received a placebo. On the basis of these results, we have applied for and received approval from the FDA to reduce the number of additional patients in the trial to 134, for a total of 154 patients. The SEISMIC, MYOHEART and MARVEL Trials have been designed to test the safety and efficacy of MyoCell in treating patients with severe, chronic damage to the heart. Upon regulatory approval of MyoCell, we intend to generate revenue in the United States from the sale of MyoCell cell-culturing services for treatment of patients by qualified physicians.
We received approval from the FDA in July of 2009 to conduct a Phase I safety study on 15 patients of a combined therapy (Myocell with SDF-1), which we believe was the first approval of a study combining gene and cell therapies. We initially commenced work on this study, called the REGEN Trial, during the first quarter of 2010. We suspended activity on the trial in 2010 while seeking additional funding necessary to conduct the trial.
We are seeking to secure sufficient funds to reinitiate enrollment in the MARVEL and REGEN trials. If we successfully secure such funds, we intend to re-engage a contract research organization, or CRO, investigators and certain suppliers to advance such trials. We have initiated and enrolled our first patient in the MIRROR trial in 2013. The trial is very similar to the MARVEL trial but focusses on sites outside the US. We will continue enrollment in the MIRROR trial once we have secured sufficient funds.
We have completed the Phase 1 Angel Trial for AdipoCell (adipose derived stem cells). Five patients were enrolled and treated in the second quarter of 2013.
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We have also initiated several Institutional Review Board studies in 2013 using adipose derived stem cells for various indications including dry macular degeneration, degenerative disc disease, erectile dysfunction and chronic obstructive pulmonary disease.
In Q2, 2014, the company announced the treatment of a patient in Honduras with congestive heart failure using AdipoCell and MyoCell. This was the first patient treated in the world using a combination of stem cells.
We have begun two clinical trials in India. The first cardiac patient has successfully been enrolled and treated in India using AdipoCell™ or adipose derived stem cells. The second trial will involve the combination of AdipoCell and MyoCell® or muscle derived stem cells for congestive heart failure patients. These trials are active and ongoing
MyoCath Product Candidate
The MyoCath is a deflecting tip needle injection catheter that has a larger (25 gauge) needle to allow for better flow rates and less leakage than systems that are 27 gauge. This larger needle allows for thicker compositions to be injected, which helps with cell retention in the heart. Also, the MyoCath needle has more fluoroscopic brightness than the normally used nitinol needle, enabling superior visualization during the procedure. Seeing the needle well during injections enables the physician who is operating the catheter to pinpoint targeted areas more precisely. The MyoCath is used to inject cells into cardiac tissue in therapeutic procedures to treat chronic heart ischemia and congestive heart failure. Investigators in our MARVEL Trial may use either our MyoCath catheters or Biosense Websters (a Johnson & Johnson company) NOGA® Cardiac Navigation System along with the MyoStar™ injection catheter for the delivery of MyoCell to patients enrolled in the trial. We are currently producing Myocath catheters with a contract manufacturer on an as needed basis.
We conduct operations in one business segment. We may organize our business into more discrete business units when and if we generate significant revenue from the sale of our product candidates. Our revenue since inception has been generated inside and outside the United States, and the majority of our long-lived assets are located in the United States.
Results of Operations Overview
Three and Six Months Ended June 30, 2014 as compared to the Three and Six Months Ended June 30, 2014
Revenues
We have not generated any material revenues from our MyoCell product candidate. The revenues we have recognized to date are related to (i) sales of MyoCath, (iii) revenues generated from patient paid studies, (iv) revenues from the sale of our AdipoCell system and related supplies and (v) revenues generated for providing cell culturing and banking services. We did not generate significant revenues in 2013. Our revenue may vary substantially from quarter to quarter and from year to year. We expect to have steady growth of revenue as the above programs grow and expand.
We recognized revenues of $497,034 and $819,606 for the three and six months ended June 30, 2014, respectively, compared to revenues of $20,129 and $24,321 for the three and six months ended June 30, 2013, respectively. Our revenue in 2014 was generated from the sale of MyoCath catheters, AdipoCell, physician training, patient studies and laboratory services. Our revenues for 2013 were generated from the sale of MyoCath Catheters and laboratory services.
Cost of Sales
Cost of sales consists of the costs associated with the production of MyoCath, laboratory supplies necessary for laboratory services, production of AdipoCell systems and materials, physician course materials and clinic supplies required for patient studies.
Cost of sales was $107,119 and $201,565 in the three and six month periods ended June 30, 2014 compared to $-0- in the three and six months periods ended June 30, 2013.
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Research and Development
Our research and development expenses consist of costs incurred in identifying, developing and testing our product candidates. These expenses consist primarily of costs related to our clinical trials, the acquisition of intellectual property licenses and preclinical studies. We expense research and development costs as incurred.
Clinical trial expenses include costs related to the culture and preparation of cells in connection with our clinical trials, costs of contract research, costs of clinical trial facilities, costs of delivery systems, salaries and related expenses for clinical personnel and insurance costs. Preclinical study expenses include costs of contract research, salaries and related expenses for personnel, costs of development biopsies, costs of delivery systems and costs of lab supplies.
We are focused on the development of a number of autologous cell-based therapies, and related devices, for the treatment of heart damage. Accordingly, many of our costs are not attributable to a specifically identified product candidate. We use our employee and infrastructure resources across several projects, and we do not account for internal research and development costs on a product candidate by product candidate basis. From inception through June 30, 2014, we incurred aggregate research and development costs of approximately $65.3 million (unaudited) related to our product candidates. We estimate that at least $48.4 million (unaudited) of these expenses relate to our preclinical and clinical development of MyoCell and at least $5.2 million (unaudited) of these expenses relate to our preclinical and clinical development of MyoCath.
During the third quarter 2009, we received notification that approximately $630,000 in pending projects (Indiana University, University of Florida, Northwestern University, and other sites) was completed. As of June 30, 2014 and December 31, 2013, of the $630,000, we still have an accrual of $219,000 for the completed contracts.
Clinical trials and preclinical studies are time-consuming and expensive. Our expenditures on current and future preclinical and clinical development programs are subject to many uncertainties. We generally test our products in several preclinical studies and then conduct clinical trials for those product candidates that we determine to be the most promising. As we obtain results from clinical trials, we may elect to discontinue or delay trials for some product candidates in order to focus our resources on more promising product candidates. Completion of clinical trials may take several years or more, but the length of time generally varies substantially according to the type, size of trial and intended use of the product candidate.
Due to the risks inherent in the clinical trial process, development completion dates and costs vary significantly for each product candidate, are difficult to estimate and are likely to change as clinical trials progress.
The cost of clinical trials may vary significantly over the life of a project as a result of a variety of factors, including the number of patients who participate in the clinical trials, the number of sites included in the clinical trials, the length of time required to enroll trial participants, the efficacy and safety profile of our product candidates and the costs and timing of and our ability to secure regulatory approvals.
Research and development expenses were $15,478 in the three month period ended in June 30, 2013, a decrease of $156,929 from the research and development expenses of $172,407 in the three month period ended in June 30, 2013. The decrease was primarily attributable to a decrease in the amount of funds allocated to our clinical trials.
Research and development expenses were $25,335 in the six month period ended in June 30, 2013, a decrease of $156,929 from the research and development expenses of $336,381 in the six month period ended in June 30, 2013. The decrease was primarily attributable to a decrease in the amount of funds allocated to our clinical trials.
The timing and amount of our planned research and development expenditures is dependent on our ability to obtain additional financing. See Existing Capital Resources and Future Capital Requirements and Item 1A. Risk Factors We will need to secure additional financing as filed with our Form 10-K with the Securities and Exchange Commission on April 12, 2012.
Marketing, General and Administrative
Our marketing, general and administrative expenses primarily consist of the costs associated with our general management and clinical marketing and trade 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.
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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 employees 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.
The Company follows 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 valuing 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 of our competitors; and
• prospects of a liquidity event.
In April 1, 2013, the Board of Directors approved, subject to shareholder approval, the establishment of the Bioheart 2013 Omnibus Equity Compensation Plan, or the 2013 Omnibus Plan. The 2013 Omnibus Plan reserves up to fifty million shares of common stock for issuance.
Marketing, general and administrative expenses were approximately $831,362 in the three month period ended June 30, 2014, an increase of $391,973 from marketing, general and administrative expenses of approximately $439,389 in the three month period ended in June 30, 2013. The increase in marketing, general and administrative expenses is attributable, in part, to stock based compensation paid in the current period of $87,555 for services and increase in employee compensation and service providers.
Marketing, general and administrative expenses were approximately $1,669,691 in the six month period ended June 30, 2014, an increase of $859,769 from marketing, general and administrative expenses of approximately $809,922 in the six month period ended in June 30, 2013. The increase in marketing, general and administrative expenses is attributable, in part, to stock based compensation paid in the current period of $258,799 for services and increase in employee compensation and service providers.
Interest Expense
Interest expense during the three and six months ended June 30, 2014 and 2013 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, the amortization of debt discounts and non-cash incurred relating to our issued convertible notes payable. The debt discounts are being amortized to interest expense over the terms of the respective loans using the effective interest method.
Critical Accounting Policies
Our discussion and analysis of our financial condition and results of operations is based upon our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. While our critical accounting policies are described in Note 1 to our financial statements appearing elsewhere in this report, we believe the following policies are important to understanding and evaluating our reported financial results:
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Revenue Recognition
At the time of each transaction, we assess whether the fee associated with the transaction is fixed or determinable and whether or not collection is reasonably assured. The assessment of whether the fee is fixed or determinable is based upon the payment terms of the transaction. If a significant portion of a fee is due after our normal payment terms or upon implementation or client acceptance, the fee is accounted for as not being fixed or determinable and revenue is recognized as the fees become due or after implementation or client acceptance has occurred. Collectability is assessed based on a number of factors, including past transaction history with the client and the creditworthiness of the client.
Revenues for test kits and equipment sold are not recorded until test kits are delivered. The Company has revenue sharing arrangements for the sale of goods whereby the Company is the primary obligor, sets pricing with the customers and bears all associated credit risks with the customers. Sales under revenue share arrangements are recorded as gross sales and any portion shared with third parties under such arrangements are recorded as cost of sales. Revenues from trainings are not recorded until the completion of the training. Any cash received as a deposit for trainings are recorded by the company as a liability.
Unbilled revenue is revenue that is recognized but is not currently billable to the customer pursuant to contractual terms. In general, such amounts become billable in accordance with predetermined payment schedules, but recognized as revenue as services are performed. Amounts included in unbilled revenue are expected to be collected within one year and are included within current assets.
Research and Development Activities
We account 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.
Derivative financial instruments
Accounting Standards Codification subtopic 815-40, Derivatives and Hedging, Contracts in Entitys own Equity (ASC 815-40) became effective for the Company on October 1, 2009. The Company has identified the embedded derivatives related to the issued Notes and anti-dilutive warrants. These embedded derivatives included in our debt contain certain conversion features and reset provision. The accounting treatment of derivative financial instruments requires that the Company record fair value of the derivatives as of the inception date of Asher Notes and to fair value as of each subsequent reporting date.
Inflation
Our opinion is that inflation has not had, and is not expected to have, a material effect on our operations.
Climate Change
Our opinion is that neither climate change, nor governmental regulations related to climate change, have had, or are expected to have, any material effect on our operations.
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Concentrations of Credit Risk
As of June 30, 2014, one customer represented 45% of the Companys accounts receivable.
As of December 31, 2013, three customers represented 20%, 20% and 36% (total 76%) of the Companys accounts receivable.
Liquidity and Capital Resources
In the three months ended June 30, 2014, we continued to finance our considerable operational cash needs with cash generated from financing activities.
Operating Activities
Net cash used in operating activities was $507,059 in the six month period ended June 30, 2014 as compared to $1,095,156 of cash used in the six month period ended in June 30, 2013.
Our use of cash for operations in the six months ended June 30, 2014 reflected a net income generated during the period of $226,034, adjusted for non-cash items such as stock-based compensation of $282,119, fair value of warrants issued of $112,070, depreciation of $1,986, amortization of debt discounts of $201,615 and non-cash interest paid of $280,876, loss on change in fair value of derivative liabilities of $177,957, net gain on settlement of debt of $2,187,054. In addition we had a net increase in operating assets of $88,707 and an increase in accrued expenses of $230,653 and in accounts payable of $255,392.
Our use of cash for operations in the six months ended June 30, 2013 reflected a net loss generated during the period of approximately $1,269,000, adjusted for non-cash items such as stock-based compensation of $38,380, depreciation of $1,250, amortization of debt discounts of $242,635, loss on change in fair value of derivative liabilities of $89,413, preferred stock issued in settlement of debt and forbearance agreement of $274,050 and non-cash interest paid of $221,395, net with gain on settlement of debt of $1,004,224. In addition we had a net decrease in operating assets of $101,517 and an increase in accrued expenses of $277,294 and a decrease in accounts payable of $71,135.
Investing Activities
Net cash used in investing activities was $6,366 for the six months ended June 30, 2014 were to acquire office equipment as compared to nil cash used for the same period of 2013.
Financing Activities
Net cash provided by financing activities was an aggregate of $558,419 in the six month period ended June 30, 2014 as compared to $1,267,911 in the six month period ended in June 30, 2013. In the six month period ended June 30, 2014 we sold, in private placements, shares of common stock and common stock purchase warrants for aggregate net cash proceeds of $371,000, received proceeds from issuance of note payable of $288,000, and proceeds from warrant exercise of $136,000, net with repayments related party advances of $13,241 and related party notes payable of $223,340.
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Existing Capital Resources and Future Capital Requirements
Our MyoCell product candidate has not received regulatory approval or generated any material revenues. We do not expect to generate any material revenues or cash from sales of our MyoCell product candidate until commercialization of MyoCell, 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. Historically, we have relied on proceeds from the sale of our common stock and our incurrence of debt to provide the funds necessary to conduct our research and development activities and to meet our other cash needs.
At June 30, 2014, we had cash and cash equivalents totaling $91,221. However our working capital deficit as of such date was approximately $9.6 million. Our independent registered public accounting firm has issued its report dated March 24, 2014 in connection with the audit of our financial statements as of December 31, 2013 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 of our unaudited financial statement for the quarter ended June 30, 2014 addresses the issue of our ability to continue as a going concern.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Not required under Regulation S-K for smaller reporting companies.
Item 4. Controls and Procedures
Disclosure Controls and Procedures
We maintain disclosure controls and procedures, which are designed to ensure that information required to be disclosed in the reports we file or submit under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commissions rules and forms, and that such information is accumulated and communicated to our management, including our CEO and Chief Accounting Officer, as appropriate, to allow timely decisions regarding required disclosure.
Under the supervision and with the participation of our management, including our CEO and Principal Financial and Accounting Officer, an evaluation was performed on the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this quarterly report. Based on that evaluation, our management, including our CEO and Principal Financial and Accounting Officer, concluded that our disclosure controls and procedures were ineffective as of the end of the period covered by this report due to the Companys limited resources and limited number of employees. To mitigate the current limited resources and limited employees, we rely heavily on direct management oversight of transactions, along with the use of legal and outsourced accounting professionals. As we grow, we expect to increase our number of employees, which, we believe, will enable us to implement adequate segregation of duties within the internal control framework.
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Changes In Internal Control Over Financial Reporting
There were no changes in the Companys internal controls over financial reporting during the most recently completed fiscal quarter that have materially affected or are reasonably likely to materially affect the Companys internal control over financial reporting.
PART II OTHER INFORMATION
Item 1. Legal Proceedings
Our Company is not involved in any material litigation and we are unaware of any threatened material litigation. However, the biotechnology and medical device industries have been characterized by extensive litigation regarding patents and other intellectual property rights. In addition, from time to time, we may become involved in litigation relating to claims arising from the ordinary course of our business.
Item 1A. Risk Factors
Not required under Regulation S-K for smaller reporting companies.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
During the six months ended June 30, 2014, the Company sold an aggregate of 24,292,783 shares of the Companys common stock and common stock purchase warrants to purchase 23,289,975 shares of the Companys common stock for aggregate gross cash proceeds of $371,000. The warrants are (i) exercisable solely for cash at an exercise price of $0.011 to $0.0214 per share, (ii) non-transferable for six months following issuance and (iii) exercisable, in whole or in part, at any time during the period commencing on the date that is six months and one day following the date of issuance and ending on the tenth year anniversary of the date of issuance.
The issuance of such shares of our common stock was effected in reliance on the exemptions for sales of securities not involving a public offering, as set forth in Rule 506 promulgated under the Securities Act of 1933, as mended (the Securities Act) and in Section 4(2) of the Securities Act, based on the following: the investors confirmed to us that they were accredited investors, as defined in Rule 501 of Regulation D promulgated under the Securities Act and had such background, education and experience in financial and business matters as to be able to evaluate the merits and risks of an investment in the securities; (b) there was no public offering or general solicitation with respect to the offering; (c) the investors were provided with certain disclosure materials and all other information requested with respect to our company; (d) the investors acknowledged that all securities being purchased were restricted securities for purposes of the Securities Act, and agreed to transfer such securities only in a transaction registered under the Securities Act or exempt from registration under the Securities Act; and (e) a legend was placed on the certificates representing each such security stating that it was restricted and could only be transferred if subsequent registered under the Securities Act or transferred in a transaction exempt from registration under the Securities Act.
Item 3. Defaults Upon Senior Securities
There were no defaults upon senior securities during the period ended June 30, 2014.
Item 4. Mine Safety Disclosures
Not applicable.
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Item 5. Other Information
Effective May 19, 2014, the Company increased the authorized shares of capital stock of the Company from nine hundred and fifty million (950,000,000) shares of common stock and twenty million (20,000,000) shares of preferred stock, both $.001 par value respectively, to two billion (2,000,000,000) shares of shares of common stock and twenty million (20,000,000) shares of preferred stock, both $.001 par value respectively.
Item 6. Exhibits
Exhibit No. | Exhibit Description | |
31.1* | Certification Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | |
32.1* | Certification Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | |
101.INS | XBRL Instance Document | |
101.SCH | XBRL Taxonomy Extension Schema Document | |
101.CAL | XBRL Taxonomy Calculation Linkbase Document | |
101.LAB | XBRL Taxonomy Labels Linkbase Document | |
101.PRE | XBRL Taxonomy Presentation Linkbase Document | |
101.DEF | XBRL Definition Linkbase Document |
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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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| Bioheart, Inc. |
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By: | /s/Mike Tomas | |
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| Mike Tomas |
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| Chief Executive Officer & President and Principal Financial and Accounting Officer |
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