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x
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the Quarterly Period Ended June 30, 2011
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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
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For the transition period from _____ to _____
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Delaware
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911789357
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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12325 Emmet Street, Omaha, Nebraska
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68164
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(Address of principal executive offices)
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(Zip Code)
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Large accelerated filer
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o
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Accelerated filer
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o
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Non-accelerated filer
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o
(Do not check if a smaller reporting company)
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Smaller Reporting Company
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x
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Page No.
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PART I.
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Item 1.
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Item 2.
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Item 4.
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PART II.
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Item 1.
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Item 1A.
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Item 6.
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Item 1.
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Financial Statements
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June 30,
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||||
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2011
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December 31,
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||||
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(unaudited)
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2010
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||||
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ASSETS
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||||
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CURRENT ASSETS:
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||||
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Cash and cash equivalents
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$
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2,639
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$
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3,454
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Accounts receivable (net of allowances for bad debts of $1,387 and $334, respectively)
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7,194
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7,601
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Inventories (net of allowances for obsolescence of $520 and $518, respectively)
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3,309
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3,344
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Other current assets
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860
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635
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Total current assets
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14,002
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15,034
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PROPERTY AND EQUIPMENT:
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||||
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Equipment
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10,118
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9,820
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Furniture, fixtures & leasehold improvements
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3,723
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3,479
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13,841
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13,299
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Less: accumulated depreciation
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(12,070
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)
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(11,697
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)
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1,771
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1,602
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OTHER ASSETS:
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||||
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Goodwill
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6,275
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6,275
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Intangibles (net of accumulated amortization of $843 and $519, respectively)
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8,522
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8,962
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Other assets
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130
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154
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$
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30,700
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$
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32,027
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LIABILITIES AND STOCKHOLDERS’ EQUITY
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||||
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CURRENT LIABILITIES:
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||||
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Accounts payable
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$
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1,400
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$
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1,360
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Accrued compensation
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1,006
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875
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Short term debt and current maturities of long term debt
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1,728
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989
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Accrued liabilities
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3,681
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3,231
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Contractual obligation
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1,573
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1,628
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Current portion of lease obligations
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217
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170
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Preferred stock dividend payable
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300
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—
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Total current liabilities
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9,905
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8,253
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LONG TERM LIABILITIES:
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||||
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Long term debt less current maturities
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7,406
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8,640
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Preferred stock conversion feature
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7,600
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1,983
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Preferred stock warrant liability
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3,000
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2,351
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Other long-term liabilities
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1,008
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843
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Total liabilities
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28,919
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22,070
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Redeemable Series A convertible preferred stock, $.01 par value, 3,879,307 shares authorized, 2,586,205 shares issued and outstanding
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1,670
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1,457
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STOCKHOLDERS’ EQUITY:
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||||
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Preferred stock, $.01 par value, 15,000,000 shares authorized, 2,586,205 shares issued and outstanding
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—
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—
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Common stock, $.01 par value, 100,000,000 shares authorized, 49,299,672 and 49,289,672 shares issued and outstanding, respectively
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498
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498
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Additional paid-in capital
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140,502
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139,730
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Accumulated other comprehensive income
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1,731
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1,589
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Accumulated deficit
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(142,620
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)
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(133,317
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)
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Total stockholders’ equity
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111
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8,500
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$
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30,700
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$
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32,027
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Three Months Ended
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Six Months Ended
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||||||||||||
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June 30,
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June 30,
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||||||||||||
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2011
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2010
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2011
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2010
|
||||||||
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NET SALES
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$
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7,667
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$
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5,095
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$
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15,148
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$
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10,537
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COST OF GOODS SOLD
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3,112
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2,608
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6,406
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5,166
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Gross profit
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4,555
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2,487
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8,742
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5,371
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OPERATING EXPENSES:
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Selling, general and administrative
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5,589
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3,033
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9,946
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5,464
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||||
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Research and development
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579
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512
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1,135
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1,339
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||||
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Restructuring Charges
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11
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—
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35
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—
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||||
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6,179
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3,545
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11,116
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6,803
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|
||||
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LOSS FROM OPERATIONS
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(1,624
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)
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(1,058
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)
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(2,374
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)
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(1,432
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)
|
||||
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OTHER INCOME (EXPENSE):
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||||||||
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Interest income (expense), net
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(240
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)
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1
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(478
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)
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1
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|
||||
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Expense on preferred stock
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(4,239
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)
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—
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(6,266
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)
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—
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|
||||
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Other, net
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1
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—
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232
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|
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—
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||||
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(4,478
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)
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1
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(6,512
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)
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1
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||||
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LOSS BEFORE INCOME TAXES
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(6,102
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)
|
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(1,057
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)
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(8,886
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)
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|
(1,431
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)
|
||||
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INCOME TAX EXPENSE (BENEFIT)
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(104
|
)
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|
89
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|
|
(110
|
)
|
|
38
|
|
||||
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NET LOSS
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$
|
(5,998
|
)
|
|
$
|
(1,146
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)
|
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$
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(8,776
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)
|
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$
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(1,469
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)
|
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PREFERRED STOCK DIVIDENDS AND ACCRETION
|
(267
|
)
|
|
—
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(527
|
)
|
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—
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|
||||
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NET LOSS AVAILABLE TO COMMON STOCKHOLDERS
|
$
|
(6,265
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)
|
|
$
|
(1,146
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)
|
|
$
|
(9,303
|
)
|
|
$
|
(1,469
|
)
|
|
BASIC AND DILUTED LOSS PER COMMON SHARE
|
$
|
(0.13
|
)
|
|
$
|
(0.02
|
)
|
|
$
|
(0.19
|
)
|
|
$
|
(0.03
|
)
|
|
BASIC AND DILUTED WEIGHTED AVERAGE SHARES OF COMMON STOCK OUTSTANDING
|
49,299,672
|
|
|
49,206,339
|
|
|
49,296,339
|
|
|
49,198,005
|
|
||||
|
|
Common Stock
|
|
|
|
|
|
|
|
|
|||||||||||||
|
|
Outstanding
Shares
|
|
Par
Value
|
|
Additional
Paid-in
Capital
|
|
Accumulated
Deficit
|
|
Accumulated
Other
Comprehensive
Income (Loss)
|
|
Total
|
|||||||||||
|
Balance, January 1, 2011
|
49,289,672
|
|
|
$
|
498
|
|
|
$
|
139,730
|
|
|
$
|
(133,317
|
)
|
|
$
|
1,589
|
|
|
$
|
8,500
|
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(8,776
|
)
|
|
(8,776
|
)
|
|
(8,776
|
)
|
|||||
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
|
Foreign currency translation adjustment, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
142
|
|
|
142
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|
|||||
|
Comprehensive loss
|
|
|
|
|
|
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|
|
(8,634
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)
|
|
|
||||||||||
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Non-cash stock-based compensation
|
—
|
|
|
—
|
|
|
765
|
|
|
—
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|
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—
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|
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765
|
|
|||||
|
Issuance of shares for employee stock options
|
10,000
|
|
|
—
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7
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|
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—
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|
|
—
|
|
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7
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|
|||||
|
Preferred stock accretion
|
—
|
|
|
—
|
|
|
—
|
|
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(227
|
)
|
|
|
|
(227
|
)
|
||||||
|
Dividends on preferred stock
|
—
|
|
|
—
|
|
|
—
|
|
|
(300
|
)
|
|
—
|
|
|
(300
|
)
|
|||||
|
Balance, June 30, 2011
|
49,299,672
|
|
|
498
|
|
|
140,502
|
|
|
(142,620
|
)
|
|
$
|
1,731
|
|
|
$
|
111
|
|
|||
|
|
Six Months Ended
|
||||||
|
|
June 30,
|
||||||
|
|
2011
|
|
2010
|
||||
|
CASH FLOWS PROVIDED BY (USED IN) OPERATING ACTIVITIES:
|
|
|
|
||||
|
Net loss
|
$
|
(8,776
|
)
|
|
$
|
(1,469
|
)
|
|
Adjustments to reconcile net loss to net cash flows provided by (used in) operating activities:
|
|
|
|
||||
|
Depreciation and amortization
|
992
|
|
|
378
|
|
||
|
Non-cash, stock based compensation
|
765
|
|
|
(50
|
)
|
||
|
Provision for losses on doubtful accounts
|
1,227
|
|
|
2
|
|
||
|
Provision for losses on inventory obsolescence
|
48
|
|
|
67
|
|
||
|
Preferred stock revaluation
|
6,266
|
|
|
—
|
|
||
|
Changes in operating assets and liabilities:
|
|
|
|
||||
|
Accounts receivable
|
(769
|
)
|
|
565
|
|
||
|
Inventories
|
2
|
|
|
62
|
|
||
|
Prepaid expenses and other current assets
|
215
|
|
|
147
|
|
||
|
Accounts payable
|
(196
|
)
|
|
(99
|
)
|
||
|
Accrued liabilities
|
276
|
|
|
404
|
|
||
|
Other long term liabilities
|
24
|
|
|
(47
|
)
|
||
|
Long term deferred income taxes
|
13
|
|
|
13
|
|
||
|
Net cash flows provided by (used in) operating activities
|
87
|
|
|
(27
|
)
|
||
|
CASH FLOWS USED IN INVESTING ACTIVITIES:
|
|
|
|
||||
|
Purchase of property and equipment
|
(216
|
)
|
|
(108
|
)
|
||
|
Change in other assets
|
(139
|
)
|
|
(18
|
)
|
||
|
Net cash flows used in investing activities
|
(355
|
)
|
|
(126
|
)
|
||
|
CASH FLOWS PROVIDED BY (USED IN) FINANCING ACTIVITIES:
|
|
|
|
||||
|
Principal payments on capital lease obligations
|
(156
|
)
|
|
—
|
|
||
|
Issuance of common stock
|
7
|
|
|
42
|
|
||
|
Principal payment on note payable
|
(495
|
)
|
|
—
|
|
||
|
Net cash flows provided by (used in) financing activities
|
(644
|
)
|
|
42
|
|
||
|
EFFECT OF FOREIGN CURRENCY EXCHANGE RATE CHANGES ON CASH
|
97
|
|
|
(115
|
)
|
||
|
NET CHANGE IN CASH AND CASH EQUIVALENTS
|
(815
|
)
|
|
(226
|
)
|
||
|
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
|
3,454
|
|
|
5,642
|
|
||
|
CASH AND CASH EQUIVALENTS AT END OF PERIOD
|
$
|
2,639
|
|
|
$
|
5,416
|
|
|
SUPPLEMENTAL CASH FLOW INFORMATION
|
|
|
|
||||
|
Cash paid during the period for:
|
|
|
|
||||
|
Interest
|
$
|
480
|
|
|
$
|
—
|
|
|
Income taxes, net
|
13
|
|
|
2
|
|
||
|
SUPPLEMENTAL DISCLOSURE OF NON-CASH INFORMATION
|
|
|
|
||||
|
Acquisition of equipment through capital leases
|
$
|
390
|
|
|
$
|
—
|
|
|
Dividends payable on preferred stock
|
300
|
|
|
—
|
|
||
|
A.
|
BUSINESS DESCRIPTION
|
|
•
|
Molecular Clinical Reference Laboratory. The molecular clinical reference laboratory specializes in genetic testing for oncology, hematology and inherited disorders. Located in New Haven, Connecticut and Omaha, Nebraska the molecular clinical reference laboratories are certified under the Clinical Laboratory Improvement Amendment (CLIA) as high complexity labs and our Omaha facility is accredited by CAP (College of American Pathologists).
|
|
•
|
Pharmacogenomics Research Services. Pharmacogenomics research services are provided by our Contract Research Organization located in Omaha, Nebraska. This lab specializes in pharmacogenomic, biomarker and mutation discovery research serving the pharmaceutical and biomedical industries world-wide for disease research, drug and diagnostic development and clinical trial support.
|
|
•
|
Bioinstruments. Our proprietary product is the WAVE
®
System which has broad applicability to genetic variation detection in both molecular genetic research and molecular diagnostics. There is a worldwide installed base of over 1,500 WAVE Systems as of
June 30, 2011
. We also distribute bioinstruments produced by other manufacturers (“OEM Equipment”) through our sales and distribution network. Service contracts to maintain installed systems are sold and supported by technical support personnel.
|
|
•
|
Bioconsumables. The installed WAVE base and some OEM platforms generate a demand for consumables that are required for the continued operation of the bioinstruments. We develop, manufacture and sell these consumable products. In addition, we manufacture and sell consumable products that can be used on multiple, independent platforms. These products include SURVEYOR
®
Nuclease and a range of chromatography columns.
|
|
B.
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
|
|
Dollars in Thousands
|
||||||||||||||
|
|
Beginning
Balance
|
|
Provision
|
|
Write Offs
|
|
Ending
Balance
|
||||||||
|
Three Months Ended June 30, 2011
|
$
|
716
|
|
|
$
|
779
|
|
|
$
|
(108
|
)
|
|
$
|
1,387
|
|
|
Three Months Ended June 30, 2010
|
$
|
279
|
|
|
$
|
16
|
|
|
$
|
—
|
|
|
$
|
295
|
|
|
Six Months Ended June 30, 2011
|
$
|
334
|
|
|
$
|
1,228
|
|
|
$
|
(175
|
)
|
|
$
|
1,387
|
|
|
Six Months Ended June 30, 2010
|
$
|
310
|
|
|
$
|
(11
|
)
|
|
$
|
(4
|
)
|
|
$
|
295
|
|
|
|
Dollars in Thousands
|
||||||||||||||
|
|
Beginning
Balance
|
|
Provision
|
|
Write Offs
|
|
Ending
Balance
|
||||||||
|
Three Months Ended June 30, 2011
|
$
|
520
|
|
|
$
|
41
|
|
|
$
|
(41
|
)
|
|
$
|
520
|
|
|
Three Months Ended June 30, 2010
|
$
|
478
|
|
|
$
|
67
|
|
|
$
|
(9
|
)
|
|
$
|
536
|
|
|
Six Months Ended June 30, 2011
|
$
|
518
|
|
|
$
|
49
|
|
|
$
|
(47
|
)
|
|
$
|
520
|
|
|
Six Months Ended June 30, 2010
|
$
|
507
|
|
|
$
|
65
|
|
|
$
|
(36
|
)
|
|
$
|
536
|
|
|
Leasehold improvements
|
1 to 10 years
|
|
|
|
|
Furniture and fixtures
|
3 to 7 years
|
|
|
|
|
Production equipment
|
3 to 7 years
|
|
|
|
|
Computer equipment
|
3 to 7 years
|
|
|
|
|
Research and development equipment
|
2 to 7 years
|
|
1.
|
Intellectual Property
.
|
|
2.
|
Patents
.
|
|
3.
|
Acquired Products
.
|
|
•
|
Persuasive evidence of an arrangement exists
|
|
•
|
Delivery has occurred or services have been rendered
|
|
•
|
The seller’s price to the buyer is fixed or determinable, and
|
|
•
|
Collectability is reasonably assured.
|
|
C.
|
INVENTORIES
|
|
|
Dollars in Thousands
|
||||||
|
|
June 30,
2011
|
|
|
December 31,
2010
|
|
||
|
Finished goods
|
$
|
1,940
|
|
|
$
|
2,119
|
|
|
Raw materials and work in process
|
1,544
|
|
|
1,531
|
|
||
|
Demonstration inventory
|
345
|
|
|
212
|
|
||
|
|
$
|
3,829
|
|
|
$
|
3,862
|
|
|
Less allowance for obsolescence
|
(520
|
)
|
|
(518
|
)
|
||
|
Total
|
$
|
3,309
|
|
|
$
|
3,344
|
|
|
D.
|
INTANGIBLES AND OTHER ASSETS
|
|
|
Dollars in Thousands
|
||||||||||||||||||||||
|
|
June 30, 2011
|
|
December 31, 2010
|
||||||||||||||||||||
|
|
Cost
|
|
Accumulated
Amortization
|
|
Net Book
Value
|
|
Cost
|
|
Accumulated
Amortization
|
|
Net Book
Value
|
||||||||||||
|
Intangibles—acquired technology
|
$
|
6,535
|
|
|
$
|
455
|
|
|
$
|
6,080
|
|
|
$
|
6,535
|
|
|
$
|
—
|
|
|
$
|
6,535
|
|
|
Intangibles—assay royalties
|
1,434
|
|
|
103
|
|
|
1,331
|
|
|
1,434
|
|
|
—
|
|
|
1,434
|
|
||||||
|
Intangibles—third party payor relationships
|
367
|
|
|
—
|
|
|
367
|
|
|
367
|
|
|
—
|
|
|
367
|
|
||||||
|
Intangibles—tradenames and trademarks
|
344
|
|
|
25
|
|
|
319
|
|
|
344
|
|
|
—
|
|
|
344
|
|
||||||
|
Patents
|
665
|
|
|
256
|
|
|
409
|
|
|
511
|
|
|
245
|
|
|
266
|
|
||||||
|
Intellectual property
|
20
|
|
|
4
|
|
|
16
|
|
|
290
|
|
|
274
|
|
|
16
|
|
||||||
|
|
$
|
9,365
|
|
|
$
|
843
|
|
|
$
|
8,522
|
|
|
$
|
9,481
|
|
|
$
|
519
|
|
|
$
|
8,962
|
|
|
|
|
|
|
Estimated Useful Life
|
|
Intellectual property
|
10 years
|
|
Patents
|
7 years
|
|
Intangibles—acquired technology
|
7 – 8 years
|
|
Intangibles—third party payor relationships
|
Indefinite
|
|
Intangibles—assay royalties
|
7 years
|
|
Intangibles—tradenames and trademarks
|
7 years
|
|
E.
|
|
|
|
Dollars in Thousands
|
||||||
|
|
June 30,
2011 |
|
December 31,
2010 |
||||
|
PGxHealth note payable (1)
|
$
|
8,640
|
|
|
$
|
8,640
|
|
|
PGxHealth note payable (2)
|
494
|
|
|
989
|
|
||
|
|
$
|
9,134
|
|
|
$
|
9,629
|
|
|
(1)
|
The First Note is a three year senior secured promissory note to PGxHealth, LLC entered into on December 29, 2010 in conjunction with our acquisition of the FAMILION family of genetic tests from PGxHealth. Interest is payable at 10% per year with quarterly interest payments through March 29, 2012. Thereafter, quarterly installments will include both principal and interest through December 30, 2013.
|
|
(2)
|
The Second Note is a one year senior secured promissory note to PGxHealth, LLC entered into on December 31, 2010 for facility improvements made to the CLIA certified laboratory in New Haven, Connecticut. Interest is payable at 6.5% per year with the principal and interest payable in twelve monthly installments with the final payment due on December 31, 2011.
|
|
2011
|
$
|
1,728
|
|
|
2012
|
3,703
|
|
|
|
2013
|
3,703
|
|
|
|
|
$
|
9,134
|
|
|
F.
|
CAPITAL LEASES
|
|
|
Dollars in Thousands
|
||||||
|
|
Asset Balances at
|
||||||
|
Classes of Property
|
June 30,
2011
|
|
|
December 31,
2010
|
|
||
|
Equipment
|
$
|
784
|
|
|
$
|
394
|
|
|
Less: Accumulated amortization
|
(78
|
)
|
|
(13
|
)
|
||
|
Total
|
$
|
706
|
|
|
$
|
381
|
|
|
|
Dollars in Thousands
|
||
|
2011
|
$
|
145
|
|
|
2012
|
224
|
|
|
|
2013
|
209
|
|
|
|
2014
|
35
|
|
|
|
Total minimum lease payments
|
$
|
613
|
|
|
Less: Amount representing interest
|
(94
|
)
|
|
|
Present value of net minimum lease payments
|
$
|
519
|
|
|
G.
|
COMMITMENTS AND CONTINGENCIES
|
|
H.
|
INCOME TAXES
|
|
I.
|
EMPLOYEE BENEFIT PLAN
|
|
J.
|
STOCKHOLDERS’ EQUITY
|
|
Warrant Holder
|
|
Issue Year
|
|
Expiration
|
|
Underlying
Shares
|
|
Exercise
Price
|
|||
|
Laurus Master Fund, Ltd. (1)
|
|
2004
|
|
August 2011
|
|
400,000
|
|
|
$
|
1.13
|
|
|
Affiliates of Third Security, LLC (2)
|
|
2010
|
|
December 2015
|
|
5,172,408
|
|
|
$
|
0.58
|
|
|
Total
|
|
|
|
|
|
5,572,408
|
|
|
|
||
|
(1)
|
These warrants were issued in conjunction with two loans that had been made to us by Laurus Master Fund, Ltd. (the “Laurus Loans”), and subsequent modifications of these loans. In conjunction with the 2005 private placement, the exercise prices of these warrants were adjusted according to repricing provisions contained in the original warrant agreements. While the Laurus Loans have been terminated, the warrants remain outstanding.
|
|
(2)
|
These warrants were issued in conjunction with the Series A Convertible Preferred Stock financing (the “Financing”) with certain entities affiliated with Third Security, LLC (the “Investors”). The number of shares shown reflects the post conversion shares.
|
|
K.
|
FAIR VALUE
|
|
|
Dollars in Thousands
|
||||||||||
|
|
For the six months ended
|
||||||||||
|
|
June 30, 2011
|
||||||||||
|
|
Preferred
Stock
Conversion
Feature
|
|
Preferred
Stock Warrant Liability |
|
Total
|
||||||
|
Beginning balance at April 1, 2011
|
$
|
5,078
|
|
|
$
|
1,283
|
|
|
$
|
6,361
|
|
|
Total gains or losses:
|
|
|
|
|
|
||||||
|
Recognized in earnings
|
2,522
|
|
|
1,717
|
|
|
4,239
|
|
|||
|
Balance at June 30, 2011
|
$
|
7,600
|
|
|
$
|
3,000
|
|
|
$
|
10,600
|
|
|
|
Dollars in Thousands
|
||||||||||
|
|
For the six months ended
|
||||||||||
|
|
June 30, 2011
|
||||||||||
|
|
Preferred
Stock
Conversion
Feature
|
|
Warrants
|
|
Total
|
||||||
|
Beginning balance at January 1, 2011
|
$
|
1,983
|
|
|
$
|
2,351
|
|
|
$
|
4,334
|
|
|
Total gains or losses:
|
|
|
|
|
|
||||||
|
Recognized in earnings
|
5,617
|
|
|
649
|
|
|
6,266
|
|
|||
|
Balance at June 30, 2011
|
$
|
7,600
|
|
|
$
|
3,000
|
|
|
$
|
10,600
|
|
|
L.
|
STOCK OPTIONS
|
|
|
Number of
Options
|
|
Weighted Average
Exercise Price
|
|||
|
Balance at January 1, 2011
|
2,565,001
|
|
|
$
|
2.11
|
|
|
Granted
|
2,335,500
|
|
|
1.17
|
|
|
|
Exercised
|
(10,000
|
)
|
|
(0.70
|
)
|
|
|
Forfeited
|
(227,001
|
)
|
|
(2.06
|
)
|
|
|
Cancelled
|
(349,500
|
)
|
|
(6.67
|
)
|
|
|
Balance at June 30, 2011
|
4,314,000
|
|
|
$
|
1.22
|
|
|
Exercisable at June 30, 2011
|
2,587,715
|
|
|
$
|
1.30
|
|
|
M.
|
OPERATING SEGMENT AND GEOGRAPHIC INFORMATION
|
|
|
Dollars in Thousands
|
||||||||||||||||||||||
|
|
2011
|
|
2010
|
||||||||||||||||||||
|
|
Laboratory
Services
|
|
Instrument
Business
|
|
Total
|
|
Laboratory
Services
|
|
Instrument
Business
|
|
Total
|
||||||||||||
|
Net Sales
|
$
|
4,866
|
|
|
$
|
2,801
|
|
|
$
|
7,667
|
|
|
$
|
1,241
|
|
|
$
|
3,854
|
|
|
$
|
5,095
|
|
|
Gross Profit
|
3,064
|
|
|
1,491
|
|
|
4,555
|
|
|
418
|
|
|
2,069
|
|
|
2,487
|
|
||||||
|
Net Loss before Taxes
|
(5,743
|
)
|
|
(359
|
)
|
|
(6,102
|
)
|
|
(506
|
)
|
|
(551
|
)
|
|
(1,057
|
)
|
||||||
|
Income Tax Expense (Benefit)
|
—
|
|
|
(104
|
)
|
|
(104
|
)
|
|
—
|
|
|
89
|
|
|
89
|
|
||||||
|
Net Loss
|
$
|
(5,743
|
)
|
|
$
|
(255
|
)
|
|
$
|
(5,998
|
)
|
|
$
|
(506
|
)
|
|
$
|
(640
|
)
|
|
$
|
(1,146
|
)
|
|
Depreciation/Amortization
|
444
|
|
|
46
|
|
|
490
|
|
|
73
|
|
|
48
|
|
|
121
|
|
||||||
|
Restructure
|
—
|
|
|
11
|
|
|
11
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
|
Interest Income (Expense)
|
(240
|
)
|
|
—
|
|
|
(240
|
)
|
|
—
|
|
|
1
|
|
|
1
|
|
||||||
|
|
Dollars in Thousands
|
||||||||||||||||||||||
|
|
2011
|
|
2010
|
||||||||||||||||||||
|
|
Laboratory
Services
|
|
Instrument
Business
|
|
Total
|
|
Laboratory
Services
|
|
Instrument
Business
|
|
Total
|
||||||||||||
|
Net Sales
|
$
|
8,623
|
|
|
$
|
6,525
|
|
|
$
|
15,148
|
|
|
$
|
2,512
|
|
|
$
|
8,025
|
|
|
$
|
10,537
|
|
|
Gross Profit
|
4,850
|
|
|
3,892
|
|
|
8,742
|
|
|
901
|
|
|
4,470
|
|
|
5,371
|
|
||||||
|
Net Loss before Taxes
|
(9,278
|
)
|
|
392
|
|
|
(8,886
|
)
|
|
(1,118
|
)
|
|
(313
|
)
|
|
(1,431
|
)
|
||||||
|
Income Tax Expense (Benefit)
|
—
|
|
|
(110
|
)
|
|
(110
|
)
|
|
—
|
|
|
38
|
|
|
38
|
|
||||||
|
Net Loss
|
$
|
(9,278
|
)
|
|
$
|
502
|
|
|
$
|
(8,776
|
)
|
|
$
|
(1,118
|
)
|
|
$
|
(351
|
)
|
|
$
|
(1,469
|
)
|
|
Depreciation/Amortization
|
872
|
|
|
95
|
|
|
967
|
|
|
152
|
|
|
104
|
|
|
256
|
|
||||||
|
Restructure
|
—
|
|
|
35
|
|
|
35
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
|
Interest Income (Expense)
|
(473
|
)
|
|
(5
|
)
|
|
(478
|
)
|
|
—
|
|
|
1
|
|
|
1
|
|
||||||
|
|
6/30/2011
|
|
6/30/2010
|
||||||||||||||||||||
|
Total Assets
|
$
|
22,621
|
|
|
$
|
8,079
|
|
|
$
|
30,700
|
|
|
$
|
7,395
|
|
|
$
|
7,051
|
|
|
$
|
14,446
|
|
|
|
Dollars in Thousands
|
|
Dollars in Thousands
|
||||||||||||
|
|
Three Months Ended
|
|
Six Months Ended
|
||||||||||||
|
|
June 30,
|
|
June 30,
|
||||||||||||
|
|
2011
|
|
2010
|
|
2011
|
|
2010
|
||||||||
|
Laboratory Services:
|
|
|
|
|
|
|
|
||||||||
|
Molecular Clinical Reference Laboratory
|
$
|
3,864
|
|
|
$
|
931
|
|
|
$
|
7,351
|
|
|
$
|
1,873
|
|
|
Pharmacogenomics Research Services
|
1,002
|
|
|
310
|
|
|
1,272
|
|
|
639
|
|
||||
|
|
4,866
|
|
|
1,241
|
|
|
8,623
|
|
|
2,512
|
|
||||
|
Instrument Related Business:
|
|
|
|
|
|
|
|
||||||||
|
Bioinstruments
|
1,319
|
|
|
2,217
|
|
|
3,157
|
|
|
4,569
|
|
||||
|
Bioconsumables
|
1,482
|
|
|
1,637
|
|
|
3,368
|
|
|
3,456
|
|
||||
|
|
2,801
|
|
|
3,854
|
|
|
6,525
|
|
|
8,025
|
|
||||
|
Total Net Sales
|
$
|
7,667
|
|
|
$
|
5,095
|
|
|
$
|
15,148
|
|
|
$
|
10,537
|
|
|
|
Dollars in Thousands
|
|
Dollars in Thousands
|
||||||||||||
|
|
Three Months Ended
|
|
Six Months Ended
|
||||||||||||
|
|
June 30,
|
|
June 30,
|
||||||||||||
|
|
2011
|
|
2010
|
|
2011
|
|
2010
|
||||||||
|
Laboratory Services:
|
|
|
|
|
|
|
|
||||||||
|
Molecular Clinical Reference Laboratory
|
$
|
1,435
|
|
|
$
|
495
|
|
|
$
|
3,023
|
|
|
$
|
957
|
|
|
Pharmacogenomics Research Services
|
367
|
|
|
328
|
|
|
750
|
|
|
654
|
|
||||
|
|
1,802
|
|
|
823
|
|
|
3,773
|
|
|
1,611
|
|
||||
|
Instrument Related Business:
|
|
|
|
|
|
|
|
||||||||
|
Bioinstruments
|
585
|
|
|
1,024
|
|
|
1,107
|
|
|
1,956
|
|
||||
|
Bioconsumables
|
725
|
|
|
761
|
|
|
1,526
|
|
|
1,599
|
|
||||
|
|
1,310
|
|
|
1,785
|
|
|
2,633
|
|
|
3,555
|
|
||||
|
Total Cost of Goods Sold
|
$
|
3,112
|
|
|
$
|
2,608
|
|
|
$
|
6,406
|
|
|
$
|
5,166
|
|
|
|
Dollars in Thousands
|
|
Dollars in Thousands
|
||||||||||||
|
|
Three Months Ended
|
|
Six Months Ended
|
||||||||||||
|
|
June 30,
|
|
June 30,
|
||||||||||||
|
|
2011
|
|
2010
|
|
2011
|
|
2010
|
||||||||
|
United States
|
$
|
5,669
|
|
|
$
|
2,070
|
|
|
$
|
10,705
|
|
|
$
|
4,401
|
|
|
Italy
|
785
|
|
|
721
|
|
|
1,611
|
|
|
1,487
|
|
||||
|
United Kingdom
|
233
|
|
|
200
|
|
|
491
|
|
|
767
|
|
||||
|
France
|
225
|
|
|
359
|
|
|
413
|
|
|
604
|
|
||||
|
Germany
|
182
|
|
|
345
|
|
|
394
|
|
|
905
|
|
||||
|
United Arab Emirates
|
—
|
|
|
774
|
|
|
—
|
|
|
774
|
|
||||
|
All Other Countries
|
573
|
|
|
626
|
|
|
1,534
|
|
|
1,599
|
|
||||
|
Total
|
$
|
7,667
|
|
|
$
|
5,095
|
|
|
$
|
15,148
|
|
|
$
|
10,537
|
|
|
N.
|
SUBSEQUENT EVENTS
|
|
Item 2.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
|
•
|
Molecular Clinical Reference Laboratory. The molecular clinical reference laboratory specializes in genetic testing for oncology, hematology and inherited disorders. Located in New Haven, Connecticut and Omaha, Nebraska the molecular clinical reference laboratories are certified under the Clinical Laboratory Improvement Amendment (CLIA) as high complexity labs and our Omaha facility is accredited by CAP (College of American Pathologists).
|
|
•
|
Pharmacogenomics Research Services. Pharmacogenomics research services are provided by our Contract Research Organization located in Omaha, Nebraska. This lab specializes in pharmacogenomic, biomarker and mutation discovery research serving the pharmaceutical and biomedical industries world-wide for disease research, drug and diagnostic development and clinical trial support.
|
|
•
|
Bioinstruments. Our proprietary product is the WAVE
®
System which has broad applicability to genetic variation detection in both molecular genetic research and molecular diagnostics. There is a worldwide installed base of over 1,500 WAVE Systems as of
June 30, 2011
. We also distribute bioinstruments produced by other manufacturers (“OEM Equipment”) through our sales and distribution network. Service contracts to maintain installed systems are sold and supported by our technical support personnel.
|
|
•
|
Bioconsumables. The installed WAVE base and some OEM platforms generate a demand for consumables that are required for the continued operation of the bioinstruments. We develop, manufacture and sell these consumable products. In addition, we manufacture and sell consumable products that can be used on multiple, independent platforms. These products include SURVEYOR
®
Nuclease and a range of chromatography columns.
|
|
|
Dollars in Thousands
|
|||||||||||||
|
|
Three Months Ended
|
|
|
|||||||||||
|
|
June 30,
|
|
Change
|
|||||||||||
|
|
2011
|
|
2010
|
|
$
|
|
%
|
|||||||
|
Laboratory Services:
|
|
|
|
|
|
|
|
|||||||
|
Molecular Clinical Reference Laboratory
|
$
|
3,864
|
|
|
$
|
931
|
|
|
$
|
2,933
|
|
|
315
|
%
|
|
Pharmacogenomics Research Services
|
1,002
|
|
|
310
|
|
|
692
|
|
|
223
|
%
|
|||
|
|
4,866
|
|
|
1,241
|
|
|
3,625
|
|
|
292
|
%
|
|||
|
Instrument Related Business:
|
|
|
|
|
|
|
|
|||||||
|
Bioinstruments
|
1,319
|
|
|
2,217
|
|
|
(898
|
)
|
|
(41
|
)%
|
|||
|
Bioconsumables
|
1,482
|
|
|
1,637
|
|
|
(155
|
)
|
|
(9
|
)%
|
|||
|
|
2,801
|
|
|
3,854
|
|
|
(1,053
|
)
|
|
(27
|
)%
|
|||
|
Total Net sales
|
$
|
7,667
|
|
|
$
|
5,095
|
|
|
$
|
2,572
|
|
|
50
|
%
|
|
|
Dollars in Thousands
|
|||||||||||||
|
|
Three Months Ended
|
|
|
|||||||||||
|
|
June 30,
|
|
Change
|
|||||||||||
|
|
2011
|
|
2010
|
|
$
|
|
%
|
|||||||
|
Laboratory Services:
|
|
|
|
|
|
|
|
|||||||
|
Molecular Clinical Reference Laboratory
|
$
|
1,435
|
|
|
$
|
495
|
|
|
$
|
940
|
|
|
190
|
%
|
|
Pharmacogenomics Research Services
|
367
|
|
|
328
|
|
|
39
|
|
|
12
|
%
|
|||
|
|
1,802
|
|
|
823
|
|
|
979
|
|
|
119
|
%
|
|||
|
Instrument Related Business:
|
|
|
|
|
|
|
|
|||||||
|
Bioinstruments
|
585
|
|
|
1,024
|
|
|
(439
|
)
|
|
(43
|
)%
|
|||
|
Bioconsumables
|
725
|
|
|
761
|
|
|
(36
|
)
|
|
(5
|
)%
|
|||
|
|
1,310
|
|
|
1,785
|
|
|
(475
|
)
|
|
(27
|
)%
|
|||
|
Costs of Goods Sold
|
$
|
3,112
|
|
|
$
|
2,608
|
|
|
$
|
504
|
|
|
19
|
%
|
|
|
Dollars in Thousands
|
|||||||||||||
|
|
Six Months Ended
|
|
|
|||||||||||
|
|
June 30,
|
|
Change
|
|||||||||||
|
|
2011
|
|
2010
|
|
$
|
|
%
|
|||||||
|
Laboratory Services:
|
|
|
|
|
|
|
|
|||||||
|
Molecular Clinical Reference Laboratory
|
$
|
7,351
|
|
|
$
|
1,873
|
|
|
$
|
5,478
|
|
|
292
|
%
|
|
Pharmacogenomics Research Services
|
1,272
|
|
|
639
|
|
|
633
|
|
|
99
|
%
|
|||
|
|
8,623
|
|
|
2,512
|
|
|
6,111
|
|
|
243
|
%
|
|||
|
Instrument Related Business:
|
|
|
|
|
|
|
|
|||||||
|
Bioinstruments
|
3,157
|
|
|
4,569
|
|
|
(1,412
|
)
|
|
(31
|
)%
|
|||
|
Bioconsumables
|
3,368
|
|
|
3,456
|
|
|
(88
|
)
|
|
(3
|
)%
|
|||
|
|
6,525
|
|
|
8,025
|
|
|
(1,500
|
)
|
|
(19
|
)%
|
|||
|
Total Net sales
|
$
|
15,148
|
|
|
$
|
10,537
|
|
|
$
|
4,611
|
|
|
44
|
%
|
|
|
Dollars in Thousands
|
|||||||||||||
|
|
Six Months Ended
|
|
|
|||||||||||
|
|
June 30,
|
|
Change
|
|||||||||||
|
|
2011
|
|
2010
|
|
$
|
|
%
|
|||||||
|
Laboratory Services:
|
|
|
|
|
|
|
|
|||||||
|
Molecular Clinical Reference Laboratory
|
$
|
3,023
|
|
|
$
|
957
|
|
|
$
|
2,066
|
|
|
216
|
%
|
|
Pharmacogenomics Research Services
|
750
|
|
|
654
|
|
|
96
|
|
|
15
|
%
|
|||
|
|
3,773
|
|
|
1,611
|
|
|
2,162
|
|
|
134
|
%
|
|||
|
Instrument Related Business:
|
|
|
|
|
|
|
|
|||||||
|
Bioinstruments
|
1,107
|
|
|
1,956
|
|
|
(849
|
)
|
|
(43
|
)%
|
|||
|
Bioconsumables
|
1,526
|
|
|
1,599
|
|
|
(73
|
)
|
|
(5
|
)%
|
|||
|
|
2,633
|
|
|
3,555
|
|
|
(922
|
)
|
|
(26
|
)%
|
|||
|
Costs of Goods Sold
|
$
|
6,406
|
|
|
$
|
5,166
|
|
|
$
|
1,240
|
|
|
24
|
%
|
|
|
Dollars in Thousands
|
||||||||||
|
|
June 30,
2011 |
|
December 31,
2010
|
|
|
Change
|
|||||
|
Current assets (including cash and cash equivalents of $2,639 and $3,454, respectively)
|
$
|
14,002
|
|
|
$
|
15,034
|
|
|
$
|
(1,032
|
)
|
|
Current liabilities
|
9,905
|
|
|
8,253
|
|
|
1,652
|
|
|||
|
Working capital
|
$
|
4,097
|
|
|
$
|
6,781
|
|
|
$
|
(2,684
|
)
|
|
Item 4.
|
Controls and Procedures
|
|
Item 1.
|
Legal Proceedings
|
|
Item 1A.
|
Risk Factors
|
|
Item 6.
|
Exhibits
|
|
(a)
|
Exhibits
|
|
3.1
|
|
|
Third Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to Registrant’s Report on Form 10-Q (Registration No. 000-30975) filed on November 14, 2005)
|
|
|
|
|
|
|
3.2
|
|
|
Amended and Restated Bylaws of the Registrant (incorporated by reference to Registrant’s Report on Form 8-K (Registration No. 000-30975) filed on May 25, 2007)
|
|
|
|
|
|
|
3.3
|
|
|
Certificate of Designation of Series A Convertible Preferred Stock dated as of December 28, 2010 (incorporated by reference to Exhibit 3.1 to Registrant’s Report on Form 8-K (Registration No. 000-30975) filed on January 4, 2011)
|
|
|
|
|
|
|
4.1
|
|
|
Form of Certificate of the Registrant’s Common Stock (incorporated by reference to Exhibit 4 to Registration Statement on Form S-1 (Registration No. 333-32174) filed on March 10, 2000)
|
|
|
|
|
|
|
4.2
|
|
|
Series A convertible Preferred Stock Purchase Agreement, dated December 29, 2010, by and among Transgenomic, Inc., Third Security Senior Staff 2008 LLC, Third Security Staff 2010 LLC, and Third Security Incentive 2010 LLC (incorporated by reference to Exhibit 4.1 to Registrant’s Report on Form 8-K (Registration No. 000-30975) filed on January 4, 2011)
|
|
|
|
|
|
|
4.3
|
|
|
Form of Warrant (incorporated by reference to Exhibit 4.2 to Registrant’s Report on Form 8-K (Registration No. 000-30975) filed on January 4, 2011)
|
|
|
|
|
|
|
4.4
|
|
|
Registration Rights Agreement, dated December 29, 2010, by and among Transgenomic, Inc., Third Security Senior Staff 2008 LLC, Third Security Staff 2010 LLC, and Third Security Incentive 2010 LLC (incorporated by reference to Exhibit 4.3 to Registrant’s Report on Form 8-K (Registration No. 000-30975) filed on January 4, 2011)
|
|
|
|
|
|
|
4.5
|
|
|
Secured Promissory Note, issued December 29, 2010 by Transgenomic, Inc. in favor of PGxHealth, LLC (incorporated by reference to Exhibit 4.4 to Registrant’s Report on Form 8-K (Registration No. 000-30975) filed on January 4, 2011)
|
|
|
|
|
|
|
4.6
|
|
|
Secured Promissory Note, issued December 29, 2010 by Transgenomic, Inc. in favor of PGxHealth, LLC (incorporated by reference to Exhibit 4.5 to Registrant’s Report on Form 8-K (Registration No. 000-30975) filed on January 4, 2011)
|
|
|
|
|
|
|
10.1
|
|
|
Sublease Agreement, dated December 29, 2010, by and between Transgenomic, Inc. and Clinical Data, Inc. (incorporated by reference to Exhibit 10.1 to Registrant’s Report on Form 8-K (Registration No. 000-30975) filed on January 4, 2011)
|
|
|
|
|
|
|
10.2
|
|
|
Noncompetition and Nonsolicitation Agreement, dated December 29, 2010 by and among PGxHealth, LLC, Clinical Data, Inc. and Transgenomic, Inc. (incorporated by reference to Exhibit 10.2 to Registrant’s Report on Form 8-K (Registration No. 000-30975) filed on January 4, 2011)
|
|
|
|
|
|
|
10.3
|
|
|
Security Agreement, dated December 29, 2010, by and between PGxHealth, LLC and Transgenomic, Inc. (incorporated by reference to Exhibit 10.3 to Registrant’s Report on Form 8-K (Registration No. 000-30975) filed on January 4, 2011)
|
|
|
|
|
|
|
31
|
|
|
Certifications pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
|
|
|
|
|
32
|
|
|
Certifications pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
|
|
|
|
|
101.INS
|
|
XBRL Instance Document *
|
|
|
|
|
|
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document *
|
|
|
|
|
|
|
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document *
|
|
|
|
|
|
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document *
|
|
|
|
|
|
|
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document *
|
|
|
|
|
|
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document *
|
|
|
|
|
|
|
|
*
|
|
|
XBRL information is furnished and not filed for purposes of Sections 11 and 12 of the Securities Act of 1933 and Section 18 of the Securities Act of 1934, and is not subject to liability under those sections, is not part of any registration statement or prospectus to which it relates and is not incorporated or deemed to be incorporated by reference into any registration statement, prospectus or other document.
|
|
|
|
|
|
|
|
|
TRANSGENOMIC, INC.
|
|
|
|
|
|
|
|
Date:
|
August 12, 2011
|
By:
|
/
S
/ CRAIG J. TUTTLE
|
|
|
|
|
Craig J. Tuttle
President and Chief Executive Officer
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|