e424b3
Filed
pursuant to Rule 424(b)(3)
Registration No. 333-170971
PROSPECTUS
FIBROCELL SCIENCE, INC.
10,073,693 Common Stock
This prospectus relates to the resale of our common stock by certain of our stockholders,
or Selling Stockholders, named in the section of this prospectus titled Selling Security Holders.
The following shares may be offered for resale under this prospectus:
(a) 6,349,200 shares of
common stock representing 110% of the shares underlying the Series A convertible preferred stock,
or Series A Preferred, we issued in October 2009;
(b) 1,624,996 shares of common stock underlying
Class A warrants issued in the Series A Preferred offering;
(c) 1,624,997 shares of common stock
underlying Class B warrants issued in the Series A
Preferred offering; and (d) 474,500 shares of
common stock underlying warrants issued to the placement agent in the Series A Preferred offering.
Although we will pay substantially all the expenses incident to the registration of the
shares, we will not receive any proceeds from the sales by the Selling Stockholders. We will,
however, receive proceeds if the warrants are exercised; to the extent we receive such proceeds,
they will be used for working capital purposes.
Our
common stock is presently quoted for trading under the symbol FCSC on the over the
counter bulletin board, or OTCBB. On February 7, 2011, the last sales price of the common stock, as
reported on the OTCBB was $0.60 per share.
Investing in our common stock is highly speculative and involves a high degree of risk. You
should purchase these securities only if you can afford a complete loss of your investment. You
should carefully consider the risks and uncertainties described under the heading Risk Factors
beginning on page 4 of this prospectus before making a decision to purchase our common stock.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or passed upon the accuracy or adequacy of this
prospectus. Any representation to the contrary is a criminal offense.
The
date of this prospectus is February 11, 2011
TABLE OF CONTENTS
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PROSPECTUS SUMMARY |
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RISK FACTORS |
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS |
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USE OF PROCEEDS |
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MARKET PRICE OF AND DIVIDENDS ON OUR COMMON STOCK AND RELATED STOCKHOLDER MATTERS |
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MANAGEMENTS
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS |
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BUSINESS AND PROPERTY |
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MANAGEMENT |
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RELATED PARTY TRANSACTIONS |
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PRINCIPAL STOCKHOLDERS |
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DESCRIPTION OF SECURITIES |
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SHARES ELIGIBLE FOR FUTURE SALE |
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SELLING SECURITY HOLDERS |
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PLAN OF DISTRIBUTION |
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EXPERTS |
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WHERE YOU CAN FIND MORE INFORMATION |
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INDEX TO FINANCIAL STATEMENTS
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F-1 |
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PROSPECTUS SUMMARY
This summary highlights information set forth in greater detail elsewhere in this prospectus.
It may not contain all the information that may be important to you. You should read the following
summary together with the more detailed information regarding us and our common stock being sold in
this offering. Unless the
context requires otherwise, references to the Company, Fibrocell, we, our, and us, refer
to Fibrocell Science, Inc. and its subsidiaries.
Our Company
We are an aesthetic and therapeutic development stage biotechnology company focused on
developing novel skin and tissue rejuvenation products. Our clinical development product candidates
are designed to improve the appearance of skin injured by the effects of aging, sun exposure, acne
and burn scars with a patients own, or autologous, fibroblast cells produced by our proprietary
Fibrocell process. Our clinical development programs encompass both aesthetic and therapeutic
indications. Our most advanced indication is for the treatment of nasolabial folds wrinkles (United
States adopted name, or USAN, is azficel-T) and has completed Phase III clinical studies, and the
related Biologics License Application, or BLA, has been submitted to the Food and Drug
Administration, or FDA. In October 2009, the FDAs Cellular, Tissue and Gene Therapies Advisory
Committee reviewed this indication. On December 21, 2009, Fibrocell received a Complete Response
letter from the FDA related to the BLA for azficel-T, an autologous cell therapy for the treatment
of moderate to severe nasolabial fold wrinkles in adults. A Complete Response letter is issued by
the FDAs Center for Biologics Evaluation and Research (CBER) when the review of a file is
completed and additional data are needed prior to approval. The Complete Response letter requested
that Fibrocell Science provide data from a histopathological study on biopsied tissue samples from
patients following injection of azficel-T. The histology study (IT-H-001) will evaluate tissue
treated with azficel-T as compared to tissue treated with sterile saline (placebo). The study will
also provide information about the skin after treatment, including evaluation of collagen and
elastin fibrils, and cellular structure of the sampled tissues. The Company submitted a proposed
protocol concerning a histopathological study on biopsied samples to the FDA and to the Companys
Investigational Review Board (IRB). The IRB has approved the protocol and the Company received
the comments from the FDA on the protocol in May 2010.
On May 13, 2010, the Company announced the initiation of a small histology study of azficel-T,
an autologous cell therapy currently under review by the U.S. Food and Drug Administration (FDA)
for the treatment of moderate to severe nasolabial fold wrinkles. The study has a target enrollment
of approximately 20 participants from the completed and statistically significant pivotal Phase III
studies of azficel-T (IT-R-005 and IT-R-006). The Company announced on July 8, 2010, the completion
of enrollment of and first treatment visits for participants in its histology study of azficel-T.
The second treatment visits for participants enrolled in the histology study of azficel-T were
completed by the end of July. The third treatment visits for participants enrolled in the histology
study of azficel-T were completed by the end of August.
The Complete Response letter also requested finalized Chemistry, Manufacturing and Controls
(CMC) information regarding the manufacture of azficel-T as follow-up to discussions that occurred
during the BLA review period, as well as revised policies and procedures.
The Company filed its response to the FDAs Complete Response letter on December 17,
2010. On January 12, 2011, the Company announced that the FDA has accepted for review the Companys
response submission for azficel-T, proposed brand name laViv©, for the
treatment of moderate to severe nasolabial folds and wrinkles. There is no assurance that the FDA
will approve our product. The FDA, under the Prescription Drug User Fee Act (PDUFA), has a target
six months review window to completely evaluate the Companys response upon acceptance of the
response.
During 2009 we completed a Phase II/III study for the treatment of acne scars. During 2008 we
completed our open-label Phase II study related to full face rejuvenation.
We also develop and market an advanced skin care product line through our Agera subsidiary, in
which we acquired a 57% interest in August 2006.
Exit from Bankruptcy
On August 27, 2009, the United States Bankruptcy Court for the District of Delaware in
Wilmington entered an order, or Confirmation Order, confirming the Joint First Amended Plan of
Reorganization dated July 30, 2009, as supplemented by the Plan Supplement dated August 21, 2009,
or the Plan, of Isolagen, Inc. and Isolagens wholly owned subsidiary, Isolagen Technologies, Inc.
The effective date of the Plan was September 3, 2009.
Our officers and directors as of the effective date were all deemed to have resigned and a new
board of directors was appointed. As of the effective date, our initial board of directors
consisted of: David Pernock, Paul Hopper and Kelvin Moore. Dr. Robert Langer was appointed to the
Board in late September 2009. Declan Daly remained as chief operating officer and chief financial
officer of the reorganized company, and in November 2009, he was appointed to the Board of
Directors. Mr. Pernock became our chief executive officer in February 2010.
Pursuant to the Plan, all of our equity interests, including without limitation our common
stock, options and warrants outstanding as of the effective date were cancelled. On the effective
date, we completed an exit financing of common stock in the amount of $2 million, after which the
equity holders of our company were:
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7,320,000 shares, to our pre-bankruptcy lenders and the lenders that provided us
our debtor-in-possession facility, collectively; |
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3,960,000 shares, to the holders of our 3.5% convertible subordinated notes; |
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600,000 shares, to our management as of the effective date, which was our chief
operating officer; |
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120,000 shares, to the holders of our general unsecured claims; and |
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2,666,666 shares, to the purchasers of shares in the $2 million exit financing (our
pre-bankruptcy lenders, the lenders that provided us our debtor-in-possession facility
and the holders of our 3.5% convertible subordinated notes were permitted to
participate in our exit financing). |
In the Plan, in addition to the common stock set forth above, each holder of Isolagens 3.5%
convertible subordinated notes, due November 2024, in the approximate non-converted aggregate
principal amount of $81 million, received, in full and final satisfaction, settlement, release and
discharge of and in exchange for any and all claims arising out of the 3.5% convertible
subordinated notes, its pro rata share of an unsecured note in the principal amount of $6 million,
or the New Notes. The New Notes have the following features:
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12.5% interest payable quarterly in cash or, at our option, 15% payable in kind by
capitalizing such unpaid amount and adding it to the principal as of the date it was
due; |
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mature June 1, 2012; |
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at any time prior to the maturity date, we may redeem any portion of the
outstanding principal of the New Notes in cash at 125% of the stated face value of the
New Notes; provided that we will be obligated to redeem all outstanding New Notes upon
the following events: (a) we or our subsidiary, Fibrocell Technologies, Inc.
(formerly, Isolagen Technologies, Inc.) successfully complete a capital campaign
raising in excess of $10,000,000; or (b) we or our subsidiary, Fibrocell Technologies,
Inc., are acquired by, or sell a majority stake to, an outside party; |
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the New Notes contain customary representations, warranties and covenants,
including a covenant that we and our subsidiary, Fibrocell Technologies, Inc., shall
be prohibited from the incurrence of additional debt without obtaining the consent of
66 2/3% of the New Note holders. |
Recent Developments
March
2010 Offering
On March 2, 2010 pursuant to a securities purchase agreement, we completed an offering,
referred to as the March 2010 Private Offering, in which we issued to certain accredited investors in the
aggregate 5,076,664 shares of common stock at a purchase price of $0.75 per share. Each investor
also received a warrant to purchase the same number of shares of common stock acquired in the
March 2010 Private Offering at an initial exercise price of $0.98 per share. The aggregate purchase price paid by the
investors for the common stock and the warrants was $3,807,500. The Company intends to use the
proceeds for working capital purposes.
Effect of March 2010 Private Offering on Series A Preferred
With
certain exceptions, the Certificate of Designation of the
Series A Preferred, which was issued as part of our Series A
Preferred Offering, provides
that if at any time while the Series A Preferred is outstanding, we sell or grant any option to
purchase or sell or grant any right to reprice, or otherwise dispose of or issue (or announce any
sale, grant or any option to purchase or other disposition), any common stock or common stock
equivalents at an effective price per share that is lower than the then conversion price of the Series A Preferred, then the conversion price of
the Series A Preferred will be reduced to equal the lower price.
Consequently, as a result of the purchase price of the common stock sold in the March 2010 Private
Offering, effective as of March 2, 2010, the conversion price of
the Series A Preferred was
reduced from $1.30 to $0.75.
Effect of March 2010 Private Offering on Warrants
With
certain exceptions, the Class A warrants, Class B warrants
and placement agent warrants, which were issued as part of our Series
A Preferred Offering, provide that if at any time while the warrants are outstanding, we sell or grant any option to
purchase or sell or grant any right to
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reprice, or otherwise dispose of or issue (or announce any
sale, grant or any option to purchase or other disposition), any common stock or common stock
equivalents at an effective price per share that is lower than the then exercise price of the
relevant warrant, then the exercise price of such warrant will be reduced to equal the lower price
and the number of shares issuable thereunder will be increased such that the aggregate exercise
price after the exercise price adjustment will be equal to the aggregate exercise price prior to
the adjustment.
Consequently,
as a result of the purchase price of the common stock were sold in
the March 2010 Private
Offering, effective as of March 2, 2010, (a) the exercise prices for the Class A, Class B and
placement agent warrants, which were issued as part of our Series A
Preferred
Offering, reduced from $1.62, $1.95 and $1.30 per share, respectively, to
$0.75 per share and (b) the numbers of shares underlying the Class A, Class B and placement agent
warrants were increased to 1,083,331, 1,083,332 and 433,333 respectively.
July
through November 2010 Offerings
Pursuant
to securities purchase agreements, we completed offerings in July,
September, October and November 2010 in which we issued to certain
accredited investors (i)
in the aggregate 4,640 shares of Series B Convertible Preferred Stock, with a stated value of
$1,000 per share, referred to as the Series B Preferred, and
(ii) warrants to purchase 7,733,333
shares of Company common stock at an exercise price of $0.8054 per share. The aggregate purchase
price paid by the investors for the Series B Preferred and the
warrants was $4,640,000.
Of the foregoing, to date, the Company has not received $210,000 in subscription proceeds representing 210 shares of Series B Preferred and
warrants to purchase 350,000 shares. The Company intends to use the proceeds for working capital purposes.
In connection with the
September offering, the Company recorded on its September 30, 2010 balance sheet a $450,000 receivable of subscription proceeds, representing
two subscriptions for an aggregate of 450 shares of Series B Preferred and warrants to purchase 750,000 shares. On November 17, 2010, the
Company entered into a Termination Agreement with the two Subscribers owing the $450,000 to terminate their Securities Purchase Agreements.
As a result, the Subscribers are no longer obligated to pay the Company the $450,000 and the Company is not obligated to issue the Series B
Preferred shares or warrants. Accordingly, the $450,000 receivable will not be reflected on future balance sheets.
Effect
of July through November 2010 Private Offerings on Series A Preferred
With certain exceptions, the Certificate of Designation of the Series A Preferred, which was
issued as part of our Series A Preferred Offering, provides that if at any time while the Series A
Preferred is outstanding, we sell or grant any option to purchase or sell or grant any right to
reprice, or otherwise dispose of or issue (or announce any sale, grant or any option to purchase or
other disposition), any common stock or common stock equivalents at an effective price per share
that is lower than the then conversion price of the Series A Preferred, then the conversion price
of the Series A Preferred will be reduced to equal the lower price.
Consequently, as a result of the purchase price of the common stock sold in the
July, September, October and November 2010
private offerings the conversion price of the Series A Preferred has
been reduced from $0.75 to $0.60.
Effect
of July through November 2010 Private Offerings on Warrants issued as part of Series A Preferred Offering
With certain exceptions, the Class A warrants, Class B warrants and placement agent warrants,
which were issued as part of the Series A Preferred Offering, provide that if at any time while the
warrants are outstanding, we sell or grant any option to purchase or sell or grant any right to
reprice, or otherwise dispose of or issue (or announce any sale, grant or any option to purchase or
other disposition), any common stock or common stock equivalents at an effective price per share
that is lower than the then exercise price of the relevant warrant, then the exercise price of such
warrant will be reduced to equal the lower price and the number of shares issuable thereunder will
be increased such that the aggregate exercise price after the exercise price adjustment will be
equal to the aggregate exercise price prior to the adjustment.
Consequently, as a result of the purchase price of the common stock sold in the
July, September, October and November 2010
private offerings, (a) the exercise prices for the Class A, Class B
and placement agent warrants issued as part of the Series A Preferred Offering were reduced from
$0.75 per share to $0.60 per share and (b) the numbers of shares underlying the Class A, Class B
and placement agent warrants were increased to 1,354,163, 1,354,165, and 541,667, respectively.
Effect
of July through November 2010 Private Offerings on Warrants issued as part of March 2010 Private Offering
With certain exceptions, the warrants and placement agent warrants issued as part of the March
2010 Private Offering provide that if at any time while the warrants are outstanding, we sell or
grant any option to purchase or sell or grant any right to reprice, or otherwise dispose of or
issue (or announce any sale, grant or any option to purchase or other disposition), any common
stock or common stock equivalents at an effective price per share that is lower than the then
exercise price of the relevant warrant, then the exercise price of such warrant will be reduced to
equal the lower price and the number of shares issuable thereunder will be increased such that the
aggregate exercise price after the exercise price adjustment will be equal to the aggregate
exercise price prior to the adjustment.
Consequently,
as a result of the purchase price of the common stock sold in the
July, September, October and November 2010
private offerings, (a) the exercise prices for the warrants and
placement agent warrants issued as part of the March 2010 Private Offering were reduced from $0.98
and $0.75 per share, respectively, to $0.60 per share and (b) the numbers of shares underlying the
warrants and placement agent warrants have been increased to 8,291,885 and 507,666 respectively.
December 2010 and January 2011 Offerings
In December 2010 and January 2011,
we entered into securities purchase agreements with certain accredited
investors, pursuant to which we issued: (i) 4,293 shares of Series D Convertible Preferred Stock,
with a par value of $0.001 per share and a stated value of $1,000 per share, referred to as Series
D Preferred, and (ii) warrants to purchase 8,586,000 shares of Company common stock at an exercise
price of $0.50 per share.
The aggregate purchase price to be paid by the purchasers for the Series D Preferred and the
warrants will be $4,293,000 (representing $1,000 for each share of Series D Preferred together with
warrants). The Company intends to use the proceeds for working capital purposes.
Effect of Series D Preferred Private Placement on Other Company Securities
As a result of the Series D Preferred private placement, anti-dilution provisions of other
Company securities were triggered, and as a result the following adjustments were made effective
December 8, 2010.
Conversion Price Series A Preferred Stock and Series B Preferred Stock
Section 7(b) of the Certificates of Designation for the Series A Preferred Stock and Series B
Preferred Stock requires that the Conversion Price for the Series A Preferred Stock and Series B
Preferred Stock be reduced to equal the price per share of the common stock sold in the Offering.
Accordingly, the Conversion Price for the Series A Preferred Stock and Series B Preferred Stock is
being reduced to $0.50.
Convertible Shares Series A Preferred Stock and Series B Preferred Stock
Section 6(a) of the Certificates of Designation for the Series A Preferred Stock and Series B
Preferred Stock states that each share of Preferred Stock is convertible into that number of shares
of common stock determined by dividing the Stated Value of such share of Preferred Stock
(currently, $1,000 per share) by the Conversion Price. Accordingly, each investors Series A
Preferred Stock and Series B Preferred Stock may be converted into the number of shares of common
stock equal to ($1,000/.50) multiplied by the number of shares held by the investor. After giving
effect to this anti-dilution provision, there will be (i) 5,772,000 shares of common stock
underlying the Series A Preferred Stock and (ii) 9,280,000 shares of common stock underlying the
Series B Preferred Stock.
As used below, Warrants refers to the following Company warrants: (i) the Series A and
Series B warrants issued in connection with the Series A Preferred Stock, (ii) the warrants issued
in connection with the Companys March 2010 offering, and (iii) the warrants issued in connection
with the Companys Series B Preferred Stock.
Exercise Price Warrants
Section 3(b) of the Warrants requires that the Exercise Price for the Warrants be reduced to
equal the price per share of the common stock sold in the Offering. Accordingly, the Exercise Price
for all of the Warrants is being reduced to $0.50.
Underlying Shares Warrants
Section 3(b) of the Warrants requires that the number of shares of common stock underlying the
Warrants (the Warrant Shares) be increased such that the aggregate exercise price following the
exercise price adjustment equals the aggregate exercise price prior to the exercise price
adjustment. As a result of this adjustment, the number of shares underlying each investors Warrant
will increase to equal the number of shares underlying the respective warrant multiplied by the
exercise price prior to dilution, divided by $0.50. After giving effect to this anti-dilution
provision, there will be:
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1,624,996 shares of common stock underlying the Series A warrants; |
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1,624,997 shares of common stock underlying the Series B warrants; |
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9,950,261 shares of common stock underlying the warrants issued in connection with
our March 2010 Offering; and |
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12,456,851 shares of common stock underlying the warrants issued in connection with
our Series B Offering. |
Our Contact Information
Our corporate headquarters is located at 405 Eagleview Boulevard, Exton, Pennsylvania 19341.
Our phone number is (484) 713-6000. Our corporate website is www.fibrocellscience.com. Information
contained on our website or any other website does not constitute part of this prospectus.
Risks Related to Our Business
Our business is subject to a number of risks, which you should be aware of before making an
investment decision. These risks are discussed more fully under
the section entitled Risk Factors.
Securities Being Offered
The Selling Stockholders named in this prospectus may offer for resale the following
securities:
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up to 6,349,200 shares of common stock representing 110% of the shares
underlying the Series A Preferred we issued in October 2009; |
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up to 1,624,996 shares of common stock underlying Class A warrants issued in the
Series A Preferred offering; |
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up to 1,624,997 shares of common stock underlying Class B warrants issued in the
Series A Preferred offering; and |
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up to 474,500 shares of common stock underlying warrants issued to the placement
agent in the Series A Preferred offering. |
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Although we will pay substantially all the expenses incident to the registration of the
shares, we will not receive any proceeds from the sales by the Selling Stockholders. However, we
may receive proceeds of up to $1,950,000 from the exercise of the outstanding warrants; if such
proceeds are received by us, they will be used for working capital purposes.
RISK FACTORS
Investing in our company involves a high degree of risk. Before investing in our company you should
carefully consider the following risks, together with the financial and other information contained
in this prospectus. If any of the following risks actually occurs, our business, prospects,
financial condition and results of operations
could be adversely affected. In that case, the trading price of our common stock would likely
decline and you may lose all or a part of your investment.
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We could fail to remain a going concern. We will need to raise substantial additional capital to
fund our operations through commercialization of our product candidates, and we do not have any
commitments for that capital.
There exists substantial doubt regarding our ability to continue as a going concern. As of
September 30, 2010, we had cash and cash equivalents of
$200,000 million and negative working capital of $1.1 million. Cumulatively, in
July, September, October and November 2010, we raised approximately
$4.6 million less fees as a result of the issuance of Series B
Convertible Preferred Stock and warrants.
The Company has not yet received $0.2 million in subscription proceeds from the above
raises. Although the Company believes that these outstanding funds will be received, there is no
guarantee that these funds will be received.
Additionally, in December 2010 and January 2011 the Company raised $4,293,000 less fees
as a result of the issuance of Series D Convertible Preferred Stock and warrants.
As
of February 1, 2011, the Company had cash and cash equivalents
of approximately $1.6
million and liabilities of approximately $0.6 million. Thus, the Successor Company will require to
raise additional cash resources in the very near future, or it will likely cease operations. The
Successor Company will need to access the capital markets in the future in order to fund future
operations. There is no guarantee that any such required financing will be available on terms
satisfactory to the Successor Company or available at all. These matters create uncertainty
relating to its ability to continue as a going concern.
We will need additional capital to achieve commercialization of our product candidates and to
execute our business strategy, and if we are unsuccessful in raising additional capital we will be
unable to achieve commercialization of our product candidates or unable to fully execute our
business strategy on a timely basis, if at all. If we raise additional capital through the issuance
of debt securities, the debt securities may be secured and any interest payments would reduce the
amount of cash available to operate and grow our business. If we raise additional capital through
the issuance of equity securities, such issuances will likely cause dilution to our stockholders,
particularly if we are required to do so during periods when our common stock is trading at low
price levels. If we file for bankruptcy, it is likely that our common stock will become worthless,
given that there currently exists approximately $7.2 million of
debt as of January 31, 2011, which
has a priority over common shareholders. Additionally, we do not know whether any financing, if
obtained, will be adequate to meet our capital needs and to support our growth. If adequate capital
cannot be obtained on satisfactory terms, we may terminate or delay our efforts related to
regulatory approval of one or more of our product candidates, curtail or delay the implementation
of manufacturing process improvements or delay the expansion of our sales and marketing
capabilities, any of which could cause our business to fail.
If we do not obtain additional funding, we will likely enter into bankruptcy and/or cease
operations. Further, if we do raise additional cash resources in the
very near future, it may be
raised in contemplation of or in connection with bankruptcy. If we enter into bankruptcy, it is
likely that our common stock and common stock equivalents will become worthless and our creditors
will receive significantly less than what is owed to them.
Our independent registered public accounting firm issued their report for our fiscal year
ended December 31, 2009, which included an explanatory paragraph for our uncertainty to continue as
a going concern. If we became unable to continue as a going concern, we would have to liquidate our
assets and we may likely receive significantly less than the values at which they are carried on
our consolidated financial statements. The inclusion of a going concern explanatory paragraph in
our independent registered public accounting firms audit opinion for the year ended December 31,
2009 may materially and adversely affect our stock price and our ability to raise new capital.
Obtaining FDA and other regulatory approvals is complex, time consuming and expensive, and the
outcomes are uncertain.
The process of obtaining FDA and other regulatory approvals is time consuming, expensive and
difficult. Clinical trials are required and the marketing and manufacturing of our product
candidates are subject to rigorous testing procedures. We have finished injections related to our
pivotal Phase III clinical trial for our lead facial product candidate and have submitted the
related BLA to the FDA. In October 2009, the FDA Cellular, Tissue and Gene Therapies Advisory
Committee reviewed our nasolabial fold/wrinkles product candidate. The Committee voted 11 yes to
3 no that the data presented on our product demonstrated efficacy, and 6 yes to 8 no that the
data demonstrated safety; both for the proposed indication of treatment of nasolabial fold
wrinkles. The Committees recommendations are not binding on the FDA, but the FDA will consider
their
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recommendations during their review of our application, which could adversely effect the
application. On December 21, 2009,
Fibrocell received a Complete Response letter from the FDA related to the BLA for azficel-T, an
autologous cell therapy for the treatment of moderate to severe nasolabial fold wrinkles in adults.
A Complete Response letter is issued by the FDAs Center for Biologics Evaluation and Research
(CBER) when the review of a file is completed and additional data are needed prior to approval. The
Complete Response letter requested that Fibrocell Science provide data from a histopathological
study on biopsied tissue samples from patients following injection of azficel-T. The letter also
requested finalized Chemistry, Manufacturing and Controls (CMC) information regarding the
manufacture of azficel-T as follow-up to discussions that occurred during the BLA review period, as
well as revised policies and procedures. To the extent that the data obtained from the
histopathological study is negative and/or the CMC information and revised policies and procedures
required by the FDA is not satisfactory, we may not obtain approval from the FDA or there may be a
delay in approval.
Our other product candidates will require additional clinical trials. The commencement and
completion of clinical trials for any of our product candidates could be delayed or prevented by a
variety of factors, including:
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delays in obtaining regulatory approvals to commence a study; |
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delays in identifying and reaching agreement on acceptable terms with prospective
clinical trial sites; |
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delays or failures in obtaining approval of our clinical trial protocol from an
institutional review board, or IRB, to conduct a clinical trial at a prospective study
site; |
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delays in the enrollment of subjects; |
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manufacturing difficulties; |
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failure of our clinical trials and clinical investigators to be in compliance with the
FDAs Good Clinical Practices, or GCP; |
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failure of our third-party contract research organizations, clinical site organizations
and other clinical trial managers, to satisfy their contractual duties, comply with
regulations or meet expected deadlines; |
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lack of efficacy during clinical trials; or |
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unforeseen safety issues. |
We do not know whether our clinical trials will need to be restructured or will be completed
on schedule, if at all, or whether they will provide data necessary to support necessary regulatory
approval. Significant delays in clinical trials will impede our ability to commercialize our
product candidates and generate revenue, and could significantly increase our development costs.
We utilize bovine-sourced materials to manufacture our Fibrocell Therapy. Future FDA
regulations, as well as currently proposed regulations, may require us to change the source of the
bovine-sourced materials we use in our products or to cease using bovine-sourced materials. If we
are required to use alternative materials in our products, and in the event that such alternative
materials are available to us, or if we choose to change the materials used in our products in the
future, we would need to validate the new manufacturing process and run comparability trials with
the reformulated product, which could delay our submission for regulatory approval.
Even if marketing approval from the FDA is received for one or more of our product candidates,
the FDA may impose post-marketing requirements, such as:
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labeling and advertising requirements, restrictions or limitations, including the
inclusion of warnings, precautions, contra-indications or use limitations that could have a
material impact on the future profitability of our product candidates; |
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testing and surveillance to further evaluate or monitor our future products and their
continued compliance with regulatory standards and requirements; |
5
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submitting products for inspection; or |
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imposing a risk evaluation and mitigation strategy, or REMS, to ensure that the benefits
of the drug outweigh the risks. |
Because our consolidated financial statements for the year ended December 31, 2009 reflect
fresh-start accounting adjustments made on emergence from bankruptcy and because of the effects of
the transactions that became effective pursuant to the Plan, financial information in our current
and future financial statements will not be comparable to our financial information from prior
periods.
In connection with our emergence from bankruptcy, we adopted fresh-start accounting as of
September 1, 2009 in accordance with ASC 852-10. The adoption of fresh-start accounting resulted in
our becoming a new entity for financial reporting purposes. As required by fresh-start accounting,
our assets and liabilities have been preliminarily adjusted to fair value, and certain assets and
liabilities not previously recognized in our financial statements have been recognized. In addition
to fresh-start accounting, our financial statements reflect all effects of the transactions
implemented by the Plan. Accordingly, the financial statements prior to September 1, 2009 are not
comparable with the financial statements for periods on or after September 1, 2009. Furthermore,
the estimates and assumptions used to implement fresh-start accounting are inherently subject to
significant uncertainties and contingencies beyond our control. Accordingly, we cannot provide
assurance that the estimates, assumptions, and values reflected in the valuations will be realized,
and actual results could vary materially. For further information about fresh-start accounting, see
Note 5 Fresh-Start Accounting in Notes to Consolidated Financial Statements.
Protocol deviations may release the FDA from its binding acceptance of our SPA study design, which
may result in the delay, or non-approval, by the FDA of the Fibrocell Therapy.
In connection with preparations for FDA Investigator Inspections related to our nasolabial
fold/wrinkle Phase III studies, we identified protocol deviations related to the timing of visits
and other types of deviations. The possibility exists that our special protocol assessment could no
longer be binding on the FDA if the FDA considers these deviations, individually or in aggregate,
to be significant. Further, future investigator audits may identify deviations unknown at this
time. Accordingly, the possibility exists that although our Phase III studies yielded statistically
significant results, the studies may not be acceptable to the FDA under the SPA.
Clinical trials may fail to demonstrate the safety or efficacy of our product candidates, which
could prevent or significantly delay regulatory approval and prevent us from raising additional
financing.
Prior to receiving approval to commercialize any of our product candidates, we must
demonstrate with substantial evidence from well-controlled clinical trials, and to the satisfaction
of the FDA and other regulatory authorities in the United States and abroad, that our product
candidates are both safe and effective. We will need to demonstrate our product candidates
efficacy and monitor their safety throughout the process. We have recently completed a pivotal
Phase III clinical trial related to our lead facial aesthetic product candidate. The success of
prior pre-clinical or clinical trials does not ensure the success of these trials, which are being
conducted in populations with different racial and ethnic demographics than our previous trials. If
our current trials or any future clinical trials are unsuccessful, our business and reputation
would be harmed and the price at which our stock trades could be adversely affected. In addition,
if our Phase III clinical trials related to our lead facial aesthetic product candidate is deemed
to be unacceptable or deficient in any way by the FDA, we may be unable to raise additional equity
or debt financing that we may require to continue our operations.
All of our product candidates are subject to the risks of failure inherent in the development
of biotherapeutic products. The results of early-stage clinical trials of our product candidates do
not necessarily predict the results of later-stage clinical trials. Product candidates in
later-stage clinical trials may fail to demonstrate desired safety and efficacy traits despite
having successfully progressed through initial clinical testing. Even if we believe the data
collected from clinical trials of our product candidates is promising, this data may not be
sufficient to support approval by the FDA or any other U.S. or foreign regulatory approval.
Pre-clinical and clinical data can be interpreted in different ways. Accordingly, FDA officials
could reach different conclusions in assessing such data than we do, which could delay, limit or
prevent regulatory approval. In addition, the FDA, other regulatory
authorities, our Institutional Review Boards or we, may suspend or terminate clinical trials
at any time.
6
Unlike our Phase III nasolabial/wrinkle trial, our Phase II/III Acne Scar trial is not subject
to a SPA with the FDA. In addition, we have developed a photo guide for use in the evaluators
assessment of acne study subjects. Our evaluator assessment scale and photo guide have not been
previously used in a clinical trial. To obtain FDA approval with respect to the acne scar
indication, we will require FDA concurrence with the use of our evaluator assessment scale and
photo guide.
Any failure or delay in completing clinical trials for our product candidates, or in receiving
regulatory approval for the sale of any product candidates, has the potential to materially harm
our business, and may prevent us from raising necessary, additional financing that we may need in
the future.
We may issue additional equity securities and thereby materially and adversely affect the price of
our common stock.
Sales of substantial amounts of shares of our common stock in the public market, or the
perception that those sales may occur, could cause the market price of our common stock to decline.
We have used and it is likely that we will continue to use our common stock or securities
convertible into or exchangeable for our common stock to fund our working capital needs or to
acquire technology, product rights or businesses, or for other purposes. If we issue additional
equity securities, particularly during times when our common stock is trading at relatively low
price levels, the price of our common stock may be materially and adversely affected.
We have a significant number of warrants and convertible preferred stock outstanding that contain
anti-dilution and price-protection provisions that may result in the reduction of their exercise
prices or conversion prices in the future.
In October 2009, we completed an offering of Series A Preferred Stock and warrants. In
March 2010, we completed an offering of common stock and
warrants. In July, September, October and November 2010
we completed offerings of Series B Preferred Stock and warrants.
In December 2010 and January 2011 we completed an offering of Series D Preferred
Stock and warrants.
Each of the foregoing securities
were subject to certain anti-dilution provisions, which provisions
require the lowering of the
conversion price or exercise price, as applicable, to the purchase price of future offerings.
Furthermore, with respect to the warrants, if we complete an offering below the exercise price of
such warrants, the number of shares issuable under the warrants will be proportionately increased
such that the aggregate exercise price payable after taking into account the decrease in the
exercise price, shall be equal to the aggregate exercise price prior to such adjustment. The
conversion and exercise price of securities issued in the October 2009 offering were adjusted due
to the March, July, September, October, November and December 2010 and January 2011 offerings and the conversion and exercise
price of securities issued in the March 2010 offering were
adjusted due to the July, September, October, November and December
2010 and January 2011 offerings.
Additionally, the conversion and exercise prices of the securities
issued in the July through November 2010 offerings were adjusted due
to the December 2010 and January 2011 offering. If in the future we issue securities for less than the conversion or
exercise price of the securities we issued in the October 2009,
March, July, September, October, November and December 2010 and January 2011 offerings, we may be
required to further reduce the relevant conversion or exercise prices, and the number of shares
underlying the warrants may be increased.
During the term that the warrants and preferred stock are outstanding, the holders of those
securities are given the opportunity to profit from a rise in the market price of our common stock.
In addition, certain of the warrants are not redeemable by us. We may find it more difficult to
raise additional equity capital while these warrants or preferred stock are outstanding. At any
time during which these warrants are likely to be exercised, we may be able to obtain additional
equity capital on more favorable terms from other sources.
We have yet to be profitable, losses may continue to increase from current levels and we will
continue to experience significant negative cash flow as we expand our operations, which may limit
or delay our ability to become profitable.
We have incurred losses since our inception, have never generated significant revenue from
commercial sales of our products, and have never been profitable. We are focused on product
development, and we have expended significant resources on our clinical trials, personnel and
research and development. We expect these costs to continue to rise in the future. We expect to
continue to experience increasing operating losses and negative cash flow as we expand our
operations.
7
We expect to continue to incur significant additional costs and expenses related to:
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FDA clinical trials and regulatory approvals; |
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expansion of laboratory and manufacturing operations; |
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research and development; |
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development of relationships with strategic business partners, including physicians who
might use our future products; and |
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interest expense and amortization of issuance costs related to our outstanding note
payables. |
If our product candidates fail in clinical trials or do not gain regulatory approval, if our
product candidates do not achieve market acceptance, or if we do not succeed in effectively and
efficiently implementing manufacturing process and technology improvements to make our product
commercially viable, we will not be profitable. If we fail to become and remain profitable, or if
we are unable to fund our continuing losses, our business may fail.
We will continue to experience operating losses and significant negative cash flow until we
begin to generate significant revenue from (a) the sale of our product candidates, which is
dependent on the receipt of FDA approval for our product candidates and is dependent on our ability
to successfully market and sell such product candidates, and (b) our Agera product line, which is
dependent on achieving significant market penetration in its markets.
We may be unable to successfully commercialize any of our product candidates currently under
development.
Before we can commercialize any of our product candidates in the United States, we will need
to:
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conduct substantial additional research and development; |
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successfully complete lengthy and expensive pre-clinical and clinical testing, including
the Phase II/III clinical trial for our acne scar product candidate; |
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successfully improve our manufacturing process; and |
Even if our product development efforts are successful, we cannot assure you that we will be
able to commercialize any of our product candidates currently under development. In that event, we
will be unable to generate significant revenue, and our business will fail.
We have not generated significant revenue from commercial sales of our products to date, and we do
not know whether we will ever generate significant revenue.
We are focused on product development and have not generated significant revenue from
commercial sales of our products to date. Prior to the fourth quarter of 2006 we offered the
Fibrocell Therapy for sale in the United Kingdom. Our United Kingdom operation had been operating
on a negative gross margin as we investigated means to improve manufacturing technologies for the
Fibrocell Process.
8
We do not currently offer any products for sale that are based upon our Fibrocell Therapy, and
we cannot guarantee that we will ever market any such products. We must demonstrate that our
product candidates satisfy rigorous standards of safety and efficacy before the FDA and other
regulatory authorities in the United States and abroad will approve the product candidates for
commercial marketing. We will need to conduct significant
additional research, including potentially pre-clinical testing and clinical testing before we
can file additional applications with the FDA for approval of our product candidates. We must also
develop, validate and obtain FDA approval of any improved manufacturing process. In addition, to
compete effectively our future products must be easy to use, cost-effective and economical to
manufacture on a commercial scale. We may not achieve any of these objectives, and we may never
generate revenue from our product candidates.
Our ability to effectively commercialize our product candidates depends on our ability to improve
our manufacturing process and validate such future improvements.
As part of the approval process, we must pass a pre-approval inspection of our manufacturing
facility before we can obtain marketing approval for our product candidates. The Complete Response
letter that we received from the FDA in December 2009 requested finalized Chemistry, Manufacturing
and Controls (CMC) information regarding the manufacture of azficel-T as follow-up to discussions
that occurred during the BLA review period. FDA. We cannot guarantee that this CMC information will
satisfy the FDAs requirements for approval. All of our manufacturing methods, equipment and
processes for the active pharmaceutical ingredient and finished product must comply with the FDAs
current Good Manufacturing Practices, or cGMP, requirements. We will also need to perform extensive
audits of our suppliers, vendors and contract laboratories. The cGMP requirements govern all areas
of recordkeeping, production processes and controls, personnel and quality control. To ensure that
we meet these requirements, we will expend significant time, money and effort. Due to the unique
nature of our Fibrocell Therapy, we cannot predict the likelihood that the FDA will approve our
facility as compliant with cGMP requirements even if we believe that we have taken the steps
necessary to achieve compliance.
The FDA, in its regulatory discretion, may require us to undergo additional clinical trials
with respect to any new or improved manufacturing process we develop or utilize, in the future, if
any. This could include a requirement to change the materials used in our manufacturing process.
These improvements or modifications could delay or prevent approval of our product candidates. If
we fail to comply with cGMP requirements, pass an FDA pre-approval inspection or obtain FDA
approval of our manufacturing process, we would not receive FDA approval and would be subject to
possible regulatory action. The failure to successfully implement our manufacturing process may
delay or prevent our future profitability.
Even if we obtain FDA approval in the future and satisfy the FDA with regard to a validated
manufacturing process, we still may be unable to commercially manufacture the Fibrocell Therapy
profitably. Our manufacturing cost has been subject to fluctuation, depending, in part, on the
yields obtained from our manufacturing process. There is no guarantee that future manufacturing
improvements will result in a manufacturing cost low enough to effectively compete in the market.
Further, we currently manufacture the Fibrocell Therapy on a limited basis (for research and
development and for trial purposes only) and we have not manufactured commercial levels of the
Fibrocell Therapy in the United States. Such commercial manufacturing volumes, in the future, could
lead to unexpected inefficiencies and result in unprofitable performance results.
We may not be successful in our efforts to develop commercial-scale manufacturing technology and
methods.
In order to successfully commercialize any approved product candidates, we will be required to
produce such products on a commercial scale and in a cost-effective manner. As stated in the
preceding risk factor, we intend to seek FDA approval of our manufacturing process as a component
of the BLA application and approval process. However, we can provide no assurance that we will be
able to cost-effectively and commercially scale our operations using our current manufacturing
process. If we are unable to develop suitable techniques to produce and manufacture our product
candidates, our business prospects will suffer.
9
We depend on a third-party manufacturer for our Agera product line, the loss or unavailability of
which would require us to find a substitute manufacturer, if available, resulting in delays in
production and additional expenses.
Our Agera skin care product line is manufactured by a third party. We are dependent on this
third party to manufacture Ageras products, and the manufacturer is responsible for supplying the
formula ingredients for the Agera product lines. If for any reason the manufacturer discontinues
production of Ageras products at a time when we have a low volume of inventory on hand or are
experiencing a high demand for the products, significant delays
in production of the products and interruption of product sales may result as we seek to
establish a relationship and commence production with a new manufacturer, which would negatively
impact our results of operation.
The large majority of our revenue, which relates to the Agera business segment, is to one,
international customer.
Our revenues, which relate solely to the Agera business segment, are highly concentrated in
one large, international customer. This large customer represented 64% of 2009 and 2008
consolidated revenues. Further, this large customer represented 87% and 94% of consolidated
accounts receivable, net, at December 31, 2009 and December 31, 2008, respectively. A reduction of
revenue related to this large customer, due to competitor product alternatives, pricing pressures,
the financial health of the large customer, or otherwise, would have a significant, negative impact
on the business of Agera, and the related value thereof.
If our Fibrocell Therapy is found to be unsafe or ineffective, or if our Fibrocell Therapy is
perceived to be unsafe or ineffective, our business would be materially harmed.
Our product candidates utilize our Fibrocell Therapy. In addition, we expect to utilize our
Fibrocell Therapy in the development of any future product candidates. If our Fibrocell Therapy is
found to be, or perceived to be, unsafe or ineffective, we will not be successful in obtaining
marketing approval for any product candidates then pending, and we may have to modify or cease
production of any products that previously may have received regulatory approval. Negative media
exposure, whether founded or unfounded, related to the safety and/or effectiveness of our Fibrocell
Therapy may harm our reputation and/or competitive position.
If physicians do not follow our established protocols, the efficacy and safety of our product
candidates may be adversely affected.
We are dependent on physicians to follow our established protocols both as to the
administration and the handling of our product candidates in connection with our clinical trials,
and we will continue to be dependent on physicians to follow such protocols if our product
candidates are commercialized. The treatment protocol requires each physician to verify the
patients name and date of birth with the patient and the patient records immediately prior to
injection. In the event more than one patients cells are delivered to a physician or we deliver
the wrong patients cells to the physician, which has occurred in the past, it is the physicians
obligation to follow the treatment protocol and assure that the patient is treated with the correct
cells. If the physicians do not follow our protocol, the efficacy and safety of our product
candidates may be adversely affected.
Our business, which depends on one facility, is vulnerable to natural disasters, telecommunication
and information systems failures, terrorism and similar problems, and we are not fully insured for
losses caused by all of these incidents.
We currently conduct all our research, development and manufacturing operations in one
facility located in Exton, Pennsylvania. As a result, if we obtain FDA approval of any of our
product candidates, all of the commercial manufacturing for the U.S. market are currently expected
to take place at a single U.S. facility. If regulatory, manufacturing or other problems require us
to discontinue production at that facility, we will not be able to supply product, which would
adversely impact our business.
Our Exton facility could be damaged by fire, floods, power loss, telecommunication and
information systems failures or similar events. Our insurance policies have limited coverage levels
for loss or damages in these events and may not adequately compensate us for any losses that may
occur. In addition, terrorist acts or acts of war may cause harm to our employees or damage our
Exton facility. The potential for future terrorist attacks, the national and international
responses to terrorist attacks or perceived threats to national security, and other acts of war or
hostility have created many economic and political uncertainties that could adversely affect our
business and results of operations in ways that we cannot predict, and could cause our stock price
to fluctuate or decline. We are uninsured for these types of losses.
10
As a result of our limited operating history, we may not be able to correctly estimate our future
operating expenses, which could lead to cash shortfalls.
We have a limited operating history and our primary business activities consist of conducting
clinical trials. As such, our historical financial data is of limited value in estimating future
operating expenses. Our budgeted expense levels are based in part on our expectations concerning
the costs of our clinical trials, which depend on the success of such trials and our ability to
effectively and efficiently conduct such trials, and expectations related to our efforts to achieve
FDA approval with respect to our product candidates. In addition, our budgeted expense levels are
based in part on our expectations of future revenue that we may receive from our Agera product
line, and the size of future revenue depends on the choices and demand of individuals. Our limited
operating history and clinical trial experience make these costs and revenues difficult to forecast
accurately. We may be unable to adjust our operations in a timely manner to compensate for any
unexpected increase in costs or shortfall in revenue. Further, our fixed manufacturing costs and
business development and marketing expenses will increase significantly as we expand our
operations. Accordingly, a significant increase in costs or shortfall in revenue could have an
immediate and material adverse effect on our business, results of operations and financial
condition.
Our operating results may fluctuate significantly in the future, which may cause our results to
fall below the expectations of securities analysts, stockholders and investors.
Our operating results may fluctuate significantly in the future as a result of a variety of
factors, many of which are outside of our control. These factors include, but are not limited to:
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the level of demand for the products that we may develop; |
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the timely and successful implementation of improved manufacturing processes; |
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our ability to attract and retain personnel with the necessary strategic, technical and
creative skills required for effective operations; |
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the amount and timing of expenditures by practitioners and their patients; |
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introduction of new technologies; |
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product liability litigation, class action and derivative action litigation, or other
litigation; |
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the amount and timing of capital expenditures and other costs relating to the expansion
of our operations; |
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the state of the debt and/or equity markets at the time of any proposed offering we
choose to initiate; |
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our ability to successfully integrate new acquisitions into our operations; |
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government regulation and legal developments regarding our Fibrocell Therapy in the
United States and in the foreign countries in which we may operate in the future; and |
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general economic conditions. |
As a strategic response to changes in the competitive environment, we may from time to time
make pricing, service, technology or marketing decisions or business or technology acquisitions
that could have a material adverse effect on our operating results. Due to any of these factors,
our operating results may fall below the expectations of securities analysts, stockholders and
investors in any future period, which may cause our stock price to decline.
11
We may be liable for product liability claims not covered by insurance, and, our predecessor
company was publicly threatened with claims related to our product in the United Kingdom.
Physicians who used our facial aesthetic product in the past, or who may use any of our future
products, and patients who have been treated by our facial aesthetic product in the past, or who
may use any of our future products, may bring product liability claims against us. In particular,
our predecessor company received negative publicity and negative correspondence from patients in
the United Kingdom that had previously received our
treatment. While we have taken, and continue to take, what we believe are appropriate
precautions, we may be unable to avoid significant liability exposure. We currently keep in force
product liability insurance, although such insurance may not be adequate to fully cover any
potential claims or may lapse in accordance with its terms prior to the assertion of claims. We may
be unable to obtain product liability insurance in the future, or we may be unable to do so on
acceptable terms. Any insurance we obtain or have obtained in the past may not provide adequate
coverage against any asserted claims. In addition, regardless of merit or eventual outcome, product
liability claims may result in:
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diversion of managements time and attention; |
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expenditure of large amounts of cash on legal fees, expenses and payment of damages; |
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decreased demand for our products or any of our future products and services; or |
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injury to our reputation. |
If we are the subject of any future product liability claims, our business could be adversely
affected, and if these claims are in excess of insurance coverage, if any, that we may possess, our
financial position will suffer.
Our failure to comply with extensive governmental regulation may significantly affect our operating
results.
Even if we obtain regulatory approval for some or all our product candidates, we will continue
to be subject to extensive ongoing requirements by the FDA, as well as by a number of foreign,
national, state and local agencies. These regulations will impact many aspects of our operations,
including testing, research and development, manufacturing, safety, efficacy, labeling, storage,
quality control, adverse event reporting, import and export, record keeping, approval,
distribution, advertising and promotion of our future products. We must also submit new or
supplemental applications and obtain FDA approval for certain changes to an approved product,
product labeling or manufacturing process. Application holders must also submit advertising and
other promotional material to the FDA and report on ongoing clinical trials. The FDA enforces
post-marketing regulatory requirements, including the cGMP requirements, through periodic
unannounced inspections. We do not know whether we will pass any future FDA inspections. Failure to
pass an inspection could disrupt, delay or shut down our manufacturing operations. Failure to
comply with applicable regulatory requirements could, among other things, result in:
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administrative or judicial enforcement actions; |
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changes to advertising; |
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failure to obtain marketing approvals for our product candidates; |
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revocation or suspension of regulatory approvals of products; |
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product seizures or recalls; |
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court-ordered injunctions; |
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delay, interruption or suspension of product manufacturing, distribution, marketing and
sales; or |
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civil or criminal sanctions. |
12
The discovery of previously unknown problems with our future products may result in
restrictions of the products, including withdrawal from the market. In addition, the FDA may
revisit and change its prior determinations with regard to the safety or efficacy of our future
products. If the FDAs position changes, we may be required to change our labeling or cease to
manufacture and market our future products. Even prior to any formal
regulatory action, we could voluntarily decide to cease the distribution and sale or recall
any of our future products if concerns about their safety or efficacy develop.
In their regulation of advertising and other promotion, the FDA and the FTC may issue
correspondence alleging that some advertising or promotional practices are false, misleading or
deceptive. The FDA and FTC are authorized to impose a wide array of sanctions on companies for such
advertising and promotion practices, which could result in any of the following:
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incurring substantial expenses, including fines, penalties, legal fees and costs to
comply with the FDAs requirements; |
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changes in the methods of marketing and selling products; |
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taking FDA mandated corrective action, which may include placing advertisements or
sending letters to physicians rescinding previous advertisements or promotions; or |
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disruption in the distribution of products and loss of sales until compliance with the
FDAs position is obtained. |
Improper promotional activities may also lead to investigations by federal or state
prosecutors, and result in criminal and civil penalties. If we become subject to any of the above
requirements, it could be damaging to our reputation and restrict our ability to sell or market our
future products, and our business condition could be adversely affected. We may also incur
significant expenses in defending ourselves.
Physicians may prescribe pharmaceutical or biologic products for uses that are not described
in a products labeling or differ from those tested by us and approved by the FDA. While such
off-label uses are common and the FDA does not regulate physicians choice of treatments, the FDA
does restrict a manufacturers communications on the subject of off-label use. Companies cannot
promote FDA-approved pharmaceutical or biologic products for off-label uses, but under certain
limited circumstances they may disseminate to practitioners articles published in peer-reviewed
journals. To the extent allowed by the FDA, we intend to disseminate peer-reviewed articles on our
future products to practitioners. If, however, our activities fail to comply with the FDAs
regulations or guidelines, we may be subject to warnings from, or enforcement action by, the FDA or
other regulatory or law enforcement authorities.
Our sales, marketing, and scientific/educational grant programs, if any in the future, must
also comply with applicable requirements of the anti-fraud and abuse provisions of the Social
Security Act, the False Claims Act, the federal anti-kickback law, and similar state laws, each as
amended. Pricing and rebate programs must comply with the Medicaid rebate requirements of the
Omnibus Budget Reconciliation Act of 1990 and the Veterans Health Care Act of 1992, each as
amended. If products are made available to authorized users of the Federal Supply Schedule of the
General Services Administration, additional laws and requirements apply. All of these activities
are also potentially subject to federal and state consumer protection and unfair competition laws.
The distribution of product samples to physicians must comply with the requirements of the
Prescription Drug Marketing Act.
Depending on the circumstances, failure to meet post-approval requirements can result in
criminal prosecution, fines or other penalties, injunctions, recall or seizure of products, total
or partial suspension of production, denial or withdrawal of pre-marketing product approvals, or
refusal to allow us to enter into supply contracts, including government contracts. Any government
investigation of alleged violations of law could require us to expend significant time and
resources in response, and could generate negative publicity.
13
Legislative or regulatory reform of the healthcare system may affect our ability to sell our future
products profitably.
In the United States and a number of foreign jurisdictions, there have been legislative and
regulatory proposals to change the healthcare system in ways that could impact our ability to sell
our future products profitably. For instance, there currently is no legal pathway for generic or
similar versions of BLA-approved biologics,
sometimes called follow-on biologics or biosimilars, but there is continuing interest by
Congress on this issue and on healthcare reform in general. It is unknown what type of regulatory
framework, what legal provisions, and what timeframes for issuance of regulations or guidance any
final legislation on biosimilars would contain, but the future profitability of any approved
biological product could be materially adversely impacted by the approval of a biosimilar product.
The FDAs policies may change and additional government regulations may be enacted, which could
prevent or delay regulatory approval of our product candidates. We cannot predict the likelihood,
nature or extent of adverse government regulation that may arise from future legislation or
administrative action, either in the United States or abroad. If we are not able to maintain
regulatory compliance, we might not be permitted to market our future products and our business
could suffer.
Any future products that we develop may not be commercially successful.
Even if we obtain regulatory approval for our product candidates in the United States and
other countries, those products may not be accepted by the market. A number of factors may affect
the rate and level of market acceptance of our products, including:
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labeling requirements or limitations; |
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market acceptance by practitioners and their patients; |
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our ability to successfully improve our manufacturing process; |
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the effectiveness of our sales efforts and marketing activities; and |
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the success of competitive products. |
If our current or future product candidates fail to achieve market acceptance, our
profitability and financial condition will suffer.
Our competitors in the pharmaceutical, medical device and biotechnology industries may have
superior products, manufacturing capabilities, financial resources or marketing position.
The human healthcare products and services industry is extremely competitive. Our competitors
include major pharmaceutical, medical device and biotechnology companies. Most of these competitors
have more extensive research and development, marketing and production capabilities and greater
financial resources than we do. Our future success will depend on our ability to develop and market
effectively our future products against those of our competitors. If our future products receive
marketing approval but cannot compete effectively in the marketplace, our results of operations and
financial position will suffer.
We are dependent on our key scientific and other management personnel, and the loss of any of these
individuals could harm our business.
We are dependent on the efforts of our key management and scientific staff. The loss of any of
these individuals, or our inability to recruit and train additional key personnel in a timely
manner, could materially and adversely affect our business and our future prospects. A loss of one
or more of our current officers or key personnel could severely and negatively impact our
operations. We have employment agreements with most of our key management personnel, but some of
these people are employed at-will, and any of them may elect to pursue other opportunities at any
time. We have no present intention of obtaining key man life insurance on any of our executive
officers or key management personnel.
14
We may need to attract, train and retain additional highly qualified senior executives and
technical and managerial personnel in the future.
In the future, we may need to seek additional senior executives, as well as technical and
managerial staff members. There is a high demand for highly trained executive, technical and
managerial personnel in our industry.
We do not know whether we will be able to attract, train and retain highly qualified technical
and managerial personnel in the future, which could have a material adverse effect on our business,
financial condition and results of operations.
If we are unable to effectively promote our brands and establish a competitive position in the
marketplace, our business may fail.
Our Fibrocell Therapy brand names are new and unproven. We believe that the importance of
brand recognition will increase over time. In order to gain brand recognition, we may increase our
marketing and advertising budgets to create and maintain brand loyalty. We do not know whether
these efforts will lead to greater brand recognition. If we are unable effectively to promote our
brands, including our Agera product line, and establish competitive positions in the marketplace,
our business results will be materially adversely affected.
If we are unable to adequately protect our intellectual property and proprietary technology, the
value of our technology and future products will be adversely affected, and if we are unable to
enforce our intellectual property against unauthorized use by third parties our business may be
materially harmed.
Our long-term success largely depends on our future ability to market technologically
competitive products. Our ability to achieve commercial success will depend in part on obtaining
and maintaining patent protection and trade secret protection of our technology and future
products, as well as successfully defending these patents against third party challenges. In order
to do so we must:
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obtain and protect commercially valuable patents or the rights to patents both
domestically and abroad; |
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operate without infringing upon the proprietary rights of others; and |
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prevent others from successfully challenging or infringing our proprietary rights. |
As of December 31, 2009, we had 9 issued U.S. patents, 4 pending U.S. patent applications, 28
granted foreign patents and 3 pending international patent application. However, we may not be able
to obtain additional patents relating to our technology or otherwise protect our proprietary
rights. If we fail to obtain or maintain patents from our pending and future applications, we may
not be able to prevent third parties from using our proprietary technology. We will be able to
protect our proprietary rights from unauthorized use only to the extent that these rights are
covered by valid and enforceable patents that we control or are effectively maintained by us as
trade secrets. Furthermore, the degree of future protection of our proprietary rights is uncertain
because legal means afford only limited protection and may not adequately protect our rights or
permit us to gain or keep a competitive advantage.
The patent situation of companies in the markets in which we compete is highly uncertain and
involves complex legal and factual questions for which important legal principles remain
unresolved. No consistent policy regarding the breadth of claims allowed in such companies patents
has emerged to date in the United States. The laws of other countries do not protect intellectual
property rights to the same extent as the laws of the United States, and many companies have
encountered significant problems in protecting and defending such rights in foreign jurisdictions.
The legal systems of certain countries, particularly certain developing countries, do not favor the
enforcement of patents and other intellectual property protection, particularly those relating to
biotechnology and/or pharmaceuticals, which could make it difficult for us to stop the infringement
of our patents in foreign countries in which we hold patents. Proceedings to enforce our patent
rights in the United States or in foreign jurisdictions would likely result in substantial cost and
divert our efforts and attention from other aspects of our business. Changes in either the patent
laws or in interpretations of patent laws in the United States or other countries may diminish the
value of our intellectual property. Accordingly, we cannot predict the breadth of claims that may
be allowed or enforced in our patents or in third-party patents.
15
Other risks and uncertainties that we face with respect to our patents and other proprietary
rights include the following:
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the inventors of the inventions covered by each of our pending patent applications might
not have been the first to make such inventions; |
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we might not have been the first to file patent applications for these inventions or
similar technology; |
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the future and pending applications we will file or have filed, or to which we will or
do have exclusive rights, may not result in issued patents or may take longer than we
expect to result in issued patents; |
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the claims of any patents that are issued may not provide meaningful protection; |
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our issued patents may not provide a basis for commercially viable products or may not
be valid or enforceable; |
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we might not be able to develop additional proprietary technologies that are patentable; |
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the patents licensed or issued to us may not provide a competitive advantage; |
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patents issued to other companies, universities or research institutions may harm our
ability to do business; |
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other individual companies, universities or research institutions may independently
develop or have developed similar or alternative technologies or duplicate our technologies
and commercialize discoveries that we attempt to patent; |
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other companies, universities or research institutions may design around technologies we
have licensed, patented or developed; and |
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many of our patent claims are method, rather than composition of matter, claims;
generally composition of matter claims are easier to enforce and are more difficult to
circumvent. |
Our business may be harmed and we may incur substantial costs as a result of litigation or other
proceedings relating to patent and other intellectual property rights.
A third party may assert that we, one of our subsidiaries or one of our strategic
collaborators has infringed his, her or its patents and proprietary rights or challenge the
validity or enforceability of our patents and proprietary rights. Likewise, we may need to resort
to litigation to enforce our patent rights or to determine the scope and validity of a third
partys proprietary rights.
We cannot be sure that other parties have not filed for or obtained relevant patents that
could affect our ability to obtain patents or operate our business. Even if we have previously
filed patent applications or obtain issued patents, others may file their own patent applications
for our inventions and technology, or improvements to our inventions and technology. We have become
aware of published patent applications filed after the issuance of our patents that, should the
owners pursue and obtain patent claims to our inventions and technology, could require us to
challenge such patent claims. Others may challenge our patent or other intellectual property rights
or sue us for infringement. In all such cases, we may commence legal proceedings to resolve our
patent or other intellectual property disputes or defend against charges of infringement or
misappropriation. An adverse determination in any litigation or administrative proceeding to which
we may become a party could subject us to significant liabilities, result in our patents being
deemed invalid, unenforceable or revoked, or drawn into an interference, require us to license
disputed rights from others, if available, or to cease using the disputed technology. In addition,
our involvement in any of these proceedings may cause us to incur substantial costs and result in
diversion of management and technical personnel. Furthermore, parties making claims against us may
be able to obtain injunctive or other equitable relief that could effectively block our ability to
develop, commercialize and sell products, and could result in the award of substantial damages
against us.
16
The outcome of these proceedings is uncertain and could significantly harm our business. If we
do not prevail in this type of litigation, we or our strategic collaborators may be required to:
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expend time and funding to redesign our Fibrocell Therapy so that it does not infringe
others patents while still allowing us to compete in the market with a substantially
similar product; |
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obtain a license, if possible, in order to continue manufacturing or marketing the
affected products or services, and pay license fees and royalties, which may be
non-exclusive. This license may be non-exclusive, giving our competitors access to the same
intellectual property, or the patent owner may require that we grant a cross-license to our
patented technology; or |
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stop research and commercial activities relating to the affected products or services if
a license is not available on acceptable terms, if at all. |
Any of these events could materially adversely affect our business strategy and the value of
our business.
In addition, the defense and prosecution of intellectual property suits, interferences,
oppositions and related legal and administrative proceedings in the United States and elsewhere,
even if resolved in our favor, could be expensive and time consuming and could divert financial and
managerial resources. Some of our competitors may be able to sustain the costs of complex patent
litigation more effectively than we can because they have substantially greater financial
resources.
If we are unable to keep up with rapid technological changes, our future products may become
obsolete or unmarketable.
Our industry is characterized by significant and rapid technological change. Although we
attempt to expand our technological capabilities in order to remain competitive, research and
discoveries by others may make our future products obsolete. If we cannot compete effectively in
the marketplace, our potential for profitability and financial position will suffer.
We have not declared any dividends on our common stock to date, and we have no intention of
declaring dividends in the foreseeable future.
The decision to pay cash dividends on our common stock rests with our Board of Directors and
will depend on our earnings, unencumbered cash, capital requirements and financial condition. We do
not anticipate declaring any dividends in the foreseeable future, as we intend to use any excess
cash to fund our operations. Investors in our common stock should not expect to receive dividend
income on their investment, and investors will be dependent on the appreciation of our common stock
to earn a return on their investment.
Provisions in our charter documents could prevent or delay stockholders attempts to replace or
remove current management.
Our charter documents provide for staggered terms for the members of our Board of Directors.
Our Board of Directors is divided into three staggered classes, and each director serves a term of
three years. At stockholders meetings, only those directors comprising one of the three classes
will have completed their term and be subject to re-election or replacement.
In addition, our Board of Directors is authorized to issue blank check preferred stock, with
designations, rights and preferences as they may determine. Accordingly, our Board of Directors
may, without stockholder approval, issue shares of preferred stock with dividend, liquidation,
conversion, voting or other rights that could adversely affect the voting power or other rights of
the holders of our common stock. This type of preferred stock could also be issued to discourage,
delay or prevent a change in our control.
17
In May 2006, our Board of Directors declared a dividend of one right for each share of our
common stock to purchase our newly created Series C participating preferred stock in connection
with the adoption of a stockholder
rights plan. These rights may have certain anti-takeover effects. For example, the rights may
cause substantial dilution to a person or group that attempts to acquire us in a manner which
causes the rights to become exercisable. As such, the rights may have the effect of rendering more
difficult or discouraging an acquisition of our company which is deemed undesirable by our board of
directors.
The use of a staggered Board of Directors, the ability to issue blank check preferred stock,
and the adoption of stockholder rights plans are traditional anti-takeover measures. These
provisions in our charter documents make it difficult for a majority stockholder to gain control of
the Board of Directors and of our company. These provisions may be beneficial to our management and
our Board of Directors in a hostile tender offer and may have an adverse impact on stockholders who
may want to participate in such a tender offer, or who may want to replace some or all of the
members of our Board of Directors.
Provisions in our bylaws provide for indemnification of officers and directors, which could require
us to direct funds away from our business and future products.
Our bylaws provide for the indemnification of our officers and directors. We have in the past
and may in the future be required to advance costs incurred by an officer or director and to pay
judgments, fines and expenses incurred by an officer or director, including reasonable attorneys
fees, as a result of actions or proceedings in which our officers and directors are involved by
reason of being or having been an officer or director of our company. Funds paid in satisfaction of
judgments, fines and expenses may be funds we need for the operation of our business and the
development of our product candidates, thereby affecting our ability to attain profitability.
Future sales of our common stock may depress our stock price.
The market price of our common stock could decline as a result of sales of substantial amounts
of our common stock in the public market, or as a result of the perception that these sales could
occur, which could occur if we issue a large number of shares of common stock (or securities
convertible into our common stock) in connection with a future financing, as our common stock is
trading at low levels. These factors could make it more difficult for us to raise funds through
future offerings of common stock. As of February 1, 2011, there were
20,490,255 shares of common
stock issued and outstanding. All of our outstanding shares are freely transferable without
restriction or further registration under the Securities Act.
There is a limited, volatile and sporadic public trading market for our common stock.
There is a limited, volatile and sporadic public trading market for our common stock. Without
an active trading market, there can be no assurance of any liquidity or resale value of our common
stock, and stockholders may be required to hold shares of our common stock for an indefinite period
of time.
Lack of effectiveness of internal controls over financial reporting could adversely affect the
value of our securities.
As directed by Section 404 of the Sarbanes-Oxley Act, the SEC adopted rules requiring public
companies to include a report of management on the companys internal control over financial
reporting in their annual reports on Form 10-K that contains an assessment by management of the
effectiveness of the companys internal control over financial reporting. In addition, the
independent registered public accounting firm auditing the companys financial statements has been
required to and may be required in the future to attest to and report on the companys internal
control over financial reporting. Ineffective internal controls over our financial reporting have
occurred in the past and may arise in the future. As a consequence, our investors could lose
confidence in the reliability of our financial statements, which could result in a decrease in the
value of our securities.
18
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus
contains certain
forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended, as well as information
relating to Fibrocell that is based on managements exercise of business judgment and assumptions
made by and information currently available to management. When used in this document and other
documents, releases and reports released by us, the words anticipate, believe, estimate,
expect, intend, the facts suggest and words of similar import, are intended to identify any
forward-looking statements. You should not place undue reliance on these forward-looking
statements. These statements reflect our current view of future events and are subject to certain
risks and uncertainties as noted below. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect, our actual results could differ
materially from those anticipated in these forward-looking statements. Actual events, transactions
and results may materially differ from the anticipated events, transactions or results described in
such statements. Although we believe that our expectations are based on reasonable assumptions, we
can give no assurance that our expectations will materialize. Many factors could cause actual
results to differ materially from our forward looking statements. Several of these factors include,
without limitation:
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our ability to finance our business and continue in operations; |
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whether the results of our full Phase III pivotal study and our BLA filing will
result in approval of our product candidate, and whether any approval will occur on a
timely basis; |
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our ability to meet requisite regulations or receive regulatory approvals in the
United States, Europe, Asia and the Americas, and our ability to retain any regulatory
approvals that we may obtain; and the absence of adverse regulatory developments in
the United States, Europe, Asia and the Americas or any other country where we plan to
conduct commercial operations; |
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whether our clinical human trials relating to the use of autologous cellular
therapy applications, and such other indications as we may identify and pursue can be
conducted within the timeframe that we expect, whether such trials will yield positive
results, or whether additional applications for the commercialization of autologous
cellular therapy can be identified by us and advanced into human clinical trials; |
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our ability to develop autologous cellular therapies that have specific
applications in cosmetic dermatology, and our ability to explore (and possibly
develop) applications for periodontal disease, reconstructive dentistry, treatment of
restrictive scars and burns and other health-related markets; |
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our ability to decrease our manufacturing costs for our Fibrocell Therapy product
candidates through the improvement of our manufacturing process, and our ability to
validate any such improvements with the relevant regulatory agencies; |
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our ability to reduce our need for fetal bovine calf serum by improved use of less
expensive media combinations and different media alternatives; |
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continued availability of supplies at satisfactory prices; |
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new entrance of competitive products or further penetration of existing products in
our markets; |
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the effect on us from adverse publicity related to our products or the company
itself; |
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any adverse claims relating to our intellectual property; |
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the adoption of new, or changes in, accounting principles; |
19
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our issuance of certain rights to our shareholders that may have anti-takeover
effects; |
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our dependence on physicians to correctly follow our established protocols for the
safe administration of our Fibrocell Therapy; and |
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other risks referenced from time to time elsewhere in this prospectus and in our
filings with the SEC. |
These factors are not necessarily all of the important factors that could cause actual
results of operations to differ materially from those expressed in these forward-looking
statements. Other unknown or unpredictable factors also could have material adverse effects on our
future results. We undertake no obligation and do not intend to update, revise or otherwise
publicly release any revisions to these forward-looking statements to reflect events or
circumstances after the date hereof or to reflect the occurrence of any unanticipated events. We
cannot assure you that projected results will be achieved.
USE OF PROCEEDS
This prospectus relates to the resale of shares of our common stock to be issued to persons
who convert their Series A Preferred or exercise their warrants. We will not receive any proceeds
from the sale of shares of common stock in this offering. However, we will receive proceeds from
the exercise of any warrants, up to a maximum amount of $1,950,000, and we will use any such
proceeds for working capital purposes.
MARKET PRICE OF AND DIVIDENDS ON OUR COMMON STOCK
AND RELATED STOCKHOLDER MATTERS
Market Information
On October 21, 2009, our common stock became available for trading OTCBB under the symbol
FCSC. Currently, there is only a limited, sporadic and volatile market for our stock on the
OTCBB. The table below presents the high and low bid price for our common stock each quarter during
the past two years and reflects inter-dealer prices, without retail markup, markdown, or
commission, and may not represent actual transactions.
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High |
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Year ended December 31, 2009
Fourth Quarter (from October 21, 2009)
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2.40 |
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$ |
0.50 |
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Year ended December 31, 2010
First Quarter
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$ |
1.18 |
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$ |
0.75 |
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Second Quarter
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$ |
1.04 |
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$ |
0.60 |
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Third Quarter
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$ |
0.85 |
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$ |
0.51 |
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Fourth Quarter
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$ |
0.72 |
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$ |
0.39 |
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The common stock of our predecessor company, Isolagen, Inc., traded on the NYSE Amex under the
symbol ILE. The common stock ceased trading on the NYSE Amex on May 6, 2009 and in June 2009 the
NYSE Amex delisted the common stock from listing on the NYSE Amex. Upon the effective date of our
bankruptcy plan, the outstanding common stock of Isolagen was cancelled. Consequently, the
stockholders of Isolagen prior to the effective date of the bankruptcy plan no longer have any
interest as stockholders of Fibrocell by virtue of their ownership of Isolagens common stock prior to the
emergence from bankruptcy.
As
of February 1, 2011, there were 20,490,255 shares of our common stock outstanding and held by
200 stockholders of record. As of February 1, 2011, there were 2,886 shares of Series A Preferred
issued and outstanding, 4,640 shares of Series B Preferred issued
and outstanding and 4,293 shares of Series D Preferred issued and
outstanding.
On
February 7, 2011 the last sale price of our common stock as reported on
the OTCBB was $0.60 per share.
Dividends
We have never paid any cash dividends on our common stock and our board of directors does not
intend to do so in the foreseeable future. The declaration and payment of dividends in the future,
of which there can be no
20
assurance, will be determined by the board of directors in light of
conditions then existing, including earnings, financial condition, capital requirements and other
factors.
Holders
of the Series A Preferred, holders of the Series B Preferred and holders of the Series D Preferred are entitled to receive cumulative dividends at the rate per
share (as a percentage of the stated value per share) of 6% per annum (subject to increase in
certain circumstances), payable quarterly in arrears on January 15, April 15, July 15 and October
15, beginning on April 15, 2010 for the Series A Preferred
holders, on January 15, 2011 for the Series B Preferred
holders
and July 15, 2011 for the Series D Preferred holders. The dividends are payable in cash, or at our option, in duly
authorized, validly issued, fully paid and non-assessable shares of common stock equal to 110% of
the cash dividend amount payable on the dividend payment date, or a combination thereof; provided
that we may not pay the dividends in shares of common stock unless we meet certain conditions
described in the Certificate of Designation. If we pay the dividend in shares of common stock, the
common stock will be valued for such purpose at 80% of the average of the volume weighted average
price for the 10 consecutive trading days ending on the trading day that is immediately prior to
the dividend payment date.
Shares
of common stock issued as dividends on the Series A Preferred,
Series B Preferred or Series D Preferred are not being registered
under this prospectus. Such shares are deemed to be restricted securities under Rule 144 of the
Securities Act and may only be sold in compliance with Rule 144.
Penny Stock
The SEC has adopted rules that regulate broker-dealer practices in connection with
transactions in penny stocks. Our stock is currently a penny stock. Penny stocks are generally
equity securities with a price of less than $5.00, other than securities registered on certain
national securities exchanges. The penny stock rules require a broker-dealer, prior to a
transaction in a penny stock not otherwise exempt from those rules, deliver a standardized risk
disclosure document prepared by the SEC, which: (a) contains a description of the nature and level
of risk in the market for penny stocks in both public offerings and secondary trading; (b) contains
a description of the brokers or dealers duties to the customer and of the rights and remedies
available to the customer with respect to a violation to such duties or other requirements of
securities laws; (c) contains a brief, clear, narrative description of a dealer market, including
bid and ask prices for penny stocks and significance of the spread between the bid and ask price;
(d) contains a toll-free telephone number for inquiries on disciplinary actions; (e) defines
significant terms in the disclosure document or in the conduct of trading in penny stocks; and (f)
contains such other information and is in such form as the SEC shall require by rule or regulation.
The broker-dealer also must provide to the customer, prior to effecting any transaction in a penny
stock, (a) bid and offer quotations for the penny stock; (b) the compensation of the broker-dealer
and its salesperson in the transaction; (c) the number of shares to which such bid and ask prices
apply, or other comparable information relating to the depth and liquidity of the market for such
stock; and (d) monthly account statements showing the market value of each penny stock held in the
customers account. In addition, the penny stock rules require that prior to a transaction in a
penny stock not otherwise exempt from those rules, the broker-dealer must make a special written
determination that the penny stock is a suitable investment for the purchaser and receive the
purchasers written acknowledgment of the receipt of a risk disclosure statement, a written
agreement to transactions involving penny stocks, and a signed and dated copy of a written suitably
statement.
These disclosure requirements may have the effect of reducing the trading activity in the
secondary market for our stock.
21
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
Overview
We are an aesthetic and therapeutic development stage biotechnology company focused on
developing novel skin and tissue rejuvenation products. Our clinical development product candidates
are designed to improve the appearance of skin injured by the effects of aging, sun exposure, acne
and burn scars with a patients own, or autologous, fibroblast cells produced by our proprietary
Fibrocell process. Our clinical development programs encompass both aesthetic and therapeutic
indications. Our most advanced indication is for the treatment of nasolabial folds wrinkles (United
States adopted name, or USAN, is azficel-T) and has completed Phase III clinical studies, and the
related Biologics License Application, or BLA, has been submitted to the Food and Drug
Administration, or FDA. In October 2009, the FDAs Cellular, Tissue and Gene Therapies Advisory
Committee reviewed this indication. On December 21, 2009, Fibrocell received a Complete Response
letter from the FDA related to the BLA for azficel-T, an autologous cell therapy for the treatment
of moderate to severe nasolabial fold wrinkles in adults. A Complete Response letter is issued by
the FDAs Center for Biologics Evaluation and Research (CBER) when the review of a file is
completed and additional data are needed prior to approval. The Complete Response letter requested
that Fibrocell Science provide data from a histopathological study on biopsied tissue samples from
patients following injection of azficel-T. The histology study (IT-H-001) will evaluate tissue
treated with azficel-T as compared to tissue treated with sterile saline (placebo). The study will
also provide information about the skin after treatment, including evaluation of collagen and
elastin fibrils, and cellular structure of the sampled tissues. The Company submitted a proposed
protocol concerning a histopathological study on biopsied samples to the FDA and to the Companys
Investigational Review Board (IRB). The IRB has approved the protocol and the Company received
the comments from the FDA on the protocol in May 2010.
On May 13, 2010, the Company announced the initiation of a small histology study of azficel-T,
an autologous cell therapy currently under review by the U.S. Food and Drug Administration (FDA)
for the treatment of moderate to severe nasolabial fold wrinkles. The study has a target enrollment
of approximately 20 participants from the completed and statistically significant pivotal Phase III
studies of azficel-T (IT-R-005 and IT-R-006). The Company announced on July 8, 2010, the completion
of enrollment of and first treatment visits for participants in its histology study of azficel-T.
The second treatment visits for participants enrolled in the histology study of azficel-T were
completed by the end of July. The third treatment visits for participants enrolled in the histology
study of azficel-T were completed by the end of August.
The Complete Response letter also requested finalized Chemistry, Manufacturing and Controls
(CMC) information regarding the manufacture of azficel-T as follow-up to discussions that occurred
during the BLA review period, as well as revised policies and procedures.
The Company anticipates filing its response to the FDAs Complete Response letter by the end
of 2010. There is no assurance that the FDA will accept the Companys response as it may find that
the Companys response does not provide sufficient information to address its Complete Response
letter. Even if the FDA accepts the Companys response for complete evaluation, there is no
assurance that it will approve our product. The FDA, under the Prescription Drug User Fee Act
(PDUFA), has a target six months review window to completely evaluate the Companys response upon
acceptance of the response.
During 2009 we completed a Phase II/III study for the treatment of acne scars. During 2008 we
completed our open-label Phase II study related to full face rejuvenation.
We also develop and market an advanced skin care product line through our Agera subsidiary, in
which we acquired a 57% interest in August 2006.
Emergence from Voluntary Reorganization Under Chapter 11 Proceedings and Reorganization Plan
Fibrocell emerged from Chapter 11 on September 3, 2009. See Note 1 in the accompanying
Consolidated Financial Statements.
Going Concern
The Successor Company emerged from Bankruptcy in September 2009 and continues to operate
as a going concern. At September 30, 2010, the Successor Company had cash and cash equivalents of
approximately $0.2 million and negative working capital of $1.9 million. In early July 2010, the
Successor Company raised approximately $2.7 million less fees as a result of the issuance of
preferred stock and warrants. In early September 2010, the Successor Company raised approximately
$0.3 million less fees as a result of the issuance of preferred stock and warrants. The Successor
Company has also raised approximately $1.7 million less fees as the result of the issuance of
preferred stock and warrants in the period from October 1, 2010
to November 17, 2010.
From December 2010 through January 2011 the Successor Company raised an additional $4.3 million
less fees as the of the issuance of preferred stock and warrants.
The Company has not yet received $210,000 in subscription proceeds from the above raises.
Although the Company believes that these outstanding funds will be received, there is no guarantee
that these funds will be received.
In connection with the September offering, the Company recorded on its September 30, 2010
balance sheet a $450,000 receivable of subscription proceeds, representing two subscriptions for an
aggregate of 450 shares of Series B Preferred and warrants to purchase 750,000 shares. On November
17, 2010, the Company entered into a Termination Agreement with the two Subscribers owing the
$450,000 to terminate their Securities Purchase Agreements. As a result, the Subscribers are no
longer obligated to pay the Company the $450,000 and the Company is not obligated to issue the
Series B Preferred shares or warrants. Accordingly, the $450,000 receivable will not be reflected
on future balance sheets.
As
of February 1, 2011, the Company had cash and cash equivalents of
approximately $1.6
million and liabilities of approximately $0.6 million. Thus, the Successor Company will require to
raise additional cash resources in the very near future, or it will likely cease operations. The
Successor Company will need to access the capital markets in the future in order to fund future
operations. There is no guarantee that any such required financing will be available on terms
satisfactory to the Successor Company or available at all. These matters create uncertainty
relating to its ability to continue as a going concern. The accompanying consolidated financial
statements do not reflect any adjustments relating to the recoverability and classification of
assets or liabilities that might result from the outcome of these uncertainties.
Further, if the Successor Company raises additional cash resources in the very near future, it
may be raised in contemplation of or in connection with bankruptcy. In the event of a bankruptcy,
it is likely that its common stock and common stock equivalents will become worthless and our
creditors will receive significantly less than what is owed to them.
Through September 30, 2010, the Successor Company has been primarily engaged in developing its
initial product technology. In the course of its development activities, the Company has sustained
losses and expects such losses to continue through at least 2010. During the nine months ended
September 30, 2010, the Successor Company financed its operations primarily through its existing
cash, but as discussed above it now requires additional financing. There is substantial doubt about
the Successor Companys ability to continue as a going concern.
The Successor Companys ability to complete additional offerings is dependent on the state of
the debt and/or equity markets at the time of any proposed offering, and such markets reception of
the Successor Company and the offering terms. The Successor Companys ability to complete an
offering is also dependent on the status of its FDA regulatory milestones and its clinical trials,
and in particular, the status of its indication for the treatment of nasolabial fold wrinkles and
the status of the related BLA, which cannot be predicted. There is no assurance that capital in any
form would be available to the Company, and if available, on terms and conditions that are
acceptable.
As a result of the conditions discussed above, and in accordance with GAAP, there exists
substantial doubt about the Successor Companys ability to continue as a going concern, and its
ability to continue as a going concern is contingent, among other things, upon its ability to
secure additional adequate financing or capital in the very near future. If the Successor Company
does not obtain additional funding, or does not anticipate additional funding, in the very near
future, it will likely enter into bankruptcy and/or cease operations. Further, if it does raise
additional cash resources in the very near future, it may be raised in contemplation of or in
connection with bankruptcy. If the Successor Company enters into bankruptcy, it is likely that its
common stock and common stock equivalents will become worthless and its creditors, including
preferred stock, will receive significantly less than what is owed to them.
Basis of Presentation
As of September 1, 2009, the Successor Company adopted fresh-start accounting in accordance
with ASC 852-10, Reorganizations. The Successor Company selected September 1, 2009, as the date to
effectively apply fresh-start accounting based on the absence of any material contingencies at the
August 27, 2009 confirmation hearing and the immaterial impact of transactions between August 27,
2009 and September 1, 2009. The adoption of fresh-start accounting resulted in the Successor
Company becoming a new entity for financial reporting purposes.
Accordingly, the financial statements prior to September 1, 2009 are not comparable with the
financial statements for periods on or after September 1, 2009. References to Successor or
Successor Company refer to the Company on or after September 1, 2009, after giving effect to the
cancellation of Isolagen, Inc. common stock issued prior to the Effective Date, the issuance of new
Fibrocell Science, Inc. common stock in accordance with the Plan, and the application of
fresh-start accounting. References to Predecessor or Predecessor Company refer to the Company
prior to September 1, 2009. See Note 5 Fresh Start Accounting in the notes to these
Consolidated Financial Statements for further details.
For discussions on the results of operations, the Successor Company has compared the results
of operations for the three and nine months ended September 30, 2010, with the results of
operations for the three and nine months ended September 30, 2009. The Successor Company believes
that the comparison of the financial results provide management and investors a more meaningful
analysis of the Companys performance and trends.
The following discussion should be read in conjunction with the Consolidated Financial
Statements and the accompanying Notes to the Consolidated Financial Statements in Part 1, Item 1 of
this report.
Results of OperationsComparison of the three months ended September 30, 2010 and 2009
REVENUES. Revenue remained relatively constant at $0.2 million for the three months ended
September 30, 2010 and 2009. Our revenue from continuing operations is from the operations of
Agera, which we acquired on August 10, 2006. Agera markets and sells a complete line of advanced
skin care systems based on a wide array of proprietary formulations, trademarks and non-peptide
technology. For the three months ended September 30, 2010 and 2009, 75% and 69%, respectively, of
Ageras revenue were to one foreign customer. As such, total revenue is subject to fluctuation
depending primarily on the orders received and orders fulfilled with respect to this large
customer.
COST OF SALES. Cost of sales decreased approximately $0.2 million to $0.1 million for the
three months ended September 30, 2010 as compared to $0.3 million for the three months ended
September 30, 2009. Our cost of sales relates to the operation of Agera. As a percentage of
revenue, Agera cost of sales was approximately 49% for the three months ended September 30, 2010
and 149% for the three months ended September 30, 2009. The decrease is due to a write off of slow
moving and obsolete inventory that occurred during the three months ended September 30, 2009.
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES. Selling, general and administrative expenses
decreased by approximately $0.9 million, or 37%, to $1.6 million for the three months ended
September 30, 2010 as compared to $2.5 million for the three months ended September 30, 2009. The
decrease primarily relates to a $0.9 million decrease in payroll related expenses and $0.1 million
decrease in office expenses and promotion expense offset by $0.1 million increase related to
consultants for financing and marketing. In the three months ending September 30, 2009, there was
a recognition of the balance of the cancelled stock options which had increased the payroll
expense.
22
RESEARCH AND DEVELOPMENT. Research and development expenses increased by approximately $0.2
million, or 19%, to $1.4 million for the three months ended September 30, 2010 as compared to $1.2
million for the three months ended September 30, 2009. The increase primarily relates to a $0.2
million increase in payroll related expenses. Research and development costs are composed primarily
of costs related to our efforts to gain FDA approval for our Fibrocell Therapy for specific dermal
applications in the United States, as well as costs related to other potential indications for our
Fibrocell Therapy, such as acne scars and burn scars. Also, research and development expense
includes costs to develop manufacturing, cell collection and logistical process improvements.
Research and development costs primarily include personnel and laboratory costs related to these
FDA trials and certain consulting costs. The total inception (December 28, 1995) to date cost of
research and development as of August 31, 2009 for the Predecessor Company was $56.3 million and
total inception (September 1, 2009) to date cost of research and development as of September 30,
2010, for the Successor Company was $5.9 million.
The FDA approval process is extremely complicated and is dependent upon our study protocols
and the results of our studies. In the event that the FDA requires additional studies for our
product candidate or requires changes in our study protocols or in the event that the results of
the studies are not consistent with our expectations, the process will be more expensive and time
consuming. Due to the complexities of the FDA approval process, we are unable to predict what the
cost of obtaining approval for our dermal product candidate will be.
REORGANIZATION ITEMS, NET. On June 15, 2009, Isolagen, Inc. and its wholly-owned, U.S.
subsidiary Isolagen Technologies, Inc., filed voluntary petitions for relief under Chapter 11 of
the federal bankruptcy laws in the United States Bankruptcy Court for the District of Delaware, as
more fully discussed under Note 1 in the accompanying Consolidated Financial Statements. There were
no reorganization costs for the three months ended September 30, 2010 as compared to reorganization
gain, net of reorganization costs, of $74.1 million recorded for the three months ended September
30, 2009, which were comprised primarily of legal fees and the unamortized debt acquisition costs
and gain on discharge of debt.
INTEREST EXPENSE. Interest expense decreased $0.1 million to $0.2 million for the three months
ended September 30, 2010, as compared to $0.3 million for the three months ended September 30,
2009. Our 2010 interest expense is related to our $6.0 million (in original principal amount) 12.5%
notes. Our interest expense for the three months ended September 30, 2009, was primarily related to
our 3.5% convertible subordinated notes, which with the emergence out of bankruptcy was exchanged
for $6.0 million of debt and 3,960,000 shares of new common stock. As of September 30, 2010 and
2009, $6.0 million of debt was outstanding. There was no amortization of debt issuance costs for
the three months ended September 30, 2009 because of the bankruptcy. There was an expense of $0.2
million of debt issuance costs related to the DIP financing in the three months ending September
30, 2009.
NET LOSS ATTRIBUTABLE TO COMMON SHAREHOLDERS. Net loss attributable to common shareholders
decreased approximately $2.3 million to a net loss of $1.8 million for the three months ended
September 30, 2010, as compared to a net loss of $4.1 million (excluding the reorganization gain of
$74.1 million) for the three months ended September 30, 2009. This decrease in loss primarily
represents the recording of the warrant liability revaluation gain of $1.3 million for the
preferred stock warrants issued in October 2009, July 2010 and September 2010 and the warrants
attached to the common shares issued in March 2010.
Results of OperationsComparison of the nine months ended September 30, 2010 and 2009
REVENUES. Revenue increased approximately $0.1 million for the nine months ended September 30,
2010 to $0.7 million as compared to $0.6 million for the nine months ended September 30, 2009. Our
revenue from continuing operations is from the operations of Agera which we acquired on August 10,
2006. Agera markets and sells a complete line of advanced skin care systems based on a wide array
of proprietary formulations, trademarks and non-peptide technology. For the nine months ended
September 30, 2010 and 2009, 73% and 60%, respectively, of Ageras revenue were to one foreign
customer. As such, total revenue is subject to fluctuation depending primarily on the orders
received and orders fulfilled with respect to this large customer. Due to our financial statement
presentation of our United Kingdom operation as a discontinued operation, our revenue for all
periods presented is representative of only Agera, as all historical United Kingdom revenue is
reflected in loss from discontinued operations.
COST OF SALES. Cost of sales decreased approximately $0.1 million to $0.4 million for the nine
months ended September 30, 2010 as compared to $0.5 million for the nine months ended September 30,
2009. Our cost of sales relates to the operation of Agera. As a percentage of revenue, Agera cost
of sales was approximately 55% and 78% for the nine months ended September 30, 2010 and 2009,
respectively. The decrease is due to a write off of slow moving and obsolete inventory that
occurred during the nine months ended September 30, 2009.
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES. Selling, general and administrative expenses
increased by approximately $0.6 million, or 13%, to $5.4 million for the nine months ended
September 30, 2010 as compared to $4.8 million for the nine months ended September 30, 2009. The
increase primarily relates to a $0.4 million increase related to general and administrative
expenses associated with consultants for financing and marketing as well as office expenses, $0.4
million increase related to legal expenses, offset by a $0.2 million decrease in payroll related
expenses. Legal expenses for the nine months ended September 30, 2009 were less than ($0.1)
million due to a $0.3 million reimbursement received from our insurance carrier related to defense
costs associated with our class action and derivative matters. Had we not received this
reimbursement, legal expenses for the nine months ended September 30, 2010 and September 30, 2009
would have been $0.4 million and $0.2 million, respectively.
RESEARCH AND DEVELOPMENT. Research and development expenses increased by approximately $1.4
million, or 52%, to $4.1 million for the nine months ended September 30, 2010 as compared to $2.7
million for the nine months ended September 30, 2009. The increase primarily relates to a $0.5
million increase in payroll related expenses, $0.6 million increase in consulting fees and $0.3
million increase in laboratory costs associated with clinical and manufacturing activities in our
Exton, Pennsylvania location. Research and development costs are composed primarily of costs
related to our efforts to gain FDA approval for our Fibrocell Therapy for specific dermal
applications in the United States, as well as costs related to other potential indications for our
Fibrocell Therapy, such as acne scars and burn scars. Also, research and development expense
includes costs to develop manufacturing, cell collection and logistical process improvements.
Research and development costs primarily include personnel and laboratory costs related to these
FDA trials and certain consulting costs. The total inception (December 28, 1995) to date cost of
research and development as of August 31, 2009 for the Predecessor Company was $56.3 million and
total inception (September 1, 2009) to date cost of research and development as of September 30,
2010, for the Successor Company was $5.9 million.
The FDA approval process is extremely complicated and is dependent upon our study protocols
and the results of our studies. In the event that the FDA requires additional studies for our
product candidate or requires changes in our study protocols or in the event that the results of
the studies are not consistent with our expectations, the process will be more expensive and time
consuming. Due to the complexities of the FDA approval process, we are unable to predict what the
cost of obtaining approval for our dermal product candidate will be.
REORGANIZATION ITEMS, NET. On June 15, 2009, Isolagen, Inc. and its wholly-owned, U.S.
subsidiary Isolagen Technologies, Inc., filed voluntary petitions for relief under Chapter 11 of
the federal bankruptcy laws in the United States Bankruptcy Court for the District of Delaware, as
more fully discussed under Note 1 in the accompanying Consolidated Financial Statements. A
reorganization gain, net of reorganization costs, of less than $0.1 million was recorded for the
nine months ended September 30, 2010, which was comprised primarily of administrative costs offset
by the gain of discharge of liabilities. Reorganization gain, net or reorganization costs, of $73.5
million were recorded for the nine months ended September 30, 2009, which were comprised primarily
of legal fees and the unamortized debt acquisition costs, and gain on discharge of liabilities.
INTEREST EXPENSE. Interest expense decreased $1.7 million to $0.6 million for the nine months
ended September 30, 2010, as compared to $2.3 million for the nine months ended September 30, 2009.
Our 2010 interest expense is related to our $6.0 million (in original principal amount) 12.5%
notes. Our 2009 interest expense was primarily related to our 3.5% convertible subordinated notes,
which with the emergence out of bankruptcy was exchanged for $6.0 million of debt and 3,960,000
shares of the new common stock. There was related amortization of debt issuance costs of
$1.0 million for the nine months ended September 30, 2009.
NET LOSS ATTRIBUTABLE TO COMMON SHAREHOLDERS. Net loss attributable to common shareholders
decreased approximately $1.5 million to a net loss of $8.3 million for the nine months ended
September 30, 2010, as compared to a net loss of $9.8 million (excluding the reorganization gain of
$73.5 million) for the nine months ended September 30, 2009.
23
Results of OperationsComparison of Years Ending December 31, 2009 and 2008
REVENUES. Revenue decreased $0.2 million to $0.9 million for the year ended December 31,
2009, as compared to $1.1 million for the year ended December 31, 2008. Our revenue from continuing
operations is from the operations of Agera which we acquired on August 10, 2006. Agera markets and
sells a complete line of advanced skin care systems based on a wide array of proprietary
formulations, trademarks and non-peptide technology. Due to our financial statement presentation of
our United Kingdom operation as a discontinued operation, our revenue for all periods presented is
representative of only Agera, as all historical United Kingdom revenue is reflected in loss from
discontinued operations. We believe that the decline in Ageras sales in fiscal 2009 was due to the
general economic conditions during 2009.
COST OF SALES. Costs of sales remained constant at $0.6 million for the year ended December
31, 2009 and December 31, 2008. Our cost of sales relates to the operation of Agera. As a
percentage of revenue, Agera cost of sales were approximately 70% for the year ended December 31,
2009 and 55% for the year ended December 31, 2008. Cost of sales as a percentage of revenue has
increased primarily due to a reserve recorded during the three months ended September 30, 2009 of
approximately $0.2 million, as compared to a reserve of less than $0.1 million recorded for slow
moving and/or obsolete inventory recorded during the three months ended September 30, 2008, and
changes in Ageras product mix.
IMPAIRMENT OF LONG-LIVED ASSETS. There was no impairment of assets in 2009. During 2008, due
to the likelihood of bankruptcy and in connection with the Companys review for impairment of
long-lived assets in accordance with ASC 360, Accounting for the Impairment or Disposal of
Long-lived Assets, we recorded a full
impairment on all of our long-lived assets as of December 31, 2008 in the consolidated statement of
operations, and as such, we have recorded an impairment charge of $6.7 million during the year
ended December 31, 2008.
24
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES. Selling, general and administrative expenses
decreased approximately $2.4 million, or 28%, to $6.1 million for the year ended December 31, 2009,
as compared to $8.5 million for the year ended December 31, 2008. The decrease in selling, general
and administrative expense is primarily due to the following:
a) Salaries, bonuses and payroll taxes decreased by approximately $1.0 million to $2.8
million for the year ended December 31, 2009, as compared to $3.8 million for the year ended
December 31, 2008, due to a decrease in the number of our employees which resulted in lower
salary expense.
b) Marketing expense decreased by less than $0.1 million to less than $0.1 million for
the year ended December 31, 2009, as compared to $0.1 million during the year ended December
31, 2008 due primarily to decreased marketing and promotional efforts related to marketing and
selling our Agera line of advanced skin care systems.
c) Travel expense decreased by approximately $0.1 million to $0.1 million for the year
ended December 31, 2009, as compared to $0.2 million for the year ended December 31, 2008 due
to the decrease in the number of our employees, primarily at the executive management level and
focused efforts to conserve cash resources during 2009.
d) Other general and administrative expenses decreased by approximately $1.1 million
to $3.0 million for the year ended December 31, 2009, as compared to $4.1 million for the year
ended December 31, 2008. The decrease of $1.1 million in other general and administrative
expenses are due to cost-saving measures continued during 2009, including savings related to
accounting and audit expenses, insurance premiums, consultants and other general costs.
e) Legal expenses decreased by approximately $0.1 million to $0.2 million for the
year ended December 31, 2009, as compared to $0.3 million for the year ended December 31, 2008.
For the years ended December 31, 2009 and December 30, 2008, we received $0.3 million and $1.3
million, respectively, of reimbursements from our insurance carrier as reimbursement for
defense costs related to our class action and derivative matters. If we had not received these
reimbursements, our legal expenses would have been $0.5 million for the year ended December 31,
2009 and $1.6 million for the year ended December 31, 2008. As such, excluding reimbursements
of legal defense costs, our legal expenses have decreased $1.1 million in 2009 from the prior
year as a result of the June 2008 mediation efforts which resulted in a settlement in principle
related to our class action and derivative action matters. Our legal expenses fluctuated
primarily as a result of the amount and timing of defense costs related to our class action and
derivative action matters, as well as a result of the amount and timing of defense cost
reimbursements from our insurance carrier. Such reimbursements are recorded when received. We
also incurred $0.2 million in legal costs, during the year ended December 31, 2008, related to
investigating and responding to claims related to our previous United Kingdom operation.
RESEARCH AND DEVELOPMENT. Research and development expenses decreased by approximately $6.3
million for the year ended December 31, 2009 to $3.9 million, as compared to $10.2 million for the
year ended December 31, 2008. Research and development costs are composed primarily of costs
related to our efforts to gain FDA approval for our Fibrocell Therapy for specific dermal
applications in the United States, as well as costs related to other potential indications for our
Fibrocell Therapy, such as acne scars and burn scars. Also, research and development expense
includes costs to develop manufacturing, cell collection and logistical process improvements.
Research and development costs primarily include personnel and laboratory costs related to these
FDA trials and certain consulting costs. The total inception cost of research and development as of
August 31, 2009 for the Predecessor Company was $56.3 million and total inception (September 1,
2009) to date cost of research and development as of December 31, 2009, for the Successor Company
was $1.8 million.
25
The FDA approval process is extremely complicated and is dependent upon our study protocols
and the results of our studies. In the event that the FDA requires additional studies for our
product candidate or requires
changes in our study protocols or in the event that the results of the studies are not
consistent with our expectations, the process will be more expensive and time consuming. Due to the
complexities of the FDA approval process, we are unable to predict what the cost of obtaining
approval for our dermal product candidate will be.
The major changes in research and development expenses are due primarily to the following:
a) Consulting expense decreased by approximately $3.3 million to $1.6 million for the year
ended December 31, 2009, as compared to $4.9 million for the year ended December 31, 2008,
primarily as a result of decreased expenditures related to our Phase III wrinkle/nasolabial fold
study, which concluded during 2008.
b) Salaries, bonuses and payroll taxes decreased by approximately $1.5 million to $0.9 million
for the year ended December 31, 2009, as compared to $2.4 million for the year ended December 31,
2008, as a result of decreased employees engaged in research and development activities.
c) Laboratory costs decreased by approximately $0.4 million to $0.6 million for the year ended
December 31, 2009, as compared to $1.0 million for the year ended December 31, 2008, as a result of
decreased clinical and manufacturing activities in our Exton, Pennsylvania location, primarily due
to the completion of the Phase III nasolabial folds trials during 2008.
d) Contract labor support related to our clinical manufacturing operation decreased $0.2
million to less than $0.1 million for the year ended December 31, 2009, as compared to $0.2 million
for the year ended December 31, 2008, as a result of decreased clinical activities in our Exton,
Pennsylvania location.
e) Facilities, depreciation and travel costs decreased $0.9 million to $0.8 million for the
year ended December 31, 2009 as compared to $1.7 million for the year ended December 31, 2008. The
decrease is due primarily to the impairment of fixed assets at December 31, 2008 resulting in no
depreciation for 2009.
LOSS FROM DISCONTINUED OPERATIONS.
Discontinued operations had income of less than $0.1 million for the year ended December 31,
2009 as compared to a loss of $4.5 million for the year ended December 31, 2008. The $4.5 million
loss from discontinued operations for the year ended December 31, 2008, primarily related to the
sale of our Swiss campus in March 2008. In connection with this sale, we recorded a loss on sale of
$6.3 million, offset by a foreign currency exchange gain of $2.1 million upon the substantial
liquidation of the Swiss subsidiary. The foreign exchange gain recorded during the three months
ended March 31, 2008 results from removing from the accumulated foreign currency translation
adjustment account in stockholders equity, a credit balance which related to the translation into
U.S. dollars of our Swiss franc assets and liabilities. The credit balance which had accumulated,
and the resulting gain recorded upon the substantial liquidation of our Swiss franc assets,
reflected the increase in the value of the Swiss franc relative to the U.S. dollar over the period
that we had operated in Switzerland. Administrative costs and facility costs related to the United
Kingdom and Swiss operations comprised approximately $0.3 million, net, during the year ended
December 31, 2008.
As of December 31, 2008, all previously leased facilities related to discontinued operations
have been exited, and all buildings, property and equipment related to discontinued operations have
been sold or otherwise disposed of.
INTEREST INCOME. Interest income decreased approximately $0.2 million to less than $0.1
million for the year ended December 31, 2009, as compared to $0.2 million for the year ended
December 31, 2008. The decrease in interest income of $0.2 million resulted from a decrease in the
amount of cash, cash equivalents and restricted cash balances, as a result of our use of these
balances primarily to fund our operating activities related to our efforts to gain FDA approval for
our Fibrocell Therapy.
REORGANIZATION ITEMS, NET. On June 15, 2009, Isolagen, Inc. and its wholly-owned, U.S.
subsidiary Isolagen Technologies, Inc., filed voluntary petitions for relief under Chapter 11 of
the federal bankruptcy laws in the United States Bankruptcy Court for the District of Delaware, as
more fully discussed under Bankruptcy, Debt and Going Concern. A reorganization gain, net of
reorganization costs, of $73.5 million was
recorded for the year ended December 31, 2009, which was comprised primarily of legal fees and
the unamortized debt acquisition costs, and gain of discharge of liabilities.
26
INTEREST EXPENSE. Interest expense decreased $1.4 million to $2.5 million for the year ended
December 31, 2009, as compared to $3.9 million for the year ended December 31, 2008. Our interest
expense is related to our $90.0 million, 3.5% convertible subordinated notes, as well as the
related amortization of deferred debt issuance costs of $0.1 million and interest expense related
to the secured bridge loan and DIP financing until the emergence out of bankruptcy for the year
ended December 31, 2009. With the emergence out of bankruptcy, the 3.5% convertible subordinated
notes were exchanged for $6.0 million of debt and 3,960,000 shares of the new common stock. There
is also interest expense related to the 12.5% note for the year end December 31, 2009. For the year
ended December 31, 2008, our interest expense is related to our $90.0 million, 3.5% convertible
subordinated notes, as well as the related amortization of deferred debt issuance costs of $0.8
million.
NONCONTROLLING INTEREST. The noncontrolling interest loss was $0.2 million for the year ended
December 31, 2009, as compared to noncontrolling interest income of $1.7 million for the year ended
December 31, 2008. The decrease in minority interest income of $1.5 million is primarily due to an
impairment charge recorded during the year ended December 31, 2008 of $3.7 million, which related
to the full impairment of the Agera segment intangible assets, and the associated 43% minority
interest ownership of Agera.
NET INCOME/(LOSS). Net loss, excluding reorganization items, was $12.8 million for the year
ended December 31, 2009 as compared to a net loss of $31.4 million for the year ended December 31,
2008. This decrease in our net loss primarily is a result of a decrease in research and development
expenses, general and administrative expenses, the reduction in employees and compensation expense
and cost saving measures continued in 2009, offset by the impairment charge of $6.7 million related
to long-lived assets for the year ended December 31, 2008, the increase in loss from discontinued
operations and reductions in interest income, as discussed above. Net income of $60.7 million for
the year ended December 31, 2009, included reorganization items of $73.5 million as a result of the
emergence out of bankruptcy and discharge of debt and unsecured liabilities.
Liquidity
and Capital Resources
Cash Flows
Net cash provided by (used in) operating, investing and financing activities for the nine
months ended September 30, 2010, the one month ended September 30, 2009 and the eight months ended
August 31, 2009, respectively, were as follows:
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Successor |
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Successor |
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Predecessor |
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Nine Months |
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One Month |
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Eight Months |
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Ended |
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Ended |
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Ended |
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September 30, |
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September 30, |
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August 31, |
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2010 |
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2009 |
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2009 |
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(in millions) |
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Cash flows from operating activities |
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$ |
(6.9 |
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$ |
(1.6 |
) |
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$ |
(4.7 |
) |
Cash flows from investing activities |
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Cash flows from financing activities |
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5.8 |
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1.8 |
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2.8 |
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OPERATING ACTIVITIES. Cash used in operating activities during the nine months ended
September 30, 2010 amounted to $6.9 million, an increase of $0.6 million over the nine months ended
September 30, 2009. The increase in our cash used in operating activities over the prior year is
primarily due to an increase in net losses (adjusted for non-cash items) of $0.9 million, in
addition to an increase of $0.3 million of operating cash inflows from changes in operating assets
and liabilities.
Our negative operating cash flows for the nine months ended September 30,
2010 were funded from cash on hand at December 31, 2009, which was primarily the result of the issuance of preferred
stock in 2009. Funds were also received from the proceeds of the issuance of common stock in March
2010 and the issuance of preferred stock series B in July 2010 and September 2010, discussed
further below.
INVESTING ACTIVITIES. Less than $0.1 million cash was provided by or used for investing
activities during the nine months ended September 30, 2010 and the nine months ended September 30,
2009.
FINANCING ACTIVITIES. There was $5.8 million, net of fees, cash proceeds from financing
activities during the nine months ended September 30, 2010, as compared to cash received of $4.6
million from financing activities during the nine months ended September 30, 2009. In March 2010,
we sold to investors in the aggregate 5,076,664 shares of Company common stock at a purchase price
of $0.75 per share. Each purchaser also received a warrant to purchase the same number of shares of
common stock acquired in the offering at an exercise price of $0.98 per share. In July and
September 2010, we sold to investors in the aggregate 5,711,666 shares of Company Preferred Stock
Series B at a purchase price of $.60 per share. Each purchaser also received a warrant to purchase
one share of common stock for every share of Preferred Stock Series B owned at a purchase price of
$0.8054 per share.
Working Capital
As of September 30,
2010, we had cash and cash equivalents of approximately $0.2 million and
negative working capital of $1.9 million. As discussed in the above paragraph, in early March 2010,
we raised approximately $3.4 million, net of fees as a result of the issuance of common stock and
warrants.
In early July 2010, the Successor Company raised approximately
$2.7 million less fees as a result of the issuance of preferred stock and warrants. In early September 2010, the Successor
Company raised approximately $0.3 million less fees as a result of the issuance of preferred stock
and warrants. The Successor Company has also raised approximately $1.7 million less fees as the
result of the issuance of preferred stock and warrants in the period
from October 1, 2010 to
November 17, 2010. Total funds raised for the Preferred Stock Series B for the period July 1, 2010 through November
17, 2010 is approximately $4.6 million, net of fees.
The Company has not yet received $210,000
in subscription proceeds from the above raises. Although the Company believes that these outstanding funds will be received, there is no guarantee
that these funds will be received.
In December 2010 and January 2011,
the Successor Company raised, in the aggregate, approximately $4.3 million
less fees as a result of the issuance of preferred stock and warrants.
In connection with the September offering, the
Company recorded on its September 30, 2010 balance sheet a $450,000 receivable of subscription proceeds,
representing two subscriptions for an aggregate of 450 shares of Series B Preferred and warrants to purchase
750,000 shares. On November 17, 2010, the Company entered into a Termination Agreement with the two
Subscribers owing the $450,000 to terminate their Securities Purchase Agreements. As a result, the Subscribers are
no longer obligated to pay the Company the $450,000 and the Company is not obligated to issue the Series B
Preferred shares or warrants. Accordingly, the $450,000 receivable will not be reflected on future balance sheets.
As
of February 1, 2011, the Company had cash and cash equivalents of
approximately $1.6
million and liabilities of approximately $0.6 million. Thus, the Successor Company will require
to raise additional cash resources in the very near future, or it will likely cease operations. The
Successor Company will need to access the capital markets in the future in order to fund future
operations. There is no guarantee that any such required financing will be available on terms
satisfactory to the Successor Company or available at all. These matters create uncertainty
relating to its ability to continue as a going concern. The accompanying consolidated financial
statements do not reflect any adjustments relating to the recoverability and classification of
assets or liabilities that might result from the outcome of these uncertainties.
Factors Affecting Our Capital Resources
Inflation did not have a significant impact on the Companys results during the nine months
ended September 30, 2010.
27
Off-Balance Sheet Transactions
We do not engage in material off-balance sheet transactions.
Critical Accounting Policies
The
preceding discussion and analysis of financial condition and results of operations are
based upon our consolidated financial statements, which have been prepared in conformity with
accounting principles generally accepted in the United States of America. However, certain
accounting policies and estimates are particularly important to the understanding of our financial
position and results of operations and require the application of significant judgment by our
management or can be materially affected by changes from period to period in economic factors or
conditions that are outside of the control of management. As a result they are subject to an
inherent degree of uncertainty. In applying these policies, our management uses their judgment to
determine the appropriate assumptions to be used in the determination of certain estimates. Those
estimates are based on our historical operations, our future business plans and projected financial
results, the terms of existing contracts, our observance of trends in the industry, information
provided by our customers and information available from other outside sources, as appropriate. The
following discusses our critical accounting policies and estimates.
Intangible assets: Intangible assets are research and development assets related to the
Successor Companys primary study that was recognized upon emergence from bankruptcy (see Note 5).
Intangibles are tested for recoverability whenever events or changes in circumstances indicate the
carrying amount may not be recoverable. An impairment loss, if any, would be measured as the excess
of the carrying value over the fair value determined by discounted cash flows. There was no
impairment of the intangible assets as of September 30, 2010.
Warrant Liability: The warrants for the Successor Company are measured at fair value and
liability-classified under ASC 815, Derivatives and Hedging, (ASC 815) because the warrants
contain down-round protection and therefore, do not meet the scope exception for treatment as a
derivative under ASC 815. Since down-round protection is not an input into the calculation of
the fair value of the warrants, the warrants cannot be considered indexed to the Companys own
stock which is a requirement for the scope exception as outlined under ASC 815. The fair value of
the warrants is determined using the Black-Scholes option pricing model and is affected by changes
in inputs to that model including our stock price, expected stock price volatility, the contractual
term, and the risk-free interest rate. We will continue to classify the fair value of the warrants
as a liability until the warrants are exercised, expire or are amended in a way that would no
longer require these warrants to be classified as a liability.
Stock-Based Compensation: We account for stock-based awards to employees and non-employees
using the fair value based method to determine compensation for all arrangements where shares of
stock or equity instruments are issued for compensation. We use a Black-Scholes options-pricing
model to determine the fair value of each option grant as of the date of grant for expense
incurred. The Black-Scholes model requires inputs for risk-free interest rate, dividend yield,
volatility and expected lives of the options. Expected volatility is based on historical
volatility of our competitors stock since the Predecessor Company ceased trading as part of the
bankruptcy and emerged as a new entity. The risk-free rate for periods within the contractual
life of the option is based on the U.S. Treasury yield curve in effect at the time of the grant.
The expected lives for options granted represents the period of time that options granted are
expected to be outstanding and is derived from the contractual terms of the options granted. We
estimate future forfeitures of options based upon expected forfeiture rates.
Income taxes: An asset and liability approach is used for financial accounting and
reporting for income taxes. Deferred income taxes arise from temporary differences between income
tax and financial reporting and principally relate to recognition of revenue and expenses in
different periods for financial and tax accounting purposes and are measured using currently
enacted tax rates and laws. In addition, a deferred tax asset can be generated by net operating
loss (NOLs) carryover. If it is more likely than not that some portion or all of a deferred tax
asset will not be realized, a valuation allowance is recognized.
In the event the Company is charged interest or penalties related to income tax matters, the
Company would record such interest as interest expense and would record such penalties as other
expense in the consolidated statements of operations. No such charges have been incurred by the
Company. As of September 30, 2010 and December 31, 2009, the Successor Company had no accrued
interest related to uncertain tax positions.
At September 30, 2010 and December 31, 2009, the Company has provided a full valuation
allowance for the net deferred tax assets, the large majority of which relates to the future
benefit of loss carryovers. In addition, as a result of fresh-start accounting, the Successor
Company may be limited by section 382 of the Internal Revenue Service Code. The tax years 2006
through 2009 remain open to examination by the major taxing jurisdictions to which we are subject.
The deferred tax liability at September 30, 2010 and December 31, 2009, relates to the intangible
assets recognized upon fresh-start accounting.
28
Research and Development Expenses: Research and development costs are expensed as incurred
and include salaries and benefits, costs paid to third-party contractors to perform research,
conduct clinical trials, develop and manufacture drug materials and delivery devices, and a portion
of facilities cost. Clinical trial costs are a significant component of research and development
expenses and include costs associated with third-party contractors. Invoicing from third-party
contractors for services performed can lag several months. We accrue the costs of services rendered
in connection with third-party contractor activities based on our estimate of management fees, site
management and monitoring costs and data management costs. Actual clinical trial costs may differ
from estimated clinical trial costs and are adjusted for in the period in which they become known.
Recently Issued Accounting Pronouncements
In October 2009, the FASB issued ASU No. 2009-13, Multiple-Deliverable Revenue Arrangements,
or ASU 2009-13. ASU 2009-13, amends existing revenue recognition accounting pronouncements that
are currently within the scope of FASB ASC Topic 605. This consensus provides accounting
principles and application guidance on how the arrangement should be separated, and the
consideration allocated. This guidance changes how to determine the fair value of undelivered
products and services for separate revenue recognition. Allocation of consideration is now based
on managements estimate of the selling price for an undelivered item where there is no other means
to determine the fair value of that undelivered item. This new approach is effective prospectively
for revenue arrangements entered into or materially modified in fiscal years beginning on or after
June 15, 2010. We are currently evaluating the guidance to
determine the impact on the Companys results of operations,
cash flows, and financial position.
In
March 2010, the FASB codified the consensus reached in EITF Issue No. 08-9, Milestone Method of Revenue Recognition.
FASB ASU 2010-17 provides guidance on defining a milestone and
determining when it may be appropriate to apply the milestone method
of revenue recognition for research and development transactions. The Task Force concluded that the milestone method is a valid application of the proportional performance model for revenue
recognition if the milestones are substantive and there is substantive uncertainty about whether
the milestones will be achieved. The Task Force agreed that whether a milestone is substantive is
a judgment that should be made at the inception of the arrangement. To meet the definition of a
substantive milestone, the consideration earned by achieving the milestone (1) would have to be
commensurate with either the level of effort required to achieve the milestone or the enhancement
in the value of the item delivered, (2) would have to relate solely to past performance, and (3)
should be reasonable relative to all deliverables and payment terms in the arrangement. No
bifurcation of an individual milestone is allowed and there can be more than one milestone in an
arrangement. The new guidance became effective for interim and annual periods beginning on or
after June 15, 2010. We are currently evaluating the guidance to
determine the impact on the Companys results of operations,
cash flows, and financial position.
29
BUSINESS AND PROPERTY
Overview
We are an aesthetic and therapeutic development stage biotechnology company focused on
developing novel skin and tissue rejuvenation products. Our clinical development product candidates
are designed to improve the appearance of skin injured by the effects of aging, sun exposure, acne
and burn scars with a patients own, or autologous, fibroblast cells produced by our proprietary
Fibrocell process. Our clinical development programs encompass both aesthetic and therapeutic
indications. Our most advanced indication is for the treatment of nasolabial folds wrinkles (United
States adopted name, or USAN, is azficel-T) and has completed Phase III clinical studies, and the
related Biologics License Application, or BLA, has been submitted to the Food and Drug
Administration, or FDA. In October 2009, the FDAs Cellular, Tissue and Gene Therapies Advisory
Committee reviewed this indication. On December 21, 2009, Fibrocell received a Complete Response
letter from the FDA related to the BLA for azficel-T, an autologous cell therapy for the treatment
of moderate to severe nasolabial fold wrinkles in adults. A Complete Response letter is issued by
the FDAs Center for Biologics Evaluation and Research (CBER) when the review of a file is
completed and additional data are needed prior to approval. The Complete Response letter requested
that Fibrocell Science provide data from a histopathological study on biopsied tissue samples from
patients following injection of azficel-T. The histology study (IT-H-001) will evaluate tissue
treated with azficel-T as compared to tissue treated with sterile saline (placebo). The study will
also provide information about the skin after treatment, including evaluation of collagen and
elastin fibrils, and cellular structure of the sampled tissues. The Company submitted a proposed
protocol concerning a histopathological study on biopsied samples to the FDA and to the Companys
Investigational Review Board (IRB). The IRB has approved the protocol and the Company received
the comments from the FDA on the protocol in May 2010.
On May 13, 2010, the Company announced the initiation of a small histology study of azficel-T,
an autologous cell therapy currently under review by the U.S. Food and Drug Administration (FDA)
for the treatment of moderate to severe nasolabial fold wrinkles. The study has a target enrollment
of approximately 20 participants from the completed and statistically significant pivotal Phase III
studies of azficel-T (IT-R-005 and IT-R-006). The Company announced on July 8, 2010, the completion
of enrollment of and first treatment visits for participants in its histology study of azficel-T.
The second treatment visits for participants enrolled in the histology study of azficel-T were
completed by the end of July. The third treatment visits for participants enrolled in the histology
study of azficel-T were completed by the end of August.
The Complete Response letter also requested finalized Chemistry, Manufacturing and Controls
(CMC) information regarding the manufacture of azficel-T as follow-up to discussions that occurred
during the BLA review period, as well as revised policies and procedures.
The Company filed its response to the FDAs Complete Response letter on December 17,
2010. On January 12, 2011, the Company announced that the FDA has accepted for review the Companys
response submission for azficel-T, proposed brand name laViv©, for the
treatment of moderate to severe nasolabial folds and wrinkles. There is no assurance that the FDA
will approve our product. The FDA, under the Prescription Drug User Fee Act (PDUFA), has a target
six months review window to completely evaluate the Companys response upon acceptance of the
response.
During 2009 we completed a Phase II/III study for the treatment of acne scars. During 2008 we
completed our open-label Phase II study related to full face rejuvenation.
We also develop and market an advanced skin care product line through our Agera subsidiary, in
which we acquired a 57% interest in August 2006.
Exit from Bankruptcy
On August 27, 2009, the United States Bankruptcy Court for the District of Delaware in
Wilmington entered an order, or Confirmation Order, confirming the Joint First Amended Plan of
Reorganization dated July 30, 2009, as supplemented by the Plan Supplement dated August 21, 2009,
or the Plan, of Isolagen, Inc. and Isolagens wholly owned subsidiary, Isolagen Technologies, Inc.
The effective date of the Plan was September 3, 2009. Isolagen, Inc. and Isolagen Technologies,
Inc. were subsequently renamed Fibrocell Science, Inc. and Fibrocell Technologies, Inc.,
respectively.
Our officers and directors as of the effective date were all deemed to have resigned and a new
board of directors was appointed. As of the effective date, our initial board of directors
consisted of: David Pernock, Paul Hopper and Kelvin Moore. Dr. Robert Langer was appointed to the
Board in late September 2009. Declan Daly remained as chief operating officer and chief financial
officer of the reorganized company, and in November 2009, he was appointed to the Board of
Directors. Mr. Daly also acted as interim chief executive officer until February 1, 2010 when
David Pernock became the chief executive officer.
Pursuant to the Plan, all our equity interests, including without limitation our common stock,
options and warrants outstanding as of the effective date were cancelled. On the effective date, we
completed an exit financing of common stock in the amount of $2 million, after which the equity
holders of our Successor Company were:
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7,320,000 shares, to our pre-bankruptcy lenders and the lenders that provided us our
debtor-in-possession facility, collectively; |
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3,960,000 shares, to the holders of our 3.5% convertible subordinated notes; |
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600,000 shares, to our management as of the effective date, which was our chief
operating officer; |
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120,000 shares, to the holders of our general unsecured claims; and |
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2,666,666 shares, to the purchasers of shares in the $2 million exit financing (our
pre-bankruptcy lenders, the lenders that provided us our debtor-in-possession facility and
the holders of our 3.5% convertible subordinated notes were permitted to participate in our
exit financing). |
30
In the Plan, in addition to the common stock set forth above, each holder of Isolagens 3.5%
convertible subordinated notes, due November 2024, in the approximate non-converted aggregate
principal amount of $81 million, received, in full and final satisfaction, settlement, release and
discharge of and in exchange for any and all claims arising out of the 3.5% convertible
subordinated notes, its pro rata share of an unsecured note in the principal amount of $6 million,
or the New Note. The New Note has the following features:
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12.5% interest payable quarterly in cash or, at our option, 15% payable in kind by
capitalizing such unpaid amount and adding it to the principal as of the date it was due; |
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matures June 1, 2012; |
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at any time prior to the maturity date, we may redeem any portion of the outstanding
principal of the New Notes in cash at 125% of the stated face value of the New Notes;
provided that we will be obligated to redeem all outstanding New Notes upon the following
events: (a) we or our subsidiary, Fibrocell Technologies, Inc. (formerly, Isolagen
Technologies, Inc.) successfully complete a capital campaign raising in excess of
$10,000,000; or (b) we or our subsidiary, Fibrocell Technologies, Inc., are acquired by, or
sell a majority stake to, an outside party; |
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the New Notes contain customary representations, warranties and covenants, including
a covenant that we and our subsidiary, Fibrocell Technologies, Inc., shall be prohibited
from the incurrence of additional debt without obtaining the consent of 66 2/3% of the New
Note holders. |
31
Fibrocell Sciences Technology Platform
We use our proprietary Fibrocell Science Process to produce an autologous living cell therapy.
We refer to this autologous living cell therapy as the Fibrocell Therapy. We believe this therapy
addresses the normal effects of aging or injury to the skin. Each of our product candidates is
designed to use Fibrocell Therapy to treat an indicated condition. We use our Fibrocell Science
Process to harvest autologous fibroblasts from a small skin punch biopsy from behind the ear with
the use of a local anesthetic. We chose this location both because of limited exposure to the sun
and to avoid creating a visible scar. In the case of our dental product candidate, the biopsy is
taken from the patients palette. The biopsy is then packed in a vial in a special shipping
container and shipped to our laboratory where the fibroblast cells are released from the biopsy and
initiated into our cell culture process where the cells proliferate until they reach the required
cell count. The fibroblasts are then harvested, tested by quality control and released by quality
assurance prior to shipment. The number of cells and the frequency of injections may vary and will
depend on the indication or application being studied.
If and when approved, we expect our product candidates will offer patients their own living
fibroblast cells in a personalized therapy designed to improve the appearance of damaged skin and
wrinkles; or in the case of restrictive burn scars, improve range of motion. Our product candidates
are intended to be a minimally invasive alternative to surgical intervention and a viable natural
alternative to other chemical, synthetic or toxic treatments. We also believe that because our
product candidates are autologous, the risk of an immunological or allergic response is low. With
regard to the therapeutic markets, we believe that our product candidates may address an
insufficiently met medical need for the treatment of each of restrictive burn scars, acne scars and
dental papillary insufficiency, or gum recession, and potentially help patients avoid surgical
intervention. Certain of our product candidates are still in clinical development and, as such,
benefits we expect to see associated with our product candidates may not be validated in our
clinical trials. In addition, disadvantages of our product candidates may become known in the
future.
Our Strategy
Our business strategy is primarily focused on our approval efforts related to our nasolabial
fold/wrinkle indication, for which we have submitted a BLA in March 2009. Our additional objectives
include achieving regulatory milestones related to our other Phase II/III Acne Scar program and
potentially pursuing other clinical trials in burn scarring, vocal scarring and the dental arena,
as funding permits in the future. Refer to Clinical Development Programs below for current status.
Trading of Common Stock
The Predecessors common stock ceased trading on the NYSE Amex on May 6, 2009 and in June 2009
the NYSE Amex delisted the Predecessors common stock from listing on the NYSE Amex. Upon the
Effective Date, the outstanding common stock of the Predecessor Company was cancelled for no
consideration. Consequently, the Predecessors stockholders prior to the Effective Date no longer
have any interest as stockholders of the Successor Company by virtue of their ownership of the
Predecessors common stock prior to the emergence from bankruptcy. On October 21, 2009, the
Successor Company was available for trading on the OTC Bulletin Board under the symbol FCSC.
Clinical Development Programs
Our product development programs are focused on the aesthetic and therapeutic markets. These
programs are supported by a number of clinical trial programs at various stages of development.
Our aesthetics development programs include product candidates to treat targeted areas or
wrinkles and to provide full-face rejuvenation that includes the improvement of fine lines,
wrinkles, skin texture and appearance. Our therapeutic development programs are designed to treat
acne scars, restrictive burn scars and dental papillary recession. All of our product candidates
are non-surgical and minimally invasive. Although the discussions below may include estimates of
when we expect trials to be completed, the prediction of when a clinical trial will be completed is
subject to a number of factors and uncertainties. Also, please refer to
the section contained herein entitled Risk Factors for a discussion of certain of our risk factors related to our clinical development
programs, as well as other risk factors related to our business.
32
Aesthetic Development Programs
Nasolabial Fold Wrinkles Phase III Trials: In October 2006, we reached an agreement
with the FDA, on the design of a Phase III pivotal study protocol for the treatment of nasolabial
fold wrinkles (lines which run from the sides of the nose to the corners of the mouth). The
randomized, double-blind protocol was submitted to the FDA under the agencys Special Protocol
Assessment, or SPA. Pursuant to this assessment process, the FDA has agreed that our study design
for two identical trials, including subject numbers, clinical endpoints, and statistical analyses,
is adequate to provide the necessary data that, depending on the outcome, could form the basis of
an efficacy claim for a marketing application. The pivotal Phase III trials evaluated the efficacy
and safety of our Fibrocell therapy (USAN name azficel-T) against placebo in approximately 400
subjects total with approximately 200 subjects enrolled in each trial. The injections were
completed in January 2008 and the trial data results were disclosed in October 2008. The Phase III
trial data results indicated statistically significant efficacy results for the treatment of
nasolabial fold wrinkles. The Phase III data analysis, including safety results, was disclosed in
October 2008. We submitted the related BLA to the FDA in March 2009. In May 2009, the FDA accepted
our BLA submission for filing. On October 9, 2009, the FDAs Cellular, Tissue and Gene Therapies
Advisory Committee reviewed azficel-T. The committee voted 11 yes to 3 no that the data
presented on azficel-T demonstrated efficacy, and 6 yes to 8 no that the data demonstrated
safety, both for the proposed indication. The Committees recommendations are not binding on the
FDA, but the FDA will consider their recommendations during their review of our application. On
December 21, 2009, Fibrocell Science received a Complete Response letter from the FDA related to
the BLA for azficel-T. A Complete Response letter is issued by the FDAs Center for Biologics
Evaluation and Research (CBER) when the review of a file is completed and additional data are
needed prior to approval. The Complete Response letter requested that Fibrocell Science provide
data from a histopathological study on biopsied tissue samples from patients following injection of
azficel-T. The letter also requested finalized Chemistry, Manufacturing and Controls (CMC)
information regarding the manufacture of azficel-T as follow-up to discussions that occurred during
the BLA review period, as well as revised policies and procedures regarding shipping practices, and
proposed labeling. The Company is currently working on obtaining the finalized CMC information for
the FDA as well as the revised policies and procedures regarding shipping practices and the
proposed labeling. In addition, the Company has submitted a proposed protocol concerning a
histopathological study on biopsied samples to the FDA and to the Companys Investigational Review
Board (IRB). The IRB has approved the protocol and the
Company received comments from the FDA on the protocol in May 2010.
On May 13, 2010, the Company announced the initiation of a small histology study (ITH-001) of azficel-T, an autologous cell therapy currently under review by the U.S. Food and
Drug Administration (FDA) for the treatment of moderate to severe nasolabial fold wrinkles.
The study has a target enrollment of approximately 20 participants from the completed and
statistically significant pivotal Phase III studies of azficel-T
(IT-R-005 and IT-R-006). The Company announced on July 8, 2010,
the completion of enrollment of and first treatment visits for
participants in its histology study of azficel-T. The second
treatment visits for participants enrolled in the histology study of
azficel-T were completed by the end of July.
The third treatment visits for participants enrolled in the histology
study of azficel-T were completed by the end of August.
The Complete Response letter also requested finalized Chemistry, Manufacturing and Controls
(CMC) information regarding the manufacture of azficel-T as follow-up to discussions that occurred
during the BLA review period, as well as revised policies and procedures regarding shipping
practices, and proposed labeling. The Company is currently working on obtaining the finalized CMC
information for the FDA as well as the revised policies and procedures regarding shipping practices
and the proposed labeling.
The Company filed its response to the FDAs Complete Response letter on December 17,
2010. On January 12, 2011, the Company announced that the FDA has accepted for review the Companys
response submission for azficel-T, proposed brand name laViv©, for the
treatment of moderate to severe nasolabial folds and wrinkles. There is no assurance that the FDA
will approve our product. The FDA, under the Prescription Drug User Fee Act (PDUFA), has a target
six months review window to completely evaluate the Companys response upon acceptance of the
response.
The United States Adopted Names (USAN) Council adopted the USAN name, azficel-T, on October
28, 2009, and the FDA is currently evaluating a proposed brand name, Laviv.
Full Face Rejuvenation Phase II Trial: In March 2007, the Predecessor Company
commenced an open label (unblinded) trial of approximately 50 subjects. Injections of azficel-T
began to be administered in July 2007. This trial was designed to further evaluate the safety and
use of azficel-T to treat fine lines and wrinkles for the full face. Five investigators across the
United States participated in this trial. The subjects received two series of injections
approximately one month apart. In late December 2007, all 45 remaining subjects completed
injections. The subjects were followed for twelve months following each subjects last injection.
Data results related to this trial were disclosed in August 2008, which included top line positive
efficacy results related to this open label Phase II trial.
Additional safety data from this trial, collected through telephone calls placed to
participating subjects twelve months from the date of their final study treatment, were submitted
to the FDA on November 1, 2009. No changes to the safety profile of azficel-T were identified
during our review of this data.
Therapeutic Development Programs
Acne Scars Phase II/III Trial: In November 2007, the Predecessor Company commenced
an acne scar Phase II/III study. This study included approximately 95 subjects. This placebo
controlled trial was designed to evaluate the use of azficel-T to correct or improve the appearance
of acne scars. Each subject served as their own control, receiving azficel-T on one side of their
face and placebo on the other. The subjects received three treatments two weeks apart. The
follow-up and evaluation period was completed four months after each subjects last injection. In
March 2009, the Predecessor Company disclosed certain trial data results, which included
statistically significant
efficacy results for the treatment of moderate to severe acne scars. Compilation of safety data and
data related to the validation of the study photo guide assessment scale discussed below is ongoing
and is also subject to additional financing.
33
In connection with this acne scar program, the Predecessor Company developed a photo guide for
use in the evaluators assessment of acne study subjects. The Predecessor Company had originally
designed the acne scar clinical program as two randomized, double-blind, Phase III,
placebo-controlled trials. However, our evaluator assessment scale and photo guide have not
previously been utilized in a clinical trial. In November 2007, the FDA recommended that the
Predecessor Company consider conducting a Phase II study in order to address certain study issues,
including additional validation related to our evaluator assessment scale. As such, the Predecessor
Company modified our clinical plans to initiate a single Phase II/III trial. This Phase II/III
study, was powered to demonstrate efficacy, and has allowed for a closer assessment of the
evaluator assessment scale and photo guide that is ongoing. The
Successor Company submitted on August 9, 2010, a clinical study
report for its Phase II/III study of azficel-T for the treatment
of moderate to severe acne scars to the FDA. The next step is to
initiate a discussion with the FDA concerning the validation of the evaluator assessment scale and
agree the path forward. These steps will be subject to obtaining sufficient financial resources.
Restrictive Burn Scars Phase II Trial: In January 2007, the Predecessor Company met
with the FDA to discuss our clinical program for the use of azficel-T for restrictive burn scar
patients. This Phase II trial would evaluate the use of azficel-T to improve range of motion,
function and flexibility, among other parameters, in existing restrictive burn scars in
approximately 20 patients. However, the Predecessor Company delayed the screening and enrollment in
this trial until such time as we raise sufficient additional financing and gather additional data
regarding the burn scar market.
Dental Study Phase II Trial: In late 2003, the Predecessor Company completed a Phase
I clinical trial for the treatment of condition relating to periodontal disease, specifically to
treat Interdental Papillary Insufficiency. In the second quarter of 2005, the Predecessor Company
concluded the Phase II dental clinical trial with the use of azficel-T and subsequently announced
that investigator and subject visual analog scale assessments demonstrated that the azficel-T was
statistically superior to placebo at four months after treatment. Although results of the
investigator and subject assessment demonstrated that the azficel-T was statistically superior to
placebo, an analysis of objective linear measurements did not yield statistically significant
results.
In 2006, the Predecessor Company commenced a Phase II open-label dental trial for the
treatment of Interdental Papillary Insufficiency. This single site study included 11 subjects. All
study treatment and follow up visits were completed, but full analysis of the study was previously
placed on internal hold due to our financial resource constraints. The Company is also currently
reviewing potential other clinical paths in the dental arena.
Agera Skincare Systems
The Successor Company markets and sells a skin care product line through our majority-owned
subsidiary, Agera Laboratories, Inc., which the Predecessor Company acquired in August 2006. Agera
offers a complete line of skincare systems based on a wide array of proprietary formulations,
trademarks and nano-peptide technology. These skincare products can be packaged to offer
anti-aging, anti-pigmentary and acne treatment systems. Agera primarily markets its products
primarily in the United States and Europe (primarily the United Kingdom).
Our Target Market Opportunities
Aesthetic Market Opportunity
Our product candidate for wrinkles/nasolabial folds and full face rejuvenation are directed
primarily at the aesthetic market. Aesthetic procedures have traditionally been performed by
dermatologists, plastic surgeons and other cosmetic surgeons. According to the American Society for
Aesthetic Plastic Surgery, or ASAPS, the total market for non-surgical cosmetic procedures was
approximately $4.5 billion in 2009. We believe the aesthetic procedure market is driven by:
|
|
|
aging of the baby boomer population, which currently includes ages approximately
46 to 64; |
|
|
|
the desire of many individuals to improve their appearance; |
34
|
|
|
impact of managed care and reimbursement policies on physician economics, which
has motivated physicians to establish or expand the menu of elective, private-pay aesthetic
procedures that they offer; and |
|
|
|
broadening base of the practitioners performing cosmetic procedures beyond
dermatologists and plastic surgeons to non-traditional providers. |
According to the ASAPS, 10.0 million surgical and non-surgical cosmetic procedures were
performed in 2009, as compared to 10.3 million in 2008. Also according to the ASAPS, approximately
8.5 million non-surgical procedures were performed in 2009 and 2008. We believe that the concept of
non-surgical cosmetic procedures involving injectable materials has become more mainstream and
accepted. According to the ASAPS, the following table shows the top five non-surgical cosmetic
procedures performed in 2009:
|
|
|
|
|
Procedure |
|
Number |
|
Botulinum toxin type A |
|
|
2,557,068 |
|
Hyaluronic acid |
|
|
1,313,038 |
|
Laser hair removal |
|
|
1,280,031 |
|
Microdermabrasion |
|
|
621,943 |
|
Chemical peel |
|
|
529,285 |
|
Procedures among the 35 to 50 year old age group made up approximately 44% of all cosmetic
procedures in 2009. The 51 to 64 year old age group made up 27% of all cosmetic procedures in 2009,
while the 19 to 34 year old age group made up 20% of cosmetic procedures in 2009. The Botulinum
toxin type A injection was the most popular treatment among the 35 to 50 year old age group.
Therapeutic Market Opportunities
In addition to the aesthetic market, we believe there are opportunities for our Fibrocell
Therapy to treat certain medical conditions such as acne scars, restrictive burn scars and tissue
loss due to papillary recession. Presently, we are studying therapeutic applications of our
technology for acne scars. Indications related to restrictive burn scars and periodontal disease
are on internal company hold. We are not aware of other autologous cell-based treatments for any of
these therapeutic applications.
Sales and Marketing
While our Fibrocell Therapy product candidates are still in the pre-approval phase in the
United States, no marketing or sales can occur within the United States. Our Agera skincare
products are primarily sold directly to our established distributors and salons, with historically
and recently very little focus on marketing efforts. We continue to attempt to identify additional
third party distributors for our Agera product line. We believe that our Agera products have the
potential to complement our Fibrocell Therapy product candidates in the future.
Intellectual Property
We believe that patents, trademarks, copyrights, proprietary formulations (related to our
Agera skincare products) and other proprietary rights are important to our business. We also rely
on trade secrets, know-how and continuing technological innovations to develop and maintain our
competitive position. We seek to protect our intellectual property rights by a variety of means,
including obtaining patents, maintaining trade secrets and proprietary know-how, and technological
innovation to operate without infringing on the proprietary rights of others and to prevent others
from infringing on our proprietary rights. Our policy is to seek to protect our proprietary
position by, among other methods, actively seeking patent protection in the United States and
certain foreign countries.
As of December 31, 2009, we had 9 issued U.S. patents, 4 pending U.S. patent applications, 28
granted foreign patents and 3 pending international patent applications. Our issued patents and
patent applications primarily cover the method of using autologous cell fibroblasts for the repair
of skin and soft tissue defects and the use of autologous fibroblast cells for tissue regeneration.
We are in the process of pursuing several other patent applications.
35
In January 2003, we acquired two pending U.S. patent applications. As consideration, we issued
100,000 shares of Predecessor Company common stock and agreed to pay a royalty on revenue from commercial
applications and licensing, up to a maximum of $2.0 million.
In August 2006, we acquired 57% of the common stock of Agera Laboratories. Agera has a number
of trade names, trademarks, exclusive proprietary rights to product formulations and specified
peptides that are used in the Agera skincare products.
Our success depends in part on our ability to maintain our proprietary position through
effective patent claims and their enforcement against our competitors, and through the protection
of our trade secrets. Although we believe our patents and patent applications provide a competitive
advantage, the patent positions of companies like ours are generally uncertain and involve complex
legal and factual questions. We do not know whether any of our patent applications or those patent
applications which we have acquired will result in the issuance of any patents. Our issued patents,
those that may be issued in the future or those acquired by us, may be challenged, invalidated or
circumvented, and the rights granted under any issued patent may not provide us with proprietary
protection or competitive advantages against competitors with similar technology. In particular, we
do not know if competitors will be able to design variations on our treatment methods to circumvent
our current and anticipated patent claims. Furthermore, competitors may independently develop
similar technologies or duplicate any technology developed by us. Because of the extensive time
required for the development, testing and regulatory review of a potential product, it is possible
that, before any of our products can be commercialized or marketed, any related patent claim may
expire or remain in force for only a short period following commercialization, thereby reducing the
advantage of the patent.
We also rely upon trade secrets, confidentiality agreements, proprietary know-how and
continuing technological innovation to remain competitive, especially where we do not believe
patent protection is appropriate or obtainable. We continue to seek ways to protect our proprietary
technology and trade secrets, including entering into confidentiality or license agreements with
our employees and consultants, and controlling access to and distribution of our technologies and
other proprietary information. While we use these and other reasonable security measures to protect
our trade secrets, our employees or consultants may unintentionally or willfully disclose our
proprietary information to competitors.
Our commercial success will depend in part on our ability to operate without infringing upon
the patents and proprietary rights of third parties. It is uncertain whether the issuance of any
third party patents would require us to alter our products or technology, obtain licenses or cease
certain activities. Our failure to obtain a license to technology that we may require to discover,
develop or commercialize our future products may have a material adverse impact on us. One or more
third-party patents or patent applications may conflict with patent applications to which we have
rights. Any such conflict may substantially reduce the coverage of any rights that may issue from
the patent applications to which we have rights. If third parties prepare and file patent
applications in the United States that also claim technology to which we have rights, we may have
to participate in interference proceedings in the United States Patent and Trademark Office to
determine priority of invention.
We have collaborated and may collaborate in the future with other entities on research,
development and commercialization activities. Disputes may arise about inventorship and
corresponding rights in know-how and inventions resulting from the joint creation or use of
intellectual property by us and our subsidiaries, collaborators, partners, licensors and
consultants. As a result, we may not be able to maintain our proprietary position.
Competition
The pharmaceutical and dermal aesthetics industries are characterized by intense competition,
rapid product development and technological change. Competition is intense among manufacturers of
prescription pharmaceuticals and dermal injection products. Our core products are considered dermal
injection products.
If certain of our product candidates are approved, we will compete with a variety of companies
in the dermatology and plastic surgery markets, many of which offer substantially different
treatments for similar problems. These include silicone injections, laser procedures, facial
surgical procedures, such as facelifts and eyelid surgeries, fat injections, dermabrasion,
collagen, allogenic cell therapies, hyaluronic acid injections and Botulinum toxin injections, and
other dermal fillers. Indirect competition comes from facial care treatment products. Items
catering to the growing
demand for therapeutic skin care products include facial scrubs, anti-aging treatments, tonics,
astringents and skin-restoration formulas.
36
Many of our competitors are large, well-established pharmaceutical, chemical, cosmetic or
health care companies with considerably greater financial, marketing, sales and technical resources
than those available to us. Additionally, many of our present and potential competitors have
research and development capabilities that may allow them to develop new or improved products that
may compete with our product lines. Our products could be rendered obsolete or made uneconomical by
the development of new products to treat the conditions addressed by our products, technological
advances affecting the cost of production, or marketing or pricing actions by one or more of our
competitors. Our facial aesthetics product may compete for a share of the existing market with
numerous products and/or technologies that have become relatively accepted treatments recommended
or prescribed by dermatologists and administered by plastic surgeons and aesthetic dermatologists.
There are several dermal filler products under development and/or in the FDA pipeline for
approval which claim to offer certain facial aesthetic benefits. Depending on the clinical outcomes
of the Fibrocell Science Therapy trials in aesthetics, the success or failure of gaining approval
and the label granted by the FDA if and when the therapy is approved, the competition for the
Fibrocell Therapy may prove to be direct competition to certain dermal fillers, laser technologies
or new technologies. However, if we gain approval, we believe our Fibrocell Therapy would be a
first to market autologous cellular technology that could complement other modalities of
treatment and represent a significant additional market opportunity.
The field for therapeutic treatments or tissue regeneration for use in wound healing is
rapidly evolving. A number of companies are either developing or selling therapies involving stem
cells, human-based, animal-based or synthetic tissue products. If approved as a therapy for acne
scars, restrictive burn scars or periodontal disease, our product candidates would or may compete
with synthetic, human or animal derived cell or tissue products marketed by companies larger and
better capitalized than us.
The market for skincare products is quite competitive with low barriers to entry.
Government Regulation
Our Fibrocell Therapy technologies are subject to extensive government regulation, principally
by the FDA and state and local authorities in the United States and by comparable agencies in
foreign countries. Governmental authorities in the United States extensively regulate the
pre-clinical and clinical testing, safety, efficacy, research, development, manufacturing,
labeling, storage, record-keeping, advertising, promotion, import, export, marketing and
distribution, among other things, of pharmaceutical products under various federal laws including
the Federal Food, Drug and Cosmetic Act, or FFDCA, the Public Health Service Act, or PHSA, and
under comparable laws by the states and in most foreign countries.
Domestic Regulation
In the United States, the FDA, under the FFDCA, the PHSA, and other federal statutes and
regulations, subjects pharmaceutical and biologic products to rigorous review. If we do not comply
with applicable requirements, we may be fined, the government may refuse to approve our marketing
applications or allow us to manufacture or market our products or product candidates, and we may be
criminally prosecuted. The FDA also has the authority to discontinue or suspend manufacture or
distribution, require a product withdrawal or recall or revoke previously granted marketing
authorizations if we fail to comply with regulatory standards or if we encounter problems following
initial marketing.
37
FDA Approval Process
To obtain approval of a new product from the FDA, we must, among other requirements, submit
data demonstrating the products safety and efficacy as well as detailed information on the
manufacture and composition of the product candidate. In most cases, this entails extensive
laboratory tests and pre-clinical and clinical trials. This testing and the preparation of
necessary applications and processing of those applications by the FDA are expensive and typically
take many years to complete. The FDA may deny our applications or may not act quickly or favorably
in
reviewing these applications, and we may encounter significant difficulties or costs in our efforts
to obtain FDA approvals that could delay or preclude us from marketing any products we may develop.
The FDA also may require post-marketing testing and surveillance to monitor the effects of approved
products or place conditions on any approvals that could restrict the commercial applications of
these products. Regulatory authorities may withdraw product approvals if we fail to comply with
regulatory standards or if we encounter problems following initial marketing. With respect to
patented products or technologies, delays imposed by the governmental approval process may
materially reduce the period during which we will have the exclusive right to exploit the products
or technologies.
The FDA does not apply a single regulatory scheme to human tissues and the products derived
from human tissue. On a product-by-product basis, the FDA may regulate such products as drugs,
biologics, or medical devices, in addition to regulating them as human cells, tissues, or cellular
or tissue-based products (HCT/Ps), depending on whether or not the particular product triggers
any of an enumerated list of regulatory factors. A fundamental difference in the treatment of
products under these classifications is that the FDA generally permits HCT/Ps that do not trigger
any of those regulatory factors to be commercially distributed without marketing approval. In
contrast, products that trigger those factors, such as if they are more than minimally manipulated
when processed or manufactured, are regulated as drugs, biologics, or medical devices and require
FDA approval. We have determined that our Fibrocell Therapy triggers regulatory factors that
make it a biologic, in addition to an HCT/P, and consequently, we must obtain approval from FDA
before marketing Fibrocell Therapy and must also satisfy all regulatory requirements for
HCT/Ps.
The process required by the FDA before a new drug or biologic may be marketed in the United
States generally involves the following:
|
|
|
completion of pre-clinical laboratory tests or trials and formulation studies; |
|
|
|
submission to the FDA of an IND for a new drug or biologic, which must become
effective before human clinical trials may begin; |
|
|
|
performance of adequate and well-controlled human clinical trials to establish the
safety and efficacy of the proposed drug or biologic for its intended use; |
|
|
|
detailed information on product characterization and manufacturing process; and |
|
|
|
submission and approval of a New Drug Application, or NDA, for a drug, or a
Biologics License Application, or BLA, for a biologic. |
Pre-clinical tests include laboratory evaluation of product chemistry formulation and
stability, as well as animal and other studies to evaluate toxicity. In view of the autologous
nature of our product candidates and our prior clinical experience with our product candidates, we
concluded that it was reasonably safe to initiate clinical trials without pre-clinical studies and
that the clinical trials would be adequate to further assess both the safety and efficacy of our
product candidates. Under FDA regulations, the results of any pre-clinical testing, together with
manufacturing information and analytical data, are submitted to the FDA as part of an IND
application. The FDA requires a 30-day waiting period after the filing of each IND application
before clinical trials may begin, in order to ensure that human research subjects will not be
exposed to unreasonable health risks. At any time during this 30-day period or at any time
thereafter, the FDA may halt proposed or ongoing clinical trials, or may authorize trials only on
specified terms. The IND application process may become extremely costly and substantially delay
development of our products. Moreover, positive results of pre-clinical tests will not necessarily
indicate positive results in clinical trials.
38
The sponsor typically conducts human clinical trials in three sequential phases, which may
overlap. These phases generally include the following:
|
|
|
Phase I: The product is usually first introduced into healthy humans or, on
occasion, into patients, and is tested for safety, dosage tolerance, absorption,
distribution, excretion and metabolism. |
|
|
|
Phase II: The product is introduced into a limited subject population to: |
|
|
|
assess its efficacy in specific, targeted indications; |
|
|
|
assess dosage tolerance and optimal dosage; and |
|
|
|
identify possible adverse effects and safety risks. |
|
|
|
Phase III: These are commonly referred to as pivotal studies. If a product is found
to have an acceptable safety profile and to be potentially effective in Phase II
clinical trials, new clinical trials will be initiated to further demonstrate clinical
efficacy, optimal dosage and safety within an expanded and diverse subject population
at geographically-dispersed clinical study sites. |
|
|
|
If the FDA does ultimately approve the product, it may require post-marketing
testing, including potentially expensive Phase IV studies, to confirm or further
evaluate its safety and effectiveness. |
Before proceeding with a study, sponsors may seek a written agreement from the FDA regarding
the design, size, and conduct of a clinical trial. This is known as a Special Protocol Assessment,
or SPA. Among other things, SPAs can cover clinical studies for pivotal trials whose data will form
the primary basis to establish a products efficacy. SPAs thus help establish up-front agreement
with the FDA about the adequacy of a clinical trial design to support a regulatory approval, but
the agreement is not binding if new circumstances arise. Even if the FDA agrees to an SPA, the
agreement may be changed by the sponsor or the FDA on written agreement by both parties, or a
senior FDA official determines that a substantial scientific issue essential to determining the
safety or effectiveness of the product was identified after the testing began. There is no
guarantee that a study will ultimately be adequate to support an approval even if the study is
subject to an SPA. The FDA retains significant latitude and discretion in interpreting the terms of
the SPA agreement and the data and results from any study that is the subject of the SPA agreement.
Clinical trials must meet requirements for Institutional Review Board, or IRB, oversight,
patient informed consent and the FDAs Good Clinical Practices. Prior to commencement of each
clinical trial, the sponsor must submit to the FDA a clinical plan, or protocol, accompanied by the
approval of the committee responsible for overseeing clinical trials at the clinical trial sites.
The FDA or the IRB at each institution at which a clinical trial is being performed may order the
temporary or permanent discontinuation of a clinical trial at any time if it believes that the
clinical trial is not being conducted in accordance with FDA requirements or presents an
unacceptable risk to the clinical trial subjects. Data safety monitoring committees, who monitor
certain studies to protect the welfare of study subjects, may also require that a clinical study be
discontinued or modified.
The sponsor must submit to the FDA the results of the pre-clinical and clinical trials,
together with, among other things, detailed information on the manufacturing and composition of the
product, and proposed labeling, in the form of an NDA, or, in the case of a biologic, a BLA. The
applicant must also submit with the NDA or BLA a substantial user fee payment, unless a waiver or
reduction applies. On February 17, 2009, the US Small Business Administration issued a letter
formally determining that we are a small business and therefore qualify for the Small Business
Exception to the Prescription Drug and User fee Act of 1992 (21 USC § 379h(b)(2)) related to our
BLA submission for the nasolabial folds/wrinkles indication. For fiscal year 2009, this fee was
$1,247,200 for companies that did not receive an exception. The FDA has advised us it is regulating
our Fibrocell Therapy as a biologic. Therefore, we expect to submit BLAs to obtain approval of our
product candidates. In some cases, we may be able to expand the indications in an approved BLA
through a Prior Approval Supplement. Each NDA or BLA submitted for FDA approval is usually reviewed
for administrative completeness and reviewability within 45 to 60 days following submission of the
application. If deemed complete, the FDA will file the NDA or BLA, thereby triggering substantive
review of the application. The FDA can refuse to file any NDA or BLA that it deems incomplete or
not properly reviewable. Once the submission has been accepted for filing, the FDA will review the
application and will usually respond to the applicant in accordance with performance goals the FDA
has established for the review of NDAs and BLAs six months from the receipt of the application
for priority applications and ten months for regular applications. The review process is often
significantly extended by FDA requests for additional information, preclinical or clinical studies,
clarification, or a risk evaluation and mitigation strategy, or REMS, or by changes to the
application submitted by the applicant in the form of amendments. The FDA may refer the BLA to an
advisory committee for review, evaluation and recommendation as to whether the application should
be approved, but the FDA is not bound by the recommendation of an advisory committee.
39
It is possible that our product candidates will not successfully proceed through this approval
process or that the FDA will not approve them in any specific period of time, or at all. The FDA
may deny or delay approval of applications that do not meet applicable regulatory criteria, or if
the FDA determines that the clinical data do not adequately establish the safety and efficacy of
the product. Satisfaction of FDA pre-market approval requirements for a new biologic is a process
that may take a number of years and the actual time required may vary substantially based upon the
type, complexity and novelty of the product or disease. The FDA reviews these applications and,
when and if it decides that adequate data are available to show that the product is both safe and
effective and that other applicable requirements have been met, approves the drug or biologic for
marketing. Government regulation may delay or prevent marketing of potential products for a
considerable period of time and impose costly procedures upon our activities. Success in early
stage clinical trials does not assure success in later stage clinical trials. Data obtained from
clinical activities is not always conclusive and may be susceptible to varying interpretations that
could delay, limit or prevent regulatory approval. Upon approval, a product candidate may be
marketed only for those indications approved in the BLA or NDA and may be subject to labeling and
promotional requirements or limitations, including warnings, precautions, contraindications and use
limitations, which could materially impact profitability. Once approved, the FDA may withdraw the
product approval if compliance with pre- and post-market regulatory standards is not maintained or
if safety, efficacy or other problems occur after the product reaches the marketplace.
The FDA may, during its review of an NDA or BLA, ask for additional test data. If the FDA does
ultimately approve the product, it may require post-marketing testing, including potentially
expensive Phase IV studies, to confirm or otherwise further evaluate the safety and effectiveness
of the product. The FDA also may require, as a condition to approval or continued marketing of a
drug, a risk evaluation and mitigation strategy, or REMS, if deemed necessary to manage a known or
potential serious risk associated with the product. An REMS can include additional educational
materials for healthcare professionals and patients such as Medication Guides and Patient Package
Inserts, a plan for communicating information to healthcare professionals, and restricted
distribution of the product.
In addition, the FDA may, in some circumstances, impose restrictions on the use of the product,
which may be difficult and expensive to administer and may require prior approval of promotional
materials. Following approval, FDA may require labeling changes or impose new post-approval study,
risk management, or distribution restriction requirements.
Ongoing FDA Requirements
Before approving an NDA or BLA, the FDA usually will inspect the facilities at which the
product is manufactured and will not approve the product unless the manufacturing facilities are in
compliance with the FDAs current Good Manufacturing Practices, or cGMP, requirements which govern
the manufacture, holding and distribution of a product. Manufacturers of human cellular or
tissue-based biologics also must comply with the FDAs Good Tissue Practices, as applicable, and
the general biological product standards. Following approval, the FDA periodically inspects drug
and biologic manufacturing facilities to ensure continued compliance with the cGMP requirements.
Manufacturers must continue to expend time, money and effort in the areas of production, quality
control, record keeping and reporting to ensure compliance with those requirements. Failure to
comply with these requirements subjects the manufacturer to possible legal or regulatory action,
such as suspension of manufacturing, seizure of product, voluntary recall of product, withdrawal of
marketing approval or civil or criminal penalties. Adverse experiences with the product must be
reported to the FDA and could result in the imposition of marketing restrictions through labeling
changes or market removal. Product approvals may be withdrawn if compliance with regulatory
requirements is not maintained or if problems concerning safety or efficacy of the product occur
following approval.
The labeling, advertising, promotion, marketing and distribution of a drug or biologic product
also must be in compliance with FDA and FTC requirements which include, among others, standards and
regulations for direct-to-consumer advertising, industry-sponsored scientific and educational
activities, and promotional activities involving the internet. In general, all product promotion
must be consistent with the FDA approval for such product, contain a balanced presentation of
information on the products uses and benefits and important safety information and limitations on
use, and otherwise not be false or misleading. The FDA and FTC have very broad enforcement
authority, and failure to abide by these regulations can result in penalties, including the
issuance of a Warning Letter directing a
company to correct deviations from regulatory standards and enforcement actions that can include
seizures, injunctions and criminal prosecution.
40
Manufacturers are also subject to various laws and regulations governing laboratory practices,
the experimental use of animals and the use and disposal of hazardous or potentially hazardous
substances in connection with their research. In each of the above areas, the FDA has broad
regulatory and enforcement powers, including the ability to levy fines and civil penalties, suspend
or delay issuance of approvals, seize or recall products and deny or withdraw approvals.
HIPAA Requirements
Other federal legislation may affect our ability to obtain certain health information in
conjunction with our research activities. The Health Insurance Portability and Accountability Act
of 1996, or HIPAA, mandates, among other things, the adoption of standards designed to safeguard
the privacy and security of individually identifiable health information. In relevant part, the
U.S. Department of Health and Human Services, or HHS, has released two rules to date mandating the
use of new standards with respect to such health information. The first rule imposes new standards
relating to the privacy of individually identifiable health information. These standards restrict
the manner and circumstances under which covered entities may use and disclose protected health
information so as to protect the privacy of that information. The second rule released by HHS
establishes minimum standards for the security of electronic health information. While we do not
believe we are directly regulated as a covered entity under HIPAA, the HIPAA standards impose
requirements on covered entities conducting research activities regarding the use and disclosure of
individually identifiable health information collected in the course of conducting the research. As
a result, unless they meet these HIPAA requirements, covered entities conducting clinical trials
for us may not be able to share with us any results from clinical trials that include such health
information.
Other U.S. Regulatory Requirements
In the United States, the research, manufacturing, distribution, sale, and promotion of drug
and biological products are potentially subject to regulation by various federal, state and local
authorities in addition to the FDA, including the Centers for Medicare and Medicaid Services
(formerly the Health Care Financing Administration), other divisions of the U.S. Department of
Health and Human Services (e.g., the Office of Inspector General), the U.S. Department of Justice
and individual U.S. Attorney offices within the Department of Justice, and state and local
governments. For example, sales, marketing and scientific/educational grant programs must comply
with the anti-fraud and abuse provisions of the Social Security Act, the False Claims Act, and
similar state laws, each as amended. Pricing and rebate programs must comply with the Medicaid
rebate requirements of the Omnibus Budget Reconciliation Act of 1990 and the Veterans Health Care
Act of 1992, each as amended. If products are made available to authorized users of the Federal
Supply Schedule of the General Services Administration, additional laws and requirements apply. All
of these activities are also potentially subject to federal and state consumer protection, unfair
competition, and other laws.
International Regulation
The regulation of our product candidates outside of the United States varies by country.
Certain countries regulate human tissue products as a pharmaceutical product, which would require
us to make extensive filings and obtain regulatory approvals before selling our product candidates.
Certain other countries classify our product candidates as human tissue for transplantation but may
restrict its import or sale. Other countries have no application regulations regarding the import
or sale of products similar to our product candidates, creating uncertainty as to what standards we
may be required to meet.
Manufacturing
We currently have one operational manufacturing facility located in Exton, Pennsylvania. The
costs incurred in operating our Exton facility (except for costs related to general corporate
administration) are currently classified as research and development expenses as the activities
there have been devoted to the research and development of our clinical applications and the
development of a commercial scale and in a cost-effective production method. All component parts
used in our Exton, Pennsylvania manufacturing process are readily available with short lead times,
and all machinery is maintained and calibrated. We believe we have made improvements in our
manufacturing processes, and we expect to continue such efforts in the future.
41
Our Agera products are manufactured by a third-party contract manufacturer under a contract
manufacturing agreement. The agreement is effective through July 2014.
Research and Development
In addition to our clinical development activities, our research and development activities
include improving our manufacturing processes and reducing manufacturing costs. We expense research
and development costs as they are incurred. For the years ended December 31, 2009 and 2008, we
incurred research and development expenses of $3.9 million and
$10.2 million, respectively. For the three months ended
September 30, 2010, we incurred research and development expenses of
$1.4 million, which is an 19% increase over the research and
development expenses we incurred for the three months ended September 30, 2009.
Employees
As
of February 1, 2011, we employed 23 people on a full-time basis, all located in the United
States, and one employee, our Chief Operating and Chief Financial Officer, who is based in Ireland
and works in both Ireland and the United States. We also employ one full-time and one part-time
Agera employees. None of our employees are covered by a collective bargaining agreement, and we
consider our relationship with our employees to be good. We also employ consultants and temporary
labor on an as needed basis to supplement existing staff.
Segment Information
Financial information concerning the Companys business segments and geographic areas of
operation is included in Note 17 in the Notes to Consolidated Financial Statements contained herein.
Discontinued Operations
As part of our continuing efforts to evaluate the best uses of our resources, in the fourth
quarter of 2006 our Board of Directors approved the closing of our United Kingdom operation. On
March 31, 2007, we completed the closure of the United Kingdom manufacturing facility. As a result
of the completion of the closure of the United Kingdom manufacturing facility, as of March 31, 2007
our United Kingdom operation was classified as a discontinued operation. In addition, as a result
of the closure of our United Kingdom operation, the operations that we previously conducted in
Switzerland and Australia, which had been absorbed into the United Kingdom operation, were also
classified as discontinued operations as of March 31, 2007. Accordingly, the historical results of
the United Kingdom, Switzerland and Australia have been retrospectively adjusted herein, for all
periods presented, to reflect the treatment of these operations as discontinued operations.
Corporate History
On August 10, 2001, our company, then known as American Financial Holding, Inc., acquired
Isolagen Technologies through the merger of our wholly-owned subsidiary, Isolagen Acquisition
Corp., and an affiliated entity, Gemini IX, Inc., with and into Isolagen Technologies. As a result
of the merger, Isolagen Technologies became our wholly owned subsidiary. On November 13, 2001, we
changed our name to Isolagen, Inc. On August 27, 2009, the United States Bankruptcy Court for the
District of Delaware in Wilmington entered an order, or Confirmation Order, confirming the Joint
First Amended Plan of Reorganization dated July 30, 2009, as supplemented by the Plan Supplement
dated August 21, 2009, or the Plan, of Isolagen, Inc. and Isolagens wholly owned subsidiary,
Isolagen Technologies, Inc. The effective date of the Plan was September 3, 2009. Isolagen, Inc.
and Isolagen Technologies, Inc. were subsequently renamed Fibrocell Science, Inc. and Fibrocell
Technologies, Inc. respectively.
Properties
Our corporate headquarters and manufacturing operations are located in
one location, Exton, Pennsylvania. The Exton, Pennsylvania location
is leased and consists of approximately 86,500 square feet. The lease is noncancelable through March 31, 2013.
MANAGEMENT
The following table sets forth the names and ages of all of our directors and executive
officers as of February 1, 2011. Our officers are appointed by, and serve at the pleasure of, the
Board of Directors.
42
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|
|
|
|
Name |
|
Title |
|
Age |
David Pernock |
|
Director and Chief Executive Officer |
|
55 |
|
|
|
|
|
Declan Daly |
|
Director, Chief Operating Officer and Chief
Financial Officer |
|
47 |
|
|
|
|
|
Kelvin Moore |
|
Director |
|
61 |
|
|
|
|
|
Robert Langer |
|
Director |
|
61 |
|
|
|
|
|
|
|
Marc Mazur
|
|
Director
|
|
51 |
|
|
|
|
|
|
|
|
George J. Korkos
|
|
Director
|
|
79 |
|
Biographical information with respect to our directors and executive officers is provided
below. There are no family relationships between any of our executive officers or directors.
Declan Daly. Mr. Daly has served as Fibrocells Chief Operating Officer and Chief Financial
Officer since September 2009, and as a director of Fibrocell since November 2009. Mr. Daly served
as Isolagens Chief Executive Officer and President from January 2008 until September 3, 2009, as
Chief Financial Officer from June 2006 until March 2008, and as Chief Operating Officer from
June 2007 until January 2008. Mr. Daly was elected to the Board of Directors of Isolagen in
June 2008. Mr. Daly served as Executive Vice President and Chief Financial Officer of Inamed Corp.
from November 2004 until March 2006, prior to which he served as Inameds Senior Vice President
since September 2002 and as the Corporate Controller and Principal Accounting Officer since
March 2002. He was previously Vice President of Finance & Administration for Inamed International
Corp. from 1998 to 2002. From 1996 to 1998, Mr. Daly was a Senior Manager with BDO Simpson Xavier,
Chartered Accountants or BDO, in Dublin. Prior to joining BDO, he worked with
PricewaterhouseCoopers in Dublin and London. Mr. Daly holds a B.A. in Management Science and
Industrial Systems Studies from Trinity College, Dublin and he is also a Fellow of the Institute of
Chartered Accountants in Ireland.
David Pernock. Mr. Pernock has served as a chairman of the board of Fibrocell since September
2009 and as our Chief Executive Officer since February 2010. From December 1993 until
November 2009, Mr. Pernock held various positions at GlaxoSmithKline, eventually serving as Senior
Vice President of Pharmaceuticals, Vaccines (Biologics), Oncology, Acute Care, and HIV Divisions.
Mr. Pernock is a director of Martek Biosciences Corporation. Mr. Pernock holds a B.S. in Business
Administration from Arizona State University.
Kelvin Moore. Mr. Moore has served as a director of Fibrocell since September 2009. Since
March 2009, Mr. Moore has served as the consultant sales director for the UK based Seaborne Group
developing their business in building constructions from converting shipping sea containers. Since
July 2008, Mr. Moore has been a director of Acorn Cultural Developments Limited which is
developing a social networking site. Between June 2004 and May 2008, Mr. Moore was a senior advisor
with Exit Strategy Planning dealing with the sale of businesses. Mr. Moore holds a London
University Degree in Geography and Pure Mathematics.
Robert Langer. Dr. Langer has served as a director of Fibrocell since September 2009. Dr.
Langer was named an Institute Professor at Massachusetts Institute of Technology in 2006 and has
been on the faculty of Massachusetts Institute of Technology since 1978. Dr. Langer is also a
Director of Alseres Pharmaceuticals, Inc. and Echo Therapeutics, Inc. Dr. Langer received his
Bachelors Degree from Cornell University in 1970 and his Sc.D. from the Massachusetts Institute of
Technology in 1974, both in Chemical Engineering.
Marc B. Mazur. Mr. Mazur has served as a director of Fibrocell since April 2010. Since
May 2009, Mr. Mazur has served as the Chairman of Elsworthy Capital Management Ltd., a
London-based European equity hedge fund. From October 2006 until December 2009, Mr.
Mazur served as the CEO of Brevan Howard U.S. Asset Management, the U.S. arm of London-based
Brevan Howard. In 2001 Mr. Mazur founded Ambassador Capital Group, a privately held
investment and advisory entity providing capital, business development and strategic planning
advice to companies in the healthcare, financial services and real estate fields. Mr. Mazur
received his B.A. in political science from Columbia University in 1981 and a J.D. from
Villanova University in 1984.
George J. Korkos. Dr. Korkos has served as a director of Fibrocell since July 2010. Since 1965, Dr. Korkos has served as President of both Plastic Surgery Associates and Rejuva
Skin Care & Laser Center, each of which is located in Waukesha, Wisconsin. Dr. Korkos also presently serves as Associate Clinical Professor at the Medical College of Wisconsin in
Milwaukee. Dr. Korkos received his D.D.S. from Marquette University School of Dentistry, his M.D. and general surgery degrees from Medical College of Wisconsin, and his degree in
plastic and reconstructive surgery from St. Louis University Medical School.
In connection with our emergence from bankruptcy, our plan of reorganization provided that our
directors prior to our emergence from bankruptcy were all deemed to have resigned, and a new board
of directors was appointed as of the effective date of our emergence from bankruptcy. Pursuant to
the plan of reorganization, the new board of directors was determined by the lenders that provided
us debtor-in-possession while we were in bankruptcy and the investors that provided us exit
financing. The members of our board of directors that were designated in our plan of reorganization
are David Pernock, Paul Hopper and Kelvin Moore.
43
No director is related to any other director or executive officer of our company or our
subsidiaries, and, subject to the above paragraph, there are no arrangements or understandings
between a director and any other person pursuant to which such person was elected as director.
Our Certificate of Incorporation, as amended, provides that the Board of Directors be divided
into three classes. Each director serves a term of three years. At each annual meeting, the
stockholders elect directors for a full term or the remainder thereof, as the case may be, to
succeed those whose terms have expired. Each director holds office for the term for which elected
or until his or her successor is duly elected.
No director or officer of our company has, during the last five years: (i) been convicted of
any criminal proceeding (excluding traffic violations or similar misdemeanors) or (ii) been a party
to a civil proceeding of a judicial or administrative body of competent jurisdiction and as a
result of such proceeding was or is subject to a judgment, decree or final order enjoining future
violations of, or prohibiting or mandating activities subject to, United States federal or state
securities laws or finding any violations with respect to such laws.
Board Committees
We do not currently have an audit committee, compensation committee or nominating committee.
Our full board currently performs the duties and responsibilities of such committees.
Executive Officer Compensation
The following table sets forth information regarding compensation with respect to the fiscal
years ended December 31, 2010, 2009 and 2008 paid or accrued by us to or on behalf of those persons who,
during the fiscal year ended December 31, 2010, served as our Chief Executive Officer or Chief
Financial Officer, as well as our most highly compensated key employees as of December 31, 2010
(the named executive officers).
Summary Compensation Table 2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
All Other |
|
|
|
|
|
|
|
|
Salary |
|
Bonus |
|
Stock Awards |
|
Option Awards |
|
Compensation |
|
Total |
Name and Principal Position |
|
Year |
|
($) |
|
($) |
|
($)(1) |
|
($)(1) |
|
($) |
|
($) |
David Pernock, |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chief Executive Officer (2) |
|
|
2010 |
|
|
|
415,385 |
|
|
|
|
|
|
|
|
|
|
|
1,036,491 |
|
|
|
104,167 |
(3) |
|
|
1,556,043 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Declan Daly, |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chief Financial Officer and |
|
|
2010 |
|
|
|
300,000 |
|
|
|
71,500 |
|
|
|
|
|
|
|
120,761 |
|
|
|
113,297 |
(4) |
|
|
605,558 |
|
Chief Operating Officer |
|
|
2009 |
|
|
|
403,538 |
|
|
|
100,000 |
|
|
|
288,000 |
(5) |
|
|
17,908 |
|
|
|
|
|
|
|
809,446 |
|
|
|
|
2008 |
|
|
|
427,635 |
|
|
|
25,000 |
|
|
|
|
|
|
|
766,839 |
(6) |
|
|
|
|
|
|
1,219,474 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
John Maslowski, |
|
|
2010 |
|
|
|
147,019 |
|
|
|
21,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
168,519 |
|
Vice President of Operations |
|
|
2009 |
|
|
|
149,279 |
|
|
|
|
|
|
|
|
|
|
|
16,117 |
(7) |
|
|
|
|
|
|
165,396 |
|
Karen Donhauser, |
|
|
2010 |
|
|
|
122,131 |
|
|
|
12,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
134,131 |
|
Vice President of Quality |
|
|
2009 |
|
|
|
110,936 |
|
|
|
|
|
|
|
|
|
|
|
9,670 |
(8) |
|
|
|
|
|
|
120,606 |
|
44
|
|
|
|
(1) |
|
Except as disclosed in footnotes (7) and (8), represents the full grant date fair value of
the stock award or option grant, as applicable, calculated in accordance with FASB ASC Topic
718. |
|
|
|
|
|
For the purposes of making the option calculation for 2010, the following assumptions
were made: : (a) expected life (years) 5.5 for options to Mr. Pernock and 5.25 for options
to Mr. Daly; (b) volatility 64.82% for options to Mr. Pernock and 63.26% for options to Mr.
Daly; (c) dividend yield none; and (d) discount rate 2.38% for options to Mr. Pernock
and 1.43% for options to Mr. Daly. |
|
|
|
|
For the purposes of making the stock award calculation in
2009 for Mr. Daly, an assumed value of $0.48 per share was utilized. For the purposes of
making the option calculation for 2009, the following assumptions were made: (a) expected life
(years) 3.5 (for the options issued to Mr. Maslowski and Ms. Donhauser); expected life
(years) 2.5 (for the options issued to Mr. Daly); (b) volatility 65.87%; (c) dividend
yield none; and (d) discount rate 1.64% (for the options issued to Mr. Maslowski and Ms.
Donhauser); discount rate 0.99% (for the options issued to Mr. Daly). |
|
|
|
|
For the purposes of
making the option calculation for 2008, the following assumptions were made: (a) expected life
(years) 10; (b) volatility 82.87%; (c) dividend yield none; and (d) discount rate
3.89%. We excluded the assumed forfeiture rate for the purposes of the calculations in the
table. |
|
|
|
(2) |
|
Mr. Pernock agreed to become our Chief Executive Officer in February 2010. All amounts shown
in the table include all compensation received during 2010. |
|
|
|
(3) |
|
Represents a one-time payment of $100,000 for services rendered prior to becoming Chief
Executive Officer, which payment was made during 2010, and $4,167 of Board fees paid prior to
Mr. Pernock becoming Chief Executive Officer. |
|
|
|
(4) |
|
Represents a tax gross-up payment made during 2010. |
|
|
|
(5) |
|
Pursuant to our bankruptcy plan, our management was granted shares of our common stock. Mr.
Daly received 600,000 shares of common stock, of which 300,000 shares vested in September
2009, 150,000 shares vested September 2010, and the remaining shares shall vest on September
2011; provided that if we do not renew Mr. Dalys employment agreement at the end of its term
or in the event of a change of control, any unvested shares will automatically vest. |
|
|
|
(6) |
|
During 2008, Mr. Daly was granted options to purchase 450,000 shares of common stock. These
options were terminated in our bankruptcy and are no longer outstanding. |
|
|
|
(7) |
|
Consists of an option to purchase 100,000 shares of common stock at an exercise price of
$0.75 per share of which 50,000 shares vested on October 6, 2010 and 50,000 shares vest if our
BLA is approved by the FDA. The grant date fair value in the table above excludes the 50,000
shares that would vest if our BLA is approved by the FDA as that portion of the option is
subject to performance conditions and is not considered to be probable pursuant to FASB ASC
Topic 718. The full grant date fair value of the option assuming the performance conditions
are met was $32,234. |
|
|
|
(8) |
|
Consists of an option to purchase 60,000 shares of common stock at an exercise price of $0.75
per share of which 30,000 shares vested on October 6, 2010 and 30,000 shares vest if our BLA
is approved by the FDA. The grant date fair value in the table above excludes the 30,000
shares that would vest if our BLA is approved by the FDA as that portion of the option is
subject to performance conditions and is not considered to be probable pursuant to FASB ASC
Topic 718. The full grant date fair value of the option assuming the performance conditions
are met was $19,341. |
|
45
Equity Awards
The following table sets forth certain information concerning our outstanding options
for our named executive officers at December 31, 2010.
Outstanding Equity Awards At Fiscal Year-End2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
Number of |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Securities |
|
Securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Underlying |
|
Underlying |
|
|
|
|
|
|
|
|
|
Number of |
|
Market value of |
|
|
Unexercised |
|
Unexercised |
|
|
|
|
|
|
|
|
|
shares of stock |
|
shares of stock |
|
|
Options |
|
Options |
|
Option Exercise |
|
|
|
that have not |
|
that have not |
|
|
(#) |
|
(#) |
|
Price |
|
Option |
|
vested |
|
vested |
Name |
|
Exercisable |
|
Unexercisable |
|
($) |
|
Expiration Date |
|
(#) |
|
($) |
David Pernock |
|
|
611,110 |
(1) |
|
|
1,038,890 |
(1) |
|
|
1.08 |
|
|
|
2/1/2020 |
|
|
|
|
|
|
|
|
|
|
|
|
450,000 |
|
|
|
|
|
|
|
0.75 |
|
|
|
9/30/2019 |
|
|
|
|
|
|
|
|
|
Declan Daly |
|
|
80,000 |
(2) |
|
|
320,000 |
(2) |
|
|
0.55 |
|
|
|
8/24/2020 |
|
|
|
|
|
|
|
|
|
|
|
|
50,000 |
|
|
|
|
|
|
|
0.75 |
|
|
|
11/20/2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
150,000 |
|
|
|
76,500 |
(3) |
John Maslowski |
|
|
50,000 |
(4) |
|
|
50,000 |
(4) |
|
|
0.75 |
|
|
|
10/6/2014 |
|
|
|
|
|
|
|
|
|
Karen Donhauser |
|
|
30,000 |
(5) |
|
|
30,000 |
(5) |
|
|
0.75 |
|
|
|
10/6/2014 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Consists of an option to purchase 1,650,000 shares issued in connection with Mr. Pernocks
employment agreement. Of the unexercised portion of the option, 938,890 shares vest in 26
equal installments of 36,111 shares on the first day of each month commencing January 1, 2011,
and 100,000 shares vest upon the closing of a strategic partnership or licensing deal. |
|
|
|
(2) |
|
Consists of an option to purchase 400,000 shares issued in connection with Mr. Dalys
employment agreement. Of the unexercised portion of the option, 320,000 shares vest in 32
equal installments of 10,000 shares on the first day of each month commencing January 24,
2011. |
|
|
|
(3) |
|
Based on the closing price of our common stock of $0.51 on December 31, 2010. |
|
|
|
(4) |
|
Consists of an option to purchase 100,000 shares of common stock at an exercise price of
$0.75 per share of which 50,000 shares vested on October 6, 2010 and 50,000 shares vest if our
BLA is approved by the FDA. |
|
|
|
(5) |
|
Consists of an option to purchase 60,000 shares of common stock at an exercise price of $0.75
per share of which 30,000 shares vested on October 6, 2010 and 30,000 shares vest if our BLA
is approved by the FDA. |
|
None of our named executive officers has exercised any options.
Pension Benefits
None of our named executives participate in or have account balances in qualified
or non-qualified defined benefit plans sponsored by us.
Nonqualified Deferred Compensation
None of our named executives participate in or have account
balances in non-qualified defined contribution plans or other deferred compensation plans
maintained by us.
46
Director Compensation
In September 2009, our board of directors approved a compensation plan for
its non-executive directors pursuant to which each such director will receive an annual fee of
$50,000, payable in monthly installments, and upon appointment to the board of directors will
receive an initial option grant to purchase 200,000 shares of Company common stock at the fair
market value of the Company on the date of issuance.
Director Compensation Table2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fees Earned or Paid |
|
|
|
|
|
All other |
|
|
|
|
in Cash |
|
Option Awards |
|
compensation |
|
Total |
Name |
|
($) |
|
($)(1) |
|
($) |
|
($) |
Robert Langer |
|
|
37,500 |
|
|
|
|
(3) |
|
|
37,500 |
(2) |
|
|
75,000 |
|
Kelvin Moore |
|
|
37,500 |
|
|
|
|
(3) |
|
|
|
|
|
|
37,500 |
|
Marc Mazur |
|
|
25,000 |
|
|
|
118,378 |
(3) |
|
|
|
|
|
|
143,378 |
|
George Korkos |
|
|
9,946 |
|
|
|
90,738 |
(3) |
|
|
|
|
|
|
100,684 |
|
Paul Hopper |
|
|
37,500 |
|
|
|
|
(3) |
|
|
|
|
|
|
37,500 |
|
|
|
|
|
(1) |
|
Represents the full grant date fair value of the option grant calculated in accordance with
FASB ASC Topic 718. For the purposes of making the option calculation, the following
assumptions were made: (a) expected life (years) 2.5 for the options issued to Messrs.
Hopper, Langer and Moore and 5.25 for options issued to Mr. Mazur and Dr. Korkos; (b)
volatility 66.75% for the options issued to Messrs. Hopper, Langer and Moore, 64.01% for
options issued to Mr. Mazur, and 63.26% for options issued to Dr. Korkos; (c) dividend yield
none; and (d) discount rate 1.36% for the options issued to Messrs. Hopper, Langer and
Moore, 2.71% and for options issued to Mr. Mazur, and 1.795% for options issued to Dr.
Korkos. |
|
|
|
(2) |
|
Consists of consulting fees. |
|
|
|
(3) |
|
As of December 31, 2010: (i) Messrs. Langer, Moore, and Hooper each held an option to
purchase 200,000 shares of our common stock with an exercise price of $0.75 per share; (ii)
Mr. Mazur held an option to purchase 200,000 shares of our common stock with an exercise price
of $1.04 per share; and (iii) Dr. Korkos held an option to purchase 200,000 shares of our
common stock with an exercise price of $0.82 per share. |
|
Equity Incentive Plan
We currently have an outstanding equity incentive plan, the Fibrocell Science, Inc. 2009 Equity
Incentive Plan, or Incentive Plan, that permits us to grant awards in the form of incentive stock
options, as defined in Section 422 of the Internal Revenue Code, or Code, as well as options which
do not so qualify, called non-qualified stock options, stock units, stock awards, stock
appreciation rights, and other stock-based awards. The purpose of the plan is to promote the
interests of Fibrocell, and to motivate, attract and retain the services of the people upon whose
efforts and contributions our success depends.
On January 14, 2011, our board of directors agreed to provide: (i) Mr. Pernock with an option to
purchase 2,100,000 shares of common stock; (ii) Mr. Daly with an option to purchase 1,065,000
shares of common stock; and (iii) Messrs. Kelvin Moore, Robert Langer, Marc Mazur, and George
Korkos each with an option to purchase 200,000 shares of common stock. Each of the foregoing
options has: (i) a ten-year term, (ii) an exercise price equal to the closing price of our common
stock on the date of grant, and (iii) vests 50% on the date of grant; 25% on the one-year
anniversary of the date of grant; and 25% on the two-year anniversary of the date of grant;
provided in each case that the grantee is providing service to us on the vesting date.
The three outstanding stock option plans we had prior to our reorganization, (a) our 2001 Stock
Option and Appreciation Rights Plan reserving 5,000,000 shares of common stock for the issuance of
options to employees, directors and consultants, (b) our 2003 Stock Option and Appreciation Rights
Plan reserving 2,250,000 shares of common stock for the issuance of options to employees, directors
and consultants, and(c) our 2005 Equity Incentive Plan reserving 2,100,000 shares of common stock
for the issuance of options to employees, directors and consultants, terminated as of the effective
date of our reorganization and all outstanding options issued pursuant to the plans were cancelled.
Management Agreements
47
On February 1, 2010, the Company entered into an employment agreement with Mr. Pernock
pursuant to which Mr. Pernock agreed to serve as Chief Executive Officer of the Company for an
initial term ending February 1, 2013, which may be renewed for an additional one-year term by
mutual agreement. The agreement provides for an annual salary of $450,000. Mr. Pernock is entitled
to receive an annual bonus each year, payable subsequent to the issuance of the Companys final
audited financial statements, but in no case later than 120 days after the end of its most recently
completed fiscal year. The final determination on the amount of the annual bonus will be made by
the Board of Directors (or the Compensation Committee of the Board of Directors, if such committee
has been formed), based on criteria established by the Board of Directors (or the Compensation
Committee of the Board of Directors, if such committee has been formed). The targeted amount of the
annual bonus shall be 60% of Mr. Pernocks base salary, although the actual bonus may be higher or
lower.
Under the agreement, Mr. Pernock was granted a ten-year option to purchase 1,650,000 shares at
an exercise price per share equal to the closing price of the Companys common stock on the date of
execution of the agreement, or February 1, 2010. The options vest as follows: (i) 250,000 shares
upon execution of the agreement; (ii) 100,000 shares upon the closing of a strategic partnership or
licensing deal with a major partner that enables the Company to significantly improve and/or
accelerate its capabilities in such areas as research, production, marketing and/or sales and
enable the Company to reach or exceed its major business milestones within the Companys strategic
and operational plans, provided Mr. Pernock is the CEO on the closing date of such partnership or
licensing deal (the determination of whether any partnership or licensing deal meets the foregoing
criteria will be made in good faith by the Board upon the closing of such partnership or licensing
deal); and (iii) 1,300,000 shares in equal 1/36th installments (or 36,111 shares per installment)
monthly over a three-year period, provided Executive is the CEO on each vesting date. The vesting
of all options set forth above shall accelerate upon a change in control as defined in the
agreement, provided Mr. Pernock is employed by the Company within 60 days prior to the date of such
change in control.
If Mr. Pernocks employment is terminated at the Companys election at any time, for reasons
other than death, disability, cause (as defined in the agreement) or a voluntary resignation, or by
Mr. Pernock for good reason (as defined in the agreement), Mr. Pernock shall be entitled to receive
severance payments equal to twelve months of Mr. Pernocks base salary and of the premiums
associated with continuation of Mr. Pernocks benefits pursuant to COBRA to the extent that he is
eligible for them following the termination of his employment; provided that if anytime within
eighteen months after a change in control either (i) Mr. Pernock is terminated, at the Companys
election at any time, for reasons other than death, disability, cause or voluntary resignation, or
(ii) Mr. Pernock terminates the agreement for good reason, Mr. Pernock shall be entitled to receive
severance payments equal to: (1) two years of Mr. Pernocks base salary, (2) Mr. Pernocks most
recent annual bonus payment, and (3) the premiums associated with continuation of Mr. Pernocks
benefits pursuant to COBRA to the extent that he is eligible for them following the termination of
his employment for a period of one year after termination. All severance payments shall be made in
a lump sum within ten business days of Mr. Pernocks execution and delivery of a general release of
the Company, its parents, subsidiaries and affiliates and each of its officers, directors,
48
employees, agents, successors and assigns in a form acceptable to the Company. If severance
payments are being made, Mr. Pernock has agreed not to compete with the Company until twelve months
after the termination of his employment.
On August 24, 2010, the Company entered into an amended and restated employment agreement with
Mr. Declan Daly, which replaced and terminated his prior employment agreement with the Company,
pursuant to which Mr. Daly agreed to serve as Chief Operating Officer and Chief Financial Officer
of the Company for an initial term ending August 24, 2013, which may be renewed for an additional
one-year term by mutual agreement. The agreement provides for an annual salary of $300,000. Mr.
Daly is entitled to receive an annual bonus each year, payable subsequent to the issuance of the
Companys final audited financial statements, but in no case later than 120 days after the end of
its most recently completed fiscal year. The final determination on the amount of the annual bonus
will be made by the Board of Directors (or the Compensation Committee of the Board of Directors, if
such committee has been formed), based on criteria established by the Board of Directors (or the
Compensation Committee of the Board of Directors, if such committee has been formed). The targeted
amount of the annual bonus shall be 50% of Mr. Dalys base salary, although the actual bonus may be
higher or lower.
Under the agreement, Mr. Daly was granted a ten-year option to purchase 400,000 shares at an
exercise price per share equal to the closing price of the Companys common stock on the date of
execution of the agreement, or $0.55 per share. The options vest as follows: (i) 40,000 shares upon
execution of the agreement; and (ii) 360,000 shares in equal 1/36th installments (or 10,000 shares
per installment) monthly over a three-year period, provided Mr. Daly is the COO or CFO on each
vesting date. The vesting of all options set forth above shall accelerate upon a change in
control as defined in the agreement, provided Mr. Daly is employed by the Company within 60 days
prior to the date of such change in control.
Mr. Daly is entitled to receive a one-time bonus in the amount of $50,000 (the Milestone
Bonus) upon the U.S. Food and Drug Administrations (the FDA) approval of the Companys
Biologics License Application filing, provided that Mr. Daly is the CFO or COO at the time of said
event.
If Mr. Dalys employment is terminated at the Companys election at any time, for reasons
other than death, disability, cause (as defined in the agreement) or a voluntary resignation, or by
Mr. Daly for good reason (as defined in the agreement), Mr. Daly shall be entitled to receive
severance payments equal to twelve months of Mr. Dalys base salary and of the premiums associated
with continuation of Mr. Dalys benefits pursuant to COBRA to the extent that he is eligible for
them following the termination of his employment; provided that if anytime within eighteen months
after a change in control either (i) Mr. Daly is terminated, at the Companys election at any time,
for reasons other than death, disability, cause or voluntary resignation, or (ii) Mr. Daly
terminates the agreement for good reason, Mr. Daly shall be entitled to receive severance payments
equal to: (1) two years of Mr. Dalys base salary, (2) Mr. Dalys most recent annual bonus payment,
and (3) the premiums associated with continuation of Mr. Dalys benefits pursuant to COBRA to the
extent that he is eligible for them following the termination of his employment for a period of one
year after termination. All severance payments shall be made in a lump sum within ten business
days of Mr. Dalys execution and delivery of a general release of the Company, its parents,
subsidiaries and affiliates and each of its officers, directors, employees, agents, successors and
assigns in a form acceptable to the Company. If severance payments are being made, Mr. Daly has
agreed not to compete with the Company until twelve months after the termination of his employment.
Effective upon our exit from bankruptcy on September 3, 2009, we entered into a consultant
agreement, pursuant to which Dr. Langer agreed to provide consulting services to us, including
serving a scientific advisor. The agreement has a one year term, provided that either party may
terminate the agreement on 30 days notice. The agreement provides Dr. Langer annual compensation of
$50,000.
RELATED PARTY TRANSACTIONS
Review and Approval Policies and Procedures for Related Party Transactions
Pursuant to Board policy, our executive officers and directors, and principal stockholders,
including their immediate family members and affiliates, are not permitted to enter into a related
party transaction with us without the prior consent of our audit committee, or other independent
committee of our board of directors in the case it is inappropriate for our audit committee to
review such transaction due to a conflict of interest. Any request for us to enter into a
transaction with an executive officer, director, principal stockholder, or any of such persons
immediate family members or affiliates, in which the amount involved exceeds $120,000 must first be
presented to our audit committee for review, consideration and approval. All of our directors, executive officers and employees are required to report to our
audit committee any such related party transaction. In approving or rejecting the proposed
agreement, our audit committee shall consider the relevant facts and circumstances available and
deemed relevant to the audit committee. Our audit committee shall approve only those agreements
that, in light of known circumstances, are in, or are not inconsistent with, our best interests, as
our audit committee determines in the good faith exercise of its discretion. We do not currently
have an audit committee and our full board currently performs the duties and responsibilities of
the audit committee.
PRINCIPAL STOCKHOLDERS
The following table sets forth information regarding the beneficial ownership of our common
stock as of February 1, 2011 by:
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each person known by us to be the beneficial owner of more than 5% of our
outstanding shares of common stock; |
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each of our named executive officers and directors; and |
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all of our officers and directors as a group. |
Unless otherwise indicated, we believe that all persons named in the table have sole
voting and investment power with respect to all shares of common stock beneficially owned by them.
Unless otherwise indicated, the address for our named executive officers and directors is c/o
Fibrocell Science Inc., 405 Eagleview Boulevard, Exton, Pennsylvania 19341.
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Common stock |
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Beneficially |
|
Percent of |
Name of Beneficial Owner |
|
Owned(1) |
|
Class(2) |
Declan Daly |
|
|
1,292,500 |
(3) |
|
|
6.3 |
% |
David Pernock |
|
|
2,255,554 |
(4) |
|
|
11.0 |
% |
Kelvin Moore |
|
|
300,000 |
(5) |
|
|
1.5 |
% |
Robert Langer |
|
|
300,000 |
(5) |
|
|
1.5 |
% |
Marc Mazur |
|
|
200,000 |
(6) |
|
|
1.0 |
|
George
Korkos |
|
|
200,000 |
(7) |
|
|
1.0 |
|
John Maslowski |
|
|
270,000 |
(8) |
|
|
1.3 |
|
Karen Donhauser |
|
|
110,000 |
(9) |
|
|
* |
|
All Executive Officers and Directors as a Group (7 persons) |
|
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4,928,054 |
(10) |
|
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24.1 |
% |
|
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|
|
|
|
|
|
Five percent or more of shareholders |
|
|
|
|
|
|
|
|
James E.
Flynn (11) |
|
|
1,800,000 |
|
|
|
8.8 |
% |
|
|
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(1) |
|
Beneficial ownership is determined in accordance with Rule 13d-3 under the Exchange Act.
Unless otherwise noted, all listed shares of common stock are owned of record by each person or
entity named as beneficial owner and that person or entity has sole voting and dispositive power
with respect to the shares of common stock owned by each of them. As to each person or entity named
as beneficial owners, that persons or entitys percentage of ownership is determined based on the
assumption that any options or convertible securities held by such person or entity which are
exercisable or convertible within 60 days of the date of this report have been exercised or
converted, as the case may be. |
49
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(2) |
|
Based upon 20,490,255 shares of common stock outstanding as
of February 1, 2011. |
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(3) |
|
Includes (i) 50,000 shares underlying an option exercisable at $0.75 per share, (ii) 110,000 shares underlying an option exercisable at $0.55 per share
and (iii) 532,500 shares underlying an option exercisable at $0.62 per share. |
|
(4) |
|
Includes: (i) 450,000 shares underlying an option exercisable at $0.75 per
share; (ii) 755,554 shares underlying an option exercisable at $1.08 per share (which
represents the vested portion, plus the shares that will vest within 60 days of the date of this
filing, of an option to purchase 1,650,000 shares issued in connection with Mr. Pernocks
employment agreement)
and (iii) 1,050,000 shares underlying an option exercisable at $0.62 per share. |
|
(5) |
|
Consists of 200,000 shares underlying an option exercisable at $0.75 per share
and 100,000 shares underlying an option exercisable at $0.62 per share. |
|
(6) |
|
Consists of 100,000 shares underlying an option exercisable at $1.04 per share
and 100,000 shares underlying an option exercisable at $0.62 per share. In
addition, Mr. Mazur holds an option to purchase 100,000 shares at $1.04 per share, which is
exercisable in April 2011. |
|
(7) |
|
Consists of 100,000 shares underlying an option exercisable at
$0.82 per share
and 100,000 shares underlying an option exercisable at $0.62 per share. In addition, Dr. Korkos holds an option to purchase
100,000 shares at $0.82 per share, which is exercisable in July 2011. |
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(8) |
|
Consists of 100,000 shares underlying an option exercisable at $0.75 per share
and 170,000 shares underlying an option exercisable at $0.62 per share. |
|
(9) |
|
Consists of 60,000 shares underlying an option exercisable at $0.75 per share
and 50,000 shares underlying an option exercisable at $0.62 per share. |
|
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(10) |
|
Includes options to purchase 1,744,999 shares of common stock. |
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(11) |
|
Reflects the beneficial ownership of the reported entities and their affiliates as
reported in the Schedule 13G filed March 2, 2010 and their
Form 4 filed August 18, 2010. The business address for James E. Flynn,
Deerfield Capital, L.P., Deerfield Special Situations Fund, L.P., and Deerfield Management Company,
L.P. is 780 Third Avenue, 37th Floor, New York, NY 10017. The business address for Deerfield
Special Situations Fund International Limited is c/o Bisys Management, Bison Court, Columbus
Centre, P.O. Box 3460, Road Town, Tortola, British Virgin Islands. Deerfield Capital, L.P. and
Deerfield Special Situations Fund, L.P. have shared investment
discretion over 637,200 shares.
Deerfield Management Company, L.P. and Deerfield Special Situations Fund International Limited have
shared investment discretion over 1,162,800 shares. James E. Flynn has shared investment
discretion over 1,800,000 shares. |
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50
DESCRIPTION OF SECURITIES
General
We are authorized to issue 250,000,000 shares of common stock and 5,000,000 shares of
preferred stock. As of February 1, 2011, we had 20,490,255 shares
of common stock outstanding, 2,886 shares of Series A Preferred
outstanding and 4,640 shares of Series B Preferred outstanding
and 4,293 shares of Series D Preferred outstanding. In addition, as of such date we had:
§ 5,677,000 shares of common stock issuable upon the exercise of options issued
pursuant to our current stock option plan and outside our stock option plan;
§
6,349,200 shares of common stock issuable upon the conversion of the
Series A Preferred;
§
9,280,000 shares of common stock issuable upon the conversion of the
Series B Preferred;
§
1,624,996 shares of common stock for issuance upon exercise of the Class A
warrants; 1,624,997 shares of common stock for issuance upon exercise of the Class B warrants; and
474,500 shares of common stock for issuance upon exercise of the warrants issued to the placement
agents for our Series A Preferred offering;
§
9,950,261 shares of common stock issuable upon exercise of common stock
purchase warrants issued in the March 2010 offering and 376,941 shares of common stock underlying
the warrants issued to the placement agents in such offering; and
§
12,456,851 shares of common stock issuable upon exercise of common
stock purchase warrants issued in the July through November
2010 offerings and 708,788 shares of common stock underlying the
warrants issued to the placement agents in such offering.
Common Stock
Subject to preferences that may be applicable to any preferred stock outstanding at the time,
the holders of our common stock are entitled to receive dividends out of legally available assets
at such times and in such amounts as our Board of Directors may from time to time determine. Each
stockholder is entitled to one vote for each share of common stock held on all matters submitted to
a vote of stockholders. Cumulative voting for the election of directors is not authorized.
Our common stock is not subject to conversion or redemption and holders of our common stock
are not entitled to preemptive rights. Upon the liquidation, dissolution or winding up of our
company, the remaining assets legally available for distribution to stockholders, after payment of
claims or creditors and payment of liquidation preferences, if any, on outstanding preferred stock,
are distributable ratably among the holders of our common stock and any participating preferred
stock outstanding at that time. Each outstanding share of common stock is fully paid and
nonassessable.
Preferred Stock
Our Board of Directors has the authority, without action by our stockholders, to designate and
issue preferred stock in one or more series. Our Board of Directors may also designate the rights,
preferences and privileges of each series of preferred stock, any or all of which may be greater
than the rights of the common stock. It is not possible to state the actual effect of the issuance
of any shares of preferred stock on the rights of holders of the common stock until our Board of
Directors determines the specific rights of the holders of the preferred stock. However, these
effects might include: (a) restricting dividends on the common stock; (b) diluting the voting power
of the common stock; (c) impairing the liquidation rights of the common stock; and (d) delaying or
preventing a change in control of our company without further action by our stockholders.
As
of the date of this prospectus, we have authorized four classes of preferred stock,
Series A Convertible Preferred Stock, or Series A
Preferred, Series B Convertible Preferred Stock, or
Series B Preferred, Series C Junior Participating
Preferred Stock, or Series C Preferred and Series D Convertible
Preferred Stock, or Series D Preferred. As of February 1, 2011,
there were 2,886 shares of Series A
Preferred outstanding, 4,640 shares of Series B Preferred
outstanding, no shares of Series C Preferred outstanding and 4,293
shares of Series D Preferred outstanding.
51
Series A Preferred
The Series A Preferred shares were issued in October 2009 pursuant to an agreement between us
and certain accredited investors. To designate and establish the shares of Series A Preferred, our
board approved, and on October 8, 2009, we filed with the Delaware Secretary of State, a
Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred
Stock, or Certificate of Designation.
Dividends; Rank; Liquidation
Holders of the Series A Preferred are entitled to receive cumulative dividends at the rate per
share (as a percentage of the stated value per share) of 6% per annum (subject to increase in
certain circumstances), payable quarterly in arrears on January 15, April 15, July 15 and October
15, beginning on April 15, 2010. The dividends are payable in cash, or at our option, in duly
authorized, validly issued, fully paid and non-assessable shares of common stock equal to 110% of
the cash dividend amount payable on the dividend payment date, or a combination thereof; provided
that we may not pay the dividends in shares of common stock unless we meet certain conditions
described in the Certificate of Designation. If we pay the dividend in shares of common stock, the
common stock will be valued for such purpose at 80% of the average of the volume weighted average
price for the 10 consecutive trading days ending on the trading day that is immediately prior to the dividend payment date.
Shares of common stock issued as dividends on the Series A Preferred are not being registered
under this prospectus. Such shares are deemed to be restricted securities under Rule 144 of the
Securities Act and may only be sold in compliance with Rule 144.
The Series A Preferred ranks senior to all shares of common stock.
Upon our liquidation, dissolution or winding-up, whether voluntary or involuntary, the holders
of the Series A Preferred shall be entitled to receive out of our assets, whether capital or
surplus, an amount equal to the stated value of the common stock, plus any accrued and unpaid
dividends thereon and any other fees or liquidated damages then due and owing thereon under the
Certificate of Designation, for each share of Series A Preferred before any distribution or payment
shall be made to the holders of any junior securities, and if our assets are insufficient to pay in
full such amounts, then the entire assets to be distributed to the holders of the Series A
Preferred shall be ratably distributed among the holders in accordance with the respective amounts
that would be payable on such shares if all amounts payable thereon were paid in full.
Conversion; Conversion Price; Forced Conversion; Optional Redemption
Each share of Series A Preferred is convertible into a number of shares of common stock equal
to (1) the stated value of the share ($1,000), divided by (2) the conversion price, which is
currently $0.50, but is subject to adjustment as discussed below. We refer to this price as the
Conversion Price.
With certain exceptions, if, at any time while the Series A Preferred is outstanding, we sell
or grant any option to purchase or sell or grant any right to reprice, or otherwise dispose of or
issue (or announce any sale, grant or any option to purchase or other disposition), any common
stock or common stock equivalents at an effective price per share that is lower than the then
Conversion Price, then the Conversion Price will be reduced to equal the lower price. The
Conversion Price is also subject to proportional adjustment in the event of any stock split, stock
dividend, reclassification or similar event with respect to the common stock.
Commencing six months from the date of the agreement pursuant to which we issued the Series A
Preferred, if the volume weighted average price for each of any 20 consecutive trading days exceeds
200% of the then effective Conversion Price and various other equity conditions are satisfied
(including that the resale of the shares underlying the Series A Preferred has been registered
under the Securities Act), upon 30 days notice, the Series A Preferred plus all accrued and unpaid
dividends will automatically convert into shares of common stock.
Commencing two years from the date of the agreement pursuant to which we issued the Series A
Preferred, upon 30 days notice and provided various other equity conditions are satisfied
(including that the resale of the shares
52
underlying the Series A Preferred has been registered
under the Securities Act), we may redeem some or all of the then outstanding Series A Preferred for
cash in an amount equal to the 150% of the stated value of the Series A Preferred.
Voting
The holders of the Series A Preferred have no voting rights except with respect to specified
matters affecting the rights of the Series A Preferred.
Negative Covenants
As long as any shares of Series A Preferred are outstanding, we may not, directly or
indirectly: (a) amend our charter documents in any manner that materially and adversely affects any
rights of the holders of the Series A Preferred; (b) pay cash dividends or distributions on our
junior securities (including the common stock); or (c) enter into any transaction with any affiliate of ours which would be
required to be disclosed in any public filing, unless such transaction is made on an arms-length
basis and expressly approved by a majority of our disinterested directors.
Triggering Events
In the event of a Triggering Event (as defined in the Certificate of Designation and described
below), any holder of Series A Preferred may require us to redeem all of its Series A Preferred, at
a redemption price equal to the greater of (a) 130% of the stated value and (b) the product of (i)
the volume weighted average price on the trading day immediately preceding the date of the
Triggering Event and (ii) the stated value divided by the then Conversion Price, plus all accrued
but unpaid dividends thereon and all liquidated damages and other costs, expenses or amounts due in
respect of the Series A Preferred. Triggering Events include, among other things, bankruptcy
related events, change of control transactions (as defined in the Certificate of Designation), and
various types of failures to perform under, and breaches of, the transaction documents.
Series B Preferred
The
Series B Preferred shares were issued in July, September,
October and November 2010 pursuant to agreements
between us and certain accredited investors. To designate and establish the shares of Series B
Preferred, our board of directors approved, and on July 16, 2010, we filed with the Delaware
Secretary of State, a Certificate of Designation of Preferences, Rights and Limitations of Series B
Convertible Preferred Stock.
Dividends; Rank; Liquidation
Holders of the Series B Preferred are entitled to receive cumulative dividends at the rate per
share (as a percentage of the stated value per share) of 6% per annum (subject to increase in
certain circumstances), payable quarterly in arrears on January 15, April 15, July 15 and October
15, beginning on January 15, 2011. The dividends are payable in cash, or at our option, in duly
authorized, validly issued, fully paid and non-assessable shares of common stock equal to 110% of
the cash dividend amount payable on the dividend payment date, or a combination thereof; provided
that we may not pay the dividends in shares of common stock unless we meet certain conditions
described in the Certificate of Designation. If we pay the dividend in shares of common stock, the
common stock will be valued for such purpose at 80% of the average of the volume weighted average
price for the 10 consecutive trading days ending on the trading day that is immediately prior to
the dividend payment date
The Series B Preferred ranks senior to all shares of common stock, and junior to our Series A
Convertible Preferred Stock.
Upon any liquidation, dissolution or winding-up, whether voluntary or involuntary, the holders
of the Series B Preferred shall be entitled to receive out of the assets, whether capital or
surplus, an amount equal to the stated value of the common stock, plus any accrued and unpaid
dividends thereon and any other fees or liquidated damages then due and owing thereon under the
Certificate of Designation, for each share of Series B Preferred before any distribution or payment
shall be made to the holders of any junior securities, and if our assets are insufficient to pay in
full such amounts, then the entire assets to be distributed to the holders of the Series B
Preferred shall be ratably distributed among the holders in accordance with the respective amounts
that would be payable on such shares if all amounts payable thereon were paid in full.
Conversion; Conversion Price; Forced Conversion; Optional Redemption
Each share of Series B Preferred is convertible into a number of shares of common stock equal
to (1) the stated value of the share ($1,000), divided by (2) $0.50, subject to adjustment as
discussed below. We refer to this price as the Conversion Price.
With certain exceptions, if, at any time while the Series B Preferred is outstanding, we sell
or grant any option to purchase or sells or grants any right to reprice, or otherwise disposes of
or issues (or announce any sale, grant or any option to purchase or other disposition), any common
stock or common stock equivalents at an effective price per share that is lower than the then
Conversion Price, then the Conversion Price will be reduced to equal the lower price. The
Conversion Price is also subject to proportional adjustment in the event of any stock split, stock
dividend, reclassification or similar event with respect to the common stock.
Commencing six months from the date of the agreement pursuant to which we issued the Series B
Preferred, if the volume weighted average price for each of any 20 consecutive trading days exceeds
200% of the then effective Conversion Price and various other equity conditions are satisfied
(including that the resale of the shares underlying the Series B Preferred has been registered
under the Securities Act), upon 30 days notice, the Series B Preferred plus all accrued and unpaid
dividends will automatically convert into shares of common stock.
Commencing two years from the date of the agreement pursuant to which we issued the Series B
Preferred, upon 30 days notice and provided various other equity conditions are satisfied
(including that the resale of the shares underlying the Series B Preferred has been registered
under the Securities Act), the Company may redeem some or all of the then outstanding Series B
Preferred for cash in an amount equal to the 150% of the stated value of the Series B Preferred.
Voting
The holders of the Series B Preferred have no voting rights except with respect to specified
matters affecting the rights of the Series B Preferred.
Negative Covenants
As long as any shares of Series B Preferred are outstanding, we may not, directly or
indirectly: (a) amend its charter documents in any manner that materially and adversely affects any
rights of the holders of the Series B Preferred; (b) pay cash dividends or distributions on our
junior securities (including the common stock); or (c) enter into any transaction with any of our
affiliates which would be required to be disclosed in any public filing, unless such transaction is
made on an arms-length basis and expressly approved by a majority of our disinterested directors.
Triggering Events
In the event of a Triggering Event (as defined in the Certificate of Designation and described
below), any holder of Series B Preferred may require us to redeem all of its Series B Preferred, at
a redemption price equal to the greater of (a) 130% of the stated value and (b) the product of (i)
the volume weighted average price on the trading day immediately preceding the date of the
Triggering Event and (ii) the stated value divided by the then Conversion Price, plus all accrued
but unpaid dividends thereon and all liquidated damages and other costs, expenses or amounts due in
respect of the Series B Preferred. Triggering Events include, among other things, bankruptcy
related events, change of control transactions (as defined in the Certificate of Designation), and
various types of failures to perform under, and breaches of, the transaction documents.
Series C Preferred
In 2006, our Board of Directors declared a dividend distribution of one right for each
outstanding share of common stock to stockholders of record at the close of business on May 22,
2006, the record date. Each right entitles the registered holder to purchase from us a unit
consisting of one ten-thousandth of a share of Series C Preferred at a purchase price of $35.00 per
unit, subject to adjustment. The rights are not exercisable until the distribution date and will
expire at 5:00 P.M. (New York City time) on May 12, 2016, unless such date is extended or the
rights are earlier redeemed or exchanged by us. The distribution date occurs upon the earlier of:
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ten business days following a public announcement that a person or group of
affiliated or associated persons has acquired beneficial ownership of 15% or more of
our outstanding common stock (20%, in the case of certain institutional investors)
other than as a result of repurchases of stock by us or certain inadvertent actions by
institutional or certain other stockholders; or |
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ten business days (or such later date as the Board shall determine) following the
commencement of a tender offer or exchange offer that would result in a person or
group becoming an acquiring person. |
Series D Preferred
The Series D Preferred shares were issued in December 2010 in connection with a private
placement of securities. To designate and establish the shares of Series B Preferred, our board of
directors approved, and on December 2, 2010, we filed with the Delaware Secretary of State, a
Certificate of Designation of Preferences, Rights and Limitations of Series D Convertible Preferred
Stock.
Dividends; Rank; Liquidation
Holders of the Series D Preferred are entitled to receive cumulative dividends at the rate per
share (as a percentage of the stated value per share) of 6% per annum (subject to increase in
certain circumstances), payable quarterly in arrears on January 15, April 15, July 15 and October
15, beginning on July 15, 2011. The dividends are payable in cash, or at the Companys option, in
duly authorized, validly issued, fully paid and non-assessable shares of Common Stock equal to 110%
of the cash dividend amount payable on the dividend payment date, or a combination thereof;
provided that the Company may not pay the dividends in shares of Common Stock unless the Company
meets certain conditions described in the Certificate of Designation, including that the resale of
the shares has been registered under the Securities Act of 1933, as amended (the Securities Act)
or is otherwise eligible to be resold pursuant to an exemption from the Securities Act. If the
Company pays the dividend in shares of Common Stock, the Common Stock will be valued for such
purpose at 80% of the average of the volume weighted average price for the 10 consecutive trading
days ending on the trading day that is immediately prior to the dividend payment date.
The Series D Preferred ranks senior to all shares of Common Stock, and junior to the Companys
Series A Convertible Preferred Stock and Series B Convertible Preferred Stock.
Upon any liquidation, dissolution or winding-up of the Company, whether voluntary or
involuntary, the holders of the Series D Preferred shall be entitled to receive out of the assets,
whether capital or surplus, of the Company an amount equal to the stated value of the Common Stock,
plus any accrued and unpaid dividends thereon and any other fees or liquidated damages then due and
owing thereon under the Certificate of Designation, for each share of Series D Preferred before any
distribution or payment shall be made to the holders of any junior securities, and if the assets of
the Company are insufficient to pay in full such amounts, then the entire assets to be distributed
to the holders of the Series D Preferred shall be ratably distributed among the holders in
accordance with the respective amounts that would be payable on such shares if all amounts payable
thereon were paid in full.
Conversion; Conversion Price; Forced Conversion; Optional Redemption
Each share of Series D Preferred is convertible into a number of shares of Common Stock equal
to (1) the stated value of the share ($1,000), divided by (2) $0.50, subject to adjustment as
discussed below (the Conversion Price).
With certain exceptions, if, at any time while the Series D Preferred is outstanding, the
Company sells or grants any option to purchase or sells or grants any right to reprice, or
otherwise disposes of or issues (or announces any sale, grant or any option to purchase or other
disposition), any Common Stock or Common Stock equivalents at an effective price per share that is
lower than the then Conversion Price, then the Conversion Price will be reduced to equal the lower
price. The Conversion Price is also subject to proportional adjustment in the event of any stock
split, stock dividend, reclassification or similar event with respect to the Common Stock.
Commencing six months from the date of the acquisition of the Series D Preferred, if the
volume weighted average price for each of any 20 consecutive trading days exceeds 200% of the then
effective Conversion Price and various other equity conditions are satisfied (including that the
resale of the shares underlying the Series D Preferred has been registered under the Securities
Act), upon 30 days notice, the Series D Preferred plus all accrued and unpaid dividends will
automatically convert into shares of Common Stock.
Commencing two years from the date of the acquisition of the Series D Preferred, upon 30 days
notice and provided various other equity conditions are satisfied (including that the resale of the
shares underlying the Series D Preferred has been registered under the Securities Act), the Company
may redeem some or all of the then outstanding Series D Preferred for cash in an amount equal to
the 150% of the stated value of the Series D Preferred.
Voting
The holders of the Series D Preferred have no voting rights except with respect to specified
matters affecting the rights of the Series D Preferred.
Negative Covenants
As long as any shares of Series D Preferred are outstanding, the Company may not, directly or
indirectly: (a) amend its charter documents in any manner that materially and adversely affects any
rights of the holders of the Series D Preferred; (b) pay cash dividends or distributions on junior
securities of the Company (including the Common Stock); or (c) enter into any transaction with any
affiliate of the Company which would be required to be disclosed in any public filing, unless such
transaction is made on an arms-length basis and expressly approved by a majority of the
disinterested directors of the Company.
Triggering Events
In the event of a Triggering Event (as defined in the Certificate of Designation and described
below), any holder of Series D Preferred may require the Company to redeem all of its Series D
Preferred, at a redemption price equal to the greater of (a) 130% of the stated value and (b) the
product of (i) the volume weighted average price on the trading day immediately preceding the date
of the Triggering Event and (ii) the stated value divided by the then Conversion Price, plus all
accrued but unpaid dividends thereon and all liquidated damages and other costs, expenses or
amounts due in respect of the Series D Preferred. Triggering Events include, among other things,
bankruptcy related events, change of control transactions (as defined in the Certificate of
Designation), and various types of failures to perform under, and breaches of, the transaction
documents.
Warrants
Class A Warrants, Class B Warrants and Placement Agent Warrants
Pursuant to, and contemporaneous with the execution of, the agreement in which we issued the
Series A Preferred, we issued Class A warrants to purchase 501,542 shares of common stock and
Class B warrants to purchase 416,666 shares of common stock to the investors that purchased our
Series A Preferred pursuant to the agreement in which we issued the Series A Preferred. At the same
time we also issued warrants to purchase 250,000
53
shares of common stock to the placement agents for
the Series A Preferred. Each of the warrants is exercisable upon issuance and has a five-year term.
The initial exercise price of the Class A warrants was $1.62 per share, the initial exercise price
of the Class B warrants was $1.95 per share, and the initial exercise price of the warrants issued
to the placement agents was $1.30 per share.
With certain exceptions, the Class A warrants, Class B warrants and placement agent warrants
provide that if at any time while the warrants are outstanding, we sell or grant any option to
purchase or sell or grant any right to reprice, or otherwise dispose of or issue (or announce any
sale, grant or any option to purchase or other disposition), any common stock or common stock
equivalents at an effective price per share that is lower than the then exercise price of the
relevant warrant, then the exercise price of such warrant will be reduced to equal the lower price and the number of shares issuable thereunder
will be increased such that the aggregate exercise price after the exercise price adjustment will
be equal to the aggregate exercise price prior to the
adjustment. As a result of the purchase price of the common
stock sold in the December 2010 and January 2011 private offerings discussed below (a) the exercise prices for the Class A,
Class B and placement agent warrants issued as part of the Series A
Preferred Offering were reduced from $0.60 per share to $0.50 per share and (b) the numbers of shares underlying the
Class A, Class B and placement agent warrants were increased to
1,624,996, 1,624,997, and 650,000, respectively.
March 2010 Private Offering Warrants
We entered a securities purchase agreement dated March 2, 2010 with certain accredited
investors pursuant to which the Company agreed to sell in the aggregate 5,076,664 shares of our
common stock. In addition to the common stock purchased, each investor received a warrant to
purchase the same number of shares of common stock acquired in the offering at an exercise price of
$0.98 per share. Each of the warrants was exercisable immediately and has a five-year term. The
warrants may be exercised on a cash-less basis and are non-redeemable.
With certain exceptions, the warrants provide that if, at any time while the warrants are
outstanding, we sell or grant any option to purchase or sell or grant any right to reprice, or
otherwise dispose of or issue (or announce any sale, grant or any option to purchase or other
disposition), any common stock or common stock equivalents at an effective price per share that is
lower than the then exercise price of the relevant warrant, then the exercise price of such warrant
will be reduced to equal the lower price and the number of shares issuable thereunder will be
increased such that the aggregate exercise price after the exercise price adjustment will be equal
to the aggregate exercise price prior to the adjustment. If we enter into a fundamental
transaction (which term is defined in the warrants), then at the warrant holders option,
exercisable at any time concurrently with, or within 30 days after, the announcement of a
fundamental transaction, we must redeem all or any portion of the warrant from the holder by paying
to the holder an amount of cash equal to the Black Scholes value of the remaining unexercised
portion of this warrant on or prior to the date of the consummation of such fundamental
transaction. Any cash payments to be made pursuant to the preceding sentence shall have priority to
payments to holders of common stock in connection with a fundamental transaction. The assumptions
to be used in calculating the Black Scholes value are set forth in Schedule 1 to the warrant.
As a result of the purchase price of the common stock sold in the
December 2010 and January 2011 private
offerings discussed below (a) the exercise prices for the warrants
and placement agent warrants issued as part of the March 2010 Private Offering were reduced
from $0.60 and $0.50 per share, respectively and (b) the numbers of shares
underlying the warrants and placement agent warrants have been increased to 9,950,261 and
609,200 respectively.
July
through November 2010 Private Offerings Warrants
We
entered securities purchase agreements in July, September, October
and November 2010 with certain accredited
investors pursuant to which we agreed to sell in the aggregate
(i) 4,640 shares of Series B
Convertible Preferred Stock, with a stated value of $1,000 per share, and (ii) warrants to purchase
7,733,333 shares of our common stock at an exercise price of $0.8054 per share. Each of the
warrants was exercisable immediately and has a five-year term. The warrants may be exercised on a
cash-less basis and are non-redeemable.
With certain exceptions, the warrants provide that if, at any time while the warrants are
outstanding, we sell or grant any option to purchase or sell or grant any right to reprice, or
otherwise dispose of or issue (or announce any sale, grant or any option to purchase or other
disposition), any common stock or common stock equivalents at an effective price per share that is
lower than the then exercise price of the relevant warrant, then the exercise price of such warrant
will be reduced to equal the lower price and the number of shares issuable thereunder will be
increased such that the aggregate exercise price after the exercise price adjustment will be equal
to the aggregate exercise price prior to the adjustment. If we enter into a fundamental transaction
(which term is defined in the warrants), then at the warrant holders option, exercisable at any
time concurrently with, or within 30 days after, the announcement of a fundamental transaction, we
must redeem all or any portion of the warrant from the holder by paying to the holder an amount of
cash equal to the Black Scholes value of the remaining unexercised portion of this warrant on or
prior to the date of the consummation of such fundamental transaction. Any cash payments to be made
pursuant to the preceding sentence shall have priority to payments to holders of common stock in
connection with a fundamental transaction. The assumptions to be used in calculating the Black
Scholes value are set forth in Schedule 1 to the warrant. As a result of the purchase price of
the common stock sold in the December 2010 and January 2011 private
offerings discussed below (a) the exercise prices for the warrants and placement agent warrants
issued as part of the July through November 2010 Offerings were reduced from $0.60 per share to
$0.50 per share and (b) the numbers of shares underlying the warrants and placement agent warrants
were increased to 12,456,851 and 708,788, respectively.
December 2010 and January 2011 Private Offering Warrants
In connection with our December 2010 and January 2011 private placements of securities, we issued warrants to
purchase 8,586,000 shares of our common stock at an exercise price of $0.50 per share. Each of the
warrants is exercisable upon issuance and expires on the fifth anniversary of issuance.
With certain exceptions, if, at any time while the warrants are outstanding, we sell or grant
any option to purchase or sell or grant any right to reprice, or otherwise dispose of or issue (or
announces any sale, grant or any option to purchase or other disposition), any common stock or
common stock equivalents at an effective price per share that is lower than the then exercise price
of the relevant warrant, then the exercise price of such warrant will be reduced to equal the lower
price, and the number of shares issuable under the warrant be proportionately increased such that
the aggregate exercise price payable, after taking into account the decrease in the exercise price,
shall be equal to the aggregate exercise price prior to such adjustment. If we enter into a
fundamental transaction (which term is defined in the warrants), then at the warrant holders
option, exercisable at any time concurrently with, or within 30 days after, the announcement of a
fundamental transaction, we must redeem all or any portion of the warrant from the holder by paying
to the holder an amount of cash equal to the Black Scholes value of the remaining unexercised
portion of this warrant on or prior to the date of the consummation of such fundamental
transaction. Any cash payments to be made pursuant to the preceding sentence shall have priority to
payments to holders of common stock in connection with a fundamental transaction. The assumptions
to be used in calculating the Black Scholes value are set forth in Schedule 1 to the warrant.
Registration Rights
In connection with the Series A Preferred purchase agreement, we entered into registration
rights agreements with the purchasers of the Series A Preferred, which requires us to register the
resale of the 110% of the shares of common stock underlying the Series A Preferred and the shares
of common stock underlying the Class A warrants, Class B warrants and placement agent warrant.
In connection with the March 2, 2010 securities purchase agreement, we also entered into
registration rights agreements with the purchasers of the common stock, which requires us to
register the resale of the shares of common stock issued and the shares of common stock underlying
the warrants issued.
In
connection with the July, September, October and November 2010 purchase agreements, we also entered into Registration
Rights Agreements with the purchasers, which requires us to register the resale of the shares of
common stock underlying the Series B Preferred, the shares of common stock underlying the warrants
and, at our option, all shares of common stock issuable as dividends on the Series B Preferred. We
are required to file the registration statement within the time periods set forth in the agreement
and the registration statement must be declared effective within 90 days of filing date (120 days
if the registration statement is fully reviewed by the SEC), or we will be required to pay
liquidated damages as set forth in the agreement.
12.5% Notes
54
In our bankruptcy reorganization plan, each holder of Isolagens 3.5% convertible subordinated
notes, due November 2024, in the approximate non-converted aggregate principal amount of $81
million, received, in full and final satisfaction, settlement, release and discharge of and in
exchange for any and all claims arising out of the 3.5% convertible subordinated notes, its pro
rata share of an unsecured note in the principal amount of $6 million, or the New Notes. The New Notes have the following features:
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12.5% interest payable quarterly in cash or, at our option, 15% payable in kind by
capitalizing such unpaid amount and adding it to the principal as of the date it was
due; |
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mature June 1, 2012; |
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at any time prior to the maturity date, we may redeem any portion of the
outstanding principal of the New Notes in cash at 125% of the stated face value of the
New Notes; provided that we will be obligated to redeem all outstanding New Notes upon
the following events: (a) we or our subsidiary, Fibrocell Technologies, Inc.
(formerly, Isolagen Technologies, Inc.) successfully complete a capital campaign
raising in excess of $10,000,000; or (b) we or our subsidiary, Fibrocell Technologies,
Inc., are acquired by, or sell a majority stake to, an outside party; |
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the New Notes contain customary representations, warranties and covenants,
including a covenant that we and our subsidiary, Fibrocell Technologies, Inc., shall
be prohibited from the incurrence of additional debt without obtaining the consent of
66 2/3% of the New Note holders. |
Anti-Takeover Effects of Provisions of Delaware Law
Provisions of Delaware law and our Certificate of Incorporation, as amended, and Bylaws could
make the acquisition of our company through a tender offer, a proxy contest or other means more
difficult and could make the removal of incumbent officers and directors more difficult. We expect
these provisions to discourage coercive takeover practices and inadequate takeover bids and to
encourage persons seeking to acquire control of our company to first negotiate with our Board of
Directors. We believe that the benefits provided by our ability to negotiate with the proponent of
an unfriendly or unsolicited proposal outweigh the disadvantages of discouraging these proposals.
We believe the negotiation of an unfriendly or unsolicited proposal could result in an improvement
of its terms.
Anti-Takeover Effects of Provisions of Our Charter Documents
Our Certificate of Incorporation, as amended, provides for our Board of Directors to be
divided into three classes serving staggered terms. Approximately one-third of the Board of
Directors will be elected each year. The provision for a classified board could prevent a party who
acquires control of a majority of the outstanding voting stock from obtaining control of the Board
of Directors until the second annual stockholders meeting following the date the acquirer obtains
the controlling stock interest. The classified board provision could discourage a potential
acquirer from making a tender offer or otherwise attempting to obtain control of our company and
could increase the likelihood that incumbent directors will retain their positions.
Our Bylaws do not permit stockholders to call a special meeting of stockholders. Our Bylaws
provide that special meetings of the stockholders may be called only by a majority of the members
of our Board of Directors, our Chairman of the Board of Directors, our Chief Executive Officer or
our President. Our Bylaws require that all stockholder actions be taken by a vote of the
stockholders at an annual or special meeting, and do not permit our stockholders to act by written
consent without a meeting. Our Bylaws provide for an advance notice procedure for stockholder
proposals to be brought before an annual meeting of our stockholders, including proposed
nominations of persons for election to the Board of Directors. At an annual meeting, stockholders
may only consider proposals or nominations specified in the notice of meeting or brought before the
meeting by or at the direction of the Board of Directors. Stockholders may also consider a proposal
or nomination by a person who was a stockholder of record on the record date for the meeting, who
is entitled to vote at the meeting and who has given to our Secretary timely written notice, in
proper form, of his, her or its intention to bring that business before the meeting. The Bylaws do
not give our Board of Directors the power to approve or disapprove stockholder nominations of candidates or proposals regarding other business to be conducted at a special
or annual meeting of the stockholders. However, our
55
Bylaws may have the effect of precluding the
conduct of business at a meeting if the proper procedures are not followed. These provisions may
also discourage or deter a potential acquirer from conducting a solicitation of proxies to elect
the acquirers own slate of directors or otherwise attempting to obtain control of our company.
Listing
Our common stock is listed on the OTCBB under the symbol FCSC.
Transfer Agent
The transfer agent for our common stock is American Stock Transfer & Trust Company located at
59 Maiden Lane, New York, New York 11038.
SHARES ELIGIBLE FOR FUTURE SALE
As
of February 1, 2011, there were approximately 20,490,255 shares of our common stock
outstanding.
Future sales of a substantial number of shares of our common stock in the public market could
adversely affect market prices prevailing from time to time. Under the terms of this prospectus,
the shares of common stock underlying the Series A Preferred and the warrants may be resold without
restriction or further registration under the Securities Act, except that any shares offered by our
affiliates, as that term is defined under the Securities Act, may generally only be sold in
compliance with Rule 144 under the Securities Act.
Shares Covered by this Prospectus
The following shares may be offered for resale under this prospectus:
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up to 6,349,200 shares of common stock representing 110% of the shares
underlying the Series A Preferred we issued in October 2009; |
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up to 1,624,996 shares of common stock underlying Class A warrants issued in the
Series A Preferred offering; |
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up to 1,624,997 shares of common stock underlying Class B warrants issued in the
Series A Preferred offering; and |
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up to 474,500 shares of common stock underlying warrants issued to the placement
agent in the Series A Preferred offering. |
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All of the shares being registered in this offering may be resold by the investors without
restriction under the Securities Act.
Rule 144
The SEC adopted amendments to Rule 144 which became effective on February 15, 2008, and apply
to securities acquired both before and after that date. Under these amendments, a person who has
beneficially owned restricted shares of our common stock for at least six months would be entitled
to sell their securities provided that (i) such person is not deemed to have been one of our
affiliates at the time of, or at any time during the three months preceding, a sale and (ii) we are
subject to the Exchange Act periodic reporting requirements for at least three months before the
sale.
Of
the 20,375,343 shares of our common stock issued and outstanding as
of February 1, 2011, a
total of 600,000 shares are deemed control securities, within the meaning of Rule 144. Absent
registration under the Securities Act, the sale of such shares is subject to Rule 144, as
promulgated under the Securities Act. Similarly, any shares we issue as dividends on the Series A
Preferred are deemed restricted securities under Rule 144 and may
56
only be sold in compliance with
Rule 144. The remainder of our outstanding shares may be sold without limitation or restriction.
Sales under Rule 144 by Affiliates
Persons who have beneficially owned restricted shares of our common stock for at least six
months but who are our affiliates at the time of, or at any time during the three months preceding,
a sale, would be subject to additional restrictions, by which such person would be entitled to sell
within any three-month period only a number of securities that does not exceed the greater of
either of the following:
(a) 1%
of the number of shares of common stock then outstanding, which will
equal 203,753
shares as of the date of this prospectus; or
(b) if the common stock is listed on a national securities exchange, the average weekly
trading volume of the common stock during the four calendar weeks preceding the filing of a notice
on Form 144 with respect to the sale.
However, since our shares are quoted on the OTCBB, our stockholders will not be able to rely
on the market-based volume limitation described in the second bullet above. If, in the future, our
securities are listed on an exchange, then our stockholders would be able to rely on the
market-based volume limitation. Unless and until our stock is so listed or quoted, our stockholders
can only rely on the percentage based volume limitation described in the first bullet above.
Such sales by affiliates must also comply with the manner of sale, current public information
and notice provisions of Rule 144. The selling stockholders will not be governed by the foregoing
restrictions when selling their shares pursuant to this prospectus.
Sales Under Rule 144 by Non-Affiliates
Under Rule 144, a person who is not deemed to have been one of our affiliates at the time of
or at any time during the three months preceding a sale, and who has beneficially owned their
shares proposed to be sold for at least six months, including the holding period of any prior owner
other than an affiliate, is entitled to sell their shares without complying with the manner of sale
and volume limitation or notice provisions of Rule 144. We must be current in our public reporting
if the non-affiliate is seeking to sell under Rule 144 after holding his shares between six months
and one year. After one year, non-affiliates do not have to comply with any other Rule 144
requirements.
The possibility that substantial amounts of our common stock may be sold under Rule 144 into
the public market may adversely affect prevailing market prices for the common stock and could
impair our ability to raise capital in the future through the sale of equity securities.
57
SELLING SECURITY HOLDERS
The following table presents information regarding the Selling Stockholders. The percentage of
outstanding shares beneficially owned is based on 20,490,255 shares of common stock issued and
outstanding on February 1, 2011. Beneficial ownership is determined in accordance with Rule 13d-3
under the Exchange Act. As to each person or entity named as beneficial owners, that persons or
entitys percentage of ownership is determined based on the assumption that any warrants or
convertible securities (such as the Series A Preferred) held by such person or entity which are
exercisable or convertible within 60 days of the date of this report have been exercised or
converted, as the case may be.
The Series A Preferred and warrants each provide that at no time may a holder convert the
Series A Preferred or exercise the warrants if the number of shares of common stock to be issued
pursuant to such conversion or exercise would exceed, when aggregated with all other shares of
common stock owned by such holder at such time, the number of shares of common stock which would
result in such holder beneficially owning (as determined in accordance with Section 13(d) of the
Exchange Act and the rules thereunder) in excess of 9.99% of the then issued and outstanding shares
of our common stock; provided, however, that upon the holder providing us with 61 days notice that
such holder would like to waive this provision then this provision will be of no force or effect;
provided, further, that this provision will be of no force or effect during the 61 days immediately
preceding the expiration of the Series A Preferred or warrant.
The
warrants issued in the July, September, October and November 2010 offerings each provide that at no time may a holder
exercise the warrants if the number of shares of common stock to be issued pursuant to such
exercise would exceed, when aggregated with all other shares of common stock owned by such holder
at such time, the number of shares of common stock which would result in such holder beneficially
owning (as determined in accordance with Section 13(d) of the Exchange Act and the rules
thereunder) in excess of 4.99% of the then issued and outstanding shares of our common stock;
provided, however, that upon not less than 61 days prior notice, the holder may increase or
decrease such percentage, except that such percentage may in no event exceed 9.99%.
Except as may be otherwise described below, to the best of our knowledge, the named Selling
Stockholder beneficially owns and has sole voting and investment authority as to all of the shares
set forth opposite his name, none of the selling stockholders is known to us to be a registered
broker-dealer or an affiliate of a registered broker-dealer, and none of the Selling Stockholders
has not held any position or office, or has had any material relationship with us or any of our
affiliates within the past three years. Each of the Selling Stockholders has acquired his, her or
its shares solely for investment and not with a view to or for resale or distribution of such
securities.
Information with respect to beneficial ownership is based upon information provided to us by
the Selling Stockholders. For purposes of presentation, we have assumed that the Selling
Stockholders will sell all shares offered hereby, including the shares issuable on the exercise of
warrants or conversion of their Series A Preferred.
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No. of |
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No. of |
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No. of |
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Shares of |
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Shares |
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Shares |
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Common |
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No. of |
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Issuable |
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No. of |
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Issuable |
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Stock |
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Shares |
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Upon |
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Shares |
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Upon |
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Beneficially |
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Approximate |
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Issuable |
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Exercise |
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Issuable |
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Exercise of |
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Owned Prior |
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Percentage |
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Upon |
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of the |
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Upon |
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the |
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to the |
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of Issued and |
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Conversion |
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Class A |
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Exercise of |
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Placement |
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Offering |
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Outstanding |
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No. of |
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Approximate |
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of Series A |
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Warrants |
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the Class B |
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Agent |
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(excluding |
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Shares |
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Shares |
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No. of |
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Percentage |
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Preferred |
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Owned |
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Warrants |
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Warrants |
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those set |
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Beneficially |
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Registered |
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Shares to be |
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of Shares to |
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Owned Prior |
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Prior to |
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Owned Prior |
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Owned Prior |
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forth in the |
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Owned Prior |
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and to be |
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Beneficially |
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be Owned |
Name of Selling |
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to the |
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the |
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to the |
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to the |
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prior |
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to the |
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Sold in this |
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Owned After |
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After the |
Stockholders |
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Offering (1) |
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Offering |
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Offering |
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Offering |
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columns) |
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Offering |
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Offering |
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the Offering |
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Offering |
Basu
Biosciences, LLC
(2) |
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200,000 |
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50,000 |
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50,003 |
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468,467 |
(9) |
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3.61 |
% |
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300,002 |
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468,467 |
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2.24 |
% |
MOG Capital, LLC (3) |
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2,000,000 |
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500,000 |
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500,000 |
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1,973,334 |
(10) |
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20.06 |
%(3) |
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2,999,999 |
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1,973,334 |
|
|
|
9.14 |
% |
Ravinder Holder |
|
|
100,001 |
|
|
|
25,001 |
|
|
|
24,999 |
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
|
150,000 |
|
|
|
|
|
|
|
|
|
Straus Healthcare
Partners, L.P. (4) |
|
|
682,001 |
|
|
|
170,499 |
|
|
|
170,501 |
|
|
|
|
|
|
|
1,130,289 |
(10) |
|
|
9.71 |
% |
|
|
1,023,000 |
|
|
|
1,130,289 |
|
|
|
5.35 |
% |
Option
Opportunities Corp. |
|
|
0 |
|
|
|
182,001 |
|
|
|
182,001 |
|
|
|
|
|
|
|
|
|
|
|
1.75 |
% |
|
|
364,002 |
|
|
|
|
|
|
|
|
|
Straus Partners,
L.P. |
|
|
1,090,001 |
|
|
|
272,501 |
|
|
|
272,501 |
|
|
|
|
|
|
|
229,505 |
|
|
|
8.43 |
% |
|
|
1,635,002 |
|
|
|
229,505 |
|
|
|
1.12 |
% |
Bao Ruo Wang |
|
|
375,000 |
|
|
|
93,750 |
|
|
|
93,749 |
|
|
|
|
|
|
|
87,725 |
|
|
|
3.09 |
% |
|
|
562,499 |
|
|
|
87,725 |
|
|
|
|
* |
Chen Zhang |
|
|
375,000 |
|
|
|
93,750 |
|
|
|
93,749 |
|
|
|
|
|
|
|
87,725 |
|
|
|
3.09 |
% |
|
|
562,499 |
|
|
|
87,725 |
|
|
|
|
* |
William Zuo |
|
|
375,000 |
|
|
|
93,750 |
|
|
|
93,749 |
|
|
|
|
|
|
|
87,725 |
|
|
|
3.09 |
% |
|
|
562,499 |
|
|
|
87,725 |
|
|
|
|
* |
Tao Zhou |
|
|
375,000 |
|
|
|
93,750 |
|
|
|
93,749 |
|
|
|
|
|
|
|
87,725 |
|
|
|
3.09 |
% |
|
|
562,499 |
|
|
|
87,725 |
|
|
|
|
* |
Margery M. Scotti |
|
|
200,000 |
|
|
|
50,000 |
|
|
|
50,003 |
|
|
|
|
|
|
|
2,082,741 |
(10) (11) |
|
|
10.87 |
% |
|
|
300,002 |
|
|
|
2,082,741 |
|
|
|
9.63 |
% |
George Carris (7) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
325,001 |
|
|
|
878,289 |
(5) (10) |
|
|
5.64 |
% |
|
|
325,001 |
|
|
|
878,289 |
(5) (10) |
|
|
4.12 |
% |
David Walter Boral
(8) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
162,500 |
|
|
|
287,203 |
(10) (12) |
|
|
2.17 |
% |
|
|
162,500 |
|
|
|
287,203 |
(9) (10) |
|
|
1.38 |
% |
|
|
|
* |
|
Stockholder owns less than 1% |
58
|
|
|
(1) |
|
The Selling Stockholders and any broker-dealers or agents that are involved in selling these
shares are deemed to be underwriters within the meaning of the Securities Act for such sales. An
underwriter is a person who has purchased shares from an issuer with a view towards distributing
the shares to the public. In such event, any commissions received by such broker-dealers or agents
and any profit on the resale of the shares purchased by them may be considered to be underwriting
commissions or discounts under the Securities Act. |
|
(2) |
|
Shekhar Basu, in his capacity as managing member of Basu Biosciences, LLC has voting and
dispositive power over the securities held by Basu Biosciences, LLC. |
|
(3) |
|
MOG Capital, LLC is a registered broker dealer. The registrable securities were acquired in
the ordinary course of business and not as compensation for investment banking services.
Accordingly, the selling security holder is an underwriter within the meaning of Section 2(a)(11)
of the Securities Act under the interpretations of the SEC. Jason Adler, in his capacity as
managing member of MOG Capital, LLC has voting and dispositive power over the securities held by
MOG Capital, LLC. Mr. Adler disclaims beneficial ownership of such securities. Notwithstanding the
percentage set forth in the table above, the Series A Preferred and warrants each provide that at
no time may a holder convert the Series A Preferred or exercise the warrants if the number of
shares of common stock to be issued pursuant to such conversion or exercise would exceed, when
aggregated with all other shares of common stock owned by such holder at such time, the number of
shares of common stock which would result in such holder beneficially owning (as determined in accordance with Section 13(d) of the Exchange Act and the
rules thereunder) in excess of 9.99% of the then issued and outstanding shares of our common stock;
provided, however, that upon the holder providing us with 61 days notice that such holder would
like to waive this provision then this provision will be of no force or effect; provided, further,
that this provision will be of no force or effect during the 61 days immediately preceding the
expiration of the Series A Preferred or warrant. |
|
(4) |
|
Jonathen Blumberg has voting and dispositive power over the
securities held by Option Opportunities Corp. Option Opportunities
Corp.s address is 716 Oak. St., Winnetka, Illinois 60093. |
|
(5) |
|
Includes an option to purchase 300,000 shares of common stock at $0.75 per share, a
warrant to purchase 304,600 shares underlying warrants we agreed to issue to our placement agent in
connection with our March 2010 offering and a warrant to
purchase 175,024 shares underlying warrants we agreed to issue to our
placement agent in connection with our July, September, October and
November 2010 offerings.
Mr. Carris is an affiliate of the placement agent. |
|
(6) |
|
Includes an option to purchase 400,000 shares of common stock
at $0.75 per share, a
warrant to purchase 232,259 shares underlying warrants we agreed to issue to our placement agent in
connection with our March 2010 offering and a warrant to
purchase 144,230 shares underlying warrants we agreed to issue to our
placement agent in connection with our July, September, October and
November 2010 offerings. Mr. Batista is an affiliate of the placement agent. |
|
(7) |
|
The shares being registered underlie warrants we agreed to issue to our placement agent in
connection with the Series A Preferred offering. Mr. Carris is an affiliate of the placement agent. |
59
|
|
|
|
(8) |
|
The shares being registered underlie warrants we agreed to issue to our placement agent in
connection with the Series A Preferred offering. Mr. Boral is an affiliate of the placement agent. |
|
(9) |
|
Includes (i) 200,000 shares of common stock underlying our
Series B Preferred stock issued in our July, September, October and
November 2010 offerings and (ii) Warrants to purchase 268,467 shares
of common stock that were acquired in our July, September, October
and November 2010 offerings. |
|
(10) |
|
Includes shares of common stock acquired pursuant to our March 2, 2010 securities purchase
agreement with certain accredited investors, as well as shares of common stock underlying warrants
acquired pursuant to our March 2, 2010 securities purchase agreement. |
|
(11) |
|
Includes (i) 300,000 shares of common stock underlying our
Series B Preferred stock issued in our July, September, October
and November
2010 private offerings
and (ii) Warrants to purchase 402,700 shares of common stock acquired
in our July, September, October and November 2010 private offerings. |
|
(12) |
|
Includes an option to purchase 100,000 shares of common stock at $0.75 per share, a
warrant to purchase 72,342 shares underlying warrants we agreed to issue to our placement agent in
connection with our March 2010 offering and a warrant to
purchase 77,663 shares underlying warrants we agreed to issue to our
placement agent in connection with our July, September, October and
November 2010 offerings. Mr. Boral is an affiliate of the placement agent. |
We may require the Selling Stockholders to suspend the sales of the securities offered by this
prospectus upon the occurrence of any event that makes any statement in this prospectus or the
related registration statement untrue in any material respect or that requires the changing of
statements in these documents in order to make statements in those documents not misleading.
PLAN OF DISTRIBUTION
Each Selling Stockholder of the common stock and any of their pledgees, assignees and
successors-in-interest may, from time to time, sell any or all of their shares of common stock
covered hereby on the principal trading market or any other stock exchange, market or trading
facility on which the shares are traded or in private transactions. These sales may be at fixed or
negotiated prices. A Selling Stockholder may use any one or more of the following methods when
selling shares:
|
|
|
ordinary brokerage transactions and transactions in which the broker-dealer
solicits purchasers; |
|
|
|
|
block trades in which the broker-dealer will attempt to sell the shares
as agent but may position and resell a portion of the block as principal to facilitate
the transaction; |
|
|
|
|
purchases by a broker-dealer as principal and resale by the broker-dealer
for its account; |
|
|
|
|
an exchange distribution in accordance with the rules of the applicable
exchange; |
|
|
|
|
privately negotiated transactions; |
|
|
|
|
settlement of short sales entered into after the effective date of the registration
statement of which this prospectus is a part; |
|
|
|
|
in transactions through broker-dealers that agree with the Selling
Stockholders to sell a specified number of such shares at a stipulated price per
share; |
|
|
|
|
through the writing or settlement of options or other hedging
transactions, whether through an options exchange or otherwise; |
|
|
|
|
a combination of any such methods of sale; or |
|
|
|
|
any other method permitted pursuant to applicable law. |
The Selling Stockholders may also sell shares under Rule 144 under the Securities Act, if
available, rather than under this prospectus.
60
Broker-dealers engaged by the Selling Stockholders may arrange for other brokers-dealers to
participate in sales. Broker-dealers may receive commissions or discounts from the Selling
Stockholders (or, if any broker-dealer acts as agent for the purchaser of shares, from the
purchaser) in amounts to be negotiated, but, except as set forth in a supplement to this
Prospectus, in the case of an agency transaction not in excess of a customary brokerage commission
in compliance with FINRA Rule 2440; and in the case of a principal transaction a markup or markdown
in compliance with FINRA IM-2440.
In connection with the sale of the common stock or interests therein, the Selling Stockholders
may enter into hedging transactions with broker-dealers or other financial institutions, which may
in turn engage in short sales of the common stock in the course of hedging the positions they
assume. The Selling Stockholders may also sell shares of the common stock short and deliver these
securities to close out their short positions, or loan or pledge the common stock to broker-dealers
that in turn may sell these securities. The Selling Stockholders may also enter into option or
other transactions with broker-dealers or other financial institutions or create one or more
derivative securities which require the delivery to such broker-dealer or other financial institution of shares offered by this prospectus, which shares such
broker-dealer or other financial institution may resell pursuant to this prospectus (as
supplemented or amended to reflect such transaction).
The Selling Stockholders and any broker-dealers or agents that are involved in selling the
shares may be deemed to be underwriters within the meaning of the Securities Act in connection
with such sales. In such event, any commissions received by such broker-dealers or agents and any
profit on the resale of the shares purchased by them may be deemed to be underwriting commissions
or discounts under the Securities Act. Each Selling Stockholder has informed the Company that it
does not have any written or oral agreement or understanding, directly or indirectly, with any
person to distribute the Common Stock. In no event shall any broker-dealer receive fees,
commissions and markups which, in the aggregate, would exceed 8%.
The Company is required to pay certain fees and expenses incurred by the Company incident to
the registration of the shares. The Company has agreed to indemnify the Selling Stockholders
against certain losses, claims, damages and liabilities, including liabilities under the Securities
Act.
Because Selling Stockholders may be deemed to be underwriters within the meaning of the
Securities Act, they will be subject to the prospectus delivery requirements of the Securities Act
including Rule 172 thereunder. The Selling Stockholders have advised us that there is no
underwriter or coordinating broker acting in connection with the proposed sale of the resale shares
by the Selling Stockholders.
We agreed to keep this prospectus effective until the earlier of (i) the date on which the
shares may be resold by the Selling Stockholders without registration and without regard to any
volume or manner-of-sale limitations by reason of Rule 144, without the requirement for the Company
to be in compliance with the current public information under Rule 144 under the Securities Act or
any other rule of similar effect or (ii) all of the shares have been sold pursuant to this
prospectus or Rule 144 under the Securities Act or any other rule of similar effect. The resale
shares will be sold only through registered or licensed brokers or dealers if required under
applicable state securities laws. In addition, in certain states, the resale shares of Common Stock
covered hereby may not be sold unless they have been registered or qualified for sale in the
applicable state or an exemption from the registration or qualification requirement is available
and is complied with.
Under applicable rules and regulations under the Exchange Act, any person engaged in the
distribution of the resale shares may not simultaneously engage in market making activities with
respect to the common stock for the applicable restricted period, as defined in Regulation M, prior
to the commencement of the distribution. In addition, the Selling Stockholders will be subject to
applicable provisions of the Exchange Act and the rules and regulations thereunder, including
Regulation M, which may limit the timing of purchases and sales of shares of the common stock by
the Selling Stockholders or any other person. We will make copies of this prospectus available to
the Selling Stockholders and have informed them of the need to deliver a copy of this prospectus to
each purchaser at or prior to the time of the sale (including by compliance with Rule 172 under the
Securities Act).
61
EXPERTS
The financial statements as of December 31, 2009 (Successor) and 2008 (Predecessor as
described in Note 1 of the notes to the consolidated financial
statements included herein) and for the year ended December 31, 2008 (Predecessor), for the period from January 1,
2009 to August 31, 2009 (Predecessor) and for the period from the Successors inception
(September 1, 2009) through December 31, 2009 and included in this Prospectus and in the
Registration Statement have been so included in reliance on the report of BDO USA, LLP (formerly known as BDO Seidman, LLP), an
independent registered public accounting firm, the report on the financial statements contains an
explanatory paragraph regarding the Companys ability to continue as a going concern, appearing
elsewhere herein and in the Registration Statement, given on the authority of said firm as experts
in auditing and accounting.
WHERE YOU CAN FIND MORE INFORMATION
We have filed with the SEC a registration statement on Form S-1 under the Securities Act with
respect to the common stock offered in this offering. This prospectus does not contain all of the
information set forth in the registration statement. For further information with respect to us and
the common stock offered in this offering, we refer you to the registration statement and to the
attached exhibits. With respect to each such document filed as an exhibit to the registration
statement, we refer you to the exhibit for a more complete description of the matters involved.
You may inspect our registration statement and the attached exhibits without
charge at the public reference facilities maintained by the SEC at 100 F Street, N.E., Washington,
D.C. 20549. You may obtain copies of all or any part of our registration statement from the SEC
upon payment of prescribed fees. You may obtain information on the operation of the public reference room by
calling the SEC at 1-800-SEC-0330.
Our SEC
filings, including the registration statement and the exhibits filed with the registration statement,
are also available from the SECs website at www.sec.gov, which contains reports, proxy
and information statements and other information regarding issuers
that file electronically with the SEC.
62
Fibrocell Science, Inc.
(A Development Stage Company)
Index to Consolidated Financial Statements
|
|
|
|
|
|
|
PAGE |
|
|
|
|
F-2 |
|
|
|
|
|
|
|
|
|
F-3 |
|
|
|
|
|
|
|
|
|
F-4 |
|
|
|
|
|
|
|
|
|
F-5-15 |
|
|
|
|
|
|
|
|
|
F-16-17 |
|
|
|
|
|
|
|
|
|
F-18-42 |
|
|
|
|
|
|
|
|
|
F-43 |
|
|
|
|
|
|
|
|
|
|
|
Three months ended September 30, 2010 (Successor Company), one month ended
September 30, 2009 (Successor Company) and two months ended August 31, 2009
(Predecessor Company) |
|
|
F-44 |
|
|
|
|
|
|
|
|
|
|
|
Nine months ended September 30, 2010 (Successor Company), cumulative period from
inception (September 1, 2009) to September 30, 2010 (Successor Company), one
month ended
September 30, 2009 (Successor Company), eight months ended August 31, 2009
(Predecessor Company) and cumulative period from inception (December 28, 1995) to
August 31, 2009 (Predecessor Company) |
|
|
F-45 |
|
|
|
|
|
|
|
|
|
|
|
From inception (December 28, 1995) to August 31, 2009 (Predecessor Company)
and from inception (September 1, 2009) to September 30, 2010 (Successor
Company) (unaudited) |
|
|
F-46-57 |
|
|
|
|
|
|
|
|
|
|
|
Nine months ended September 30, 2010 (Successor Company), cumulative period from
inception (September 1, 2009) to September 30, 2010 (Successor Company), one month
ended September 30, 2009 (Successor company), eight months ended August 31,
2009 (Predecessor Company) and cumulative period from inception (December 28,
1995) to August 31, 2009 (Predecessor Company) |
|
|
F-58-59 |
|
|
|
|
|
F-60-77 |
|
F-1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Shareholders of Fibrocell Science, Inc. (a development stage company)
Exton, Pennsylvania
We have audited the accompanying consolidated balance sheets of Fibrocell Science, Inc. (in the
development stage) as of December 31, 2009 (Successor) and 2008 (Predecessor as described in
Note 1 of the notes to the consolidated financial statements) and the related consolidated
statements of operations, shareholders equity (deficit) and comprehensive loss, and cash flows for
the year ended December 31, 2008 (Predecessor), for the period from January 1 to August 31, 2009
(Predecessor) and for the period from the Successors inception of operations (September 1, 2009)
through December 31, 2009. We have also audited the statements of shareholders equity (deficit)
for the period from December 28, 1995 (Predecessors inception) to December 31, 2007. These
consolidated financial statements are the responsibility of the Companys management. Our
responsibility is to express an opinion on these financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight
Board (United States). Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material misstatement. The
Company is not required to have, nor were we engaged to perform, an audit of internal control over
financial reporting as of December 31, 2009. Our audit for the four months ended December 31, 2009
(Successor) and eight months ended August 31, 2009 (Predecessor) included consideration of
internal control over financial reporting as a basis for designing audit procedures that are
appropriate in the circumstances, but not for the purpose of expressing an opinion on the
effectiveness of the Companys internal control over financial reporting. Accordingly, we express
no opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and
disclosures in the financial statements, assessing the accounting principles used and significant
estimates made by management, as well as evaluating the overall financial statement presentation.
We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all
material respects, the financial position of Fibrocell Science, Inc. at December 31, 2009
(Successor) and 2008 (Predecessor), and the results of its operations and its cash flows for
the year ended December 31, 2008 (Predecessor), for the period from January 1 to August 31, 2009
(Predecessor) and for the period from the Successors inception of operations (September 1, 2009)
through December 31, 2009 and the statements of shareholders equity (deficit) for the period from
December 28, 1995 (Predecessors inception) to August 31, 2009 and for the period from the
Successors inception of operations (September 1, 2009) through December 31, 2009, in conformity
with accounting principles generally accepted in the United States of America.
The accompanying financial statements have been prepared assuming that the Company will continue as
a going concern. As discussed in Note 3 to the financial statements, the Company has suffered
recurring losses from operations, has a net capital deficit, and has limited cash resources that
raise substantial doubt about its ability to continue as a going concern. Managements plan in
regard to these matters is also described in Note 3. The financial statements do not include any
adjustments that might result from the outcome of this uncertainty.
/s/ BDO USA, LLP (formerly known as BDO Seidman, LLP)
Houston, Texas
March 31, 2010
F-2
Fibrocell Science, Inc.
(A Development Stage Company)
Consolidated Balance Sheets
|
|
|
|
|
|
|
|
|
|
|
|
Successor |
|
|
|
Predecessor |
|
|
|
December 31, |
|
|
|
December 31, |
|
|
|
2009 |
|
|
|
2008 |
|
Assets |
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
1,362,488 |
|
|
|
$ |
2,854,300 |
|
Accounts receivable, net |
|
|
269,759 |
|
|
|
|
338,850 |
|
Inventory, net |
|
|
226,032 |
|
|
|
|
467,246 |
|
Prepaid expenses |
|
|
524,814 |
|
|
|
|
738,652 |
|
Other current assets |
|
|
|
|
|
|
|
624,365 |
|
Current assets of discontinued operations, net |
|
|
210 |
|
|
|
|
29,992 |
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
2,383,303 |
|
|
|
|
5,053,405 |
|
Other assets |
|
|
250 |
|
|
|
|
|
|
Intangible assets |
|
|
6,340,656 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
8,724,209 |
|
|
|
$ |
5,053,405 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities, Redeemable Preferred Stock, Shareholders Deficit and
Noncontrolling Interest |
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
Current debt |
|
$ |
47,795 |
|
|
|
$ |
90,072,286 |
|
Accounts payable |
|
|
245,023 |
|
|
|
|
415,909 |
|
Accrued expenses |
|
|
536,855 |
|
|
|
|
1,647,713 |
|
Deferred revenue |
|
|
|
|
|
|
|
7,522 |
|
Current liabilities of discontinued operations |
|
|
7,405 |
|
|
|
|
209,458 |
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
837,078 |
|
|
|
|
92,352,888 |
|
Long-term debt |
|
|
6,000,060 |
|
|
|
|
|
|
Deferred tax liability |
|
|
2,500,000 |
|
|
|
|
|
|
Warrant liability |
|
|
635,276 |
|
|
|
|
|
|
Other long-term liabilities |
|
|
369,210 |
|
|
|
|
1,171,638 |
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
10,341,624 |
|
|
|
|
93,524,526 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies (see Note 13) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Redeemable preferred stock series A, $1,000 par value; 9,000 shares
authorized; 3,250 shares issued |
|
|
2,511,070 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
|
|
|
Fibrocell Science, Inc. shareholders deficit: |
|
|
|
|
|
|
|
|
|
Predecessor common stock, $.001 par value; 100,000,000 shares
authorized |
|
|
|
|
|
|
|
41,639 |
|
Successor common stock, $.001 par value; 250,000,000 shares authorized |
|
|
14,692 |
|
|
|
|
|
|
Additional paid-in capital |
|
|
508,347 |
|
|
|
|
131,341,227 |
|
Predecessor treasury stock, at cost, 4,000,000 shares |
|
|
|
|
|
|
|
(25,974,000 |
) |
Accumulated deficit during development stage |
|
|
(5,049,999 |
) |
|
|
|
(194,057,337 |
) |
|
|
|
|
|
|
|
|
Total Fibrocell Science, Inc. shareholders deficit |
|
|
(4,526,960 |
) |
|
|
|
(88,648,471 |
) |
|
|
|
|
|
|
|
|
Noncontrolling interest |
|
|
398,475 |
|
|
|
|
177,350 |
|
|
|
|
|
|
|
|
|
Total deficit and noncontrolling interest |
|
|
(4,128,485 |
) |
|
|
|
(88,471,121 |
) |
|
|
|
|
|
|
|
|
Total liabilities, redeemable preferred stock, shareholders deficit and
noncontrolling interest |
|
$ |
8,724,209 |
|
|
|
$ |
5,053,405 |
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
F-3
Fibrocell Science, Inc.
(A Development Stage Company)
Consolidated Statements of Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor |
|
|
|
Predecessor |
|
|
Predecessor |
|
|
Predecessor |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
from December 28, |
|
|
|
For the four |
|
|
|
For the eight |
|
|
|
|
|
1995 (date of |
|
|
|
months ended |
|
|
|
months ended |
|
|
For the year ended |
|
|
inception) to |
|
|
|
December 31, 2009 |
|
|
|
August 31, 2009 |
|
|
December 31, 2008 |
|
|
August 31, 2009 |
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
329,941 |
|
|
|
$ |
538,620 |
|
|
$ |
1,104,885 |
|
|
$ |
4,818,994 |
|
License fees |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
260,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
|
329,941 |
|
|
|
|
538,620 |
|
|
|
1,104,885 |
|
|
|
5,078,994 |
|
Cost of sales |
|
|
182,048 |
|
|
|
|
424,139 |
|
|
|
602,511 |
|
|
|
2,279,335 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
147,893 |
|
|
|
|
114,481 |
|
|
|
502,374 |
|
|
|
2,799,659 |
|
Impairment of long-lived assets |
|
|
|
|
|
|
|
|
|
|
|
6,732,754 |
|
|
|
6,732,754 |
|
Selling, general and administrative expenses |
|
|
2,708,356 |
|
|
|
|
3,427,374 |
|
|
|
8,499,307 |
|
|
|
78,072,766 |
|
Research and development expenses |
|
|
1,823,196 |
|
|
|
|
2,107,718 |
|
|
|
10,173,117 |
|
|
|
56,269,869 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(4,383,659 |
) |
|
|
|
(5,420,611 |
) |
|
|
(24,902,804 |
) |
|
|
(138,275,730 |
) |
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
1 |
|
|
|
|
248 |
|
|
|
181,514 |
|
|
|
6,989,539 |
|
Reorganization items, net |
|
|
(72,477 |
) |
|
|
|
73,538,984 |
|
|
|
|
|
|
|
73,538,984 |
|
Other income/(expense) |
|
|
|
|
|
|
|
(6,243 |
) |
|
|
|
|
|
|
316,338 |
|
Warrant expense |
|
|
(319,084 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(247,174 |
) |
|
|
|
(2,232,138 |
) |
|
|
(3,899,239 |
) |
|
|
(18,790,218 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income/(loss) from continuing operations before income taxes |
|
|
(5,022,393 |
) |
|
|
|
65,880,240 |
|
|
|
(28,620,529 |
) |
|
|
(76,221,087 |
) |
Income tax benefit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
190,754 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income/(loss) from continuing operations |
|
|
(5,022,393 |
) |
|
|
|
65,880,240 |
|
|
|
(28,620,529 |
) |
|
|
(76,030,333 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income/(loss) from discontinued operations, net of tax |
|
|
(12,113 |
) |
|
|
|
46,923 |
|
|
|
(4,471,326 |
) |
|
|
(41,091,311 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss)/income |
|
|
(5,034,506 |
) |
|
|
|
65,927,163 |
|
|
|
(33,091,855 |
) |
|
|
(117,121,644 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deemed dividend associated with beneficial conversion |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(11,423,824 |
) |
Preferred stock dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,589,861 |
) |
Plus/(less): Net loss/(income) attributable to noncontrolling interest |
|
|
(15,493 |
) |
|
|
|
(205,632 |
) |
|
|
1,680,676 |
|
|
|
1,799,523 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income/(loss) attributable to Fibrocell Science, Inc. common
shareholders |
|
$ |
(5,049,999 |
) |
|
|
$ |
65,721,531 |
|
|
$ |
(31,411,179 |
) |
|
$ |
(128,335,806 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Per share information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income/(loss) from continuing operationsbasic and diluted |
|
$ |
(0.35 |
) |
|
|
$ |
1.72 |
|
|
$ |
(0.72 |
) |
|
$ |
(4.30 |
) |
Loss from discontinued operationsbasic and diluted |
|
|
|
|
|
|
|
|
|
|
|
(0.12 |
) |
|
|
(2.32 |
) |
Income attributable to noncontrolling interest |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0.10 |
|
Deemed dividend associated with beneficial conversion of preferred stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(0.65 |
) |
Preferred stock dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(0.09 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income/(loss) attributable to common shareholders per common
sharebasic and diluted |
|
$ |
(0.35 |
) |
|
|
$ |
1.72 |
|
|
$ |
(0.84 |
) |
|
$ |
(7.26 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of basic and diluted common shares outstanding |
|
|
14,380,381 |
|
|
|
|
38,230,886 |
|
|
|
37,639,492 |
|
|
|
17,678,219 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are
an integral part of these consolidated financial statements.
F-4
Fibrocell Science, Inc.
(A Development Stage Company)
Consolidated Statements of Shareholders Equity (Deficit) and Comprehensive Income (Loss)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Series A |
|
|
Series B |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Deficit |
|
|
Total |
|
|
|
Preferred Stock |
|
|
Preferred Stock |
|
|
Common Stock |
|
|
Additional |
|
|
Treasury Stock |
|
|
Other |
|
|
During |
|
|
Shareholders |
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Paid-In |
|
|
Number of |
|
|
|
|
|
|
Comprehensive |
|
|
Development |
|
|
Equity |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Shares |
|
|
Amount |
|
|
Income |
|
|
Stage |
|
|
(Deficit) |
|
Issuance of common stock for
cash on 12/28/95 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
2,285,291 |
|
|
$ |
2,285 |
|
|
$ |
(1,465 |
) |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
820 |
|
Issuance of common stock for
cash on 11/7/96 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,149 |
|
|
|
11 |
|
|
|
49,989 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
50,000 |
|
Issuance of common stock for
cash on 11/29/96 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,230 |
|
|
|
2 |
|
|
|
9,998 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
Issuance of common stock for
cash on 12/19/96 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,690 |
|
|
|
7 |
|
|
|
29,993 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
30,000 |
|
Issuance of common stock for
cash on 12/26/96 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,148 |
|
|
|
11 |
|
|
|
49,989 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
50,000 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(270,468 |
) |
|
|
(270,468 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, 12/31/96 (Predecessor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
2,316,508 |
|
|
$ |
2,316 |
|
|
$ |
138,504 |
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
(270,468 |
) |
|
$ |
(129,648 |
) |
Issuance of common stock for
cash on 12/27/97 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
21,182 |
|
|
|
21 |
|
|
|
94,979 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
95,000 |
|
Issuance of common stock for
services on 9/1/97 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,148 |
|
|
|
11 |
|
|
|
36,249 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
36,260 |
|
Issuance of common stock for
services on 12/28/97 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
287,193 |
|
|
|
287 |
|
|
|
9,968 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,255 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(52,550 |
) |
|
|
(52,550 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance,
12/31/97 (Predecessor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
2,636,031 |
|
|
$ |
2,635 |
|
|
$ |
279,700 |
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
(323,018 |
) |
|
$ |
(40,683 |
) |
The accompanying notes are an integral part of these consolidated financial statements.
F-5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Series A |
|
|
Series B |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Deficit |
|
|
Total |
|
|
|
Preferred Stock |
|
|
Preferred Stock |
|
|
Common Stock |
|
|
Additional |
|
|
Treasury Stock |
|
|
Other |
|
|
During |
|
|
Shareholders |
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Paid-In |
|
|
Number of |
|
|
|
|
|
|
Comprehensive |
|
|
Development |
|
|
Equity |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Shares |
|
|
Amount |
|
|
Income |
|
|
Stage |
|
|
(Deficit) |
|
Issuance of common
stock for cash on
8/23/98 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
4,459 |
|
|
$ |
4 |
|
|
$ |
20,063 |
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
20,067 |
|
Repurchase of
common stock on
9/29/98 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,400 |
|
|
|
(50,280 |
) |
|
|
|
|
|
|
|
|
|
|
(50,280 |
) |
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(195,675 |
) |
|
|
(195,675 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, 12/31/98
(Predecessor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
2,640,490 |
|
|
$ |
2,639 |
|
|
$ |
299,763 |
|
|
|
2,400 |
|
|
$ |
(50,280 |
) |
|
$ |
|
|
|
$ |
(518,693 |
) |
|
$ |
(266,571 |
) |
Issuance of
common stock for
cash on 9/10/99 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
52,506 |
|
|
|
53 |
|
|
|
149,947 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
150,000 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,306,778 |
) |
|
|
(1,306,778 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, 12/31/99
(Predecessor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
2,692,996 |
|
|
$ |
2,692 |
|
|
$ |
449,710 |
|
|
|
2,400 |
|
|
$ |
(50,280 |
) |
|
$ |
|
|
|
$ |
(1,825,471 |
) |
|
$ |
(1,423,349 |
) |
Issuance of
common stock for
cash on 1/18/00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
53,583 |
|
|
|
54 |
|
|
|
1,869 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,923 |
|
Issuance of
common stock for
services on
3/1/00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
68,698 |
|
|
|
69 |
|
|
|
(44 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25 |
|
Issuance of
common stock for
services on
4/4/00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
27,768 |
|
|
|
28 |
|
|
|
(18 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(807,076 |
) |
|
|
(807,076 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, 12/31/00
(Predecessor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
2,843,045 |
|
|
$ |
2,843 |
|
|
$ |
451,517 |
|
|
|
2,400 |
|
|
$ |
(50,280 |
) |
|
$ |
|
|
|
$ |
(2,632,547 |
) |
|
$ |
(2,228,467 |
) |
The accompanying notes are an integral part of these consolidated financial statements.
F-6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Series A |
|
|
Series B |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Deficit |
|
|
Total |
|
|
|
Preferred Stock |
|
|
Preferred Stock |
|
|
Common Stock |
|
|
Additional |
|
|
Treasury Stock |
|
|
Other |
|
|
During |
|
|
Shareholders |
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Paid-In |
|
|
Number of |
|
|
|
|
|
|
Comprehensive |
|
|
Development |
|
|
Equity |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Shares |
|
|
Amount |
|
|
Income |
|
|
Stage |
|
|
(Deficit) |
|
Issuance of common
stock for services
on 7/1/01 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
156,960 |
|
|
$ |
157 |
|
|
$ |
(101 |
) |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
56 |
|
Issuance of common
stock for services
on 7/1/01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
125,000 |
|
|
|
125 |
|
|
|
(80 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
45 |
|
Issuance of common
stock for
capitalization of
accrued salaries on
8/10/01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
70,000 |
|
|
|
70 |
|
|
|
328,055 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
328,125 |
|
Issuance of common
stock for
conversion of
convertible debt on
8/10/01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,750,000 |
|
|
|
1,750 |
|
|
|
1,609,596 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,611,346 |
|
Issuance of common
stock for
conversion of
convertible
shareholder notes
payable on 8/10/01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
208,972 |
|
|
|
209 |
|
|
|
135,458 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
135,667 |
|
Issuance of common
stock for bridge
financing on
8/10/01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
300,000 |
|
|
|
300 |
|
|
|
(192 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
108 |
|
Retirement of
treasury stock on
8/10/01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(50,280 |
) |
|
|
(2,400 |
) |
|
|
50,280 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common
stock for net
assets of Gemini on
8/10/01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,942,400 |
|
|
|
3,942 |
|
|
|
(3,942 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common
stock for net
assets of AFH on
8/10/01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,899,547 |
|
|
|
3,900 |
|
|
|
(3,900 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common
stock for cash on
8/10/01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,346,669 |
|
|
|
1,347 |
|
|
|
2,018,653 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,020,000 |
|
Transaction and
fund raising
expenses on 8/10/01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(48,547 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(48,547 |
) |
Issuance of common
stock for services
on 8/10/01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
60,000 |
|
|
|
60 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
60 |
|
Issuance of common
stock for cash on
8/28/01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
26,667 |
|
|
|
27 |
|
|
|
39,973 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
40,000 |
|
Issuance of common
stock for services
on 9/30/01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
314,370 |
|
|
|
314 |
|
|
|
471,241 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
471,555 |
|
The accompanying notes are an integral part of these consolidated financial statements.
F-7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Series A |
|
|
Series B |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Deficit |
|
|
Total |
|
|
|
Preferred Stock |
|
|
Preferred Stock |
|
|
Common Stock |
|
|
Additional |
|
|
Treasury Stock |
|
|
Other |
|
|
During |
|
|
Shareholders |
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Paid-In |
|
|
Number of |
|
|
|
|
|
|
Comprehensive |
|
|
Development |
|
|
Equity |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Shares |
|
|
Amount |
|
|
Income |
|
|
Stage |
|
|
(Deficit) |
|
Uncompensated contribution of
services3rd quarter |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
55,556 |
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
55,556 |
|
Issuance of common stock for
services on 11/1/01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
145,933 |
|
|
|
146 |
|
|
|
218,754 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
218,900 |
|
Uncompensated contribution of
services4th quarter |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,652,004 |
) |
|
|
(1,652,004 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, 12/31/01 (Predecessor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
15,189,563 |
|
|
$ |
15,190 |
|
|
$ |
5,321,761 |
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
(4,284,551 |
) |
|
$ |
1,052,400 |
|
Uncompensated contribution of
services1st quarter |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
Issuance of preferred stock
for cash on 4/26/02 |
|
|
905,000 |
|
|
|
905 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,817,331 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,818,236 |
|
Issuance of preferred stock
for cash on 5/16/02 |
|
|
890,250 |
|
|
|
890 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,772,239 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,773,129 |
|
Issuance of preferred stock
for cash on 5/31/02 |
|
|
795,000 |
|
|
|
795 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,473,380 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,474,175 |
|
Issuance of preferred stock
for cash on 6/28/02 |
|
|
229,642 |
|
|
|
230 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
712,991 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
713,221 |
|
Uncompensated contribution of
services2nd quarter |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
Issuance of preferred stock
for cash on 7/15/02 |
|
|
75,108 |
|
|
|
75 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
233,886 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
233,961 |
|
Issuance of common stock for
cash on 8/1/02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
38,400 |
|
|
|
38 |
|
|
|
57,562 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
57,600 |
|
Issuance of warrants for
services on 9/06/02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
103,388 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
103,388 |
|
Uncompensated contribution of
services3rd quarter |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
Uncompensated contribution of
services4th quarter |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
Issuance of preferred stock
for dividends |
|
|
143,507 |
|
|
|
144 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
502,517 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(502,661 |
) |
|
|
|
|
Deemed dividend associated
with beneficial conversion of
preferred stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,178,944 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(10,178,944 |
) |
|
|
|
|
Comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,433,055 |
) |
|
|
(5,433,055 |
) |
Other comprehensive income,
foreign currency translation
adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,875 |
|
|
|
|
|
|
|
13,875 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,419,180 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, 12/31/02 (Predecessor) |
|
|
3,038,507 |
|
|
$ |
3,039 |
|
|
|
|
|
|
$ |
|
|
|
|
15,227,963 |
|
|
$ |
15,228 |
|
|
$ |
25,573,999 |
|
|
|
|
|
|
$ |
|
|
|
$ |
13,875 |
|
|
$ |
(20,399,211 |
) |
|
$ |
5,206,930 |
|
The accompanying notes are an integral part of these consolidated financial statements.
F-8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Series A |
|
|
Series B |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Deficit |
|
|
Total |
|
|
|
Preferred Stock |
|
|
Preferred Stock |
|
|
Common Stock |
|
|
Additional |
|
|
Treasury Stock |
|
|
Other |
|
|
During |
|
|
Shareholders |
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Paid-In |
|
|
Number of |
|
|
|
|
|
|
Comprehensive |
|
|
Development |
|
|
Equity |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Shares |
|
|
Amount |
|
|
Income |
|
|
Stage |
|
|
(Deficit) |
|
Issuance of common stock for
cash on 1/7/03 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
61,600 |
|
|
$ |
62 |
|
|
$ |
92,338 |
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
92,400 |
|
Issuance of common stock for
patent pending acquisition on
3/31/03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
|
|
100 |
|
|
|
539,900 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
540,000 |
|
Cancellation of common stock
on 3/31/03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(79,382 |
) |
|
|
(79 |
) |
|
|
(119,380 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(119,459 |
) |
Uncompensated contribution of
services1st quarter |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
Issuance of preferred stock
for cash on 5/9/03 |
|
|
|
|
|
|
|
|
|
|
110,250 |
|
|
|
110 |
|
|
|
|
|
|
|
|
|
|
|
2,773,218 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,773,328 |
|
Issuance of preferred stock
for cash on 5/16/03 |
|
|
|
|
|
|
|
|
|
|
45,500 |
|
|
|
46 |
|
|
|
|
|
|
|
|
|
|
|
1,145,704 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,145,750 |
|
Conversion of preferred stock
into common stock2nd qtr |
|
|
(70,954 |
) |
|
|
(72 |
) |
|
|
|
|
|
|
|
|
|
|
147,062 |
|
|
|
147 |
|
|
|
40,626 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
40,701 |
|
Conversion of warrants into
common stock2nd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
114,598 |
|
|
|
114 |
|
|
|
(114 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Uncompensated contribution of
services2nd quarter |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
Issuance of preferred stock
dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,087,200 |
) |
|
|
(1,087,200 |
) |
Deemed dividend associated
with beneficial conversion of
preferred stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,244,880 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,244,880 |
) |
|
|
|
|
Issuance of common stock for
cash3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
202,500 |
|
|
|
202 |
|
|
|
309,798 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
310,000 |
|
Issuance of common stock for
cash on 8/27/03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,359,331 |
|
|
|
3,359 |
|
|
|
18,452,202 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,455,561 |
|
Conversion of preferred stock
into common
stock3rd qtr |
|
|
(2,967,553 |
) |
|
|
(2,967 |
) |
|
|
(155,750 |
) |
|
|
(156 |
) |
|
|
7,188,793 |
|
|
|
7,189 |
|
|
|
(82,875 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(78,809 |
) |
Conversion of warrants into
common stock3rd
qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
212,834 |
|
|
|
213 |
|
|
|
(213 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Compensation expense on
warrants issued to
non-employees |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
412,812 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
412,812 |
|
Issuance of common stock for
cash4th qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
136,500 |
|
|
|
137 |
|
|
|
279,363 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
279,500 |
|
Conversion of warrants into
common stock4th
qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
393 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(11,268,294 |
) |
|
|
(11,268,294 |
) |
Other comprehensive income,
foreign currency translation
adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
360,505 |
|
|
|
|
|
|
|
360,505 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(10,907,789 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, 12/31/03 (Predecessor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
26,672,192 |
|
|
$ |
26,672 |
|
|
$ |
50,862,258 |
|
|
|
|
|
|
$ |
|
|
|
$ |
374,380 |
|
|
$ |
(33,999,585 |
) |
|
$ |
17,263,725 |
|
The accompanying notes are an integral part of these consolidated financial statements.
F-9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Series A |
|
|
Series B |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Deficit |
|
|
Total |
|
|
|
Preferred Stock |
|
|
Preferred Stock |
|
|
Common Stock |
|
|
Additional |
|
|
Treasury Stock |
|
|
Other |
|
|
During |
|
|
Shareholders |
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Paid-In |
|
|
Number of |
|
|
|
|
|
|
Comprehensive |
|
|
Development |
|
|
Equity |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Shares |
|
|
Amount |
|
|
Income |
|
|
Stage |
|
|
(Deficit) |
|
Conversion of warrants into common
stock1st qtr |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
78,526 |
|
|
$ |
79 |
|
|
$ |
(79 |
) |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Issuance of common stock for cash in
connection with exercise of stock
options1st qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15,000 |
|
|
|
15 |
|
|
|
94,985 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
95,000 |
|
Issuance of common stock for cash in
connection with exercise of
warrants1st qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,000 |
|
|
|
4 |
|
|
|
7,716 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,720 |
|
Compensation expense on options and warrants
issued to non-employees and
directors1st qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,410,498 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,410,498 |
|
Issuance of common stock in connection with
exercise of warrants2nd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
51,828 |
|
|
|
52 |
|
|
|
(52 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock for
cash2nd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,200,000 |
|
|
|
7,200 |
|
|
|
56,810,234 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
56,817,434 |
|
Compensation expense on options and warrants
issued to non-employees and
directors2nd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
143,462 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
143,462 |
|
Issuance of common stock in connection with
exercise of warrants3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,431 |
|
|
|
7 |
|
|
|
(7 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock for cash in
connection with exercise of stock
options3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
110,000 |
|
|
|
110 |
|
|
|
189,890 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
190,000 |
|
Issuance of common stock for cash in
connection with exercise of
warrants3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
28,270 |
|
|
|
28 |
|
|
|
59,667 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
59,695 |
|
Compensation expense on options and warrants
issued to non-employees and
directors3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
229,133 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
229,133 |
|
Issuance of common stock in connection with
exercise of warrants4th qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
27,652 |
|
|
|
28 |
|
|
|
(28 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Compensation expense on options and warrants
issued to non-employees, employees, and
directors4th qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
127,497 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
127,497 |
|
Purchase of treasury stock4th qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,000,000 |
|
|
|
(25,974,000 |
) |
|
|
|
|
|
|
|
|
|
|
(25,974,000 |
) |
Comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(21,474,469 |
) |
|
|
(21,474,469 |
) |
Other comprehensive income, foreign currency
translation adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
79,725 |
|
|
|
|
|
|
|
79,725 |
|
Other comprehensive income, net unrealized
gain on available-for-sale investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,005 |
|
|
|
|
|
|
|
10,005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(21,384,739 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, 12/31/04 (Predecessor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
34,194,899 |
|
|
$ |
34,195 |
|
|
$ |
109,935,174 |
|
|
|
4,000,000 |
|
|
$ |
(25,974,000 |
) |
|
$ |
464,110 |
|
|
$ |
(55,474,054 |
) |
|
$ |
28,985,425 |
|
The accompanying notes are an integral part of these consolidated financial statements.
F-10
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Series A |
|
|
Series B |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Deficit |
|
|
Total |
|
|
|
Preferred Stock |
|
|
Preferred Stock |
|
|
Common Stock |
|
|
Additional |
|
|
Treasury Stock |
|
|
Other |
|
|
During |
|
|
Shareholders |
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Paid-In |
|
|
Number of |
|
|
|
|
|
|
Comprehensive |
|
|
Development |
|
|
Equity |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Shares |
|
|
Amount |
|
|
Income (Loss) |
|
|
Stage |
|
|
(Deficit) |
|
Issuance of common stock for
cash in connection with
exercise of stock
options1st qtr |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
25,000 |
|
|
$ |
25 |
|
|
$ |
74,975 |
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
75,000 |
|
Compensation expense on
options and warrants issued to
non-employees1st
qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
33,565 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
33,565 |
|
Conversion of warrants into
common stock2nd
qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
27,785 |
|
|
|
28 |
|
|
|
(28 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Compensation expense on
options and warrants issued to
non-employees2nd
qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(61,762 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(61,762 |
) |
Compensation expense on
options and warrants issued to
non-employees3rd
qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(137,187 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(137,187 |
) |
Conversion of warrants into
common stock3rd
qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,605 |
|
|
|
12 |
|
|
|
(12 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Compensation expense on
options and warrants issued to
non-employees4th
qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,844 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,844 |
|
Compensation expense on
acceleration of
options4th qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,950 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,950 |
|
Compensation expense on
restricted stock award issued
to employee4th
qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
606 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
606 |
|
Conversion of predecessor
company shares |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
94 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(35,777,584 |
) |
|
|
(35,777,584 |
) |
Other comprehensive loss,
foreign currency translation
adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,372,600 |
) |
|
|
|
|
|
|
(1,372,600 |
) |
Foreign exchange gain on
substantial liquidation of
foreign entity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
133,851 |
|
|
|
|
|
|
|
133,851 |
|
Other comprehensive loss, net
unrealized gain on
available-for-sale investments. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(10,005 |
) |
|
|
|
|
|
|
(10,005 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(37,026,338 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, 12/31/05 (Predecessor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
34,260,383 |
|
|
$ |
34,260 |
|
|
$ |
109,879,125 |
|
|
|
4,000,000 |
|
|
$ |
(25,974,000 |
) |
|
$ |
(784,644 |
) |
|
$ |
(91,251,638 |
) |
|
$ |
(8,096,897 |
) |
The accompanying notes are an integral part of these consolidated financial statements.
F-11
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
Series A |
|
|
Series B |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Deficit |
|
|
|
|
|
|
Total |
|
|
|
Preferred Stock |
|
|
Preferred Stock |
|
|
Common Stock |
|
|
Additional |
|
|
Treasury Stock |
|
|
Other |
|
|
During |
|
|
|
|
|
|
Shareholders |
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Paid-In |
|
|
Number of |
|
|
|
|
|
|
Comprehensive |
|
|
Development |
|
|
Noncontrolling |
|
|
Equity |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Shares |
|
|
Amount |
|
|
Income |
|
|
Stage |
|
|
Interest |
|
|
(Deficit) |
|
Compensation expense on options
and warrants issued to
non-employees1st
qtr |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
42,810 |
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
42,810 |
|
Compensation expense on option
awards issued to employees and
directors1st qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
46,336 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
46,336 |
|
Compensation expense on
restricted stock issued to
employees1st qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
128,750 |
|
|
|
129 |
|
|
|
23,368 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
23,497 |
|
Compensation expense on options
and warrants issued to
non-employees2nd
qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
96,177 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
96,177 |
|
Compensation expense on option
awards issued to employees and
directors2nd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
407,012 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
407,012 |
|
Compensation expense on
restricted stock to
employees2nd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,210 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,210 |
|
Cancellation of unvested
restricted stock
2nd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(97,400 |
) |
|
|
(97 |
) |
|
|
97 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock for
cash in connection with
exercise of stock
options2nd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
10 |
|
|
|
16,490 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16,500 |
|
Compensation expense on options
and warrants issued to
non-employees3rd
qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,627 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,627 |
|
Compensation expense on option
awards issued to employees and
directors3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
389,458 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
389,458 |
|
Compensation expense on
restricted stock to
employees3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,605 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,605 |
|
Issuance of common stock for
cash in connection with
exercise of stock
options3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
76,000 |
|
|
|
76 |
|
|
|
156,824 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
156,900 |
|
Acquisition of Agera |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,182,505 |
|
|
|
2,182,505 |
|
Compensation expense on options
and warrants issued to
non-employees4th
qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
34,772 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
34,772 |
|
Compensation expense on option
awards issued to employees and
directors4th qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
390,547 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
390,547 |
|
Compensation expense on
restricted stock to
employees4th qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88 |
|
Cancellation of unvested
restricted stock
award4th qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(15,002 |
) |
|
|
(15 |
) |
|
|
15 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(35,821,406 |
) |
|
|
(78,132 |
) |
|
|
(35,899,538 |
) |
Other comprehensive gain,
foreign currency translation
adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
657,182 |
|
|
|
|
|
|
|
|
|
|
|
657,182 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(35,242,356 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance 12/31/06 (Predecessor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
34,362,731 |
|
|
$ |
34,363 |
|
|
$ |
111,516,561 |
|
|
|
4,000,000 |
|
|
$ |
(25,974,000 |
) |
|
$ |
(127,462 |
) |
|
$ |
(127,073,044 |
) |
|
$ |
2,104,373 |
|
|
$ |
(39,519,209 |
) |
The accompanying notes are an integral part of these consolidated financial statements.
F-12
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
Series A |
|
|
Series B |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Deficit |
|
|
|
|
|
|
Total |
|
|
|
Preferred Stock |
|
|
Preferred Stock |
|
|
Common Stock |
|
|
Additional |
|
|
Treasury Stock |
|
|
Other |
|
|
During |
|
|
|
|
|
|
Shareholders |
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Paid-In |
|
|
Number of |
|
|
|
|
|
|
Comprehensive |
|
|
Development |
|
|
Noncontrolling |
|
|
Equity |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Shares |
|
|
Amount |
|
|
Income (Loss) |
|
|
Stage |
|
|
Interest |
|
|
(Deficit) |
|
Compensation expense on options
and warrants issued to
non-employees1st
qtr |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
39,742 |
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
39,742 |
|
Compensation expense on option
awards issued to employees and
directors1st qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
448,067 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
448,067 |
|
Compensation expense on
restricted stock issued to
employees1st qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88 |
|
Issuance of common stock for
cash in connection with
exercise of stock
options1st qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15,000 |
|
|
|
15 |
|
|
|
23,085 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
23,100 |
|
Expense in connection with
modification of employee stock
options 1st qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,178,483 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,178,483 |
|
Compensation expense on options
and warrants issued to
non-employees2nd
qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
39,981 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
39,981 |
|
Compensation expense on option
awards issued to employees and
directors2nd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
462,363 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
462,363 |
|
Compensation expense on
restricted stock issued to
employees2nd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88 |
|
Compensation expense on option
awards issued to employees and
directors3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
478,795 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
478,795 |
|
Compensation expense on
restricted stock issued to
employees3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88 |
|
Issuance of common stock upon
exercise of
warrants3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
492,613 |
|
|
|
493 |
|
|
|
893,811 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
894,304 |
|
Issuance of common stock for
cash, net of offering
costs3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,767,647 |
|
|
|
6,767 |
|
|
|
13,745,400 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,752,167 |
|
Issuance of common stock for
cash in connection with
exercise of stock
options3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,666 |
|
|
|
2 |
|
|
|
3,164 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,166 |
|
Compensation expense on option
awards issued to employees and
directors4thqtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
378,827 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
378,827 |
|
Compensation expense on
restricted stock issued to
employees4thqtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88 |
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(35,573,114 |
) |
|
|
(246,347 |
) |
|
|
(35,819,461 |
) |
Other comprehensive gain,
foreign currency translation
adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
846,388 |
|
|
|
|
|
|
|
|
|
|
|
846,388 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(34,973,073 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance 12/31/07 (Predecessor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
41,639,657 |
|
|
$ |
41,640 |
|
|
$ |
129,208,631 |
|
|
|
4,000,000 |
|
|
$ |
(25,974,000 |
) |
|
$ |
718,926 |
|
|
$ |
(162,646,158 |
) |
|
$ |
1,858,026 |
|
|
$ |
(56,792,935 |
) |
The accompanying notes are an integral part of these consolidated financial statements.
F-13
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
Series A |
|
|
Series B |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Deficit |
|
|
|
|
|
|
Total |
|
|
|
Preferred Stock |
|
|
Preferred Stock |
|
|
Common Stock |
|
|
Additional |
|
|
Treasury Stock |
|
|
Other |
|
|
During |
|
|
|
|
|
|
Shareholders |
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Paid-In |
|
|
Number of |
|
|
|
|
|
|
Comprehensive |
|
|
Development |
|
|
Noncontrolling |
|
|
Equity |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Shares |
|
|
Amount |
|
|
Income (Loss) |
|
|
Stage |
|
|
Interest |
|
|
(Deficit) |
|
Compensation expense on vested options related to
non-employees1st qtr |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
44,849 |
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
44,849 |
|
Compensation expense on option awards issued to
employees and directors1st qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
151,305 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
151,305 |
|
Expense in connection with modification of employee
stock options 1st qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,262,815 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,262,815 |
|
Retirement of restricted stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(165 |
) |
|
|
(1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1 |
) |
Compensation expense on vested options related to
non-employees2nd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
62,697 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
62,697 |
|
Compensation expense on option awards
issued to employees and directors2nd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
193,754 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
193,754 |
|
Compensation expense on vested options
related to non-employees3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
166,687 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
166,687 |
|
Compensation expense on option awards
issued to employees and directors3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
171,012 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
171,012 |
|
Compensation expense on vested options
related to non-employees4th qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(86,719 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(86,719 |
) |
Compensation expense on option awards
issued to employees and directors4th qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
166,196 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
166,196 |
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(31,411,179 |
) |
|
|
(1,680,676 |
) |
|
|
(33,091,855 |
) |
Reclassification of foreign exchange gain on
substantial liquidation of foreign entities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,152,569 |
) |
|
|
|
|
|
|
|
|
|
|
(2,152,569 |
) |
Other comprehensive gain, foreign currency translation
adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,433,643 |
|
|
|
|
|
|
|
|
|
|
|
1,433,643 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(33,810,781 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance 12/31/08 (Predecessor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
41,639,492 |
|
|
$ |
41,639 |
|
|
$ |
131,341,227 |
|
|
|
4,000,000 |
|
|
$ |
(25,974,000 |
) |
|
$ |
|
|
|
$ |
(194,057,337 |
) |
|
$ |
177,350 |
|
|
$ |
(88,471,121 |
) |
The accompanying notes are an integral part of these consolidated financial statements.
F-14
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
Series A |
|
|
Series B |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Deficit |
|
|
|
|
|
|
|
|
|
|
Preferred Stock |
|
|
Preferred Stock |
|
|
Common Stock |
|
|
Additional |
|
|
Treasury Stock |
|
|
Other |
|
|
During |
|
|
|
|
|
|
Total |
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Paid-In |
|
|
Number of |
|
|
|
|
|
|
Comprehensive |
|
|
Development |
|
|
Noncontrolling |
|
|
Equity |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Shares |
|
|
Amount |
|
|
Income (Loss) |
|
|
Stage |
|
|
Interest |
|
|
(Deficit) |
|
Compensation expense on vested options
related to non-employees1st
qtr |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
1,746 |
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
1,746 |
|
Compensation expense on option awards
issued to employees and
directors1st qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
138,798 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
138,798 |
|
Conversion of debt into common stock
1st qtr 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
37,564 |
|
|
|
38 |
|
|
|
343,962 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
344,000 |
|
Compensation expense on option awards
issued to employees and directors2nd
qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
112,616 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
112,616 |
|
Conversion of debt into common stock
2nd qtr 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,143,324 |
|
|
|
1,143 |
|
|
|
10,468,857 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,470,000 |
|
Compensation expense on option awards
issued to employees and directors2
months ended 8/31/09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
35,382 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
35,382 |
|
Balance of expense due to cancellation
of options issued to employees and
directors in bankruptcy2 months ended
8/31/09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
294,912 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
294,912 |
|
Comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
65,721,531 |
|
|
|
205,632 |
|
|
|
65,927,163 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
65,927,163 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance 8/31/09 (Predecessor) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
42,820,380 |
|
|
$ |
42,820 |
|
|
$ |
142,737,500 |
|
|
|
4,000,000 |
|
|
$ |
(25,974,000 |
) |
|
$ |
|
|
|
$ |
(128,335,806 |
) |
|
$ |
382,982 |
|
|
$ |
(11,146,504 |
) |
Cancellation of Predecessor common stock
and fresh start adjustments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(42,820,380 |
) |
|
|
(42,820 |
) |
|
|
(150,426,331 |
) |
|
|
(4,000,000 |
) |
|
|
25,974,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(124,495,151 |
) |
Elimination of Predecessor accumulated
deficit and accumulated other
comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
128,335,806 |
|
|
|
|
|
|
|
128,335,806 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance 9/1/09 (Predecessor) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(7,688,831 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
382,982 |
|
|
|
(7,305,849 |
) |
Issuance of 11.4 million shares of
common stock in connection with
emergence from Chapter 11 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,400,000 |
|
|
|
11,400 |
|
|
|
5,460,600 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,472,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance 9/1/09 (Successor) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,400,000 |
|
|
|
11,400 |
|
|
|
(2,228,231 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
382,982 |
|
|
|
(1,833,849 |
) |
Issuance of 2.7 million shares of common
stock in connection with the exit
financing |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,666,666 |
|
|
|
2,667 |
|
|
|
1,797,333 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,800,000 |
|
Issuance of common stock on Oct. 28, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,501 |
|
|
|
25 |
|
|
|
58,627 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
58,652 |
|
Compensation expense on shares issued to
management |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
600,000 |
|
|
|
600 |
|
|
|
167,400 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
168,000 |
|
Compensation expense on option awards
issued to directors |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
326,838 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
326,838 |
|
Compensation expense on option awards
issued to non-employees |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
386,380 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
386,380 |
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,049,999 |
) |
|
|
15,493 |
|
|
|
(5,034,506 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,034,506 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance 12/31/09 (Successor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
14,692,167 |
|
|
$ |
14,692 |
|
|
$ |
508,347 |
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
(5,049,999 |
) |
|
$ |
398,475 |
|
|
$ |
(4,128,485 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
F-15
Fibrocell Science, Inc.
(A Development Stage Company)
Consolidated Statements of Cash Flows
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor |
|
|
|
Predecessor |
|
|
Predecessor |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
from December 31, |
|
|
|
|
|
|
|
|
|
|
1995 (date of |
|
|
|
Four months ended |
|
|
|
Eight months ended |
|
|
For the year ended |
|
|
inception) to |
|
|
|
December 31, 2009 |
|
|
|
August 31, 2009 |
|
|
December 31, 2008 |
|
|
August 31, 2009 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income |
|
$ |
(5,049,999 |
) |
|
|
$ |
65,721,531 |
|
|
$ |
(31,411,179 |
) |
|
$ |
(115,322,121 |
) |
Adjustments to reconcile net (loss) income to net cash used in operating
activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reorganization items, net |
|
|
72,477 |
|
|
|
|
(74,648,976 |
) |
|
|
|
|
|
|
(74,648,976 |
) |
Expense related to equity awards and issuance of stock |
|
|
881,218 |
|
|
|
|
583,453 |
|
|
|
2,132,597 |
|
|
|
10,608,999 |
|
Warrant expense |
|
|
319,084 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Uncompensated contribution of services |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
755,556 |
|
Depreciation and amortization |
|
|
|
|
|
|
|
|
|
|
|
1,376,863 |
|
|
|
9,091,990 |
|
Provision for doubtful accounts |
|
|
(46,619 |
) |
|
|
|
501 |
|
|
|
7,191 |
|
|
|
337,810 |
|
Provision for excessive and/or obsolete inventory |
|
|
11,664 |
|
|
|
|
169,085 |
|
|
|
90,342 |
|
|
|
259,427 |
|
Amortization of debt issue costs |
|
|
|
|
|
|
|
985,237 |
|
|
|
749,239 |
|
|
|
4,107,067 |
|
Amortization of debt discounts on investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(508,983 |
) |
Loss on disposal or impairment of property and equipment |
|
|
|
|
|
|
|
|
|
|
|
13,059,375 |
|
|
|
17,668,477 |
|
Foreign exchange gain on substantial liquidation of foreign entity |
|
|
(2,614 |
) |
|
|
|
30,012 |
|
|
|
(2,152,569 |
) |
|
|
(2,256,408 |
) |
Net (loss) income attributable to non-controlling interest |
|
|
15,493 |
|
|
|
|
205,632 |
|
|
|
(1,680,676 |
) |
|
|
(1,799,523 |
) |
Change in operating assets and liabilities, excluding effects of acquisition: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Decrease in restricted cash |
|
|
|
|
|
|
|
|
|
|
|
451,383 |
|
|
|
|
|
Decrease (increase) in accounts receivable |
|
|
23,544 |
|
|
|
|
91,666 |
|
|
|
(26,367 |
) |
|
|
(91,496 |
) |
Decrease in other receivables |
|
|
4,740 |
|
|
|
|
23,632 |
|
|
|
46,870 |
|
|
|
218,978 |
|
Decrease (increase) in inventory |
|
|
30,923 |
|
|
|
|
29,543 |
|
|
|
111,530 |
|
|
|
(455,282 |
) |
Decrease (increase) in prepaid expenses |
|
|
(244,905 |
) |
|
|
|
628,197 |
|
|
|
64,362 |
|
|
|
34,341 |
|
Decrease (increase) in other assets |
|
|
4,120 |
|
|
|
|
(112,441 |
) |
|
|
42,937 |
|
|
|
71,000 |
|
Increase (decrease) in accounts payable |
|
|
107,622 |
|
|
|
|
(230,592 |
) |
|
|
(6,021 |
) |
|
|
57,648 |
|
Increase (decrease) in accrued expenses, liabilities subject to compromise
and other liabilities |
|
|
(425,794 |
) |
|
|
|
1,868,162 |
|
|
|
(2,874,518 |
) |
|
|
3,311,552 |
|
Increase (decrease) in deferred revenue |
|
|
|
|
|
|
|
(7,522 |
) |
|
|
7,522 |
|
|
|
(50,096 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(4,299,046 |
) |
|
|
|
(4,662,880 |
) |
|
|
(20,011,119 |
) |
|
|
(148,610,040 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition of Agera, net of cash acquired |
|
|
|
|
|
|
|
|
|
|
|
(6,679 |
) |
|
|
(2,016,520 |
) |
Purchase of property and equipment |
|
|
|
|
|
|
|
|
|
|
|
(33,337 |
) |
|
|
(25,515,170 |
) |
Proceeds from the sale of property and equipment, net of selling costs |
|
|
|
|
|
|
|
|
|
|
|
6,444,386 |
|
|
|
6,542,434 |
|
Purchase of investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(152,998,313 |
) |
Proceeds from sales and maturities of investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
153,507,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
|
|
|
|
|
|
|
|
|
|
6,404,370 |
|
|
|
(20,480,569 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from convertible debt |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
91,450,000 |
|
Offering costs associated with the issuance of convertible debt |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,746,193 |
) |
Proceeds from notes payable to shareholders, net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
135,667 |
|
Proceeds from the issuance of redeemable preferred stock, net |
|
|
2,870,000 |
|
|
|
|
|
|
|
|
|
|
|
|
12,931,800 |
|
Proceeds from the issuance of common stock, net |
|
|
1,800,000 |
|
|
|
|
|
|
|
|
|
|
|
|
93,753,857 |
|
Costs associated with secured loan and debtor-in-possession loan |
|
|
|
|
|
|
|
(360,872 |
) |
|
|
|
|
|
|
(360,872 |
) |
Proceeds from secured loan |
|
|
|
|
|
|
|
500,471 |
|
|
|
|
|
|
|
500,471 |
|
Proceeds from debtor-in-possession loan |
|
|
|
|
|
|
|
2,750,000 |
|
|
|
|
|
|
|
2,750,000 |
|
Payments on insurance loan |
|
|
(21,891 |
) |
|
|
|
(63,983 |
) |
|
|
(15,336 |
) |
|
|
(79,319 |
) |
Cash dividends paid on preferred stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,087,200 |
) |
Cash paid for fractional shares of preferred stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(38,108 |
) |
Merger and acquisition expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(48,547 |
) |
Repurchase of common stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(26,024,280 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) financing activities |
|
|
4,648,109 |
|
|
|
|
2,825,616 |
|
|
|
(15,336 |
) |
|
|
170,137,276 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash balances |
|
|
3,149 |
|
|
|
|
(6,760 |
) |
|
|
(114,335 |
) |
|
|
(36,391 |
) |
Net increase (decrease) in cash and cash equivalents |
|
|
352,212 |
|
|
|
|
(1,844,024 |
) |
|
|
(13,736,420 |
) |
|
|
1,010,276 |
|
Cash and cash equivalents, beginning of period |
|
|
1,010,276 |
|
|
|
|
2,854,300 |
|
|
|
16,590,720 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period |
|
$ |
1,362,488 |
|
|
|
$ |
1,010,276 |
|
|
$ |
2,854,300 |
|
|
$ |
1,010,276 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-16
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor |
|
|
|
Predecessor |
|
|
Predecessor |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
from December 31, |
|
|
|
|
|
|
|
|
|
|
1995 (date of |
|
|
|
Four months ended |
|
|
|
Eight months ended |
|
|
For the year ended |
|
|
inception) to |
|
|
|
December 31, 2009 |
|
|
|
August 31, 2009 |
|
|
December 31, 2008 |
|
|
August 31, 2009 |
|
Supplemental disclosures of cash flow information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Predecessor cash paid for interest |
|
$ |
|
|
|
|
$ |
|
|
|
$ |
3,150,000 |
|
|
$ |
12,715,283 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash investing and financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Predecessor deemed dividend associated with beneficial conversion of preferred
stock |
|
$ |
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
11,423,824 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Predecessor preferred stock dividend |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,589,861 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor accrued preferred stock dividend |
|
|
42,740 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Predecessor uncompensated contribution of services |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
755,556 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Predecessor common stock issued for intangible assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
540,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Predecessor common stock issued in connection with conversion of debt |
|
|
|
|
|
|
|
10,814,000 |
|
|
|
|
|
|
|
10,814,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Predecessor equipment acquired through capital lease |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
167,154 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor/Predecessor financing of insurance premiums |
|
|
81,517 |
|
|
|
|
|
|
|
|
87,623 |
|
|
|
87,623 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor issuance of notes payable |
|
|
|
|
|
|
|
6,000,060 |
|
|
|
|
|
|
|
6,000,060 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor common stock issued in connection with reorganization |
|
|
|
|
|
|
|
5,472,000 |
|
|
|
|
|
|
|
5,472,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor intangible assets |
|
|
|
|
|
|
|
6,340,656 |
|
|
|
|
|
|
|
6,340,656 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor deferred tax liability in connection with fresh-start |
|
|
|
|
|
|
|
2,500,000 |
|
|
|
|
|
|
|
2,500,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Elimination of Predecessor common stock and fresh start adjustment |
|
|
|
|
|
|
|
14,780,320 |
|
|
|
|
|
|
|
14,780,320 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor accrued warrant liability |
|
|
316,192 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
F-17
Fibrocell Science, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements
Note 1Emergence from Voluntary Reorganization Under Chapter 11 Proceedings and Reorganization
Plan
Background
On June 15, 2009 Isolagen, Inc. (the Predecessor) and Isolagens wholly owned subsidiary,
Isolagen Technologies, Inc. (Isolagen Tech) (Isolagen and Isolagen Tech are referred as the
Debtors), each filed a voluntary petition for reorganization under Chapter 11 of the United
States Bankruptcy Code (the Bankruptcy Code) in the United States Bankruptcy Court for the
District of Delaware in Wilmington (the Bankruptcy Court) under Case Nos. 09-12072 and 09-12073,
respectively.
On August 27, 2009 (the Confirmation Date), the Bankruptcy Court entered an order (the
Confirmation Order) confirming the Debtors Joint First Amended Plan of Reorganization dated July
30, 2009, as supplemented by the Plan Supplement dated August 21, 2009 (as so modified and
supplemented, the Plan). The (Effective Date) of the Plan was September 3, 2009. Isolagen and
Isolagen Tech emerged from bankruptcy as the reorganized debtors, Fibrocell Science, Inc.
(Fibrocell or the Company or the Successor) and Fibrocell Technologies, Inc. (Fibrocell
Tech), respectively (collectively, the Reorganized Debtors), and the bankruptcy cases remain
pending only to reconcile the claims asserted against the Debtors. Fibrocell now operates outside
of the restraints of the bankruptcy process, free of the debts and liabilities discharged by the
Plan.
Our officers and directors as of the effective date were all deemed to have resigned and a new
board of directors was appointed. As of the effective date, our initial board of directors
consisted of: David Pernock, Paul Hopper and Kelvin Moore. Dr. Robert Langer was appointed to the
Board in late September 2009. Declan Daly remained as chief operating officer and chief financial
officer of the reorganized company, and in November 2009, he was appointed to the Board of
Directors. Mr. Daly received 5% of the New Common Stock which is subject to a two-year vesting
schedule whereby 50% vested on the Effective Date, 25% shall vest on the first anniversary and 25%
shall vest on the second anniversary. Mr. Daly was the acting interim chief executive officer until
February 1, 2010.
Plan of Reorganization
Pursuant to the Plan, all our equity interests, including without limitation our common stock,
options and warrants outstanding as of the effective date were cancelled. On the effective date, we
completed an exit financing of common stock in the amount of $2 million, after which the equity
holders of our company were:
|
|
|
7,320,000 shares, to our pre-bankruptcy lenders and the lenders that provided us
our debtor-in-possession facility, collectively; |
|
|
|
|
3,960,000 shares, to the holders of our 3.5% convertible subordinated notes; |
|
|
|
|
600,000 shares, to our management as of the effective date, which was our chief
operating officer; |
|
|
|
|
120,000 shares, to the holders of our general unsecured claims; and |
|
|
|
|
2,666,666 shares, to the purchasers of shares in the $2 million exit financing (our
pre-bankruptcy lenders, the lenders that provided us our debtor-in-possession facility and
the holders of our 3.5% convertible subordinated notes were permitted to participate in our
exit financing). |
F-18
In the Plan, in addition to the common stock set forth above, each holder of Isolagens 3.5%
convertible subordinated notes, due November 2024, in the approximate non-converted aggregate
principal amount of $81 million, received, in full and final satisfaction, settlement, release and
discharge of and in exchange for any an all claims arising out of the 3.5% convertible subordinated
notes, its pro rata share of an unsecured note in the principal amount of $6 million, or the New
Note. The New Note has the following features:
|
|
12.5% interest payable quarterly in cash or, at our option, 15% payable in kind by
capitalizing such unpaid amount and adding it to the principal as of the date it was due; |
|
|
|
matures June 1, 2012; |
|
|
|
at any time prior to the maturity date, we may redeem any portion of the outstanding
principal of the New Notes in cash at 125% of the stated face value of the New Notes; provided that
we will be obligated to redeem all outstanding New Notes upon the following events: (a) we or our
subsidiary, Fibrocell Technologies, Inc. (formerly, Isolagen Technologies, Inc.) successfully
complete a capital campaign raising in excess of $10,000,000; or (b) we or our subsidiary,
Fibrocell Technologies, Inc., are acquired by, or sell a majority stake to, an outside party; |
|
|
|
the New Notes contain customary representations, warranties and covenants, including a
covenant that we and our subsidiary, Fibrocell Technologies, Inc., shall be prohibited from the
incurrence of additional debt without obtaining the consent of 66 2/3% of the New Note holders. |
Trading of Common Stock
The Predecessors common stock ceased trading on the NYSE Amex on May 6, 2009 and in June 2009
the NYSE Amex delisted the Predecessors common stock from listing on the NYSE Amex. Upon the
Effective Date, the outstanding common stock of the Predecessor Company was cancelled for no
consideration. Consequently, the Predecessors stockholders prior to the Effective Date no longer
have any interest as stockholders of the Predecessor Company by virtue of their ownership of the
Predecessors common stock prior to the emergence from bankruptcy. On October 21, 2009, the
Successor Company was available for trading on the OTC Bulletin Board under the symbol FCSC.
Note 2Basis of Presentation, Business and Organization
Fibrocell Science, Inc., a Delaware corporation, is the parent company of Fibrocell
Technologies, Inc. a Delaware corporation (Fibrocell Technologies) and Agera Laboratories, Inc.,
a Delaware corporation (Agera). Fibrocell Technologies is the parent company of Isolagen Europe
Limited, a company organized under the laws of the United Kingdom (Isolagen Europe), Isolagen
Australia Pty Limited, a company organized under the laws of Australia (Isolagen Australia), and
Isolagen International, S.A., a company organized under the laws of Switzerland (Isolagen
Switzerland).
The Company is an aesthetic and therapeutic company focused on developing novel skin and
tissue rejuvenation products. The Companys clinical development product candidates are designed to
improve the appearance of skin injured by the effects of aging, sun exposure, acne and burns with a
patients own, or autologous, fibroblast cells produced in the Companys proprietary Fibrocell
Process. The Company also markets an advanced skin care line with broad application in core target
markets through its Agera subsidiary.
In October 2006, the Predecessor Company reached an agreement with the U.S. Food and Drug
Administration (FDA) on the design of a Phase III pivotal study protocol for the treatment of
nasolabial fold wrinkles. The randomized, double-blind protocol was submitted to the FDA under the
agencys Special Protocol Assessment (SPA) regulations. Pursuant to this assessment process, the
FDA has agreed that the Predecessor Companys study design for two identical trials, including
patient numbers, clinical endpoints, and statistical analyses, is acceptable to the FDA to form the
basis of an efficacy claim for a marketing application. The randomized, double-blind, pivotal Phase
III trials will evaluate the efficacy and safety of
our product against placebo in approximately 400 patients with approximately 200 patients
enrolled in each trial. The Predecessor Company completed enrollment of the study and commenced
injection of subjects in early 2007. All injections were completed in January 2008 and top line
results from this trial were publically announced in August 2008. The data analysis, including
safety data, was publically released in October 2008. The related Biologics License Application
(BLA) was submitted to the FDA in March 2009. In May 2009, the Predecessor Company announced that
the FDA had completed its initial review of the Companys BLA related to its nasolabial fold
wrinkles product candidate and that the FDA had accepted (or filed) the BLA for full review.
F-19
On October 9, 2009, the FDA Cellular, Tissue and Gene Therapies Advisory Committee reviewed
our nasolabial fold wrinkles product candidate. The Committee voted 11 yes to 3 no that the
data presented on our product demonstrated efficacy, and 6 yes to 8 no that the data
demonstrated safety; both for the proposed indication of treatment of nasolabial fold wrinkles. The
Committees recommendations are not binding on the FDA, but the FDA will consider their
recommendations during their review of our application. The United States Adopted Names (USAN)
Council adopted the USAN name, azficel-T, for our nasolabial fold wrinkles product candidate on
October 28, 2009, and the FDA is currently evaluating a proposed brand name, Laviv.
On December 21, 2009, Fibrocell received a Complete Response letter from the FDA related to
the BLA for azficel-T, an autologous cell therapy for the treatment of moderate to severe
nasolabial fold wrinkles in adults. A Complete Response letter is issued by the FDAs Center for
Biologics Evaluation and Research (CBER) when the review of a file is completed and additional data
are needed prior to approval. The Complete Response letter requested that Fibrocell Science provide
data from a histopathological study on biopsied tissue samples from patients following injection of
azficel-T. The letter also requested finalized Chemistry, Manufacturing and Controls (CMC)
information regarding the manufacture of azficel-T as follow-up to discussions that occurred during
the BLA review period, as well as revised policies and procedures. In addition, the Company has
submitted a proposed protocol concerning a histopathological study on biopsied samples to the FDA
and to the Companys Investigational Review Board (IRB). The IRB has approved the protocol and
the Company is currently awaiting the FDAs comments on the protocol.
Basis of Presentation
In June 2009, the Financial Accounting Standards Board (FASB) issued Accounting
Standards Codification 105 (ASC), Generally Accepted Accounting Principles, which became the
single source of authoritative nongovernmental U.S. generally accepted accounting principles
(GAAP), superseding existing FASB, American Institute of Certified Public Accountants (AICPA),
Emerging Issues Task Force (EITF), and related accounting literature. This pronouncement
reorganizes the thousands of GAAP pronouncements into roughly 90 accounting topics and displays
them using a consistent structure. Also included is relevant Securities and Exchange Commission
guidance organized using the same topical structure in separate sections and will be effective for
financial statements issued for reporting periods that end after September 15, 2009. This will have
an impact on our financial disclosures since all future references to authoritative accounting
literature will be references in accordance with ASC 105.
Financial Reporting by Entities in Reorganization under the Bankruptcy Code
Overall, ASC 852-10, Financial Reporting by Entities in Reorganization Under the Bankruptcy
Code, (ASC 852) applies to the Companys financial statements for the periods that the Company
operated under the provisions of Chapter 11. ASC 852 does not change the application of generally
accepted accounting principles in the preparation of financial statements. However, for periods
including and subsequent to the filing of the Chapter 11 petition, ASC 852 does require that the
financial statements distinguish transactions and events that are directly associated with the
reorganization from the ongoing operations of the business. Accordingly, certain revenues,
expenses, gains, and losses that were realized or incurred during the Chapter 11 proceedings have
been classified as reorganization items, net on the accompanying consolidated statements of
operations.
F-20
As of September 1, 2009, the Successor Company adopted fresh-start accounting in accordance
with ASC 852-10. The Successor Company selected September 1, 2009, as the date to effectively
apply fresh-start accounting based on the absence of any material contingencies at the September 3,
2009 effective date and the immaterial impact of transactions between September 1, 2009 and
September 3, 2009. The adoption of fresh-start accounting resulted in the Successor Company
becoming a new entity for financial reporting purposes. The Successor Company is a development
stage company in accordance with ASC 915, Development Stage Entities. As such, the four month
period results ended December 31, 2009 equal the cumulative to-date totals.
Accordingly, the financial statements prior to September 1, 2009 are not comparable with the
financial statements for periods on or after September 1, 2009. References to Successor or
Successor Company refer to the Company on or after September 1, 2009, after giving effect to the
cancellation of Isolagen, Inc. common stock issued prior to the Effective Date, the issuance of new
Fibrocell Science, Inc. common stock in accordance with the Plan, and the application of
fresh-start accounting. References to Predecessor or Predecessor Company refer to the Company
prior to September 1, 2009. See Note 5 Fresh-Start Accounting in the notes to these
Consolidated Financial Statements for further details.
For discussions on the results of operations, the Successor Company has combined the results
of operations for the eight months ended August 31, 2009, with the results of operations for the
four months ended December 31, 2009. The combined periods have been compared to the twelve months
ended December 31, 2008. The Successor Company believes that the combined financial results
provide management and investors a more meaningful analysis of the Successor Companys performance
and trends for comparative purposes.
Note 3Going Concern
The Successor Company emerged from Bankruptcy in September 2009 and continues to operate as a
going concern. At December 31, 2009, we had cash and cash equivalents of $1.4 million and working
capital of $1.5 million. In early March 2010, we raised approximately $3.8 million less fees as a
result of the issuance of common stock and warrants. We believe that our existing capital resources
are adequate to sustain our operation through approximately mid-June 2010. As such, we will require
additional cash resources prior to or during approximately mid-June 2010, or we will likely cease
operations. The Successor Company will need to access the capital markets in the future in order to
fund future operations. There is no guarantee that any such required financing will be available on
terms satisfactory to the Successor Company or available at all. These matters create uncertainty
relating to our ability to continue as a going concern. The accompanying consolidated financial
statements do not reflect any adjustments relating to the recoverability and classification of
assets or liabilities that might result from the outcome of these uncertainties.
Further, if we do raise additional cash resources prior to mid-June 2010, it may be raised in
contemplation of or in connection with bankruptcy. In the event of a bankruptcy, it is likely that
our common stock and common stock equivalents will become worthless and our creditors will receive
significantly less than what is owed to them.
Through December 31, 2009, we have been primarily engaged in developing our initial product
technology. In the course of our development activities, we have sustained losses and expect such
losses to continue through at least 2010. In fiscal 2009 we financed our operations primarily
through our existing cash, but as discussed above we now require additional financing. There is
substantial doubt about our ability to continue as a going concern.
Our ability to complete additional offerings is dependent on the state of the debt and/or
equity markets at the time of any proposed offering, and such markets reception of the Successor
Company and the offering terms. Our ability to complete an offering is also dependent on the
status of our FDA regulatory milestones and our clinical trials, and in particular, the status of
our indication for the treatment of nasolabial fold wrinkles and the status of the related BLA,
which cannot be predicted. There is no
assurance that capital in any form would be available to us, and if available, on terms and
conditions that are acceptable.
F-21
As a result of the conditions discussed above, and in accordance with generally accepted
accounting principles in the United States, there exists substantial doubt about our ability to
continue as a going concern, and our ability to continue as a going concern is contingent, among
other things, upon our ability to secure additional adequate financing or capital prior to or
during approximately mid-June 2010. If we do not obtain additional funding, or do not anticipate
additional funding, prior to or during approximately mid-June 2010, we will likely enter into
bankruptcy and/or cease operations. Further, if we do raise additional cash resources prior to
mid-June 2010, it may be raised in contemplation of or in connection with bankruptcy. If we enter
into bankruptcy, it is likely that our common stock and common stock equivalents will become
worthless and our creditors will receive significantly less than what is owed to them.
Note 4Summary of Significant Accounting Policies
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally
accepted in the United States of America requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities, disclosures of contingent assets and
liabilities at the date of the financial statements and the reported amounts of revenue and
expenses during the reporting period. In addition, managements assessment of the Successor
Companys ability to continue as a going concern involves the estimation of the amount and timing
of future cash inflows and outflows. Actual results may differ materially from those estimates.
Under fresh-start accounting, the Successor Companys asset values are remeasured and
allocated in conformity with ASC 805-20, Business Combinations, Identifiable Assets and
Liabilities, and Any Noncontrolling Interest, (ASC 805). In addition, fresh-start accounting also
requires that all liabilities, other than deferred taxes and pension and other postretirement
benefit obligations, be reported at fair value or the present values of the amounts to be paid
using appropriate market interest rates.
Estimates of fair value represent the Successor Companys best estimates based on
independent appraisals and valuations, industry data and trends to relevant market rates and
transactions. The estimates and assumptions are inherently subject to significant uncertainties and
contingencies beyond the control of the Successor Company. Accordingly, we cannot provide assurance
that the estimates, assumptions, and values reflected in the valuations will be realized, and
actual results could vary materially. Any adjustments to the recorded fair values of these assets
and liabilities may impact the amount of recorded intangibles.
Cash and Cash Equivalents
The Company considers highly liquid investments with an original maturity of three months or
less when purchased to be cash equivalents.
Concentration of Credit Risk
As of December 31, 2009, the Successor Company maintains the majority of its cash primarily
with one major U.S. domestic bank. The amounts held in this bank exceed the insured limit of
$250,000. The terms of these deposits are on demand to minimize risk. The Successor Company has not
incurred losses related to these deposits. Cash and cash equivalents of approximately $0.2 million,
related to Agera and the Successor Companys Swiss subsidiary, is maintained in two separate
financial institutions. The Successor Company invests these funds primarily in demand deposit
accounts.
F-22
Allowance for Doubtful Accounts
The Successor Company maintains an allowance for doubtful accounts related to its accounts
receivable that have been deemed to have a high risk of collectability. Management reviews its
accounts receivable on a monthly basis to determine if any receivables will potentially be
uncollectible. One foreign customer represents 87% and 94% of accounts receivable, net, at December
31, 2009 and December 31, 2008, respectively. Management analyzes historical collection trends and
changes in its customer payment patterns, customer concentration, and creditworthiness when
evaluating the adequacy of its allowance for doubtful accounts. In its overall allowance for
doubtful accounts, the Successor Company includes any receivable balances that are determined to be
uncollectible. Based on the information available, management believes the allowance for doubtful
accounts is adequate; however, actual write-offs might exceed the recorded allowance.
The allowance for doubtful accounts related to continuing operations was $37,098 and $25,303
at December 31, 2009 and 2008, respectively. The allowance for doubtful accounts related to
discontinued operations was zero and $51,354 at December 31, 2009 and 2008, respectively.
Inventory
Agera purchases the large majority of its inventory from one contract manufacturer. Agera
accounts for its inventory on the first-in-first-out method. At December 31, 2009, Ageras
inventory of $0.2 million consisted of $0.2 million of raw materials and less than $0.1 million of
finished goods. At December 31, 2008, Ageras inventory of $0.5 million consisted of $0.2 million
of raw materials and $0.3 million of finished goods.
Intangible assets
Intangible assets are research and development assets related to our primary study that were
recognized upon emergence from bankruptcy (see Note 5). Intangibles are tested for recoverability
whenever events or changes in circumstances indicate the carrying amount may not be recoverable. An
impairment loss, if any, would be measured as the excess of the carrying value over the fair value
determined by discounted cash flows. There was no impairment of the intangible assets as of
December 31, 2009.
Revenue recognition
The Successor Company recognizes revenue over the period the service is performed in
accordance with ASC 605, Revenue Recognition (ASC 605). In general, ASC 605 requires that four
basic criteria must be met before revenue can be recognized: (1) persuasive evidence of an
arrangement exists, (2) delivery has occurred or services rendered, (3) the fee is fixed and
determinable and (4) collectability is reasonably assured.
Revenue from the sale of Ageras products is recognized upon transfer of title, which is upon
shipment of the product to the customer. The Successor Company believes that the requirements of
ASC 605 are met when the ordered product is shipped, as the risk of loss transfers to our customer
at that time, the fee is fixed and determinable and collection is reasonably assured. Any advanced
payments are deferred until shipment.
Shipping and handling costs
Agera charges its customers for shipping and handling costs. Such charges to customers are
presented net of the costs of shipping and handling, as selling, general and administrative
expense, and are not significant to the consolidated statements of operations.
Advertising cost
Agera advertising costs are expensed as incurred and include the costs of public relations and
certain marketing related activities. These costs are included in selling, general and
administrative expenses in the accompanying consolidated statements of operations.
F-23
Research and development expenses
Research and development costs are expensed as incurred and include salaries and benefits,
costs paid to third-party contractors to perform research, conduct clinical trials, develop and
manufacture drug materials and delivery devices, and a portion of facilities cost. Research and
development costs also include costs to develop manufacturing, cell collection and logistical
process improvements.
Clinical trial costs are a significant component of research and development expenses and
include costs associated with third-party contractors. Invoicing from third-party contractors for
services performed can lag several months. The Successor Company accrues the costs of services
rendered in connection with third-party contractor activities based on its estimate of management
fees, site management and monitoring costs and data management costs. Actual clinical trial costs
may differ from estimated clinical trial costs and are adjusted for in the period in which they
become known.
Warrant Liability
We account for our warrants in accordance with U.S. GAAP. The warrants are measured at fair
value and liability-classified under ASC 815, Derivatives and Hedging, (ASC 815) because the
warrants contain down-round protection and therefore, do not meet the scope exception for
treatment as a derivative under ASC 815. Since down-round protection is not an input into the
calculation of the fair value of the warrants, the warrants cannot be considered indexed to the
Companys own stock which is a requirement for the scope exception as outlined under ASC 815. The
fair value of the warrants is determined using the Black-Scholes option pricing model and is
affected by changes in inputs to that model including our stock price, expected stock price
volatility, the contractual term, and the risk-free interest rate. We will continue to classify the
fair value of the warrants as a liability until the warrants are exercised, expire or are amended
in a way that would no longer require these warrants to be classified as a liability.
Stock-based Compensation
We account for stock-based awards to employees and non-employees using the fair value based
method to determine compensation for all arrangements where shares of stock or equity instruments
are issued for compensation. We use a Black-Scholes options-pricing model to determine the fair
value of each option grant as of the date of grant for expense incurred. The Black-Scholes model
requires inputs for risk-free interest rate, dividend yield, volatility and expected lives of the
options. Expected volatility is based on historical volatility of our competitors stock since the
Predecessor Company ceased trading as part of the bankruptcy and emerged as a new entity. The
risk-free rate for periods within the contractual life of the option is based on the U.S. Treasury
yield curve in effect at the time of the grant. The expected lives for options granted represents
the period of time that options granted are expected to be outstanding and is derived from the
contractual terms of the options granted. We estimate future forfeitures of options based upon
expected forfeiture rates.
Income taxes
An asset and liability approach is used for financial accounting and reporting for income
taxes. Deferred income taxes arise from temporary differences between income tax and financial
reporting and principally relate to recognition of revenue and expenses in different periods for
financial and tax accounting purposes and are measured using currently enacted tax rates and laws.
In addition, a deferred tax asset can be generated by net operating loss (NOLs) carryover. If it
is more likely than not that some portion or all of a deferred tax asset will not be realized, a
valuation allowance is recognized.
In the event the Company is charged interest or penalties related to income tax matters, the
Company would record such interest as interest expense and would record such penalties as other
expense in the consolidated statement of operations. No such charges have been incurred by the
Company. As of December 31, 2009 and December 31, 2008, the Successor and Predecessor Company had
no accrued interest related to uncertain tax positions.
F-24
At December 31, 2009 and December 31, 2008, the Successor and Predecessor have provided a full
valuation allowance for the net deferred tax assets, the large majority of which relates to the
future benefit of loss carryovers. In addition, as a result of fresh-start accounting, the
Successor Company may be limited by section 382 of the Internal Revenue Service Code. The tax
years 2006 through 2009 remain open to examination by the major taxing jurisdictions to which we
are subject. The deferred tax liability at December 31, 2009 relates to the intangible assets
recognized upon fresh-start accounting.
Earnings (Loss) per share data
Basic earnings (loss) per share is calculated based on the weighted average common shares
outstanding during the period. Diluted earnings per share (Diluted EPS) also gives effect to the
dilutive effect of stock options, warrants, restricted stock and convertible preferred stock
calculated based on the treasury stock method.
The Predecessor and Successor Companys potentially dilutive securities consist of potential
common shares related to stock options, warrants, restricted stock and convertible preferred stock.
Diluted EPS includes the impact of potentially dilutive securities except in periods in which
there is a loss because the inclusion of the potential common shares would be anti-dilutive. There
were no potentially dilutive securities issued or outstanding for the four months ended December
31, 2009. There were no potentially dilutive securities for the eight months ended August 31,
2009, due to the cancellation of the convertible notes and the cancellation of all the outstanding
stock option plans and the last known market price was less than exercise price.
Fair Value of Financial Instruments
The carrying values of certain of the Successor Companys financial instruments, including
cash equivalents and accounts payable approximates fair value due to their short maturities. The
fair values of the Successor Companys long-term obligations are based on assumptions concerning
the amount and timing of estimated future cash flows and assumed discount rates reflecting varying
degrees of risk. The carrying values of the Successor Companys long-term obligations approximate
their fair values.
The fair value of the reorganization value which applies in fresh-start accounting was
estimated by applying the income approach and a market approach. This fair value measurement is
based on significant inputs that are not observable in the market and, therefore, represents a
Level 3 measurement as defined in ASC 820, Fair Value Measurements.
New Pronouncements
On December 15, 2009, the FASB issued ASU No. 2010-06 Fair Value Measurements and Disclosures
Topic 820 Improving Disclosures about Fair Value Measurements. This ASU requires some new
disclosures and clarifies some existing disclosure requirements about fair value measurement as set
forth in Codification Subtopic 820-10. The FASBs objective is to improve these disclosures and,
thus, increase the transparency in financial reporting. The adoption of this ASU will not have a
material impact on the Companys consolidated financial statements.
In August 2009, the FASB issued Accounting Standard Update No. 2009-05, Measuring Liabilities
at Fair Value, or ASU 2009-05. ASU 2009-05 amends ASC 820, Fair Value Measurements. Specifically,
ASU 2009-05 provides clarification that in circumstances in which a quoted price in an active
market for the identical liability is not available, a reporting entity is required to measure fair
value using one or more of the following methods: 1) a valuation technique that uses a) the quoted
market price of the identical liability when trades as an asset or b) quoted prices for similar
liabilities or similar liabilities when trades as assets and/or 2) a valuation technique that is
consistent with the principles of ASC Topic 820. ASU 2009-05 also clarifies that when estimating
the fair value of a liability, a reporting entity is not required to adjust inputs relating to the
existence of transfer restrictions on that liability. The adoption of this standard did not have
an impact on our financial position or results of operations; however, this standard may impact us
in future periods.
F-25
In May 2009, the FASB released a new accounting pronouncement which establishes the accounting
for and disclosures of events that occur after the balance sheet date but before financial
statements are issued or are available to be issued. This pronouncement requires the disclosure of
the date through which an entity has evaluated subsequent events and the basis for that date, that
is, whether that date represents the date the financial statements were issued or were available to
be issued. See Basis of Presentation for the related disclosures. The adoption of this
pronouncement did not have a material impact on our financial statements.
In December 2007, the FASB issued a pronouncement which establishes new accounting and
reporting standards for the noncontrolling interest in a subsidiary and for the deconsolidation of
a subsidiary. We adopted the pronouncement on January 1, 2009 with no impact on operating results
or financial position.
Note 5Fresh-Start Accounting
On September 1, 2009, the Successor Company adopted fresh-start accounting upon the emergence
of bankruptcy in accordance with ASC 852-10, Reorganization. Fresh-start accounting results in the
Company becoming a new entity for financial reporting purposes. Accordingly, the Companys
consolidated financial statements for periods prior to September 1, 2009 are not comparable to
consolidated financial statements presented on or after September 1, 2009. The Company selected
September 1, 2009, as the date to apply fresh-start accounting based on the absence of any material
contingencies at the September 3, 2009 effective date and the immaterial impact of transactions
between September 1, 2009 and September 3, 2009.
Under ASC 852-10, the Successor Company must determine a value to be assigned to the equity of
the emerging company as of the date of the adoption of fresh-start accounting. The Successor
Company obtained an independent appraisal to value the equity and it served as the fair market
value of the emerging Companys equity.
Fresh-start accounting reflects the value of the Successor Company as determined in the
confirmed Plan. Under fresh-start accounting, the Successor Companys assets values are remeasured
and allocated in conformity with ASC 805-20, Business Combinations, Identifiable Assets and
Liabilities, and Any Noncontrolling Interest. Fresh-start accounting also requires that all
liabilities should be stated at fair value. The portion of the reorganization value which was
attributed to identified intangible assets was $6,340,656. This value is related to research and
development assets that are not subject to amortization. In accordance with ASC 805-20, this
amount is reported as intangibles in the consolidated financial statements as of December 31, 2009,
and is not being amortized.
The following fresh-start Consolidated Balance Sheet presents the financial effects on the
Successor Company with the implementation of the Plan and the adoption of fresh-start accounting.
The effect of the consummation of the transactions contemplated in the Plan included the settlement
of liabilities and the issuance of common stock.
F-26
The effects of the Plan and fresh-start reporting on the Successor Companys Consolidated
Balance Sheet are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Predecessor |
|
|
Reclassifications |
|
|
|
Fresh Start |
|
|
Successor |
|
|
|
August 31, |
|
|
And Plan of |
|
|
|
Accounting |
|
|
September 1, |
|
|
|
2009 |
|
|
Reorganization |
|
|
|
Adjustments |
|
|
2009 |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
1,010,277 |
|
|
$ |
|
|
|
|
$ |
|
|
|
$ |
1,010,277 |
|
Accounts receivable, net |
|
|
246,684 |
|
|
|
|
|
|
|
|
|
|
|
|
246,684 |
|
Inventory, net |
|
|
268,619 |
|
|
|
|
|
|
|
|
|
|
|
|
268,619 |
|
Prepaid expenses |
|
|
221,225 |
|
|
|
|
|
|
|
|
|
|
|
|
221,225 |
|
Other current assets |
|
|
4,140 |
|
|
|
|
|
|
|
|
|
|
|
|
4,140 |
|
Current assets of discontinued operations, net |
|
|
785 |
|
|
|
|
|
|
|
|
|
|
|
|
785 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
1,751,730 |
|
|
|
|
|
|
|
|
|
|
|
|
1,751,730 |
|
Intangible assets |
|
|
|
|
|
|
|
|
|
|
|
6,340,656 |
(e) |
|
|
6,340,656 |
|
Other assets |
|
|
1,671 |
|
|
|
|
|
|
|
|
|
|
|
|
1,671 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
1,753,401 |
|
|
$ |
|
|
|
|
$ |
6,340,656 |
|
|
$ |
8,094,057 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities, Shareholders Equity/(Deficit) and Noncontrolling Interests |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current debt |
|
$ |
8,304 |
|
|
$ |
|
|
|
|
$ |
|
|
|
$ |
8,304 |
|
Accounts payable |
|
|
137,401 |
|
|
|
|
|
|
|
|
|
|
|
|
137,401 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accrued expenses |
|
|
849,395 |
|
|
|
|
|
|
|
|
|
|
|
|
849,395 |
|
Liabilities subject to compromise |
|
|
82,181,741 |
|
|
|
(82,181,741 |
)(a) |
|
|
|
|
|
|
|
|
|
Prepetition secured loan, subject to compromise |
|
|
500,471 |
|
|
|
(500,471 |
)(b) |
|
|
|
|
|
|
|
|
|
Debtor-in-possession loan |
|
|
2,750,000 |
|
|
|
(2,750,000 |
)(b) |
|
|
|
|
|
|
|
|
|
Current liabilities of discontinued operations |
|
|
25,668 |
|
|
|
|
|
|
|
|
|
|
|
|
25,668 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
86,452,980 |
|
|
|
(85,432,212 |
) |
|
|
|
|
|
|
|
1,020,768 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other long term liabilities of continuing operations |
|
|
407,078 |
|
|
|
|
|
|
|
|
|
|
|
|
407,078 |
|
Notes payable |
|
|
|
|
|
|
6,000,060 |
(a) |
|
|
|
|
|
|
|
6,000,060 |
|
Deferred tax liability |
|
|
|
|
|
|
|
|
|
|
|
2,500,000 |
(f) |
|
|
2,500,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
86,860,058 |
|
|
|
(79,432,152 |
) |
|
|
|
2,500,000 |
|
|
|
9,927,906 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders Equity (Deficit): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Predecessor common stock |
|
|
42,821 |
|
|
|
(42,821 |
)(c) |
|
|
|
|
|
|
|
|
|
Predecessor additional paid-in capital |
|
|
142,737,499 |
|
|
|
(25,931,179 |
)(c) |
|
|
|
(116,806,320 |
)(g) |
|
|
|
|
Predecessor treasury stock |
|
|
(25,974,000 |
) |
|
|
25,974,000 |
(c) |
|
|
|
|
|
|
|
|
|
Successor common stock |
|
|
|
|
|
|
11,400 |
(a)(b) |
|
|
|
|
|
|
|
11,400 |
|
Successor additional paid-in capital |
|
|
|
|
|
|
5,460,600 |
(a)(b) |
|
|
|
(7,688,831 |
)(g) |
|
|
(2,228,231 |
) |
Accumulated deficit during development stage |
|
|
(202,295,959 |
) |
|
|
73,960,152 |
(a)(b)(c)(d) |
|
|
|
128,335,807 |
(g) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total shareholders equity (deficit) |
|
|
(85,489,639 |
) |
|
|
79,432,152 |
|
|
|
|
3,840,656 |
|
|
|
(2,216,831 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Noncontrolling interest |
|
|
382,982 |
|
|
|
|
|
|
|
|
|
|
|
|
382,982 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total equity (deficit) and noncontrolling interests |
|
|
(85,106,657 |
) |
|
|
79,432,152 |
|
|
|
|
3,840,656 |
|
|
|
(1,833,849 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities, shareholders equity/(deficit) and noncontrolling interests |
|
$ |
1,753,401 |
|
|
$ |
|
|
|
|
$ |
6,340,656 |
|
|
$ |
8,094,057 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes to Plan of Reorganization and fresh-start accounting adjustments
|
|
|
(a) |
|
This adjustment reflects the discharge of liabilities subject to compromise in accordance with
the Plan of Reorganization and the issuance of $6 million in Notes payable and the issuance of
4,080,000 shares of Successor Company common stock in satisfaction of such claims. |
|
(b) |
|
This adjustment reflects the discharge of prepetition loan and debtor in-possession loan in
accordance with the Plan of Reorganization and the issuance of 7,320,000 shares of the Successor
Company common stock in satisfaction of such claims. |
|
(c) |
|
This adjustment reflects the cancellation of the Predecessor Companys common stock, additional
paid-in capital and treasury stock. |
|
(d) |
|
To reset accumulated deficit to zero for the consolidated subsidiaries included in the Plan of
Reorganization. |
|
(e) |
|
This adjustment reflects the portion of the reorganization value which was attributed to
identified intangible assets. |
|
(f) |
|
To record deferred tax liability as a result of the impact of fresh-start accounting fair value
adjustments. |
|
(g) |
|
To reset Predecessor additional paid-in capital, accumulated deficit to zero and record net
fresh-start adjustments. |
F-27
Note 6Liabilities Subject to Compromise and Reorganization Items
Liabilities subject to compromise refers to pre-petition obligations that were impacted by the
Chapter 11 reorganization process. For further information regarding the discharge of liabilities
subject to compromise, see Note 5- Fresh-Start Accounting in the notes of these Financial
Statements. As of December 31, 2009, there were no liabilities subject to compromise.
The Company incurred certain professional fees and other expenses directly associated with the
bankruptcy proceedings. In addition, the Company has made adjustments to the carrying value of
certain prepetition liabilities. Such costs and adjustments are classified as reorganization
items, net and are presented separately in the unaudited consolidated statements of operations.
For the year ended December 31, 2009, the following have been incurred:
|
|
|
|
|
|
|
|
|
|
|
|
Successor |
|
|
|
Predecessor |
|
|
|
Four months ended |
|
|
|
Eight months ended |
|
|
|
December 31, 2009 |
|
|
|
August 31, 2009 |
|
Professional fees expense |
|
$ |
(13,825 |
) |
|
|
$ |
(533,271 |
) |
Debt issuance costs related to DIP facility |
|
|
|
|
|
|
|
(295,757 |
) |
Other debt issuance costs |
|
|
|
|
|
|
|
(280,964 |
) |
Gain (loss) on discharge of liabilities
subject to compromise |
|
|
(58,652 |
) |
|
|
|
74,648,976 |
|
|
|
|
|
|
|
|
|
Total reorganization items, net |
|
$ |
(72,477 |
) |
|
|
$ |
73,538,984 |
|
|
|
|
|
|
|
|
|
The $74.6 million gain from discharge of liabilities subject to compromise is the result
of the settlement of 3.5% Subordinated Notes in exchange for $6.0 million in Notes Payable and
3,960,000 shares of the Successor company, Debtor-in-Possession Credit Facility and Prepetition
Secured Loan in exchange for 7,320,000 shares of the Successor Companys common stock and unsecured
claims in exchange for 120,000 shares. On the Effective Date, all stock option plans of the
Predecessor Company were cancelled.
Cash paid for reorganization items during the year ended December 31, 2009 was $0.6 million.
Professional fees include financial, legal and valuation services directly associated with the
reorganization process.
Note 7Agera Laboratories, Inc.
On August 10, 2006, the Predecessor Company acquired 57% of the outstanding common shares of
Agera. Agera is a skincare company that has proprietary rights to a scientifically-based advanced
line of skincare products. Agera markets its product primarily in the United States and Europe. The
results of Ageras operations and cash flows have been included in the consolidated financial
statements from the date of the acquisition. The assets and liabilities of Agera have been included
in the consolidated balance sheets since the date of the acquisition.
Note 8 Discontinued Operations and Exit Costs
In 2007, the Predecessor Company completed the closure of its United Kingdom operation. As a
result of the closure of the United Kingdom operation, the operations that the Predecessor Company
previously conducted in Switzerland and Australia, which when closed had been absorbed into the
United Kingdom operation, were also classified as discontinued operations in 2007. All assets,
liabilities and results of operations of the United Kingdom, Switzerland and Australian operations
are reflected as discontinued operations in the accompanying consolidated financial statements. All
prior period information has been restated to reflect the presentation of discontinued operations.
F-28
The balance sheet components of discontinued operations as of December 31, 2009 and December
31, 2008 are comprised of less than $0.1 million and $0.2 million, respectively, of accrued
expenses and other current liabilities.
The following sets forth the results of operations of discontinued operations for the four
months ended December 31, 2009, eight months ended August 31, 2009 and for the year ended December
31, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor |
|
|
|
Predecessor |
|
|
Predecessor |
|
|
|
Four months |
|
|
|
Eight months |
|
|
Year ended |
|
|
|
December 31, |
|
|
|
August 31, |
|
|
December 31, |
|
(in millions) |
|
2009 |
|
|
|
2009 |
|
|
2008 |
|
Net revenue |
|
$ |
|
|
|
|
$ |
|
|
|
$ |
|
|
Gross loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss on sale of Swiss campus, before foreign currency gain |
|
|
|
|
|
|
|
|
|
|
|
(6.3 |
) |
Operating gain/(loss) |
|
|
|
|
|
|
|
0.2 |
|
|
|
(6.7 |
) |
Foreign exchange gain on substantial liquidation of foreign entity |
|
|
|
|
|
|
|
|
|
|
|
2.1 |
|
Other income/(loss) |
|
|
|
|
|
|
|
(0.1 |
) |
|
|
0.1 |
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from discontinued operations |
|
$ |
|
|
|
|
$ |
0.1 |
|
|
$ |
(4.5 |
) |
|
|
|
|
|
|
|
|
|
|
|
Note 9Property and Equipment
Property and equipment is comprised of:
|
|
|
|
|
|
|
|
|
|
|
|
Successor |
|
|
|
Predecessor |
|
|
|
Year ended |
|
|
|
Year ended |
|
|
|
December 31, |
|
|
|
December 31, |
|
|
|
2009 |
|
|
|
2008 |
|
Leasehold improvements |
|
$ |
|
|
|
|
$ |
3,753,998 |
|
Lab equipment |
|
|
|
|
|
|
|
1,447,218 |
|
Computer equipment and software |
|
|
|
|
|
|
|
1,101,097 |
|
Office furniture and fixtures |
|
|
|
|
|
|
|
18,236 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,320,549 |
|
Less: Accumulated depreciation and amortization |
|
|
|
|
|
|
|
(3,938,622 |
) |
Less: Impairment valuation |
|
|
|
|
|
|
|
(2,381,927 |
) |
|
|
|
|
|
|
|
|
Property and equipment, net |
|
$ |
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
The amounts of depreciation and amortization expense for the above property and equipment
included in the statement of operations are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
Successor |
|
|
|
Predecessor |
|
|
|
Year ended |
|
|
|
Year ended |
|
|
|
December 31, |
|
|
|
December 31, |
|
|
|
2009 |
|
|
|
2008 |
|
Depreciation expense related to
continuing operations: |
|
|
|
|
|
|
|
|
|
Selling, general,
administrative, research and development
expenses |
|
$ |
|
|
|
|
$ |
1,032,032 |
|
In 2008, due to the likelihood of bankruptcy and in connection with the Companys review for
impairment of long-lived assets in accordance with ASC 360, Accounting for the Impairment or
Disposal of Long-lived Assets, the Company has recorded a full impairment on all of its long-lived
assets as of December 31, 2008, and as such, has recorded an impairment charge of $6.7 million
during the year ended
December 31, 2008. $2.4 million of this $6.7 million impairment charge recorded during the
year ended December 31, 2008 related to property and equipment, as shown in the table above.
F-29
Note 10Accrued Expenses
Accrued expenses are comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
|
Successor |
|
|
|
Predecessor |
|
|
|
December 31, |
|
|
|
December 31, |
|
|
|
2009 |
|
|
|
2008 |
|
Accrued professional fees |
|
$ |
147,410 |
|
|
|
$ |
479,943 |
|
Accrued settlement fees |
|
|
|
|
|
|
|
325,000 |
|
Accrued compensation |
|
|
7,208 |
|
|
|
|
17,570 |
|
Accrued interest |
|
|
246,578 |
|
|
|
|
525,000 |
|
Dividend on preferred stock payable |
|
|
42,740 |
|
|
|
|
|
|
Accrued other |
|
|
92,919 |
|
|
|
|
300,200 |
|
|
|
|
|
|
|
|
|
Accrued expenses |
|
$ |
536,855 |
|
|
|
$ |
1,647,713 |
|
|
|
|
|
|
|
|
|
Note 11Debt
As part of the Plan of Reorganization, the Successor Company was discharged of the
Pre-petition Secured Loan, Debtor-in-Possession Credit Facility, related accrued interest and
converted the 3.5% Convertible Subordinated Notes into new 12.5% Promissory notes as defined below.
The Successor Company recorded a $74,648,976 gain relating to the extinguishment of debt as a
result of this Plan of Reorganization.
The Successor Companys outstanding long-term debt at December 31, 2009 consists of $6 million
of 12.5% Unsecured Promissory Notes (New Notes). The New Notes have the following features: (1)
12.5% interest payable quarterly in cash or, at the Successor Companys option, 15% payable in kind
by capitalizing such unpaid amount and adding it to the principal as of the date it was due; (2)
maturing June 1, 2012; (3) at any time prior to the maturity date, the Successor Company may redeem
any portion of the outstanding principal of the New Notes in Cash at 125% of the stated face value
of the New Notes. There is a mandatory redemption feature that requires the Successor Company to
redeem all outstanding new notes if: (1) the Successor Company successfully completes a capital
campaign raising in excess of $10 million; or (2) the Successor Company is acquired by, or sell a
majority stake to, an outside party.
Total debt is comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
|
Successor |
|
|
|
Predecessor |
|
|
|
December 31, |
|
|
|
December 31, |
|
|
|
2009 |
|
|
|
2008 |
|
Convertible Subordinated Notes |
|
$ |
|
|
|
|
$ |
90,072,286 |
|
|
|
|
|
|
|
|
|
Total Current Debt |
|
|
|
|
|
|
|
90,072,286 |
|
Promissory Note |
|
|
6,000,060 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total debt |
|
$ |
6,000,060 |
|
|
|
$ |
90,072,286 |
|
|
|
|
|
|
|
|
|
Note 12Income Taxes
Fibrocell Science, Inc. and Fibrocell Technologies, Inc. file a consolidated U.S. Federal
income tax return. During the third quarter of 2006, the Company acquired a 57% interest in Agera
(see Note 7). Agera files a separate U.S. Federal income tax return. The Companys foreign
subsidiaries, which comprise loss from discontinued operations, file income tax returns in their
respective jurisdictions. The geographic source of loss from continuing operations is the United
States.
F-30
The components of the income tax expense/(benefit) related to continuing operations, are as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor |
|
|
|
Predecessor |
|
|
Predecessor |
|
|
|
Four months |
|
|
|
Eight months |
|
|
Year ended |
|
|
|
December 31, |
|
|
|
August 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
|
2009 |
|
|
2008 |
|
U.S. Federal: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Current. |
|
$ |
|
|
|
|
$ |
|
|
|
$ |
|
|
Deferred |
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. State: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Current. |
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
The reconciliation between income taxes/(benefit) at the U.S. federal statutory rate and the
amount recorded in the accompanying consolidated financial statements is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor |
|
|
|
Predecessor |
|
|
Predecessor |
|
|
|
Four months |
|
|
|
Eight months |
|
|
Year ended |
|
|
|
December 31, |
|
|
|
August 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
|
2009 |
|
|
2008 |
|
Tax/(benefit) at U.S. federal statutory rate |
|
$ |
(1,757,838 |
) |
|
|
$ |
23,058,084 |
|
|
$ |
(10,017,185 |
) |
Increase/(decrease) in domestic valuation allowance |
|
|
2,303,065 |
|
|
|
|
(30,209,991 |
) |
|
|
11,815,611 |
|
State income taxes/(benefit) before valuation
allowance, net of federal benefit |
|
|
(357,619 |
) |
|
|
|
4,690,990 |
|
|
|
(1,797,593 |
) |
Deferred tax impact of reorganization |
|
|
(172,395 |
) |
|
|
|
2,261,359 |
|
|
|
|
|
Other |
|
|
(15,213 |
) |
|
|
|
199,558 |
|
|
|
(833 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
The components of the Companys net deferred tax liabilities at December 31, 2009 and 2008 are
as follows:
|
|
|
|
|
|
|
|
|
|
|
|
Successor |
|
|
|
Predecessor |
|
|
|
December 31, |
|
|
|
December 31, |
|
|
|
2009 |
|
|
|
2008 |
|
Deferred tax liabilities: |
|
|
|
|
|
|
|
|
|
Intangible assets |
|
$ |
2,500,000 |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
Total deferred tax liabilities |
|
$ |
2,500,000 |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred tax assets: |
|
|
|
|
|
|
|
|
|
Loss carryforwards |
|
$ |
32,942,543 |
|
|
|
$ |
57,112,820 |
|
Property and equipment |
|
|
1,559,631 |
|
|
|
|
1,708,838 |
|
Accrued expenses and other |
|
|
1,551,822 |
|
|
|
|
2,625,285 |
|
Stock compensation |
|
|
548,078 |
|
|
|
|
2,476,915 |
|
|
|
|
|
|
|
|
|
Total deferred tax assets |
|
|
36,602,074 |
|
|
|
|
63,923,858 |
|
Less: valuation allowance |
|
|
(36,602,074 |
) |
|
|
|
(63,923,858 |
) |
|
|
|
|
|
|
|
|
Total deferred tax assets |
|
$ |
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net deferred tax liabilities |
|
$ |
2,500,000 |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
F-31
As of December 31, 2009, the Company had generated U.S. net operating loss carryforwards of
approximately $68.9 million which expire from 2026 to 2029 and net loss carryforwards in certain
non-US jurisdictions of approximately $24.9 million. The U.S. net operating loss carryforwards
were reduced by approximately $74 million as a result of the Companys emergence from bankruptcy
(see Note 1, Emergence from Voluntary Reorganization Under Chapter 11 Proceedings and
Reorganization Plan). The net operating loss carryforwards are available to reduce future taxable
income. However, a, change in ownership, as defined by federal income tax regulations, could
significantly limit the Companys ability to utilize its U.S. net operating loss carryforwards.
Additionally, because federal tax laws limit the time during which the net operating loss
carryforwards may be applied against future taxes, if the Company fails to generate taxable income
prior to the expiration dates it may not be able to fully utilize the net operating loss
carryforwards to reduce future income taxes. As the Company has had cumulative losses and there is
no assurance of future taxable income, valuation allowances have been recorded to fully offset the
deferred tax asset at December 31, 2009 and 2008. The valuation allowance decreased by $27.3
million during 2009, due primarily to the impact from the Companys reorganization described above
and the current year net loss, and increased by $9.1 million during 2008, due primarily to the
Companys net loss in that period.
Note 13Commitments and Contingencies
Legal Proceedings
In connection with certain federal securities and derivative litigations of Isolagen
previously described in the Predecessor Companys public reports, Mr. Jeffrey Tomz, who formerly
served as Isolagens Chief Financial Officer, demanded reimbursement of his costs of defense, and
reimbursement for the costs of responding to a Securities and Exchange Commission investigation of
his alleged insider trading in Isolagen stock. In connection with the reorganized companys exit
from bankruptcy, Mr. Tomz claim was treated as a general unsecured claim and was awarded its pro
rata share of the common stock issued to the general unsecured creditors.
Employment Agreements
On February 1, 2010, the Company entered into an employment agreement with Mr. Pernock
pursuant to which Mr. Pernock agreed to serve as Chief Executive Officer of the Company for an
initial term ending February 1, 2013, which may be renewed for an additional one-year term by
mutual agreement. The agreement provides for an annual salary of $450,000. Mr. Pernock is entitled
to receive an annual bonus each year, payable subsequent to the issuance of the Companys final
audited financial statements, but in no case later than 120 days after the end of its most recently
completed fiscal year. The final determination on the amount of the annual bonus will be made by
the Board of Directors (or the Compensation Committee of the Board of Directors, if such committee
has been formed), based on criteria established by the Board of Directors (or the Compensation
Committee of the Board of Directors, if such committee has been formed). The targeted amount of the
annual bonus shall be 60% of Mr. Pernocks base salary, although the actual bonus may be higher or
lower.
Under the agreement, Mr. Pernock was granted a ten-year option to purchase 1,650,000 shares at
an exercise price per share equal to the closing price of the Companys common stock on the date of
execution of the agreement, or February 1, 2010. The options vest as follows: (i) 250,000 shares
upon execution of the agreement; (ii) 100,000 shares upon the closing of a strategic partnership or
licensing deal with a major partner that enables the Company to significantly improve and/or
accelerate its capabilities in such areas as research, production, marketing and/or sales and
enable the Company to reach or exceed its major business milestones within the Companys strategic
and operational plans, provided Mr. Pernock is the CEO on the closing date of such partnership or
licensing deal (the determination of whether any partnership or licensing deal meets the foregoing
criteria will be made in good faith by the Board upon the closing of such partnership or licensing
deal); and (iii) 1,300,000 shares in equal 1/36th installments (or 36,111 shares per installment)
monthly over a three-year period, provided Executive is the CEO on each vesting date. The vesting
of all options set forth above shall accelerate upon a change in control as
defined in the agreement, provided Mr. Pernock is employed by the Company within 60 days prior
to the date of such change in control.
F-32
If Mr. Pernocks employment is terminated at the Companys election at any time, for reasons
other than death, disability, cause (as defined in the agreement) or a voluntary resignation, or by
Mr. Pernock for good reason (as defined in the agreement), Mr. Pernock shall be entitled to receive
severance payments equal to twelve months of Mr. Pernocks base salary and of the premiums
associated with continuation of Mr. Pernocks benefits pursuant to COBRA to the extent that he is
eligible for them following the termination of his employment; provided that if anytime within
eighteen months after a change in control either (i) Mr. Pernock is terminated, at the Companys
election at any time, for reasons other than death, disability, cause or voluntary resignation, or
(ii) Mr. Pernock terminates the agreement for good reason, Mr. Pernock shall be entitled to receive
severance payments equal to: (1) two years of Mr. Pernocks base salary, (2) Mr. Pernocks most
recent annual bonus payment, and (3) the premiums associated with continuation of Mr. Pernocks
benefits pursuant to COBRA to the extent that he is eligible for them following the termination of
his employment for a period of one year after termination. All severance payments shall be made in
a lump sum within ten business days of Mr. Pernocks execution and delivery of a general release of
the Company, its parents, subsidiaries and affiliates and each of its officers, directors,
employees, agents, successors and assigns in a form acceptable to the Company. If severance
payments are being made, Mr. Pernock has agreed not to compete with the Company until twelve months
after the termination of his employment.
Mr. Daly is entitled to receive an annual bonus, payable each year subsequent to the issuance
of final audited financial statements, but in no case later than 120 days after the end of our most
recently completed fiscal year. The final determination on the amount of the annual bonus will be
made by the Compensation Committee of the Board of Directors, based primarily on criteria mutually
agreed upon with Mr. Daly. The targeted amount of the annual bonus shall be 50% of Mr. Dalys base
salary. Mr, Dalys annual based salary is $300,000. The actual annual bonus for any given period
may be higher or lower than 50%. For any fiscal year in which Mr. Daly is employed for less than
the full year (other than for 2009), he shall receive a bonus which is prorated based on the number
of full months in the year which are worked. Mr. Daly is entitled to a bonus of $50,000 if we are
able to complete a capital raise or series of capital raises in excess of $6.0 million, provided
Mr. Daly is our chief operating officer at such time. Mr. Daly is entitled to a bonus of $50,000 if
our BLA is approved by the FDA, provided Mr. Daly is our chief operating officer at such time.
Consulting Agreements
Effective upon our exit from bankruptcy on September 3, 2009, we entered into a consultant
agreement, pursuant to which Dr. Langer agreed to provide consulting services to us, including
serving as a scientific advisor. The agreement has a one year term, provided that either party may
terminate the agreement on 30 days notice. The agreement provides Dr. Langer annual compensation
of $50,000.
In October 2009, we entered into two consulting agreements with two individuals. We issued the
two consultants options to purchase 200,000 shares and 150,000 shares, respectively. The options
have an expiration date five years from the date of issuance and an exercise price of $0.75 per
share.
In December 2009, we entered into a consulting agreement with one individual and issued the
consultant options to purchase 100,000 shares. The options have an expiration date five years from
the date of issuance and an exercise price of $1.25 per share.
F-33
Leases
The Company has entered into a lease for office, warehouse and laboratory facilities in Exton,
Pennsylvania under a third party non-cancelable operating lease through 2013. Future minimum lease
commitments at December 31, 2009 are as follows:
|
|
|
|
|
Year Ending |
|
|
|
|
December 31, |
|
|
|
|
2010 |
|
$ |
1,177,570 |
|
2011 |
|
|
1,177,570 |
|
2012 |
|
|
1,177,570 |
|
2013 |
|
|
294,393 |
|
|
|
|
|
Total |
|
$ |
3,827,103 |
|
|
|
|
|
For the years ended December 31, 2009 and 2008, rental expense totaled $1.4 million and $1.5
million, respectively, (which includes rent expense related to discontinued operations of $0.1
million for the year ended December 31, 2008).
In April 2005, the Company entered into a non-cancelable three year operating lease for
approximately 86,500 square feet in Exton, Pennsylvania. This facility houses members of the senior
management team, quality and manufacturing personnel, and the corporate finance department. The
Company began constructing a production line in a portion of this facility in anticipation of
eventual FDA approval. The facility was completed during September 2005. This production line is
expected to be utilized for the production of clinical supplies. During 2007, the Company extended
the lease through March 31, 2013. Lease expense is recognized on a straight-line basis through
March 31, 2013. The Exton, Pennsylvania minimum lease payments are included in the future minimum
lease commitments table above through March 31, 2013.
Note 14-Equity
Redeemable Preferred Stock
On October 13, 2009, Successor Company entered into a Securities Purchase Agreement (the
Purchase Agreement) with certain accredited investors (the Purchasers), pursuant to which the
Company agreed to sell to the Purchasers in the aggregate: (i) 3,250 shares of Series A Convertible
Preferred Stock, with a par value of $0.001 per share and a stated value of $1,000 per share
(Series A Preferred), (ii) Class A warrants to purchase 501,543 shares of Company common stock
(Common Stock) at an exercise price of $1.62 per share (the Class A Warrants); and (iii) Class
B warrants to purchase 416,667 shares of Company common stock at an exercise price of $1.95 per
share (the Class B Warrants) (the Class A Warrants and Class B Warrants, the Warrants).
The aggregate purchase price paid by the Purchasers for the Series A Preferred and the
Warrants was $3,250,000 (representing $1,000 for each share of Series A Preferred together with a
Class A Warrant and Class B Warrant). The Company intends to use the proceeds for working capital
purposes.
Dividends; Rank; Liquidation
Holders of the Series A Preferred are entitled to receive cumulative dividends at the rate per
share (as a percentage of the stated value per share) of 6% per annum (subject to increase in
certain circumstances), payable quarterly in arrears on January 15, April 15, July 15 and October
15, beginning on April 15, 2010. The dividends are payable in cash, or at our option, in duly
authorized, validly issued, fully paid and non-assessable shares of common stock equal to 110% of
the cash dividend amount payable on the dividend payment date, or a combination thereof; provided
that we may not pay the dividends in shares of common stock unless we meet certain conditions
described in the Certificate of Designation, including that the resale of the shares has been
registered under the Securities Act. If we pay the dividend in shares of common stock, the common
stock will be valued for such purpose at 80% of the average of the volume weighted average price
for the 10 consecutive trading days ending on the trading day that is immediately prior to the
dividend payment date.
F-34
The Series A Preferred ranks senior to all shares of common stock.
Upon our liquidation, dissolution or winding-up, whether voluntary or involuntary, the holders
of the Series A Preferred shall be entitled to receive out of our assets, whether capital or
surplus, an amount equal to the stated value of the common stock, plus any accrued and unpaid
dividends thereon and any other fees or liquidated damages then due and owing thereon under the
Certificate of Designation, for each share of Series A Preferred before any distribution or payment
shall be made to the holders of any junior securities, and if our assets are insufficient to pay in
full such amounts, then the entire assets to be distributed to the holders of the Series A
Preferred shall be ratably distributed among the holders in accordance with the respective amounts
that would be payable on such shares if all amounts payable thereon were paid in full.
Conversion; Conversion Price; Forced Conversion; Optional Redemption
Each share of Series A Preferred is convertible into a number of shares of common stock equal
to (1) the stated value of the share ($1,000), divided by (2) $1.30, subject to adjustment as
discussed below. We refer to this price as the Conversion Price.
With certain exceptions, if, at any time while the Series A Preferred is outstanding, we sell
or grant any option to purchase or sell or grant any right to reprice, or otherwise dispose of or
issue (or announce any sale, grant or any option to purchase or other disposition), any common
stock or common stock equivalents at an effective price per share that is lower than the then
Conversion Price, then the Conversion Price will be reduced to equal the lower price (down-round
provision). The Conversion Price is also subject to proportional adjustment in the event of any
stock split, stock dividend, reclassification or similar event with respect to the common stock.
Commencing six months from the date of the agreement pursuant to which we issued the Series A
Preferred, if the volume weighted average price for each of any 20 consecutive trading days exceeds
200% of the then effective Conversion Price and various other equity conditions are satisfied
(including that the resale of the shares underlying the Series A Preferred has been registered
under the Securities Act), upon 30 days notice, the Series A Preferred plus all accrued and unpaid
dividends will automatically convert into shares of common stock.
Commencing two years from the date of the agreement pursuant to which we issued the Series A
Preferred, upon 30 days notice and provided various other equity conditions are satisfied
(including that the resale of the shares underlying the Series A Preferred has been registered
under the Securities Act), we may redeem some or all of the then outstanding Series A Preferred for
cash in an amount equal to the 150% of the stated value of the Series A Preferred.
Voting
The holders of the Series A Preferred have no voting rights except with respect to specified
matters affecting the rights of the Series A Preferred.
Negative Covenants
As long as any shares of Series A Preferred are outstanding, we may not, directly or
indirectly: (a) amend our charter documents in any manner that materially and adversely affects any
rights of the holders of the Series A Preferred; (b) pay cash dividends or distributions on our
junior securities (including the common stock); or (c) enter into any transaction with any
affiliate of ours which would be required to be disclosed in any public filing, unless such
transaction is made on an arms-length basis and expressly approved by a majority of our
disinterested directors.
Triggering Events
In the event of a Triggering Event (as defined in the Certificate of Designation and described
below), any holder of Series A Preferred may require us to redeem all of its Series A Preferred, at
a redemption price equal to the greater of (a) 130% of the stated value and (b) the product of (i)
the volume
weighted average price on the trading day immediately preceding the date of the Triggering
Event and (ii) the stated value divided by the then Conversion Price, plus all accrued but unpaid
dividends thereon and all liquidated damages and other costs, expenses or amounts due in respect of
the Series A Preferred. Triggering Events include, among other things, bankruptcy related events,
change of control transactions (as defined in the Certificate of Designation), and various types of
failures to perform under, and breaches of, the transaction documents.
F-35
Since the Successors common stock was not trading on October 13, 2009, the market value of
the Successor Companys common stock was determined by the exit financing transaction on September
9, 2009 which was $0.75 per common share. The preferred stock has been classified within the
mezzanine section between liabilities and equity in its consolidated balance sheets because any
holder of Series A Preferred may require the Successor Company to redeem all of its Series A
Preferred in the event of a triggering event (as defined in the Certificate of Designation) which
is outside of the control of the Successor Company. The Successor Company recorded accrued
dividends at a rate of 6% per annum on the Series A Preferred stock of $42,740 for the four months
ended December 31, 2009.
Viriathus Capital LLC and John Carris Investments LLC were co-placement agents for the
Transaction, and received cash compensation of $325,000 and warrants to purchase 250,000 shares of
Common Stock at an exercise price of $1.30 per share.
Registration Rights
In connection with the Series A Preferred purchase agreement, the Successor Company entered
into a Registration Rights Agreements with the purchasers of the Series A Preferred, which requires
us to register the resale of the 110% of the shares of common stock underlying the Series A
Preferred, the shares of common stock underlying the Class A warrants, Class B warrants and
placement agent warrant, and all shares of common stock issuable as dividends on the Series A
Preferred assuming all dividend payments are made in shares of common stock and the Series A
Preferred is held for at least 3 years. The Successor Company filed a Form S-1 registration
statement with the SEC on November 27, 2009. The Registration Statement was effective on February
12, 2010.
Note 15-Warrants
Series A and B Warrants
As disclosed above in Note 14 , in connection with the preferred stock transaction, the
Successor Company issued Class A warrants to purchase 501,543 shares of Common Stock at an
exercise price of $1.62 per share Class A Warrants; and Class B Warrants to purchase 416,667 shares
of Company common stock at an exercise price of $1.95 per share. The warrants were exercisable
immediately after grant and expire five years thereafter. With certain exceptions, if, at any time
while the warrants are outstanding, the Successor Company sells or grants any option to purchase or
sells or grants any right to reprice, any common stock or common stock equivalents at an effective
price per share that is lower than the then exercise price of the relevant warrant, then the
relevant warrants, then the exercise price of such warrants will be reduced to equal the lower
price (down-round provision). As a result of the down-round price protection, the warrants are
liability-classified and they are re-measured on the Companys reporting dates. The value of the
Class A and B Warrants was computed using the Black-Scholes option pricing model. The Company
recorded the issuance of the Class A and B Warrants at their approximate fair market value of $0.3
million.
Placement Agent Warrants
As disclosed above in Note 14, the Successor Company issued Placement Agent Warrants to
purchase an aggregate of 250,000 shares of the Companys common stock to the Companys placement
agents in connection with their roles in the Offering. The placement warrants are also subject to
the down-round price protection, the warrants are liability-classified and they are re-measured
on the Companys reporting dates.
F-36
The Successor Company recorded the issuance of the Placement Agent Warrants at their
approximate fair market value of approximately $0.1 million. The warrants were exercisable
immediately after grant and expire five years thereafter. The fair market of the warrants granted
to the co-placement agents, based on the Black-Scholes valuation model, is estimated to be $0.33
per warrant. The value of the warrants granted was offset against the proceeds received from the
sale of the Series A Preferred Stock.
The Successor Company recognizes these warrants as a liability at the fair value on each
reporting date. The Company measured the fair value of these warrants as of December 31, 2009, and
recorded
warrant expense of $319,084 resulting from the increase in the liability associated with the
fair value of the warrants for the year ended December 31, 2009. The Successor Company has
accounted for the Series A and B warrants and the placement warrants as a liability due to the
down-round price protection provision. The Company computed the value of the warrants using the
Black-Scholes method.
The fair market value of the warrants was computed using the Black-Scholes option-pricing
model with the following key assumptions as of the dates indicated:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
October 13, |
|
|
|
2009 |
|
|
2009 |
|
Expected life (years) |
|
4.8 years |
|
5 years |
Interest rate |
|
2.7% |
|
2.3% |
Dividend yield |
|
|
|
|
Volatility |
|
66% |
|
66% |
The fair value of the warrants will continue to be classified as a liability until such time
as the warrants are exercised, expire or an amendment of the warrant agreements renders these
warrants to be no longer classified as a liability. The estimated fair value of our warrant
liability, at December 31, 2009, was $635,276.
Note 16Equity-based Compensation
Total stock-based compensation expense recognized using the straight-line attribution method
in the consolidated statement of operations is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor |
|
|
|
Predecessor |
|
|
Predecessor |
|
|
|
Four months |
|
|
|
Eight months |
|
|
Twelve months |
|
|
|
December 31, |
|
|
|
August 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
|
2009 |
|
|
2008 |
|
Stock option compensation expense for
employees and directors |
|
$ |
326,838 |
|
|
|
$ |
581,707 |
|
|
$ |
1,945,082 |
|
Restricted stock expense |
|
|
168,000 |
|
|
|
|
|
|
|
|
|
|
Equity awards for nonemployees issued for services |
|
|
386,380 |
|
|
|
|
1,746 |
|
|
|
187,515 |
|
|
|
|
|
|
|
|
|
|
|
|
Total stock-based compensation expense |
|
$ |
881,218 |
|
|
|
$ |
583,453 |
|
|
$ |
2,132,597 |
|
|
|
|
|
|
|
|
|
|
|
|
Successor Company
Our board of directors adopted the 2009 Equity Incentive Plan (the Plan) effective September
3, 2009. The Plan is intended to further align the interests of the Successor Company and its
stockholders with its employees, including its officers, non-employee directors, consultants and
advisors by providing incentives for such persons to exert maximum efforts for the success of the
Successor Company. The Plan allows for the issuance of up to 4,000,000 shares of the Successor
Companys common stock. The types of awards that may be granted under the Plan include options
(both nonqualified stock options and incentive stock options), stock appreciation rights, stock
awards, stock units, and other stock-based awards. Notwithstanding the foregoing, to the extent
the Successor Company is unable to obtain shareholder approval of the Plan within one year of the
effective date, any incentive stock options issued pursuant to the Plan shall automatically be
considered nonqualified stock options, and to the extent a holder of an incentive stock option
exercises his or her incentive stock option prior to such shareholder approval date, such
exercised option shall automatically be considered to have been a nonqualified stock option.
The term of each award is determined by the Board at the time each award is granted, provided that
the terms of options may not exceed ten years.
F-37
As part of the emergence from Chapter 11, the Successor Company granted stock options to
directors and non-employees for services in September 2009. In addition, restricted stock was
issued to the chief executive officer which is subject to a two-year vesting schedule whereby 50%
vested immediately on September 3, 2009, 25% shall vest on the first anniversary, and 25% shall
vest on the second anniversary.
The Successor Company issued additional stock options in the fourth quarter of 2009 to the
chief executive officer, employees and non-employees for services.
During the period September 2009 through December 2009, the weighted average fair market value
using the Black-Scholes option-pricing model of the options granted was $0.33 for this period. The
fair market value of the stock options at the date of grant was estimated using the Black-Scholes
option-pricing model with the following weighted average assumptions:
|
|
|
|
|
Four Months Ended |
|
|
December 31, |
|
|
2009 |
Expected life (years) |
|
2.7 years |
Interest rate |
|
1.4% |
Dividend yield |
|
|
Volatility |
|
67% |
There were no stock options exercised during the period September 2009 through December
2009.
A summary of option activity for the four months ended December 31, 2009 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Average |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Remaining |
|
|
Aggregate |
|
|
|
|
|
|
|
Exercise |
|
|
Contractual |
|
|
Intrinsic |
|
Options |
|
Shares |
|
|
Price |
|
|
Term |
|
|
Value |
|
|
Outstanding at September 1, 2009 |
|
|
|
|
|
$ |
0.00 |
|
|
|
|
|
|
|
|
|
Four months ended December 31, 2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
2,807,000 |
|
|
|
0.77 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2009 |
|
|
2,807,000 |
|
|
$ |
0.77 |
|
|
|
4.67 |
|
|
$ |
0.38 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at December 31, 2009 |
|
|
2,130,000 |
|
|
$ |
0.76 |
|
|
|
4.67 |
|
|
$ |
0.39 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-38
The following table summarizes the Successor Companys non-vested stock options since
September 1, 2009:
|
|
|
|
|
|
|
|
|
|
|
Non-vested Options |
|
|
|
|
|
|
|
Weighted- |
|
|
|
Number of |
|
|
Average Fair |
|
|
|
Shares |
|
|
Value |
|
Non-vested at September 1, 2009 |
|
|
|
|
|
$ |
|
|
Granted |
|
|
2,807,000 |
|
|
|
|
|
Vested |
|
|
(2,130,000 |
) |
|
|
|
|
Forfeited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-vested at December 31, 2009 |
|
|
677,000 |
|
|
$ |
0.36 |
|
|
|
|
|
|
|
|
The total fair value of shares vested during the four months ended December 31, 2009 was $0.7
million. As of December 31, 2009, there was $0.2 million of total unrecognized compensation cost,
related to non-vested stock options which vest over time. That cost is expected to be recognized
over a weighted-average period of 1 year. As of December 31, 2009, there was $83,000 of total
unrecognized compensation expense related to performance-based, non-vested employee and consultant
stock options. That cost will be recognized when the performance criteria within the respective
performance-based option grants become probable of achievement.
Restricted stock
The following table summarizes the Successors restricted stock activity for the four months
ended December 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
Non-vested Options |
|
|
|
|
|
|
|
Weighted- |
|
|
|
Number of |
|
|
Average Fair |
|
|
|
Shares |
|
|
Value |
|
Non-vested at September 1, 2009 |
|
|
|
|
|
$ |
|
|
Granted |
|
|
600,000 |
|
|
|
0.48 |
|
Vested |
|
|
(300,000 |
) |
|
|
0.48 |
|
Forfeited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-vested at December 31, 2009 |
|
|
300,000 |
|
|
$ |
0.48 |
|
|
|
|
|
|
|
|
As of December 31, 2009, there was $0.1 million of total unrecognized compensation cost
related to non-vested restricted stock that is expected to be recognized over a weighted-average
period of 1.67 years.
Predecessor Company
Prior to the Effective Date, the Predecessor Company maintained stock-based incentive
compensation plans for employees and directors of the Company. On the Effective Date, the
following stock option plans were terminated (and any and all awards granted under such plans were
terminated and will no longer be of any force or effect): (1) the 2001 Stock Option and
Appreciation Rights Plan, (2) the 2003 Stock Option and Appreciation Rights Plan, (3) the 2005
Stock Option and Appreciation Rights Plan. As a result of the cancellation of the stock options,
the Predecessor Company recorded additional stock compensation expense of $0.3 million for the
unrecognized stock compensation expense.
F-39
Note 17Segment Information and Geographical information
The Successor Company has two reportable segments: Fibrocell Therapy and Agera. The Fibrocell
Therapy segment specializes in the development and commercialization of autologous cellular
therapies for soft tissue regeneration. The Agera segment maintains proprietary rights to a
scientifically-based advanced line of skincare products. There is no intersegment revenue. The
following table provides operating financial information for the continuing operations of the
Successor Companys two reportable segments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment |
|
|
|
|
|
|
|
|
|
|
Successor |
|
|
|
|
|
|
Successor |
|
Four Months Ended December 31, 2009 |
|
Fibrocell Therapy |
|
|
Agera |
|
|
Consolidated |
|
Total operating revenue |
|
$ |
|
|
|
$ |
329,941 |
|
|
$ |
329,941 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment loss from continuing operations |
|
$ |
(5,026,024 |
) |
|
$ |
3,631 |
|
|
$ |
(5,022,393 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental information related to continuing operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization expense |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Total assets, including assets from discontinued
operations as of December 31, 2009 |
|
|
8,092,816 |
|
|
|
631,393 |
|
|
|
8,724,209 |
|
Property and equipment, net |
|
|
|
|
|
|
|
|
|
|
|
|
Intangible assets, net |
|
|
6,340,656 |
|
|
|
|
|
|
|
6,340,656 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment |
|
|
|
|
|
|
Predecessor |
|
|
|
|
|
|
Predecessor |
|
Eight Months Ended August 31, 2009 |
|
Isolagen Therapy |
|
|
Agera |
|
|
Consolidated |
|
Total operating revenue |
|
$ |
|
|
|
$ |
538,620 |
|
|
$ |
538,620 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment income from continuing operations |
|
$ |
65,498,934 |
|
|
$ |
381,306 |
|
|
$ |
65,880,240 |
|
|
|
|
|
|
|
|
|
|
|
An intercompany receivable as of December 31, 2009, of $1.0 million, due from the Agera
segment to the Fibrocell Therapy segment, is eliminated in consolidation. This intercompany
receivable is primarily due to the intercompany management fee charge to Agera by Fibrocell
Technologies, Inc., as well as Agera working capital needs provided by Fibrocell Technologies,
Inc., and has been excluded from total
assets of the Fibrocell Therapy segment in the above table. There is no intersegment revenue.
Total assets on the consolidated balance sheet at December 31, 2009 are approximately $8.7 million,
which includes assets of discontinued operations of less than $0.1 million.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment |
|
|
|
|
|
|
Predecessor |
|
|
|
|
|
|
Predecessor |
|
Year Ended December 31, 2008 |
|
Isolagen Therapy |
|
|
Agera |
|
|
Consolidated |
|
Total operating revenue |
|
$ |
|
|
|
$ |
1,104,885 |
|
|
$ |
1,104,885 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment loss from continuing operations |
|
$ |
(24,334,980 |
) |
|
$ |
(4,285,549 |
) |
|
$ |
(28,620,529 |
) |
|
|
|
|
|
|
|
|
|
|
|
Supplemental information related to continuing operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization expense |
|
$ |
1,050,024 |
|
|
$ |
326,839 |
|
|
$ |
1,376,863 |
|
Total assets, including assets from discontinued
operations as of December 31, 2008 |
|
|
4,019,714 |
|
|
|
1,033,691 |
|
|
|
5,053,405 |
|
Property and equipment, net |
|
|
|
|
|
|
|
|
|
|
|
|
Intangible assets, net |
|
|
|
|
|
|
|
|
|
|
|
|
F-40
An intercompany receivable of $1.0 million, due from the Agera segment to the Isolagen
Therapy segment as of December 31, 2008, is eliminated in consolidation. This intercompany
receivable is primarily due to the intercompany management fee charge to Agera by Isolagen, as well
as Agera working capital needs provided by Isolagen, and has been excluded from total assets of the
Isolagen Therapy segment in the above table. Total assets on the consolidated balance sheet at
December 31, 2008 are approximately $5.1 million, which includes assets of continuing operations of
$5.1 million and assets of discontinued operations of less than $0.1 million.
Geographical information concerning the Successor Companys operations and assets is as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
|
|
Revenue |
|
|
|
Successor |
|
|
|
Predecessor |
|
|
|
Four months ended |
|
|
|
Eight months ended |
|
|
Year ended |
|
|
|
December 31, 2009 |
|
|
|
August 31, 2009 |
|
|
December 31, 2008 |
|
United States |
|
$ |
68,526 |
|
|
|
$ |
187,289 |
|
|
$ |
312,139 |
|
United Kingdom |
|
|
251,615 |
|
|
|
|
308,244 |
|
|
|
712,105 |
|
Other |
|
|
9,800 |
|
|
|
|
43,087 |
|
|
|
80,641 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
329,941 |
|
|
|
$ |
538,620 |
|
|
$ |
1,104,885 |
|
|
|
|
|
|
|
|
|
|
|
|
During the four months ended December 31, 2009, revenue from one foreign customer and
one domestic customer represented 79% and 15% of consolidated revenue, respectively. During the
eight months ended August 31, 2009, revenue from one foreign customer and one domestic customer
represented 57% and 23% of consolidated revenue, respectively. During 2008, revenue from one
foreign customer and one domestic customer represented 64% and 20% of consolidated revenue,
respectively.
As of December 31, 2009 and December 31, 2008, one foreign customer represented 87% and 94%,
respectively, of accounts receivable, net.
Note 18Subsequent Events
Subsequent events have been evaluated by the Successor Company through March 31, 2010, which
is the date the financial statements were available to be issued.
On February 1, 2010, the Company entered into an employment agreement with Mr. Pernock
pursuant to which Mr. Pernock agreed to serve as Chief Executive Officer of the Company for an
initial term ending February 1, 2013, which may be renewed for an additional one-year term by
mutual agreement. The agreement provides for an annual salary of $450,000. Mr. Pernock is entitled
to receive an annual bonus each year, payable subsequent to the issuance of the Companys final
audited financial statements, but in no case later than 120 days after the end of its most recently
completed fiscal year. The
final determination on the amount of the annual bonus will be made by the Board of Directors
(or the Compensation Committee of the Board of Directors, if such committee has been formed), based
on criteria established by the Board of Directors (or the Compensation Committee of the Board of
Directors, if such committee has been formed). The targeted amount of the annual bonus shall be 60%
of Mr. Pernocks base salary, although the actual bonus may be higher or lower.
F-41
Under the agreement, Mr. Pernock was granted a ten-year option to purchase 1,650,000 shares at
an exercise price per share equal to the closing price of the Companys common stock on the date of
execution of the agreement, or February 1, 2010. The options vest as follows: (i) 250,000 shares
upon execution of the agreement; (ii) 100,000 shares upon the closing of a strategic partnership or
licensing deal with a major partner that enables the Company to significantly improve and/or
accelerate its capabilities in such areas as research, production, marketing and/or sales and
enable the Company to reach or exceed its major business milestones within the Companys strategic
and operational plans, provided Mr. Pernock is the CEO on the closing date of such partnership or
licensing deal (the determination of whether any partnership or licensing deal meets the foregoing
criteria will be made in good faith by the Board upon the closing of such partnership or licensing
deal); and (iii) 1,300,000 shares in equal 1/36th installments (or 36,111 shares per installment)
monthly over a three-year period, provided Executive is the CEO on each vesting date. The vesting
of all options set forth above shall accelerate upon a change in control as defined in the
agreement, provided Mr. Pernock is employed by the Company within 60 days prior to the date of such
change in control.
If Mr. Pernocks employment is terminated at the Companys election at any time, for reasons
other than death, disability, cause (as defined in the agreement) or a voluntary resignation, or by
Mr. Pernock for good reason (as defined in the agreement), Mr. Pernock shall be entitled to receive
severance payments equal to twelve months of Mr. Pernocks base salary and of the premiums
associated with continuation of Mr. Pernocks benefits pursuant to COBRA to the extent that he is
eligible for them following the termination of his employment; provided that if anytime within
eighteen months after a change in control either (i) Mr. Pernock is terminated, at the Companys
election at any time, for reasons other than death, disability, cause or voluntary resignation, or
(ii) Mr. Pernock terminates the agreement for good reason, Mr. Pernock shall be entitled to receive
severance payments equal to: (1) two years of Mr. Pernocks base salary, (2) Mr. Pernocks most
recent annual bonus payment, and (3) the premiums associated with continuation of Mr. Pernocks
benefits pursuant to COBRA to the extent that he is eligible for them following the termination of
his employment for a period of one year after termination. All severance payments shall be made in
a lump sum within ten business days of Mr. Pernocks execution and delivery of a general release of
the Company, its parents, subsidiaries and affiliates and each of its officers, directors,
employees, agents, successors and assigns in a form acceptable to the Company. If severance
payments are being made, Mr. Pernock has agreed not to compete with the Company until twelve months
after the termination of his employment.
On March 2, 2010, the Company entered into a Securities Purchase Agreement with certain
accredited investors, pursuant to which the Company agreed to sell to the purchasers in the
aggregate 5,076,667 shares of Company common stock at a purchase price of $0.75 per share. Each
purchaser will also receive a warrant to purchase the same number of shares of common stock
acquired in the offering at an exercise price of $0.98 per share. The aggregate purchase price to
be paid by the purchasers at closing for the common stock and the warrants will be $3,807,500. The
financing is subject to customary closing conditions. None of the shares to be issued to the
investors nor the shares underlying the warrants to be
issued to the investors or the placement agents will be or have been registered under the
Securities Act of 1933, as amended, and may not be offered or sold in the United States absent
registration or an applicable exemption from registration requirements. Viriathus Capital LLC and
John Carris Investments LLC were co-placement agents for the transaction.
F-42
PART I FINANCIAL INFORMATION
ITEM 1. Financial statements.
Fibrocell Science, Inc.
(A Development Stage Company)
Consolidated Successor Balance Sheets
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
205,083 |
|
|
$ |
1,362,488 |
|
Accounts receivable, net |
|
|
278,815 |
|
|
|
269,759 |
|
Inventory, net |
|
|
208,111 |
|
|
|
226,032 |
|
Prepaid expenses and other current assets |
|
|
562,957 |
|
|
|
525,024 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
1,254,966 |
|
|
|
2,383,303 |
|
Property and equipment, net of accumulated depreciation of $5,612 and $0, respectively |
|
|
24,062 |
|
|
|
|
|
Other assets |
|
|
250 |
|
|
|
250 |
|
Intangible assets |
|
|
6,340,656 |
|
|
|
6,340,656 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
7,619,934 |
|
|
$ |
8,724,209 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities, Redeemable Preferred Stock, Shareholders Deficit and Noncontrolling
Interest |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Current debt |
|
$ |
|
|
|
$ |
47,795 |
|
Accounts payable |
|
|
1,073,376 |
|
|
|
245,023 |
|
Accrued expenses |
|
|
2,094,432 |
|
|
|
544,260 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
3,167,808 |
|
|
|
837,078 |
|
Long-term debt |
|
|
6,000,060 |
|
|
|
6,000,060 |
|
Deferred tax liability |
|
|
2,500,000 |
|
|
|
2,500,000 |
|
Warrant liability |
|
|
4,653,838 |
|
|
|
635,276 |
|
Other long-term liabilities |
|
|
284,007 |
|
|
|
369,210 |
|
|
|
|
|
|
|
|
Total liabilities |
|
|
16,605,713 |
|
|
|
10,341,624 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred
stock series A, $0.001 par value; 9,000 shares authorized; 3,250
shares issued and outstanding |
|
|
2,365,309 |
|
|
|
2,511,070 |
|
Preferred
stock series B, $0.001 par value; 9,000 shares authorized; 2,977 shares issued and outstanding |
|
|
391,766 |
|
|
|
|
|
Preferred stock series B, $0.001 par value; subscription receivable |
|
|
(792,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Fibrocell Science, Inc. shareholders deficit: |
|
|
|
|
|
|
|
|
Successor common stock, $0.001 par value; 250,000,000 shares authorized |
|
|
19,769 |
|
|
|
14,692 |
|
Additional paid-in capital |
|
|
1,924,899 |
|
|
|
508,347 |
|
Accumulated deficit during development stage |
|
|
(13,331,244 |
) |
|
|
(5,049,999 |
) |
|
|
|
|
|
|
|
Total Fibrocell Science, Inc. shareholders deficit |
|
|
(11,386,576 |
) |
|
|
(4,526,960 |
) |
|
|
|
|
|
|
|
Noncontrolling interest |
|
|
435,722 |
|
|
|
398,475 |
|
|
|
|
|
|
|
|
Total deficit and noncontrolling interest |
|
|
(10,950,854 |
) |
|
|
(4,128,485 |
) |
|
|
|
|
|
|
|
Total liabilities, preferred stock, shareholders deficit and noncontrolling interest |
|
$ |
7,619,934 |
|
|
$ |
8,724,209 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
F-43
Fibrocell Science, Inc.
(A Development Stage Company)
Consolidated Statements of Operations
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor |
|
|
Successor |
|
|
|
Predecessor |
|
|
|
For the three months |
|
|
For the one month |
|
|
|
For the two months |
|
|
|
ended September 30, |
|
|
ended September 30, |
|
|
|
ended August 31, |
|
|
|
2010 |
|
|
2009 |
|
|
|
2009 |
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
243,677 |
|
|
$ |
75,029 |
|
|
|
$ |
130,740 |
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
|
243,677 |
|
|
|
75,029 |
|
|
|
|
130,740 |
|
Cost of sales |
|
|
118,916 |
|
|
|
53,323 |
|
|
|
|
252,420 |
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
124,761 |
|
|
|
21,706 |
|
|
|
|
(121,680 |
) |
Selling, general and administrative expenses |
|
|
1,583,418 |
|
|
|
1,372,122 |
|
|
|
|
1,158,959 |
|
Research and development expenses |
|
|
1,387,466 |
|
|
|
556,242 |
|
|
|
|
614,511 |
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(2,846,123 |
) |
|
|
(1,906,658 |
) |
|
|
|
(1,895,150 |
) |
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
|
|
|
|
1 |
|
|
|
|
1 |
|
Reorganization items, net |
|
|
|
|
|
|
|
|
|
|
|
74,132,188 |
|
Other expense |
|
|
|
|
|
|
|
|
|
|
|
(6,243 |
) |
Warrant income |
|
|
1,265,571 |
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(211,919 |
) |
|
|
(58,333 |
) |
|
|
|
(290,063 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing operations |
|
|
(1,792,471 |
) |
|
|
(1,964,990 |
) |
|
|
|
71,940,733 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from discontinued operations, net of tax |
|
|
(8,575 |
) |
|
|
5,799 |
|
|
|
|
216,203 |
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
|
(1,801,046 |
) |
|
|
(1,959,191 |
) |
|
|
|
72,156,936 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) attributable to noncontrolling interest |
|
|
(20,859 |
) |
|
|
1,644 |
|
|
|
|
(214,292 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) attributable to Fibrocell Science, Inc. common shareholders |
|
|
(1,821,905 |
) |
|
$ |
(1,957,547 |
) |
|
|
$ |
71,942,644 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Per share information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing operations-basic and diluted |
|
$ |
(0.09 |
) |
|
$ |
(0.13 |
) |
|
|
$ |
1.85 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) attributable to common shareholders per common sharebasic
and diluted |
|
$ |
(0.09 |
) |
|
$ |
(0.13 |
) |
|
|
$ |
1.85 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of basic and diluted common shares outstanding |
|
|
19,557,842 |
|
|
|
14,666,666 |
|
|
|
|
38,820,380 |
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
F-44
Fibrocell Science, Inc.
(A Development Stage Company)
Consolidated Statements of Operations
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor |
|
|
Successor |
|
|
Successor |
|
|
|
Predecessor |
|
|
Predecessor |
|
|
|
|
|
|
|
|
|
|
|
Cumulative period |
|
|
|
|
|
|
|
Cumulative period |
|
|
|
For the nine |
|
|
For the one |
|
|
from September 1, |
|
|
|
|
|
|
|
from December 28, |
|
|
|
months ended |
|
|
month ended |
|
|
2009 (date of |
|
|
|
For the eight |
|
|
1995 (date of |
|
|
|
September 30, |
|
|
September 30, |
|
|
inception) to |
|
|
|
months ended |
|
|
inception) to |
|
|
|
2010 |
|
|
2009 |
|
|
September 30, 2010 |
|
|
|
August 31, 2009 |
|
|
August 31, 2009 |
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
716,809 |
|
|
$ |
75,029 |
|
|
$ |
1,046,750 |
|
|
|
$ |
538,620 |
|
|
$ |
4,818,994 |
|
License fees |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
260,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
|
716,809 |
|
|
|
75,029 |
|
|
|
1,046,750 |
|
|
|
|
538,620 |
|
|
|
5,078,994 |
|
Cost of sales |
|
|
395,351 |
|
|
|
53,323 |
|
|
|
577,399 |
|
|
|
|
424,139 |
|
|
|
2,279,335 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
321,458 |
|
|
|
21,706 |
|
|
|
469,351 |
|
|
|
|
114,481 |
|
|
|
2,799,659 |
|
Selling, general and administrative expenses |
|
|
5,424,661 |
|
|
|
1,372,122 |
|
|
|
8,133,017 |
|
|
|
|
3,427,374 |
|
|
|
84,805,520 |
|
Research and development expenses |
|
|
4,053,817 |
|
|
|
556,242 |
|
|
|
5,877,013 |
|
|
|
|
2,107,718 |
|
|
|
56,269,869 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(9,157,020 |
) |
|
|
(1,906,658 |
) |
|
|
(13,540,679 |
) |
|
|
|
(5,420,611 |
) |
|
|
(138,275,730 |
) |
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
|
|
|
|
1 |
|
|
|
1 |
|
|
|
|
248 |
|
|
|
6,989,539 |
|
Reorganization items, net |
|
|
3,303 |
|
|
|
|
|
|
|
(69,174 |
) |
|
|
|
73,538,984 |
|
|
|
73,538,984 |
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,243 |
) |
|
|
316,338 |
|
Warrant income |
|
|
1,560,757 |
|
|
|
|
|
|
|
1,241,673 |
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(612,917 |
) |
|
|
(58,333 |
) |
|
|
(860,091 |
) |
|
|
|
(2,232,138 |
) |
|
|
(18,790,218 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing operations
before income taxes |
|
|
(8,205,877 |
) |
|
|
(1,964,990 |
) |
|
|
(13,228,270 |
) |
|
|
|
65,880,240 |
|
|
|
(76,221,087 |
) |
Income tax benefit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
190,754 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing operations |
|
|
(8,205,877 |
) |
|
|
(1,964,990 |
) |
|
|
(13,228,270 |
) |
|
|
|
65,880,240 |
|
|
|
(76,030,333 |
) |
Income (loss) from discontinued operations |
|
|
(38,121 |
) |
|
|
5,799 |
|
|
|
(50,234 |
) |
|
|
|
46,923 |
|
|
|
(41,091,311 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
|
(8,243,998 |
) |
|
|
(1,959,191 |
) |
|
|
(13,278,504 |
) |
|
|
|
65,927,163 |
|
|
|
(117,121,644 |
) |
Deemed dividend associated with beneficial
conversion |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(11,423,824 |
) |
Preferred stock dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,589,861 |
) |
Net income/(loss) attributable to
noncontrolling interest |
|
|
(37,247 |
) |
|
|
1,644 |
|
|
|
(52,740 |
) |
|
|
|
(205,632 |
) |
|
|
1,799,523 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) attributable to Fibrocell
Science, Inc. common shareholders. |
|
$ |
(8,281,245 |
) |
|
$ |
(1,957,547 |
) |
|
$ |
(13,331,244 |
) |
|
|
$ |
65,721,531 |
|
|
$ |
(128,335,806 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Per share information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing
operations-basic and diluted |
|
$ |
(0.45 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.77 |
) |
|
|
$ |
1.72 |
|
|
$ |
(4.30 |
) |
Loss from discontinued operations-basic
and
diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2.32 |
) |
Income attributable to noncontrolling
interest |
|
|
|
|
|
|
|
|
|
|
(0.01 |
) |
|
|
|
|
|
|
|
0.10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deemed dividend associated with
beneficial conversion of preferred stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(0.65 |
) |
Preferred stock dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(0.09 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) attributable to common
shareholders per common sharebasic and
diluted |
|
$ |
(0.45 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.78 |
) |
|
|
$ |
1.72 |
|
|
$ |
(7.26 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of basic and
diluted common shares outstanding |
|
|
18,291,301 |
|
|
|
14,666,666 |
|
|
|
17,104,057 |
|
|
|
|
38,230,886 |
|
|
|
17,678,219 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
F-45
Fibrocell Science, Inc.
(A Development Stage Company)
Consolidated Statements of Shareholders Equity (Deficit) and Comprehensive Income (Loss)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Series A |
|
|
Series B |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit |
|
|
Total |
|
|
|
Preferred Stock |
|
|
Preferred Stock |
|
|
Common Stock |
|
|
Additional |
|
|
Treasury Stock |
|
|
Accumulated Other |
|
|
During |
|
|
Shareholders |
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Paid-In |
|
|
Number of |
|
|
|
|
|
|
Comprehensive |
|
|
Development |
|
|
Equity |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Shares |
|
|
Amount |
|
|
Income |
|
|
Stage |
|
|
(Deficit) |
|
Issuance of common stock for
cash on 12/28/95 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
2,285,291 |
|
|
$ |
2,285 |
|
|
$ |
(1,465 |
) |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
820 |
|
Issuance of common stock for
cash on 11/7/96 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,149 |
|
|
|
11 |
|
|
|
49,989 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
50,000 |
|
Issuance of common stock for
cash on 11/29/96 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,230 |
|
|
|
2 |
|
|
|
9,998 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
Issuance of common stock for
cash on 12/19/96 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,690 |
|
|
|
7 |
|
|
|
29,993 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
30,000 |
|
Issuance of common stock for
cash on 12/26/96 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,148 |
|
|
|
11 |
|
|
|
49,989 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
50,000 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(270,468 |
) |
|
|
(270,468 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, 12/31/96 (Predecessor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
2,316,508 |
|
|
$ |
2,316 |
|
|
$ |
138,504 |
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
(270,468 |
) |
|
$ |
(129,648 |
) |
Issuance of common stock for
cash on 12/27/97 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
21,182 |
|
|
|
21 |
|
|
|
94,979 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
95,000 |
|
Issuance of common stock for
services on 9/1/97 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,148 |
|
|
|
11 |
|
|
|
36,249 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
36,260 |
|
Issuance of common stock for
services on 12/28/97 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
287,193 |
|
|
|
287 |
|
|
|
9,968 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,255 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(52,550 |
) |
|
|
(52,550 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, 12/31/97(Predecessor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
2,636,031 |
|
|
$ |
2,635 |
|
|
$ |
279,700 |
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
(323,018 |
) |
|
$ |
(40,683 |
) |
The accompanying notes are an integral part of these consolidated financial statements.
F-46
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Series A |
|
|
Series B |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Deficit |
|
|
Total |
|
|
|
Preferred Stock |
|
|
Preferred Stock |
|
|
Common Stock |
|
|
Additional |
|
|
Treasury Stock |
|
|
Other |
|
|
During |
|
|
Shareholders |
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Paid-In |
|
|
Number of |
|
|
|
|
|
|
Comprehensive |
|
|
Development |
|
|
Equity |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Shares |
|
|
Amount |
|
|
Income |
|
|
Stage |
|
|
(Deficit) |
|
Issuance of common
stock for cash on
8/23/98 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
4,459 |
|
|
$ |
4 |
|
|
$ |
20,063 |
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
20,067 |
|
Repurchase of
common stock on
9/29/98 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,400 |
|
|
|
(50,280 |
) |
|
|
|
|
|
|
|
|
|
|
(50,280 |
) |
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(195,675 |
) |
|
|
(195,675 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, 12/31/98
(Predecessor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
2,640,490 |
|
|
$ |
2,639 |
|
|
$ |
299,763 |
|
|
|
2,400 |
|
|
$ |
(50,280 |
) |
|
$ |
|
|
|
$ |
(518,693 |
) |
|
$ |
(266,571 |
) |
Issuance of
common stock for
cash on 9/10/99 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
52,506 |
|
|
|
53 |
|
|
|
149,947 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
150,000 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,306,778 |
) |
|
|
(1,306,778 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, 12/31/99
(Predecessor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
2,692,996 |
|
|
$ |
2,692 |
|
|
$ |
449,710 |
|
|
|
2,400 |
|
|
$ |
(50,280 |
) |
|
$ |
|
|
|
$ |
(1,825,471 |
) |
|
$ |
(1,423,349 |
) |
Issuance of
common stock for
cash on 1/18/00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
53,583 |
|
|
|
54 |
|
|
|
1,869 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,923 |
|
Issuance of
common stock for
services on
3/1/00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
68,698 |
|
|
|
69 |
|
|
|
(44 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25 |
|
Issuance of
common stock for
services on
4/4/00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
27,768 |
|
|
|
28 |
|
|
|
(18 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(807,076 |
) |
|
|
(807,076 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, 12/31/00
(Predecessor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
2,843,045 |
|
|
$ |
2,843 |
|
|
$ |
451,517 |
|
|
|
2,400 |
|
|
$ |
(50,280 |
) |
|
$ |
|
|
|
$ |
(2,632,547 |
) |
|
$ |
(2,228,467 |
) |
The accompanying notes are an integral part of these consolidated financial statements.
F-47
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Series A |
|
|
Series B |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Deficit |
|
|
Total |
|
|
|
Preferred Stock |
|
|
Preferred Stock |
|
|
Common Stock |
|
|
Additional |
|
|
Treasury Stock |
|
|
Other |
|
|
During |
|
|
Shareholders |
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Paid-In |
|
|
Number of |
|
|
|
|
|
|
Comprehensive |
|
|
Development |
|
|
Equity |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Shares |
|
|
Amount |
|
|
Income |
|
|
Stage |
|
|
(Deficit) |
|
Issuance of common
stock for services
on 7/1/01 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
156,960 |
|
|
$ |
157 |
|
|
$ |
(101 |
) |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
56 |
|
Issuance of common
stock for services
on 7/1/01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
125,000 |
|
|
|
125 |
|
|
|
(80 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
45 |
|
Issuance of common
stock for
capitalization of
accrued salaries on
8/10/01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
70,000 |
|
|
|
70 |
|
|
|
328,055 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
328,125 |
|
Issuance of common
stock for
conversion of
convertible debt on
8/10/01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,750,000 |
|
|
|
1,750 |
|
|
|
1,609,596 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,611,346 |
|
Issuance of common
stock for
conversion of
convertible
shareholder notes
payable on 8/10/01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
208,972 |
|
|
|
209 |
|
|
|
135,458 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
135,667 |
|
Issuance of common
stock for bridge
financing on
8/10/01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
300,000 |
|
|
|
300 |
|
|
|
(192 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
108 |
|
Retirement of
treasury stock on
8/10/01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(50,280 |
) |
|
|
(2,400 |
) |
|
|
50,280 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common
stock for net
assets of Gemini on
8/10/01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,942,400 |
|
|
|
3,942 |
|
|
|
(3,942 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common
stock for net
assets of AFH on
8/10/01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,899,547 |
|
|
|
3,900 |
|
|
|
(3,900 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common
stock for cash on
8/10/01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,346,669 |
|
|
|
1,347 |
|
|
|
2,018,653 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,020,000 |
|
Transaction and
fund raising
expenses on 8/10/01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(48,547 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(48,547 |
) |
Issuance of common
stock for services
on 8/10/01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
60,000 |
|
|
|
60 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
60 |
|
Issuance of common
stock for cash on
8/28/01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
26,667 |
|
|
|
27 |
|
|
|
39,973 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
40,000 |
|
Issuance of common
stock for services
on 9/30/01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
314,370 |
|
|
|
314 |
|
|
|
471,241 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
471,555 |
|
The accompanying notes are an integral part of these consolidated financial statements.
F-48
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Series A |
|
|
Series B |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Deficit |
|
|
Total |
|
|
|
Preferred Stock |
|
|
Preferred Stock |
|
|
Common Stock |
|
|
Additional |
|
|
Treasury Stock |
|
|
Other |
|
|
During |
|
|
Shareholders |
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Paid-In |
|
|
Number of |
|
|
|
|
|
|
Comprehensive |
|
|
Development |
|
|
Equity |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Shares |
|
|
Amount |
|
|
Income |
|
|
Stage |
|
|
(Deficit) |
|
Uncompensated contribution of
services3rd quarter |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
55,556 |
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
55,556 |
|
Issuance of common stock for
services on 11/1/01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
145,933 |
|
|
|
146 |
|
|
|
218,754 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
218,900 |
|
Uncompensated contribution of
services4th quarter |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,652,004 |
) |
|
|
(1,652,004 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, 12/31/01 (Predecessor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
15,189,563 |
|
|
$ |
15,190 |
|
|
$ |
5,321,761 |
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
(4,284,551 |
) |
|
$ |
1,052,400 |
|
Uncompensated contribution of
services1st quarter |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
Issuance of preferred stock
for cash on 4/26/02 |
|
|
905,000 |
|
|
|
905 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,817,331 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,818,236 |
|
Issuance of preferred stock
for cash on 5/16/02 |
|
|
890,250 |
|
|
|
890 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,772,239 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,773,129 |
|
Issuance of preferred stock
for cash on 5/31/02 |
|
|
795,000 |
|
|
|
795 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,473,380 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,474,175 |
|
Issuance of preferred stock
for cash on 6/28/02 |
|
|
229,642 |
|
|
|
230 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
712,991 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
713,221 |
|
Uncompensated contribution of
services2nd quarter |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
Issuance of preferred stock
for cash on 7/15/02 |
|
|
75,108 |
|
|
|
75 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
233,886 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
233,961 |
|
Issuance of common stock for
cash on 8/1/02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
38,400 |
|
|
|
38 |
|
|
|
57,562 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
57,600 |
|
Issuance of warrants for
services on 9/06/02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
103,388 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
103,388 |
|
Uncompensated contribution of
services3rd quarter |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
Uncompensated contribution of
services4th quarter |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
Issuance of preferred stock
for dividends |
|
|
143,507 |
|
|
|
144 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
502,517 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(502,661 |
) |
|
|
|
|
Deemed dividend associated
with beneficial conversion of
preferred stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,178,944 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(10,178,944 |
) |
|
|
|
|
Comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,433,055 |
) |
|
|
(5,433,055 |
) |
Other comprehensive income,
foreign currency translation
adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,875 |
|
|
|
|
|
|
|
13,875 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,419,180 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, 12/31/02 (Predecessor) |
|
|
3,038,507 |
|
|
$ |
3,039 |
|
|
|
|
|
|
$ |
|
|
|
|
15,227,963 |
|
|
$ |
15,228 |
|
|
$ |
25,573,999 |
|
|
|
|
|
|
$ |
|
|
|
$ |
13,875 |
|
|
$ |
(20,399,211 |
) |
|
$ |
5,206,930 |
|
The accompanying notes are an integral part of these consolidated financial statements.
F-49
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Series A |
|
|
Series B |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Deficit |
|
|
Total |
|
|
|
Preferred Stock |
|
|
Preferred Stock |
|
|
Common Stock |
|
|
Additional |
|
|
Treasury Stock |
|
|
Other |
|
|
During |
|
|
Shareholders |
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Paid-In |
|
|
Number of |
|
|
|
|
|
|
Comprehensive |
|
|
Development |
|
|
Equity |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Shares |
|
|
Amount |
|
|
Income |
|
|
Stage |
|
|
(Deficit) |
|
Issuance of common stock for
cash on 1/7/03 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
61,600 |
|
|
$ |
62 |
|
|
$ |
92,338 |
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
92,400 |
|
Issuance of common stock for
patent pending acquisition on
3/31/03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
|
|
100 |
|
|
|
539,900 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
540,000 |
|
Cancellation of common stock
on 3/31/03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(79,382 |
) |
|
|
(79 |
) |
|
|
(119,380 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(119,459 |
) |
Uncompensated contribution of
services1st quarter |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
Issuance of preferred stock
for cash on 5/9/03 |
|
|
|
|
|
|
|
|
|
|
110,250 |
|
|
|
110 |
|
|
|
|
|
|
|
|
|
|
|
2,773,218 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,773,328 |
|
Issuance of preferred stock
for cash on 5/16/03 |
|
|
|
|
|
|
|
|
|
|
45,500 |
|
|
|
46 |
|
|
|
|
|
|
|
|
|
|
|
1,145,704 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,145,750 |
|
Conversion of preferred stock
into common stock2nd qtr |
|
|
(70,954 |
) |
|
|
(72 |
) |
|
|
|
|
|
|
|
|
|
|
147,062 |
|
|
|
147 |
|
|
|
40,626 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
40,701 |
|
Conversion of warrants into
common stock2nd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
114,598 |
|
|
|
114 |
|
|
|
(114 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Uncompensated contribution of
services2nd quarter |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
Issuance of preferred stock
dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,087,200 |
) |
|
|
(1,087,200 |
) |
Deemed dividend associated
with beneficial conversion of
preferred stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,244,880 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,244,880 |
) |
|
|
|
|
Issuance of common stock for
cash3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
202,500 |
|
|
|
202 |
|
|
|
309,798 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
310,000 |
|
Issuance of common stock for
cash on 8/27/03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,359,331 |
|
|
|
3,359 |
|
|
|
18,452,202 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,455,561 |
|
Conversion of preferred stock
into common
stock3rd qtr |
|
|
(2,967,553 |
) |
|
|
(2,967 |
) |
|
|
(155,750 |
) |
|
|
(156 |
) |
|
|
7,188,793 |
|
|
|
7,189 |
|
|
|
(82,875 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(78,809 |
) |
Conversion of warrants into
common stock3rd
qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
212,834 |
|
|
|
213 |
|
|
|
(213 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Compensation expense on
warrants issued to
non-employees |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
412,812 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
412,812 |
|
Issuance of common stock for
cash4th qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
136,500 |
|
|
|
137 |
|
|
|
279,363 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
279,500 |
|
Conversion of warrants into
common stock4th
qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
393 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(11,268,294 |
) |
|
|
(11,268,294 |
) |
Other comprehensive income,
foreign currency translation
adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
360,505 |
|
|
|
|
|
|
|
360,505 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(10,907,789 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, 12/31/03 (Predecessor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
26,672,192 |
|
|
$ |
26,672 |
|
|
$ |
50,862,258 |
|
|
|
|
|
|
$ |
|
|
|
$ |
374,380 |
|
|
$ |
(33,999,585 |
) |
|
$ |
17,263,725 |
|
The accompanying notes are an integral part of these consolidated financial statements.
F-50
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Series A |
|
|
Series B |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Deficit |
|
|
Total |
|
|
|
Preferred Stock |
|
|
Preferred Stock |
|
|
Common Stock |
|
|
Additional |
|
|
Treasury Stock |
|
|
Other |
|
|
During |
|
|
Shareholders |
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Paid-In |
|
|
Number of |
|
|
|
|
|
|
Comprehensive |
|
|
Development |
|
|
Equity |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Shares |
|
|
Amount |
|
|
Income |
|
|
Stage |
|
|
(Deficit) |
|
Conversion of warrants into common
stock1st qtr |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
78,526 |
|
|
$ |
79 |
|
|
$ |
(79 |
) |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Issuance of common stock for cash in
connection with exercise of stock
options1st qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15,000 |
|
|
|
15 |
|
|
|
94,985 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
95,000 |
|
Issuance of common stock for cash in
connection with exercise of
warrants1st qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,000 |
|
|
|
4 |
|
|
|
7,716 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,720 |
|
Compensation expense on options and warrants
issued to non-employees and
directors1st qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,410,498 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,410,498 |
|
Issuance of common stock in connection with
exercise of warrants2nd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
51,828 |
|
|
|
52 |
|
|
|
(52 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock for
cash2nd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,200,000 |
|
|
|
7,200 |
|
|
|
56,810,234 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
56,817,434 |
|
Compensation expense on options and warrants
issued to non-employees and
directors2nd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
143,462 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
143,462 |
|
Issuance of common stock in connection with
exercise of warrants3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,431 |
|
|
|
7 |
|
|
|
(7 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock for cash in
connection with exercise of stock
options3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
110,000 |
|
|
|
110 |
|
|
|
189,890 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
190,000 |
|
Issuance of common stock for cash in
connection with exercise of
warrants3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
28,270 |
|
|
|
28 |
|
|
|
59,667 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
59,695 |
|
Compensation expense on options and warrants
issued to non-employees and
directors3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
229,133 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
229,133 |
|
Issuance of common stock in connection with
exercise of warrants4th qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
27,652 |
|
|
|
28 |
|
|
|
(28 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Compensation expense on options and warrants
issued to non-employees, employees, and
directors4th qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
127,497 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
127,497 |
|
Purchase of treasury stock4th qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,000,000 |
|
|
|
(25,974,000 |
) |
|
|
|
|
|
|
|
|
|
|
(25,974,000 |
) |
Comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(21,474,469 |
) |
|
|
(21,474,469 |
) |
Other comprehensive income, foreign currency
translation adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
79,725 |
|
|
|
|
|
|
|
79,725 |
|
Other comprehensive income, net unrealized
gain on available-for-sale investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,005 |
|
|
|
|
|
|
|
10,005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(21,384,739 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, 12/31/04 (Predecessor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
34,194,899 |
|
|
$ |
34,195 |
|
|
$ |
109,935,174 |
|
|
|
4,000,000 |
|
|
$ |
(25,974,000 |
) |
|
$ |
464,110 |
|
|
$ |
(55,474,054 |
) |
|
$ |
28,985,425 |
|
The accompanying notes are an integral part of these consolidated financial statements.
F-51
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Series A |
|
|
Series B |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Deficit |
|
|
Total |
|
|
|
Preferred Stock |
|
|
Preferred Stock |
|
|
Common Stock |
|
|
Additional |
|
|
Treasury Stock |
|
|
Other |
|
|
During |
|
|
Shareholders |
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Paid-In |
|
|
Number of |
|
|
|
|
|
|
Comprehensive |
|
|
Development |
|
|
Equity |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Shares |
|
|
Amount |
|
|
Income (Loss) |
|
|
Stage |
|
|
(Deficit) |
|
Issuance of common stock for
cash in connection with
exercise of stock
options1st qtr |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
25,000 |
|
|
$ |
25 |
|
|
$ |
74,975 |
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
75,000 |
|
Compensation expense on
options and warrants issued to
non-employees1st
qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
33,565 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
33,565 |
|
Conversion of warrants into
common stock2nd
qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
27,785 |
|
|
|
28 |
|
|
|
(28 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Compensation expense on
options and warrants issued to
non-employees2nd
qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(61,762 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(61,762 |
) |
Compensation expense on
options and warrants issued to
non-employees3rd
qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(137,187 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(137,187 |
) |
Conversion of warrants into
common stock3rd
qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,605 |
|
|
|
12 |
|
|
|
(12 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Compensation expense on
options and warrants issued to
non-employees4th
qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,844 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,844 |
|
Compensation expense on
acceleration of
options4th qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,950 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,950 |
|
Compensation expense on
restricted stock award issued
to employee4th qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
606 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
606 |
|
Conversion of predecessor
company shares |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
94 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(35,777,584 |
) |
|
|
(35,777,584 |
) |
Other comprehensive loss,
foreign currency translation
adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,372,600 |
) |
|
|
|
|
|
|
(1,372,600 |
) |
Foreign exchange gain on
substantial liquidation of
foreign entity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
133,851 |
|
|
|
|
|
|
|
133,851 |
|
Other comprehensive loss, net
unrealized gain on
available-for-sale investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(10,005 |
) |
|
|
|
|
|
|
(10,005 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(37,026,338 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, 12/31/05 (Predecessor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
34,260,383 |
|
|
$ |
34,260 |
|
|
$ |
109,879,125 |
|
|
|
4,000,000 |
|
|
$ |
(25,974,000 |
) |
|
$ |
(784,644 |
) |
|
$ |
(91,251,638 |
) |
|
$ |
(8,096,897 |
) |
The accompanying notes are an integral part of these consolidated financial statements.
F-52
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
Series A |
|
|
Series B |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Deficit |
|
|
|
|
|
|
Total |
|
|
|
Preferred Stock |
|
|
Preferred Stock |
|
|
Common Stock |
|
|
Additional |
|
|
Treasury Stock |
|
|
Other |
|
|
During |
|
|
|
|
|
|
Shareholders |
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Paid-In |
|
|
Number of |
|
|
|
|
|
|
Comprehensive |
|
|
Development |
|
|
Noncontrolling |
|
|
Equity |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Shares |
|
|
Amount |
|
|
Income |
|
|
Stage |
|
|
Interest |
|
|
(Deficit) |
|
Compensation expense on
options and warrants issued
to
non-employees1st
qtr |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
42,810 |
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
42,810 |
|
Compensation expense on
option awards issued to
employees and
directors1st qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
46,336 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
46,336 |
|
Compensation expense on
restricted stock issued to
employees1st qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
128,750 |
|
|
|
129 |
|
|
|
23,368 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
23,497 |
|
Compensation expense on
options and warrants issued
to
non-employees2nd
qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
96,177 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
96,177 |
|
Compensation expense on
option awards issued to
employees and
directors2nd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
407,012 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
407,012 |
|
Compensation expense on
restricted stock to
employees2nd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,210 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,210 |
|
Cancellation of unvested
restricted stock
2nd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(97,400 |
) |
|
|
(97 |
) |
|
|
97 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock for
cash in connection with
exercise of stock
options2nd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,000 |
|
|
|
10 |
|
|
|
16,490 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16,500 |
|
Compensation expense on
options and warrants issued
to
non-employees3rd
qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,627 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,627 |
|
Compensation expense on
option awards issued to
employees and
directors3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
389,458 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
389,458 |
|
Compensation expense on
restricted stock to
employees3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,605 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,605 |
|
Issuance of common stock for
cash in connection with
exercise of stock
options3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
76,000 |
|
|
|
76 |
|
|
|
156,824 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
156,900 |
|
Acquisition of Agera |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,182,505 |
|
|
|
2,182,505 |
|
Compensation expense on
options and warrants issued
to
non-employees4th
qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
34,772 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
34,772 |
|
Compensation expense on
option awards issued to
employees and
directors4th qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
390,547 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
390,547 |
|
Compensation expense on
restricted stock to
employees4th qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88 |
|
Cancellation of unvested
restricted stock
award4th qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(15,002 |
) |
|
|
(15 |
) |
|
|
15 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(35,821,406 |
) |
|
|
(78,132 |
) |
|
|
(35,899,538 |
) |
Other comprehensive gain,
foreign currency translation
adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
657,182 |
|
|
|
|
|
|
|
|
|
|
|
657,182 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(35,242,356 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance 12/31/06 (Predecessor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
34,362,731 |
|
|
$ |
34,363 |
|
|
$ |
111,516,561 |
|
|
|
4,000,000 |
|
|
$ |
(25,974,000 |
) |
|
$ |
(127,462 |
) |
|
$ |
(127,073,044 |
) |
|
$ |
2,104,373 |
|
|
$ |
(39,519,209 |
) |
The accompanying notes are an integral part of these consolidated financial statements.
F-53
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
Series A |
|
|
Series B |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Deficit |
|
|
|
|
|
|
Total |
|
|
|
Preferred Stock |
|
|
Preferred Stock |
|
|
Common Stock |
|
|
Additional |
|
|
Treasury Stock |
|
|
Other |
|
|
During |
|
|
|
|
|
|
Shareholders |
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Paid-In |
|
|
Number of |
|
|
|
|
|
|
Comprehensive |
|
|
Development |
|
|
Noncontrolling |
|
|
Equity |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Shares |
|
|
Amount |
|
|
Income (Loss) |
|
|
Stage |
|
|
Interest |
|
|
(Deficit) |
|
Compensation expense on
options and warrants issued
to
non-employees1st
qtr |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
39,742 |
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
39,742 |
|
Compensation expense on
option awards issued to
employees and
directors1st qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
448,067 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
448,067 |
|
Compensation expense on
restricted stock issued to
employees1st qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88 |
|
Issuance of common stock for
cash in connection with
exercise of stock
options1st qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15,000 |
|
|
|
15 |
|
|
|
23,085 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
23,100 |
|
|
|
Expense in connection with
modification of employee
stock options 1st
qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,178,483 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,178,483 |
|
Compensation expense on
options and warrants issued
to
non-employees2nd
qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
39,981 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
39,981 |
|
Compensation expense on
option awards issued to
employees and
directors2nd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
462,363 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
462,363 |
|
Compensation expense on
restricted stock issued to
employees2nd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88 |
|
Compensation expense on
option awards issued to
employees and
directors3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
478,795 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
478,795 |
|
Compensation expense on
restricted stock issued to
employees3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88 |
|
Issuance of common stock upon
exercise of
warrants3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
492,613 |
|
|
|
493 |
|
|
|
893,811 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
894,304 |
|
Issuance of common stock for
cash, net of offering
costs3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,767,647 |
|
|
|
6,767 |
|
|
|
13,745,400 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,752,167 |
|
Issuance of common stock for
cash in connection with
exercise of stock
options3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,666 |
|
|
|
2 |
|
|
|
3,164 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,166 |
|
Compensation expense on
option awards issued to
employees and
directors4thqtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
378,827 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
378,827 |
|
Compensation expense on
restricted stock issued to
employees4thqtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88 |
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(35,573,114 |
) |
|
|
(246,347 |
) |
|
|
(35,819,461 |
) |
Other comprehensive gain,
foreign currency translation
adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
846,388 |
|
|
|
|
|
|
|
|
|
|
|
846,388 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(34,973,073 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance 12/31/07 (Predecessor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
41,639,657 |
|
|
$ |
41,640 |
|
|
$ |
129,208,631 |
|
|
|
4,000,000 |
|
|
$ |
(25,974,000 |
) |
|
$ |
718,926 |
|
|
$ |
(162,646,158 |
) |
|
$ |
1,858,026 |
|
|
$ |
(56,792,935 |
) |
The accompanying notes are an integral part of these consolidated financial statements.
F-54
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
Series A |
|
|
Series B |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Deficit |
|
|
|
|
|
|
Total |
|
|
|
Preferred Stock |
|
|
Preferred Stock |
|
|
Common Stock |
|
|
Additional |
|
|
Treasury Stock |
|
|
Other |
|
|
During |
|
|
|
|
|
|
Shareholders |
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Paid-In |
|
|
Number of |
|
|
|
|
|
|
Comprehensive |
|
|
Development |
|
|
Noncontrolling |
|
|
Equity |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Shares |
|
|
Amount |
|
|
Income (Loss) |
|
|
Stage |
|
|
Interest |
|
|
(Deficit) |
|
Compensation expense on vested options related
to non-employees1st qtr |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
44,849 |
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
44,849 |
|
Compensation expense on option awards issued
to employees and directors1st qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
151,305 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
151,305 |
|
Expense in connection with modification of
employee stock options 1st qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,262,815 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,262,815 |
|
|
|
Retirement of restricted stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(165 |
) |
|
|
(1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1 |
) |
Compensation expense on vested options related
to non-employees2nd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
62,697 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
62,697 |
|
Compensation expense on option awards
issued to employees and
directors2nd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
193,754 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
193,754 |
|
Compensation expense on vested options
related to non-employees3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
166,687 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
166,687 |
|
Compensation expense on option awards
issued to employees and directors3rd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
171,012 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
171,012 |
|
Compensation expense on vested options
related to non-employees4th qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(86,719 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(86,719 |
) |
Compensation expense on option awards
issued to employees and directors4th qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
166,196 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
166,196 |
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(31,411,179 |
) |
|
|
(1,680,676 |
) |
|
|
(33,091,855 |
) |
Reclassification of foreign exchange gain on
substantial liquidation of foreign entities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,152,569 |
) |
|
|
|
|
|
|
|
|
|
|
(2,152,569 |
) |
Other comprehensive gain, foreign currency
translation adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,433,643 |
|
|
|
|
|
|
|
|
|
|
|
1,433,643 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(33,810,781 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance 12/31/08 (Predecessor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
41,639,492 |
|
|
$ |
41,639 |
|
|
$ |
131,341,227 |
|
|
|
4,000,000 |
|
|
$ |
(25,974,000 |
) |
|
$ |
|
|
|
$ |
(194,057,337 |
) |
|
$ |
177,350 |
|
|
$ |
(88,471,121 |
) |
The accompanying notes are an integral part of these consolidated financial statements.
F-55
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
Series A |
|
|
Series B |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Deficit |
|
|
|
|
|
|
|
|
|
|
Preferred Stock |
|
|
Preferred Stock |
|
|
Common Stock |
|
|
Additional |
|
|
Treasury Stock |
|
|
Other |
|
|
During |
|
|
|
|
|
|
Total |
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Paid-In |
|
|
Number of |
|
|
|
|
|
|
Comprehensive |
|
|
Development |
|
|
Noncontrolling |
|
|
Equity |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Shares |
|
|
Amount |
|
|
Income (Loss) |
|
|
Stage |
|
|
Interest |
|
|
(Deficit) |
|
Compensation expense on vested options related to non-employees1st qtr |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
1,746 |
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
1,746 |
|
Compensation expense on option awards issued to employees and directors1st qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
138,798 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
138,798 |
|
Conversion of debt into common stock 1st qtr 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
37,564 |
|
|
|
38 |
|
|
|
343,962 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
344,000 |
|
Compensation expense on option awards issued to employees and directors2nd qtr |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
112,616 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
112,616 |
|
Conversion of debt into common stock 2nd qtr 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,143,324 |
|
|
|
1,143 |
|
|
|
10,468,857 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,470,000 |
|
Compensation expense on option awards issued to employees and directors2 months ended 8/31/09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
35,382 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
35,382 |
|
Balance of expense due to cancellation of options issued to employees and directors in bankruptcy2 months ended 8/31/09 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
294,912 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
294,912 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
65,721,531 |
|
|
|
205,632 |
|
|
|
65,927,163 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
65,927,163 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance 8/31/09 (Predecessor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
42,820,380 |
|
|
$ |
42,820 |
|
|
$ |
142,737,500 |
|
|
|
4,000,000 |
|
|
$ |
(25,974,000 |
) |
|
$ |
|
|
|
$ |
(128,335,806 |
) |
|
$ |
382,982 |
|
|
$ |
(11,146,504 |
) |
Cancellation of Predecessor common stock and fresh start adjustments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(42,820,380 |
) |
|
|
(42,820 |
) |
|
|
(150,426,331 |
) |
|
|
(4,000,000 |
) |
|
|
25,974,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(124,495,151 |
) |
Elimination of Predecessor accumulated deficit and accumulated other comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
128,335,806 |
|
|
|
|
|
|
|
128,335,806 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance 9/1/09 (Predecessor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
(7,688,831 |
) |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
382,982 |
|
|
$ |
(7,305,849 |
) |
Issuance of 11.4 million shares of common stock in connection with emergence from Chapter 11 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,400,000 |
|
|
|
11,400 |
|
|
|
5,460,600 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,472,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance 9/1/09 (Successor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
11,400,000 |
|
|
$ |
11,400 |
|
|
$ |
(2,228,231 |
) |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
382,982 |
|
|
$ |
(1,833,849 |
) |
Issuance of 2.7 million shares of common stock in connection with the exit financing |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,666,666 |
|
|
|
2,667 |
|
|
|
1,797,333 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,800,000 |
|
Issuance of common stock on Oct. 28, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,501 |
|
|
|
25 |
|
|
|
58,627 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
58,652 |
|
Compensation expense on shares issued to management |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
600,000 |
|
|
|
600 |
|
|
|
167,400 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
168,000 |
|
Compensation expense on option awards issued to directors |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
326,838 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
326,838 |
|
Compensation expense on option awards issued to non-employees |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
386,380 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
386,380 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,049,999 |
) |
|
|
15,493 |
|
|
|
(5,034,506 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,034,506 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance 12/31/09 (Successor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
14,692,167 |
|
|
$ |
14,692 |
|
|
$ |
508,347 |
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
(5,049,999 |
) |
|
$ |
398,475 |
|
|
$ |
(4,128,485 |
) |
The accompanying notes are an integral part of these consolidated financial statements.
F-56
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
Series A |
|
|
Series B |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
Deficit |
|
|
|
|
|
|
|
|
|
|
Preferred Stock |
|
|
Preferred Stock |
|
|
Common Stock |
|
|
Additional |
|
|
Treasury Stock |
|
|
Other |
|
|
During |
|
|
|
|
|
|
Total |
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
Paid-In |
|
|
Number of |
|
|
|
|
|
|
Comprehensive |
|
|
Development |
|
|
Noncontrolling |
|
|
Equity |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Shares |
|
|
Amount |
|
|
Income (Loss) |
|
|
Stage |
|
|
Interest |
|
|
(Deficit) |
|
Issuance of 5.1 million shares of common stock in March 2010, net of issuance costs of $338,100 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
5,076,664 |
|
|
$ |
5,077 |
|
|
$ |
3,464,323 |
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
3,469,400 |
|
Warrant fair value associated with common shares issued in March 2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,890,711 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,890,711 |
) |
Compensation expense on shares issued to management 1Q10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,000 |
|
Compensation expense on option awards issued to directors/employees-1Q10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
324,377 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
324,377 |
|
Compensation expense on option awards issued to non-employees-1Q10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,391 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,391 |
|
Compensation expense on shares issued to management 2Q10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,000 |
|
Compensation expense on option awards issued to directors/employees-2Q10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
222,011 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
222,011 |
|
Compensation expense on option awards issued to non-employees-2Q10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
33,206 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
33,206 |
|
Compensation expense on shares issued to management 3Q10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,000 |
|
Compensation expense on option awards issued to directors/employees-3Q10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
183,231 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
183,231 |
|
Compensation expense on option awards issued to non-employees-3Q10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,724 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,724 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(8,281,245 |
) |
|
|
37,247 |
|
|
|
(8,243,998 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(8,243,998 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance 9/30/10 (Successor) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
19,768,831 |
|
|
$ |
19,769 |
|
|
$ |
1,924,899 |
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
(13,331,244 |
) |
|
$ |
435,722 |
|
|
$ |
(10,950,854 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
F-57
Fibrocell Science, Inc.
(A Development Stage Company)
Consolidated Statements of Cash Flows
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor |
|
|
Successor |
|
|
Successor |
|
|
|
Predecessor |
|
|
Predecessor |
|
|
|
|
|
|
|
|
|
|
|
Cumulative |
|
|
|
|
|
|
|
Cumulative |
|
|
|
|
|
|
|
|
|
|
|
period from |
|
|
|
|
|
|
|
period from |
|
|
|
|
|
|
|
|
|
|
|
September 1, |
|
|
|
|
|
|
|
December 28, |
|
|
|
Nine months |
|
|
One month |
|
|
2009 (date of |
|
|
|
Eight months |
|
|
1995 (date of |
|
|
|
ended |
|
|
ended |
|
|
inception) to |
|
|
|
ended |
|
|
inception) to |
|
|
|
September 30, |
|
|
September 30, |
|
|
September 30, |
|
|
|
August 31, |
|
|
August 31, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
|
2009 |
|
|
2009 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income |
|
$ |
(8,281,245 |
) |
|
$ |
(1,957,547 |
) |
|
$ |
(13,331,244 |
) |
|
|
$ |
65,721,531 |
|
|
$ |
(115,322,121 |
) |
Adjustments to reconcile net (loss) income to net cash used in operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reorganization items, net |
|
|
|
|
|
|
|
|
|
|
72,477 |
|
|
|
|
(74,648,976 |
) |
|
|
(74,648,976 |
) |
Expense related to equity awards and issuance of stock |
|
|
842,940 |
|
|
|
745,616 |
|
|
|
1,724,158 |
|
|
|
|
583,453 |
|
|
|
10,608,999 |
|
Warrant income |
|
|
(1,560,757 |
) |
|
|
|
|
|
|
(1,241,673 |
) |
|
|
|
|
|
|
|
|
|
Uncompensated contribution of services |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
755,556 |
|
Depreciation and amortization |
|
|
5,612 |
|
|
|
|
|
|
|
5,612 |
|
|
|
|
|
|
|
|
9,091,990 |
|
Provision for doubtful accounts |
|
|
(12,839 |
) |
|
|
668 |
|
|
|
(59,458 |
) |
|
|
|
501 |
|
|
|
337,810 |
|
Provision for excessive and/or obsolete inventory |
|
|
(51,165 |
) |
|
|
5,126 |
|
|
|
(39,501 |
) |
|
|
|
169,085 |
|
|
|
259,427 |
|
Amortization of debt issue costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
985,237 |
|
|
|
4,107,067 |
|
Amortization of debt discounts on investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(508,983 |
) |
Loss on disposal or impairment of property and equipment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17,668,477 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange (gain) loss on substantial liquidation of foreign entity |
|
|
(3,031 |
) |
|
|
(7,084 |
) |
|
|
(5,645 |
) |
|
|
|
30,012 |
|
|
|
(2,256,408 |
) |
Net loss (income) attributable to non-controlling interest |
|
|
37,247 |
|
|
|
(1,644 |
) |
|
|
52,740 |
|
|
|
|
205,632 |
|
|
|
(1,799,523 |
) |
Change in operating assets and liabilities, excluding effects of acquisition: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Decrease (increase) in accounts receivable |
|
|
3,783 |
|
|
|
15,226 |
|
|
|
27,327 |
|
|
|
|
91,666 |
|
|
|
(91,496 |
) |
Decrease (increase) in other receivables |
|
|
(105 |
) |
|
|
4,126 |
|
|
|
4,635 |
|
|
|
|
23,632 |
|
|
|
218,978 |
|
Decrease (increase) in inventory |
|
|
69,086 |
|
|
|
23,508 |
|
|
|
100,009 |
|
|
|
|
29,543 |
|
|
|
(455,282 |
) |
Decrease (increase) in prepaid expenses |
|
|
(37,812 |
) |
|
|
(301,488 |
) |
|
|
(282,717 |
) |
|
|
|
628,197 |
|
|
|
34,341 |
|
Decrease (increase) in other assets |
|
|
|
|
|
|
4,120 |
|
|
|
4,120 |
|
|
|
|
(112,441 |
) |
|
|
71,000 |
|
Increase (decrease) in accounts payable |
|
|
828,353 |
|
|
|
4,184 |
|
|
|
935,975 |
|
|
|
|
(230,592 |
) |
|
|
57,648 |
|
Increase (decrease) in accrued expenses, liabilities subject to compromise and other liabilities |
|
|
1,228,707 |
|
|
|
(192,824 |
) |
|
|
802,913 |
|
|
|
|
1,868,162 |
|
|
|
3,311,552 |
|
Decrease in deferred revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(7,522 |
) |
|
|
(50,096 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(6,931,226 |
) |
|
|
(1,658,013 |
) |
|
|
(11,230,272 |
) |
|
|
|
(4,662,880 |
) |
|
|
(148,610,040 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition of Agera, net of cash acquired |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,016,520 |
) |
Purchase of property and equipment |
|
|
(29,675 |
) |
|
|
|
|
|
|
(29,675 |
) |
|
|
|
|
|
|
|
(25,515,170 |
) |
Proceeds from the sale of property and equipment, net of selling costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,542,434 |
|
Purchase of investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(152,998,313 |
) |
Proceeds from sales and maturities of investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
153,507,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(29,675 |
) |
|
|
|
|
|
|
(29,675 |
) |
|
|
|
|
|
|
|
(20,480,569 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from convertible debt |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
91,450,000 |
|
Offering costs associated with the issuance of convertible debt |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,746,193 |
) |
Proceeds from notes payable to shareholders, net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
135,667 |
|
Proceeds from the issuance of preferred stock, net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,931,800 |
|
Proceeds from the issuance of redeemable preferred stock series A, net |
|
|
|
|
|
|
|
|
|
|
2,870,000 |
|
|
|
|
|
|
|
|
|
|
Proceeds from the issuance of redeemable preferred stock series B, net |
|
|
2,388,168 |
|
|
|
|
|
|
|
2,388,168 |
|
|
|
|
|
|
|
|
|
|
Deposit received for issuance of shares in October 2010 |
|
|
130,000 |
|
|
|
|
|
|
|
130,000 |
|
|
|
|
|
|
|
|
|
|
Proceeds from the issuance of common stock, net |
|
|
3,469,400 |
|
|
|
1,800,000 |
|
|
|
5,269,400 |
|
|
|
|
|
|
|
|
93,753,857 |
|
Costs associated with secured loan and debtor-in-possession loan |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(360,872 |
) |
|
|
(360,872 |
) |
Proceeds from secured loan |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
500,471 |
|
|
|
500,471 |
|
Proceeds from debtor-in-possession loan |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,750,000 |
|
|
|
2,750,000 |
|
Payments on insurance loan |
|
|
(47,795 |
) |
|
|
(8,304 |
) |
|
|
(69,686 |
) |
|
|
|
(63,983 |
) |
|
|
(79,319 |
) |
Cash dividends paid on preferred stock |
|
|
(139,750 |
) |
|
|
|
|
|
|
(139,750 |
) |
|
|
|
|
|
|
|
(1,087,200 |
) |
Cash paid for fractional shares of preferred stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(38,108 |
) |
Merger and acquisition expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(48,547 |
) |
Repurchase of common stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(26,024,280 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
5,800,023 |
|
|
|
1,791,696 |
|
|
|
10,448,132 |
|
|
|
|
2,825,616 |
|
|
|
170,137,276 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash balances |
|
|
3,473 |
|
|
|
3,174 |
|
|
|
6,622 |
|
|
|
|
(6,760 |
) |
|
|
(36,391 |
) |
Net increase (decrease) in cash and cash equivalents |
|
|
(1,157,405 |
) |
|
|
136,857 |
|
|
|
(805,193 |
) |
|
|
|
(1,844,024 |
) |
|
|
1,010,276 |
|
F-58
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor |
|
|
Successor |
|
|
Successor |
|
|
|
Predecessor |
|
|
Predecessor |
|
|
|
|
|
|
|
|
|
|
|
Cumulative |
|
|
|
|
|
|
|
Cumulative |
|
|
|
|
|
|
|
|
|
|
|
period from |
|
|
|
|
|
|
|
period from |
|
|
|
|
|
|
|
|
|
|
|
September 1, |
|
|
|
|
|
|
|
December 28, |
|
|
|
Nine months |
|
|
One month |
|
|
2009 (date of |
|
|
|
Eight months |
|
|
1995 (date of |
|
|
|
ended |
|
|
ended |
|
|
inception) to |
|
|
|
ended |
|
|
inception) to |
|
|
|
September 30, |
|
|
September 30, |
|
|
September 30, |
|
|
|
August 31, |
|
|
August 31, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
|
2009 |
|
|
2009 |
|
Cash and cash equivalents, beginning of period |
|
|
1,362,488 |
|
|
|
1,010,276 |
|
|
|
1,010,276 |
|
|
|
|
2,854,300 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period |
|
$ |
205,083 |
|
|
$ |
1,147,133 |
|
|
$ |
205,083 |
|
|
|
$ |
1,010,276 |
|
|
$ |
1,010,276 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosures of cash flow information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Predecessor cash paid for interest |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
$ |
|
|
|
$ |
12,715,283 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor cash paid for dividends |
|
|
139,750 |
|
|
|
|
|
|
|
139,750 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash investing and financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Predecessor deemed dividend associated with beneficial conversion of preferred stock |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
$ |
|
|
|
$ |
11,423,824 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Predecessor preferred stock dividend |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,589,861 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor accrued preferred stock dividend |
|
|
85,183 |
|
|
|
|
|
|
|
85,183 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Predecessor uncompensated contribution of services |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
755,556 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Predecessor common stock issued for intangible assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
540,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Predecessor common stock issued in connection with conversion of debt |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,814,000 |
|
|
|
10,814,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Predecessor equipment acquired through capital lease |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
167,154 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor/Predecessor financing of insurance premiums |
|
|
|
|
|
|
|
|
|
|
81,517 |
|
|
|
|
|
|
|
|
87,623 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor issuance of notes payable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,000,060 |
|
|
|
6,000,060 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor common stock issued in connection with reorganization |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,472,000 |
|
|
|
5,472,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor intangible assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,340,656 |
|
|
|
6,340,656 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor deferred tax liability in connection with fresh-start |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,500,000 |
|
|
|
2,500,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Elimination of Predecessor common stock and fresh start adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,780,320 |
|
|
|
14,780,320 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor
subscription receivable |
|
|
792,000 |
|
|
|
|
|
|
|
792,000 |
|
|
|
|
|
|
|
|
|
|
Successor accrued warrant liability |
|
|
5,579,319 |
|
|
|
|
|
|
|
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The accompanying notes are an integral part of these consolidated financial statements.
F-59
Fibrocell Science, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements
Note 1Emergence from Voluntary Reorganization Under Chapter 11 Proceedings and Reorganization Plan
Background
On June 15, 2009 Isolagen, Inc. (the Predecessor) and Isolagens wholly owned subsidiary,
Isolagen Technologies, Inc. (Isolagen Tech) (Isolagen and Isolagen Tech are referred as the
Debtors), each filed a voluntary petition for reorganization under Chapter 11 of the United
States Bankruptcy Code (the Bankruptcy Code) in the United States Bankruptcy Court for the
District of Delaware in Wilmington (the Bankruptcy Court) under Case Nos. 09-12072 and 09-12073,
respectively.
On August 27, 2009 (the Confirmation Date), the Bankruptcy Court entered an order (the
Confirmation Order) confirming the Debtors Joint First Amended Plan of Reorganization dated July
30, 2009, as supplemented by the Plan Supplement dated August 21, 2009 (as so modified and
supplemented, the Plan). The effective date of the Plan (Effective Date) was September 3, 2009.
Isolagen and Isolagen Tech emerged from bankruptcy as the reorganized debtors, Fibrocell Science,
Inc. (Fibrocell or the Company or the Successor) and Fibrocell Technologies, Inc. (Fibrocell
Technologies), respectively (collectively, the Reorganized Debtors). Fibrocell now operates
outside of the restraints of the bankruptcy process, free of the debts and liabilities discharged
by the Plan.
The Predecessor Companys officers and directors as of the effective date were all deemed to
have resigned and a new board of directors was appointed. As of the effective date, the Successor
Companys initial board of directors consisted of: David Pernock, Paul Hopper and Kelvin Moore.
Dr. Robert Langer was appointed to the Board in late September 2009. Declan Daly remained as chief
operating officer and chief financial officer of the reorganized company, and in November 2009, he
was appointed to the Board of Directors. Mr. Daly received 5% of the Common Stock of the Successor
as of the date of his appointment, which is subject to a two-year vesting schedule whereby 50%
vested on the Effective Date, 25% shall vest on the first anniversary and 25% shall vest on the
second anniversary. Mr. Daly was the acting interim chief executive officer until February 1, 2010.
On February 1, 2010, David Pernock became the Chief Executive Officer. Marc Mazur was appointed to
the Board of Directors in April 2010. George J. Korkos, M.D., D.D.S., F.A.C.S. was appointed to the
Board of Directors in July 2010.
Plan of Reorganization
Pursuant to the Plan, all of the Predecessor Companys equity interests, including without
limitation its common stock, options and warrants outstanding as of the effective date were
cancelled. On the effective date, the Successor Company completed an exit financing of common stock
in the amount of $2 million, after which the equity holders of the Successor Company were:
7,320,000 shares, to our pre-bankruptcy lenders and the lenders that provided us our
debtor-in-possession facility, collectively;
3,960,000 shares, to the holders of our 3.5% convertible subordinated notes;
600,000 shares, to our management as of the effective date, which was our chief
operating officer;
120,000 shares, to the holders of our general unsecured claims; and
2,666,666 shares, to the purchasers of shares in the $2 million exit financing (our
pre-bankruptcy lenders, the lenders that provided us our debtor-in-possession facility and
the holders of our 3.5% convertible subordinated notes were permitted to participate in our
exit financing).
F-60
In the Plan, in addition to the common stock set forth above, each holder of Isolagens 3.5%
convertible subordinated notes, due November 2024, in the approximate non-converted aggregate
principal amount of $81 million, received, in full and final satisfaction, settlement, release and
discharge of and in exchange for any and all
claims arising out of the 3.5% convertible subordinated notes, its pro rata share of an
unsecured note in the principal amount of $6 million, or the Notes. The Notes have the following
features:
12.5% interest payable quarterly in cash or, at the Companys option, 15% payable in
kind by capitalizing such unpaid amount and adding it to the principal as of the date it was
due;
matures June 1, 2012;
at any time prior to the maturity date, the Company may redeem any portion of the
outstanding principal of the Notes in cash at 125% of the stated face value of the Notes;
provided that the Company will be obligated to redeem all outstanding Notes upon the
following events: (a) the Company or its subsidiary, Fibrocell Technologies, Inc. (formerly,
Isolagen Technologies, Inc.) successfully complete a capital campaign raising in excess of
$10,000,000; or (b) the Company or its subsidiary, Fibrocell Technologies, Inc., are
acquired by, or sell a majority stake to, an outside party;
the Notes contain customary representations, warranties and covenants, including a
covenant that the Company and its subsidiary, Fibrocell Technologies, Inc., shall be
prohibited from the incurrence of additional debt without obtaining the consent of 66 2/3%
of the Note holders.
Trading of Common Stock
The Predecessors common stock ceased trading on the NYSE Amex on May 6, 2009 and in June 2009
the NYSE Amex delisted the Predecessors common stock from listing on the NYSE Amex. Upon the
Effective Date, the outstanding common stock of the Predecessor Company was cancelled for no
consideration. Consequently, the Predecessors stockholders prior to the Effective Date no longer
have any interest as stockholders of the Predecessor Company by virtue of their ownership of the
Predecessors common stock prior to the emergence from bankruptcy. On October 21, 2009, the
Successor Company was available for trading on the OTC Bulletin Board under the symbol FCSC.
Note 2Basis of Presentation, Business and Organization
Fibrocell is the parent company of Fibrocell Technologies and Agera Laboratories, Inc., a
Delaware corporation (Agera). Fibrocell Technologies is the parent company of Isolagen Europe
Limited, a company organized under the laws of the United Kingdom (Isolagen Europe), Isolagen
Australia Pty Limited, a company organized under the laws of Australia (Isolagen Australia), and
Isolagen International, S.A., a company organized under the laws of Switzerland (Isolagen
Switzerland).
The Company is an aesthetic and therapeutic company focused on developing novel skin and
tissue rejuvenation products. The Companys clinical development product candidates are designed to
improve the appearance of skin injured by the effects of aging, sun exposure, acne and burns with a
patients own, or autologous, fibroblast cells produced in the Companys proprietary Fibrocell
Process. The Company also markets an advanced skin care line with broad application in core target
markets through its Agera subsidiary.
In October 2006, the Predecessor Company reached an agreement with the U.S. Food and Drug
Administration (FDA) on the design of a Phase III pivotal study protocol for the treatment of
nasolabial fold wrinkles. The randomized, double-blind protocol was submitted to the FDA under the
agencys Special Protocol Assessment (SPA) regulations. Pursuant to this assessment process, the
FDA has agreed that the Predecessor Companys study design for two identical trials, including
patient numbers, clinical endpoints, and statistical analyses, is acceptable to the FDA to form the
basis of an efficacy claim for a marketing application. The randomized, double-blind, pivotal Phase
III trials will evaluate the efficacy and safety of our product against placebo in approximately
400 patients with approximately 200 patients enrolled in each trial. The Predecessor Company
completed enrollment of the study and commenced injection of subjects in early 2007. All injections
were completed in January 2008 and top line results from this trial were publically announced in
August 2008. The data analysis, including safety data, was publically released in October 2008. The
related Biologics License Application (BLA) was submitted to the FDA in March 2009. In May 2009,
the Predecessor Company announced that the
FDA had completed its initial review of the Companys BLA related to its nasolabial fold
wrinkles product candidate and that the FDA had accepted (or filed) the BLA for full review.
F-61
On October 9, 2009, the FDA Cellular, Tissue and Gene Therapies Advisory Committee reviewed
the Companys nasolabial fold wrinkles product candidate. The Committee voted 11 yes to 3 no
that the data presented on our product demonstrated efficacy, and 6 yes to 8 no that the data
demonstrated safety; both for the proposed indication of treatment of nasolabial fold wrinkles. The
Committees recommendations are not binding on the FDA, but the FDA will consider their
recommendations during their review of our application. The United States Adopted Names (USAN)
Council adopted the USAN name, azficel-T, for our nasolabial fold wrinkles product candidate on
October 28, 2009, and the FDA is currently evaluating a proposed brand name, Laviv.
On December 21, 2009, Fibrocell received a Complete Response letter from the FDA related to
the BLA for azficel-T, an autologous cell therapy for the treatment of moderate to severe
nasolabial fold wrinkles in adults. A Complete Response letter is issued by the FDAs Center for
Biologics Evaluation and Research (CBER) when the review of a file is completed and additional data
are needed prior to approval. The Complete Response letter requested that Fibrocell Science provide
data from a histopathological study on biopsied tissue samples from patients following injection of
azficel-T. The histology study (IT-H-001) will evaluate tissue treated with azficel-T as compared
to tissue treated with sterile saline (placebo). The study will also provide information about the
skin after treatment, including evaluation of collagen and elastin fibrils, and cellular structure
of the sampled tissues. The Company submitted a proposed protocol concerning a histopathological
study on biopsied samples to the FDA and to the Companys Investigational Review Board (IRB).
The IRB has approved the protocol and the Company received the comments from the FDA on the
protocol in May 2010.
On May 13, 2010, the Company announced the initiation of a small histology study of azficel-T,
an autologous cell therapy currently under review by the U.S. Food and Drug Administration (FDA)
for the treatment of moderate to severe nasolabial fold wrinkles. The study has a target enrollment
of approximately 20 participants from the completed and statistically significant pivotal Phase III
studies of azficel-T (IT-R-005 and IT-R-006). The Company announced on July 8, 2010, the completion
of enrollment of and first treatment visits for participants in its histology study of azficel-T.
The second treatment visits for participants enrolled in the histology study of azficel-T were
completed by the end of July. The third treatment visits for participants enrolled in the
histology study of azficel-T were completed by the end of August.
The Complete Response letter also requested finalized Chemistry, Manufacturing and Controls
(CMC) information regarding the manufacture of azficel-T as follow-up to discussions that occurred
during the BLA review period, as well as revised policies and procedures.
The Company anticipates filing its response to the FDAs Complete Response letter by the end
of 2010. There is no assurance that the FDA will accept the Companys response as it may find that
the Companys response does not provide sufficient information to address its Complete Response
letter. Even if the FDA accepts the Companys response for complete evaluation, there is no
assurance that it will approve our product. The FDA, under the Prescription Drug User Fee Act
(PDUFA), has a target six months review window to completely evaluate the Companys response upon
acceptance of the response.
Basis of Presentation
For discussions on the results of operations, the Successor Company has compared the three and
nine months ended September 30, 2010 (Successor Company) to the three and nine months ended
September 30, 2009 (Predecessor Company). The Successor Company believes that the financial
results provide management and investors a more meaningful analysis of the Successor Companys
performance and trends for comparative purposes.
The consolidated financial statements and notes thereto presented herein are unaudited. In the
opinion of management, all adjustments (consisting of normal accruals) have been made that are
necessary to present fairly the financial position of the Company as of September 30, 2010, and the
results of its operations and cash flows for the nine months ended September 30, 2010 and the
cumulative period from September 1, 2009 (date of inception) to
September 30, 2010. These financial statements should be read in conjunction with the
financial statements that were included in the Companys Annual Report on Form 10-K for the period
ended December 31, 2009.
F-62
In June 2009, the Financial Accounting Standards Board (FASB) issued Accounting Standards
Codification 105 (ASC), Generally Accepted Accounting Principles, which became the single source
of authoritative nongovernmental U.S. generally accepted accounting principles (GAAP),
superseding existing FASB, American Institute of Certified Public Accountants (AICPA), Emerging
Issues Task Force (EITF), and related accounting literature. This pronouncement reorganizes the
thousands of GAAP pronouncements into roughly 90 accounting topics and displays them using a
consistent structure. Also included is relevant Securities and Exchange Commission (SEC) guidance
organized using the same topical structure in separate sections and will be effective for financial
statements issued for reporting periods that end after September 15, 2009. The impact on the
Companys financial disclosures is that references to authoritative accounting literature will be
references in accordance with ASC 105.
Financial Reporting by Entities in Reorganization under the Bankruptcy Code
Overall, ASC 852-10, Financial Reporting by Entities in Reorganization Under the Bankruptcy
Code, (ASC 852) applies to the Companys financial statements for the periods that the Company
operated under the provisions of Chapter 11. ASC 852 does not change the application of generally
accepted accounting principles in the preparation of financial statements. However, for periods
including and subsequent to the filing of the Chapter 11 petition, ASC 852 does require that the
financial statements distinguish transactions and events that are directly associated with the
reorganization from the ongoing operations of the business. Accordingly, certain revenues,
expenses, gains, and losses that were realized or incurred during the Chapter 11 proceedings have
been classified as reorganization items, net on the accompanying consolidated statements of
operations.
As of September 1, 2009, the Successor Company adopted fresh-start accounting in accordance
with ASC 852-10. The Successor Company selected September 1, 2009, as the date to effectively
apply fresh-start accounting based on the absence of any material contingencies at the September 3,
2009 effective date and the immaterial impact of transactions between September 1, 2009 and
September 3, 2009. The adoption of fresh-start accounting resulted in the Successor Company
becoming a new entity for financial reporting purposes. The Successor Company is a development
stage company in accordance with ASC 915, Development Stage Entities.
Accordingly, the financial statements prior to September 1, 2009 are not comparable with the
financial statements for periods on or after September 1, 2009. References to Successor or
Successor Company refer to the Company on or after September 1, 2009, after giving effect to the
cancellation of Isolagen, Inc. common stock issued prior to the Effective Date, the issuance of new
Fibrocell Science, Inc. common stock in accordance with the Plan, and the application of
fresh-start accounting. References to Predecessor or Predecessor Company refer to the Company
prior to September 1, 2009. See Note 5 Fresh-Start Accounting in the notes to these
Consolidated Financial Statements for further details.
Note 3Going Concern
The Successor Company emerged from Bankruptcy in September 2009 and continues to operate as a
going concern. At September 30, 2010, the Successor Company had cash and cash equivalents of
approximately $0.2 million and negative working capital of $1.1 million. In early July 2010, the
Successor Company raised approximately $2.7 million less fees as a result of the issuance of
preferred stock and warrants. In early September 2010, the Successor Company raised approximately
$0.7 million less fees as a result of the issuance of preferred stock and warrants. The Successor
Company has also raised approximately $1.0 million less fees as the result of the issuance of
preferred stock and warrants in the period from October 1, 2010 to November 12, 2010.
The Company has not yet received $0.7 million in subscription proceeds from the above raises.
Although the Company believes that these outstanding funds will be received, there is no guarantee
that these funds will be received.
F-63
As
of November 12, 2010, the Company had cash and cash equivalents
of approximately $0.2 million and liabilities of approximately
$1.6 million. Thus, the Successor
Company will require to raise additional cash resources in the very near future, or it will likely cease
operations. The Successor Company will need to access the capital markets in the future in order to
fund future operations. There is no guarantee that any such required financing will be available on
terms satisfactory to the Successor Company or available at all. These matters create uncertainty
relating to its ability to continue as a going concern. The accompanying consolidated financial
statements do not reflect any adjustments relating to the recoverability and classification of
assets or liabilities that might result from the outcome of these uncertainties.
Further, if the Successor Company raises additional cash resources in the very near future, it
may be raised in contemplation of or in connection with bankruptcy. In the event of a bankruptcy,
it is likely that its common stock and common stock equivalents will become worthless and our
creditors will receive significantly less than what is owed to them.
Through September 30, 2010, the Successor Company has been primarily engaged in developing its
initial product technology. In the course of its development activities, the Company has sustained
losses and expects such losses to continue through at least 2010. During the nine months ended
September 30, 2010, the Successor Company financed its operations primarily through its existing
cash, but as discussed above it now requires additional financing. There is substantial doubt about
the Successor Companys ability to continue as a going concern.
The Successor Companys ability to complete additional offerings is dependent on the state of
the debt and/or equity markets at the time of any proposed offering, and such markets reception of
the Successor Company and the offering terms. The Successor Companys ability to complete an
offering is also dependent on the status of its FDA regulatory milestones and its clinical trials,
and in particular, the status of its indication for the treatment of nasolabial fold wrinkles and
the status of the related BLA, which cannot be predicted. There is no assurance that capital in any
form would be available to the Company, and if available, on terms and conditions that are
acceptable.
As a result of the conditions discussed above, and in accordance with GAAP, there exists
substantial doubt about the Successor Companys ability to continue as a going concern, and its
ability to continue as a going concern is contingent, among other things, upon its ability to
secure additional adequate financing or capital in the very near future. If the Successor Company
does not obtain additional funding, or does not anticipate additional funding, in the very near
future, it will likely enter into bankruptcy and/or cease operations. Further, if it does raise
additional cash resources in the very near future, it may be raised in contemplation of or in
connection with bankruptcy. If the Successor Company enters into bankruptcy, it is likely that its
common stock and common stock equivalents will become worthless and
its creditors, including preferred stock, will receive
significantly less than what is owed to them.
Note 4Summary of Significant Accounting Policies
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make
estimates and assumptions that affect the reported amounts in the consolidated financial statements
and notes. In addition, managements assessment of the Successor Companys ability to continue as a
going concern involves the estimation of the amount and timing of future cash inflows and outflows.
Actual results may differ materially from those estimates.
Cash and Cash Equivalents
The Company considers highly liquid investments with an original maturity of three months or
less when purchased to be cash equivalents.
Concentration of Credit Risk
As of September 30, 2010, the Successor Company maintains the majority of its cash primarily
with one major U.S. domestic bank. The amounts held in this bank do not exceed the insured limit of
$250,000. The terms of these deposits are on demand to minimize risk. The Successor Company has not
incurred losses related to these deposits. Cash and cash equivalents of approximately $0.1 million,
related to Agera and the Successor Companys
Swiss subsidiary, is maintained in two separate financial institutions. The Successor Company
invests these funds primarily in demand deposit accounts.
F-64
Allowance for Doubtful Accounts
The Successor Company maintains an allowance for doubtful accounts related to its accounts
receivable that have been deemed to have a high risk of collectability. Management reviews its
accounts receivable on a monthly basis to determine if any receivables will potentially be
uncollectible. One foreign customer represents 89% and 87% of accounts receivable, net, at
September 30, 2010 and December 31, 2009, respectively. Management analyzes historical collection
trends and changes in its customer payment patterns, customer concentration, and creditworthiness
when evaluating the adequacy of its allowance for doubtful accounts. In its overall allowance for
doubtful accounts, the Successor Company includes any receivable balances that are determined to be
uncollectible. Based on the information available, management believes the allowance for doubtful
accounts is adequate; however, actual write-offs might exceed the recorded allowance.
The allowance for doubtful accounts was $24,259 and $37,098 at September 30, 2010 and December
31, 2009, respectively.
Inventory
Agera purchases the large majority of its inventory from one contract manufacturer. Agera
accounts for its inventory on the first-in-first-out method. At September 30, 2010, Ageras
inventory of $0.2 million consisted of $0.1 million of raw materials and $0.1 million of finished
goods. At December 31, 2009, Ageras inventory of $0.2 million consisted of $0.2 million of raw
materials and less than $0.1 million of finished goods.
Property and equipment
Property and equipment is carried at cost less accumulated depreciation and amortization.
Generally, depreciation and amortization for financial reporting purposes is provided by the
straight-line method over the estimated useful life of three years, except for leasehold
improvements which are amortized using the straight-line method over the remaining lease term or
the life of the asset, whichever is shorter. The cost of repairs and maintenance is charged as an
expense as incurred.
Intangible assets
Intangible assets are research and development assets related to the Successor Companys
primary study that was recognized upon emergence from bankruptcy (see Note 5). Intangibles are
tested for recoverability whenever events or changes in circumstances indicate the carrying amount
may not be recoverable. An impairment loss, if any, would be measured as the excess of the carrying
value over the fair value determined by discounted cash flows. There was no impairment of the
intangible assets as of September 30, 2010.
Revenue recognition
The Successor Company recognizes revenue over the period the service is performed in
accordance with ASC 605, Revenue Recognition (ASC 605). In general, ASC 605 requires that four
basic criteria must be met before revenue can be recognized: (1) persuasive evidence of an
arrangement exists, (2) delivery has occurred or services rendered, (3) the fee is fixed and
determinable and (4) collectability is reasonably assured.
Revenue from the sale of Ageras products is recognized upon transfer of title, which is upon
shipment of the product to the customer. The Successor Company believes that the requirements of
ASC 605 are met when the ordered product is shipped, as the risk of loss transfers to our customer
at that time, the fee is fixed and determinable and collection is reasonably assured. Any advanced
payments are deferred until shipment.
F-65
Shipping and handling costs
Agera charges its customers for shipping and handling costs. Such charges to customers are
presented net of the costs of shipping and handling, as selling, general and administrative
expense, and are not significant to the consolidated statements of operations.
Advertising cost
Agera advertising costs are expensed as incurred and include the costs of public relations and
certain marketing related activities. These costs are included in selling, general and
administrative expenses in the accompanying consolidated statements of operations.
Research and development expenses
Research and development costs are expensed as incurred and include salaries and benefits,
costs paid to third-party contractors to perform research, conduct clinical trials, develop and
manufacture drug materials and delivery devices, and a portion of facilities cost. Research and
development costs also include costs to develop manufacturing, cell collection and logistical
process improvements.
Clinical trial costs are a significant component of research and development expenses and
include costs associated with third-party contractors. Invoicing from third-party contractors for
services performed can lag several months. The Successor Company accrues the costs of services
rendered in connection with third-party contractor activities based on its estimate of management
fees, site management and monitoring costs and data management costs. Actual clinical trial costs
may differ from estimated clinical trial costs and are adjusted for in the period in which they
become known.
Warrant Liability
The warrants for the Successor Company are measured at fair value and liability-classified
under ASC 815, Derivatives and Hedging, (ASC 815) because the warrants contain down-round
protection and therefore, do not meet the scope exception for treatment as a derivative under ASC
815. Since down-round protection is not an input into the calculation of the fair value of the
warrants, the warrants cannot be considered indexed to the Companys own stock which is a
requirement for the scope exception as outlined under ASC 815. The fair value of the warrants is
determined using the Black-Scholes option pricing model and is affected by changes in inputs to
that model including our stock price, expected stock price volatility, the contractual term, and
the risk-free interest rate. The Successor Company will continue to classify the fair value of the
warrants as a liability until the warrants are exercised, expire or are amended in a way that would
no longer require these warrants to be classified as a liability.
Stock-based Compensation
The Successor Company accounts for stock-based awards to employees and non-employees using the
fair value based method to determine compensation for all arrangements where shares of stock or
equity instruments are issued for compensation. The Successor Company uses a Black-Scholes
options-pricing model to determine the fair value of each option grant as of the date of grant for
expense incurred. The Black-Scholes model requires inputs for risk-free interest rate, dividend
yield, volatility and expected lives of the options. Expected volatility is based on historical
volatility of the Companys competitors stock since the Predecessor Company ceased trading as part
of the bankruptcy and emerged as a new entity. The risk-free rate for periods within the
contractual life of the option is based on the U.S. Treasury yield curve in effect at the time of
the grant. The expected lives for options granted represents the period of time that options
granted are expected to be outstanding and is derived from the contractual terms of the options
granted. The Successor Company estimates future forfeitures of options based upon expected
forfeiture rates.
Income taxes
An asset and liability approach is used for financial accounting and reporting for income
taxes. Deferred income taxes arise from temporary differences between income tax and financial
reporting and principally relate to recognition of revenue and expenses in different periods for
financial and tax accounting purposes and are measured using currently enacted tax rates and laws.
In addition, a deferred tax asset can be generated by net operating loss
(NOLs) carryover. If it is more likely than not that some portion or all of a deferred tax
asset will not be realized, a valuation allowance is recognized.
F-66
In the event the Company is charged interest or penalties related to income tax matters, the
Company would record such interest as interest expense and would record such penalties as other
expense in the consolidated statements of operations. No such charges have been incurred by the
Company. As of September 30, 2010 and December 31, 2009, the Successor Company had no accrued
interest related to uncertain tax positions.
At September 30, 2010 and December 31, 2009, the Company has provided a full valuation
allowance for the net deferred tax assets, the large majority of which relates to the future
benefit of loss carryovers. In addition, as a result of fresh-start accounting, the Successor
Company may be limited by section 382 of the Internal Revenue Service Code. The tax years 2006
through 2009 remain open to examination by the major taxing jurisdictions to which we are subject.
The deferred tax liability at September 30, 2010 and December 31, 2009, relates to the intangible
assets recognized upon fresh-start accounting.
Earnings (loss) per share data
Basic earnings (loss) per share is calculated based on the weighted average common shares
outstanding during the period. Diluted earnings per share (Diluted EPS) also gives effect to the
dilutive effect of stock options, warrants, restricted stock and convertible preferred stock
calculated based on the treasury stock method.
The Predecessor and Successor Companys potentially dilutive securities consist of potential
common shares related to stock options, warrants, restricted stock and convertible preferred stock.
Diluted EPS includes the impact of potentially dilutive securities except in periods in which
there is a loss because the inclusion of the potential common shares would be anti-dilutive. The
Company does not present diluted earnings per share for years in which it incurred net losses as
the effect is anti-dilutive. There were no potentially dilutive securities for the eight months
ended August 31, 2009, due to the cancellation of the convertible notes and the cancellation of all
the outstanding stock option plans and the last known market price was less than exercise price.
Fair Value of Financial Instruments
The carrying values of certain of the Successor Companys financial instruments, including
cash equivalents and accounts payable approximates fair value due to their short maturities. The
fair values of the Successor Companys long-term obligations are based on assumptions concerning
the amount and timing of estimated future cash flows and assumed discount rates reflecting varying
degrees of risk. The carrying values of the Successor Companys long-term obligations approximate
their fair values.
The fair value of the reorganization value which applies in fresh-start accounting was
estimated by applying the income approach and a market approach. This fair value measurement is
based on significant inputs that are not observable in the market and, therefore, represents a
Level 3 measurement as defined in ASC 820, Fair Value Measurements.
Adoption of Standards
In March 2010, the FASB amended the disclosure requirements so that SEC filers are no longer
required to disclose the date through which subsequent events have been evaluated in originally
issued and revised financial statements. This revised guidance is effective immediately and we
adopted this pronouncement on March 31, 2010 and have revised the disclosures as required.
On December 15, 2009, the FASB issued ASU No. 2010-06 Fair Value Measurements and Disclosures
Topic 820 Improving Disclosures about Fair Value Measurements. This ASU requires some new
disclosures and clarifies some existing disclosure requirements about fair value measurement as set
forth in Codification Subtopic 820-10. The FASBs objective is to improve these disclosures and,
thus, increase the transparency in financial reporting. The adoption of this ASU did not have a
material impact on the Companys consolidated financial statements.
F-67
Note 5Fresh-Start Accounting
On September 1, 2009, the Successor Company adopted fresh-start accounting upon the emergence
of bankruptcy in accordance with ASC 852-10, Reorganization. Fresh-start accounting results in the
Company becoming a new entity for financial reporting purposes. Accordingly, the Companys
consolidated financial statements for periods prior to September 1, 2009 are not comparable to
consolidated financial statements presented on or after September 1, 2009. The Company selected
September 1, 2009, as the date to apply fresh-start accounting based on the absence of any material
contingencies at the September 3, 2009 effective date and the immaterial impact of transactions
between September 1, 2009 and September 3, 2009.
Under ASC 852-10, the Successor Company must determine a value to be
assigned to the equity of the emerging company as of the date of the adoption of fresh-start
accounting. The Successor Company obtained an independent appraisal to value the equity and it
served as the fair market value of the emerging Companys equity.
Fresh-start accounting reflects the value of the Successor Company as determined in the
confirmed Plan. Under fresh-start accounting, the Successor Companys assets values are remeasured
and allocated in conformity with ASC 805-20, Business Combinations, Identifiable Assets and
Liabilities, and any Noncontrolling Interest. Fresh-start accounting also requires that all
liabilities should be stated at fair value. The portion of the reorganization value which was
attributed to identified intangible assets was $6,340,656. This value is related to research and
development assets that are not subject to amortization. In accordance with ASC 805-20, this
amount is reported as intangibles in the consolidated financial statements as of September 30,
2010, and is not being amortized.
The following fresh-start Consolidated Balance Sheet presents the financial effects on the
Successor Company with the implementation of the Plan and the adoption of fresh-start accounting.
The effect of the consummation of the transactions contemplated in the Plan included the settlement
of liabilities and the issuance of common stock.
The effects of the Plan and fresh-start reporting on the Successor Companys Consolidated
Balance Sheet are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Predecessor |
|
|
Reclassifications |
|
|
|
Fresh Start |
|
|
Successor |
|
|
|
August 31, |
|
|
And Plan of |
|
|
|
Accounting |
|
|
September 1, |
|
|
|
2009 |
|
|
Reorganization |
|
|
|
Adjustments |
|
|
2009 |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
1,010,277 |
|
|
$ |
|
|
|
|
$ |
|
|
|
$ |
1,010,277 |
|
Accounts receivable, net |
|
|
246,684 |
|
|
|
|
|
|
|
|
|
|
|
|
246,684 |
|
Inventory, net |
|
|
268,619 |
|
|
|
|
|
|
|
|
|
|
|
|
268,619 |
|
Prepaid expenses |
|
|
221,225 |
|
|
|
|
|
|
|
|
|
|
|
|
221,225 |
|
Other current assets |
|
|
4,140 |
|
|
|
|
|
|
|
|
|
|
|
|
4,140 |
|
Current assets of discontinued operations, net |
|
|
785 |
|
|
|
|
|
|
|
|
|
|
|
|
785 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
1,751,730 |
|
|
|
|
|
|
|
|
|
|
|
|
1,751,730 |
|
Intangible assets |
|
|
|
|
|
|
|
|
|
|
|
6,340,656 |
(e) |
|
|
6,340,656 |
|
Other assets |
|
|
1,671 |
|
|
|
|
|
|
|
|
|
|
|
|
1,671 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
1,753,401 |
|
|
$ |
|
|
|
|
$ |
6,340,656 |
|
|
$ |
8,094,057 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities, Shareholders Equity/(Deficit) and Noncontrolling Interests |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current debt |
|
$ |
8,304 |
|
|
$ |
|
|
|
|
$ |
|
|
|
$ |
8,304 |
|
Accounts payable |
|
|
137,401 |
|
|
|
|
|
|
|
|
|
|
|
|
137,401 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accrued expenses |
|
|
849,395 |
|
|
|
|
|
|
|
|
|
|
|
|
849,395 |
|
Liabilities subject to compromise |
|
|
82,181,741 |
|
|
|
(82,181,741 |
)(a) |
|
|
|
|
|
|
|
|
|
Prepetition secured loan, subject to compromise |
|
|
500,471 |
|
|
|
(500,471 |
)(b) |
|
|
|
|
|
|
|
|
|
Debtor-in-possession loan |
|
|
2,750,000 |
|
|
|
(2,750,000 |
)(b) |
|
|
|
|
|
|
|
|
|
Current liabilities of discontinued operations |
|
|
25,668 |
|
|
|
|
|
|
|
|
|
|
|
|
25,668 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
86,452,980 |
|
|
|
(85,432,212 |
) |
|
|
|
|
|
|
|
1,020,768 |
|
F-68
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Predecessor |
|
|
Reclassifications |
|
|
|
Fresh Start |
|
|
Successor |
|
|
|
August 31, |
|
|
And Plan of |
|
|
|
Accounting |
|
|
September 1, |
|
|
|
2009 |
|
|
Reorganization |
|
|
|
Adjustments |
|
|
2009 |
|
Other long term liabilities of continuing operations |
|
|
407,078 |
|
|
|
|
|
|
|
|
|
|
|
|
407,078 |
|
Notes payable |
|
|
|
|
|
|
6,000,060 |
(a) |
|
|
|
|
|
|
|
6,000,060 |
|
Deferred tax liability |
|
|
|
|
|
|
|
|
|
|
|
2,500,000 |
(f) |
|
|
2,500,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
86,860,058 |
|
|
|
(79,432,152 |
) |
|
|
|
2,500,000 |
|
|
|
9,927,906 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders Equity (Deficit): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Predecessor common stock |
|
|
42,821 |
|
|
|
(42,821 |
)(c) |
|
|
|
|
|
|
|
|
|
Predecessor additional paid-in capital |
|
|
142,737,499 |
|
|
|
(25,931,179 |
)(c) |
|
|
|
(116,806,320 |
)(g) |
|
|
|
|
Predecessor treasury stock |
|
|
(25,974,000 |
) |
|
|
25,974,000 |
(c) |
|
|
|
|
|
|
|
|
|
Successor common stock |
|
|
|
|
|
|
11,400 |
(a)(b) |
|
|
|
|
|
|
|
11,400 |
|
Successor additional paid-in capital |
|
|
|
|
|
|
5,460,600 |
(a)(b) |
|
|
|
(7,688,831 |
)(g) |
|
|
(2,228,231 |
) |
|
|
Accumulated deficit during development stage |
|
|
(202,295,959 |
) |
|
|
73,960,152 |
(a)(b)(c)(d) |
|
|
|
128,335,807 |
(g) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total shareholders equity (deficit) |
|
|
(85,489,639 |
) |
|
|
79,432,152 |
|
|
|
|
3,840,656 |
|
|
|
(2,216,831 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Noncontrolling interest |
|
|
382,982 |
|
|
|
|
|
|
|
|
|
|
|
|
382,982 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total equity (deficit) and noncontrolling interests |
|
|
(85,106,657 |
) |
|
|
79,432,152 |
|
|
|
|
3,840,656 |
|
|
|
(1,833,849 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities, shareholders equity/(deficit) and noncontrolling interests |
|
$ |
1,753,401 |
|
|
$ |
|
|
|
|
$ |
6,340,656 |
|
|
$ |
8,094,057 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes to Plan of Reorganization and fresh-start accounting adjustments
|
|
|
(a) |
|
This adjustment reflects the discharge of liabilities subject to compromise in accordance with
the Plan of Reorganization and the issuance of $6 million in Notes payable and the issuance of
4,080,000 shares of Successor Company common stock in satisfaction of such claims. |
|
(b) |
|
This adjustment reflects the discharge of prepetition loan and debtor in-possession loan in
accordance with the Plan of Reorganization and the issuance of 7,320,000 shares of the Successor
Company common stock in satisfaction of such claims. |
|
(c) |
|
This adjustment reflects the cancellation of the Predecessor Companys common stock, additional
paid-in capital and treasury stock. |
|
(d) |
|
To reset accumulated deficit to zero for the consolidated subsidiaries included in the Plan of Reorganization. |
|
(e) |
|
This adjustment reflects the portion of the reorganization value which was attributed to identified intangible assets. |
|
(f) |
|
To record deferred tax liability as a result of the impact of fresh-start accounting fair value adjustments. |
|
(g) |
|
To reset Predecessor additional paid-in capital, accumulated deficit to zero and record net fresh-start adjustments. |
Note 6Liabilities Subject to Compromise and Reorganization Items
Liabilities subject to compromise refers to pre-petition obligations that were impacted by the
Chapter 11 reorganization process. For further information regarding the discharge of liabilities
subject to compromise, see Note 5- Fresh-Start Accounting in the notes of these Financial
Statements. As of September 30, 2010, there were no liabilities subject to compromise.
The Company incurred certain professional fees and other expenses directly associated with the
bankruptcy proceedings. In addition, the Company has made adjustments to the carrying value of
certain prepetition liabilities. Such costs and adjustments are classified as reorganization
items, net and are presented separately in the unaudited consolidated statements of operations.
There were no reorganization costs for the three months ended September 30, 2010. For the nine
months ended September 30, 2010, there was $13,150 in professional fees offset by the gain from
discharge of a liability of $16,453 for a net gain of $3,303.
F-69
For the nine months ended September 30, 2009, the following have been incurred:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor |
|
|
|
Predecessor |
|
|
|
One month ended |
|
|
|
Two months ended |
|
|
Eight months ended |
|
|
|
September 30, 2009 |
|
|
|
August 31, 2009 |
|
|
August 31, 2009 |
|
Professional fees (expense) |
|
$ |
|
|
|
|
$ |
(334,738 |
) |
|
$ |
(533,271 |
) |
Debt issuance costs related to DIP facility |
|
|
|
|
|
|
|
(182,050 |
) |
|
|
(295,757 |
) |
Other debt issuance costs |
|
|
|
|
|
|
|
|
|
|
|
(280,964 |
) |
Gain on discharge of liabilities subject to compromise |
|
|
|
|
|
|
|
74,648,976 |
|
|
|
74,648,976 |
|
|
|
|
|
|
|
|
|
|
|
|
Total reorganization items, net |
|
$ |
|
|
|
|
$ |
74,132,188 |
|
|
$ |
73,538,984 |
|
|
|
|
|
|
|
|
|
|
|
|
The $74.6 million gain from discharge of liabilities subject to compromise is the result
of the settlement of 3.5% Subordinated Notes in exchange for $6.0 million in Notes Payable and
3,960,000 shares, Debtor-in-Possession Credit Facility and Prepetition Secured Loan in exchange for
7,320,000 shares of the Successor Companys common stock and unsecured claims in exchange for
120,000 shares. On the Effective Date, all stock option plans of the Predecessor company were
cancelled.
Cash paid for reorganization items during the three and nine months ended September 30, 2009
was $0.4 and $0.6 million, respectively. Professional fees include financial, legal and valuation
services directly associated with the reorganization process.
Note 7Agera Laboratories, Inc.
On August 10, 2006, the Predecessor Company acquired 57% of the outstanding common shares of
Agera. Agera is a skincare company that has proprietary rights to a scientifically-based advanced
line of skincare products. Agera markets its product primarily in the United States and Europe. The
results of Ageras operations and cash flows have been included in the consolidated financial
statements from the date of the acquisition. The assets and liabilities of Agera have been included
in the consolidated balance sheets since the date of the acquisition.
Note 8Accrued Expenses
Accrued expenses are comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
Successor |
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
Accrued professional fees |
|
$ |
447,790 |
|
|
$ |
147,410 |
|
Accrued compensation |
|
|
360,136 |
|
|
|
7,208 |
|
Accrued interest |
|
|
858,538 |
|
|
|
246,578 |
|
Dividend on preferred stock payable |
|
|
85,183 |
|
|
|
42,740 |
|
Accrued other |
|
|
342,785 |
|
|
|
100,324 |
|
|
|
|
|
|
|
|
Accrued expenses |
|
$ |
2,094,432 |
|
|
$ |
544,260 |
|
|
|
|
|
|
|
|
F-70
Note 9-Equity
Preferred Stock Series A
In October 2009, the Successor Company completed an offering of Series A Preferred Stock,
Class A Warrants and Class B Warrants (the October 2009 Offering). Each of the foregoing
securities were subject to the down-round protection, which provisions require the lowering of
the conversion price or exercise price, as applicable, to the purchase price in the current
offering, or $0.75, and with respect to the warrants, the number of shares issuable under the
warrants issued in the October 2009 Offering will be proportionately increased such that the
aggregate exercise price payable, after taking into consideration the decrease in exercise price,
shall be equal to the aggregate exercise price prior to such adjustment. The preferred stock has
been classified within the mezzanine section between liabilities and equity in its consolidated
balance sheets because any holder of Series A Preferred Stock may require the Successor Company to
redeem all of its Series A Preferred Stock in the event of a triggering event which is outside of
the control of the Successor Company. The Successor Company records accrued dividends at a rate of
6% per annum on the Series A Preferred stock. A dividend payment of $91,000 was paid in April 2010
for the dividends accrued as of March 31, 2010 and $48,750 was paid in July 2010 for the dividends
accrued as of June 30, 2010. As of September 30, 2010, $48,750 is accrued for dividends payable.
Preferred Stock Series B
On July 16, 2010, the Company entered into a Securities Purchase Agreement (the Purchase
Agreement) with certain accredited investors (the Purchasers), pursuant to which the Company
agreed to sell to the Purchasers in the aggregate: (i) 2,702 shares of Series B Convertible
Preferred Stock, with a par value of $0.001 per share and a stated value of $1,000 per share
(Series B Preferred), and (ii) warrants to purchase 4,503,334 shares of Company common stock
(Common Stock) at an exercise price of $0.8054 per share (the Warrants). Of the foregoing, to date, the Company has not received $210,000 in subscription proceeds
representing 210 shares Series B Preferred and Warrants to purchase 350,000 shares. The Successor Company records accrued dividends at a rate of 6% per annum on
the Series B Preferred stock. As of September 30, 2010, $36,433 is accrued for dividends payable.
The aggregate purchase price paid by the Purchasers for the Series B Preferred and the
Warrants was $2,702,000 (representing $1,000 for each share of Series B Preferred together with the
Warrants). The Company used the proceeds for working capital purposes.
Viriathus Capital LLC and John Carris Investments LLC were co-placement agents for the
Transaction, and received, in the aggregate, cash compensation of $216,160 and warrants to purchase
360,267 shares of Common Stock at an exercise price of $0.60 per share.
On September 8, 2010, the Company entered into Securities Purchase Agreements (the Purchase
Agreements) with certain accredited investors (the Purchasers), pursuant to which the Company
agreed to sell to the Purchasers in the aggregate: (i) 725 shares of Series B Convertible Preferred
Stock, with a par value of $0.001 per share and a stated value of $1,000 per share (Series B
Preferred), and (ii) warrants to purchase 1,208,333 shares of Company common stock (Common
Stock) at an exercise price of $0.8054 per share (the Warrants) (the Transactions).
The aggregate purchase price to be paid by the Purchasers for the Series B Preferred and the
Warrants will be $725,000 (representing $1,000 for each share of Series B Preferred together with
Warrants). Of the foregoing, to date, the Company has not received $450,000 in subscription
proceeds representing 450 shares Series B Preferred and Warrants to purchase 750,000 shares. Upon
receipt of these subscription proceeds, the Company will issue the foregoing securities. The
remaining securities sold in the Transactions have been issued. The Company intends to use the
proceeds for working capital purposes.
Viriathus Capital LLC and John Carris Investments LLC were co-placement agents for the
Transactions, and will receive cash compensation of $58,000 and warrants to purchase 96,667 shares
of Common Stock at an exercise price of $0.60 per share (assuming all subscription proceeds are
received in the Transactions).
Common Stock Offering
On March 2, 2010, the Company entered into a Securities Purchase Agreement (the Purchase
Agreement) with certain accredited investors (the Purchasers), pursuant to which the Company
sold to the Purchasers in the aggregate 5,076,664 shares of common stock at a purchase price of
$0.75 per share. Each Purchaser also received a warrant to purchase the same number of shares of
common stock acquired in the offering at an exercise price of $0.98 per share (the Warrants).
F-71
The aggregate purchase price paid by the Purchasers for the common stock and the warrants was
$3,807,500. The Company used the proceeds for working capital purposes.
Viriathus Capital LLC and John Carris Investments LLC were co-placement agents for the
transaction, and received cash compensation of $304,600 and warrants to purchase 406,133 shares of
common stock at an exercise price of $0.75 per share upon the closing.
Note 10-Warrants
Preferred Stock Series A Class A and B Warrants and Placement Agent Warrants
As disclosed above in Note 9, the Successor Company issued Class A warrants, Class B warrants
and placement agent warrants in connection with the October 2009 preferred stock transaction. The
warrants are liability classified since they have down-round price protection and they are
re-measured on the Companys reporting dates. As a result of the March 2, 2010 common stock
financing and the down-round provision, the Class A warrants, Class B warrants and placement
agent warrants were reissued to purchase 2.6 million shares of Common Stock at an exercise price of
$0.60 per share.
Preferred Stock Series B Warrants and Co-placement Agent Warrants
In connection with the Series B Convertible Preferred Stock transaction, the Successor Company
issued 5,711,666 warrants at an exercise price of $0.8054 per share and 456,934 placement agent
warrants at an exercise price of $0.60 per share. The warrants are liability classified since they
have down-round price protection and they are re-measured on the Companys reporting dates. The
weighted average fair market value of the warrants, at the date of issuance, granted to the
accredited investors and co-placement agents, based on the Black-Scholes valuation model, is
estimated to be $0.43 per warrant and $0.46 per warrant, respectively.
Common Stock Warrants and Co-placement Agent Warrants
In connection with the March 2, 2010 financing, the Successor Company issued 5,076,664
warrants at an exercise price of $0.98 per share to the accredited investors and 406,133 warrants
at an exercise price of $0.75 to the co-placement agents upon closing. The warrants are liability
classified since they have down-round price protection and they are re-measured on the Companys
reporting dates. The warrants were exercisable immediately after grant and expire five years
thereafter. The fair market value of the warrants, at the date of issuance, granted to the
accredited investors and co-placement agents, based on the Black-Scholes valuation model, is
estimated to be $0.52 per warrant and $0.58 per warrant, respectively. As a result of the
Convertible Preferred Stock Series B financing and the down-round provision, the Common Stock
warrants and placement agent warrants were reissued to purchase 8.8 million shares of Common Stock
at an exercise price of $0.60 per share.
The Successor Company recognizes these warrants as a liability at the fair value on each
reporting date due to the down-round price protection provision. The Company measured the fair
value of these warrants as of September 30, 2010, and recorded warrant income of $1.3 million
resulting from the decrease in the liability associated with the fair value of the warrants for the
three months ended September 30, 2010. The Company computed the value of the warrants using the
Black-Scholes method. The fair value of the warrants will continue to be classified as a liability
until such time as the warrants are exercised, expire or an amendment of the warrant agreements
renders these warrants to be no longer classified as a liability.
The weighted average fair market value of the warrants was computed using the Black-Scholes
option-pricing model with the following key assumptions as of the date indicated:
|
|
|
|
|
|
|
September 30, |
|
|
|
2010 |
|
Expected life (years) |
|
|
4.5 years |
|
Interest rate |
|
|
1.1 |
% |
Dividend yield |
|
|
|
|
Volatility |
|
|
63 |
% |
F-72
Rollforward of warrant liability from December 31, 2009 through September 30, 2010:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2009 |
|
|
Additions |
|
|
Revaluation |
|
|
September 30, 2010 |
|
Preferred stock class A warrants |
|
$ |
275,378 |
|
|
$ |
|
|
|
$ |
68,565 |
|
|
$ |
343,943 |
|
Preferred stock class B warrants |
|
|
207,611 |
|
|
|
|
|
|
|
136,332 |
|
|
|
343,943 |
|
Preferred stock co-placement warrants |
|
|
152,287 |
|
|
|
|
|
|
|
(14,710 |
) |
|
|
137,577 |
|
Common stock warrants |
|
|
|
|
|
|
2,654,752 |
|
|
|
(453,877 |
) |
|
|
2,200,875 |
|
Common stock placement warrants |
|
|
|
|
|
|
235,958 |
|
|
|
(101,211 |
) |
|
|
134,747 |
|
Preferred stock series B warrants |
|
|
|
|
|
|
2,466,374 |
|
|
|
(1,100,968 |
) |
|
|
1,365,406 |
|
Preferred stock series B co-placement warrants |
|
|
|
|
|
|
222,235 |
|
|
|
(94,888 |
) |
|
|
127,347 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
635,276 |
|
|
$ |
5,579,319 |
|
|
$ |
(1,560,757 |
) |
|
$ |
4,653,838 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant liability is comprised of the following as of September 30, 2010:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor |
|
|
|
Number of |
|
|
Fair Value of |
|
|
Balance as of |
|
|
|
Warrants |
|
|
Warrants |
|
|
September 30, 2010 |
|
Preferred stock class A warrants |
|
|
1,354,164 |
|
|
$ |
0.25 |
|
|
$ |
343,943 |
|
Preferred stock class B warrants |
|
|
1,354,164 |
|
|
|
0.25 |
|
|
|
343,943 |
|
Preferred stock co-placement warrants |
|
|
541,667 |
|
|
|
0.25 |
|
|
|
137,577 |
|
Common stock warrants |
|
|
8,291,885 |
|
|
|
0.27 |
|
|
|
2,200,875 |
|
Common stock placement warrants |
|
|
507,666 |
|
|
|
0.27 |
|
|
|
134,747 |
|
Preferred stock series B warrants |
|
|
5,711,666 |
|
|
|
0.24 |
|
|
|
1,365,406 |
|
Preferred stock series B co-placement warrants |
|
|
456,934 |
|
|
|
0.28 |
|
|
|
127,347 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
18,218,146 |
|
|
|
|
|
|
$ |
4,653,838 |
|
|
|
|
|
|
|
|
|
|
|
Warrant liability is comprised of the following as of December 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Successor |
|
|
|
Number of |
|
|
Fair Value of |
|
|
Balance as of |
|
|
|
Warrants |
|
|
Warrants |
|
|
December 31, 2009 |
|
Preferred stock class A warrants |
|
|
501,543 |
|
|
$ |
0.55 |
|
|
$ |
275,378 |
|
Preferred stock class B warrants |
|
|
416,667 |
|
|
|
0.50 |
|
|
|
207,611 |
|
Preferred stock co-placement warrants |
|
|
250,000 |
|
|
|
0.61 |
|
|
|
152,287 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
1,168,210 |
|
|
|
|
|
|
$ |
635,276 |
|
|
|
|
|
|
|
|
|
|
|
Note 11Equity-based Compensation
Total stock-based compensation expense recognized in the three and nine months ended September
30, 2010, using the straight-line attribution method in the consolidated statement of operations is
as follows:
|
|
|
|
|
|
|
|
|
|
|
Successor |
|
|
Successor |
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, 2010 |
|
|
September 30, 2010 |
|
Stock option compensation expense for employees
and directors |
|
$ |
183,231 |
|
|
$ |
729,619 |
|
Restricted stock expense |
|
|
18,000 |
|
|
|
54,000 |
|
Equity awards for nonemployees issued for services |
|
|
7,724 |
|
|
|
59,321 |
|
|
|
|
|
|
|
|
Total stock-based compensation expense |
|
$ |
208,955 |
|
|
$ |
842,940 |
|
|
|
|
|
|
|
|
F-73
Total stock-based compensation expense recognized in the one month ended September 30, 2009
(successor) and the eight months ending August 31, 2009 (Predecessor) using the straight-line
attribution method in the consolidated statement of operations is as follows:
|
|
|
|
|
|
|
|
|
|
|
Successor |
|
|
Predecessor |
|
|
|
One month ended |
|
|
Eight months ended |
|
|
|
September 30, 2009 |
|
|
August 31, 2009 |
|
Stock option compensation expense for employees
and directors |
|
$ |
286,622 |
|
|
$ |
581,707 |
|
Restricted stock expense |
|
|
150,000 |
|
|
|
|
|
Equity awards for nonemployees issued for services |
|
|
308,994 |
|
|
|
1,746 |
|
|
|
|
|
|
|
|
Total stock-based compensation expense |
|
$ |
745,616 |
|
|
$ |
583,453 |
|
|
|
|
|
|
|
|
On February 23, 2010, modifications were made to all fiscal year 2009 grants for
directors and employees. The modifications provided for all options granted under the 2009 Plan in
fiscal year 2009 to extend to a ten year term and allowed Directors to extend the exercise period
after departure to one year. As a result of the modifications, the Successor Company recognized
incremental compensation cost of $163,445 in the nine months ended September 30, 2010.
On February 1, 2010, the Successor Company granted options to purchase 1,650,000 shares of
common stock to the chief executive officer. The weighted average fair market value using the
Black-Scholes option-pricing model of these options granted was $0.63.
On April 1, 2010 and June 16, 2010, the Successor Company granted options to purchase 800,000
shares of common stock to a director and consultants. The weighted average fair market value using
the Black-Scholes option-pricing model of these options granted was $0.46.
During the three months ended September 30, 2010, the Successor Company granted 720,000 shares
of common stock to directors and consultant. The weighted average fair value using the
Black-Scholes option-pricing model of these options granted was $0.34. The fair market value of
the stock options at the date of grant was estimated using the Black-Scholes option-pricing model
with the following weighted average assumptions:
|
|
|
|
|
|
|
Successor |
|
|
|
Three Months Ended |
|
|
|
September 30, 2010 |
|
Expected life (years) |
|
|
4.9 years |
|
Interest rate |
|
|
1.5 |
% |
Dividend yield |
|
|
|
|
Volatility |
|
|
63 |
% |
There were no stock options exercised during the three and nine months ended September 30,
2010.
The total fair value of shares vested during the third quarter 2010 was $0.2
million. As of September 30, 2010, there was $0.9 million of total unrecognized compensation
cost, related to non-vested stock options which vest over time. That cost is expected to be
recognized over a weighted-average period of 2.2 years. As of September 30, 2010, there was
$0.3 million of total unrecognized compensation expense related to performance-based,
non-vested employee and consultant stock options. That cost will be recognized when the
performance criteria within the respective performance-based option grants become probable of
achievement.
Restricted stock
As of September 30, 2010, there was $0.1 million of total unrecognized
compensation cost related to non-vested restricted stock that is expected to be recognized over a
weighted-average period of 0.9 years.
Predecessor Company
Prior to September 3, 2009, the Predecessor Company maintained stock-based incentive
compensation plans for employees and directors of the Company. On the Effective Date, the following
stock option plans were terminated (and any and all awards granted under such plans were terminated
and will no longer be of any force or effect): (1) the 2001 Stock Option and Appreciation Rights
Plan, (2) the 2003 Stock Option and Appreciation Rights Plan, and (3) the 2005 Stock Option and
Appreciation Rights Plan.
F-74
Note 12Segment Information and Geographical information
The Successor Company has two reportable segments: Fibrocell Therapy and Agera. The Fibrocell
Therapy segment specializes in the development and commercialization of autologous cellular
therapies for soft tissue regeneration. The Agera segment maintains proprietary rights to a
scientifically-based advanced line of skincare products. There is no intersegment revenue. The
following table provides operating financial information for the continuing operations of the
Successor Companys two reportable segments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment |
|
|
|
|
|
|
Successor |
|
|
|
|
|
|
Successor |
|
Three Months Ended September 30, 2010 |
|
Fibrocell Therapy |
|
|
Agera |
|
|
Consolidated |
|
Total operating revenue |
|
$ |
|
|
|
$ |
243,677 |
|
|
$ |
243,677 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment loss from continuing operations |
|
$ |
(1,816,681 |
) |
|
$ |
24,210 |
|
|
$ |
(1,792,471 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental information related to continuing operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization expense |
|
$ |
2,472 |
|
|
$ |
|
|
|
$ |
2,472 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment |
|
|
|
Successor |
|
|
|
|
|
|
Successor |
|
Nine Months Ended September 30, 2010 |
|
Fibrocell Therapy |
|
|
Agera |
|
|
Consolidated |
|
Total operating revenue |
|
$ |
|
|
|
$ |
716,809 |
|
|
$ |
716,809 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment income (loss) from continuing operations |
|
$ |
(8,219,599 |
) |
|
$ |
13,722 |
|
|
$ |
(8,205,877 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental information related to continuing operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization expense |
|
$ |
5,612 |
|
|
$ |
|
|
|
$ |
5,612 |
|
Total assets as of September 30, 2010 |
|
|
7,030,849 |
|
|
|
589,085 |
|
|
|
7,619,934 |
|
Property and equipment, net |
|
|
24,062 |
|
|
|
|
|
|
|
24,062 |
|
Intangible assets |
|
|
6,340,656 |
|
|
|
|
|
|
|
6,340,656 |
|
An intercompany receivable as of September 30, 2010, of $0.9 million, due from the Agera
segment to the Fibrocell Therapy segment, is eliminated in consolidation. This intercompany
receivable is primarily due to the intercompany management fee charge to Agera by Fibrocell
Technologies, as well as Agera working capital needs provided by Fibrocell Technologies, and has
been excluded from total assets of the Fibrocell Therapy segment in the above table. There is no
intersegment revenue. Total assets on the consolidated balance sheet at September 30, 2010 are
approximately $7.6 million.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment |
|
|
|
|
|
|
Predecessor |
|
|
|
|
|
|
Predecessor |
|
One Month Ended September 30, 2009 |
|
Isolagen Therapy |
|
|
Agera |
|
|
Consolidated |
|
Total operating revenue |
|
$ |
|
|
|
$ |
75,029 |
|
|
$ |
75,029 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment loss from continuing operations |
|
$ |
(1,953,067 |
) |
|
$ |
(11,923 |
) |
|
$ |
(1,964,990 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment |
|
|
|
|
|
|
Predecessor |
|
|
|
|
|
|
Predecessor |
|
Two
Months Ended August 31, 2009 |
|
Isolagen Therapy |
|
|
Agera |
|
|
Consolidated |
|
Total operating revenue |
|
$ |
|
|
|
$ |
130,740 |
|
|
$ |
130,740 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment income from continuing operations |
|
$ |
71,465,993 |
|
|
$ |
474,740 |
|
|
$ |
71,940,733 |
|
|
|
|
|
|
|
|
|
|
|
F-75
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment |
|
|
|
|
|
|
Predecessor |
|
|
|
|
|
|
Predecessor |
|
Eight Months Ended August 31, 2009 |
|
Isolagen Therapy |
|
|
Agera |
|
|
Consolidated |
|
Total operating revenue |
|
$ |
|
|
|
$ |
538,620 |
|
|
$ |
538,620 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment loss from continuing operations |
|
$ |
65,498,934 |
|
|
$ |
381,306 |
|
|
$ |
65,880,240 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental information related to continuing operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization expense |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Total assets as of September 30, 2009 |
|
|
7,886,894 |
|
|
|
592,746 |
|
|
|
8,479,640 |
|
Property and equipment, net |
|
|
|
|
|
|
|
|
|
|
|
|
Intangible assets, net |
|
|
|
|
|
|
|
|
|
|
|
|
An intercompany receivable as of September 30, 2009, of $1.0 million, due from the Agera
segment to the Fibrocell Therapy segment, is eliminated in consolidation. This intercompany
receivable is primarily due to the intercompany management fee charge to Agera by Fibrocell
Technologies, Inc., as well as Agera working capital needs provided by Fibrocell Technologies,
Inc., and has been excluded from total assets of the Fibrocell Therapy segment in the above table.
There is no intersegment revenue. Total assets on the consolidated balance sheet at September 30,
2009 are approximately $8.5 million, which includes assets of discontinued operations of less than
$0.1 million.
Geographical information concerning the Successor Companys and Predecessor Companys
operations and assets are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
|
Revenue |
|
|
|
Revenue |
|
|
|
Successor |
|
|
Successor |
|
|
|
Predecessor |
|
|
|
Three months ended |
|
|
One month ended |
|
|
|
Two months ended |
|
|
|
September 30, 2010 |
|
|
September 30, 2009 |
|
|
|
August 31, 2009 |
|
United States |
|
$ |
54,367 |
|
|
$ |
16,259 |
|
|
|
$ |
40,656 |
|
United Kingdom |
|
|
181,931 |
|
|
|
58,567 |
|
|
|
|
84,134 |
|
Other |
|
|
7,379 |
|
|
|
203 |
|
|
|
|
5,950 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
243,677 |
|
|
$ |
75,029 |
|
|
|
$ |
130,740 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
|
Revenue |
|
|
|
Revenue |
|
|
|
Successor |
|
|
Successor |
|
|
|
Predecessor |
|
|
|
Nine months ended |
|
|
One month ended |
|
|
|
Eight months ended |
|
|
|
September 30, 2010 |
|
|
September 30, 2009 |
|
|
|
September 30, 2009 |
|
United States |
|
$ |
176,215 |
|
|
$ |
16,259 |
|
|
|
$ |
187,289 |
|
United Kingdom |
|
|
472,721 |
|
|
|
58,567 |
|
|
|
|
308,244 |
|
Other |
|
|
67,873 |
|
|
|
203 |
|
|
|
|
43,087 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
716,809 |
|
|
$ |
75,029 |
|
|
|
$ |
538,620 |
|
|
|
|
|
|
|
|
|
|
|
|
During the three months ended September 30, 2010, revenue from one foreign customer and one
domestic customer represented 75% and 15% of consolidated revenue, respectively. During the one
month ended September 30, 2009, revenue from one foreign customer and one domestic customer
represented 78% and 17% of consolidated revenue, respectively. During the two months ended August
31, 2009 revenue from one foreign customer and one domestic customer represented 64% and 20% of
consolidated revenue, respectively.
F-76
During the nine months ended September 30, 2010, revenue from one foreign customer and one
domestic customer represented 73% and 17% of consolidated revenue, respectively. During the one
month ended September 30, 2009, revenue from one foreign customer and one domestic customer
represented 78% and 17% of consolidated revenue, respectively. During the eight months ended
August 31, 2009, revenue from one foreign customer and one domestic customer represented 57% and
23% of consolidated revenue, respectively.
As of September 30, 2010 and December 31, 2009, one foreign customer represented 89% and 87%,
respectively, of accounts receivable, net.
Note 13Subsequent Events
The Successor Company has raised approximately $1.7 million less fees as the result
of the issuance of preferred stock and warrants in the period from October 1, 2010 to November 17,
2010.
The Successor Company has also raised approximately $4.3 million less fees as the result of
the issuance of preferred stock and warrants in December 2010 and January 2011.
Viriathus Capital LLC and John Carris Investments LLC were co-placement agents for the
Transactions, and will receive cash compensation of $476,477 and warrants to purchase (i) 1,729
shares of Common Stock at an exercise price of $0.60 per share
and (ii) 686,880 shares of Common Stock at an exercise price of $0.50 per share.
In connection with the September offering, the Company recorded on its September 30, 2010
balance sheet a $450,000 receivable of subscription proceeds, representing two subscriptions for an
aggregate of 450 shares of Series B Preferred and warrants to purchase 750,000 shares. On November
17, 2010, the Company entered into a Termination Agreement with the two Subscribers owing the
$450,000 to terminate their Securities Purchase Agreements. As a result, the Subscribers are no
longer obligated to pay the Company the $450,000 and the Company is not obligated to issue the
Series B Preferred shares or warrants. Accordingly, the $450,000 receivable will not be reflected
on future balance sheets.
The Company announced on November 3, 2010, that it has signed an agreement to establish a
joint venture (JV) with Hefei Meifu Bio-Tech Limited Co. (Meifu) for developing and marketing
autologous fibroblast therapies in Asia, excluding Japan. The JV will be called Fibrocell Science
Asia Co. Ltd.
Under the terms of the agreement, Fibrocell will provide access to its intellectual property,
clinical data and manufacturing processes. Meifu will be responsible for all costs associated with
construction and operation of a manufacturing facility in Hefei and commercialization, as well as
all ongoing operational, research and development expenses.
On January 14, 2011, the board of
directors agreed to provide: (i) Mr. David Pernock, Chief Executive Officer and
President, with an option to purchase 2,100,000 shares of Company common stock; (ii) Mr. Declan Daly, Chief
Financial Officer, with an option to purchase 1,065,000 shares of Company common stock; and (iii) Messrs. Kelvin
Moore, Robert Langer, Marc Mazur, and George Korkos, each a director of the Company, with an option to
purchase 200,000 shares of Company common stock. Each of the foregoing options has: (i) a ten-year term, (ii) an
exercise price equal to the closing price of the Companys common stock on the date of grant, and (iii) vests 50% on
the date of grant; 25% on the one-year anniversary of the date of grant; and 25% on the two-year anniversary of the
date of grant; provided in each case that the grantee is providing service to the Company on the vesting date.
F-77
FIBROCELL SCIENCE, INC.
10,073,693 Shares of Common Stock
PROSPECTUS
February
11, 2011
You should rely only on the information contained in this prospectus. No
dealer, salesperson or other person is authorized to give information that is not contained in this prospectus. This prospectus is not an
offer to sell nor is it seeking an offer to buy these securities in any jurisdiction where the offer or sale is not permitted. The
information contained in this prospectus is correct only as of the date of this prospectus, regardless of the time of the delivery of this
prospectus or the sale of these securities.