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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 March 31, 2013
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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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x
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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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o
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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 3.
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Quantitative and Qualitative Disclosures About Market Risk
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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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March 31,
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||||
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2013
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December 31,
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||||
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(unaudited)
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2012
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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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7,729
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$
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4,497
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Accounts receivable, net
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7,897
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8,081
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Inventories, net
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4,783
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5,092
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Other current assets
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1,185
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1,047
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Total current assets
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21,594
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18,717
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PROPERTY AND EQUIPMENT:
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||||
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Equipment
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10,723
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10,682
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Furniture, fixtures & leasehold improvements
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3,861
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3,848
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14,584
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14,530
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Less: accumulated depreciation
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(12,513
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)
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(12,340
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)
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2,071
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2,190
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OTHER ASSETS:
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||||
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Goodwill
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6,918
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6,918
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Intangibles, net
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10,362
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10,764
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Other assets
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453
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202
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$
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41,398
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$
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38,791
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LIABILITIES AND STOCKHOLDERS’ EQUITY
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||||
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CURRENT LIABILITIES:
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Accounts payable
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$
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1,516
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$
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2,052
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Accrued compensation
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1,125
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1,121
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Current maturities of long term debt
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364
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6,171
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Accrued expenses
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2,826
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3,686
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Deferred revenue
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1,155
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1,171
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Other liabilities
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1,067
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1,067
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Accrued preferred stock dividend
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1,441
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1,260
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Total current liabilities
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9,494
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16,528
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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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6,069
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—
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Common stock warrant liability
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500
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900
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Other long-term liabilities
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1,266
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1,089
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Total liabilities
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17,329
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18,517
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STOCKHOLDERS’ EQUITY:
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Series A preferred stock, $.01 par value, 15,000,000 shares authorized, 2,586,205 shares issued and outstanding
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26
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26
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Common stock, $.01 par value, 150,000,000 shares authorized, 88,245,725 and 71,645,725 shares issued and outstanding, respectively
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887
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721
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Additional paid-in capital
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178,450
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170,881
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Accumulated other comprehensive income
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262
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435
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Accumulated deficit
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(155,556
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)
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(151,789
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)
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Total stockholders’ equity
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24,069
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20,274
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$
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41,398
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$
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38,791
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Three Months Ended
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||||||
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March 31,
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||||||
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2013
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2012
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NET SALES
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$
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7,374
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$
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7,206
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COST OF GOODS SOLD
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3,693
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4,102
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Gross profit
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3,681
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3,104
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OPERATING EXPENSES:
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Selling, general and administrative
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6,737
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4,994
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Research and development
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764
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549
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7,501
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5,543
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LOSS FROM OPERATIONS
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(3,820
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)
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(2,439
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)
|
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OTHER INCOME (EXPENSE):
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||||
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Interest expense, net
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(153
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)
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(273
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)
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Change in fair value of warrants
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400
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—
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Other, net
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53
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20
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300
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(253
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)
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LOSS BEFORE INCOME TAXES
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(3,520
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)
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(2,692
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)
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INCOME TAX EXPENSE
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66
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4
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NET LOSS
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$
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(3,586
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)
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$
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(2,696
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)
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PREFERRED STOCK DIVIDENDS AND ACCRETION
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(181
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)
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(165
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)
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NET LOSS AVAILABLE TO COMMON STOCKHOLDERS
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$
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(3,767
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)
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$
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(2,861
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)
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BASIC AND DILUTED LOSS PER COMMON SHARE
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$
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(0.04
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)
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$
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(0.05
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)
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BASIC AND DILUTED WEIGHTED AVERAGE SHARES OF COMMON STOCK OUTSTANDING
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84,003,503
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62,683,527
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Three Months Ended
|
||||||
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March 31,
|
||||||
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|
2013
|
|
2012
|
||||
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Net Loss
|
$
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(3,586
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)
|
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$
|
(2,696
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)
|
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Other Comprehensive Income (Loss); foreign currency translation adjustment, net of tax
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(173
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)
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61
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|
||
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Comprehensive Loss
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$
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(3,759
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)
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$
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(2,635
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)
|
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|
||||
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Preferred Stock
|
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Common Stock
|
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||||||||||||||||||
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Outstanding
Shares |
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Par
Value |
|
Outstanding
Shares
|
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Par
Value
|
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Additional
Paid-in
Capital
|
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Accumulated
Deficit
|
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Accumulated
Other
Comprehensive
Income
|
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Total
|
||||||||||||||
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Balance, January 1, 2013
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2,586,205
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$26
|
|
71,645,725
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$
|
721
|
|
|
$
|
170,881
|
|
|
$
|
(151,789
|
)
|
|
$
|
435
|
|
|
$
|
20,274
|
|
||
|
Net loss
|
|
|
|
|
—
|
|
|
—
|
|
|
—
|
|
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(3,586
|
)
|
|
—
|
|
|
(3,586
|
)
|
||||||||
|
Foreign currency translation adjustment, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(173
|
)
|
|
(173
|
)
|
||||||
|
Non-cash stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
164
|
|
|
—
|
|
|
—
|
|
|
164
|
|
||||||
|
Private Placement, net
|
—
|
|
|
—
|
|
|
16,600,000
|
|
|
166
|
|
|
7,405
|
|
|
—
|
|
|
—
|
|
|
7,571
|
|
||||||
|
Dividends on preferred stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(181
|
)
|
|
—
|
|
|
(181
|
)
|
||||||
|
Balance, March 31, 2013
|
2,586,205
|
|
|
$
|
26
|
|
|
88,245,725
|
|
|
$
|
887
|
|
|
$
|
178,450
|
|
|
$
|
(155,556
|
)
|
|
$
|
262
|
|
|
$
|
24,069
|
|
|
|
Three Months Ended
|
||||||
|
|
March 31,
|
||||||
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2013
|
|
2012
|
||||
|
CASH FLOWS USED IN OPERATING ACTIVITIES:
|
|
|
|
||||
|
Net loss
|
$
|
(3,586
|
)
|
|
$
|
(2,696
|
)
|
|
Adjustments to reconcile net loss to net cash flows used in operating activities:
|
|
|
|
||||
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Depreciation and amortization
|
744
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513
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|
||
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Non-cash, stock based compensation
|
164
|
|
|
273
|
|
||
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Provision for losses on doubtful accounts
|
1,581
|
|
|
474
|
|
||
|
Provision for losses on inventory obsolescence
|
—
|
|
|
1
|
|
||
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Warrant revaluation
|
(400
|
)
|
|
—
|
|
||
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Loss on sale of fixed assets
|
9
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|
|
—
|
|
||
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Gain on foreign currency settlement
|
(62
|
)
|
|
—
|
|
||
|
Changes in operating assets and liabilities:
|
|
|
|
||||
|
Accounts receivable
|
(1,474
|
)
|
|
448
|
|
||
|
Inventories
|
212
|
|
|
(128
|
)
|
||
|
Other current assets
|
(157
|
)
|
|
(204
|
)
|
||
|
Accounts payable
|
(720
|
)
|
|
(1,057
|
)
|
||
|
Accrued expenses
|
356
|
|
|
(292
|
)
|
||
|
Other long term liabilities
|
(1
|
)
|
|
(97
|
)
|
||
|
Long term deferred income taxes
|
—
|
|
|
5
|
|
||
|
Net cash flows used in operating activities
|
(3,334
|
)
|
|
(2,760
|
)
|
||
|
CASH FLOWS USED IN INVESTING ACTIVITIES:
|
|
|
|
||||
|
Purchases of property and equipment
|
(87
|
)
|
|
(198
|
)
|
||
|
Acquisition
|
(849
|
)
|
|
—
|
|
||
|
Change in other assets
|
(127
|
)
|
|
(67
|
)
|
||
|
Net cash flows used in investing activities
|
(1,063
|
)
|
|
(265
|
)
|
||
|
CASH FLOWS PROVIDED BY USED IN FINANCING ACTIVITIES:
|
|
|
|
||||
|
Principal payments on capital lease obligations
|
(104
|
)
|
|
(52
|
)
|
||
|
Issuance of common stock and warrants, net
|
7,570
|
|
|
17,483
|
|
||
|
Payment of deferred financing costs
|
(60
|
)
|
|
—
|
|
||
|
Proceeds from borrowings
|
6,433
|
|
|
—
|
|
||
|
Principal payment on note payable
|
(6,171
|
)
|
|
(82
|
)
|
||
|
Net cash flows provided by financing activities
|
7,668
|
|
|
17,349
|
|
||
|
EFFECT OF FOREIGN CURRENCY EXCHANGE RATE CHANGES ON CASH
|
(39
|
)
|
|
21
|
|
||
|
NET CHANGE IN CASH AND CASH EQUIVALENTS
|
3,232
|
|
|
14,345
|
|
||
|
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
|
4,497
|
|
|
4,946
|
|
||
|
CASH AND CASH EQUIVALENTS AT END OF PERIOD
|
$
|
7,729
|
|
|
$
|
19,291
|
|
|
SUPPLEMENTAL CASH FLOW INFORMATION
|
|
|
|
||||
|
Cash paid during the period for:
|
|
|
|
||||
|
Interest
|
$
|
262
|
|
|
$
|
495
|
|
|
Income taxes, net
|
—
|
|
|
2
|
|
||
|
SUPPLEMENTAL DISCLOSURE OF NON-CASH INFORMATION
|
|
|
|
||||
|
Acquisition of equipment through capital leases
|
$
|
—
|
|
|
$
|
12
|
|
|
Dividends accrued on preferred stock
|
181
|
|
|
165
|
|
||
|
Note Payable converted to Equity
|
—
|
|
|
3,000
|
|
||
|
Deferred financing costs in accounts payable
|
197
|
|
|
—
|
|
||
|
•
|
Laboratory Services. Our clinical laboratories specialize in genetic testing for cardiology, neurology, mitochondrial disorders and oncology. Our clinical laboratories located in New Haven, Connecticut and Omaha, Nebraska are certified under the Clinical Laboratory Improvement Amendment (CLIA) as high complexity labs and our Omaha facility is also accredited by the College of American Pathologists (CAP). Our laboratory located in Omaha, Nebraska also provides pharmacogenomics research services supporting Phase II and Phase III clinical trials conducted by pharmaceutical companies. Our laboratories employ a variety of genomic testing service technologies, including ICE COLD-PCR technology. ICE COLD-PCR is a proprietary platform technology that can be run in any laboratory with standard PCR technology and that enables detection of mutations from virtually any sample type including tissue biopsies, blood and circulating tumor cells (CTCs) at levels greater than 1,000-fold higher than standard DNA sequencing techniques.
|
|
•
|
Diagnostic Tools. Our proprietary product is the WAVE
®
System, which has broad applicability to genetic variation detection in both molecular genetic research and molecular diagnostics. 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. The installed WAVE base and some OEM Equipment 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
|
||||||||||||||
|
|
Beginning
Balance
|
|
Provision
|
|
Write Offs
|
|
Ending
Balance
|
||||||||
|
Three Months Ended March 31, 2013
|
$
|
2,171
|
|
|
$
|
1,581
|
|
|
$
|
(1,203
|
)
|
|
$
|
2,549
|
|
|
Three Months Ended March 31, 2012
|
$
|
1,088
|
|
|
$
|
474
|
|
|
$
|
(483
|
)
|
|
$
|
1,079
|
|
|
|
Dollars in Thousands
|
||||||||||||||
|
|
Beginning
Balance
|
|
Provision
|
|
Write Offs
|
|
Ending
Balance
|
||||||||
|
Three Months Ended March 31, 2013
|
$
|
616
|
|
|
$
|
—
|
|
|
$
|
(5
|
)
|
|
$
|
611
|
|
|
Three Months Ended March 31, 2012
|
$
|
511
|
|
|
$
|
1
|
|
|
$
|
(3
|
)
|
|
$
|
509
|
|
|
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
|
|
•
|
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.
|
|
|
Dollars in Thousands
|
||||||
|
|
March 31,
2013 |
|
December 31,
2012
|
|
|||
|
Finished goods
|
$
|
3,725
|
|
|
$
|
4,057
|
|
|
Raw materials and work in process
|
1,542
|
|
|
1,547
|
|
||
|
Demonstration inventory
|
127
|
|
|
104
|
|
||
|
|
$
|
5,394
|
|
|
$
|
5,708
|
|
|
Less allowance for obsolescence
|
(611
|
)
|
|
(616
|
)
|
||
|
Total
|
$
|
4,783
|
|
|
$
|
5,092
|
|
|
|
Dollars in Thousands
|
||||||||||||||||||||||
|
|
March 31, 2013
|
|
December 31, 2012
|
||||||||||||||||||||
|
|
Cost
|
|
Accumulated
Amortization
|
|
Net Book
Value
|
|
Cost
|
|
Accumulated
Amortization
|
|
Net Book
Value
|
||||||||||||
|
Intangibles—acquired technology
|
$
|
9,009
|
|
|
$
|
2,226
|
|
|
$
|
6,783
|
|
|
$
|
9,009
|
|
|
$
|
1,910
|
|
|
$
|
7,099
|
|
|
Intangibles—assay royalties
|
1,434
|
|
|
461
|
|
|
973
|
|
|
1,434
|
|
|
410
|
|
|
1,024
|
|
||||||
|
Intangibles—third party payor relationships
|
367
|
|
|
55
|
|
|
312
|
|
|
367
|
|
|
49
|
|
|
318
|
|
||||||
|
Intangibles—tradenames and trademarks
|
824
|
|
|
145
|
|
|
679
|
|
|
824
|
|
|
115
|
|
|
709
|
|
||||||
|
Intangibles—customer relationships
|
652
|
|
|
22
|
|
|
630
|
|
|
652
|
|
|
11
|
|
|
641
|
|
||||||
|
Intangibles—covenants not to compete
|
184
|
|
|
31
|
|
|
153
|
|
|
184
|
|
|
15
|
|
|
169
|
|
||||||
|
Patents
|
975
|
|
|
293
|
|
|
682
|
|
|
929
|
|
|
280
|
|
|
649
|
|
||||||
|
Intellectual property
|
170
|
|
|
20
|
|
|
150
|
|
|
170
|
|
|
15
|
|
|
155
|
|
||||||
|
|
$
|
13,615
|
|
|
$
|
3,253
|
|
|
$
|
10,362
|
|
|
$
|
13,569
|
|
|
$
|
2,805
|
|
|
$
|
10,764
|
|
|
|
|
|
|
Estimated Useful Life
|
|
Acquired technology
|
7-8 years
|
|
Assay royalties
|
7 years
|
|
Third party payor relationships
|
15 years
|
|
Tradenames and trademarks
|
7 years
|
|
Customer relationships
|
15 years
|
|
Covenants not to compete
|
3 years
|
|
Patents
|
Life of the patent
|
|
Intellectual property
|
7 years
|
|
|
|
Dollars in Thousands
|
||||||
|
|
|
March 31, 2013
|
|
December 31, 2012
|
||||
|
Revolving Line of Credit
(1)
|
|
$
|
2,433
|
|
|
$
|
—
|
|
|
Term Loan
(2)
|
|
4,000
|
|
|
—
|
|
||
|
PGxHealth note payable (the "First Note")
(3)
|
|
—
|
|
|
6,171
|
|
||
|
Total debt, including short term debt
|
|
6,433
|
|
|
6,171
|
|
||
|
Current maturities of long term debt
|
|
(364
|
)
|
|
(6,171
|
)
|
||
|
Long-term debt, net of current maturities
|
|
$
|
6,069
|
|
|
$
|
—
|
|
|
(1)
|
Revolving Line of Credit
Amounts advanced under the Revolving Line bear interest at an annual rate equal to the greater of (a)
4.25%
or (b) the
Wall Street Journal
prime rate plus
1%
. Interest is payable on a monthly basis, with the balance payable at the maturity of the Revolving Line. The current interest rate is 4.25%. Under the Loan Agreement, we paid the Lenders an upfront fee of
$20,000
, and will pay the Lenders an additional commitment fee of
$20,000
on each anniversary of the Effective Date during the term of the Revolving Line. In addition, a fee of
0.5%
per year is payable quarterly on the unused portion of the Revolving Line. The Revolving Line matures on September 1, 2016.
|
|
(2)
|
Term Loan
We received
$4.0 million
under the Term Loan on the Effective Date. We are required to make interest-only payments under the Term Loan through December 31, 2013 and principal and interest payments on a monthly basis, beginning on January 1, 2014, over
33 months
using a straight-line amortization rate. Interest under the Term Loan will accrue at the annual rate of one month LIBOR plus
6.1%
, subject to a LIBOR floor of
3%
. The current interest rate is
9.1%
.
|
|
(3)
|
The First Note was a
three
year senior secured promissory note payable to PGxHealth, LLC entered into on
December 29, 2010
in conjunction with our acquisition of the FAMILION family of genetic tests. Interest was payable at
10%
per year with quarterly interest payments through March 29, 2012. Thereafter, quarterly installments include both principal and interest through December 30, 2013. The First Note was paid in full on March 13, 2013.
|
|
Warrant Holder
|
|
Issue Year
|
|
Expiration
|
|
Underlying
Shares
|
|
Exercise
Price
|
|
Affiliates of Third Security, LLC
(1)
|
|
2010
|
|
December 2015
|
|
5,172,408
|
|
$0.58
|
|
Various Institutional Holders
(2)
|
|
2012
|
|
February 2017
|
|
11,435,158
|
|
$1.08
|
|
Affiliates of Third Security, LLC
(2)
|
|
2012
|
|
February 2017
|
|
1,736,110
|
|
$1.08
|
|
Various Institutional Holders
(3)
|
|
2013
|
|
January 2018
|
|
5,300,000
|
|
$0.75
|
|
Affiliates of Third Security, LLC
(3)
|
|
2013
|
|
January 2018
|
|
3,000,000
|
|
$0.75
|
|
|
|
|
|
|
|
26,643,676
|
|
|
|
(1)
|
This warrant was issued in connection with the issuance of warrants to purchase shares of our Series A Preferred Stock to affiliates of Third Security, LLC in December 2010. The number of underlying shares shown reflects the number of shares of common stock issuable upon conversion of the shares of Series A Preferred Stock for which this warrant is currently exercisable.
|
|
(2)
|
These Warrants were issued in connection with the private placement completed in February 2012. Warrants were repriced and additional warrants were issued in connection with the warrants issued with the private placement completed in January 2013.
|
|
(3)
|
These warrants were issued in connection with the private placement completed in January 2013.
|
|
|
|
Dollars in Thousands
|
||
|
|
|
For the Three Months Ended
|
||
|
|
|
March 31, 2013
|
||
|
Beginning balance at January 1, 2013
|
|
$
|
900
|
|
|
Total gains or losses:
|
|
|
||
|
Recognized in earnings
|
|
(400
|
)
|
|
|
Balance at March 31, 2013
|
|
$
|
500
|
|
|
|
|
Dollars in Thousands
|
||
|
|
|
For the Three Months Ended
|
||
|
|
|
March 31, 2012
|
||
|
Beginning balance at January 1, 2012
|
|
$
|
—
|
|
|
Additions
|
|
3,100
|
|
|
|
Total gains or losses:
|
|
|
||
|
Recognized in earnings
|
|
—
|
|
|
|
Balance at March 31, 2012
|
|
$
|
3,100
|
|
|
|
|
|
|
|
Number of
Options
|
|
Weighted Average
Exercise Price
|
|||
|
Balance at January 1, 2013
|
4,353,167
|
|
|
$
|
1.05
|
|
|
Granted
|
307,500
|
|
|
0.57
|
|
|
|
Exercised
|
—
|
|
|
—
|
|
|
|
Forfeited
|
(40,334
|
)
|
|
(1.16
|
)
|
|
|
Expired
|
—
|
|
|
—
|
|
|
|
Balance at March 31, 2013
|
4,620,333
|
|
|
$
|
1.02
|
|
|
Exercisable at March 31, 2013
|
2,852,310
|
|
|
$
|
1.04
|
|
|
|
Dollars in Thousands
|
||||||||||
|
|
2013
|
||||||||||
|
|
Laboratory Services
|
|
Diagnostic
Tools |
|
Total
|
||||||
|
Net Sales
|
$
|
4,427
|
|
|
$
|
2,947
|
|
|
$
|
7,374
|
|
|
Gross Profit
|
2,193
|
|
|
1,488
|
|
|
3,681
|
|
|||
|
Net Loss before Taxes
|
(3,085
|
)
|
|
(435
|
)
|
|
(3,520
|
)
|
|||
|
Income Tax Expense
|
—
|
|
|
66
|
|
|
66
|
|
|||
|
Net Loss
|
$
|
(3,085
|
)
|
|
$
|
(501
|
)
|
|
$
|
(3,586
|
)
|
|
Depreciation/Amortization
|
$
|
563
|
|
|
$
|
181
|
|
|
$
|
744
|
|
|
Interest Expense, net
|
$
|
135
|
|
|
$
|
18
|
|
|
$
|
153
|
|
|
|
|
|
|
|
|
||||||
|
|
March 31, 2013
|
||||||||||
|
Total Assets
|
$
|
30,366
|
|
|
$
|
11,032
|
|
|
$
|
41,398
|
|
|
|
|
|
|
|
|
||||||
|
|
Dollars in Thousands
|
||||||||||
|
|
2012
|
||||||||||
|
|
Laboratory Services
|
|
Diagnostic
Tools |
|
Total
|
||||||
|
Net Sales
|
$
|
4,001
|
|
|
$
|
3,205
|
|
|
$
|
7,206
|
|
|
Gross Profit
|
1,648
|
|
|
1,456
|
|
|
3,104
|
|
|||
|
Net Income (Loss) before Taxes
|
(2,087
|
)
|
|
(605
|
)
|
|
(2,692
|
)
|
|||
|
Income Tax Expense (Benefit)
|
—
|
|
|
4
|
|
|
4
|
|
|||
|
Net Income (Loss)
|
$
|
(2,087
|
)
|
|
$
|
(609
|
)
|
|
$
|
(2,696
|
)
|
|
Depreciation/Amortization
|
$
|
448
|
|
|
$
|
65
|
|
|
$
|
513
|
|
|
Interest Expense, net
|
$
|
252
|
|
|
$
|
21
|
|
|
$
|
273
|
|
|
|
|
|
|
|
|
||||||
|
|
March 31, 2012
|
||||||||||
|
Total Assets
|
$
|
30,595
|
|
|
$
|
16,589
|
|
|
$
|
47,184
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dollars in Thousands
|
||||||
|
|
Three Months Ended
|
||||||
|
|
March 31,
|
||||||
|
|
2013
|
|
2012
|
||||
|
United States
|
$
|
5,348
|
|
|
$
|
4,724
|
|
|
Italy
|
455
|
|
|
799
|
|
||
|
All Other Countries
|
1,571
|
|
|
1,683
|
|
||
|
Total
|
$
|
7,374
|
|
|
$
|
7,206
|
|
|
Item 2.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
|
•
|
Laboratory Services. Our clinical laboratories specialize in genetic testing for cardiology, neurology, mitochondrial disorders and oncology. Our clinical laboratories located in New Haven, Connecticut and Omaha, Nebraska are certified under the Clinical Laboratory Improvement Amendment (CLIA) as high complexity labs and our Omaha facility is also accredited by the College of American Pathologists (CAP). Our laboratory located in Omaha, Nebraska also provides pharmacogenomics research services supporting Phase II and Phase III clinical trials conducted by pharmaceutical companies. Our laboratories employ a variety of genomic testing service technologies including ICE COLD-PCR technology. ICE COLD-PCR is a proprietary platform technology that can be run in any laboratory with standard PCR technology and that enables detection of mutations from virtually any sample type including tissue biopsies, blood and circulating tumor cells (CTCs) at levels greater than 1,000-fold higher than standard DNA sequencing techniques.
|
|
•
|
Diagnostic Tools. Our proprietary product is the WAVE
®
System which has broad applicability to genetic variation detection in both molecular genetic research and molecular diagnostics. 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. The installed WAVE base and some OEM Equipment 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
|
|
|
|||||||||||
|
|
March 31,
|
|
Change
|
|||||||||||
|
|
2013
|
|
2012
|
|
$
|
|
%
|
|||||||
|
Laboratory Services
|
$
|
4,427
|
|
|
$
|
4,001
|
|
|
$
|
426
|
|
|
11
|
%
|
|
Diagnostic Tools
|
2,947
|
|
|
3,205
|
|
|
(258
|
)
|
|
(8
|
)%
|
|||
|
Total Net Sales
|
$
|
7,374
|
|
|
$
|
7,206
|
|
|
$
|
168
|
|
|
2
|
%
|
|
|
Dollars in Thousands
|
||||||||||||
|
|
Three Months Ended
|
|
|
||||||||||
|
|
March 31,
|
|
Margin %
|
||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||
|
Laboratory Services
|
$
|
2,193
|
|
|
$
|
1,648
|
|
|
50
|
%
|
|
41
|
%
|
|
Diagnostic Tools
|
1,488
|
|
|
1,456
|
|
|
50
|
%
|
|
45
|
%
|
||
|
Gross Profit
|
$
|
3,681
|
|
|
$
|
3,104
|
|
|
50
|
%
|
|
43
|
%
|
|
|
Dollars in Thousands
|
||||||||||
|
|
March 31,
2013 |
|
December 31,
2012
|
|
|
Change
|
|||||
|
Current assets (including cash and cash equivalents of $7,729 and $4,497, respectively)
|
$
|
21,594
|
|
|
$
|
18,717
|
|
|
$
|
2,877
|
|
|
Current liabilities
|
9,494
|
|
|
16,528
|
|
|
(7,034
|
)
|
|||
|
Working capital
|
$
|
12,100
|
|
|
$
|
2,189
|
|
|
$
|
9,911
|
|
|
Item 4.
|
Controls and Procedures
|
|
Item 1.
|
Legal Proceedings
|
|
Item 1A.
|
Risk Factors
|
|
Item 6.
|
Exhibits
|
|
(a)
|
Exhibits
|
|
2.1**
|
|
|
Asset Purchase Agreement among the Registrant, Scoli Acquisition Sub, Inc. and Axial Biotech, Inc. dated August 27, 2012
|
|
|
|
|
|
|
3.1
|
|
|
Third Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant's Quarterly 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 Exhibit 3(ii) to the Registrant's Current 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 the Registrant's Current Report on Form 8-K (Registration No. 000-30975) filed on January 4, 2011)
|
|
|
|
|
|
|
3.4
|
|
|
Certificate of Amendment of Third Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant's Current Report on Form 8-K (Registration No. 000-30975) filed on May 29, 2012)
|
|
|
|
|
|
|
3.5
|
|
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Certificate of Amendment of Certificate of Designation of Series A Convertible Preferred Stock of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant's Current Report on Form 8-K (Registration No. 000-30975) filed on May 29, 2012)
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4.1
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Form of Certificate of the Registrant's Common Stock (incorporated by reference to Exhibit 4 to the Registrant's Registration Statement on Form S-1 (Registration No. 333-32174) filed on March 10, 2000)
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4.2
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Common Stock Purchase Warrant by and between the Registrant and Laurus Master Fund, Ltd., dated December 3, 2003 (incorporated by reference to Exhibit 10.4 to the Registrant's Registration Statement on Form S-3 (Registration No. 333-111442) filed on December 22, 2003)
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4.3
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Registration Rights Agreement by and between the Registrant and Laurus Master Fund, Ltd., dated December 3, 2003 (incorporated by reference to Exhibit 10.5 to the Registrant's Registration Statement on Form S-3 (Registration No. 333-111442) filed on December 22, 2003)
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4.4
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Common Stock Purchase Warrant by and between the Registrant and Laurus Master Fund, Ltd., dated February 19, 2004, as amended on April 15, 2004 (incorporated by reference to Exhibit 10.3 to the Registrant's Registration Statement on Form S-3 (Registration No. 333-114661) filed on April 21, 2004)
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4.5
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Registration Rights Agreement by and between the Registrant and Laurus Master Fund, Ltd., dated February 19, 2004 (incorporated by reference to Exhibit 10.4 to the Registrant's Registration Statement on Form S-3 (Registration No. 333-114661) filed on April 21, 2004)
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4.6
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Common Stock Purchase Warrant by and between the Registrant and Laurus Master Fund, Ltd., dated August 31, 2004 (incorporated by reference to Exhibit 10.3 to the Registrant's Registration Statement on Form S-3 (Registration No. 333-118970) filed on September 14, 2004)
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4.7
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Common Stock Purchase Warrant by and between the Registrant and Oppenheimer & Co., Inc. dated October 27, 2005 (incorporated by reference to Exhibit 10.34 to the Registrant's Annual Report on Form 10-K filed on March 31, 2006)
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4.8
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Form of Series A Convertible Preferred Stock Warrant issued to Third Security Senior Staff 2008 LLC, Third Security Staff 2010 LLC, and Third Security Incentive 2010 LLC (incorporated by reference to Exhibit 4.2 to the Registrant's Current Report on Form 8-K (Registration No. 000-30975) filed on January 4, 2011)
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4.9
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Registration Rights Agreement, dated December 29, 2010, by and among the Registrant, 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 the Registrant's Current Report on Form 8-K (Registration No. 000-30975) filed on January 4, 2011)
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4.10
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First Amendment to Registration Rights Agreement dated November 8, 2011 (incorporated by reference to Exhibit 4.2 to the Registrant's Current Report on Form 8-K filed on November 14, 2011)
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4.11
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Secured Promissory Note, issued December 29, 2010 by the Registrant in favor of PGxHealth, LLC (incorporated by reference to Exhibit 4.4 to the Registrant's Current Report on Form 8-K (Registration No. 000-30975) filed on January 4, 2011)
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4.12
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Secured Promissory Note, issued December 29, 2010 by the Registrant in favor of PGxHealth, LLC (incorporated by reference to Exhibit 4.5 to the Registrant's Current Report on Form 8-K (Registration No. 000-30975) filed on January 4, 2011)
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4.13
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Convertible Promissory Note by and between the Registrant and Third Security Senior Staff 2008 LLC dated December 30, 2011 (incorporated by reference to Exhibit 10.2 to the Registrant's Current Report on Form 8-K filed on January 6, 2012)
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4.14
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Convertible Promissory Note by and between the Registrant and Third Security Staff 2010 LLC dated December 30, 2011 (incorporated by reference to Exhibit 10.3 to the Registrant's Current Report on Form 8-K filed on January 6, 2012)
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4.15
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Convertible Promissory Note by and between the Registrant and Third Security Incentive 2010 LLC dated December 30, 2011(incorporated by reference to Exhibit 10.2 to the Registrant's Current Report on Form 8-K filed on January 6, 2012)
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4.16
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Form of Warrant issued by the Registrant to the Third Security Entities on February 7, 2012 (incorporated by reference to Exhibit 10.2 to the Registrant's Current Report on Form 8-K filed on February 7, 2012)
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4.17
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Form of Warrant issued by the Registrant to the Investors on February 7, 2012 (incorporated by reference to Exhibit 10.3 to the Registrant's Current Report on Form 8-K filed on February 7, 2012)
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4.18
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Form of Registration Rights Agreement entered into by and among the Registrant, the Third Security Entities and the Investors dated February 2, 2012 (incorporated by reference to Exhibit 10.4 to the Registrant's Current Report on Form 8-K filed on February 7, 2012)
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10.1
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Securities Purchase Agreement, by and among the Registrant and the Investors, dated January 24, 2013 (incorporated by reference to Exhibit 10.1 to the Registrant's Current Report on Form 8-K/A filed on January 31, 2013)
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10.2
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Form of Warrant issued by the Registrant to the Investors on January 30, 2013 (incorporated by reference to Exhibit 10.2 to the Registrant's Current Report on Form 8-K/A filed on January 31, 2013)
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10.3
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Registration Rights Agreement, by and among the Registrant and the Investors, dated January 24, 2013 (incorporated by reference to Exhibit 10.3 to the Registrant's Current Report on Form 8-K/A filed on January 31, 2013)
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10.4
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Forbearance Agreement, dated February 7, 2013, by and between the Registrant and Dogwood Pharmaceuticals, Inc. (incorporated by reference to Exhibit 10.1 to the Registrant's Current Report on Form 8-K filed on February 8, 2013)
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10.5
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Loan and Security Agreement among the Registrant, Third Security Senior Staff 2008 LLC, as administrative agent and a lender, and the other lenders party thereto, dated March 13, 2013 (incorporated by reference to Exhibit 10.39 to the Registrant's Annual Report on Form 10-K filed on March 14, 2013)
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10.6#
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Amendment No. 1 to Employment Agreement Extension, dated February 27, 2013, by and between the Registrant and Craig J. Tuttle
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10.7#
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Amendment No. 1 to Employment Agreement, dated February 27, 2013, by and between the Registrant and Mark P. Colonnese
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31.1
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Certification of Craig J. Tuttle, President and Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended
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31.2
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Certification of Mark P. Colonnese, Executive Vice President and Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, as amended
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32.1
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Certification of Craig J. Tuttle, President and Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, as amended
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32.2
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Certification of Mark P. Colonnese, Executive Vice President and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, as amended
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101.INS
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XBRL Instance Document *
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101.SCH
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XBRL Taxonomy Extension Schema Document *
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101.CAL
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XBRL Taxonomy Extension Calculation Linkbase Document *
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101.DEF
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XBRL Taxonomy Extension Definition Linkbase Document *
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101.LAB
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XBRL Taxonomy Extension Label Linkbase Document *
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101.PRE
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XBRL Taxonomy Extension Presentation Linkbase Document *
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**
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Pursuant to Item 601(b)(2) of Regulation S-K, the schedules to this agreement have been omitted. The Registrant agrees to furnish supplementally a copy of any omitted schedule to the Securities and Exchange Commission upon request.
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#
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Indicates management contract or compensatory plan.
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*
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Attached as Exhibit 101 to this report are documents formatted in XBRL (Extensible Business Reporting Language). Users of this data are advised that, pursuant to Rule 406T of Regulation S-T, the interactive data file is deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, is deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is otherwise not subject to liability under these sections.
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TRANSGENOMIC, INC.
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Date:
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May 9, 2013
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By:
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/
S
/ CRAIG J. TUTTLE
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Craig J. Tuttle
President and Chief Executive Officer
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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 |
|---|