In 2010, the Company entered into a research agreement with this affiliate, with funding for the project emanating from venture capital funds controlled by the same two board members. In connection with its funding of the REGEN trial, Ascent Medical Technology Fund II, LP, the Ascent Medical Technology Fund, LP, and Ascent Medical Product Development Centre Inc. are being issued a total of 1,044,451 shares of the Company’s common stock, and warrants to purchase 90,861 shares at exercise prices 20% above the price at which the related common will be issued.
In February 2010, the Company sold to four members of the Board of Directors, in a private placement, an aggregate of 121,450 shares of the Company’s common stock and warrants to purchase 36,435 shares of the Company’s common stock for aggregate gross cash proceeds of $70,441.
In February 2010 the Company’s Chief Science and Technology Officer and his spouse filed divorce papers. Pursuant to the divorce, their jointly owned shares and their ownership of the loan to Bioheart which they hold as a result of their payment of $3 million of principal and related interest to Bank of America on behalf of Bioheart, would be divided equally between them. As a result, the Chief Science and Technology Officer’s common shares were then reduced to 2,513,840 and his percentage shareholding of the Company to 13.8%, with his former spouse assuming ownership of the same number of common shares and percentage shareholding of the Company. Their commonly owned loan and related interest, as of March 29, 2010, $4,140,201, was been equally split. The Chief Science and Technology Officer on March 29, 2010, elected to convert his portion of the loan and related interest to restricted common stock and warrants. As a result, Howard Leonhardt, the Company’s Chief Science and Technology Officer, owns as of March 31, 2010 approximately 22 % of the Company.
On August 6, 2008, the Company amended its Articles of Incorporation to increase the number of authorized shares of its common stock from 50 million to 75 million shares. This amendment was approved by the Company’s shareholders at the Annual Meeting of Shareholders held on July 30, 2008.
In September 2007, by way of a written consent, the Company’s shareholders holding a majority of its outstanding shares of common stock, the Company’s shareholders approved an amendment to Bioheart’s Articles of Incorporation, increasing the number of authorized shares of capital stock so that, following the reverse stock split that was effectuated on September 27, 2007, the Company had 50 million shares of common stock authorized with a par value of $0.001 per share and five million shares of preferred stock authorized with a par value of $0.001 per share.
As further discussed in Note 1, on February 22, 2008 the Company completed its IPO pursuant to which it sold 1,100,000 shares of common stock at a price per share of $5.25 for net proceeds of approximately $1.45 million after deducting underwriter discounts of approximately $400,000 and offering costs of approximately $3.92 million. The Consolidated Statement of Cash Flows for the year ended December 31, 2008 reflects the Company’s receipt of approximately $4.24 million of “Proceeds from (payments for) initial public offering of common stock, net”. The $4.24 million cash proceeds figure is approximately $2.79 million higher than the $1.45 million net proceeds figure identified above due to payment of $2.79 million of various offering expenses prior to January 1, 2008.
The accompanying notes are an integral part of these consolidated financial statements.
Bioheart, Inc. and Subsidiaries
(A development stage enterprise)
Notes to Consolidated Interim Financial Statements — (Continued)
(Unaudited)
In December 2009, the Company also sold, in a private placement an aggregate of 255,830 shares of its common stock and warrants (the “Warrants”) to purchase 76,749 shares of its common stock for aggregate gross cash proceeds of approximately $188,996. The Warrants are (i) exercisable solely for cash at a weighted average exercise price of $0.89 per share, (ii) non-transferable for six months following issuance and (iii) exercisable, in whole or in part, at any time and from time to time during the period commencing on the date that is six months and one day following the date of issuance and ending on the third year anniversary of the date of issuance.
In 2009, the Company also sold, in a private placement initiated in 2008, an aggregate of 2,509,480 shares of its common stock and warrants (the “Warrants”) to purchase 752,844 shares of its common stock for aggregate gross cash proceeds of approximately $1,74 million. The Warrants are (i) exercisable solely for cash at a weighted average exercise price of $0.83 per share, (ii) non-transferable for six months following issuance and (iii) exercisable, in whole or in part, at any time and from time to time during the period commencing on the date that is six months and one day following the date of issuance and ending on the third year anniversary of the date of issuance. In connection with the private placement, the Company paid to a finder who introduced certain investors to the Company aggregate cash fees of $17,856 and warrants to purchase 26,592 shares of common stock at a weighted average exercise price of $0.89 per share. The warrants issued to the finder have the same terms and conditions as the Warrants issued in the private placement. The 2008 PIPE was closed on October 31, 2009, with total capital raised of $3,887,032.
In 2008, the Company also sold, in a private placement, an aggregate of 1,230,280 shares of its common stock and warrants (the “Warrants”) to purchase 369,084 shares of its common stock for aggregate gross cash proceeds of approximately $2.14 million. The Warrants are (i) exercisable solely for cash at a weighted average exercise price of $2.09 per share, (ii) non-transferable for six months following issuance and (iii) exercisable, in whole or in part, at any time and from time to time during the period commencing on the date that is six months and one day following the date of issuance and ending on the third year anniversary of the date of issuance. In connection with the private placement, the Company paid to a finder who introduced certain investors to the Company aggregate cash fees of $24,325 and warrants to purchase 24,325 shares of common stock at a weighted average exercise price of $1.95 per share. The warrants issued to the finder have the same terms and conditions as the Warrants issued in the private placement.
In 2007, the Company sold 529,432 shares of common stock at a price of $7.69 per share to various investors for net proceeds of approximately $3.9 million.
In 2006, the Company sold 1,069,699 shares of common stock at a price of $7.69 per share to various investors. The Company also issued 63,566 shares in exchange for services at a price ranging from $5.67 to $7.69 per share.
In 2005, the Company sold 1,994,556 shares of common stock at a price of $5.67 per share to various investors. The Company also issued 1,210 shares in exchange for services and issued 95,807 shares in exchange for debt at a price of $5.67 per share.
In 2004, the Company sold 808,570 shares of common stock at a price of $5.67 per share to various investors. The Company also issued 1,854 shares to various vendors in exchange for services valued at $10,500. The Company also issued 15,150 shares to the Company’s Chairman of the Board as compensation for services valued at $85,830.
The accompanying notes are an integral part of these consolidated financial statements.
22
Bioheart, Inc. and Subsidiaries
(A development stage enterprise)
Notes to Consolidated Interim Financial Statements — (Continued)
(Unaudited)
In March 2003, the Company effected a recapitalization. The recapitalization provided two shares of common stock for every one share issued as of that date. The Company’s former Chairman of the Board and founding shareholder, who owned 4,405,541 shares of common stock, did not participate in the recapitalization. The number of shares and prices per share in the accompanying financial statements has been retroactively adjusted to reflect the effect of the recapitalization.
After the 2003 recapitalization, the Company sold 561,701 shares of common stock at a price of $5.67 per share to various investors. The Company issued 72,980 shares valued at $416,383 to employees as compensation for services related to the closing of various locations. The Company also issued 4,248 shares to various vendors in exchange for services valued at $24,066 and issued 67,073 shares to the Company’s former Chairman of the Board as compensation for services provided to the Company during 2003 and 2002.
In 2002, the Company sold 1,092,883 shares of common stock at a price of $6.47 per share to various investors. The Company also issued 35,137 shares to various vendors in exchange for services valued at $227,503.
In 2001, the Company sold 985,668 shares of common stock at a price of $6.47 per share to various investors. The Company also issued 8,291 shares to various vendors in exchange for services valued at $54,001 and issued 81,084 shares to the Company’s Chairman of the Board as compensation for services provided to the Company during 2001.
In 2000, the Company sold 1,493,575 shares of common stock at a price of $6.47 per share to various investors. Of the 1,493,575 shares sold in 2000, payment on 77,222 of these shares was not received until January 2001. The Company also issued 7,964 shares to various vendors in exchange for services valued at $52,001.
In 1999, the Company’s Chief Science and Technology Officer contributed $400,000 to the Company in exchange for 4,324,458 shares of common stock.
8. | | Stock Options and Warrants |
Stock Options
In July 2008, the Board of Directors approved, subject to shareholder approval, the establishment of the Bioheart Omnibus Equity Compensation Plan (the “Omnibus Plan”). The establishment of the Omnibus Plan was approved by the Company’s shareholders at the Annual Meeting of Shareholders held on July 30, 2008. Pursuant to the Omnibus Plan, the Company may grant restricted stock, incentive stock options, non-statutory stock options, stock appreciation rights, deferred stock, stock awards, performance shares, and other stock-based awards consisting of cash, restricted stock or unrestricted stock in various combinations to the Company’s employees, directors and consultants. 5,000,000 shares of common stock have been reserved for issuance under the Omnibus Plan. As of December 31, 2008, no instruments had been issued under the Omnibus Plan.
In December 1999, the Company adopted two stock option plans; an employee stock option plan and a directors and consultants stock option plan (collectively referred to as the “Stock Option Plans”), under which a total of 1,235,559 shares of common stock were reserved for issuance upon exercise of options granted by the Company. In 2001, the Company amended the Stock Option Plans to increase the total shares of common stock reserved for issuance to 1,698,894. In 2003, the Company approved an increase of 308,890 shares,
The accompanying notes are an integral part of these consolidated financial statements.
23
Bioheart, Inc. and Subsidiaries
(A development stage enterprise)
Notes to Consolidated Interim Financial Statements — (Continued)
(Unaudited)
making the total 2,007,784 shares available for issuance under the Stock Option Plans. In 2006, the Company approved an increase of 1,081,114 shares, making the total 3,088,898 shares available for issuance under the Stock Option Plans. The Stock Option Plans provide for the granting of incentive and non-qualified options. The terms of stock options granted under the Stock Option Plans are determined by the Compensation Committee of the Board of Directors at the time of grant, including the exercise price, vesting provisions and contractual term of such options. The exercise price of incentive stock options must equal at least the fair value of the common stock on the date of grant, and the exercise price of non-qualified stock options may be no less than the per share par value. The options have terms of up to ten years after the date of grant and become exercisable as determined upon grant, typically over either three or four year periods from the date of grant. Certain outstanding options vested over a one-year period and some vested immediately. On February 24, 2010, by way of a written consent, the Company’s Board of Directors amended the Directors and Consultants 1999 Stock Option Plan to extend the termination date of the Plan to December 1, 2011.
A summary of options at March 31, 2010 and activity during the three-month period then ended is presented below:
| | | | Shares
| | Weighted- Average Exercise Price
| | Weighted- Average Remaining Contractual Term (in years)
| | Aggregate Intrinsic Value (1)
|
---|
Options outstanding at January 1, 2010 | | | | | 2,119,431 | | | $ | 3.28 | | | | | | | | | |
Granted | | | | | 750,426 | | | $ | 0.35 | | | | | | | | | |
Exercised | | | | | (367,012 | ) | | $ | 0.001 | | | | | | | | | |
Forfeited | | | | | (490,307 | ) | | $ | 2.80 | | | | | | | | | |
Options outstanding at March 31, 2010 | | | | | 2,012,538 | | | $ | 3.31 | | | | 6.3 | | | $ | 33,497 | |
Options exercisable at March 31, 2010 | | | | | 1,605,652 | | | $ | 3.90 | | | | 5.6 | | | $ | 22,335 | |
Available for grant at March 31, 2010 | | | | | 6,158,692 | | | | | | | | | | | | | |
The aggregate intrinsic value represents the amount by which the fair market value of the Company’s common stock exceeds the exercise price of options at March 31, 2010. The weighted average fair value of options granted in the three month periods ended March 31, 2010 and 2009 was $0.48 and $0.46 per share, respectively. The total intrinsic value of options exercised in the three month period ended March 31, 2010 was $247,547.
For the three month period ended March 31, 2010, the Company recognized a net $47,298 in stock based compensation expense. This amount consisted of $26,655 in stock-based compensation that was included in research and development expenses and $20,643 that was included in marketing, general and administrative expenses. No tax benefits were attributed to the stock-based compensation expense because a valuation allowance was maintained for all net deferred tax assets. The Company elected to adopt the alternative method of calculating the historical pool of windfall tax benefits as permitted by ASC Topic 718, formerly FSP No. SFAS 123R-c,Transition Election Related to Accounting for the Tax Effects of Share-Based Payment Awards. This is a simplified method to determine the pool of windfall tax benefits that is used in determining the tax effects of stock compensation in the results of operations and cash flow reporting for awards that were outstanding as of the adoption of ASC Topic 718, formerly SFAS No. 123R.
The accompanying notes are an integral part of these consolidated financial statements.
24
Bioheart, Inc. and Subsidiaries
(A development stage enterprise)
Notes to Consolidated Interim Financial Statements — (Continued)
(Unaudited)
The following information applies to options outstanding and exercisable at March 31, 2010:
| | | | Options Outstanding
| | Options Exercisable
| |
---|
| | | | Shares
| | Weighted- Average Remaining Contractual Term
| | Weighted- Average Exercise Price
| | Shares
| | Weighted- Average Exercise Price
|
---|
$0.001 — $0.70 | | | | | 383,414 | | | | 9.7 | | | $ | 0.68 | | | | 250,000 | | | $ | 0.68 | |
$0.71 — $1.28 | | | | | 590,008 | | | | 7.1 | | | $ | 0.85 | | | | 333,411 | | | $ | 0.84 | |
$5.25 — $5.67 | | | | | 992748 | | | | 4.4 | | | $ | 5.58 | | | | 975,873 | | | $ | 5.59 | |
$7.69 | | | | | 39,572 | | | | 6.4 | | | $ | 7.69 | | | | 39,572 | | | $ | 7.69 | |
$8.47 | | | | | 6,796 | | | | 7.0 | | | $ | 8.47 | | | | 6,796 | | | $ | 8.47 | |
| | | | | 2,012,538 | | | | 6.3 | | | $ | 3.31 | | | | 1,605,652 | | | $ | 3.90 | |
The Company uses the Black-Scholes valuation model to determine the fair value of options on the date of grant. This model derives the fair value of options based on certain assumptions related to expected stock price volatility, expected option life, risk-free interest rates and dividend yield. The Company’s expected volatility is based on the historical volatility of other publicly traded development stage companies in the same industry. Prior to January 1, 2008, the Company estimated the expected term for stock option grants by review of similar data from a peer group of companies. The Company adopted SAB 110 effective January 1, 2008 and will apply the simplified method in SAB 107 until enough historical experience is readily available to provide a reasonable estimate of the expected term for stock option grants. The risk-free interest rate assumption is based upon the U.S. Treasury yield curve appropriate for the term of the expected life of the options.
For the three-month periods ended March 31, 2010 and 2009, the fair value of each option grant was estimated on the date of grant using the following weighted-average assumptions.
| | | | For the Three Months ended March 31,
| |
---|
| | | | 2010
| | 2009
|
---|
Expected dividend yield | | | | | 0.0 | % | | | 00.0 | % |
Expected price volatility | | | | | 110 | % | | | 139 | % |
Risk free interest rate | | | | | 3.72 | % | | | 2.44 | % |
Expected life of options in years | | | | | 10 | | | | 5.8 | |
During the three month period ended March 31, 2010, the Company issued options to purchase an aggregate of 750,426 shares of its common stock at a weighted average exercise price of $0.35 per share. These options consisted of the following:
• | | stock options to purchase an aggregate of 307,692 shares of common stock at an exercise price of $0.001 per share issued to a related party as discussed in Note 9. The options vested immediately upon issuance and will expire on the tenth anniversary of the issuance date. |
• | | stock options to purchase an aggregate of 59,320 shares of common stock at an exercise price of $0.001 per share issued to Consultants. The options vested immediately upon issuance and will |
The accompanying notes are an integral part of these consolidated financial statements.
25
Bioheart, Inc. and Subsidiaries
(A development stage enterprise)
Notes to Consolidated Interim Financial Statements — (Continued)
(Unaudited)
| | expire on the tenth anniversary of the issuance date. |
• | | stock options to purchase an aggregate of 250,000 shares of common stock at an exercise price of $0.68 per share issued to certain members of the Company’s Board of Directors. The options vested immediately upon issuance and will expire on the tenth anniversary of the issuance date. |
• | | Stock options to purchase an aggregate of 133,414 shares of common stock at an exercise price of $0.68 per share issued to employees. The options vest in 4 equal annual installments, commencing one month after the date of grant, and will expire on the tenth anniversary of the issuance date. |
In its meeting of August 12, 2009, the Board of Directors approved the repricing of current employees’ stock options (other than Executive Officers). In accordance with regulations concerning such a repricing and in conformance with generally accepted procedures, all options granted before August 12, 2008, were repriced on the basis of the 5-day average closing price of BHRT, during the period of August 11 through August 17, 2009.
The following information applies to the repricing which occurred as of October 8, 2009.
Original Exercise Price | | | | New Exercise Price | | | Number of shares underlying Options |
---|
$1.28 | | | | $0.71 | | | 61,778 | |
$4.11 | | | | $0.71 | | | 10,000 | |
$5.67 | | | | $0.71 | | | 409,144 | |
$7.69 | | | | $0.71 | | | 12,851 | |
$8.47 | | | | $0.71 | | | 38,163 | |
| | | | | | | 531,936 | |
Of those options listed above, 61,778 expired in December 2009 without having been exercised and 334,891 expired in March 2010 without having been exercised. .
Stock Warrants
The Company does not have a formal plan in place for the issuance of stock warrants. However, at times, the Company will issue warrants to non-employees or in connection with financing transactions. The exercise price, vesting period, and term of these warrants is determined by the Company’s Board of Directors at the time of issuance. A summary of warrants at March 31, 2010 and activity during the three-month period then ended is presented below:
The accompanying notes are an integral part of these consolidated financial statements.
26
Bioheart, Inc. and Subsidiaries
(A development stage enterprise)
Notes to Consolidated Interim Financial Statements — (Continued)
(Unaudited)
| | | | Shares
| | Weighted- Average Exercise Price
| | Weighted- Average Remaining Contractual Term (in years)
| | Aggregate Intrinsic Value
|
---|
Outstanding at January 1, 2010 | | | | | 7,355,057 | | | $ | 3.06 | | | | | | | | | |
Issued | | | | | 1,784,577 | | | $ | 0.73 | | | | | | | | | |
Exercised | | | | | 0 | | | $ | 0.00 | | | | | | | | | |
Forfeited | | | | | 116,763 | | | $ | 0.66 | | | | | | | | | |
Outstanding at March 31, 2010 | | | | | 9,030,668 | | | $ | 2.63 | | | | 8.0 | | | $ | 6,785,212 | |
Exercisable at March 31, 2010 | | | | | 4,818,248 | | | $ | 2.04 | | | | 6.8 | | | $ | 4,014,314 | |
The Company uses the Black-Scholes valuation model to determine the fair value of warrants on the date of issuance. The Company’s expected volatility is based on the historical volatility of other publicly traded development stage companies in the same industry. The expected life of the warrants is based primarily on the contractual life of the warrants. The risk-free interest rate assumption is based upon the U.S. Treasury yield curve appropriate for the term of the expected life of the warrants.
The Company did not issue any warrants that require Fair Value Calculation during the Quarter ending March 31, 2010. For the period ended March 31, 2009, the fair value of warrants issued in transactions that resulted in the recognition of expense, was estimated on the date of issuance using the following weighted-average assumptions.
| | | | For the Three Month Period ended March 31,
| |
---|
| | | | 2010
| | 2009
|
---|
Expected dividend yield | | | | | n/a | | | | 00.0 | % |
Expected price volatility | | | | | n/a | | | | 75 | % |
Risk free interest rate | | | | | n/a | | | | 2.0 | % |
Expected life of options in years | | | | | n/a | | | | 10.0 | |
The following information applies to warrants outstanding and exercisable at March 31, 2010:
The accompanying notes are an integral part of these consolidated financial statements.
27
Bioheart, Inc. and Subsidiaries
(A development stage enterprise)
Notes to Consolidated Interim Financial Statements — (Continued)
(Unaudited)
| | | | Warrants Outstanding
| | Warrants Exercisable
| |
---|
| | | | Shares
| | Weighted- Average Remaining Contractual Term
| | Weighted- Average Exercise Price
| | Shares
| | Weighted- Average Exercise Price
|
---|
$0.53 — $0.68 | | | | | 3,668,111 | | | | 7.4 | | | $ | 0.59 | | | | 3,018,626 | | | $ | 0.58 | |
$0.70 — $1.89 | | | | | 2,396,262 | | | | 1.8 | | | $ | 0.79 | | | | 396,224 | | | $ | 0.88 | |
$1.90 — $2.60 | | | | | 413,686 | | | | 1.6 | | | $ | 2.08 | | | | 395,239 | | | $ | 2.08 | |
$3.60 — $4.93 | | | | | 105,000 | | | | 3.4 | | | $ | 4.87 | | | | 105,000 | | | $ | 4.87 | |
$5.67 — $7.69 | | | | | 2,447,609 | | | | 13.0 | | | $ | 7.47 | | | | 903,159 | | | $ | 7.09 | |
| | | | | 9,030,668 | | | | 7.1 | | | $ | 2.63 | | | | 4,818,248 | | | $ | 2.04 | |
• | | During the three month period ended March 31, 2010, the Company issued warrants to purchase an aggregate of 1,675,614 shares of its common stock at a weighted average exercise price of $0.73 per share. These warrants were issued in connection with a private placement. The warrant vests six months following issuance and expires on the third year anniversary of the date of issuance. |
• | | During the three month period ended March 31, 2010 the Company canceled and reissued warrants to purchase 108,963 shares of its common stock that had previously been issued in a private placement. |
The Company is not subject to any legal proceedings.
10. Contingency
The Company believes that it may have issued options to purchase common stock to certain of its employees, directors and consultants in California in violation of the registration or qualification provisions of applicable California securities laws. As a result, the Company intends to make a rescission offer to these persons. The Company will make this offer to all persons who have a continuing right to rescission, which it believes to include two persons. In the rescission offer, in accordance with California law, the Company will offer to repurchase all unexercised options issued to these persons at 77% of the option exercise price multiplied by the number of option shares, plus interest at the rate of 7% from the date the options were granted. Based upon the number of options that were subject to rescission as of December 31, 2009, assuming that all such options are tendered in the rescission offer, the Company estimated that its total rescission liability would be up to approximately $371,000. However, as the Company believes there is only a remote likelihood the rescission offer will be accepted by any of these persons in an amount that would result in a material expenditure by the Company, no liability was recorded as of December 31, 2009 or 2008.
11. Supplemental Disclosure of Cash Flow Information
During the three months ended March 31, 2010 and December 31, 2009, the Company issued warrants in connection with the renewal of the BlueCrest Loan with an aggregate fair value of $687,677 and $1,580,575, respectively.
For the quarter ended March 31, 2010 the Company issued Common Stock in connection with the settlement of Accounts Payable with an aggregate value of $17,000.
For the Quarter ended March 31, 2010 the Company issued Common Stock in connection with amount due to loan guarantor for payment of $666,600 to Bank of America.
For the Quarter ended March 31, 2010 the Company issued Common Stock in connection with payment of the subordinated related party loan for $1,500,000.
For the Quarter ended March 31, 2010 the Company issued Common Stock in connection with the payment of accrued interest and loans fees due to Bank of America loan guarantors for $798,770.
The accompanying notes are an integral part of these consolidated financial statements.
28
Bioheart, Inc. and Subsidiaries
(A development stage enterprise)
Notes to Consolidated Interim Financial Statements — (Continued)
(Unaudited)
12. Subsequent Events
Private Placement — Common Stock and Warrants
In April 2010, the Company sold, an aggregate of 849,690 shares of the Company’s common stock and warrants to purchase 254,907 shares of the Company’s common stock for aggregate gross cash proceeds of $213,500. The warrants are (i) exercisable solely for cash at an exercise price of $0.65 to $0.84 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 third year anniversary of the date of issuance.
Patient Treatment at Center of Excellence
On April 14, 2010, the Company announced that treatment with stem cell therapy on two congestive heart failure (CHF) patients was performed successfully at the Hospital Angeles Tijuana, Mexico, through Bioheart’s Center of Excellence program with Regenerative Medicine Institute..
The accompanying notes are an integral part of these consolidated financial statements.
29
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Unless otherwise indicated, references in this Quarterly Report on Form 10-Q to “we,” “us,” and “our” are to the Company. The following discussion and analysis by our management of our financial condition and results of operations should be read in conjunction with our unaudited consolidated interim financial statements and the accompanying related notes included in this quarterly report and our audited consolidated financial statements and related notes and Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2009 filed with the Securities and Exchange Commission.
Cautionary Statement Regarding Forward-Looking Statements
This report may contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act, and we intend that such forward-looking statements be subject to the safe harbors created thereby. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Any such forward-looking statements would be contained principally in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors.” Forward-looking statements include information concerning our possible or assumed future results of operations, business strategies, financing plans, competitive position, industry environment, potential growth opportunities and the effects of regulation. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as “anticipates,” “believes,” “could,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or similar expressions.
Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We discuss many of these risks in greater detail in “Risk Factors.” Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent our management’s beliefs and assumptions only as of the date of this report. You should read this report and the documents that we reference in this report and have filed as exhibits to the report completely and with the understanding that our actual future results may be materially different from what we expect. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
Additional information concerning these and other risks and uncertainties is contained in our filings with the Securities and Exchange Commission, including the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2009.
Our Ability To Continue as a Going Concern
Our independent registered public accounting firm has issued its report dated, March 31, 2010, in connection with the audit of our financial statements as of December 31, 2009, that included an explanatory paragraph describing the existence of conditions that raise substantial doubt about our ability to continue as a going concern. Our consolidated financial statements as of March 31, 2010 have been prepared under the assumption that we will continue as a going concern. If we are not able to continue as a going concern, it is likely that holders of our common stock will lose all of their investment. Our financial statements do not include any adjustments that might result from the outcome of this uncertainty.
30
Overview
We are committed to maintaining our leading position within the cardiovascular sector of the cell technology industry, delivering cell therapies, intelligent devices and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. We work to prevent the worsening of any condition with devices that monitor and diagnose. Our goals are to cause damaged tissue to be regenerated, if possible, and to improve a patient’s quality of life and reduce health care costs and hospitalizations.
Biotechnology Product Candidates
Specific to biotechnology, 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 and peripheral vascular disease. MyoCell is a clinical muscle-derived cell therapy 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. Our most recent clinical trials of MyoCell include the SEISMIC Trial, a completed 40-patient, randomized, multicenter, controlled, Phase II-a study conducted in Europe and the MYOHEART Trial, a completed 20-patient, multicenter, Phase I dose-escalation trial conducted in the United States. We were approved by the U.S. Food and Drug Administration (the “FDA”) to proceed with a 330-patient, multicenter Phase II/III trial of MyoCell in North America and Europe (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 October, 2009, showing a dramatic (35%) improvement in 6 minute walk distance for those patients who were treated, and less distance from baseline for those who received a placebo. We are planning, on the basis of these results, to ask the FDA to consider the MARVEL Trial a pivotal trial (pivotal from Phase II to Phase III) and to reduce the number of patients in the trial to 150 from 390. 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 or MyCell SDF-1, our second generation therapy, discussed below, we intend to generate revenue in the United States from the sale of cell-culturing services for treatment of patients by qualified physicians. Abroad, we are identifying centers where it is acceptable to use the MyoCell and MyoCell SDF-1 treatments so that patients with this problem can have access to treatment.
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), the first approval of a study combining gene and cell therapies. Work commenced on this study, called the REGEN trial, during the first quarter of 2010. Based on the results of the trial, we intend to either incorporate the combination treatment into the MARVEL trial, or continue with the MARVEL trial based on the use of MyoCell alone.
In our pipeline, we have multiple product candidates for the treatment of heart damage, including Bioheart Acute Cell Therapy, an autologous, adipose cell treatment for acute heart damage designed to be used in connection with the TGI 1200TM tissue processing system, and MyoCell® SDF-1. Tissue Genesis, Inc., the entity from whom we have obtained the worldwide right to sell or lease the TGI 1200TM announced on November 13, 2008 that the TGI 1200TM had been certified with a CE Marking, thus making the system available throughout the European marketplace. We understand that Tissue Genesis is in the process of evaluating the regulatory pathway that should be pursued for the TGI 1200TM device. We hope to demonstrate that our various product candidates are safe and effective complements to existing therapies for chronic and acute heart damage as well as peripheral arterial disease.
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MyoCath
The MyoCath was developed by Bioheart co-founder Robert Lashinski specifically for delivering new cells to damaged tissue. It is a deflecting tip needle injection catheter that has a larger needle which is 25 gauge 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, thus improving safety. The MyoCath competes well with other biological delivery systems on price and efficiency and allows the physician to utilize standard fluoroscopy and echo equipment found in every cath lab.
The MyoCath is being used to inject cells into cardiac tissue in therapeutic procedures to treat chronic heart ischemic and congestive heart failure.
Center of Excellence Program
On March 23, 2010, the Company announced plans for establishing five Centers of Excellence in Latin America to provide its cell therapy procedures to patients suffering from congestive heart failure (CHF) and peripheral arterial disease (PAD). Bioheart entered into its first agreement with a leading treatment facilitator, Regenerative Medicine Institute of Tijuana, Mexico. Therapies for CHF and PAD patients will be made available at the Hospital Angeles Tijuana, a fully equipped state-of—the-art private specialties hospital. This is the first of five Centers of Excellence with four additional Centers to be announced in the coming months
On April 14, 2010, the Company announced that treatment with stem cell therapy on two congestive heart failure (CHF) patients was performed successfully at the Hospital Angeles Tijuana, Mexico, through Bioheart’s Center of Excellence program with Regenerative Medicine Institute.
Intelligent Devices — Distribution Agreements
Effective as of April 3, 2008, we entered into a distribution agreement with RTX Healthcare A/S (Denmark) (“RTX”) pursuant to which we secured worldwide, non-exclusive distribution rights to the Bioheart 3370 Heart Failure Monitor, an interactive and simple-to-use at-home intelligent device designed specifically to improve available healthcare to patients outside hospitals who are suffering from heart failure. The device, manufactured by RTX, has 510(k) market clearance from the U.S. Food and Drug Administration for marketing in the United States and CE mark approval for marketing in Europe and other countries that follow this mark. The compact Bioheart 3370 Heart Failure Monitor engages patients through personalized daily interactions and questions, while collecting vital signs and transmitting the information directly into a database. The data are regularly monitored by a remotely located medical professional, who watches for any abnormal readings that may signal a change in the patient’s health status. These changes are reported back to the treating physician. We do not have any minimum purchase commitment under the agreement. However, the per unit purchase price payable by us is inversely related to the number of units we purchase per annum. The distribution agreement has an initial term of two years and is subject to automatic renewal for additional one-year periods unless either party indicates an intent to terminate the agreement prior to the end of the then current term. The distribution agreement may be terminated by either party upon the other party’s default.
The company has signed distribution agreements with Restoration Medical, McRay Medical, Alamo Scientific and Morey Medical. These distributors will assist Bioheart with introducing its Home Heart Failure Monitoring Systems to physicians and hospitals throughout the United States. McRay Medical will distribute the systems in Northern California; Alamo Scientific will distribute in Texas, Louisiana and Arkansas; Morey
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Medical will distribute in Okalahoma and parts of Kansas; Restoration Medical will distribute the monitoring systems in the rest of the country.
Effective as of October 22, 2009, the Company entered into a distribution agreement with Morey Medical Inc. pursuant to which Morey was granted exclusive rights to market and promote the Bioheart 3370-1 Heart Failure Monitor throughout a specific territory. In consideration for identifying purchasers who purchase or rent the Bioheart 3370-1 Heart Failure Monitor from the Company, the Company will pay to Morey a set fee. Morey is required to meet certain quarterly minimum purchase commitments under the agreement. The agreement has an initial term of one year and is subject to automatic renewal for additional one-year periods unless either party indicates intent to terminate the agreement no less than 60 days prior to the end of the then current term.
Effective as of December 10, 2009, the Company entered into a distribution agreement with McRay Medical, LLC, pursuant to which McRay was granted exclusive rights to market and promote the Bioheart 3370-1 Heart Failure Monitor throughout a specific territory. In consideration for identifying purchasers who purchase or rent the Bioheart 3370-1 Heart Failure Monitor from the Company the Company will pay to McRay a set fee. McRay is required to meet certain quarterly minimum purchase commitments under the agreement. The agreement has an initial term of one year and is subject to automatic renewal for additional one-year periods unless either party indicates intent to terminate the agreement no less than 60 days prior to the end of the then current term.
Effective as of October 22, 2009, the Company entered into a distribution agreement with Alamo Scientific, Inc. pursuant to which Alamo was granted exclusive rights to market and promote the Bioheart 3370-1 Heart Failure Monitor throughout a specific territory. In consideration for identifying purchasers who purchase or rent the Bioheart 3370-1 Heart Failure Monitor from the Company the Company will pay to Alamo a set fee. Alamo is required to meet certain quarterly minimum purchase commitments under the agreement. The agreement has an initial term of one year and is subject to automatic renewal for additional one-year periods unless either party indicates intent to terminate the agreement no less than 60 days prior to the end of the then current term.
Effective as of December 18, 2009, the Company entered into a distribution agreement with Restoration Medical Inc. pursuant to which Restoration was granted exclusive rights to market the Bioheart 3370-1 Heart Failure Monitoring System throughout those territories not covered by Morey Medical, McRay Medical and Alamo Scientific. In consideration for identifying purchasers who purchase or lease the Bioheart 3370-1 Heart Failure Monitoring System from the Company, the Company will pay to Restoration a set fee. Restoration is required to meet certain quarterly minimum purchase commitments under the agreement. The agreement has an initial term of one year and is subject to automatic renewal for additional one-year periods unless either party indicates intent to terminate the agreement no less than 60 days prior to the end of the then current term.
The heart failure monitors are reimbursed by Medicare to the home health companies. In 2009, reimbursement was added to the National Episode Rate for cardiac patients. The monitors in conjunction with the nurse’s visit are essential to the well being of chronic heart failure patients. Care Plan Oversight (CPO) reimbursement also allows physicians to bill Medicare for their time overseeing the care of home care or hospice patients.
Operations
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. Substantially all of our revenue since inception has been generated in the United States, and the majority of our long-lived assets are located in the United States.
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Critical Accounting Policies
Our discussion and analysis of our financial condition and results of operations is based upon our consolidated 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 consolidated financial statements appearing elsewhere in this report, we believe the following policies are important to understanding and evaluating our reported financial results:
Stock-Based Compensation
On January 1, 2006, we adopted the provisions of Statement of Financial Accounting Standards No. 123R,Share-Based Payment (“SFAS No. 123R”) using the modified prospective transition method. SFAS No. 123R requires us to measure all share-based payment awards granted after January 1, 2006, including those with employees, at fair value. Under SFAS No. 123R, the fair value of stock options and other share-based compensation must be recognized as expense in the statements of operations over the requisite service period of each award.
The fair value of share-based awards granted subsequent to January 1, 2006 is determined using the Black-Scholes valuation model and compensation expense is recognized on a straight-line basis over the vesting period of the awards. Beginning January 1, 2006, we also began recognizing compensation expense under SFAS No. 123R for the unvested portions of outstanding share-based awards previously granted under our stock option plans, over the periods these awards continue to vest. Our future share-based compensation expense will depend on the number of equity instruments granted and the estimated value of the underlying common stock at the date of grant.
We account for certain share-based awards, including warrants, with non-employees in accordance with SFAS No. 123R and related guidance, including EITF Issue No. 96-18,Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling Goods or Services. We estimate the fair value of such awards using the Black-Scholes valuation model at each reporting period and expense the fair value over the vesting period of the share-based award, which is generally the period in which services are provided.
Revenue Recognition
Since inception, we have not generated any material revenues from our MyoCell product candidate. In accordance with Staff Accounting Bulletin No. 101,Revenue Recognition in Financial Statements, as amended by SEC Staff Accounting Bulletin No. 104,Revenue Recognition, our revenue policy is to recognize revenues from product sales and service transactions generally when persuasive evidence of an arrangement exists, the price is fixed or determined, collection is reasonably assured and delivery of product or service has occurred.
We initially recorded payments received by us pursuant to our agreements with ACS as deferred revenue. Revenues are recognized on a pro rata basis as the catheters are delivered pursuant to those agreements.
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Research and Development Activities
Research and development expenditures, including payments to collaborative research partners, are charged to expense as incurred. We expense amounts paid to obtain patents or acquire licenses as the ultimate recoverability of the amounts paid is uncertain.
Results of Operations
We are a development stage company and neither our MyoCell product candidate nor our other product candidates has received regulatory approval or generated any material revenues and is not expected to until 2011, if ever. We have generated substantial net losses and negative cash flow from operations since inception and anticipate incurring significant net losses and negative cash flows from operations for the foreseeable future as we continue clinical trials, undertake new clinical trials, apply for regulatory approvals, make capital expenditures, add information systems and personnel, make payments pursuant to our license agreements upon our achievement of certain milestones, continue development of additional product candidates using our technology, establish sales and marketing capabilities and incur the additional cost of operating as a public company.
Comparison of the three months Ended March 31, 2010 and 2009
Revenues
We recognized revenues of $29,800 in the three month period ended March 31, 2010 compared to revenues of $109,000 in the three month period ended March 31, 2009.. Our revenue in the three month period ended March 31, 2010 was generated mainly from the sale of Cardio Devices and the revenue in the three month period ended March 31, 2009 was generated mainly from the sale of MyoCath catheters.
Cost of Sales
Cost of sales was $14,404 in the three month period ended March 31, 2010 compared to $49,296 in the three month period ended March 31, 2009.
Research and Development
Research and development expenses were approximately $415,900 in the three month period ended in March 31, 2010, a decrease of approximately $210,500 from research and development expenses of $626,400 in 2009. The decrease was primarily attributable to a reduction 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 ....”
Marketing, General and Administrative
Marketing, general and administrative expenses were approximately $427,000 in the three month period ended March 31 2010, a decrease of $220,000 from marketing, general and administrative expenses of approximately $647,000 in 2009. The decrease in marketing, general and administrative expenses is attributable, in part, to a decrease in insurance, legal and rent expenses.
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Interest Income
Interest income consists of interest earned on our cash and cash equivalents. Interest income was $0.83 in the three month period ended March 31, 2010 compared to interest income of $10.32 in 2009..The decrease in interest income was primarily attributable to lower cash balances in the three month period ended March 31, 2010 compared to 2009.
Interest Expense
On June 1, 2007, we entered into the BlueCrest Loan and the Bank of America Loan, both in the principal amount of $5.0 million, with interest rates of 12.85% and 4.75% (prime plus 1.5%), respectively, at December 31, 2008. On August 20, 2008, we borrowed $1.0 million from a third party at an interest rate of 13.5% per annum. Interest expense primarily consists of interest incurred on the principal amount of these loans, accrued fees and interest earned by the guarantors of the Bank of America Loan, the amortization of related deferred loan costs and the amortization of the fair value of warrants issued in connection with the BlueCrest and Bank of America Loans. The fair value of the warrants originally issued in connection with the Bank of America Loan was amortized by the end of January 2008.
Interest expense was $683,110 in the three month period ended March 31, 2010 compared to interest expense of $557,682 in 2009. Interest incurred on the principal amount of our outstanding loans and interest and fees earned by the guarantors totaled $299,755 in the three month period ended March 31, 2010 and $277,280 in 2009. Amortization of deferred loan costs and amortization of the fair value of warrants issued in connection with the BlueCrest and Bank of America Loans totaled $381,300 in the three month period ended March 31, 2010 compared to $277,000 in 2009.
Liquidity and Capital Resources
In the three month period ended March 31, 2010, we continued to finance our considerable operational cash needs with cash generated from financing activities.
Operating Activities
Net cash used in operating activities was $504,000 in the three month period ended March 31, 2010 as compared to $101,018 of cash used in 2009.
Our use of cash for operations in the three months ended March 31, 2010 reflected a net loss generated during the period of $1.5 million, adjusted for non-cash items such as stock-based compensation of $47,298, amortization of the fair value of warrants granted in connection with the BlueCrest Loan and Bank of America Loan of $354,234, amortization of loan costs incurred in connection with the BlueCrest Loan and Bank of America Loan of $27,024.. A decrease in prepaid and other current assets of $19,000 and an increase in accounts payable of $37,800 contributed to our use of operating cash in 2009. The decrease in prepaid expenses and other current assets was due mainly to the decrease in prepaid insurance. Partially offsetting these uses of cash were decreases in accrued expenses of $553,902..
Our use of cash for operations in the three month period ended March 31, 2009 reflected a net loss generated during the period of $1.8 million. However, our net loss was significantly offset by a decrease in prepaid expenses and other current assets of $441,000, an increase in accounts payable of $494,000 and an increase in accrued expenses of $445,000. The decrease in prepaid expenses was due to the refund of upfront payments under an agreement with the contract research organization that we were utilizing for the MARVEL trial. Accounts payable increased as we have sought to conserve cash until significant additional financing was obtained.
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Investing Activities
Net cash used in investing activities was $688.00 in 2009 as compared to $19,000 in 2008. All of the cash utilized in investing activities for 2009 and 2008 related to our acquisition of property and equipment.
Financing Activities
Net cash provided by financing activities was $498,000 in the three month period ended March 31, 2010 as compared to $222,000 in 2009.
In the three month period ended March 31, 2010 we sold, in a private placement, shares of common stock for aggregate net cash proceeds of approximately $438,463.
Existing Capital Resources and Future Capital Requirements
Neither our MyoCell product candidate nor our other product candidates has received regulatory approval or generated any material revenues. We do not expect to generate any material revenues or cash from sales of our MyoCell and other product candidates until 2011 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 additional debt to provide the funds necessary to conduct our research and development activities and to meet our other cash needs.
At March 31, 2010 we had cash and cash equivalents totaling $49,312 however, our working capital deficit as of such date was $8.8 million. Our independent registered public accounting firm has issued its report dated March 31, 2010 in connection with the audit of our financial statements as of December 31, 2009 that included an explanatory paragraph describing the existence of conditions that raise substantial doubt about 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.
Recent Accounting Pronouncements
Refer to Note 1.Organization and Summary of Significant Accounting Policies in the notes to our consolidated financial statements for a discussion of recent accounting pronouncements.
Item 3. | | Quantitative and Qualitative Disclosures About Market Risk |
Not Applicable.
Item 4. | | Controls and Procedures |
Disclosure Controls and Procedures
We have established disclosure controls and procedures to ensure that material information relating to us is made known to the officers who certify our financial reports, as well as to other members of senior management and the Board of Directors.
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We carried out an evaluation, under the supervision and with the participation of our management, including our Principal Executive Officer, as well as our Principal Financial and Accounting Officer of the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act as of the end of the period covered by this quarterly report on Form 10-Q. Based on such evaluation, our Principal Executive Officer, as well as our Principal Financial and Accounting Officer concluded that, as of March 31, 2010, our disclosure controls and procedures were effective. In making this assessment, we used the criteria set forth inInternal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. The controls that management sought to identify and evaluate were those processes designed by, or under the supervision of, the Company’s principal financial officer, or persons performing similar functions, and implemented by our board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:
(1) pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the Company;
(2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the issuer are being made only in accordance with authorizations of management and directors of the Company; and
(3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the issuer’s assets that could have a material effect on the financial statements.
A deficiency in the design of internal control over financial reporting exists when (a) necessary controls are missing or (b) existing controls are not properly designed so that, even if the control operates as designed, the financial reporting risks would not be addressed.
A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the company’s annual or interim financial statements will not be prevented or detected on a timely basis. Management has determined that, as of March 31, 2010, the Company did not have a deficiency or material weakness in our internal control over financial reporting.
This Quarterly Report on Form 10-Q does not, and is not required to; include an attestation report of the Company’s independent registered public accounting firm regarding internal control over financial reporting.
Changes In Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended March 31, 2010 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II — OTHER INFORMATION
Item 1. | | Legal Proceedings |
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.
There have been no material changes in our risk factors from those disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2009.
Item 2. | | Unregistered Sales of Equity Securities and Use of Proceeds |
Private Placement — Common Stock and Warrants
In January 2010, the Company sold, in a private placement, an aggregate of 162,460 shares of the Company’s common stock and warrants to purchase 48,738 shares of the Company’s common stock for aggregate gross cash proceeds of $105,964. The warrants are (i) exercisable solely for cash at an exercise price of $0.71 to $0.79 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 third year anniversary of the date of issuance.
In February 2010, the Company sold, in a private placement, an aggregate of 260,050 shares of the Company’s common stock and warrants to purchase 78,015 shares of the Company’s common stock for aggregate gross cash proceeds of $149,441.The warrants are (i) exercisable solely for cash at an exercise price of $0.68 to $0.70 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 third year anniversary of the date of issuance.
In March 2010, the Company sold, in a private placement, an aggregate of 368,440 shares of the Company’s common stock and warrants to purchase 110,532 shares of the Company’s common stock for aggregate gross cash proceeds of $197,263. The warrants are (i) exercisable solely for cash at an exercise price of $0.64 to $0.68 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 third year anniversary of the date of issuance
In March of 2010 Howard Leonhardt, the Chief Science and Technology Officer elected to convert his portion of a $4,140,201 Note Receivable to restricted common stock and warrants. Upon conversion he was issued 3,136,520 shares and warrants to purchase 940,956 shares of the Company’s common stock. The warrants are (i) exercisable solely for cash at an exercise price of $0.79 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 third year anniversary of the date of issuance As a result, the Company’s Chief Science and Technology Officer, as of March 31, 2010, owns approximately 22% of the Company.
In March of 2010, one of the Guarantors paid directly to Bank of America the $672,000 of the loan that he had been guaranteeing, and a pro rata portion of accrued interest on behalf of the Company. That Guarantor agreed to accept from the Company the equivalent of his payment to Bank of America in restricted common
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stock and warrants. Upon conversion the former Guarantor was issued 1,657,910 shares and warrants to purchase 497,373 shares of the Company’s common stock. The warrants are (i) exercisable solely for cash at an exercise price of $0.65 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 third year anniversary of the date of issuance
With his acceptance of the restricted common stock and warrants, the former Guarantor owns approximately 8% of the Company.
Each of the listed sales was exempt from registration in reliance upon Section 4(s) of the Securities Act of 1933, as amended (the “Securities Act”), for transactions by an issuer not involving a public offering. The offer and sale of such securities was made without general solicitation or advertising to “accredited investors” as defined in Rule 501(a) of Regulation D promulgated by the Securities Act.
Item 3. | | Defaults Upon Senior Securities |
Not Applicable
Item 4. | | Removed and Reserved |
Item 5. | | Other Information |
On February 24, 2010, by way of a written consent, the Company’s Board of Directors amended the Directors and Consultants 1999 Stock Option Plan to extend the termination date of the Plan to December 1, 2011.
On February 10, 2010, the Board of Directors asked Peggy A. Farley to serve as Chief Financial Officer in addition to serving as Chief Operating Officer and asked Mark P. Borman to serve as Chairman of the Audit Committee. Both agreed. The change enabled increased autonomy between executive management and the Audit Committee.
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Exhibit No.
|
| | | Exhibit Description
|
---|
3.1 | (6) | | | Amended and Restated Articles of Incorporation of the registrant, as amended |
3.2 | (9) | | | Articles of Amendment to the Articles of Incorporation of the registrant |
3.3 | (8) | | | Amended and Restated Bylaws |
4.1 | (5) | | | Loan and Security Agreement, dated as of May 31, 2007 by and between BlueCrest Capital Finance, L.P. and the registrant |
4.2 | (12) | | | Notice of Event of Default, from BlueCrest Venture Finance Master Fund Limited to the Company, dated January 28, 2009 |
4.3 | (12) | | | Notice of Acceleration, from BlueCrest Venture Finance Master Fund Limited to the Company, dated February 2, 2009 |
4.4 | (13) | | | Amendment to Loan and Security Agreement, between the Company and BlueCrest Venture Finance Master Fund Limited, dated as of April 2, 2009 |
4.5 | (13) | | | Grant of Security Interest (Patents), between the Company and BlueCrest Venture Finance Master Fund Limited, dated as of April 2, 2009 |
4.6 | (13) | | | Security Agreement (Intellectual Property), between the Company and BlueCrest Venture Finance Master Fund Limited, dated as of April 2, 2009 |
4.7 | (13) | | | Subordination Agreement, by Hunton & Williams, LLP in favor of BlueCrest Venture Finance Master Fund Limited, entered into and effective April 2, 2009 |
4.8 | (13) | | | Amended and Restated Promissory Note, dated April 2, 2009, by the Company to BlueCrest Venture Finance Master Fund Limited |
4.9 | (13) | | | Warrant to purchase 1,315,542 shares of the registrant’s common stock, dated April 2, 2009, issued to BlueCrest Venture Finance Master Fund Limited |
4.10 | (14) | | | Warrant to purchase 451,043 shares of the registrant’s common stock, dated April 2, 2009, issued to Rogers Telecommunications Limited |
4.11 | (14) | | | Warrant to purchase 173,638 shares of the registrant’s common stock, dated April 2, 2009, issued to Hunton & Williams, LLP |
10.1 | **(1) | | | 1999 Officers and Employees Stock Option Plan |
10.2 | **(1) | | | 1999 Directors and Consultants Stock Option Plan |
10.2 | (a) | | | | | |
10.3 | (1) | | | Form of Option Agreement under 1999 Officers and Employees Stock Option Plan |
10.4 | (3) | | | Form of Option Agreement under 1999 Directors and Consultants Stock Option Plan |
10.5 | **(4) | | | Employment Letter Agreement between the registrant and Scott Bromley, dated August 24, 2006. |
10.6 | (1) | | | Lease Agreement between the registrant and Sawgrass Business Plaza, LLC, as amended, dated November 14, 2006. |
10.7 | (1) | | | Asset Purchase Agreement between the registrant and Advanced Cardiovascular Systems, Inc., dated June 24, 2003. |
10.8 | (4) | | | Conditionally Exclusive License Agreement between the registrant, Dr. Peter Law and Cell Transplants International, LLC, dated February 7, 2000, as amended. |
10.9 | (4) | | | Loan Guarantee, Payment and Security Agreement, dated as of June 1, 2007, by and between the registrant, Howard J. Leonhardt and Brenda Leonhardt |
10.10 | (4) | | | Loan Guarantee, Payment and Security Agreement, dated as of June 1, 2007, by and between the registrant and William P. Murphy Jr., M.D. |
10.11 | (4) | | | Loan Agreement, dated as of June 1, 2007, by and between the registrant and Bank of America, N.A. |
10.12 | (4) | | | Warrant to purchase shares of the registrant’s common stock issued to Howard J. Leonhardt and Brenda Leonhardt |
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Exhibit No.
|
| | | Exhibit Description
|
---|
10.13 | (4) | | | Warrant to purchase shares of the registrant’s common stock issued to Howard J. Leonhardt and Brenda Leonhardt |
10.14 | (4) | | | Warrant to purchase shares of the registrant’s common stock issued to William P. Murphy Jr., M.D. |
10.15 | (4) | | | Warrant to purchase shares of the registrant’s common stock issued to the R&A Spencer Family Limited Partnership |
10.16 | (4) | | | Supply and License Agreement, dated June 7, 2007, by and between the registrant and BioLife Solutions, Inc.*** |
10.17 | (5) | | | Warrant to purchase shares of the registrant’s common stock issued to BlueCrest Capital Finance, L.P. |
10.18 | (6) | | | Loan Guarantee, Payment and Security Agreement, dated as of September 12, 2007, by and between the registrant and Samuel S. Ahn, M.D. |
10.19 | (6) | | | Loan Guarantee, Payment and Security Agreement, dated as of September 12, 2007, by and between the registrant and Dan Marino |
10.20 | (6) | | | Warrant to purchase shares of the registrant’s common stock issued to Samuel S. Ahn, M.D. |
10.21 | (6) | | | Loan Guarantee, Payment and Security Agreement, dated as of September 19, 2007, by and between the registrant and Jason Taylor |
10.22 | (7) | | | Loan Guarantee, Payment and Security Agreement, dated as of October 10, 2007, by and between the registrant and Howard and Brenda Leonhardt |
10.23 | (7) | | | Warrant to purchase shares of the registrant’s common stock issued to Howard and Brenda Leonhardt |
10.24 | (7) | | | Second Amendment to Loan Guarantee, Payment and Security Agreement, dated as of October 10, 2007, by and between the registrant and Howard and Brenda Leonhardt |
10.25 | (7) | | | Second Amendment to Loan Guarantee, Payment and Security Agreement, dated as of October 10, 2007, by and between the registrant and William P. Murphy, Jr., M.D. |
10.26 | **(10) | | | Bioheart, Inc. Omnibus Equity Compensation Plan |
10.27 | (11) | | | Form of Warrant Agreement for October 2008 Private Placement |
10.28 | (11) | | | Form of Registration Rights Agreement for October 2008 Private Placement |
10.29 | (19) | | | 10% Convertible Promissory Note Due July 23, 2010, in the amount of $20,000, payable to Dana Smith |
10.30 | (19) | | | 10% Convertible Promissory Note Due July 23, 2010, in the amount of $100,000, payable to Bruce Meyers |
10.31 | (19) | | | Registration Rights Agreement, dated July 23, 2009 |
10.32 | (19) | | | Subordination Agreement, dated July 23, 2009 |
10.33 | (19) | | | Note Purchase Agreement, dated July 23, 2009 |
10.34 | (19) | | | Closing Confirmation of Conversion Election, dated July 23, 2009 |
31.1 | * | | | Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
31.2 | * | | | 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 |
32.2 | * | | | Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
** | | Indicates management contract or compensatory plan. |
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(1) | | Incorporated by reference to the Company’s Form S-1 filed with the Securities and Exchange Commission on February 13, 2007 |
(3) | | Incorporated by reference to Amendment No. 2 to the Company’s Form S-1 filed with the Securities and Exchange Commission on July 12, 2007 |
(4) | | Incorporated by reference to Amendment No. 3 to the Company’s Form S-1 filed with the Securities and Exchange Commission on August 9, 2007 |
(5) | | Incorporated by reference to Amendment No. 4 to the Company’s Form S-1 filed with the Securities and Exchange Commission on September 6, 2007 |
(6) | | Incorporated by reference to Amendment No. 5 to the Company’s Form S-1 filed with the Securities and Exchange Commission on October 1, 2007 |
(7) | | Incorporated by reference to Post-effective Amendment No. 1 to the Company’s Form S-1 filed with the Securities and Exchange Commission on October 11, 2007 |
(8) | | Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on July 3, 2008 |
(9) | | Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on August 8, 2008 |
(10) | | Incorporated by reference to the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 14, 2008 |
(11) | | Incorporated by reference to the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 14, 2008 |
(12) | | Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 3, 2009 |
(13) | | Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on April 8, 2009 |
(14) | | Incorporated by reference to the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on April 15, 2009 |
(15) | | Incorporated by reference to the Company’s Annual Report on Form 10-K/A filed with the Securities and Exchange Commission on April 30, 2009 |
(16) | | Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on May 18, 2009 |
(17) | | Incorporated by reference to the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 20, 2009 |
(18) | | Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on July 9, 2009 |
(19) | | Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on July 23, 2009 |
(20) | | Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on August 3, 2009 |
(21) | | Incorporated by reference to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on August 18, 2009 |
(22) | | Incorporated by reference to Exhibit 4.6 to the Company’s Post Effective Amendment to Registration Statement on Form S-8/A, filed with the Securities and Exchange Commission on April 28, 2010 |
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SIGNATURES
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.
| | | | Bioheart, Inc. |
|
Date: May 14, 2010 | | | | By:/s/ Karl E. Groth, Ph.D. |
| | | | Karl E. Groth, Ph.D.Chairman of the Board and Chief Executive Officer |
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