10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the Quarterly Period Ended September 30, 2010
OR
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o |
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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 0-52491
MIMEDX GROUP, INC.
(Exact name of registrant as specified in its charter)
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Florida
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26-2792552 |
(State or other jurisdiction of incorporation)
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(I.R.S. Employer Identification Number) |
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811 Livingston Court, Suite B |
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Marietta, GA
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30067 |
(Address of principal executive offices)
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(Zip Code) |
(678) 384-6720
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 þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Website, 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 þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See definitions of large
accelerated filer, accelerated filer, and smaller reporting company in Rule 12b-2 of the
Exchange Act. (Check one):
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Large accelerated filer o
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Accelerated filer o
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Non-accelerated filer o
(Do not check if a smaller reporting company)
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Smaller reporting company þ |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes o No þ
As of
November 15, 2010, there were 63,825,931 shares outstanding of the registrants common
stock.
MIMEDX GROUP, INC.
TABLE OF CONTENTS
2
MIMEDX GROUP, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE ENTERPRISE)
CONDENSED CONSOLIDATED BALANCE SHEETS
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September 30, |
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2010 |
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December 31, |
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(unaudited) |
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2009 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
428,493 |
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$ |
2,653,537 |
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Accounts receivable, net |
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259,476 |
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Inventory |
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117,821 |
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30,920 |
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Prepaid expenses and other current assets |
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123,669 |
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121,277 |
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Total current assets |
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929,459 |
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2,805,734 |
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Property and equipment,
net of accumulated depreciation of $1,286,038
and $948,445, respectively |
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861,189 |
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1,049,597 |
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Goodwill |
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857,597 |
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857,597 |
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Intangible assets, net of accumulated amortization of $1,965,623
and $1,464,674, respectively |
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4,096,377 |
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4,597,326 |
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Deferred financing costs |
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192,627 |
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Deposits and other long term assets |
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102,500 |
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189,202 |
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Total assets |
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$ |
6,847,122 |
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$ |
9,692,083 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable and accrued expenses |
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$ |
1,143,645 |
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$ |
629,349 |
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Total current liabilities |
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1,143,645 |
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629,349 |
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Long term convertible debt, face value $3,472,000, less unamortized
discount of $550,748 and including accrued interest of $69,604 (December) |
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2,990,856 |
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Total liabilities |
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1,143,645 |
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3,620,205 |
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Commitments and contingency (Notes 4 and 9) |
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Stockholders equity: |
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Preferred stock; $.001 par value; 5,000,000
shares authorized and 0 (September and December) shares
issued and outstanding |
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Common stock; $.001 par value; 100,000,000 shares authorized;
and 61,770,931 (September) and 50,002,887 (December) shares issued;
61,720,931 (September) and 49,952,887 (December) shares outstanding |
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61,771 |
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50,003 |
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Additional paid-in capital |
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54,767,409 |
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46,454,482 |
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Treasury stock (50,000 shares at cost) |
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(25,000 |
) |
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(25,000 |
) |
Deficit accumulated during the development stage |
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(49,100,703 |
) |
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(40,407,607 |
) |
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Total stockholders equity |
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5,703,477 |
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6,071,878 |
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Total liabilities and stockholders equity |
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$ |
6,847,122 |
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$ |
9,692,083 |
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See notes to condensed consolidated financial statements
3
MIMEDX GROUP, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE ENTERPRISE)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
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Period from |
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Inception |
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Three Months Ended |
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Nine Months Ended |
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(November 22, 2006) |
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September 30, |
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September 30, |
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through |
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2010 |
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2009 |
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2010 |
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2009 |
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September 30, 2010 |
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REVENUES: |
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Net Sales |
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$ |
108,027 |
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$ |
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$ |
544,956 |
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$ |
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$ |
545,757 |
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OPERATING COSTS AND EXPENSES: |
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Cost of products sold |
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539,697 |
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1,355,210 |
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1,355,450 |
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Research and development expenses |
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842,929 |
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949,281 |
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2,168,043 |
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2,200,168 |
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10,907,879 |
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Acquired in-process research and development |
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7,177,000 |
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Selling, General and Administrative expenses |
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1,579,259 |
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1,457,965 |
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5,121,933 |
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4,621,295 |
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25,765,940 |
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Gain on sale of assets |
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(275,428 |
) |
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LOSS FROM OPERATIONS |
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(2,853,858 |
) |
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(2,407,246 |
) |
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(8,100,230 |
) |
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(6,821,463 |
) |
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(44,385,084 |
) |
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OTHER INCOME (EXPENSE), net |
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Financing expense associated with issuance of common
stock for registration rights waivers |
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(1,305,100 |
) |
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|
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|
(1,305,100 |
) |
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|
(1,305,100 |
) |
Financing expense associated with warrants issued
in connection with convertible promissory note |
|
|
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(683,416 |
) |
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(683,416 |
) |
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(975,833 |
) |
Net interest (expense) income, net |
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(584 |
) |
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(90,814 |
) |
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(592,866 |
) |
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(146,124 |
) |
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(222,496 |
) |
Change in fair value of investment,
related party |
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(41,775 |
) |
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LOSS BEFORE INCOME TAXES |
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(2,854,442 |
) |
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(4,486,576 |
) |
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(8,693,096 |
) |
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(8,956,103 |
) |
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(46,930,288 |
) |
Income taxes |
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NET LOSS |
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|
(2,854,442 |
) |
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|
(4,486,576 |
) |
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|
(8,693,096 |
) |
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|
(8,956,103 |
) |
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|
(46,930,288 |
) |
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Accretion of redeemable common stock and
common stock with registration rights
to fair value |
|
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|
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(2,158,823 |
) |
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Loss attributable to common shareholders |
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$ |
(2,854,442 |
) |
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$ |
(4,486,576 |
) |
|
$ |
(8,693,096 |
) |
|
$ |
(8,956,103 |
) |
|
$ |
(49,089,111 |
) |
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Net loss per common share |
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Basic and diluted |
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$ |
(0.05 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.15 |
) |
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$ |
(0.23 |
) |
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Shares used in computing net loss per common share |
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Basic and diluted |
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61,049,942 |
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41,576,491 |
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|
57,874,093 |
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39,803,573 |
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See notes to condensed consolidated financial statements
4
MIMEDX GROUP, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE ENTERPRISE)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
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Period from |
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Inception |
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Nine Months Ended |
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(November 22, 2006) |
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September 30, |
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through |
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2010 |
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2009 |
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September 30, 2010 |
|
Cash flows from operating activities: |
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Net loss |
|
$ |
(8,693,096 |
) |
|
$ |
(8,956,104 |
) |
|
$ |
(46,930,288 |
) |
Adjustments to reconcile net loss to net cash flows from
operating activities, net of effects of acquisition: |
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Provision for bad debts |
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(28,745 |
) |
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|
(28,745 |
) |
Gain on settlement of payables |
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|
(566,219 |
) |
|
|
(584,969 |
) |
(Gain)/loss on sale of equipment |
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|
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|
5,440 |
|
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|
(275,428 |
) |
Acquired in-process research and development |
|
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|
|
|
|
|
|
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|
7,177,000 |
|
Depreciation |
|
|
337,594 |
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|
338,831 |
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|
1,292,671 |
|
Amortization of intangible assets |
|
|
500,949 |
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|
500,114 |
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|
1,988,823 |
|
Amortization of debt discount and deferred financing costs |
|
|
499,610 |
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|
136,194 |
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|
669,349 |
|
Employee share-based compensation expense |
|
|
731,216 |
|
|
|
687,138 |
|
|
|
2,702,927 |
|
Other share-based compensation expense |
|
|
105,062 |
|
|
|
474,045 |
|
|
|
863,154 |
|
Financing expense associated with issuance of common stock
for waivers of registration rights |
|
|
|
|
|
|
1,305,100 |
|
|
|
1,305,100 |
|
Financing expense associated with warrants issued in
connection with convertible promissory note |
|
|
|
|
|
|
683,416 |
|
|
|
975,833 |
|
Modifications of options and purchase of treasury stock |
|
|
|
|
|
|
48,000 |
|
|
|
48,000 |
|
Issuance of common stock for transaction fees |
|
|
|
|
|
|
|
|
|
|
1,126,379 |
|
Accrued interest on notes receivable, related party |
|
|
|
|
|
|
|
|
|
|
(48,894 |
) |
Change in fair value of investment, related party |
|
|
|
|
|
|
|
|
|
|
41,775 |
|
Increase (decrease) in cash resulting from changes in: |
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|
|
|
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|
|
|
Accounts receivable |
|
|
(230,731 |
) |
|
|
|
|
|
|
(230,731 |
) |
Inventory |
|
|
(86,901 |
) |
|
|
|
|
|
|
(117,821 |
) |
Prepaid expenses and other current assets |
|
|
(2,392 |
) |
|
|
(129,933 |
) |
|
|
(44,591 |
) |
Other assets |
|
|
86,702 |
|
|
|
|
|
|
|
86,702 |
|
Accounts payable and accrued expenses |
|
|
609,276 |
|
|
|
483,466 |
|
|
|
1,170,031 |
|
Deferred interest income |
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|
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|
|
|
(43,200 |
) |
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|
Net cash flows from operating activities |
|
|
(6,171,456 |
) |
|
|
(4,990,512 |
) |
|
|
(28,856,923 |
) |
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Cash flows from investing activities: |
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|
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|
|
|
|
|
|
Purchase of equipment |
|
|
(149,183 |
) |
|
|
(39,511 |
) |
|
|
(1,817,488 |
) |
Proceeds from sale of assets |
|
|
|
|
|
|
6,580 |
|
|
|
366,830 |
|
Cash paid in conjunction with sales of assets |
|
|
|
|
|
|
|
|
|
|
(86,332 |
) |
Cash paid for intangible asset |
|
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|
|
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|
|
|
|
|
(100,000 |
) |
Cash received in acquisition of SpineMedica Corp. |
|
|
|
|
|
|
|
|
|
|
1,957,405 |
|
Cash paid for acquisition costs of SpineMedica Corp. |
|
|
|
|
|
|
|
|
|
|
(227,901 |
) |
Advances to related party |
|
|
|
|
|
|
|
|
|
|
(2,008,522 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash flows from investing activities |
|
|
(149,183 |
) |
|
|
(32,931 |
) |
|
|
(1,916,008 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from convertible debt offering |
|
|
|
|
|
|
3,472,000 |
|
|
|
3,472,000 |
|
Proceeds from bridge loan |
|
|
|
|
|
|
295,000 |
|
|
|
|
|
Proceeds from convertible promissory note |
|
|
|
|
|
|
|
|
|
|
500,000 |
|
Repayment of convertible promissory note |
|
|
|
|
|
|
|
|
|
|
(500,000 |
) |
Proceeds from Series A preferred stock |
|
|
|
|
|
|
|
|
|
|
14,016,000 |
|
Proceeds from Series C preferred stock |
|
|
|
|
|
|
|
|
|
|
3,855,000 |
|
Proceeds from sale of common stock and
warrants and common stock with registration rights |
|
|
785,000 |
|
|
|
525,000 |
|
|
|
7,602,507 |
|
Proceeds from exercise of stock options |
|
|
102,626 |
|
|
|
|
|
|
|
104,794 |
|
Net proceeds from exercise of warrants |
|
|
3,207,969 |
|
|
|
|
|
|
|
3,207,969 |
|
Offering costs paid in connection with convertible debt offering |
|
|
|
|
|
|
(127,540 |
) |
|
|
(138,040 |
) |
Offering costs paid in connection with Series A preferred
stock offering |
|
|
|
|
|
|
|
|
|
|
(918,806 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash flows from financing activities |
|
|
4,095,595 |
|
|
|
4,164,460 |
|
|
|
31,201,424 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in cash |
|
|
(2,225,044 |
) |
|
|
(858,983 |
) |
|
|
428,493 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, beginning of period |
|
|
2,653,537 |
|
|
|
864,768 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, end of period |
|
$ |
428,493 |
|
|
$ |
5,785 |
|
|
$ |
428,493 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for interest |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for income taxes |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of non-cash financing activity:
|
|
During the three months ended March 31, 2010: |
|
* |
|
the Company converted its outstanding convertible debt and accrued interest to
equity by issuing 7,135,114 shares of common stock. |
|
|
During the three months ended March 31, 2009: |
|
* |
|
the Company issued 315,520 warrants to purchase common stock, valued at $98,574
and recognized a beneficial conversion feature of $676,500 in conjunction with our
convertible debt offering. |
|
|
* |
|
the Company issued common stock valued at $42,000 for prepaid expenses, $81,375
for accrued directors fees, and $93,822 for accrued executive compensation. |
|
|
* |
|
the Company reclassified $3,761,250 of common stock with registration rights to equity
as the result of the termination of such rights (Note 7). |
See notes to condensed consolidated financial statements
5
MIMEDX GROUP, INC. AND SUBSIDARIES
(A DEVELOPMENT STAGE ENTERPRISE)
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
PERIOD FROM INCEPTION (NOVEMBER 22, 2006) THROUGH SEPTEMBER 30, 2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit |
|
|
|
|
|
|
Convertible |
|
|
Convertible |
|
|
Convertible |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Preferred Stock |
|
|
Preferred Stock |
|
|
Preferred Stock |
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
|
Stock |
|
|
Note |
|
|
During the |
|
|
|
|
|
|
Series A |
|
|
Series B |
|
|
Series C |
|
|
Common Stock |
|
|
Paid-in |
|
|
Treasury |
|
|
Subscriptions |
|
|
Receivable, |
|
|
Development |
|
|
|
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Stock |
|
|
Receivable |
|
|
Related party |
|
|
Stage |
|
|
Total |
|
Balances, November 22, 2006 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Issuance of common stock at inception |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,880,000 |
|
|
|
12,880 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(11,592 |
) |
|
|
1,288 |
|
Employee share-based compensation
expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,409 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,409 |
|
Other share-based compensation expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17,980 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17,980 |
|
Common stock issued in connection
with purchase of license agreement |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,120,000 |
|
|
|
1,120 |
|
|
|
894,880 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
896,000 |
|
Issuance of note receivable, related
party |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,000,000 |
) |
|
|
|
|
|
|
(2,000,000 |
) |
Sale of Series A Preferred stock |
|
|
11,212,800 |
|
|
|
14,016,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(918,806 |
) |
|
|
|
|
|
|
(1,233,750 |
) |
|
|
|
|
|
|
|
|
|
|
11,863,444 |
|
Accrued interest income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(7,644 |
) |
|
|
|
|
|
|
(7,644 |
) |
Net loss for the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(650,777 |
) |
|
|
(650,777 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances, March 31, 2007 |
|
|
11,212,800 |
|
|
|
14,016,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,000,000 |
|
|
|
14,000 |
|
|
|
7,463 |
|
|
|
|
|
|
|
(1,233,750 |
) |
|
|
(2,007,644 |
) |
|
|
(662,369 |
) |
|
|
10,133,700 |
|
Employee share-based compensation
expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
649,783 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
649,783 |
|
Other share-based compensation
expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
158,247 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
158,247 |
|
Collection of stock subscription
receivable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,233,750 |
|
|
|
|
|
|
|
|
|
|
|
1,233,750 |
|
Accrued interest income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(41,250 |
) |
|
|
|
|
|
|
(41,250 |
) |
SpineMedica Corp. acquisition |
|
|
|
|
|
|
|
|
|
|
5,922,397 |
|
|
|
7,402,996 |
|
|
|
|
|
|
|
|
|
|
|
2,911,117 |
|
|
|
2,911 |
|
|
|
2,316,908 |
|
|
|
|
|
|
|
|
|
|
|
2,048,894 |
|
|
|
|
|
|
|
11,771,709 |
|
Sale of Series C Preferred stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,285,001 |
|
|
|
3,855,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,855,000 |
|
Stock options issued in connection
with purchase of intellectual property |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
116,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
116,000 |
|
Exercise of stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,200 |
|
|
|
1 |
|
|
|
2,159 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,160 |
|
Alynx Merger Recapitalization |
|
|
7,207,398 |
|
|
|
11,257,996 |
|
|
|
(5,922,397 |
) |
|
|
(7,402,996 |
) |
|
|
(1,285,001 |
) |
|
|
(3,855,000 |
) |
|
|
926,168 |
|
|
|
926 |
|
|
|
(926 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alynx Merger Transaction Costs (expensed) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
205,851 |
|
|
|
206 |
|
|
|
1,126,173 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,126,379 |
|
Conversion of Preferred stock |
|
|
(18,420,198 |
) |
|
|
(25,273,996 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,420,198 |
|
|
|
18,420 |
|
|
|
25,255,576 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock issued in connection
with purchase of license agreement |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
400,000 |
|
|
|
400 |
|
|
|
2,595,600 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,596,000 |
|
Net loss for the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(17,371,475 |
) |
|
|
(17,371,475 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances, March 31, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
36,864,534 |
|
|
|
36,864 |
|
|
|
32,226,983 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(18,033,844 |
) |
|
|
14,230,003 |
|
Employee share-based compensation
expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
945,062 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
945,062 |
|
Other share-based compensation
expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
130,076 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
130,076 |
|
Cashless exercise of stock warrants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
417,594 |
|
|
|
418 |
|
|
|
(418 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sale of warrants in connection with private
placement of redeemable commoon stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
595,073 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
595,073 |
|
Exercise of stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
57,500 |
|
|
|
58 |
|
|
|
(52 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6 |
|
Accretion of redeemable common stock and
common stock with registration rights to
fair value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,158,823 |
) |
|
|
(2,158,823 |
) |
Warrants issued in connection with the amendment
of private placement of common stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
334,100 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
334,100 |
|
Net loss for the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(11,919,271 |
) |
|
|
(11,919,271 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances, March 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
37,339,628 |
|
|
|
37,340 |
|
|
|
34,230,824 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(32,111,938 |
) |
|
|
2,156,226 |
|
Employee share-based compensation
expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
363,457 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
363,457 |
|
Other share-based compensation
expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
117,689 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
117,689 |
|
Beneficial conversion feature recognized
on convertible debt |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
676,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
676,500 |
|
Warrants issued to placement agents in
conjunction with convertible debt |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
98,574 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
98,574 |
|
Exercise of stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,000 |
|
|
|
20 |
|
|
|
(18 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2 |
|
Common stock issued for waivers
of registration rights |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,490,000 |
|
|
|
2,490 |
|
|
|
1,302,610 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,305,100 |
|
Reclassification of common stock with
registration rights |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,905,000 |
|
|
|
1,905 |
|
|
|
3,759,345 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,761,250 |
|
Common stock issued for accrued directors
fees |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
162,750 |
|
|
|
163 |
|
|
|
81,212 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
81,375 |
|
Common stock issued for accrued executive
compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
187,644 |
|
|
|
187 |
|
|
|
93,635 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
93,822 |
|
Common Stock issued in connection with
purchase of license agreement |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
|
|
100 |
|
|
|
70,900 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
71,000 |
|
Sale of common stock and warrants
(net of $42,000 of offering costs) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,697,865 |
|
|
|
7,698 |
|
|
|
4,569,021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,576,719 |
|
Common stock issued for services in
conjunction with private placement |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100,000 |
|
|
|
100 |
|
|
|
41,900 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
42,000 |
|
Warrants issued in conjunction with
convertible promissory note |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
975,833 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
975,833 |
|
Modification of stock options and
purchase of treasury stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
73,000 |
|
|
|
(25,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
48,000 |
|
Net loss for the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(8,295,669 |
) |
|
|
(8,295,669 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances, December 31, 2009 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
50,002,887 |
|
|
$ |
50,003 |
|
|
$ |
46,454,482 |
|
|
$ |
(25,000 |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
(40,407,607 |
) |
|
$ |
6,071,878 |
|
Employee share-based compensation
expense (unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
731,216 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
731,216 |
|
Other share-based compensation
expense (unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
105,062 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
105,062 |
|
Sale of common stock and
warrants (unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,308,332 |
|
|
|
1,308 |
|
|
|
783,692 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
785,000 |
|
Exercise of stock options (unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
105,250 |
|
|
|
106 |
|
|
|
102,520 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
102,626 |
|
Exercise of warrants (unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,219,348 |
|
|
|
3,219 |
|
|
|
3,204,750 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,207,970 |
|
Shares issued in conjunction with conversion
of convertible debt (unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,135,114 |
|
|
|
7,135 |
|
|
|
3,385,687 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,392,822 |
|
Net loss for the peiod (unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(8,693,096 |
) |
|
|
(8,693,096 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances, September 30, 2010 (unaudited) |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
61,770,931 |
|
|
$ |
61,771 |
|
|
$ |
54,767,409 |
|
|
$ |
(25,000 |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
(49,100,703 |
) |
|
$ |
5,703,477 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See notes to condensed consolidated financial statements
6
MIMEDX GROUP, INC.
(A DEVELOPMENT STAGE ENTERPRISE)
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE THREE AND NINE MONTH PERIODS ENDED SEPTEMBER 30, 2010 AND 2009 AND THE PERIOD FROM
INCEPTION (NOVEMBER 22, 2006) THROUGH SEPTEMBER 30, 2010
1. |
|
Basis of Presentation: |
The accompanying unaudited condensed consolidated financial statements have been prepared in
accordance with accounting principles generally accepted in the United States of America
(GAAP) for interim financial information and with the instructions to Form 10-Q and Article
10 of Regulations S-X. Accordingly, they do not include all of the information and footnotes
required by GAAP for complete financial statements. In the opinion of management, all
adjustments (consisting of normal recurring accruals) considered necessary for a fair
presentation of the results of operations for the periods presented have been included.
Operating results for the three and nine months ended September 30, 2010 and 2009, are not
necessarily indicative of the results that may be expected for the fiscal year. The balance
sheet at December 31, 2009, has been derived from the audited consolidated financial
statements at that date, but does not include all of the information and footnotes required by
GAAP for complete financial statements.
You should read these condensed consolidated financial statements together with the historical
consolidated financial statements of the Company for the period ended December 31, 2009, and
year ended March 31, 2009, and the period from inception (November 22, 2006) through December
31, 2009, included in our Annual Report on Form 10-K for the period ended December 31, 2009,
filed with the Securities and Exchange Commission (SEC) on March 30, 2010.
On March 31, 2008, MiMedx Group, Inc., a Florida Corporation, and Alynx merged. As a result
of this transaction, MiMedx Group, Inc. became the surviving corporation. The Company
refers to MiMedx Group, Inc., a development stage company, as well as its two operating
subsidiaries: MiMedx, Inc. and SpineMedica, LLC (SpineMedica).
MiMedx acquired a license for the use, adoption and development of certain core technologies
developed at the Shriners Hospital for Children and the University of South Florida Research
Foundation. This technology focuses on biomaterials for soft tissue repair, such as tendons,
ligaments and cartilage, as well as other biomaterial-based products for numerous other
medical applications.
On July 23, 2007, MiMedx, Inc. acquired SpineMedica Corp. through its wholly-owned subsidiary,
SpineMedica, LLC. SpineMedica Corp. was incorporated in the State of Florida on June 9, 2005,
and its successor, SpineMedica, LLC, was incorporated in the State of Florida on June 27,
2007. SpineMedica has licensed the right to use Salubria®, or similar poly-vinyl alcohol
(PVA) -based biomaterials, for certain applications within the body.
The Company operates in one business segment, Biomaterials, which includes the design,
manufacture, and marketing of products for the Orthopedics and Spine market categories using
the Companys two proprietary biomaterialsCollaFix and HydroFix.
The Company is a development stage enterprise and will remain as such until significant
revenues are generated, if ever.
7
2. |
|
Significant accounting policies: |
Please see the Companys 10-K filing for the fiscal year ended December 31, 2009 for a
description of all significant accounting policies.
Revenue Recognition
Sales Revenue
The Company recognizes revenue in accordance with Financial Accounting Standards Board (FASB)
Accounting Standards Codification (ASC) Subtopic 605-10-S99, Revenue Recognition.
Sales revenue is generally recognized when the products are shipped. Advance payments received
for products are recorded as deferred revenue and are generally recognized when the product is
shipped. The Company reduces sales revenue for estimated customer returns and other
allowances. The Company recorded $5,096 and $0 for net sales returns provisions, respectively,
for the three months ended September 30, 2010 and 2009. For the nine months ended September
30, 2010 and 2009, there were net sales returns provisions of $29,545 and $0, respectively.
Net loss per share
Basic net loss per common share is computed using the weighted-average number of common shares
outstanding during the period. Diluted net loss per common share is typically computed using
the weighted-average number of common and dilutive common equivalent shares from stock
options, warrants and convertible debt using the treasury stock method.
For all periods presented, diluted net loss per share is the same as basic net loss per share,
as the inclusion of equivalent shares from outstanding common stock options, warrants and
convertible debt would be anti-dilutive.
The following table sets forth the computation of basic and diluted net loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months ended September 30, |
|
|
Nine Months ended September 30, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
Net loss |
|
$ |
(2,854,442 |
) |
|
$ |
(4,486,576 |
) |
|
$ |
(8,693,096 |
) |
|
$ |
(8,956,103 |
) |
Denominator for basic earnings per share weighted average shares |
|
|
61,049,942 |
|
|
|
41,576,491 |
|
|
|
57,874,093 |
|
|
|
39,803,573 |
|
Effect of dilutive securities: Stock
options and warrants outstanding
(a) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator for diluted earnings per
share weighted average shares adjusted
for dilutive securities |
|
|
61,049,942 |
|
|
|
41,576,491 |
|
|
|
57,874,093 |
|
|
|
39,803,573 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per common share basic and diluted |
|
$ |
(0.05 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.15 |
) |
|
$ |
(0.23 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
Securities outstanding that were excluded from the computation, prior to the use of the
treasury stock method, because they would have been anti-dilutive are as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months ended September 30, |
|
|
Nine Months ended September 30, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
Outstanding Stock Options |
|
|
8,255,650 |
|
|
|
6,000,000 |
|
|
|
8,255,650 |
|
|
|
6,000,000 |
|
Outstanding Warrants |
|
|
4,426,185 |
|
|
|
2,459,104 |
|
|
|
4,426,185 |
|
|
|
2,459,104 |
|
Hybrid Debt Instrument |
|
|
|
|
|
|
491,667 |
|
|
|
|
|
|
|
491,667 |
|
Convertible Debt |
|
|
|
|
|
|
6,944,000 |
|
|
|
|
|
|
|
6,944,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,681,835 |
|
|
|
15,894,771 |
|
|
|
12,681,835 |
|
|
|
15,894,771 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8
Goodwill
The Company accounts for goodwill under the provisions of FASB ASC Topic 350, Intangibles -
Goodwill and Other (ASC 350). Goodwill is not amortized, but is subject to impairment tests
on an annual basis or at an interim date if certain events or circumstances indicate that the
asset might be impaired. The most recent annual test as of December 31, 2009, indicated
that goodwill was not impaired. There were no indicators of impairment as of September 30,
2010.
Recently issued accounting pronouncements:
In February 2010, the FASB issued authoritative guidance that amends the disclosure
requirements related to subsequent events. This guidance includes the definition of a
Securities and Exchange Commission filer, removes the definition of a public entity, redefines
the reissuance disclosure requirements and allows companies to omit the disclosure of the date
through which subsequent events have been evaluated. This guidance is effective for financial
statements issued for interim and annual periods ending after February 2010. This guidance did
not materially impact the Companys results of operations or financial position, but did
require changes to the Companys disclosures in its financial statements.
In October 2009, the FASB issued Accounting Standards Update No. 2009-13 (ASU 2009-13),
which addresses the accounting for multiple-deliverable arrangements to enable vendors to
account for products or services (deliverables) separately rather than as a combined unit. ASU
2009-13 is effective prospectively for revenue arrangements entered into or materially
modified beginning in fiscal years on or after June 15, 2010. Early adoption is permitted. The
Company does not expect the adoption of this standard to have any effect on its financial
statements until or unless it enters into agreements covered by this standard.
3. |
|
Liquidity and managements plans: |
The accompanying financial statements have been prepared assuming the Company will continue as
a going concern. For the period from inception (November 22, 2006) through September 30,
2010, the Company experienced net losses of $49,089,000 (unaudited) and cash used in
operations was $28,857,000 (unaudited). As of September 30, 2010, the Company had $428,000
of cash in the bank and has not emerged from the development stage. In October 2010, the
Company borrowed $150,000 from its Chairman and Chief Executive Officer and $50,000 each from
two other company directors under a 5% Convertible Promissory Note (see Note 10). In
November, the Company borrowed an additional $150,000 from its Chairman and Chief Executive
Officer under the same 5% Convertible Promissory Note (see Note 10). Also in November, the
Company received $244,000 from the US Federal Government for qualified investments under the
US Federal Government therapeutic discovery project grant program. Additionally, the Company
commenced a private placement to sell common stock and warrants to accredited investors.
Through November 15, 2010, the Company has received aggregate proceeds of $2,000,000 under
this arrangement, and assuming it receives no additional funds, and the holders of the 5%
Convertible Promissory Notes exercise the conversion option, estimates that it has sufficient
funds to operate through December 2010. In order to fund ongoing operations beyond that
point, or to further accelerate and execute our business plan, we need to raise significant
additional funds. Therefore, the Company intends to extend the
current private placement. In view of these matters, the Companys ability to continue as a going
concern is dependent on our ability to secure additional financing sufficient to support our
research and development activities and regulatory clearance or approval processes, as well as
our investments in working capital and necessary capital expenditures. Since inception, the
Company has financed its activities principally from the sale of equity securities and
convertible debt. While the Company has been successful in the past in obtaining the necessary
capital to support its operations, there is no assurance that the Company will be able to
obtain government grants or additional equity capital or other financing under commercially
reasonable terms and conditions, or at all. Furthermore, if the Company issues equity or debt
securities to raise additional funds, existing shareholders may experience dilution and the
new equity or debt securities it issues may have rights, preferences and privileges senior to
those of existing shareholders. In addition, if the
Company raises additional funds through collaboration, licensing or other similar
arrangements, it may be necessary to relinquish valuable rights to products or proprietary
technologies, or grant licenses on terms that are not favorable. If the Company does not
achieve its revenue projections, secure government funding or cannot raise funds on acceptable
terms, the Company will not be able to continue as a going concern, develop or enhance
products, obtain the required regulatory clearances or approvals, execute the Companys
business plan, take advantage of future opportunities, or respond to competitive pressure or
unanticipated customer requirements. Any of these events would adversely affect the Companys
ability to achieve the Companys development and commercialization goals, which could have a
material adverse effect on the Companys business, results of operations and financial
condition. The Companys financial statements do not include any adjustments relating to the
recoverability or classification of assets or the amounts of liabilities that might result
from the outcome of these uncertainties.
9
4. |
|
Intangible assets and royalty agreement: |
Intangible assets activity is summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
September 30, 2010 |
|
|
December 31, 2009 |
|
|
|
Average |
|
|
Gross |
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Amortization |
|
|
Carrying |
|
|
Accumulated |
|
|
Carrying |
|
|
Accumulated |
|
|
|
Lives |
|
|
Value |
|
|
Amortization |
|
|
Value |
|
|
Amortization |
|
License-Shriners Hsp for Children & USF Research (a) |
|
10 years |
|
$ |
996,000 |
|
|
|
(363,533 |
) |
|
$ |
996,000 |
|
|
$ |
(288,833 |
) |
License SaluMedica LLC Spine Repair (b) |
|
10 years |
|
|
2,399,000 |
|
|
|
(943,553 |
) |
|
|
2,399,000 |
|
|
|
(721,541 |
) |
License Polyvinyl Alcohol Cryogel (c) |
|
10 years |
|
|
2,667,000 |
|
|
|
(658,537 |
) |
|
|
2,667,000 |
|
|
|
(454,300 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets |
|
|
|
|
|
$ |
6,062,000 |
|
|
$ |
(1,965,623 |
) |
|
$ |
6,062,000 |
|
|
$ |
(1,464,674 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
On January 29, 2007, the Company acquired a license from Shriners Hospitals for
Children and University of South Florida Research Foundation, Inc. The acquisition price
of this license was a one-time fee of $100,000 and 1,120,000 shares of common stock valued
at $896,000 (based upon the estimated fair value of the common stock on the transaction
date). Within 30 days after the receipt by the Company of approval by the FDA allowing the
sale of the first licensed product, the Company is required to pay an additional $200,000
to the licensor. Due to its contingent nature, this amount is not recorded as a liability.
The Company will also be required to pay a royalty of 3% on all commercial sales revenues
from the licensed products. |
|
(b) |
|
License from SaluMedica, LLC (SaluMedica) for the use of certain developed technologies
related to spine repair. This license was acquired through the acquisition of SpineMedica
Corp. |
|
(c) |
|
On March 31, 2008, the Company entered into a license agreement for the use of certain
developed technologies related to surgical sheets made of polyvinyl alcohol cryogel. The
acquisition price of the asset was 400,000 shares of common stock valued at $2,596,000
(based upon the closing price of the common stock on the transaction date). On December
31, 2009, the Company completed the sale of its first commercial product and issued an
additional 100,000 shares of common stock to the licensor valued at $71,000. The agreement
also provides for the issuance of an additional 500,000 shares of common stock upon the
Companys meeting additional milestones related to future sales. Due to its contingent
nature, there are no amounts accrued for this obligation. |
Expected future amortization of intangible assets is as follows:
|
|
|
|
|
12-month period ended December 31, |
|
|
|
|
2010 |
|
$ |
667,932 |
|
2011 |
|
|
667,932 |
|
2012 |
|
|
667,932 |
|
2013 |
|
|
667,932 |
|
2014 |
|
|
667,932 |
|
2015 |
|
|
540,027 |
|
Thereafter |
|
|
717,639 |
|
|
|
|
|
|
|
$ |
4,597,326 |
|
|
|
|
|
10
In April 2009, the Company commenced a private placement to sell 3% Convertible Senior Secured
Promissory Notes (the Notes) to accredited investors. The Company completed the offering on
June 17, 2009, and received aggregate proceeds of $3,472,000; also representing the face value
of the Notes. The aggregate proceeds include $250,000 of Notes sold to the Chairman of the
Board and CEO, and $150,000 of Notes sold to one other director.
In total, the Notes were convertible into up to 6,944,000 shares of common stock at $.50 per
share (a) at any time upon the election of the holder of the note; (b) automatically
immediately prior to the closing of the sale of all or substantially all of the assets or more
than 50% of the equity securities of the Company by way of a merger transaction or otherwise
which would yield a price per share of not less than $.50; or (c) at the election of the
Company, at such time as the closing price per share of the Companys common stock (as
reported by the OTCBB or on any national securities exchange on which the Companys shares may
be listed, as the case may be) closes at not less than $1.50 for not less than 20 consecutive
trading days in any period prior to the maturity date. If converted, the Common Stock will be
available to be sold following satisfaction of the applicable conditions set forth in Rule
144. The Notes mature in three years and earn interest at 3% per annum on the outstanding
principal amount payable in cash on the maturity date or convertible into shares of common
stock of the Company as provided for above. The Notes were secured by a first priority lien on
all of the assets, including intellectual property, of MiMedx, Inc. The Notes were junior in
payment and lien priority to any bank debt of the Company in an amount not to exceed
$5,000,000 hereafter incurred by the Company.
We evaluated the Notes for accounting purposes in accordance with Financial Accounting
Standards Board (FASB) Accounting Standards Codification (ASC) 815 Derivatives and Hedging and
have determined that the conversion feature meets the conventional-convertible exemption and,
accordingly, bifurcation and fair-value measurement of the conversion feature was not
required. We were required to re-evaluate this conclusion upon each financial statement
closing date while the Notes were outstanding. The Notes were issued with a beneficial
conversion feature, having an intrinsic value of approximately $676,500. The intrinsic value
of the beneficial conversion feature was determined in accordance with ASC 470 Debt with
Conversion and Other Options by comparing the contracted conversion price to the fair value of
the common stock on the date of the respective Notes. A beneficial conversion feature only
exists when the embedded conversion feature is in-the-money at the commitment date.
As a result of the beneficial conversion feature, the Notes were recorded net of a discount of
$676,500 related to the beneficial conversion feature, which was recorded in paid-in capital,
and the discount has been amortized through periodic charges to interest expense over the term
of the Notes using the effective interest method.
In conjunction with the offering the Company was obligated to pay a placement fee of $138,040
of which $127,540 was paid prior to June 30, 2009. In addition, the Company issued warrants
to the placement agents totaling 315,520 at an exercise price of $.50 per share. The fair
value of the warrants was determined to be $98,574 using the Black-Scholes-Merton valuation
technique. The total direct costs of $236,614 were recorded as deferred financing costs and
were being amortized over the term of the Notes using the effective interest method. Further,
the placement agent warrants are classified in stockholders equity because they achieved all
of the requisite conditions for equity classification in accordance with ASC 815 Derivatives
and Hedging.
On March 31, 2010, the Company elected to exercise its right to convert into common stock of the
Company at a conversion price of $0.50 per share the outstanding Note Payable amount including
accrued interest of $3,532,361, resulting in the issuance of 7,064,721 shares of common stock. This
decision was made based upon the Trading Value Conversion event per the terms of the Note whereby
as of March 30, 2010, the trading price of the Common Stock closed at not less than $1.50 per share
for not less than 20 consecutive trading days prior to the Maturity Date. Prior to this event,
certain individuals had voluntarily elected to convert their Notes into Common Stock resulting in
the issuance of 70,393 shares of common stock. As a result of the Companys election to convert
the remaining Notes, the Company was required immediately to recognize the remaining unamortized
discount of $499,610 related to the beneficial conversion feature as interest expense in the
statement of operations for the three months ended March 31, 2010. Additionally, the $174,739 in
unamortized deferred financing costs were charged against additional paid in capital.
11
October 2009 Private Placement
In October 2009, the Company commenced a private placement to sell common stock and warrants.
From October 30, 2009, through December 31, 2009, the Company sold 7,697,865 shares of common
stock at a price of $.60 per share and received proceeds of $4,618,720. Under the terms of
the offering, for every two shares of common stock purchased, the investor received a 5-year
warrant to purchase one share of common stock for $1.50 (a Warrant). Through December 31,
2009, the Company issued a total of 3,848,933 warrants. From January 1, 2010, through January
21, 2010, the Company sold an additional 1,308,332 shares of common stock and issued an
additional 654,163 warrants and received proceeds of $785,000. The warrants met all the
requirements for equity classification under GAAP and are recorded in stockholders equity.
The Company closed the offering on January 21, 2010.
In connection with the October 2009 Private Placement, the Company entered into a registration
rights agreement that provides Piggy-Back registration rights to each investor.
7. |
|
Stock Options and Warrants |
Stock Options:
Activity with respect to the stock options is summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
Remaining |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Contractual |
|
|
Aggregate |
|
|
|
Number of |
|
|
Exercise |
|
|
Term |
|
|
Intrinsic |
|
|
|
Shares |
|
|
Price |
|
|
(in years) |
|
|
Value |
|
Outstanding at January 1, 2010 |
|
|
6,182,500 |
|
|
$ |
1.10 |
|
|
|
|
|
|
$ |
307,535 |
|
Granted |
|
|
2,265,400 |
|
|
$ |
1.42 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(105,250 |
) |
|
$ |
0.98 |
|
|
|
|
|
|
|
|
|
Forfeited or cancelled |
|
|
(87,000 |
) |
|
$ |
0.80 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2010 |
|
|
8,255,650 |
|
|
$ |
1.19 |
|
|
|
6.5 |
|
|
$ |
1,245,538 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested or expected to vest at September 30, 2010 |
|
|
5,472,717 |
|
|
$ |
1.27 |
|
|
|
5.2 |
|
|
$ |
805,736 |
|
There were no options exercised during the three months ended September 30, 2010.
Following is a summary of stock options outstanding and exercisable at September 30, 2010:
12
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
|
Options Exercisable |
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contractual |
|
|
Weighted- |
|
|
|
|
|
|
Weighted- |
|
|
|
Number |
|
|
Term |
|
|
Average |
|
|
Number |
|
|
Average |
|
Range of Exercise Prices |
|
outstanding |
|
|
(in years) |
|
|
Exercise Price |
|
|
Exercisable |
|
|
Exercise Price |
|
$0.0001 $0.50 |
|
|
1,011,500 |
|
|
|
4.0 |
|
|
$ |
0.49 |
|
|
|
569,013 |
|
|
$ |
0.48 |
|
$0.65 $1.00 |
|
|
3,442,500 |
|
|
|
6.6 |
|
|
$ |
0.80 |
|
|
|
2,699,693 |
|
|
$ |
0.82 |
|
$1.04 $1.80 |
|
|
3,051,650 |
|
|
|
8.3 |
|
|
$ |
1.57 |
|
|
|
1,264,216 |
|
|
$ |
1.73 |
|
$2.40 |
|
|
750,000 |
|
|
|
2.0 |
|
|
$ |
2.40 |
|
|
|
939,795 |
|
|
$ |
2.40 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,255,650 |
|
|
|
6.5 |
|
|
$ |
1.19 |
|
|
|
5,472,717 |
|
|
$ |
1.27 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A summary of the status of the Companys unvested stock options follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
Average |
|
|
|
Number of |
|
|
Grant Date Fair |
|
Unvested Stock Options |
|
Shares |
|
|
Value |
|
Unvested at January 1, 2010 |
|
|
2,520,418 |
|
|
$ |
0.50 |
|
Granted |
|
|
2,265,400 |
|
|
$ |
1.12 |
|
Cancelled/expired |
|
|
(87,000 |
) |
|
$ |
0.41 |
|
Vested |
|
|
(1,915,885 |
) |
|
$ |
0.54 |
|
|
|
|
|
|
|
|
Unvested at September 30, 2010 |
|
|
2,782,933 |
|
|
$ |
0.91 |
|
|
|
|
|
|
|
|
Total unrecognized compensation expense related to granted stock options at September 30,
2010, was approximately $2,716,868 and will be charged to expense through July 2015.
The fair value of options granted by the Company is estimated on the date of grant using the
Black-Scholes-Merton option-pricing model that uses assumptions for expected volatility,
expected dividends, expected term, and the risk-free interest rate. Expected volatilities are
based on historical volatility of peer companies and other factors estimated over the expected
term of the options. The term of employee options granted is derived using the simplified
method which computes expected term as the average of the sum of the vesting term plus the
contract term. The term for non-employee options is generally based upon the contractual term
of the option. The risk-free rate is based on the U.S. Treasury yield curve in effect at the
time of grant for the period of the expected term or contractual term as described.
The assumptions used in calculating the fair value of options using the Black-Scholes-Merton
option-pricing model are set forth in the following table:
|
|
|
|
|
|
|
|
|
|
|
Nine Months ended |
|
|
|
September 30, 2010 |
|
|
September 30, 2009 |
|
Expected volatility |
|
|
59.0 60.2 |
% |
|
|
112.06 140.74 |
% |
Expected life (in years) |
|
|
6 |
|
|
|
3.5 to 6 |
|
Expected dividend yield |
|
|
0.00 |
% |
|
|
0.00 |
% |
Risk-free interest rate |
|
|
1.59% 2.75 |
% |
|
|
1.54% 2.53 |
% |
The weighted-average grant date fair value for options granted during the nine months
ended September 30, 2010 and 2009 was approximately $1.12 and $0.49, respectively.
13
Warrants:
A summary of our common stock warrant activity for the nine months ended September 30, 2010, is as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
Average |
|
|
|
Number of |
|
|
Exercise Price per |
|
|
|
Warrants |
|
|
Warrant |
|
Warrants outstanding at January 1, 2010 |
|
|
6,991,371 |
|
|
$ |
1.14 |
|
Issued in connection with private placement of common stock |
|
|
654,163 |
|
|
$ |
1.50 |
|
Exercised in connection with private placement of common stock |
|
|
(3,219,348 |
) |
|
$ |
1.00 |
|
|
|
|
|
|
|
|
Warrants outstanding at September 30, 2010 |
|
|
4,426,186 |
|
|
$ |
0.94 |
|
|
|
|
|
|
|
|
In April 2010, the Company offered investors in the October 2009 Private Placement a discount
to their existing $1.50 warrant exercise price to $1.00 if they exercised their warrants to
purchase common stock for cash by May 1, 2010. As a result of this offer, the Company
received proceeds of approximately $3,200,000, net of placement agent fees, and issued
3,200,000 shares of common stock as of May 1, 2010. The aggregate proceeds include $833,000
in common stock issued to the Chairman and CEO, $20,850 to the President and Chief Operating
Officer and $20,833 to one other company director. As a result of this activity, the number
of warrants outstanding as of September 30, 2010 was 4,426,186. The Company grants common
stock warrants, in connection with equity share purchases by investors as an additional
incentive for providing long term equity capital to the Company, to placement agents in
connection with direct equity share and convertible debt purchases by investors and as
additional compensation to consultants and advisors.
Warrants may be exercised in whole or in part by:
|
|
|
notice given by the holder accompanied by payment of an amount equal to the warrant
exercise price multiplied by the number of warrant shares being purchased; or |
|
|
|
election by the holder to exchange the warrant (or portion thereof) for that number of
shares equal to the product of (a) the number of shares issuable upon exercise of the
warrant (or portion) and (b) a fraction, (x) the numerator of which is the market price
of the shares at the time of exercise minus the warrant exercise price per share at the
time of exercise and (y) the denominator of which is the market price per share at the
time of exercise. |
These warrants are not mandatorily redeemable, do not obligate the Company to repurchase its
equity shares by transferring assets or issue a variable number of shares.
The warrants require that the Company deliver shares as part of a physical settlement or a
net-share settlement, at the option of the holder, and do not provide for a net-cash
settlement.
All of our warrants are classified as equity.
The Company has incurred net losses since its inception and, therefore, no current income tax
liabilities have been incurred for the periods presented. Due to the Companys losses,
management has established a valuation allowance equal to the amount of net deferred tax
assets since management cannot determine that realization of these benefits is more likely
than not.
14
9. |
|
Contractual Commitments: |
The table below sets forth our known contractual obligations as of September 30, 2010:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period |
|
|
|
|
|
|
|
Less than 1 |
|
|
1 - 3 |
|
|
3 - 5 |
|
|
More than 5 |
|
|
|
Total |
|
|
Year |
|
|
Years |
|
|
Years |
|
|
Years |
|
Operating leases |
|
$ |
329,576 |
|
|
$ |
244,402 |
|
|
$ |
85,173 |
|
|
$ |
|
|
|
$ |
|
|
Minimum Royalties |
|
|
155,000 |
|
|
|
25,000 |
|
|
|
80,000 |
|
|
|
50,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual obligations |
|
$ |
484,576 |
|
|
$ |
269,402 |
|
|
$ |
165,173 |
|
|
$ |
50,000 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hybrid Debt Instrument
In October 2010, the Company and its Chairman of the Board and CEO as well as two other
company directors entered into a Subscription Agreement for a 5% Convertible Promissory Note
(Subscription Agreement) and, in connection therewith, issued a 5% Convertible Promissory
Note (Note) and a Warrant to Purchase Common Stock (Warrant), which expires in three
years.
Under the terms of the Subscription Agreement, the Chairman & CEO has agreed to advance the
Company $400,000, and the two company directors have agreed to advance $50,000 each to fund
its working capital needs. Such indebtedness is evidenced by the Note, which bears interest at
the rate of 5% per annum, is due and payable in full on December 31, 2010, and, at the option
of the holder, is convertible into the number of shares of common stock of the Company on the
same terms as the Company sells any Common Stock and Warrants between the date of issuance and
payment in full of the Note, provided that, once converted, the terms of such conversion are
final.
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations.
Forward-Looking Statements
This Form 10-Q and certain information incorporated herein by reference contain
forward-looking statements and information within the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, and Section
21E of the Securities Exchange Act of 1934. This information includes assumptions made by, and
information currently available to management, including statements regarding future economic
performance and financial condition, liquidity and capital resources, acceptance of the Companys
products by the market, and managements plans and objectives. In addition, certain
statements included in this and our future filings with the Securities and Exchange Commission
(SEC), in press releases, and in oral and written statements made by us or with our approval,
which are not statements of historical fact, are forward-looking statements. Words such as may,
could, should, would, believe, expect, anticipate, estimate, intend, seeks,
plan, project, continue, predict, will, should, and other words or expressions of
similar meaning are intended by us to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. These forward-looking statements are
found at various places throughout this report and in the documents incorporated herein by
reference. These statements are based on our current expectations about future events or results
and information that is currently available to us, involve assumptions, risks, and uncertainties,
and speak only as of the date on which such statements are made.
All forward-looking statements are subject to the risks and uncertainties inherent in
predicting the future. Our actual results may differ materially from those projected, stated or
implied in these forward-looking statements as a result of many factors, including our critical
accounting policies and risks and uncertainties related to, but not limited to, overall industry
environment, delay in the introduction of products, regulatory delays, negative clinical results,
and our financial condition. These and other risks and uncertainties are described in more detail
in our most recent Annual Report on Form 10-K, as well as other reports that we file with the SEC.
15
Forward-looking statements speak only as of the date they are made and should not be relied
upon as representing our views as of any subsequent date. We undertake no obligation to update or
revise such statements to reflect new circumstances or unanticipated events as they occur, except
as required by applicable laws, and you are urged to review and consider disclosures that we make
in this and other reports that we file with the SEC that discuss factors germane to our business.
Overview
We are a development stage enterprise based in Marietta, Georgia. The Company has generated
only modest revenues to date and has a history of losses since its inception in November 2006.
MiMedx Group, Inc. (MiMedx Group) is an integrated developer, manufacturer and marketer of
patent protected biomaterial-based products. MiMedx Group is emerging from a development-focused
start-up company into a fully integrated operating company with the expertise to capitalize on its
science and technology and the capacity to generate sales growth and profitability.
Repair, dont replace is the mantra of the MiMedx Group biochemists, engineers, and
designers who are developing todays biomaterial-based solutions for patients and physicians.
Market research shows the first desire of patients ranging from active baby-boomers and weekend
warriors to high-school and professional athletes is to augment repair when possible, rather than
replace traumatized, but otherwise healthy tissues and structures. Clinical research has proven
that biomaterials can be used to achieve augmentation and repair.
Results of Operations for the Three Months Ended September 30, 2010, Compared to the Three Months
Ended September 30, 2009
Revenues
Revenues were approximately $108,000 for the three months ended September 30, 2010, as
compared to $0 revenue for the three months ended September 30, 2009. The increase in revenue is
driven by the continued market penetration of our HydroFix Vaso Shield in the United States and
our HydroFix Spine Shield in Europe, the Middle East and Asia. Revenue for the quarter was down
from the previous quarter due to health related issues with our European sales representative and a
family member. During the quarter the company added several sales representative groups in the
United States as well as stocking distributors in markets outside of the United States.
Cost of Products Sold
Cost of products sold approximated $540,000 during the three months ended September 30, 2010,
compared to $0 in the comparable period a year ago. Included in these costs for 2010 are the
initial costs to set up production of our CollaFix products. Due to a high degree of fixed costs
during our commercial manufacturing ramp-up and the early stages of market acceptance of our
products, sales and production volumes were not at high enough levels to enable us to produce unit
costs that were lower than the current market price of our products resulting in a negative gross
margin. As of September 30, 2010, we employed 9 employees devoted to manufacturing and quality
assurance. We expect that as demand increases for our products it will enable us to more
efficiently absorb fixed overhead costs resulting in significantly lower per unit costs.
Research and Development Expenses
Our research and development expenses decreased approximately $106,000 or 11.2% to $843,000
during the three months ended September 30, 2010, compared to approximately $949,000 for the three
months ended September 30, 2009. The decrease in expenses reflects the transfer of certain
personnel into manufacturing departments to support production, offset by an increase in spending
on animal studies. Our research and development expenses consist of internal personnel costs, fees
paid to external consultants and service providers supporting our development efforts, and supplies
and instruments used in our laboratories. As of September 30, 2010, we employed 13 employees
devoted to research and development, compared to 24 employees devoted to research and development
at September 30, 2009. We anticipate continued activity in the area of research and development in
the foreseeable future as we progress our technologies into clinical development to obtain
clearance from the FDA to market our technologies.
16
Selling, General and Administrative Expenses
Our selling, general and administrative expenses increased approximately $121,000 or 8.3% for
the three month period ending September 30, 2010, as compared to the same period in 2009. The
increase in these expenses was primarily the result of an increase in stock based compensation
expense of approximately $138,000. Our selling, general and administrative expenses consist of
personnel costs, professional fees, sales commissions, sales training costs, industry trade show
fees and expenses, product promotions and product literature costs, facilities costs and other
sales, marketing and administrative costs. As of September 30, 2010, we employed 11 personnel in
selling, general and administrative functions as compared to 11 as of September 30, 2009.
During the three months ended September 30, 2010, we recorded approximately $114,000 in
depreciation expense and $167,000 in amortization expense as compared to $111,000 and $167,000,
respectively, for these expenses in the same period in 2009. We depreciate our assets on a
straight-line basis, principally over five to seven years, and amortize our intangible assets over
a period of 10 years, which we believe represents the remaining useful lives of the patents
underlying the licensing rights and intellectual property. We do not amortize goodwill, but at
least
annually we test goodwill for impairment and periodically evaluate other intangibles for
impairment based on events or changes in circumstances as they occur.
Share Based Compensation
The total share based compensation recognized during the three months ended September 30, 2010
and 2009, approximated $333,000 and $262,000, respectively. These amounts are included in Selling,
General and Administrative expenses in our statements of operations.
Other Expense/Income
We recorded other expense of approximately $600 during the three months ended September 30,
2010, compared with approximately $2,078,000 of other expense during the three months ended
September 30, 2009. The Other expense in 2009 included financing expense of approximately
$1,305,000 associated with the issuance of common stock for registration rights waivers and
$683,000 associated with warrants issued in connection with a convertible promissory note.
Results of Operations for the Nine Months Ended September 30, 2010 Compared to the Nine Months
Ended September 30, 2009
Revenues
Net sales for the first nine months ended September 30, 2010, were approximately $545,000 as
compared to $0 revenue for the nine months ended September 30, 2009. In the first quarter of 2010
we launched our HydroFix Vaso Shield in the United States and our HydroFix Spine Shield in
Europe. On June 7, 2010 the Company announced that it had received notification by the FDA that
the Companys proprietary device, HydroFix TM Vaso Shield, has received 510(k) clearance for
additional thicknesses and sizes. The FDA has now cleared HydrofixTM Vaso Shield for thicknesses
ranging from 0.4mm to 1.0mm and multiple sizes. Initial quantities of the product were shipped in
June to customers. Additionally, significant progress has been made in terms of building a
distribution network of third party sales representatives and stocking distributors to market and
distribute the product. As the distribution networks grows, so do the Companys efforts in
providing leading edge training tools to shorten the learning curve and improve speed to first
revenue for new customers.
17
Cost of Products Sold
Cost of products sold approximated $1,355,000 during the nine months ended September 30, 2010,
compared to $0 in the comparable period a year ago. Included in the costs for 2010 are the initial
costs to set up production of our CollaFix products. As of September 30, 2010, we employed 9
employees in manufacturing and quality assurance. Due to a high degree of fixed costs during our
commercial manufacturing ramp-up and the early stages of market acceptance of our products, sales
and production volumes were not at high enough levels to enable us to produce unit costs that were
lower than the current market price of our products resulting in a negative gross margin. We
expect that as demand increases for our products it will enable us to more efficiently absorb fixed
overhead costs resulting in significantly lower per unit costs.
Research and Development Expenses
Our research and development expenses decreased approximately $32,000 or 1.5% to approximately
$2,168,000 for the nine months ended September 30, 2010, compared to $2,200,000
during the nine months ended September 30, 2009. Excluding a one-time credit of $153,000 for
settlement of disputed prior period accounts payable recorded in the nine months ended September
30, 2009, research and development expenses decreased $185,000 or 8.4% in the period ended
September 30, 2010 as compared to the same period in 2009. This decrease is primarily attributable
to reductions in headcount, consulting services and the transfer of personnel to manufacturing,
offset somewhat by an increase in investments in animal studies required for various regulatory
clearances. Our research and development expenses consist of internal personnel costs, fees paid to
external consultants and service providers supporting our development efforts, and supplies and
instruments used in our laboratories. As of September 30, 2010, we employed 13 employees devoted
to research and development, compared to 24 employees devoted to research and development at
September 30, 2009. We anticipate continued activity in the area of research and development in
the foreseeable future as we progress our technologies into clinical development to obtain
clearance from the FDA to market our technologies.
Selling, General and Administrative Expenses
Our selling, general and administrative expenses increased approximately $501,000 or 10.8% for
the nine month period ending September 30, 2010, as compared to the same period in 2009. Excluding
a one-time credit of $413,000 for settlement of disputed prior year period accounts payable
primarily related to legal expense, S,G&A expenses increased $88,000 or 1.9% as compared to the
period ended September 30, 2009. The increase is primarily attributable to our investment in Sales
& Marketing in support of the planned establishment of our global third party sales distribution
network.
Our selling, general and administrative expenses consist of personnel costs, professional
fees, sales commissions, sales training costs, industry trade show fees and expenses, product
promotions and product literature costs, facilities costs and other sales, marketing and
administrative costs. As of September 30, 2010, we employed 11 personnel in selling, general and
administrative functions as compared to 11 as of September 30, 2009; however, administrative
headcount reductions were offset by the addition of sales and marketing personnel.
During the nine months ended September 30, 2010, we recorded $338,000 in depreciation expense
and $501,000 in amortization expense as compared to $339,000 and $500,000, respectively, for these
expenses in the same period in 2009. We depreciate our assets on a straight-line basis,
principally over five to seven years, and amortize our intangible assets over a period of 10 years,
which we believe represents the remaining useful lives of the patents underlying the licensing
rights and intellectual property. We do not amortize goodwill, but at least annually we test
goodwill for impairment and periodically evaluate other intangibles for impairment based on events
or changes in circumstances as they occur.
18
Share Based Compensation
The total share based compensation recognized during the nine months ended September 30, 2010
and 2009, was approximately $836,000 and $1,162,000 respectively. These amounts are included in
Selling, General and Administrative expenses in our statements of operations.
Other Expense/Income
We recorded interest expenses of approximately $593,000 during the nine months ended September
30, 2010, compared with approximately $2,133,000 of other expense during the nine months ended
September 30, 2009 including $1,305,000 of expense related to the issuance of additional shares for
registration rights waivers and $683,000 of expense related to the issuance of warrants issued in
connection with a convertible promissory note.
On March 31, 2010 we converted all of our remaining 3% Convertible Senior Secured Promissory
Notes to shares of our common stock. As a result we recognized as interest expense approximately
$499,610 of remaining unamortized debt discount related to these notes.
Liquidity and Capital Resources
Since inception, we have funded our development, operating costs and capital expenditures
through issuances of stock or convertible debt. We had approximately $428,000 of cash and cash
equivalents on hand as of September 30, 2010.
As of September 30, 2010, the Company had $428,000 of cash in the bank and has not emerged
from the development stage. In October 2010, the Company borrowed $150,000 from its Chairman and
Chief Executive Officer and $50,000 each from two other company directors under a 5% Convertible
Promissory Note (see Note 10). In November, the Company borrowed an additional $150,000 from its
Chairman and Chief Executive Officer under the same 5% Convertible Promissory Note (see Note 10).
Also in November, the Company received $244,000 from the U.S. Federal Government for qualified
investments under the US Federal Government therapeutic discovery project grant program.
Additionally, the Company commenced a private placement to sell common stock and warrants to
accredited investors. Through November 15, 2010, the Company has received aggregate proceeds of
$2,000,000 under this arrangement, and assuming it receives no additional funds and the holders of
the 5% Convertible Promissory Notes exercise the conversion option, estimates that it has
sufficient funds to operate through December 2010. In order to fund ongoing operations beyond that
point, or to further accelerate and execute the business plan, we need to raise additional
significant funds. Therefore, the Company intends to extend the
current private placement. In view of these matters, the ability of the Company to continue as a going
concern is dependent on our ability to secure additional financing sufficient to support its
research and development activities, approval of developed products for sale by regulatory
authorities, including the FDA, and its investments in working capital. Since inception, the
Company has financed its activities principally from the sale of equity securities and convertible
debt. While the Company has been successful in the past in obtaining the necessary capital to
support its operations, there is no assurance that the Company will be able to obtain government
grants or additional equity capital or other financing under commercially reasonable terms and
conditions, or at all. Furthermore, if the Company issues equity or debt securities to raise
additional funds, existing shareholders may experience dilution and the new equity or debt
securities it issues may have rights, preferences and privileges senior to those of existing
shareholders. In addition, if the Company raises additional funds through collaboration, licensing
or other similar arrangements, it may be necessary to relinquish valuable rights to products or
proprietary technologies, or grant licenses on terms that are not favorable. If the Company does
not achieve its revenue projections, secure government funding or cannot raise funds on acceptable
terms, the Company will not be able to continue as a going concern, develop or enhance products,
obtain the required regulatory clearances or approvals, execute the Companys business plan, take
advantage of future opportunities, or respond to competitive pressure or unanticipated customer
requirements. Any of these events would adversely affect the Companys ability to achieve the
Companys development and commercialization goals, which could have a material adverse effect on
the Companys business, results of operations and financial condition. The Companys financial
statements do not include any adjustments relating to the recoverability or classification of
assets or the amounts of liabilities that might result from the outcome of these uncertainties.
19
Discussion of cash flows
Net cash used in operations during the nine months ended September 30, 2010, increased
approximately $1,180,000 to $6,171,000 compared to $4,991,000 used in operating activities for the
nine month period ended September 30, 2009 reflecting our increased activity and acceleration
of our efforts to transition into an operating company. The increase in our accounts
receivable as well as building inventories available for commercial sales is contributing to this
increase in cash outflow.
As discussed above, the Companys ability to continue as a going concern is dependent upon the
Companys ability to raise additional funds as well as to achieve its budgeted revenue growth
objectives to support its research and development activities and regulatory clearance or approval
processes as well as our working capital and necessary capital expenditures. Funding from other
sources such as government grants are also being pursued to support our near term cash
requirements.
Contractual Obligations
Contractual obligations associated with our ongoing business activities are expected to result
in cash payments in future periods. A table summarizing the amounts and estimated timing of these
future cash payments as of September 30, 2010, is provided in Note 9 of the unaudited condensed
consolidated financial statements included in Item 1.
Critical Accounting Policies
In preparing our financial statements we follow accounting principles generally accepted in
the United States, which require us to make certain estimates and apply judgments that affect our
financial position and results of operations. We continually review our accounting policies and
financial information disclosures. A summary of our significant accounting policies that require
the use of estimates and judgments in preparing the financial statements was provided in our Annual
Report on Form 10-K for the year ended December 31, 2009. During the first nine months of fiscal
2010, there were no material changes to the accounting policies and assumptions previously
disclosed.
Recent Accounting Pronouncements
In February 2010, the FASB issued authoritative guidance that amends the disclosure
requirements related to subsequent events. This guidance includes the definition of a Securities
and Exchange Commission filer, removes the definition of a public entity, redefines the reissuance
disclosure requirements and allows companies to omit the disclosure of the date through which
subsequent events have been evaluated. This guidance is effective for financial statements issued
for interim and annual periods ending after February 2010. This guidance did not materially impact
the Companys results of operations or financial position, but did require changes to the Companys
disclosures in its financial statements.
In October 2009, the FASB issued Accounting Standards Update No. 2009-13 (ASU 2009-13),
which addresses the accounting for multiple-deliverable arrangements to enable vendors to account
for products or services (deliverables) separately rather than as a combined unit. ASU 2009-13 is
effective prospectively for revenue arrangements entered into or materially modified beginning in
fiscal years on or after June 15, 2010. Early adoption is permitted. The Company does not expect
the adoption of this standard to have any effect on its financial statements until or unless it
enters into agreements covered by this standard.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements.
20
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
The Companys business is anticipated to be directly dependent on foreign operations as the
Companys sales to customers outside the U.S. become significant. A portion of the Companys total
revenues are anticipated to be dependent on selling to distributors outside the U.S. There is a
risk related to the changes in foreign currency exchange rates as it relates to our revenues paid
to us in U.S. dollars for end-user sales within foreign countries. We are currently considering
taking affirmative steps to hedge the risk of fluctuations in foreign currency exchange rates as
revenues continue to increase. We do not expect our financial position, results of operations or
cash flows to be materially impacted due to a sudden change in foreign currency exchange rates
fluctuations relative to the U.S. Dollar over the next three months.
Our exposure to market risk relates to our cash and investments.
The primary objective of our investment activities is to preserve principal while at the same
time maximizing yields without significantly increasing risk. To achieve this objective, we invest
our excess cash in debt instruments of the U.S. Government and its agencies, bank obligations,
repurchase agreements and high-quality corporate issuers, and, by policy, restrict our exposure to
any single corporate issuer by imposing concentration limits. To minimize the exposure due to
adverse shifts in interest rates, we maintain investments at an average maturity of generally less
than three months.
Item 4. Controls and Procedures.
Disclosure Controls and Procedures
As required by Rule 13a-15(b) under the Securities Exchange Act of 1934, as amended (the
Exchange Act), we have carried out an evaluation of the effectiveness of the design and operation
of our disclosure controls and procedures as of the end of the period covered by this report. This
evaluation was carried out under the supervision and with the participation of our management,
including our Chief Executive Officer and Principal Financial Officer. Based upon that evaluation,
our Chief Executive Officer and Principal Financial Officer concluded that our controls and
procedures were effective as of the end of the period covered by this report.
Disclosure controls and procedures are controls and other procedures that are designed to
ensure that information required to be disclosed in our reports filed or submitted under the
Exchange Act is recorded, processed, summarized, and reported within the time periods specified in
the SECs rules and forms. Disclosure controls and procedures include controls and procedures
designed to ensure that information required to be disclosed in our reports filed under the
Exchange Act is accumulated and communicated to management, including our Chief Executive Officer
and Principal Financial Officer, as appropriate, to allow timely decisions regarding disclosures.
Changes in Internal Control Over Financial Reporting
There was no change in our internal control over financial reporting that occurred during the
nine months ended September 30, 2010, that has materially affected, or is reasonably likely to
materially affect, our internal control over financial reporting.
21
Limitations on the Effectiveness of Controls
We have confidence in our internal controls and procedures. Nevertheless, our management,
including our Chief Executive Officer and Principal Financial Officer, does not expect that our
disclosure procedures and controls or our internal controls will prevent all errors or intentional
fraud. An internal control system, no matter how well-conceived and operated, can provide only
reasonable, not absolute, assurance that the objectives of such internal controls are met. Further,
the design of an internal control system must reflect the fact that there are resource constraints,
and the benefits of controls must be considered relative to their costs. Because of the inherent
limitations in all internal control systems, no evaluation of controls can provide absolute
assurance that all our control issues and instances of fraud, if any, have been detected.
PART II OTHER INFORMATION
Item 1. Legal Proceedings
None.
Item 1A. Risk Factors
As of the date of this report, there have been no material changes to the risk factors
included in Item 1A to our Annual Report on Form 10-K for the nine months ended December 31, 2009.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
In March, 2010, the Company converted its 3% Convertible Senior Secured Notes into Common
Stock. As a result of the conversion, the Company issued 7,135,114 shares of common stock
representing the principal balance of the notes ($3,472,000) and accrued interest payable of
approximately $96,000.
In April 2010, the Company offered investors in the October 2009 Private Placement a discount
to their existing $1.50 warrant exercise price to $1.00 if they exercised their warrants to
purchase common stock for cash by May 1, 2010. As a result of this offer, the Company received
proceeds of approximately $3,207,969, net of placement agent fees, and issued 3,207,969 shares of
common stock as of May 1, 2010. The aggregate proceeds include $833,000 in common stock sold to
the Chairman and CEO, $20,850 to the President and Chief Operating Officer and $20,833 to one other
company director.
The issuance of the aforementioned securities was not registered in reliance on Section 4(2)
of the Securities Act of 1933, as amended.
Item 3. Default Upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders
None.
Item 5. Other Information
None.
22
Item 6. Exhibits.
|
|
|
|
|
|
|
Exhibit Number |
|
Reference |
|
Description |
|
|
|
|
|
|
|
|
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 |
|
|
#
|
|
Certification of Chief Executive Officer
pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 |
|
|
|
|
|
|
|
|
32.2 |
|
|
#
|
|
Certification of Chief Financial Officer
pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 |
23
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.
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MIMEDX GROUP, INC.
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Date: November 15, 2010 |
By: |
/s/ Michael J. Senken
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Michael J. Senken |
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Chief Financial Officer |
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Exhibit 31.1
Exhibit 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER
PURSUANT TO RULES 13a-14(A) AND 15d-14(A)
OF THE SECURITIES EXCHANGE ACT OF 1934
I, Parker H. Petit, certify that:
1. I have reviewed this Form 10-Q for the quarter ended September 30, 2010, of MiMedx Group, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or
omit to state a material fact necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading with respect to the period covered by this
report;
3. Based on my knowledge, the financial statements, and other financial information included in
this report, fairly present in all material respects the financial condition, results of operations
and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer and I are responsible for establishing and maintaining
disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and
internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and
15d-15(f)) for the registrant and have:
a. Designed such disclosure controls and procedures, or caused such disclosure controls and
procedures to be designed under our supervision, to ensure that material information relating
to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
b. Designed such internal control over financial reporting, or caused such internal control
over financial reporting to be designed under our supervision, to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
c. Evaluated the effectiveness of the registrants disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the disclosure controls
and procedures, as of the end of the period covered by this report based on such evaluation;
and
d. Disclosed in this report any change in the registrants internal control over financial
reporting that occurred during the registrants most recent fiscal quarter (the registrants
fourth fiscal quarter in the case of an annual report) that has materially affected, or is
reasonably likely to materially affect, the registrants internal control over financial
reporting; and
5. The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the audit
committee of the registrants board of directors (or persons performing the equivalent functions):
a. All significant deficiencies and material weaknesses in the design or operation of internal
control over financial reporting which are reasonably likely to adversely affect the
registrants ability to record, process, summarize and report financial information; and
b. Any fraud, whether or not material, that involves management or other employees who have a
significant role in the registrants internal control over financial reporting.
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Date: November 15, 2010 |
/s/ Parker H. Petit
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Parker H. Petit |
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Chief Executive Officer |
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Exhibit 31.2
Exhibit 31.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER
PURSUANT TO RULES 13a-14(A) AND 15d-14(A)
OF THE SECURITIES EXCHANGE ACT OF 1934
I, Michael J. Senken, certify that:
1. I have reviewed this Form 10-Q for the quarter ended September 30, 2010, of MiMedx Group, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or
omit to state a material fact necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading with respect to the period covered by this
report;
3. Based on my knowledge, the financial statements, and other financial information included in
this report, fairly present in all material respects the financial condition, results of operations
and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a. Designed such disclosure controls and procedures, or caused such disclosure controls and
procedures to be designed under our supervision, to ensure that material information relating
to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
b. Designed such internal control over financial reporting, or caused such internal control
over financial reporting to be designed under our supervision, to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
c. Evaluated the effectiveness of the registrants disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the disclosure controls
and procedures, as of the end of the period covered by this report based on such evaluation;
and
d. Disclosed in this report any change in the registrants internal control over financial
reporting that occurred during the registrants most recent fiscal quarter (the registrants
fourth fiscal quarter in the case of an annual report) that has materially affected, or is
reasonably likely to materially affect, the registrants internal control over financial
reporting; and
5. The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the audit
committee of the registrants board of directors (or persons performing the equivalent functions):
a. All significant deficiencies and material weaknesses in the design or operation of internal
control over financial reporting which are reasonably likely to adversely affect the
registrants ability to record, process, summarize and report financial information; and
b. Any fraud, whether or not material, that involves management or other employees who have a
significant role in the registrants internal control over financial reporting.
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Date: November 15, 2010 |
/s/ Michael J. Senken
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Michael J. Senken |
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Chief Financial Officer |
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Exhibit 32.1
Exhibit 32.1
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350 AS ADOPTED
PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of MiMedx Group, Inc. (the Company) on Form 10-Q for the
quarter ended September 30, 2010 as filed with the Securities and Exchange Commission on the date
hereof (the Report), I, Parker H. Petit, Chief Executive Officer of the Company, pursuant to 18
U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, hereby
certify, that to the best of my knowledge:
(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities
Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company.
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Date: November 15, 2010 |
/s/ Parker H. Petit
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Parker H. Petit |
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Chief Executive Officer |
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Exhibit 32.2
Exhibit 32.2
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350 AS ADOPTED
PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of MiMedx Group, Inc. (the Company) on Form 10-Q for the
quarter ended September 30, 2010 as filed with the Securities and Exchange Commission on the date
hereof (the Report), I, Michael J. Senken, Chief Financial Officer of the Company, pursuant to 18
U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, hereby
certify, that to the best of my knowledge:
(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities
Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company.
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Date: November 15, 2010 |
/s/ Michael J. Senken
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Michael J. Senken |
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Chief Financial Officer |
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