Nuo Therapeutics, Inc. - Quarter Report: 2012 June (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the Quarterly Period Ended June 30, 2012
OR
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 001-32518
CYTOMEDIX, INC.
(Exact Name of Registrant as Specified in its Charter)
Delaware | 23-3011702 | |
(State or Other Jurisdiction of Incorporation or Organization) |
(IRS Employer Identification No.) |
209 Perry Parkway, Suite 7
Gaithersburg, MD 20877
(Address of Principal Executive Offices) (Zip Code)
(240) 499-2680
(Registrants Telephone Number, Including Area Code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.Yes x No o
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).Yes x No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
Large Accelerated Filer o | Accelerated Filer o | |
Non-accelerated Filer o | Smaller Reporting Company x |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).Yes x No o
APPLICABLE ONLY TO CORPORATE ISSUERS
As of July 31, 2012, the Company had 90,695,117 shares of common stock, par value $.0001, issued and outstanding.
CYTOMEDIX, INC.
TABLE OF CONTENTS
i
PART I
FINANCIAL INFORMATION
Item 1. Financial Statements
CYTOMEDIX, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
June 30, 2012 |
December 31, 2011 |
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ASSETS |
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Current assets |
||||||||
Cash (including $4.7 million of cash in 2012 dedicated for clinical trials and related matters) | $ | 8,544,617 | $ | 2,246,050 | ||||
Short-term investments, restricted | 53,176 | 52,840 | ||||||
Accounts and other receivable, net | 1,944,003 | 1,480,463 | ||||||
Inventory | 899,195 | 548,159 | ||||||
Prepaid expenses and other current assets | 791,716 | 695,567 | ||||||
Deferred costs, current portion | 136,436 | 136,436 | ||||||
Total current assets | 12,369,143 | 5,159,515 | ||||||
Property and equipment, net | 2,135,085 | 978,893 | ||||||
Deferred costs | 249,001 | 317,219 | ||||||
Intangible assets, net | 34,318,454 | 2,916,042 | ||||||
Goodwill | 1,323,649 | 706,823 | ||||||
Total assets | $ | 50,395,332 | $ | 10,078,492 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current liabilities |
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Accounts payable and accrued expenses | $ | 3,193,289 | $ | 1,849,133 | ||||
Deferred revenues, current portion | | 654,721 | ||||||
Dividends payable on preferred stock | | 105,533 | ||||||
Derivative liabilities, current portion | | 528,467 | ||||||
Total current liabilities | 3,193,289 | 3,137,854 | ||||||
Note payable | 2,100,000 | 2,100,000 | ||||||
Derivative and other liabilities | 2,230,520 | 1,559,055 | ||||||
Total liabilities | 7,523,809 | 6,796,909 | ||||||
Commitments and contingencies |
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Stockholders' equity |
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Series A Convertible preferred stock; $.0001 par value, authorized 5,000,000 shares; |
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2012 issued and outstanding 0 shares; |
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2011 issued and outstanding 97,663 shares; |
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2012 liquidation preference of $0; |
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2011 liquidation preference of $97,663 | | 10 | ||||||
Series B Convertible preferred stock; $.0001 par value, authorized 5,000,000 shares; |
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2012 issued and outstanding 0 shares; |
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2011 issued and outstanding 65,784 shares; |
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2012 liquidation preference of $0; |
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2011 liquidation preference of $65,784 | | 7 |
The accompanying notes are an integral part of these condensed consolidated financial statements.
1
CYTOMEDIX, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (continued)
(unaudited)
June 30, 2012 |
December 31, 2011 |
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Series D Convertible preferred stock; $.0001 par value, authorized 2,000,000 shares; |
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2012 issued and outstanding 0 shares; |
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2011 issued and outstanding 3,300 shares; |
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2012 liquidation preference of $0; |
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2011 liquidation preference of $3,300,000 | | | ||||||
Series E Convertible preferred stock; $.0001 par value, authorized 250,000 |
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2012 issued and outstanding 0 shares; |
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2011 issued and outstanding 0 shares; |
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2012 liquidation preference of $0; |
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2011 liquidation preference of $0 | | | ||||||
Common stock; $.0001 par value, authorized 160,000,000 shares; |
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2012 issued and outstanding 90,688,450 shares; |
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2011 issued and outstanding 55,536,292 shares | 9,068 | 5,554 | ||||||
Common stock issuable | 471,250 | | ||||||
Additional paid-in capital | 105,752,831 | 54,458,170 | ||||||
Accumulated deficit | (63,361,626 | ) | (51,182,158 | ) | ||||
Total stockholders' equity | 42,871,523 | 3,281,583 | ||||||
Total liabilities and stockholders' equity | $ | 50,395,332 | $ | 10,078,492 |
The accompanying notes are an integral part of these condensed consolidated financial statements.
2
CYTOMEDIX, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
Three Months Ended June 30, |
Six Months Ended June 30, |
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2012 | 2011 | 2012 | 2011 | |||||||||||||
Revenues |
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Product Sales | $ | 1,813,972 | $ | 1,394,294 | $ | 3,500,364 | $ | 2,759,907 | ||||||||
License Fees | 1,824,360 | | 3,154,722 | | ||||||||||||
Royalties | 47,021 | | 47,021 | | ||||||||||||
Total revenues | 3,685,353 | 1,394,294 | 6,702,107 | 2,759,907 | ||||||||||||
Cost of revenues |
||||||||||||||||
Cost of sales | 974,910 | 639,227 | 1,823,346 | 1,284,611 | ||||||||||||
Cost of royalties | 5,116 | | 5,116 | | ||||||||||||
Total cost of revenues | 980,026 | 639,227 | 1,828,462 | 1,284,611 | ||||||||||||
Gross profit | 2,705,327 | 755,067 | 4,873,645 | 1,475,296 | ||||||||||||
Operating expenses |
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Salaries and wages | 1,779,095 | 733,410 | 3,841,223 | 1,459,473 | ||||||||||||
Consulting expenses | 454,296 | 298,751 | 1,283,343 | 635,233 | ||||||||||||
Professional fees | 203,464 | 213,230 | 666,501 | 450,151 | ||||||||||||
Research, development, trials and studies | 1,091,258 | 42,107 | 1,448,566 | 102,053 | ||||||||||||
General and administrative expenses | 1,525,724 | 705,547 | 2,701,951 | 1,549,091 | ||||||||||||
Total operating expenses | 5,053,837 | 1,993,045 | 9,941,584 | 4,196,001 | ||||||||||||
Loss from operations | (2,348,510 | ) | (1,237,978 | ) | (5,067,939 | ) | (2,720,705 | ) | ||||||||
Other income (expense) |
||||||||||||||||
Interest, net | (267,987 | ) | (121,712 | ) | (535,132 | ) | (372,093 | ) | ||||||||
Change in fair value of derivative liabilities | (26,207 | ) | | (246,521 | ) | 378,125 | ||||||||||
Change in fair value of contingent consideration | (4,334,932 | ) | | (4,334,932 | ) | | ||||||||||
Gain on debt restructuring | | 576,677 | | 576,677 | ||||||||||||
Inducement expense | (1,223 | ) | | (1,513,371 | ) | | ||||||||||
Settlement of contingency | (471,250 | ) | | (471,250 | ) | | ||||||||||
Other | (1,105 | ) | (3,348 | ) | (1,105 | ) | (53,585 | ) | ||||||||
Total other income (expenses) | (5,102,704 | ) | 451,617 | (7,102,311 | ) | 529,124 | ||||||||||
Loss before provision for income taxes | (7,451,214 | ) | (786,361 | ) | (12,170,250 | ) | (2,191,581 | ) | ||||||||
Income tax provision | 4,609 | 5,000 | 9,218 | 10,000 | ||||||||||||
Net loss | (7,455,823 | ) | (791,361 | ) | (12,179,468 | ) | (2,201,581 | ) | ||||||||
Preferred dividends: |
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Series A preferred stock | | 2,242 | | 4,441 | ||||||||||||
Series B preferred stock | | 1,526 | | 3,022 | ||||||||||||
Series D preferred stock | | 82,875 | 13,562 | 165,750 | ||||||||||||
Net loss to common stockholders | $ | (7,455,823 | ) | $ | (878,004 | ) | $ | (12,193,030 | ) | $ | (2,374,794 | ) | ||||
Loss per common share |
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Basic and diluted | $ | (0.09 | ) | $ | (0.02 | ) | $ | (0.17 | ) | $ | (0.05 | ) | ||||
Weighted average shares outstanding |
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Basic and diluted | 80,891,576 | 50,588,129 | 72,077,137 | 48,336,096 |
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
CYTOMEDIX, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Six Months Ended June 30, |
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2012 | 2011 | |||||||
CASH FLOWS FROM OPERATING ACTIVITIES: |
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Net loss | $ | (12,179,468 | ) | $ | (2,201,581 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
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Bad debt expense | 3,990 | | ||||||
Depreciation and amortization | 519,255 | 318,911 | ||||||
Stock-based compensation | 1,534,450 | 138,955 | ||||||
Change in fair value of derivative liabilities | 246,521 | (378,125 | ) | |||||
Change in fair value of contingent consideration | 4,334,932 | | ||||||
Settlement of contingency | 471,250 | | ||||||
Amortization of deferred costs | 68,218 | 133,657 | ||||||
Non-cash interest expense amortization of debt discount | 326,307 | | ||||||
Deferred income tax provision | 9,218 | 10,000 | ||||||
Loss (Gain) on disposal of assets | 35,351 | (19,580 | ) | |||||
Inducement expense | 1,513,371 | | ||||||
Gain on debt restructuring | | (576,677 | ) | |||||
Change in operating assets and liabilities, net of those acquired: |
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Accounts and other receivable, net | (432,136 | ) | (695,020 | ) | ||||
Inventory | (351,036 | ) | 226,072 | |||||
Prepaid expenses and other current assets | (9,094 | ) | 19,080 | |||||
Accounts payable and accrued expenses | 297,151 | 369,419 | ||||||
Deferred revenues | (654,721 | ) | | |||||
Other liabilities | (13,478 | ) | | |||||
Net cash used in operating activities | (4,279,919 | ) | (2,654,889 | ) | ||||
CASH FLOWS FROM INVESTING ACTIVITIES: |
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Property and equipment acquisitions | (1,002,125 | ) | (1,561 | ) | ||||
Cash acquired in business combination | 24,563 | | ||||||
Proceeds from sale of equipment | 236,401 | 46,576 | ||||||
Net cash (used in) provided by investing activities | (741,161 | ) | 45,015 | |||||
CASH FLOWS FROM FINANCING ACTIVITIES: |
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Proceeds from issuance of debt | | 2,100,000 | ||||||
Proceeds from issuance of common stock, net | 7,853,924 | 2,814,235 | ||||||
Redemption of preferred stock | (169,986 | ) | | |||||
Repayment of note payable | | (2,641,506 | ) | |||||
Proceeds from option and warrant exercises | 3,672,304 | | ||||||
Dividends paid on preferred stock | (36,595 | ) | | |||||
Net cash provided by financing activities | 11,319,647 | 2,272,729 | ||||||
Net increase (decrease) in cash | 6,298,567 | (337,145 | ) | |||||
Cash, beginning of period | 2,246,050 | 638,868 | ||||||
Cash, end of period | $ | 8,544,617 | $ | 301,723 |
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
CYTOMEDIX, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 1 Business and Presentation
Description of Business
Cytomedix, Inc. (Cytomedix, the Company, we, us, or our) is a regenerative therapy company, harnessing the bodys own capacity to heal itself. Cytomedix develops and commercializes innovative autologous therapies that promote healing by harnessing the innate regenerative capacity of platelets and adult stem cells. We currently have a growing commercial operation, and a robust clinical pipeline seeking to exploit large market opportunities with unmet medical needs.
Our current commercial offerings are centered around our platelet rich plasma (PRP) platform technology, and primarily include the Angel® Whole Blood Separation System (Angel) and the AutoloGelTM System (AutoloGel). These products primarily address the areas of wound care, and support of healing and recovery following orthopedic procedures. Our sales are predominantly in the United States, where we sell our products through a combination of direct sales representatives and independent sales agents. In Europe, the Middle East, Canada, and Australia we have a network of distributors covering several major markets.
Our clinical pipeline primarily involves the ALDHbr cell-based therapies, acquired through the acquisition of Aldagen, Inc. , a privately held biopharmaceutical company, in February 2012, and the expansion of the Angel System for use in other clinical indications.
Basis of Presentation and Significant Accounting Policies
The unaudited financial statements included herein are presented on a condensed consolidated basis and have been prepared by Cytomedix pursuant to the rules and regulations of the Securities and Exchange Commission. The financial statements reflect all adjustments that are, in the opinion of management, necessary to fairly state such information. All such adjustments are of a normal recurring nature. Although the Company believes that the disclosures are adequate to make the information presented not misleading, certain information and footnote disclosures, including a description of significant accounting policies normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America, have been condensed or omitted pursuant to such rules and regulations.
The year-end balance sheet data were derived from audited financial statements but do not include all disclosures required by accounting principles generally accepted in the United States of America.
These financial statements should be read in conjunction with the financial statements and the notes thereto included in the Companys 2011 Annual Report on Form 10-K filed with the Securities and Exchange Commission. The results of operations for interim periods are not necessarily indicative of the results for any subsequent quarter or the entire fiscal year ending December 31, 2012.
Basic and Diluted Loss Per Share
Basic and diluted net loss per common share is presented in accordance with established standards for all periods presented. We compute basic and diluted net loss per common share using the weighted-average number of shares of common stock outstanding during the period. During periods of net losses, shares associated with outstanding stock options, stock warrants, convertible preferred stock, and convertible debt are not included because the inclusion would be anti-dilutive (i. e. , would reduce the net loss per share). The total numbers of such shares excluded from the calculation of diluted net loss per common share were 20,249,909 for the three and six months ended June 30, 2012, and 27,214,526 for the three and six months ended June 30, 2011.
Goodwill and Intangible Assets
Goodwill represents the excess of the purchase price over the net tangible and intangible assets acquired in business combinations. The Company conducts an impairment test of goodwill on an annual basis as of October 1 of each year. The Company will also conduct tests if events occur or circumstances change that would, more likely than not, reduce the fair value of the Company below its carrying value.
5
CYTOMEDIX, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 1 Business and Presentation (continued)
Indefinite lived intangible assets consist of in-process research and development (IPR&D) acquired in the acquisition of Aldagen. The acquired IPR&D consists of specific cell populations (that are related to a specific indication) and the use of the cell populations in treating particular medical conditions. The Company evaluates its indefinite-lived intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable, and at least on an annual basis on October 1 of each year, by comparing the fair value of the asset with its carrying amount. If the carrying amount of the intangible asset exceeds its fair value, the Company would recognize an impairment loss in the amount of that excess.
Identifiable intangible assets with finite lives consist of trademarks, technology (including patents), and customer relationships acquired in business combinations. These intangibles are amortized using the straight-line method over their estimated useful lives. The Company reviews its finite-lived intangible assets for potential impairment when circumstances indicate that the carrying amount of assets may not be recoverable.
Note 2 Recent Accounting Pronouncements
ASU No. 2011-08, Intangibles Goodwill and Other (Topic 350) Testing Goodwill for Impairment. The amendments in this update are intended to reduce complexity and costs by allowing an entity the option to make a qualitative evaluation about the likelihood of goodwill impairment to determine whether it should calculate the fair value of a reporting unit. The amendments also improve previous guidance by expanding upon the examples of events and circumstances that an entity should consider between annual impairment tests in determining whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount. Also, the amendments improve the examples of events and circumstances that an entity having a reporting unit with a zero or negative carrying amount should consider in determining whether to measure an impairment loss, if any, under the second step of the goodwill impairment test. The amendments are effective for annual and interim goodwill impairment tests performed for fiscal years beginning after December 15, 2011. Early adoption is permitted, including for annual and interim goodwill impairment tests performed as of a date before September 15, 2011, if an entitys financial statements for the most recent annual or interim period have not yet been issued. ASU 2011-08 became effective for the Company on January 1, 2012 and did not have a significant impact on the Companys financial statements.
ASU No. 2012-02, Intangibles Goodwill and Other (Topic 350) Testing Indefinite-Lived Intangible Assets for Impairment. The objective of the amendments in this Update is to reduce the cost and complexity of performing an impairment test for indefinite-lived intangible assets by simplifying how an entity tests those assets for impairment and to improve consistency in impairment testing guidance among long-lived asset categories. The amendments permit an entity first to assess qualitative factors to determine whether it is more likely than not that an indefinite-lived intangible asset is impaired as a basis for determining whether it is necessary to perform the quantitative impairment test in accordance with Subtopic 350-30, Intangibles Goodwill and Other General Intangibles Other than Goodwill. The more-likely-than-not threshold is defined as having a likelihood of more than 50 percent. The amendments in this Update apply to all entities, both public and nonpublic, that have indefinite-lived intangible assets, other than goodwill, reported in their financial statements. The amendments are effective for annual and interim impairment tests performed for fiscal years beginning after September 15, 2012. Early adoption is permitted, including for annual and interim impairment tests performed as of a date before July 27, 2012, if a public entitys financial statements for the most recent annual or interim period have not yet been issued or, for nonpublic entities, have not yet been made available for issuance. The Company is currently evaluating the impact, if any, that the adoption of this amendment will have on its financial statements.
6
CYTOMEDIX, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 3 Business Combinations
Business Combination Aldagen, Inc.
Cytomedix develops, sells, and licenses regenerative biological therapies intended to aid the human body in regenerating/healing itself, to primarily address the areas of wound care, infection control, and orthopedic surgery. On February 8, 2012, the Company acquired control of Aldagen, Inc. (Aldagen) by purchasing all of Aldagens issued and outstanding capital stock and convertible promissory notes. The acquisition of Aldagen allows the Company to expand its approach to developing regenerative biological therapies, by using Aldagens proprietary ALDH bright cell (ALDHbr) technology.
As initial consideration, Cytomedix issued 135,398 shares of its Series E Convertible Preferred Stock (the Series E Preferred Stock) to Aldagens former investors. In May 2012, the Series E Preferred Stock automatically converted into shares of common stock pursuant to its terms, in a 100-for-1 shares ratio, upon the Companys filing of an amended Certificate of Incorporation to increase the number of authorized shares of common stock.
In addition to the Series E Preferred Stock, Aldagens former investors have the right to receive up to 20,309,723 shares of the Companys common stock (the Contingent Consideration), contingent upon the achievement of certain milestones related to the current ALD-401 Phase II clinical trial. Finally, each holder of warrants to acquire shares of Aldagen capital stock agreed to exchange the Aldagen warrants for warrants to acquire an aggregate of 2,115,596 shares of the Companys common stock with an exercise price of $1.42 per share (the Replacement Warrants). Each Replacement Warrants expire December 31, 2014 and, subject to call provisions of the Replacement Warrants, are exercisable as follows: (i) commencing on the issuance date, for up to 30% of the total shares of the Companys common stock exercisable under the Replacement Warrants, and (ii) upon issuance of the final tranche of the Contingent Consideration, for the remaining balance of the shares under the Replacement Warrants. The Replacement Warrants also contain exercise price adjustments, cashless exercise and other provisions customary to instruments of this nature.
As part of the acquisition of Aldagen, the Company incurred approximately $528,000 in acquisition costs in 2012. These costs are included in operating expenses as follows:
Consulting expenses | $ | 274,000 | ||
Professional fees | $ | 225,000 | ||
General and administrative expenses | $ | 29,000 | ||
Total acquisition costs | $ | 528,000 |
Simultaneous with the closing of the Acquisition, the Company executed several other transactions, which are not considered part of the purchase consideration, as follows.
Issuance of Common Stock
On February 8, 2012 and simultaneous with the closing of the Acquisition, the Company entered into subscription agreements (the Subscription Agreements) with certain accredited investors, with respect to the sale of shares of its common stock, for gross proceeds of $5 million. See Note 15.
Redemption of Series A and Series B Redeemable Convertible Preferred Stock
The Company redeemed all outstanding shares of its Series A and Series B Convertible Preferred Stock, for $208,000 in cash, pursuant to their terms. See Note 15.
Series D Convertible Preferred Stock Conversions
All holders of the Companys outstanding Series D Convertible Preferred Stock (the Series D Preferred Stock) purchased in a private placement of the Companys securities in April 2010 converted those preferred shares into shares of the Companys common stock prior to the original redemption date of April 2013, under
7
CYTOMEDIX, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 3 Business Combinations (continued)
the terms of such securities at the conversion price of $0.4392 per share (or $0.558 per share in case of affiliates), for the total of 7,790,350 shares of common stock, which included 330,000 shares of common stock representing forgone dividend payments to such holders through April 2013. See Note 15.
Warrant Exercises
An offer was extended to certain holders of Company warrants (holding warrants to purchase approximately 5.7 million shares of the Companys common stock) acquired in previously reported transactions in 2010 and 2011 requesting them to exercise their respective warrants pursuant to the terms of individually negotiated and executed warrant exercise agreements, in exchange for additional equity considerations. In consideration for such early exercises and estimated proceeds of approximately $2.8 million, the Company agreed to issue additional warrants to purchase an aggregate of 1,180,547 shares of common stock, at an exercise price per share of $1.42. Each warrant expires December 31, 2014 and, subject to call provisions of the warrant, is exercisable as follows: (i) commencing on the issuance date, for up to 30% of shares of the Companys common stock under each warrant, and (ii) upon issuance of the final tranche of the Contingent Consideration, for the remaining balance of the warrant. Each warrant also contains exercise price adjustments, cashless exercise and other provisions customary to the instruments of this nature. See Note 15.
Post-Combination Stock-Based Compensation
Each outstanding option to acquire shares of Aldagen capital stock was cancelled and, in satisfaction of a closing condition, the Companys Board granted approximately 1.7 million options to acquire shares of the Companys stock to certain newly added employees, officers, directors and advisors under the Companys Long-Term Incentive Plan. The new options vest during a post-combination service period and will be expensed during such service period. See Note 15.
The following table represents the allocation of the purchase consideration to the assets acquired and liabilities assumed on February 8, 2012:
Estimated Fair Value | ||||
Purchase Consideration: |
||||
Series E Preferred Stock | $ | 18,955,742 | ||
Contingent Consideration | $ | 11,109,020 | ||
Replacement Warrants | $ | 1,883,751 | ||
Total Consideration | $ | 31,948,513 | ||
Tangible Assets Acquired: |
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Cash | $ | 24,563 | ||
Receivables | $ | 35,394 | ||
Property and equipment | $ | 772,486 | ||
Other | $ | 87,391 | ||
Identifiable Intangible Assets Acquired: |
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IPR&D Technology | $ | 29,585,000 | ||
Trademarks and Tradename | $ | 1,990,000 | ||
Liabilities Assumed: |
||||
Accounts Payable and Accrued Expenses | $ | (1,044,530 | ) | |
Other | $ | (118,617 | ) | |
Goodwill | $ | 616,826 | ||
$ | 31,948,513 |
8
CYTOMEDIX, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 3 Business Combinations (continued)
As the Series E Preferred Stock contains no liquidation preferences or special dividend rights, and is automatically converted into common stock once sufficient common stock is authorized, the Company determined that its fair value is essentially the same as the fair value of the underlying common stock into which it is exchangeable. Accordingly, the Company valued the Series E Preferred Stock using the closing price of its common stock on the acquisition date.
Aldagens former investors have the right to receive up to 20,309,723 shares of the Companys common stock contingent upon the achievement of certain milestones related to the current ALD-401 Phase II clinical trial. The total undiscounted value of the contingent consideration assuming the successful completion of all specified milestones and using the Companys stock price as of the acquisition date is approximately $28.4 million. As of the acquisition date, the Company recorded $11.1 million in contingent consideration. The Company determined the fair value of the contingent consideration with the assistance of a third party valuation expert; the fair value was determined using a probability weighted cash flow approach, which includes unobservable inputs such as projected achievement of certain technical milestones, the estimated dates of the achievement of the milestones, and discount rate.
The Company determined the fair value of the Replacement Warrants using the Black-Scholes option pricing model. The Black-Scholes option pricing model requires the use of unobservable inputs such as the expected term, anticipated volatility and expected dividends.
Identifiable intangible assets associated with trademarks and tradenames will be amortized on a straight-line basis over their estimated useful lives of 20 years. Identifiable intangible assets associated with IPR&D are initially classified as indefinite lived; such classification will be reassessed every reporting period based on the status of the research and development projects. Goodwill, primarily related to expected clinical and commercial synergies gained from combining operations, sales growth from future product offerings and customers, together with certain intangible assets that do not qualify for separate recognition, including assembled workforce, which is not tax deductible since the transaction was structured as a tax-free exchange, is considered an indefinite lived asset.
Aldagen recognized approximately $70,000 of revenue and $2,661,000 of net losses from the acquisition date through June 30, 2012, which results are included in the Companys 2012 consolidated financial statements.
The following unaudited pro forma financial information summarizes the results of operations for the periods indicated as if the purchase of Aldagen had been completed as of January 1, 2011. Pro forma information primarily reflects adjustments relating to (i) elimination of the interest on Aldagens promissory notes, (ii) additional stock-based compensation expense, (iii) elimination of the impact of the changes in the fair value of Aldagens derivative liabilities, and (iv) the amortization of intangibles acquired. The pro forma amounts do not purport to be indicative of the results that would have actually been obtained if the acquisition occurred as of January 1, 2011 or that may be obtained in the future.
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
2012 | 2011 | 2012 | 2011 | |||||||||||||
Total revenues | $ | 3,685,000 | $ | 1,634,000 | $ | 6,702,000 | $ | 3,161,000 | ||||||||
Net loss | $ | (6,985,000 | ) | $ | (1,999,000 | ) | $ | (12,248,000 | ) | $ | (4,942,000 | ) |
Note 4 License Fees
In October 2011, the Company entered into an option agreement with a top 20 global pharmaceutical company granting the potential partner an exclusive option period through June 30, 2012 regarding U. S. supply and distribution of the AutoloGel System. In exchange for this period of exclusivity, to date we have received non-refundable fees totaling $4.5 million. The revenue for these non-refundable fees is recognized, on a straight-line basis, over the exclusive option period based on the relative selling price, with the remaining
9
CYTOMEDIX, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 4 License Fees (continued)
balance recognized at the expiration of the option period. The option period related to the non-refundable fees ended June 30, 2012 and, as a result, revenue has been recognized in full. On June 30, 2012, we agreed to a further period of exclusivity through August 30, 2012, to which there were no associated license fees. Subsequently, the parties agreed to the early termination of the August 30, 2012 exclusivity period and ceased further negotiations concerning a distribution agreement.
Note 5 Fair Value Measurements
Fair value is the price that would be received from the sale of an asset or paid to transfer a liability assuming an orderly transaction in the most advantageous market at the measurement date. U. S. GAAP establishes a hierarchical disclosure framework which prioritizes and ranks the level of observability of inputs used in measuring fair value.
Short-term Financial Instruments
The inputs used in measuring the fair value of cash and short-term investments are considered to be Level 1 in accordance with the three-tier fair value hierarchy. The fair market values are based on period-end statements supplied by the various banks and brokers that held the majority of the Companys funds. The fair value of other short-term financial instruments (primarily accounts receivable, inventory, prepaid expenses and other current assets, and accounts payable and accrued expenses) approximate their carrying values because of their short-term nature.
Other Financial Instruments
The Company has segregated its financial assets and liabilities that are measured at fair value into the most appropriate level within the fair value hierarchy based on the inputs used to determine the fair value at the measurement date in the table below (in thousands). The Company has no non-financial assets and liabilities that are measured at fair value.
The carrying amounts of the liabilities measured at fair value are as follows:
Description | Level 1 | Level 2 | Level 3 | Total | ||||||||||||
Liabilities at June 30, 2012: |
||||||||||||||||
Embedded conversion options | $ | | $ | | $ | 1,689,807 | $ | 1,689,807 | ||||||||
Total measured at fair value | $ | | $ | | $ | 1,689,807 | $ | 1,689,807 | ||||||||
Liabilities at December 31, 2011: |
||||||||||||||||
Embedded conversion options | $ | | $ | | $ | 1,823,207 | $ | 1,823,207 | ||||||||
Total measured at fair value | $ | | $ | | $ | 1,823,207 | $ | 1,823,207 |
The liabilities related to the embedded conversion options measured at fair value in the above table are classified as derivative and other liabilities in the accompanying condensed consolidated balance sheets.
The following table sets forth a summary of changes in the fair value of Level 3 liabilities for the six months ended June 30, 2012:
Description | Balance at December 31, 2011 | Established in 2012 | Conversion to Common Stock | Change in Fair Value | Reclass to Equity | Balance at June 30 , 2012 | ||||||||||||||||||
Derivative liabilities: |
||||||||||||||||||||||||
Embedded conversion options | $ | 1,823,207 | $ | | $ | (379,921 | ) | $ | 246,521 | $ | | $ | 1,689,807 | |||||||||||
Contingent consideration | $ | | $ | 11,109,020 | $ | | $ | 4,334,932 | $ | (15,443,952 | ) | $ | |
The gains (losses) resulting from the changes in the fair value of the derivative instruments are classified as the change in the fair value of derivative instruments in the accompanying condensed consolidated
10
CYTOMEDIX, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 5 Fair Value Measurements (continued)
statements of operations. The fair value of the embedded conversion options is determined based on the Black-Scholes option pricing model, and includes the use of unobservable inputs such as the expected term, anticipated volatility and expected dividends. Changes in any of the assumptions related to the unobservable inputs identified above may change the embedded conversion options fair value; increases in expected term, anticipated volatility and expected dividends generally result in increased in fair value, while decreases in these unobservable inputs generally result in decreases in fair value.
In connection with the acquisition of Aldagen, the Company may owe additional purchase consideration (contingent consideration) based on the achievement of specific milestones associated with the ongoing phase II clinical trial. The gains (losses) resulting from the changes in the fair value of the contingent consideration are classified as the change in fair value of contingent consideration in the accompanying condensed consolidated statements of operations. The fair value of the contingent consideration was determined using a probability weighted cash flow approach, which includes unobservable inputs such as the probability of successful clinical trial results, and discount rate. Changes in any of the assumptions related to the unobservable inputs identified above may change the contingent considerations fair value; increases in expected probability and decreases in discount rate generally result in increased in fair value, while decreases in expected probability and increases in discount rate generally result in decreases in fair value. As a result of the authorization of additional shares of common stock on May 18, 2012, the contingent consideration was adjusted to fair value and reclassified to equity.
In July and November 2011, we issued convertible notes that contained embedded conversion options which met the criteria for derivative liabilities. The fair value of the face amount of the convertible debt instruments approximates $1,441,000 at June 30, 2012.
Note 6 Cash
At June 30, 2012, the Company had dedicated $4,680,832 of its cash balance for use in conjunction with the ALD-401 Phase II clinical trial and related matters, pursuant to provisions in the Aldagen acquisition agreements.
Note 7 Accounts and Other Receivables
Accounts receivable, net consisted of the following:
June 30, 2012 |
December 31, 2011 | |||||||
Trade receivables | $ | 980,290 | $ | 904,891 | ||||
Other receivables | 997,956 | 613,806 | ||||||
1,978,246 | 1,518,697 | |||||||
Less allowance for doubtful accounts | (34,243 | ) | (38,234 | ) | ||||
$ | 1,944,003 | $ | 1,480,463 |
Other receivables consist primarily of the cost of raw materials needed to manufacture the Angel products that are sourced by the Company and immediately resold, at cost, to the contract manufacturer.
11
CYTOMEDIX, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 8 Inventory
The carrying amounts of inventories are as follows:
June 30, 2012 |
December 31, 2011 | |||||||
Raw materials | $ | 66,126 | $ | 15,216 | ||||
Finished goods | 833,069 | 532,943 | ||||||
$ | 899,195 | $ | 548,159 |
Note 9 Property and Equipment
Property and equipment consists of the following:
June 30, 2012 |
December 31, 2011 | |||||||
Medical equipment | $ | 2,341,906 | $ | 1,283,726 | ||||
Office equipment | 84,690 | 73,927 | ||||||
Manufacturing equipment | 303,143 | 262,290 | ||||||
Leasehold improvements | 385,051 | | ||||||
3,114,790 | 1,619,943 | |||||||
Less accumulated depreciation and amortization | (979,705 | ) | (641,050 | ) | ||||
$ | 2,135,085 | $ | 978,893 |
For the six months ended June 30, 2012, we recorded depreciation expense of approximately $346,700 with $176,500 reported as cost of sales and $170,200 reported as general and administrative expenses. Amortization of leasehold improvements is included in accumulated depreciation.
Note 10 Goodwill and Identifiable Intangible Assets
Goodwill
As a result of the Companys acquisition of Aldagen in February 2012, Cytomedix recorded goodwill of approximately $617,000.
Prior to the acquisition of Aldagen, the Company had goodwill of approximately $707,000 as a result of the acquisition of the Angel Business in April 2010. The Company conducts an impairment test of goodwill on an annual basis as of October 1 of each year. The Company will also conduct tests if events occur or circumstances change that would, more likely than not, reduce the fair value of the Company below its carrying value. No such triggering events were identified during the three- and six-months periods ended June 30, 2012.
12
CYTOMEDIX, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 10 Goodwill and Identifiable Intangible Assets (continued)
Identifiable Intangible Assets
Cytomedixs identifiable intangible assets consist of trademarks, technology (including patents), customer relationships, and in-process research and development. These assets are a result of the Angel Business and Aldagen acquisitions. The carrying value of those intangible assets, and the associated amortization, were as follows:
June 30, 2012 |
December 31, 2011 | |||||||
Trademarks | $ | 2,310,000 | $ | 320,000 | ||||
Technology | 2,355,000 | 2,355,000 | ||||||
Customer relationships | 708,000 | 708,000 | ||||||
In-process research and development | 29,585,000 | | ||||||
Total | $ | 34,958,000 | $ | 3,383,000 | ||||
Less accumulated amortization | (639,546 | ) | (466,958 | ) | ||||
$ | 34,318,454 | $ | 2,916,042 |
The Companys intangible assets that have finite lives are amortized over their useful lives and reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable, and at least on an annual basis on October 1 of each year. If any indicators were present, the Company would test for recoverability by comparing the carrying amount of the asset to the net undiscounted cash flows expected to be generated from the asset. If those net undiscounted cash flows do not exceed the carrying amount (i. e. , the asset is not recoverable), the Company would perform the next step, which is to determine the fair value of the asset and record an impairment loss, if any. The Company periodically reevaluates the useful lives for these intangible assets to determine whether events and circumstances warrant a revision in their remaining useful lives. No impairment charges were recorded during 2012 or 2011.
The Company evaluates its indefinite-lived intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable, and at least on an annual basis on October 1 of each year, by comparing the fair value of the asset with its carrying amount. If the carrying amount of the intangible asset exceeds its fair value, the Company would recognize an impairment loss in the amount of that excess. The Company sole indefinite-lived intangible asset is its in-process research and development acquired in connection with its acquisition of Aldagen; no impairment charges were recorded during 2012. The in-process research and development asset consists of its ALDH bright cell platform. The Company is currently conducting a phase II clinical trial for this technology in ischemic stroke. Enrollment in that trial is expected to complete within the coming 12 months and top-line data is expected to be available approximately four months following completion of enrollment. If the trial is successful, it should provide efficacy data sufficient to appropriately power a phase III trial and would also further validate the technology. However, there is no assurance that this trial will be successful.
13
CYTOMEDIX, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 10 Goodwill and Identifiable Intangible Assets (continued)
Amortization expense of approximately $78,500 was recorded to cost of sales and approximately $94,100 was recorded to general and administrative expense for the six months ended June 30, 2012. Amortization expense for the remainder of 2012 is expected to be approximately $183,200. Annual amortization expense based on our existing intangible assets and their estimated useful lives is expected to be approximately:
2013 | 366,500 | |||
2014 | 366,500 | |||
2015 | 366,500 | |||
2016 | 366,500 | |||
2017 | 366,500 | |||
Thereafter | 2,718,600 |
Note 11 Accounts Payable and Accrued Expenses
Accounts payable and accrued expenses consisted of the following:
June 30, 2012 |
December 31, 2011 | |||||||
Trade payables | $ | 2,142,516 | $ | 1,175,023 | ||||
Accrued compensation and benefits | 525,790 | 227,323 | ||||||
Accrued professional fees | 130,379 | 194,658 | ||||||
Accrued interest | 63,700 | 86,100 | ||||||
Other payables | 330,904 | 166,029 | ||||||
$ | 3,193,289 | $ | 1,849,133 |
Note 12 Derivative and Other Liabilities
Derivative and other liabilities consisted of the following:
June 30, 2012 |
December 31, 2011 | |||||||
Derivative liability, long-term portion | $ | 1,689,807 | $ | 1,294,740 | ||||
Long-term portion of convertible debt, net of unamortized discount | 387,849 | 223,333 | ||||||
Deferred rent | 90,532 | | ||||||
Deferred tax liability | 41,218 | 32,000 | ||||||
Interest payable | 21,114 | 8,982 | ||||||
$ | 2,230,520 | $ | 1,559,055 |
Note 13 Debt
4% Convertible Notes
On July 15, 2011, Cytomedix issued $1.3 million of its 4% Convertible Notes (the July 4% Convertible Notes) to an unaffiliated third party. The July 4% Convertible Notes mature on July 15, 2014 and bear a one-time interest charge of 4% due on maturity. The July 4% Convertible Notes (plus accrued interest) convert at the option of the holder, in whole or in part and from time to time, into shares of the Companys common stock at a conversion rate equal to (i) the lessor of $0.80 per share or (ii) 80% of the average of the three lowest closing prices of the Companys common stock for the previous 20 trading days prior to conversion (subject to a floor price of $0.25 per share). At June 30, 2012, $941,200 face amount of the July 4% Convertible Notes remained outstanding and were convertible into approximately 1.2 million shares of common stock at a conversion price of $0.80 per share.
14
CYTOMEDIX, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 13 Debt (continued)
On November 18, 2011, Cytomedix issued $0.5 million of its 4% Convertible Notes (the November 4% Convertible Notes) to the same unaffiliated third party. The November 4% Convertible Notes mature on November 18, 2014 and bear a one-time interest charge of 4% due on maturity. The November 4% Convertible Notes (plus accrued interest) convert at the option of the holder, in whole or in part and from time to time, into shares of the Companys common stock at a conversion rate equal to 80% of the average of the three lowest closing prices of the Companys common stock for the previous 20 trading days prior to conversion (subject to a floor price of $0.25 per share). At June 30, 2012, the November 4% Convertible Notes were convertible into approximately 0.4 million shares of common stock at a conversion price of $1.14 per share.
The investor has the option to provide additional funding of up to $1.0 million on substantially the same terms; however, the Company may elect to cancel such notes, in its sole discretion, with no penalty.
The conversion option embedded in the July and November 4% Convertible Notes is accounted for as a derivative liability, and resulted in the creation at issuance of a discount to the carrying amount of the debt, totaling $1.8 million, which is being amortized as additional interest expense using the straight-line method over the term of the July and November 4% Convertible Notes (the Company determined that using the straight-line method of amortization did not yield a materially different amortization schedule than the effective interest method). The embedded conversion option is recorded at fair value and is marked to market at each period, with the resulting change in fair value being reflected as change in fair value of derivative liabilities in the accompanying condensed consolidated statements of operations.
12% Interest Only Note
On April 28, 2011, the Company borrowed $2.1 million pursuant to a secured promissory note that matures April 28, 2015. The note accrues interest at a rate of 12% per annum, and requires interest-only payments each quarter commencing September 30, 2011, with the then outstanding principal due on the maturity date, or April 28, 2015. The note may be accelerated by the lender if Cytomedix defaults in the performance of the terms of the promissory note, if the representations and warranties made by us in the note are materially incorrect, or if we undergo a bankruptcy event. The note is secured by business assets acquired from Sorin USA , Inc. (Sorin). The proceeds were used to fully satisfy the Companys then existing obligation under a separate note payable to Sorin.
In connection with the issuance of the new secured promissory note, the Company issued the lender a warrant to purchase up to 1,000,000 shares at an exercise price of $0.50 per share vesting as follows: (a) 666,667 shares upon issuance of the note, (b) 83,333 shares if the note has not been prepaid by the first anniversary of its issuance, (c) 116,667 shares if the note has not been prepaid by the second anniversary of its issuance, and (d) 133,333 shares if the note has not been prepaid by the third anniversary of its issuance.
Of the $2,100,000 due under the note, our payment obligations with respect to $1,400,000 under the note were guaranteed by certain insiders, affiliates, and shareholders of the Company, including Mr. David Jorden, one of the Companys directors. In connection with this guarantee, the Company issued the guarantors warrants to purchase an aggregate of up to 1,500,000 shares, on a pro rata basis based on the amount of the guarantee, at an exercise price of $0.50 per share vesting as follows: (a) 833,333 shares upon issuance of the note, (b) 166,667 shares if the note has not been prepaid by the first anniversary of its issuance, (c) 233,333 shares if the note has not been prepaid by the second anniversary of its issuance, and (d) 266,667 shares if the note has not been prepaid by the third anniversary of its issuance.
The warrants issued to the lender and the guarantors were valued at approximately $546,000, were recorded as deferred debt issuance costs, and are being amortized to interest expense on a straight-line basis over the four-year guarantee period. The Company determined that the straight-line method of amortization did not yield a materially different amortization schedule from the effective interest method.
15
CYTOMEDIX, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 14 Income Taxes
The Company accounts for income taxes using the asset and liability approach. This approach requires the recognition of tax benefits or expenses on the temporary differences between the financial reporting and tax bases of the Companys assets and liabilities. For interim periods, the Company recognizes a provision (benefit) for income taxes based on an estimated annual effective tax rate expected for the entire year. A valuation allowance is established when necessary to reduce deferred tax assets to the amounts expected to be realized. The Company also recognizes a tax benefit from uncertain tax positions only if it is more likely than not that the position is sustainable based on its technical merits. The Companys policy is to recognize interest and penalties on uncertain tax positions as a component of income tax expense.
Note 15 Capital Stock Activity
The Company issued 35,141,580 shares of common stock during the six months ended June 30, 2012. The following table lists the sources of and the proceeds from those issuances:
Source | # of Shares | Total Proceeds | ||||||
Conversion of Series D Convertible Preferred shares | 7,460,350 | $ | | |||||
Inducement to remaining shareholders of Series D Convertible Preferred stock to convert all outstanding shares | 330,000 | $ | | |||||
Conversion of Series E Convertible Preferred shares | 13,539,816 | $ | | |||||
Exercise of August 2008 warrants | 200,001 | $ | 200,001 | |||||
Exercise of August 2009 warrants | 418,968 | $ | 213,674 | |||||
Exercise of April 2010 warrants | 2,833,493 | $ | 1,521,028 | |||||
Exercise of Guarantor 2010 warrants | 1,333,334 | $ | 715,734 | |||||
Exercise of October 2010 warrants | 375,000 | $ | 225,000 | |||||
Exercise of Guarantor 2011 warrants | 1,583,335 | $ | 791,667 | |||||
Exercise of options issued under the Long-Term Incentive Plan | 10,000 | $ | 5,200 | |||||
Common stock issued in lieu of cash for dividend payable on Series D Convertible Preferred shares | 76,461 | $ | | |||||
Partial conversion of 4% Convertible Notes | 450,000 | $ | | |||||
Sale of shares pursuant to private offering | 4,231,192 | $ | 5,000,000 | |||||
Sale of shares pursuant to October 2010 equity purchase agreement | 2,125,000 | $ | 2,853,922 | |||||
Common stock issued in lieu of cash for fees incurred pursuant to October 2010 equity purchase agreement | 174,630 | $ | | |||||
Totals | 35,141,580 | $ | 11,526,226 |
The following table summarizes the stock options granted by the Company during the three and six months ended June 30, 2012. These options were granted to employees (primarily employees of Aldagen at the time of acquisition), board members, and service providers under the Companys Long-Term Incentive Plan
Three Months Ended June 30, 2012 |
Six Months Ended June 30, 2012 |
|||||||||||
Options Granted | Exercise Price | Options Granted | Exercise Price | |||||||||
163,500 | $ | 1.88 - $2.28 | 2,228,500 | $ | 1.13 - $2.28 |
During the six months ended June 30, 2012, 26,834 options were forfeited by contract due to the termination of the underlying service arrangement.
No dividends were declared or paid on the Companys Common stock in any of the periods discussed in this report.
16
CYTOMEDIX, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 15 Capital Stock Activity (continued)
The Company had the following outstanding warrants and options:
# Outstanding | ||||||||
Equity Instrument | June 30, 2012 | December 31, 2011 | ||||||
Fitch/Coleman Warrants(1) | 975,000 | 975,000 | ||||||
August 2008 Warrants(2) | 800,006 | 1,000,007 | ||||||
August 2009 Warrants(3) | 1,070,916 | 1,489,884 | ||||||
April 2010 Warrants(4) | 1,295,138 | 4,128,631 | ||||||
Guarantor 2010 Warrants(5) | | 1,333,334 | ||||||
October 2010 Warrants(6) | 1,488,839 | 1,863,839 | ||||||
Guarantor 2011 Warrants(7) | 916,665 | 2,500,000 | ||||||
February 2012 Inducement Warrants(8) | 1,180,547 | | ||||||
February 2012 Aldagen Warrants(9) | 2,115,596 | | ||||||
Other warrants(10) | 300,149 | 360,149 | ||||||
Options issued under the Long-Term Incentive Plan(11) | 8,467,221 | 5,323,054 |
(1) | These warrants were issued in connection with the August 2, 2007 Term Sheet Agreement and Shareholders Agreement with the Companys then outside patent counsel, Fitch Even Tabin & Flannery and The Coleman Law Firm, and have a 7.5 year term. The strike prices on the warrants are: 325,000 at $1.25 (Group A); 325,000 at $1.50 (Group B); and 325,000 at $1.75 (Group C). The Company may call up to 100% of these warrants, provided that the closing stock price is at or above the following call prices for ten consecutive trading days: Group A $4/share; Group B $5/share; Group C $6/share. If the Company exercises its right to call, it shall provide at least 45 days notice for one-half of the warrants subject to the call and at least 90 days notice for the remainder of the warrants subject to the call. |
(2) | These warrants were issued in connection with the August 2008 financing, are voluntarily exercisable at $1.00 per share, provided that the exercise does not result in the holder owning in excess of 9.99% of the outstanding shares of the Companys Common stock, and expire on August 29, 2012. |
(3) | These warrants were issued in connection with the August 2009 financing, are voluntarily exercisable at $0.51 per share and expire in February 2014. These amounts reflect adjustments for an additional 420,896 warrants due to anti-dilutive provisions. These warrants were previously accounted for as a derivative liability through January 28, 2011. At that time, they were modified to remove non-standard anti-dilution clauses and the associated derivative liability and related deferred financing costs were reclassified to APIC. |
(4) | These warrants were issued in connection with the April 2010 Series D preferred stock offering, are voluntarily exercisable at $0.54 per share and expire on April 9, 2015. |
(5) | These warrants were issued in April 2010 pursuant to the Guaranty Agreements executed in connection with the Promissory Note payable to Sorin existing at that time. These warrants had an exercise price of $0.54 per share and were fully exercised as of June 30, 2012. |
(6) | These warrants were issued in connection with the October 2010 financing. They have an exercise price of $0.60 and expire on April 7, 2016. These warrants were previously accounted for as a derivative liability through January 28, 2011. At that time, they were modified to remove non-standard anti-dilution clauses and the associated derivative liability and related deferred financing costs were reclassified to APIC. |
(7) | These warrants were issued pursuant to the Guaranty Agreements executed in connection with the Promissory Note issued in April 2011. These warrants have an exercise price of $0.50 per share and expire on April 28, 2016. |
(8) | These warrants were issued in connection with the February 2012 warrant exercise agreements executed with certain existing Cytomedix warrant holders. These warrants have an exercise price of $1.42 per share and expire on December 31, 2014. |
17
CYTOMEDIX, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 15 Capital Stock Activity (continued)
(9) | These warrants were issued in February 2012 in connection with the warrant exchange agreements between Cytomedix and various warrant holders of Aldagen. These warrants have an exercise price of $1.42 per share and expire on December 31, 2014. |
(10) | These warrants were issued to consultants and other professional service providers in exchange for services provided. They have terms ranging from 5 to 10 years with various expiration dates through February 24, 2014 and exercise prices ranging from $1.10 to $1.50 as of June 30, 2012. They are voluntarily exercisable once vested. There is no call provision associated with these warrants. |
(11) | These options were issued under the Companys shareholder approved Long-Term Incentive Plan. |
On January 17, 2012, pursuant to the terms of the Certificate of Designation, the Company paid a dividend on its Series D Preferred stock in the form of shares of its common stock. The total dividend paid to all Series D Preferred stock holders was 76,461 common shares.
On February 8, 2012, in connection with the acquisition of Aldagen, the Company sold 4,231,192 shares of common stock at a purchase price of $1.18 per share for an aggregate amount of $5 million to certain owners of Aldagen, Inc. The shares were sold in transactions exempt from registration under the Securities Act of 1933, in reliance on Section 4(2) thereof and Rule 506 of Regulation D thereunder. Each purchaser represented that it was an accredited investor as defined in Regulation D.
On February 8, 2012, in connection with the acquisition of Aldagen, Series D convertible preferred stockholders converted their preferred stock into 7,460,350 shares of common stock. In order to induce such conversion the Company issued an aggregate of 330,000 additional shares of common stock to these shareholders.
On February 8, 2012, in connection with the acquisition of Aldagen, the Company issued 135,398.16 shares of its newly designated Series E convertible preferred stock. These shares automatically converted into 13,539,816 shares of Common stock upon shareholder approval of an increase in the Companys authorized Common stock at a special shareholders meeting held on May 18, 2012.
On February 8, 2012, in connection with the acquisition of Aldagen, the Company executed warrant exercise agreements with various existing Cytomedix warrant holders. These agreements obligated the warrant holders to exercise approximately $2.8 million worth of warrants, representing 5,288,256 shares, no later than June 30, 2012. As of June 30, 2012, these warrant exercise agreements have been fulfilled. The Company issued 1,180,547 of new warrants to the shareholders as an inducement for their commitment. The new warrants have an exercise price of $1.42 per share and expire December 31, 2014. Of these warrants, 30% vested upon issuance and 70% will vest only upon the achievement of certain clinical milestones defined in the exchange and purchase agreement related to the Aldagen acquisition.
On February 8, 2012, in connection with the acquisition of Aldagen, the Company issued 2,115,596 warrants to existing Aldagen warrant holders in exchange for then existing Aldagen warrants. The new warrants have an exercise price of $1.42 per share and expire December 31, 2014. Of these warrants, 30% vested upon issuance and 70% will vest only upon the achievement of certain clinical milestones defined in the exchange and purchase agreement related to the Aldagen acquisition.
On February 13, 2012, the Company redeemed all of the then outstanding Series A and B convertible preferred stock for an aggregate amount of approximately $170,000 and satisfied all accrued, but unpaid, dividends on said stock in the aggregate amount of approximately $37,000.
18
CYTOMEDIX, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 16 Supplemental Cash Flow Disclosures Non-Cash Transactions
Non-cash transactions for the six months ended June 30, 2012 include:
2012 | ||||
Accrued dividends on preferred stock | $ | 13,562 | ||
Preferred dividends paid by issuance of stock | (82,493 | ) | ||
Conversion of convertible debt to common stock | (541,667 | ) | ||
Business combination: |
||||
Issuance of Series E liability | 18,955,742 | |||
Issuance of contingent consideration | 11,109,020 | |||
Issuance of replacement warrants | 1,883,751 |
Note 17 Commitments and Contingencies
Under the Companys plan of reorganization upon emergence from bankruptcy in July 2002, the Series A Preferred stock and the dividends accrued thereon that existed prior to emergence from bankruptcy were to be exchanged into one share of new Common stock for every five shares of Series A Preferred stock held as of the date of emergence from bankruptcy. This exchange was contingent on the Companys attaining aggregate gross revenues for four consecutive quarters of at least $10,000,000 and if met would result in the issuance of 325,000 shares of the Companys Common stock. The Company reached such aggregate revenue levels as of the end of the quarter ended June 30, 2012 and, as a result, expensed approximately $471,000 related to the resolution of the contingency. The expense amount, classified as other expenses in the accompanying condensed consolidated statement of operations, represents the fair value of 325,000 shares of the Companys Common stock to be issued to former Series A Preferred Stock holders at prescribed times over the next 15 months. The Common stock issuable is classified as equity.
Aldagens former investors have the right to receive up to 20,309,723 shares of the Companys common stock (the Contingent Consideration), contingent upon the achievement of certain milestones related to the current ALD-401 Phase II clinical trial.
In March 2011, the Company entered into a development agreement in which a consultant was granted 250,000 options to purchase the Companys common stock, of which 50,000 vested immediately, and the remaining 200,000 vesting in tranches upon the achievement of certain pre-defined milestones. Furthermore, if the Company chooses to materially modify the objectives and strategy of the project, 50% of the then unvested options would become immediately vested, and the remaining 50% would be cancelled.
In conjunction with its FDA clearance, the Company agreed to conduct a post-market surveillance study to further analyze the safety profile of bovine thrombin as used in the AutoloGelTM System. This study was estimated to cost between $500,000 and $700,000 over a period of several years, which began in the third quarter of 2008. As of June 30, 2012, approximately $353,000 had been incurred. Since the inception of this study, the Company has enrolled 120 patients, noting no adverse events. Based on an analysis of the positive safety data, the Company has suspended further enrollment in this study pending further discussion with the FDA.
In July 2009, in satisfaction of a new Maryland law pertaining to Wholesale Distributor Permits, the Company established a Letter of Credit, in the amount of $50,000, naming the Maryland Board of Pharmacy as the beneficiary. This Letter of Credit serves as security for the performance by the Company of its obligations under applicable Maryland law regarding this permit and is collateralized by a Certificate of Deposit (CD) purchased from the Companys commercial bank. The CD bears interest at an annual rate of 0.50% and matures on October 24, 2012.
The Companys offices and warehouse facilities are located in Gaithersburg, Maryland, and comprise approximately 4,100 square feet under a 40-month operating lease expiring December 2013. Monthly rent, including our share of certain annual operating costs and taxes, is approximately $5,800 per month. The Company also leases a 16,300 square foot facility located in Durham, North Carolina. This facility falls under two leases with monthly rent, including our share of certain annual operating costs and taxes, at approximately $11,000 and $6,000 per month with the leases expiring April 30 and December 31, 2013, respectively.
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Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
This Quarterly Report on Form 10-Q contains forward-looking statements regarding Cytomedix, Inc. (Cytomedix, the Company, we, us, or our) and our business, financial condition, results of operations and prospects within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those that express plans, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact. These forward-looking statements are based on our current expectations and projections about future events and they are subject to risks and uncertainties known and unknown that could cause actual results and developments to differ materially from those expressed or implied in such statements. Although forward-looking statements in this Quarterly Report reflect the good faith judgment of our management, such statements can only be based on facts and factors currently known by us. Consequently, forward-looking statements are inherently subject to risks and uncertainties and actual results and outcomes may differ materially from the results and outcomes discussed in or anticipated by the forward-looking statements. 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. Other unknown, unidentified or unpredictable factors could materially and adversely impact our future results. You should read the following discussion and analysis in conjunction with our unaudited financial statements contained in this report, as well as the audited financial statements, Managements Discussion and Analysis of Financial Condition and Results of Operations, and Risk Factors contained in our Annual Report on Form 10-K for the fiscal year ended December 31, 2011. The Company undertakes no obligation to update the forward-looking statements contained in this report to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as may occur as part of its ongoing periodic reports filed with the SEC. Given these uncertainties, the reader is cautioned not to place undue reliance on such statements.
Description of the Business
Overview
Cytomedix, Inc. (Cytomedix, the Company, we, us, or our) is a regenerative therapy company, harnessing the bodys own capacity to heal itself. Cytomedix develops and commercializes innovative autologous therapies that promote healing by harnessing the innate regenerative capacity of platelets and adult stem cells. We currently have a growing commercial operation, and a robust clinical pipeline seeking to exploit large market opportunities with unmet medical needs.
Our current commercial offerings are centered around our platelet rich plasma (PRP) platform technology, and primarily include the Angel® Whole Blood Separation System (Angel) and the AutoloGelTM System (AutoloGel). These products primarily address the areas of wound care, and support of healing and recovery following orthopedic procedures. Our sales are predominantly in the United States, where we sell our products through a combination of direct sales representatives and independent sales agents. In Europe, the Middle East, Canada, and Australia we have a network of distributors covering several major markets.
Our clinical pipeline primarily involves the ALDHbr cell-based therapies, acquired through the acquisition of Aldagen, Inc. , a privately held biopharmaceutical company, in February 2012, and the expansion of the Angel System for use in other clinical indications.
Angel Product Line
The Angel Whole Blood Separation System, acquired from Sorin USA, Inc. (Sorin) in April 2010, is designed for single patient use at the point of care, and provides a simple yet flexible means for producing quality PRP and platelet poor plasma (PPP) clinical blood components. The system is easy to set up and
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maintain and is capable of processing up to 180 ml of whole blood. In surgical procedures, the PRP can be mixed with bone graft material prior to application.
We have grown worldwide sales of Angel steadily since acquiring the product line in April 2010 and expect this trend to continue. After acquiring Angel from Sorin in 2010, we successfully worked to ensure that we did not experience any net attrition of sales and any major supply chain interruptions, and our integration and transition efforts are now complete. Our focus is on growing sales in both the U. S. and international markets, and seeking efficiencies in the supply chain. We expect that future sales growth of these products will be driven through a combination of a focused marketing effort, strengthened distributor relationships, expanded indications, and direct sales. We expect our international distributors to drive increased sales in the coming quarters. In the long term, we expect new technology applications for Angel and expansion into other surgical and orthopedic applications will provide future growth opportunities.
The Angel product line also includes ancillary products such as phlebotomy and applicator supplies, and activAT®. activAT is designed to produce autologous thrombin serum from platelet poor plasma and is sold exclusively in Europe and Canada, where it provides a safe alternative to bovine-derived products. It currently represents less than 1% of our total sales revenue.
We continue to make progress on our efforts to obtain FDA clearance for additional indications for Angel, specifically, bone marrow aspirate processing. In August 2011, we filed a 510(k) submission with the FDA for bone marrow aspirate processing. Following discussions with FDA regarding this application, we have been collecting additional data which will be submitted in the third quarter of 2012.
AutoloGelTM System
The AutoloGel System is a device for the production of autologous PRP gel. AutoloGel is cleared by the FDA for use on a variety of exuding wounds and is currently marketed to the chronic wound market. The AutoloGelTM System harnesses the patients natural healing processes to provide growth factors, chemokines and cytokines known to promote angiogenesis and to regulate cell growth and formation of new tissue. PRP technology restores the balance in the wound environment to transform a non-healing wound to a wound that heals naturally. In October 2011, the Company entered into an option agreement with a top 20 global pharmaceutical company granting the potential partner an exclusive option period through June 30, 2012 regarding U. S. supply and distribution of the AutoloGel System. In exchange for this period of exclusivity, to date we have received non-refundable fees totaling $4.5 million. Effective June 30, 2012, we agreed to a further period of exclusivity through August 30, 2012, within which we expected to negotiate the material terms and provisions of a distribution agreement. However, subsequent to the foregoing and as of the date of this Report, the parties agreed to the early termination of the August 30, 2012 exclusivity period and ceased further negotiations concerning a distribution agreement. As noted above, $4.5 million received by the Company to date for this exclusivity is non-refundable. The Company is now able to pursue potential partnerships and commercial agreements for the product with other interested parties.
We continue to make progress on a next generation device, enhancing the separation of blood components to provide the added convenience and effectiveness that treating clinicians are looking for at the point of care. Importantly, the new device allows for the whole blood collection and the separation of the platelet rich plasma to be accomplished with a single specially designed closed syringe system that maintains an aseptic environment. This streamlines the process, improves safety and ease-of-use and may be more conducive for certain developing orthopedic indications. The sterilization studies are complete. We expect to file a 510(k) application, in the first quarter of 2013, with the FDA upon the completion of platelet characterization and validation studies.
Since 1992, the Centers for Medicare and Medicaid Services (CMS) had maintained a national non-coverage determination for autologous PRP in wound care. This severely restricted the markets which Autologel could address commercially. In late 2011, based on significant amounts of additional positive data regarding the effectiveness of AutoloGel, CMS accepted our request to reconsider its non-coverage determination. On August 2, 2012, CMS issued a final National Coverage Determination (NCD) for autologous blood-derived products for chronic non-healing wounds. As previously reported, on May 9, 2012 CMS posted its proposed NCD, which was followed by a 30-day public comment period that ended on June 8. In the final decision memo released August 2nd, CMS responded to these comments, refined its
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decision and confirmed coverage for autologous platelet rich plasma (PRP) in patients with diabetic, pressure and/or venous wounds via its Coverage with Evidence Development (CED) program. CED is a process through which CMS provides reimbursement coverage for items and services while generating additional clinical data to demonstrate their impact on health outcomes.
This determination provides for an appropriate research study with practical study designs that we believe will demonstrate that patients treated with AutoloGelTM experience clinically significant health outcomes.
ALDHbr Cell Technology and Development Pipeline
We acquired Aldagen in February 2012 in an all equity transaction valued, based on our volume weighted common stock price at the time of acquisition, at approximately $40 million in up-front and contingent consideration. The Aldagen technology utilizes an intracellular enzyme marker to fractionate essential regenerative cells from a patients bone marrow. This core technology was originally licensed from Duke University and Johns Hopkins University. This proprietary bone marrow fractionation process identifies and isolates active stem and progenitor cells expressing high levels of the enzyme aldehyde dehydrogenase, or ALDH, which is a key enzyme involved in the regulation of gene activities associated with cell proliferation and differentiation. The selected biologically instructive cells (ALDHbr) have the potential to promote the repair and regeneration of multiple types of cells and tissues, including the growth of new blood vessels, or angiogenesis, which is critical to the generation of healthy tissue.
Our lead product candidate, ALD-401, is for the treatment of post-acute ischemic stroke. ALD-401 is currently being evaluated in the RECOVER-Stroke clinical study, an ongoing 100-patient, double-blind, placebo-controlled Phase II study in patients with unilateral, cerebral ischemic stroke with an NIH stroke scale score of between 7 and 22. In this study ALD-401 is delivered via the carotid artery, and a single infusion is administered 13 to 19 days post the ischemic event. The trial is being conducted at up to 10 15 sites in the U. S. The primary endpoint of the trial is safety and the efficacy endpoint is post-stroke recovery of neural function based on the modified Rankin Scale at three months post treatment.
We recently completed the initial safety stage of the study. The independent Data Safety Monitoring Board (DSMB) reviewing the safety data has recommended that the Phase 2 trial of ALD-401 can continue as designed. Additional DSMB reviews are scheduled at 30 and 60 patients per the clinical protocol. We are in the process of expanding the study to between 10 and 15 sites. We expect to complete enrollment within the coming 12 months and to have top-line data approximately four months following completion of enrollment.
In July of 2012, we announced the initiation of a Phase I clinical study with ALD-451 in brain cancer patients in collaboration with Duke University Medical Center. The open-label study will enroll up to 12 patients and is intended to demonstrate the feasibility and safety of ALD-451 when administered intravenously in World Health Organization (WHO) grade IV malignant glioma patients following surgery, radiation therapy and treatment with temozolomide. The trial also will obtain an initial description of the effects of ALD-451 on neurocognition. The clinical study is open for enrollment having received Investigational New Drug clearance from the U. S. Food and Drug Administration and Investigational Review Board clearance from Duke University Medical Center. Cytomedix will be responsible for manufacturing ALD-451 for the clinical trial. Duke University Medical Center, through the Robertson Clinical & Translational Cell Therapy Program, will fund the trial and be responsible for all other aspects of the study.
An additional product candidate, ALD-301, is in clinical development for critical limb ischemia (CLI). We have completed a Phase I/II study of ALD-301 in CLI. The results showed improvement in limb perfusion as well as improvements in key parameters measuring CLI severity, and was published in the medical journal Catheterization and Cardiovascular Interventions. FDA clearance has been received to begin a 150-patient, double-blind, placebo-controlled Phase II study of Rutherford Category 4 or 5 patients who are not candidates for blood flow restoration procedures.
We have also completed a Phase I study with ALD-201 to treat end-stage heart failure. In this study, the trial provided initial evidence of improved blood flow and improved clinical status. A paper detailing the clinical data was recently published in the American Heart Journal in an article entitled: Randomized, double-blind pilot study of transendocardial injection of autologous aldehyde dehydrogenasebright stem cells in patients with ischemic heart failure.
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Our current development strategy involves seeking partners to further advance the ALD-301 and ALD-201 programs. We expect one additional trial, funded by a third party, to start in the fourth quarter of 2012. This study leverages our data and positive clinical experiences in CLI with ALD-301.
Comparison of Operating Results for the Three- and Six-Month Periods Ended June 30, 2012 and 2011
Certain numbers in this section have been rounded for ease of analysis.
Product sales continued along a steady growth trend, with total product sales of $1.8 million in the second quarter of 2012 and $3.5 million for the year. In February 2012, we also received a $2.5 million non-refundable exclusivity fee (in addition to the $2.0 million exclusivity fee received in the fourth quarter of 2011) from a top 20 global pharmaceutical partner in conjunction with a potential supply and distribution agreement for AutoloGel. Also in February of this year, we acquired Aldagen, Inc. , a privately held autologous adult stem cell company, in an all equity transaction valued at approximately $40 million, provided certain clinical milestones are met. Aldagens lead product candidate, ALD-401, is currently in a phase II clinical trial involving post-acute ischemic stroke patients.
Our revenues will be insufficient to cover our operating expenses in the near term. Operating expenses primarily consist of employee compensation, professional fees, consulting expenses, clinical trial costs, and other general business expenses such as insurance, travel related expenses, and sales and marketing related items. Operating expenses have risen to support the continuing growth of product sales, our substantial efforts with regard to Medicare reimbursement for AutoloGel, and the more recent ALD-401 phase II clinical trial involving patients with ischemic stroke. We therefore expect losses to continue for the foreseeable future.
Revenues
Revenues increased $2,291,000 (164%) to $3,685,000 and $3,942,000 (143%) to $6,702,000 comparing the three and six months ended June 30, 2012, respectively, to the same periods last year.
For the three-month period, the increase was due to higher product sales of $420,000, license fee revenue of $1,824,000, and royalty revenue of $47,000. Sales of Angel increased $350,000 (27%) and AutoloGel increased $56,000 (51%). Royalty revenue was a result of royalties received from our Aldefluor® license.
For the six-month period, the increase was primarily due to higher product sales of $740,000 and license fee revenue of $3,155,000. The increased product sales were primarily due to an increase in Angel sales of $586,000 (23%) and AutoloGel sales of $131,000 (66%).
License fee revenue was a result of exclusivity fee payments recognized with respect to an option agreement with a top 20 global pharmaceutical company.
Gross Profit
Gross Profit increased $1,950,000 (258%) to $2,705,000 and $3,398,000 (230%) to $4,874,000 comparing the three and six months ended June 30, 2012, respectively, to the same periods last year.
For the three-month period, the increase was primarily attributable to $1.8 million in licensing revenue (which had no associated cost) as well as increased profit on product sales.
For the six-month period, the increase was primarily attributable to $3.2 million in licensing revenue (which had no associated cost) as well as increased profit on product sales.
For the same periods, gross margin increased to 73% from 54% and to 73% from 53%, comparing the three and six months ended June 30, 2012. The increase was primarily due to the license fee revenue which had no associated cost of revenue. Gross margin on product sales decreased to 46% from 54% and to 48% from 53%, for the same periods respectively. The decrease was primarily due to sales on lower margin products, specifically Angel machines sold to international distributors, which made up a more significant portion of the product mix.
Operating Expenses
Operating expenses increased $3,061,000 (154%) to $5,054,000 and increased $5,746,000 (137%) to $9,942,000 comparing the three and six months ended June 30, 2012, to the same periods last year. A discussion of the various components of operating expenses follows below.
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Salaries and Wages
Salaries and wages increased $1,046,000 (143%) to $1,779,000 and $2,382,000 (163%) to $3,841,000 comparing the three and six months ended June 30, 2012 to the same period last year. The increases were primarily due to increased stock-based compensation expense and additional employees as a result of the Aldagen acquisition, in addition to increased bonus expense.
Consulting Expenses
Consulting expenses increased $156,000 (52%) to $454,000 and $648,000 (102%) to $1,283,000 comparing the three and six months ended June 30, 2012 to the same period last year.
For the three-month period, the increase was primarily due to consulting expense associated with clinical, finance, and European distribution channel activities.
For the six-month period, the increase was primarily due to consulting expenses related to the Aldagen acquisition, in addition to consulting expense associated with clinical, finance, and European distribution channel activities.
Professional Fees
Professional fees decreased $10,000 (5%) to $203,000 and increased $216,000 (48%) to $667,000 comparing the three and six months ended June 30, 2012 to the same period last year. The increase for the six-month period was primarily due to legal and accounting costs related to the Aldagen acquisition.
Research, Development, Trials and Studies
Trials and studies expenses increased $1,049,000 (2,492%) to $1,091,000 and $1,347,000 (1,319%) to $1,449,000 comparing the three and six months ended June 30, 2012 to the same period last year. The increases were primarily due to research and development costs related to the ALD-401 Phase II clinical trial.
General and Administrative Expenses
General and administrative expenses increased $820,000 (116%) to $1,526,000 and $1,153,000 (74%) to $2,702,000 comparing the three and six months ended June 30, 2012 to the same period last year.
For the three- and six-month period, the increase was primarily due to higher stock based compensation due to additional members of the board of directors, rent, employee benefits, and amortization expense as a result of the acquisition of Aldagen. Additionally, travel, marketing, and European services increased as we made further investments in our sales and marketing distribution efforts.
Other Income and Expense
Other expense, net totaled $5,103,000 and $7,102,000 in the three and six months ended June 30, 2012 compared to $452,000 and $529,000 in other income in the same periods last year.
For the three-month period, the change was primarily due to an increase in expense of approximately $4,335,000 related to the increase in the fair value of the contingent consideration mainly due to the change in the Companys stock price and $471,000 due to the settlement of a contingency. The settlement expense realized was a result of a contingency resolved, in the second quarter of 2012, that resulted in common stock issuable to our pre-bankruptcy Series A Preferred stock holders as outlined in the Companys plan of reorganization in 2002. In addition, there was a gain of approximately $577,000 recognized in 2011 related to the Companys renegotiation of the note payable due to Sorin.
For the six-month period, the change was primarily due to an increase in expense of approximately $4,335,000 related to the increase in the fair value of the contingent consideration mainly due to the change in the Companys stock price. In addition, there was approximately $1,513,000 in non-cash inducement expense, $471,000 in settlement expense, and a $625,000 non-cash change in the fair value of derivative liabilities. The settlement expense realized was a result of a contingency resolved, in the second quarter of 2012, that resulted in common stock issuable to our pre-bankruptcy Series A Preferred stock holders as outlined in the Companys plan of reorganization in 2002. The non-cash inducement expense is associated with common stock issued to compensate Series D preferred stockholders for forgone preferred dividend payments due to
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the early conversion of preferred stock incentive warrants issued in exchange for the early exercise of existing warrants. These were partially offset by a gain of approximately $577,000 recognized in 2011 related to the Companys renegotiation of the note payable due to Sorin.
Liquidity and Capital Resources
Since inception we have incurred, and continue to incur significant losses from operations. Although our recent acquisition of Aldagen was an all equity transaction, the on-going Phase II study and general corporate activities at Aldagen will increase our operational expenditures over the next two years. Historically, we have financed our operations through a combination of the sale of debt, equity and equity-linked securities, and licensing, royalty, and product revenues. The Companys commercial products are currently generating approximately $7 million in revenue per year on a run-rate basis. The Company needs to sustain and grow these sales to meet its business objectives and satisfy its cash requirements.
At June 30, 2012, we had approximately $8.5 million cash on hand including approximately $4.7 million dedicated for use in the ALD-401 clinical trial and related matters. We believe we will have sufficient cash to sustain the Company at least through 2012. However, we will require additional capital to finance the further development of our business operations, in particular the completion of the Phase II RECOVER Stroke trial, beyond that point.
If a license and/or distribution agreement is finalized with the pharmaceutical company mentioned above, we would expect such agreement to incorporate up-front fees, milestone payments, and a profit sharing arrangement on future U. S. sales of AutoloGel. We also continue to have exploratory conversations with large companies regarding their interest in our various products and technologies. We will seek to leverage these relationships and this heightened interest to secure further non-dilutive sources of funding.
The Company may also access additional capital through a purchase agreement with Lincoln Park Capital (LPC). Under this agreement, which expires in January 2013, the Company may, within certain parameters, raise up to an additional $4.6 million. To date, the Company has raised $6.9 million by selling a total of 11.8 million shares to LPC with approximately 67% of those shares sold prior to June 30, 2011. Given the parameters within which the Company may draw down from LPC, there is no assurance that the amounts available from LPC will be sufficient to fund our future operational cash flow needs.
If significant amounts are not available to the Company from future strategic partnerships or under the LPC agreement, additional funding will be required for the Company to pursue all elements of its strategic plan. Specific programs that may require additional funding include, without limitation, continued investment in the sales, marketing, distribution, and customer service areas, further expansion into the international markets, completion of the ongoing Phase II RECOVER Stroke trial, significant new product development or modifications, and pursuit of other opportunities. We would likely raise such additional capital through the issuance of our equity or equity-linked securities, which may result in significant additional dilution to our investors. The Companys ability to raise additional capital is dependent on, among other things, the state of the financial markets at the time of any proposed offering. To secure funding through strategic partnerships, it may be necessary to partner one or more of our technologies at an earlier stage of development, which could cause the Company to share a greater portion of the potential future economic value of those programs with its partners. There is no assurance that additional funding, through any of the aforementioned means, will be available on acceptable terms, or at all. If adequate capital cannot be obtained on a timely basis and on satisfactory terms, the Companys operations could be materially negatively impacted.
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Net cash provided by (used in) operating, investing, and financing activities for the six months ended June 30, 2012 and 2011 were as follows:
June 30, 2012 |
June 30, 2011 |
|||||||
(in millions) | ||||||||
Cash flows used in operating activities | $ | (4.3 | ) | $ | (2.7 | ) | ||
Cash flows used in investing activities | $ | (0.7 | ) | $ | | |||
Cash flows from financing activities | $ | 11.3 | $ | 2.3 |
Operating Activities
Cash used in operating activities in 2012 of $4.3 million primarily reflects our net loss of $12.2 million adjusted by a (i) $4.3 million increase for change in contingent consideration relating to the Aldagen acquisition, (ii) $1.5 million increase for non-cash inducement expense associated with warrant exercise agreements, (iii) $1.5 million increase for stock-based compensation, (iv) $1.2 million decrease for changes in assets and liabilities, (v) $0.5 million increase for depreciation and amortization, (vi) $0.5 million increase for settlement of contingency expense, (vii) $0.2 million increase for change in derivative liabilities, and (viii) $0.3 million increase for non-cash interest expense. The $1.2 million decrease due to changes in assets and liabilities, in part reflects a net $0.7 million decrease in deferred revenue for revenue recognized relating to the non-refundable exclusivity fees received from a potential global pharmaceutical partner.
Cash used in operating activities in 2011 primarily reflects our net loss of $2.2 million adjusted for a (i) $0.6 million decrease for gain on debt restructuring relating to the Companys renegotiation of the note payable to Sorin, (ii) $0.4 decrease for change in derivative liabilities, (iii) net $0.1 million decrease for changes in assets and liabilities, (iv) $0.3 million increase for depreciation and amortization, (v) $0.1 million increase for amortization of deferred costs relating to debt issuances, and (vi) $0.1 million increase for stock-based compensation.
Investing Activities
Cash used in investing activities in 2012 primarily reflects the net activity of purchases and sales of Angel and AutoloGel centrifuge devices.
Financing Activities
In 2012, we raised $7.9 million through the issuance of common stock ($5.0 million of which was sold to existing Aldagen investors, concurrent with the acquisition of Aldagen), and received $3.7 million from warrant exercises. This was offset by a $0.2 million cash payment for the redemption of Series A and B Convertible Preferred Stock and the satisfaction of accrued but unpaid dividends thereon.
In 2011, we raised $2.1 million through the issuance of traditional debt, and $2.8 million through the sale of common stock ($2.5 million of which was sold to LPC). These amounts were partly offset by a $2.6 million repayment of the note payable to Sorin.
Contractual Obligations
The Companys primary office and warehouse facilities are located in Gaithersburg, Maryland, and comprise approximately 4,100 square feet under a 40-month operating lease expiring December 2013. Monthly rent, including our share of certain annual operating costs and taxes, is approximately $5,800 per month. The Company also leases a 16,300 square foot facility located in Durham, North Carolina. This facility falls under two leases with monthly rent, including our share of certain annual operating costs and taxes, at approximately $11,000 and $6,000 per month with the leases expiring April 30 and December 31, 2013, respectively.
The Company has also committed to purchase approximately $905,000 of new Angel machines through January 2013 in order to support demand for the Angel products.
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Critical Accounting Policies
A complete summary of our critical accounting policies can be found in our Annual Report on Form 10-K for the year ended December 31, 2011. The following accounting policies changed or were adopted in 2012.
Basic and Diluted Loss Per Share
Basic and diluted net loss per common share is presented in accordance with established standards for all periods presented. We compute basic and diluted net loss per common share using the weighted-average number of shares of common stock outstanding during the period. During periods of net losses, shares associated with outstanding stock options, stock warrants, convertible preferred stock, and convertible debt are not included because the inclusion would be anti-dilutive (i.e., would reduce the net loss per share). The total numbers of such shares excluded from the calculation of diluted net loss per common share were 20,249,909 for the three and six months ended June 30, 2012, and 27,214,526 for the three and six months ended June 30, 2011.
Goodwill and Intangible Assets
Goodwill represents the excess of the purchase price over the net tangible and intangible assets acquired in business combinations. The Company conducts an impairment test of goodwill on an annual basis as of October 1 of each year. The Company will also conduct tests if events occur or circumstances change that would, more likely than not, reduce the fair value of the Company below its carrying value.
Indefinite lived intangible assets consist of in-process research and development (IPR&D) acquired in the acquisition of Aldagen. The acquired IPR&D consists of specific cell populations (that are related to a specific indication) and the use of the cell populations in treating particular medical conditions. The Company evaluates its indefinite-lived intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable, and at least on an annual basis on October 1 of each year, by comparing the fair value of the asset with its carrying amount. If the carrying amount of the intangible asset exceeds its fair value, the Company would recognize an impairment loss in the amount of that excess.
Identifiable intangible assets with finite lives consist of trademarks, technology (including patents), and customer relationships acquired in business combinations. These intangibles are amortized using the straight-line method over their estimated useful lives. The Company reviews its finite-lived intangible assets for potential impairment when circumstances indicate that the carrying amount of assets may not be recoverable.
Recent Accounting Pronouncements
ASU No. 2011-08, Intangibles Goodwill and Other (Topic 350) Testing Goodwill for Impairment. The amendments in this update are intended to reduce complexity and costs by allowing an entity the option to make a qualitative evaluation about the likelihood of goodwill impairment to determine whether it should calculate the fair value of a reporting unit. The amendments also improve previous guidance by expanding upon the examples of events and circumstances that an entity should consider between annual impairment tests in determining whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount. Also, the amendments improve the examples of events and circumstances that an entity having a reporting unit with a zero or negative carrying amount should consider in determining whether to measure an impairment loss, if any, under the second step of the goodwill impairment test. The amendments are effective for annual and interim goodwill impairment tests performed for fiscal years beginning after December 15, 2011. Early adoption is permitted, including for annual and interim goodwill impairment tests performed as of a date before September 15, 2011, if an entitys financial statements for the most recent annual or interim period have not yet been issued. ASU 2011-08 became effective for the Company on January 1, 2012 and did not have a significant impact on the Companys financial statements
ASU No. 2012-02, Intangibles Goodwill and Other (Topic 350) Testing Indefinite-Lived Intangible Assets for Impairment. The objective of the amendments in this Update is to reduce the cost and complexity of performing an impairment test for indefinite-lived intangible assets by simplifying how an entity tests those assets for impairment and to improve consistency in impairment testing guidance among long-lived asset
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categories. The amendments permit an entity first to assess qualitative factors to determine whether it is more likely than not that an indefinite-lived intangible asset is impaired as a basis for determining whether it is necessary to perform the quantitative impairment test in accordance with Subtopic 350-30, Intangibles Goodwill and Other General Intangibles Other than Goodwill. The more-likely-than-not threshold is defined as having a likelihood of more than 50 percent. The amendments in this Update apply to all entities, both public and nonpublic, that have indefinite-lived intangible assets, other than goodwill, reported in their financial statements. The amendments are effective for annual and interim impairment tests performed for fiscal years beginning after September 15, 2012. Early adoption is permitted, including for annual and interim impairment tests performed as of a date before July 27, 2012, if a public entitys financial statements for the most recent annual or interim period have not yet been issued or, for nonpublic entities, have not yet been made available for issuance. The Company is currently evaluating the impact, if any, that the adoption of this amendment will have on its financial statements.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
As a smaller reporting issuer (as defined in Item 10(f)(1) of Regulation S-K), the Company is not required to report quantitative and qualitative disclosures about market risk specified in Item 305 of Regulation S-K.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures and Changes in Internal Control over Financial Reporting
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer (the Certifying Officers), evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) of the Securities Exchange Act of 1934, as amended (the Exchange Act)) as of the end of the period covered by this report. Based on that evaluation, the Certifying Officers concluded that our disclosure controls and procedures as of the end of the period covered by this report were effective in ensuring that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commissions rules and forms. We believe that a control system, no matter how well designed and operated, cannot provide absolute assurance that the objectives of the control system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected.
There was no change in our internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) that occurred during the period covered by this report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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PART II
OTHER INFORMATION
Item 1. Legal Proceedings
At present, the Company is not engaged in or the subject of any material pending legal proceedings.
Item 1A. Risk Factors
There were no material changes from the risk factors as previously disclosed on our Annual Report on Form 10-K filed with the Securities and Exchange Commission for the year ended December 31, 2011.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
None.
Item 6. Exhibits
The exhibits listed in the accompanying Exhibit Index are furnished as part of this report.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
CYTOMEDIX, INC. | ||
Date: August 14, 2012 | By: /s/ Martin P. Rosendale | |
Date: August 14, 2012 | By: /s/ Andrew S. Maslan |
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EXHIBIT INDEX
Number | Exhibit Table | |
2.1 | First Amended Plan of Reorganization with All Technical Amendments (Previously filed on June 28, 2002, as exhibit to Current Report on Form 8-K, File No. 000-28443, and incorporated by reference herein). | |
2.2 | Amended and Restated Official Exhibits to the First Amended Plan of Reorganization of Cytomedix, Inc. with All Technical Amendments (Previously filed on May 10, 2004, as exhibit to Form 10-QSB for the quarter ended March 31, 2004, File No. 000-28443, and incorporated by reference herein). | |
2.3 | Asset Purchase Agreement by and among Sorin Group USA, Inc. , Cytomedix Acquisition Company and Cytomedix, Inc, dated as of April 9, 2010 (Previously filed on April 12, 2010 as exhibit to the Current Report on Form 8-K, File no. 001-32518, and incorporated by reference herein). | |
2.4 | Exchange and Purchase Agreement by and among, Cytomedix, Inc. , Aldagen, Inc. , a Delaware corporation and Aldagen Holdings, LLC, a North Carolina limited liability company, dated February 8, 2012 (Previously filed on February 9, 2012, as exhibit to Current Report on Form 8-K, File No. 000-28443 and incorporated by reference herein). | |
3(i) | Restated Certificate of Incorporation of Cytomedix, Inc. (Previously filed on November 7, 2002, as exhibit to Form 10-QSB for quarter ended June 30, 2001, File No. 000-28443, and incorporated by reference herein). | |
3(i)(1) | Amendment to Restated Certificate of Incorporation of Cytomedix, Inc. (Previously filed on November 15, 2004, as exhibit to Form 10-QSB for quarter ended September 30, 2004, File No. 000-28443, and incorporated by reference herein). | |
3(i)(2) | Certificate of Amendment to the Certificate of Incorporation (Previously filed on July 1, 2010 as exhibit to the Current Report on Form 8-K, File no. 001-32518, and incorporated by reference herein). | |
3(i)(3) | Certificate of Amendment to the Certificate of Incorporation (previously filed on May 21, 2012 as exhibit to the Current Report on Form 8-K and is incorporated by reference herein). | |
3(ii) | Restated Bylaws of Cytomedix, Inc. (Previously filed on November 7, 2002, as exhibit to Form 10-QSB for quarter ended June 30, 2001, File No. 000-28443, and incorporated by reference herein). | |
4.1 | Form of Warrant (Previously filed on April 12, 2010 as exhibit to the Current Report on Form 8-K, File no. 001-32518, and incorporated by reference herein). | |
4.2 | Certificate of Designation, Relative Rights and Preferences of the 10% Series D Convertible Preferred Stock (Previously filed on April 12, 2010 as exhibit to the Current Report on Form 8-K, File no. 001-32518, and incorporated by reference herein). | |
4.3 | Form of Warrant (Previously filed on October 8, 2010 as exhibit to the Current Report on Form 8-K, File No. 001-32518, and incorporated by reference herein). | |
4.4 | Form of Warrant (Previously filed on May 16, 2011 as exhibit to the Quarterly Report on Form 10-Q, File No. 001-32518, and incorporated by reference herein). | |
4.5 | Certificate of Designation, Relative Rights and Preferences of the Series E Convertible Preferred Stock (Previously filed on February 9, 2012, as exhibit to Current Report on Form 8-K, File No. 000-28443 and incorporated by reference herein). | |
4.6 | Form Warrant (Previously filed on February 9, 2012, as exhibit to Current Report on Form 8-K, File No. 000-28443 and incorporated by reference herein). | |
10.1 | Form of Transition Agreement, dated as of April 9, 2010 (Previously filed on April 12, 2010 as exhibit to the Current Report on Form 8-K, File no. 001-32518, and incorporated by reference herein). |
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Number | Exhibit Table | |
10.2 | Form of Asset Transfer and Assumption Agreement, dated as of April 9, 2010 (Previously filed on April 12, 2010 as exhibit to the Current Report on Form 8-K, File no. 001-32518, and incorporated by reference herein). | |
10.3 | Form of Subscription Agreement (Previously filed on April 12, 2010 as exhibit to the Current Report on Form 8-K, File no. 001-32518, and incorporated by reference herein). | |
10.4 | Form of Registration Rights Agreement (Previously filed on April 12, 2010 as exhibit to the Current Report on Form 8-K, File no. 001-32518, and incorporated by reference herein). | |
10.5 | Form of Promissory Note (Previously filed on April 12, 2010 as exhibit to the Current Report on Form 8-K, File no. 001-32518, and incorporated by reference herein). | |
10.6 | Flex Space Office Lease by and between Cytomedix, Inc. and Saul Holdings Limited Partnership, dated as of May 19, 2010 (Previously filed on August 16, 2010, as exhibit to Form 10-Q for quarter ended June 30, 2010, File No. 001-32518, and incorporated by reference herein). | |
10.7 | Form of the Purchase Agreement (Previously filed on October 8, 2010 as exhibit to the Current Report on Form 8-K, File No. 001-32518, and incorporated by reference herein). | |
10.8 | Form of the Registration Rights Agreement (Previously filed on October 8, 2010 as exhibit to the Current Report on Form 8-K, File No. 001-32518, and incorporated by reference herein). | |
10.9 | Form of the Securities Purchase Agreement (Previously filed on October 8, 2010 as exhibit to the Current Report on Form 8-K, File No. 001-32518, and incorporated by reference herein). | |
10.10 | Form of the Lincoln Purchase Agreement (Previously filed on October 8, 2010 as exhibit to the Current Report on Form 8-K, File No. 001-32518, and incorporated by reference herein). | |
10.11 | Form of Settlement Agreement dated as of April 28, 2011 (Previously filed on May 16, 2011 as exhibit to the Quarterly Report on Form 10-Q, File No. 001-32518, and incorporated by reference herein). | |
10.12 | Form of Subscription Agreement (Previously filed on May 16, 2011 as exhibit to the Quarterly Report on Form 10-Q, File No. 001-32518, and incorporated by reference herein). | |
10.13 | Form of Promissory Note dated as of April 28, 2011 (Previously filed on May 16, 2011 as exhibit to the Quarterly Report on Form 10-Q, File No. 001-32518, and incorporated by reference herein). | |
10.14 | JMJ Promissory Note dated July 15, 2011 (Previously filed on August 15, 2011 as exhibit to the Quarterly Report on Form 10-Q, File No. 001-32518, and incorporated by reference herein). | |
10.15 | JMJ Letter Agreement and Additional Default Provisions dated August 15, 2011 (Previously filed on May 16, 2011 as exhibit to the Quarterly Report on Form 10-Q, File No. 001-32518, and incorporated by reference herein). | |
10.16 | JMJ Collateralized Note dated July 15, 2011 (Previously filed on August 15, 2011 as exhibit to the Quarterly Report on Form 10-Q, File No. 001-32518, and incorporated by reference herein). | |
10.17 | Form Lockup Letter (Previously filed on February 9, 2012, as exhibit to Current Report on Form 8-K, File No. 000-28443 and incorporated by reference herein). | |
10.18 | Form Voting Agreement (Previously filed on February 9, 2012, as exhibit to Current Report on Form 8-K, File No. 000-28443 and incorporated by reference herein). | |
10.19 | Form Subscription Agreement (Previously filed on February 9, 2012, as exhibit to Current Report on Form 8-K, File No. 000-28443 and incorporated by reference herein). | |
10.20 | Form Warrant Agreement (Previously filed on February 9, 2012, as exhibit to Current Report on Form 8-K, File No. 000-28443 and incorporated by reference herein). | |
10.21 | Lyle A. Hohnke Agreement (Previously filed on February 9, 2012, as exhibit to Current Report on Form 8-K, File No. 000-28443 and incorporated by reference herein)* | |
10.22 | Edward Field Employment Letter (Previously filed on February 9, 2012, as exhibit to Current Report on Form 8-K, File No. 000-28443 and incorporated by reference herein)* |
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Number | Exhibit Table | |
21 | List of Subsidiaries (Previously filed on March 29, 2012, as exhibit to Annual Report on Form 10-K, File No. 001-32518 and incorporated by reference herein). | |
31.1 | Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
31.2 | Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
32.1 | Certificate of Chief Executive Officer pursuant to 18 U. S. C. ss. 1350. | |
32.2 | Certificate of Chief Financial Officer pursuant to 18 U. S. C. ss. 1350. | |
101. INS | XBRL Instance Document | |
101. SCH | XBRL Taxonomy Extension Schema Document | |
101. CAL | XBRL Taxonomy Calculation Linkbase Document | |
101. LAB | XBRL Taxonomy Extension Label Linkbase Document | |
101. PRE | XBRL Taxonomy Extension Presentation Linkbase Document | |
101. DEF | XBRL Taxonomy Extension Definition Linkbase Document |
* | Management or compensatory arrangement or agreement. |
** | Pursuant to Rule 406T of Regulation S-T, these interactive data files are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933 or Section 18 of the Securities Exchange Act of 1934 and otherwise are not subject to liability. |
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