UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
/A
Amendment No. 1
QUARTERLY REPORT PURSUANT TO SECTION
13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March
31, 2012
Commission File Number 1-14798
IVAX DIAGNOSTICS, INC.
(Exact name of registrant as specified
in its charter)
Delaware
|
|
11-3500746
|
(State or other jurisdiction of
|
|
(I.R.S. Employer
|
incorporation or organization)
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|
Identification No.)
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2140 North Miami
Avenue, Miami, Florida
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33127
|
(Address of principal executive offices)
|
(Zip Code)
|
(305) 324-2300
(Registrant's telephone number, including
area code)
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports),
and (2) has been subject to such filing requirements for the past 90 days.
Yes
x
No
¨
Indicate
by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive
Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the
preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
Yes
x
No
¨
Indicate by check
mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting
company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting
company” in Rule 12b-2 of the Exchange Act.
Large Accelerated Filer
¨
|
Accelerated Filer
¨
|
|
|
Non-Accelerated Filer
¨
(Do not check if a smaller reporting company)
|
Smaller Reporting Company
x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes
¨
No
x
Indicate the number
of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date.
34,991,554 shares
of Common Stock, $ .01 par value, outstanding as of May 18, 2012.
EXPLANATORY NOTE
IVAX Diagnostics, Inc. (the “Company”) is filing this Amendment No. 1 to its Quarterly Report on Form 10-Q
for the three months ended March 31, 2012 (this “Amendment”) to correct an error the Company identified in its Quarterly Report
on Form 10-Q for the three months ended March 31, 2012 (the “Original Form 10-Q”) filed with the Securities and Exchange Commission
on May 21, 2012. In the Consolidated Statements of Comprehensive Loss in the Original Form 10-Q, the Company erroneously reported
comprehensive loss of $43,257 for the three months ended March 31, 2012. The Company actually experienced comprehensive income
of $43,257 for the three months ended March 31, 2012.
In connection with this Amendment, new XBRL interactive data files are
attached as exhibits hereto. In addition, as required by Rule 12b-15 under the Securities Exchange Act of 1934, new certifications
by the Company’s Chief Executive Officer and Chief Financial Officer are filed as exhibits to this Amendment.
For the convenience
of the reader, this Amendment contains the full text of the Original Form 10-Q in its entirety, as amended hereby. However,
this Amendment does not reflect subsequent events that may have occurred after the filing date of the Original Form 10-Q and,
except as described above, it does not change, modify or update the disclosures made therein.
IVAX DIAGNOSTICS, INC.
INDEX
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PAGE
NO.
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PART I - FINANCIAL INFORMATION
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Item 1
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-
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Financial Statements
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Consolidated Balance Sheets as of March 31, 2012 (unaudited)
and December 31, 2011
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2
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Consolidated Statements of Comprehensive Income (Loss) (unaudited)
for the three months ended March 31, 2012 and 2011
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3
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Consolidated Statement of Changes in Shareholders’ Equity (unaudited)
for the three months ended March 31, 2012
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4
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Consolidated Statements of Cash Flows (unaudited)
for the three months ended March 31, 2012 and 2011
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5
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Condensed Notes to Consolidated Financial Statements (unaudited)
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6
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Item 2
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-
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Management’s Discussion and Analysis of Financial Condition and Results of Operations
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15
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Item 4
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-
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Controls and Procedures
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27
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PART II - OTHER INFORMATION
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Item 1
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-
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Legal Proceedings
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28
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Item 6
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-
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Exhibits
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28
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PART I - FINANCIAL INFORMATION
Item 1 - Financial Statements
IVAX DIAGNOSTICS,
INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE
SHEETS
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March 31,
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December 31,
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2012
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2011
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(Unaudited)
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ASSETS
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Current assets:
|
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Cash and cash equivalents
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$
|
3,511,167
|
|
|
$
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3,653,244
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|
Accounts receivable, net of allowances for doubtful
accounts of $685,315 in 2012 and $716,599 in 2011
|
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6,043,004
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5,950,621
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Inventories, net
|
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3,681,509
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|
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3,830,295
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Other current assets
|
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397,332
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|
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|
231,992
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|
Total current assets
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13,633,012
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|
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13,666,152
|
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Property, plant and equipment, net
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1,384,684
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1,456,940
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Equipment on lease, net
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622,526
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674,504
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Product license
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282,936
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282,936
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Goodwill
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870,290
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870,290
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Restricted deposits
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118,527
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|
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127,859
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Other assets
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123,752
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|
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128,203
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Total assets
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|
$
|
17,035,727
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$
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17,206,884
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|
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LIABILITIES AND SHAREHOLDERS’
EQUITY
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Current liabilities:
|
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Accounts payable
|
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$
|
2,029,978
|
|
|
$
|
2,345,838
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|
Capital lease obligation
|
|
|
81,493
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|
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|
79,186
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|
Accrued license payable
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133,000
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|
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|
129,490
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Revolving line of credit
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660,995
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|
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736,566
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Other accrued expenses
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1,880,353
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1,744,221
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Total current liabilities
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4,785,819
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5,035,301
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Other long-term liabilities:
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Capital lease obligation
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-
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21,287
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Deferred tax liabilities
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444,549
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428,676
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Other long-term liabilities
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1,034,830
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994,348
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Total other long-term liabilities
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1,479,379
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1,444,311
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Commitments and contingencies
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Shareholders’ equity:
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Common stock, $0.01 par value, authorized 100,000,000
shares, issued and outstanding 34,391,554 in 2012 and 2011
|
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343,915
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|
343,915
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Capital in excess of par value
|
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46,035,037
|
|
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46,035,037
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Accumulated deficit
|
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(35,062,269
|
)
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(34,983,815
|
)
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Accumulated other comprehensive
loss
|
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(546,154
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)
|
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(667,865
|
)
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Total shareholders’ equity
|
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10,770,529
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|
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|
10,727,272
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Total liabilities and shareholders’
equity
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$
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17,035,727
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$
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17,206,884
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|
The accompanying Condensed Notes to Consolidated Financial
Statements are an integral part of these financial statements
IVAX DIAGNOSTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF
COMPREHENSIVE INCOME (LOSS)
(Unaudited)
Three Months Ended March 31,
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2012
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2011
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Net revenues
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$
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4,273,274
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$
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4,134,357
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Cost of sales
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2,150,936
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2,019,142
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Gross profit
|
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2,122,338
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2,115,215
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Operating expenses:
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Selling
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970,893
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1,225,489
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General and administrative
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1,075,387
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1,347,001
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Research and development
|
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195,544
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|
550,235
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Total operating expenses
|
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2,241,824
|
|
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3,122,725
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Loss from operations
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(119,486
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)
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(1,007,510
|
)
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Other income (expense):
|
|
|
|
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|
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Interest expense
|
|
|
(12,666
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)
|
|
|
(3,391
|
)
|
Other income, net
|
|
|
81,366
|
|
|
|
19,192
|
|
Total other income, net
|
|
|
68,700
|
|
|
|
15,801
|
|
|
|
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|
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Loss before income taxes
|
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|
(50,786
|
)
|
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|
(991,709
|
)
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|
|
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Provision for income taxes
|
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27,668
|
|
|
|
28,308
|
|
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|
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Net loss
|
|
|
(78,454
|
)
|
|
|
(1,020,017
|
)
|
|
|
|
|
|
|
|
|
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Other comprehensive income-foreign
currency translation adjustments
|
|
|
121,711
|
|
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|
224,482
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|
|
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Comprehensive income (loss)
|
|
$
|
43,257
|
|
|
$
|
(795,535
|
)
|
|
|
|
|
|
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|
|
|
Net loss per share - basic and
diluted
|
|
$
|
(0.00
|
)
|
|
$
|
(0.04
|
)
|
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE NUMBER OF SHARES
OUTSTANDING:
|
|
|
|
|
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Basic
|
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|
34,391,554
|
|
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|
27,649,887
|
|
Diluted
|
|
|
34,391,554
|
|
|
|
27,649,887
|
|
The accompanying Condensed Notes to
Consolidated Financial Statements are an integral part of these financial statements.
IVAX DIAGNOSTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENT OF CHANGES IN
SHAREHOLDERS’ EQUITY
(Unaudited)
|
|
|
|
|
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|
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|
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Accumulated
|
|
|
|
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|
|
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Additional
|
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Other
|
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Total
|
|
|
|
Common Stock
|
|
|
Paid-in
|
|
|
Accumulated
|
|
|
Comprehensive
|
|
|
Shareholders’
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Deficit
|
|
|
Loss
|
|
|
Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
BALANCE, December 31, 2011
|
|
|
34,391,554
|
|
|
$
|
343,915
|
|
|
$
|
46,035,037
|
|
|
$
|
(34,983,815
|
)
|
|
$
|
(667,865
|
)
|
|
$
|
10,727,272
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(78,454
|
)
|
|
|
-
|
|
|
|
(78,454
|
)
|
Other comprehensive income
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
121,711
|
|
|
|
121,711
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE, March 31, 2012
|
|
|
34,391,554
|
|
|
$
|
343,915
|
|
|
$
|
46,035,037
|
|
|
$
|
(35,062,269
|
)
|
|
$
|
(546,154
|
)
|
|
$
|
10,770,529
|
|
The accompanying Condensed Notes to
Consolidated Financial Statements are an integral part of these financial statements.
IVAX DIAGNOSTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Three Months Ended March 31,
|
|
2012
|
|
|
2011
|
|
|
|
|
|
|
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(78,454
|
)
|
|
$
|
(1,020,017
|
)
|
Adjustments to reconcile net loss to net cash flows
used in operating activities:
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
192,990
|
|
|
|
192,597
|
|
Net reduction in provision for doubtful accounts receivable
|
|
|
(48,209
|
)
|
|
|
(29,632
|
)
|
Provision for inventory obsolescence
|
|
|
-
|
|
|
|
52,124
|
|
Amortization of other assets
|
|
|
17,667
|
|
|
|
-
|
|
Deferred income taxes
|
|
|
15,873
|
|
|
|
15,873
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(44,174
|
)
|
|
|
(483,834
|
)
|
Inventories
|
|
|
148,786
|
|
|
|
(164,096
|
)
|
Other current assets
|
|
|
(177,965
|
)
|
|
|
(29,951
|
)
|
Other assets
|
|
|
(591
|
)
|
|
|
4
|
|
Accounts payable and accrued expenses
|
|
|
(176,217
|
)
|
|
|
608,898
|
|
Other long-term liabilities
|
|
|
40,482
|
|
|
|
3,225
|
|
Net cash flows used in operating activities
|
|
|
(109,812
|
)
|
|
|
(854,809
|
)
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
Capital expenditures
|
|
|
(9,490
|
)
|
|
|
(13,213
|
)
|
Decrease in restricted deposits
|
|
|
9,332
|
|
|
|
68
|
|
Acquisitions of equipment on lease
|
|
|
(43,243
|
)
|
|
|
(29,716
|
)
|
|
|
|
|
|
|
|
|
|
Net cash flows used in investing activities
|
|
|
(43,401
|
)
|
|
|
(42,861
|
)
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
Capital lease payments
|
|
|
(18,980
|
)
|
|
|
(17,360
|
)
|
Payments under revolving line of credit, net
|
|
|
(75,571
|
)
|
|
|
-
|
|
Net cash flows used in financing activities
|
|
|
(94,551
|
)
|
|
|
(17,360
|
)
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash and cash equivalents
|
|
|
105,687
|
|
|
|
15,860
|
|
Net decrease in cash and cash equivalents
|
|
|
(142,077
|
)
|
|
|
(899,170
|
)
|
Cash and cash equivalents at the beginning of the period
|
|
|
3,653,244
|
|
|
|
1,826,228
|
|
Cash and cash equivalents at the end of the period
|
|
$
|
3,511,167
|
|
|
$
|
927,058
|
|
The accompanying Condensed Notes to Consolidated Financial
Statements are an integral part of these financial statements.
IVAX DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS
(Unaudited)
(1) ORGANIZATION AND OPERATIONS
:
The accompanying unaudited
interim consolidated financial statements of IVAX Diagnostics, Inc. (the “Company,” “IVAX Diagnostics,”
we,” “us” or “our”) have been prepared pursuant to the rules and regulations of the Securities and
Exchange Commission for reporting on Form 10-Q and, therefore, do not include all information normally included in audited financial
statements. However, in the opinion of management, all adjustments necessary to state fairly the results of operations, financial
position, changes in stockholders’ equity and cash flows have been made. The results of operations, financial position,
changes in stockholders’ equity and cash flows for the three months ended March 31, 2012 are not necessarily indicative
of the results of operations, financial position, changes in stockholders’ equity and cash flows which may be reported for
the remainder of 2012. The balance sheet as of December 31, 2011 was derived from audited financial statements, but does not include
all disclosures required by accounting principles generally accepted in the United States of America (“GAAP”). The
accompanying unaudited interim consolidated financial statements should be read in conjunction with the audited consolidated financial
statements and the related notes to consolidated financial statements included in the Company’s Annual Report on Form 10-K
for the year ended December 31, 2011.
On September 1, 2010,
ERBA Diagnostics Mannheim GmbH, an in vitro diagnostics company headquartered in Germany (“ERBA”), the parent company
of which is Transasia Bio-Medicals Ltd. (“Transasia”), purchased all of the approximately 72.4% of the outstanding
shares of the Company’s common stock owned by the Debregeas-Kennedy Group for an aggregate purchase price of approximately
$15,000,000, or $0.75 per share (the “Share Acquisition”). See also Note 14, Related Party Transactions, with respect
to subsequent transactions with ERBA, including ERBA’s purchase from the Company, and the Company’s issuance to ERBA,
of 6,666,667 shares of the Company’s common stock in the initial transactions contemplated by the Investment and ERBA’s
exercise, in part, of the warrant, as further described below, for 600,000 shares of the Company’s common stock (the “Investment”).
As a result of the Share Acquisition, the consummation of the initial transactions contemplated by the Investment and the exercise,
in part, of the Warrant, ERBA now beneficially owns, directly or indirectly, approximately 78.0% of the outstanding shares of
the Company’s common stock.
(2) LIQUIDITY:
The Company incurred
a net loss of $78,454 during the three months ended March 31, 2012 and a net loss of $1,020,017 for the three months ended March
31, 2011 and used cash from operations of $109,812 and $854,809 for those respective periods.
The Company has taken
or is in the process of evaluating or undertaking certain actions which, if successful, it believes will be sufficient to provide
the Company with the ability to continue in existence. The Company expects operating results to improve from the operating
results achieved during 2011 and the three months ended March 31, 2012 and 2011, based principally upon increases in revenue as
a result of the commercial launch of the Mago® 4S in the United States during 2011 and increases in the United States and
international revenue from new channels of distribution. The Company also expects operating results to improve as a
result of certain initiatives it has adopted or is considering adopting in order to reduce expenses.
As discussed below in
Note 14, Related Party Transactions, the Company entered into a stock purchase agreement (the “Stock Purchase Agreement”)
with ERBA, on April 8, 2011. The Company and ERBA modified the Stock Purchase Agreement such that the additional shares and warrants
will only be issued on the date that is 60 days after the date on which a majority of the independent directors on the Company’s
board of directors determines by vote or written consent that such additional transaction shall occur and causes notice thereof
to be delivered to ERBA.
As discussed below in
Note 15, Revolving Line of Credit, on June 10, 2011, Diamedix Corporation (“Diamedix”), a wholly-owned subsidiary
of the Company, entered into a loan agreement (the “Loan Agreement”) with City National Bank of Florida, which provides
for a secured, revolving credit facility of up to $975,000 (the “Line of Credit”).
As discussed below in
Note 16, Subsequent Events, on April 16, 2012, ERBA exercised, in part, a warrant by paying an aggregate exercise price of $450,000
to the Company and, in connection therewith, the Company issued to ERBA 600,000 shares of the Company’s common stock.
(3) STOCK-BASED COMPENSATION
:
Valuations are based upon highly subjective
assumptions about the future, including stock price volatility and exercise patterns. The fair value of share-based payment awards
was estimated using the Black-Scholes option pricing model. Expected volatilities are based on the historical volatility of the
Company’s stock. The Company uses historical data to estimate option exercise and employee terminations. The expected term
of options granted represents the period of time that options granted are expected to be outstanding. The risk-free rate for periods
within the expected life of the option is based on the U.S. Treasury yield curve in effect at the time of the grant.
The Company has historically granted options
under the Company’s option plans with an option exercise price equal to the closing market value of the stock on the date
of the grant and with vesting, primarily for Company employees, ranging from all at once to equal annual amounts over a four year
period, and, primarily for non-employee directors, immediately.
The following chart summarizes option
activity as of March 31, 2012 and changes during the three months ended March 31, 2012 for outstanding and exercisable options
granted by the Company:
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
Average
|
|
|
|
Number of
|
|
|
Exercise
|
|
|
|
Shares
|
|
|
Price
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2011
|
|
|
1,020,870
|
|
|
$
|
1.36
|
|
Granted
|
|
|
-
|
|
|
|
-
|
|
Expired
|
|
|
-
|
|
|
|
-
|
|
Terminated
|
|
|
-
|
|
|
|
-
|
|
Exercised
|
|
|
-
|
|
|
|
-
|
|
Outstanding at March 31, 2012
|
|
|
1,020,870
|
|
|
$
|
1.36
|
|
There was no stock compensation expense
for the three months ended March 31, 2012 or 2011.
(4) CASH EQUIVALENTS
:
The Company considers
certain short-term investments in marketable debt securities with original maturities of three months or less to be cash equivalents.
A significant portion of the Company’s
cash and cash equivalents are presently held in money market accounts at one international securities brokerage firm. Accordingly,
the Company is subject to credit risk if this brokerage firm is unable to repay the balance in the account or deliver the Company's
securities or if the brokerage firm should become bankrupt or otherwise insolvent. It is the Company’s current policy to
invest in select money market instruments, United States Treasury investments, municipal and other governmental agency securities
and corporate issuers.
(5) FAIR VALUE MEASUREMENT
:
In June 2009, the Financial Accounting
Standards Board (“FASB”) issued new accounting standards that establish the FASB Accounting Standards Codification
(the “ASC”) as the official single source of authoritative GAAP and supersedes all previous accounting standards.
ASC Section 820,
Fair Value Measurements
and Disclosures,
formerly
Statement of Financial Accounting Standard (“SFAS”) No. 157, defines fair value
as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or
most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date.
The three levels of inputs used to measure fair value are as follows:
Level 1 – Quoted prices in active
markets for identical assets or liabilities.
Level 2 – Observable inputs other
than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets; quoted prices
for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable or can be
corroborated by observable market data.
Level 3 – Unobservable inputs that
are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. This includes
certain pricing models, discounted cash flow methodologies and similar techniques that use significant unobservable inputs.
All of the Company’s financial assets,
which do not include cash on hand, as of March 31, 2012 and December 31, 2011, were Level 1 assets composed of money market funds
with balances of $147,548 and $17,334, included as part of cash and cash equivalents in the accompanying balance sheet, respectively,
and Level 3 assets composed of the product license discussed in Note 7,
Product License
. Financial instruments consist
primarily of cash and cash equivalents, accounts receivable and accounts payable. At March 31, 2012 and December 31, 2011, the
fair value of these instruments approximates the carrying amount of these items due to the short-term maturities of these instruments.
(6) INVENTORIES, NET
:
Inventories, net consist of the following:
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2012
|
|
|
2011
|
|
|
|
|
|
|
|
|
Raw materials
|
|
$
|
850,512
|
|
|
$
|
716,268
|
|
Work-in-process
|
|
|
522,061
|
|
|
|
717,390
|
|
Finished goods
|
|
|
2,308,936
|
|
|
|
2,396,637
|
|
Total inventories, net
|
|
$
|
3,681,509
|
|
|
$
|
3,830,295
|
|
(7) PRODUCT LICENSE
:
In September 2004, the Company entered
into a license agreement with an Italian diagnostics company to obtain a perpetual, worldwide, royalty-free license of product
technology used by the Italian diagnostics company. This licensed hepatitis product technology is existing technology, which the
Italian diagnostics company had developed and successfully commercialized to manufacture hepatitis products sold by them and for
which it had already received “CE Marking” approval from the European Union. Through the acquisition of this existing
technology in its current form, the Company expects to be able to derive revenue from the manufacture and sale of new hepatitis
products. In exchange for the Italian diagnostics company’s assistance in transferring the know-how of the manufacturing
technology, the Company agreed to pay a total of 1,000,000 Euro in the form of four milestone payments upon the Italian diagnostics
company’s achievement of certain enumerated performance objectives related to the transfer of such existing technology.
Three of the four milestone payments, totaling 900,000 Euro, were made in prior years. The remaining milestone payment of Euro
100,000, or equivalent to approximately $133,000, is included in accrued license payable in the accompanying consolidated balance
sheet as of March 31, 2012. In October 2011, the Company received “CE Marking” granting approval for the remaining
products covered under the license agreement and expects to begin to manufacture and market the products in 2012. Amortization
of the product license will begin following the initial sale of the hepatitis products manufactured by the Company.
(8) LOSS PER SHARE
:
Loss per share is computed by dividing
net loss by the weighted average number of shares of common stock outstanding during the period. All outstanding stock options
and warrants are considered potential common stock. The dilutive effect, if any, of stock options and warrants is calculated using
the treasury stock method.
Outstanding stock options (1,020,870 as
of both March 31, 2012 and December 31, 2011) and warrants (6,666,667 exercisable as of December 31, 2011 and 13,333,333 not yet
exercisable as of that date) have not been included in the calculation of loss per share because their impact would be anti-dilutive.
(9) INCOME TAXES
:
The provision for income taxes consists
of the following:
Three Months Ended March 31,
|
|
2012
|
|
|
2011
|
|
Current:
|
|
|
|
|
|
|
|
|
Domestic
|
|
$
|
-
|
|
|
$
|
-
|
|
Foreign
|
|
|
11,795
|
|
|
|
12,435
|
|
Deferred:
|
|
|
|
|
|
|
|
|
Domestic
|
|
|
15,873
|
|
|
|
15,873
|
|
Foreign
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Total provision for income taxes
|
|
$
|
27,668
|
|
|
$
|
28,308
|
|
The Company is susceptible to large fluctuations
in its effective tax rate and has thereby recognized tax expense on a discrete pro-rata basis for the three months ended March
31, 2012 and March 31, 2011. No current domestic tax provision was recorded during the three months ended March 31, 2012 or March
31, 2011 due to the increase in the valuation allowance to offset the benefit of domestic losses of approximately $52,000. The
foreign current income tax provisions for the three months ended March 31, 2012 and 2011 were the result of Italian local income
taxes based upon applicable statutory rates effective in Italy.
As
of March 31, 2012 and December 31, 2011, the Company has established a full valuation allowance on both its domestic and foreign
net deferred tax assets, which are primarily comprised of net operating loss carryforwards.
Due to the cumulative net losses
from the operations of both domestic and foreign operations,
the Company
had no net deferred tax asset as of March 31, 2012 or December 31, 2011. As of March 31, 2012 and December 31, 2011, the Company
had net deferred tax liabilities relating to tax deductible goodwill of $444,549 and $428,676, respectively, and recorded corresponding
deferred tax provisions of $15,873 during each of the three months ended March 31, 2012 and 2011. Subsequent revisions to the
estimated net realizable value of the deferred tax asset or deferred tax liability could cause the provision for income taxes
to vary significantly from period to period.
Domestic
net operating losses generated by the Company total $18,802,000 as of December 31, 2011 and are subject to any applicable limitations
as described below. The net operating losses included in the domestic net deferred tax asset will begin to expire in 2022. Under
Section 382 of the Internal Revenue Code, the Company’s use of its net operating loss carryforwards will be limited in the
future as a result of the September 1, 2010 acquisition by ERBA of the approximately 72.4% of the outstanding shares of the Company’s
common stock previously owned by the Debregeas-Kennedy Group. As a result of that acquisition, the Company’s ability to
utilize net operating loss carryforwards to offset any future taxable income is currently limited to approximately $825,000 per
year, plus both any limitation unused since the acquisition and any unused net operating losses generated after the September
1, 2010 acquisition date. The amount of the
annual limitation will be adjusted upwards for any recognized built-in gains
on certain assets sold during the five year period commencing with the ownership change. The limitations of these net operating
loss carryforwards did not impact the Company’s results for the three months ended March 31, 2012 or 2011.
United States income taxes have not been
provided on undistributed earnings of foreign subsidiaries, as such earnings are being retained indefinitely by such subsidiaries
for reinvestment. The distribution of these earnings would first reduce the domestic valuation allowance before resulting
in additional United States income taxes.
(10) CONCENTRATION OF CREDIT RISK
:
The Company performs periodic credit evaluations
of its customers' financial condition and provides allowances for doubtful accounts as required. The Company's accounts receivables
are generated from sales made both domestically and abroad. As of March 31, 2012 and December 31, 2011, $4,059,000 and $4,203,000,
respectively, of the Company's total net accounts receivable were due in Italy. Of the total net accounts receivable, approximately
35%, or $2,108,000, at March 31, 2012 and 36%, or $2,167,000, at December 31, 2011 were due from hospitals and laboratories controlled
by the Italian government. The Company maintains allowances for doubtful accounts, particularly in Italy where payment cycles
are longer than in the United States, for potential credit losses based on the age of the accounts receivable and the results
of the Company’s periodic credit evaluations of its customers’ financial condition. Additionally, the Company periodically
receives payments based upon negotiated agreements with governmental regions in Italy, acting on behalf of hospitals located in
the region, in satisfaction of previously outstanding accounts receivable balances.
Recently, the Italian government has been
experiencing severe fiscal and debt crises and a recession, including its increasingly uncertain ability to service its sovereign
debt obligations, caused in part by the declining global markets and economic conditions. Accordingly, we are subject to certain
economic, business and, in particular, credit risk if our customers located in Italy which are hospitals or laboratories controlled
by the Italian government do not pay amounts owed to us, extend payment cycles even further or ask us to accept a lower payment
amount than is owed to us. Our current allowances for doubtful accounts may not be adequate and we may be required to make additional
allowances, which would adversely affect, and could materially adversely affect, our operating results in the period in which
the determination or allowance is or was made. Any of these factors could materially and adversely affect our business, prospects,
operating results, financial condition and cash flows in the near term.
(11) SEGMENT INFORMATION
:
The Company’s management reviews
financial information, allocates resources and manages its business by geographic region. The Domestic region, which includes
corporate expenditures, contains the Company’s subsidiaries located in the United States. The European region contains the
Company’s subsidiary located in Italy. The information provided is based on internal reports and was developed and utilized
by management to track trends and changes in the results of the regions. The information, including the allocations of expense
and overhead, was calculated based on a management approach and may not reflect the actual economic costs, contributions or results
of operations of the regions as stand-alone businesses. If a different basis of presentation or allocation were utilized, the
relative contributions of the regions might differ but the relative trends would, in management's view, likely not be materially
impacted. The table below sets forth net revenues, loss from operations, total assets and goodwill by region.
Net Revenues by Region
|
|
|
|
Three Months Ended March 31,
|
|
2012
|
|
|
2011
|
|
|
|
|
|
|
|
|
Domestic
|
|
|
|
|
|
|
|
|
External net revenues
|
|
$
|
2,863,037
|
|
|
$
|
2,744,628
|
|
Intercompany revenues
|
|
|
134,935
|
|
|
|
118,754
|
|
|
|
|
2,997,972
|
|
|
|
2,863,382
|
|
European
|
|
|
|
|
|
|
|
|
External net revenues
|
|
|
1,410,237
|
|
|
|
1,389,729
|
|
Intercompany revenues
|
|
|
19,917
|
|
|
|
69,883
|
|
|
|
|
1,430,154
|
|
|
|
1,459,612
|
|
|
|
|
|
|
|
|
|
|
Eliminations
|
|
|
(154,852
|
)
|
|
|
(188,637
|
)
|
|
|
|
|
|
|
|
|
|
Consolidated net revenues
|
|
$
|
4,273,274
|
|
|
$
|
4,134,357
|
|
Loss from Operations by Region
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
2012
|
|
|
2011
|
|
|
|
|
|
|
|
|
Domestic
|
|
$
|
(153,548
|
)
|
|
$
|
(577,101
|
)
|
European
|
|
|
34,062
|
|
|
|
(430,409
|
)
|
Loss from operations
|
|
$
|
(119,486
|
)
|
|
$
|
(1,007,510
|
)
|
Total Assets by Region
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2012
|
|
|
2011
|
|
|
|
|
|
|
|
|
Domestic
|
|
$
|
10,685,646
|
|
|
$
|
7,929,836
|
|
European
|
|
|
6,350,081
|
|
|
|
7,225,759
|
|
Total assets
|
|
$
|
17,035,727
|
|
|
$
|
15,155,395
|
|
Goodwill by Region
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2012
|
|
|
2011
|
|
|
|
|
|
|
|
|
Domestic
|
|
$
|
870,290
|
|
|
$
|
870,290
|
|
European
|
|
|
-
|
|
|
|
-
|
|
Total goodwill
|
|
$
|
870,290
|
|
|
$
|
870,290
|
|
(12) COMMITMENTS AND CONTINGENCIES
:
The Company is involved in various legal
claims and actions and regulatory matters, and other notices and demand proceedings arising in the ordinary course of business.
While it is not possible to predict or determine the outcome of these proceedings, in the opinion of management, based on a review
with legal counsel, any losses resulting from such legal proceedings would not have a material adverse impact on the financial
position, results of operations or cash flows of the Company.
(13) RECENTLY ISSUED ACCOUNTING STANDARDS
:
In January 2010, the FASB issued
additional disclosure requirements for fair value measurements. According to the guidance, the fair value hierarchy disclosures
are further disaggregated by class of assets and liabilities. A class is often a subset of assets or liabilities within a line
item in the statement of financial position. In addition, significant transfers between Levels 1 and 2 of the fair value hierarchy
are required to be disclosed. These additional requirements, which became effective January 1, 2010 for quarterly and annual
reporting, did not have an impact on the Company’s consolidated financial results, as this guidance related only to additional
disclosures. In addition, the guidance requires more detailed disclosures of the changes in Level 3 instruments. These changes
were effective January 1, 2011 and did not have a material impact on the Company’s consolidated financial statements.
In October 2009, the FASB issued
amended revenue recognition guidance for arrangements with multiple deliverables. The new guidance requires the use of management’s
best estimate of selling price (BESP) for the deliverables in an arrangement when vendor specific objective evidence (VSOE), vendor
objective evidence (VOE) or third party evidence (TPE) of the selling price is not available. In addition, excluding specific
software revenue guidance, the residual method of allocating arrangement consideration is no longer permitted, and an entity is
required to allocate arrangement consideration using the relative selling price method. This guidance was effective for all new
or materially modified arrangements entered into on or after January 1, 2011, with earlier application permitted as of the
beginning of any prior fiscal year. Full retrospective application of the new guidance is optional. The Company implemented the
new guidance effective January 1, 2011. The provisions of this update did not have a material impact on the Company’s financial
statements.
In October 2009, the FASB also issued
guidance which amended the scope of existing software revenue recognition guidance. Tangible products containing software components
and non-software components that function together to deliver the tangible product’s essential functionality is no longer
within the scope of software revenue guidance and is accounted for based on other applicable revenue recognition guidance. In
addition, the amendments exclude hardware components of a tangible product containing software components from the software revenue
guidance. This guidance is effective for all new or materially modified arrangements entered into on or after January 1,
2011, with earlier application permitted as of the beginning of any prior fiscal year. Full retrospective application of the new
guidance is optional. This guidance must be adopted in the same period that the Company adopts the amended accounting for arrangements
with multiple deliverables described in the preceding paragraph. The Company implemented the new guidance effective January 1,
2011. These new requirements did not have a material impact on the Company’s consolidated financial statements.
In September 2011, the FASB issued the
FASB Accounting Standards Update No. 2011-08 “Intangibles—Goodwill and Other: Testing Goodwill for Impairment”
(“ASU 2011-08”). This guidance is to simplify how public and nonpublic entities test goodwill for impairment. The
amendments permit an entity to first assess qualitative factors to determine whether it is more likely than not that the fair
value of a reporting unit is less than its carrying amount as a basis for determining whether it is necessary to perform the two-step
goodwill impairment test described in Topic 350. Under the amendments in this Update, an entity is not required to calculate the
fair value of a reporting unit unless the entity determines that it is more likely than not that its fair value is less than its
carrying amount. The Company implemented the new guidance effective January 1, 2011. The provisions of this guidance did not have
a material impact on the Company’s financial statements.
In December 2011,
the FASB issued the FASB Accounting Standards Update No. 2011-12 “Comprehensive Income: Deferral of the Effective
Date for Amendments to the Presentation of Reclassifications of Items Out of Accumulated Other Comprehensive Income in Accounting
Standards Guidance No. 2011-05” (“ASU 2011-12”). This guidance is a deferral of the effective date pertaining
to reclassification adjustments out of accumulated other comprehensive income in ASU 2011-05. FASB is to going to reassess the
costs and benefits of those provisions in ASU 2011-05 related to reclassifications out of accumulated other comprehensive income.
Due to the time required to properly make such a reassessment and to evaluate alternative presentation formats, the FASB decided
that it is necessary to reinstate the requirements for the presentation of reclassifications out of accumulated other comprehensive
income that were in place before the issuance of ASU 2011-05. All other requirements in ASU 2011-05 are not affected by this guidance,
including the requirement to report comprehensive income either in a single continuous financial statement or in two separate
but consecutive financial statements. The Company implemented the new guidance effective January 1, 2011. The provisions of this
guidance did not have a material impact on the Company’s financial statements.
(14) RELATED PARTY TRANSACTIONS
:
During the three months ended March 31,
2012 and 2011, ImmunoVision, Inc. (“ImmunoVision”), a wholly-owned subsidiary of the Company, paid $6,000 to John
B. Harley, M.D., Ph.D., under that certain oral consulting agreement between Dr. Harley and ImmunoVision pursuant to which Dr.
Harley is paid $2,000 per month in consideration for his provision of technical guidance and business assistance to ImmunoVision
on an as-needed basis. Dr. Harley continues to serve on the Company’s Board of Directors.
Pursuant to a license agreement between
the Company and Dr. Harley, he has granted an exclusive worldwide license to the Company for certain patents, rights and technology
relating to monoclonal antibodies against autoimmune RNA proteins developed by him in exchange for specified royalty payments,
including an annual minimum royalty of $10,000
for each licensed product utilized by the Company. During the three months
ended March 31, 2012, the Company accrued a payment of $2,500 to Dr. Harley under such license.
The amounts paid to Dr. Harley were in
addition to the amounts he received for his service as member of the Company’s Board of Directors and the committees of
the Board of Directors on which he served.
During the three months ended March 31,
2012 and 2011, the Company sold products to Transasia and a subsidiary of ERBA for a total amount of Euro 236,000 and 148,000,
respectively, equivalent to approximately $309,000 and $204,000, respectively.
In the fourth quarter of 2011, a subsidiary
of the Company entered into a contract research and development agreement with ERBA, as amended, for a total of Euro 754,000,
pursuant to which ERBA has agreed to pay the subsidiary a total amount of Euro 133,000, equivalent to approximately $186,000,
during the fourth quarter of 2011 and an additional Euro 621,000 during 2012 for the results of certain research and development.
For the three months ended March 31, 2012, contract research and development revenue under this agreement approximated Euro 112,000
($147,000). The Company and its subsidiaries had net accounts receivable from ERBA and Transasia of $301,000 at March 31, 2012
and $387,000 at December 31, 2011 related to the above transactions.
The Company entered into the Stock Purchase
Agreement with ERBA, on April 8, 2011, pursuant to which the Company has agreed to the Investment in which it would sell and issue
to ERBA an aggregate of 20,000,000 shares of the Company’s common stock for an aggregate purchase price of $15,000,000,
or $0.75 per share of the Company’s common stock, and warrants to purchase an additional 20,000,000 shares of the Company’s
common stock. The consummation of the Investment was subject to, among other things, the approval of holders of at
least 66-2/3% of the issued and outstanding shares of the Company’s common stock (excluding any shares beneficially owned,
directly or indirectly, by ERBA). At the Company’s 2011 Annual Meeting of Stockholders held on June 10, 2011,
the required approval of the Company’s stockholders was achieved.
On June 30, 2011, ERBA paid the Company
$5,000,000 in order to consummate the initial transactions contemplated by the Investment (the “Initial Closing”).
As a result, the Company issued to ERBA 6,666,667 shares of the Company’s common stock and, in connection with the consummation
of the initial transactions contemplated by the Investment, a warrant to purchase 20,000,000 shares of the Company’s
common stock (the “Warrant”). After giving effect to transaction costs of $399,700 relating to the Stock Purchase
Agreement and the Investment, the Company received net proceeds of $4,600,300 at the consummation of the initial transactions
contemplated by the Investment. As previously reported, the Warrant has a five year term and an exercise price per
share of the Company’s common stock of $0.75. T
he Warrant is exercisable only to the extent that
shares of the Company’s common stock have been purchased under the Stock Purchase Agreement. As of March 31, 2011, the Warrant
was exercisable for 6,666,667 shares of the Company’s common stock.
As discussed below in Note 16,
Subsequent
Events
, on April 16, 2012, ERBA exercised, in part, the Warrant by paying an aggregate exercise price of $450,000 to the Company
and, in connection therewith, the Company issued to ERBA 600,000 shares of the Company’s common stock.
As previously reported, pursuant to the
Stock Purchase Agreement, the Company also agreed to issue to ERBA an additional 6,666,667 shares of the Company’s common
stock for an aggregate purchase price of $5,000,000, on or prior to the date which is six months after the Initial Closing (the
“Second Closing”), as well as an additional 6,666,666 shares of the Company’s common stock for an aggregate
purchase price of $5,000,000, on or prior to the date which is one year after the Initial Closing (the “Final Closing”).
As also previously reported, on December 29, 2011, the Company and ERBA entered into an amendment to the Stock Purchase Agreement
(the “Amendment”). Pursuant to the Amendment, the Stock Purchase Agreement has been amended to state that: (i) the
Second Closing will take place, after the Initial Closing, on the date that is sixty (60) days after the date on which a majority
of the independent directors on the Company’s Board of Directors determines by vote or written consent that the Second Closing
shall occur and causes the Company to provide notice thereof to ERBA; and (ii) the Final Closing will take place, after the Initial
Closing and after or simultaneously with the Second Closing, on the date that is sixty (60) days after the date on which a majority
of the independent directors on the Company’s Board of Directors determines by vote or written consent that the Final Closing
shall occur and causes the Company to provide notice thereof to ERBA. The Amendment was unanimously approved by the independent
directors on the Company’s Board of Directors.
(15) REVOLVING LINE OF CREDIT
:
On June 10, 2011, Diamedix entered into
the Loan Agreement with City National Bank of Florida, which provides for a secured, revolving credit facility of up to $975,000
(the “Line of Credit”). Amounts outstanding under the Line of Credit will accrue interest at an annual
rate equal to the 30-day LIBOR plus 4.00%, and the loan will become due and payable on June 10, 2013, subject to acceleration
upon the occurrence of certain specified events of default that the Company believes are customary for transactions of this type. The
interest rate will increase by two percentage points (2.00%) per annum if certain covenants contained in the Loan Agreement are
not met.
Amounts outstanding under the Line of
Credit are collateralized by all of the assets of Diamedix, including, without limitation, the Company’s corporate headquarters
located in Miami, Florida. In addition, the Company and its other wholly-owned domestic subsidiary – ImmunoVision,
Inc. – have guaranteed the repayment of amounts drawn on the Line of Credit.
The Loan Agreement also includes, among
other things, the following financial covenants applicable to Diamedix:
|
·
|
Minimum
Tangible Net Worth
(as defined therein)
of not less than
$1,000,000 as of
December 3l of each
year.
|
|
·
|
Fixed
Charge Coverage
Ratio (as defined
therein) of not
less than 1.50 to
1.00 as of the last
day of each fiscal
quarter, as measured
for compliance on
a rolling four quarter
basis.
|
|
·
|
Maximum
Funded Debt to EBITDA
Ratio (as defined
therein) of not
less than 2.50 to
1.00 as of the last
day of each fiscal
quarter.
|
As of March 31, 2012 and December 31,
2011, the Company was in compliance with all of the above financial covenants. Closing costs and other transaction costs aggregating
$101,000 were incurred in 2011 related to the Loan Agreement and the Line of Credit. These costs have been classified as debt
issuance costs on the accompanying consolidated balance sheet and are being amortized over the 24-month term of the Line of Credit
commencing in June 2011.
As of March 31, 2012 and December 31,
2011, $660,995 and $736,566, respectively, was outstanding under the Line of Credit and this amount and related debt issuance
costs have been classified as current due to the terms of the related lockbox arrangement. As of March 31, 2012, the availability
after giving effect to amounts outstanding on the Line of Credit was $314,005.
(16) SUBSEQUENT EVENT
:
On April 16, 2012, ERBA exercised, in
part, the Warrant (see Note 15) by paying an aggregate exercise price of $450,000 to the Company and, in connection therewith,
the Company issued to ERBA 600,000 shares of the Company’s common stock. A total of 19,400,000 warrants remained unexercised
at April 16, 2012.
Item 2 - Management’s Discussion
and Analysis of Financial Condition and Results of Operations
The following discussion and analysis
should be read in conjunction with the consolidated financial statements and the related notes to consolidated financial statements
included in our Annual Report on Form 10-K for the year ended December 31, 2011 and the unaudited interim consolidated financial
statements and the related notes to unaudited interim consolidated financial statements included in Item 1 of this Quarterly Report
on Form 10-Q.
We have made forward-looking statements,
which are subject to risks and uncertainties, in this Quarterly Report on Form 10-Q. Forward-looking statements may be preceded
by, followed by or otherwise include the words "may," "will," "believes," "expects," "anticipates,"
"intends," "plans," "estimates," "projects," "could," "would," "should,"
or similar expressions or statements that certain events or conditions may occur. Actual results, performance or achievements
could differ materially from those contemplated, expressed or implied by these forward-looking statements. These forward-looking
statements are based largely on our expectations and the beliefs and assumptions of our management and on the information currently
available to it and are subject to a number of risks and uncertainties, including, but not limited to, the risks and uncertainties
associated with:
|
·
|
our
ability to continue
as a going concern;
|
|
·
|
our
ability to generate
positive cash flow
or otherwise improve
our liquidity, whether
from existing operations,
strategic initiatives
or possible future
sources of liquidity,
including, without
limitation, from
the Investment or
the line of credit,
issuing debt or
equity securities,
incurring indebtedness
or curtailing or
reducing our operations;
|
|
·
|
the
remaining transactions
contemplated by
the Investment under
the stock purchase
agreement, as amended,
may not be consummated
on the contemplated
terms, in the time
frame anticipated,
or at all;
|
|
·
|
the
net proceeds of
the Investment,
whether or not the
warrants are exercised,
may not provide
adequate cash resources
to fund our operations
or liquidity needs
for the reasonably
foreseeable future;
|
|
·
|
our
ability to achieve
or sustain profitability
from our operations
or otherwise secure
funds to provide
the basis for our
long-term liquidity;
|
|
·
|
our
broad discretion
in our use of the
net proceeds from
the investment;
|
|
·
|
the
warrants may not
be exercised, in
whole or in part;
|
|
·
|
the
decision to exercise
the warrants will
be made by ERBA
based upon considerations
it deems appropriate,
which may include,
among other things,
the future market
price of our common
stock, which is
subject to volatility
and a number of
other factors, many
of which are beyond
our control, and,
when making any
such decision to
exercise the warrants,
ERBA’s interests
may conflict with
our interests;
|
|
·
|
our
ability to pay when
due the principal
and interest on
our outstanding
indebtedness under
the line of credit;
|
|
·
|
our
ability to operate
our business under
the restrictions
imposed by the positive
and negative covenants
to which we are
subject under the
loan agreement in
connection with
the line of credit;
|
|
·
|
economic,
competitive, political,
governmental and
other factors affecting
us and our operations,
markets and products;
|
|
·
|
the
success of technological,
strategic and business
initiatives, including
our automation strategy;
|
|
·
|
the
ability of the Mago
®
4S to perform
as expected;
|
|
·
|
the
impact of the commercial
release of the Mago
®
4S on the
judgments and estimates
we have made with
respect to our financial
condition, operating
results and cash
flows;
|
|
·
|
the
impact on our financial
condition and operating
results of making
or changing judgments
and estimates as
a result of future
design changes to,
or the development
of improved instrument
versions of, the
Mago
®
4 or Mago
®
4S or as a
result of future
demand for the Mago
®
4 or Mago
®
4S;
|
|
·
|
the
ability of the Mago
®
4 or Mago
®
4S to be a
source of revenue
growth for us;
|
|
·
|
our
ability to receive
financial benefits
or achieve improved
operating results
as a result of the
commercial release
of the Mago
®
4 or the Mago
®
4S;
|
|
·
|
the
ability of the Mago
®
4 or Mago
®
4S to be a
factor in our growth;
|
|
·
|
the
ability of the Mago
®
4 or Mago
®
4S to expand
the menu of test
kits we offer;
|
|
·
|
making
derivations of and
upgrades to the
Mago
®
our primary platforms
for marketing our
kits;
|
|
·
|
our
ability to successfully
market the Mago
®
4 or Mago
®
4S;
|
|
·
|
our
customers’
integration of the
Mago
®
4 or Mago
®
4S into their
operations;
|
|
·
|
our
ability to successfully
market the DSX™
and DS2™ instrument
systems from Dynex
Technologies in
conjunction with
our test kits on
a worldwide basis;
|
|
·
|
the
success of our comprehensive
review of our business
plans and operations
and the initiatives
that we have implemented
or may implement
based on the results
of such review;
|
|
·
|
our
ability to improve
our competitive
position to the
extent anticipated,
or at all, as a
result of our comprehensive
review of our business
plans and operations
and the initiatives
that we have implemented
or may implement
based on the results
of such review;
|
|
·
|
our
ability to expand
the menu of test
kits that we offer
to include other
complementary infectious
disease or autoimmune
testing sectors
or otherwise;
|
|
·
|
the
response of our
current customer
base to an expansion
of our menu of test
kits;
|
|
·
|
our
ability to achieve
organic growth;
|
|
·
|
our
ability to identify
or consummate acquisitions
of businesses or
products;
|
|
·
|
our
ability to integrate
acquired businesses
or products;
|
|
·
|
our
ability to enhance
our position in
laboratory automation;
|
|
·
|
our
ability to expand
our product offerings
and/or market reach,
including, without
limitation, our
ability to increase
our presence in
key countries in
Europe, South America,
Asia as well as
other international
markets, or become
a leader in the
diagnostics industry;
|
|
·
|
the
impact the existing
global economic
conditions may have
on our financial
condition, operating
results and cash
flows;
|
|
·
|
the
impact of healthcare
regulatory reform;
|
|
·
|
constantly
changing, and our
compliance with,
governmental regulation;
|
|
·
|
the
impact of our adoption
or implementation
of new accounting
statements and pronouncements
on our financial
condition and operating
results;
|
|
·
|
our
limited operating
revenues and history
of primarily operational
losses;
|
|
·
|
our
ability to collect
our accounts receivable,
particularly in
Italy, and the impact
of making or changing
judgments and estimates
regarding our allowances
for doubtful accounts
on our financial
condition and operating
results;
|
|
·
|
our
ability to utilize
our net operating
losses, whether
subject to limitations
or not, and its
impact on our financial
condition and operating
results;
|
|
·
|
the
impact of any future
limitations on our
ability to utilize
our net operating
losses in the event
of any future change
in control or similar
transaction;
|
|
·
|
the
impact of making
or changing judgments
and estimates regarding
our deferred tax
liabilities and
our valuation allowances
and reserves against
our deferred tax
assets on our financial
condition and operating
results;
|
|
·
|
the
impact of making
or changing judgments
and estimates regarding
our goodwill, including
the remaining goodwill
recorded at ImmunoVision,
and other intangible
assets, such as
our hepatitis technology
product license,
on our financial
condition and operating
results;
|
|
·
|
our
ability to achieve
cost advantages
from our own manufacture
of instrument systems,
reagents and test
kits;
|
|
·
|
our
ability to grow
beyond the autoimmune
and infectious disease
markets and to expand
into additional
diagnostic test
sectors;
|
|
·
|
our
ability to obtain
product technology
from the Italian
diagnostics company
that would enable
us to manufacture
our own hepatitis
products;
|
|
·
|
our
ability to introduce
and market our own
hepatitis products
in the European
Union when expected,
or at all, including
the potential that
any further delays
may require us to
record an additional
impairment charge
with respect to
the value of our
hepatitis technology
product license
or pay all or a
portion of our accrued
payables relating
to the product license;
|
|
·
|
our
ability to internally
manufacture our
own hepatitis products
and raw materials
for these products
and to become competitive
in markets outside
of the United States;
|
|
·
|
our
ability to derive
revenue from our
manufacture and
sale of our own
hepatitis products;
|
|
·
|
the
impact of the anticipated
timing of the commercial
launch of our own
hepatitis products
on the judgments
and estimates we
have made with respect
to our financial
condition, operating
results and cash
flows;
|
|
·
|
our
production capacity
at our facility
in Miami, Florida;
|
|
·
|
our
ability to successfully
improve our facilities
and upgrade or replace
our equipment and
information systems
in the timeframe
and utilizing the
amount of funds
anticipated or at
all;
|
|
·
|
our
dependence on agreements
with IVAX Corporation,
third party distributors
and key personnel;
|
|
·
|
consolidation
of our customers
affecting our operations,
markets and products;
|
|
·
|
reimbursement
policies of governmental
and private third
parties affecting
our operations,
markets and products;
|
|
·
|
price
constraints imposed
by our customers
and governmental
and private third
parties;
|
|
·
|
our
ability to increase
the volume of our
reagent production
to meet increased
demand;
|
|
·
|
protecting
our intellectual
property;
|
|
·
|
political
and economic instability
and foreign currency
fluctuation affecting
our foreign operations;
|
|
·
|
the
effects of utilizing
cash to assist Delta
Biologicals, S.r.L.,
our wholly-owned
subsidiary in Italy,
in maintaining its
compliance with
capital requirements
established by Italian
law;
|
|
·
|
the
holding of a significant
portion our cash
and cash equivalents
at a single brokerage
firm, including
risks relating to
the bankruptcy or
insolvency of such
brokerage firm;
|
|
·
|
litigation
regarding products,
distribution rights,
intellectual property
rights, product
liability and labor
and employment matters;
|
|
·
|
voting
control of our common
stock by ERBA;
|
|
·
|
conflicts
of interest with
ERBA and its affiliates,
including Suresh
Vazirani and/or
Kishore “Kris”
Dudani, and with
our officers, employees
and other directors;
and
|
|
·
|
other
factors discussed
elsewhere in this
Quarterly Report
on Form 10-Q.
|
See the section entitled “Risk Factors”
in our Annual Report on Form 10-K for the year ended December 31, 2011 for further discussion of certain risks and uncertainties
that could materially and adversely affect our business, operating results or financial condition. Many of these factors are beyond
our control.
MAJORITY STOCKHOLDERS
On September 1, 2010, ERBA Diagnostics
Mannheim GmbH, or ERBA, an in vitro diagnostics company headquartered in Germany, the parent company of which is Transasia Bio-Medicals
Ltd., or Transasia, purchased all of the approximately 72.4% of the outstanding shares of our common stock then owned by the Debregeas-Kennedy
Group for an aggregate purchase price of approximately $15,000,000, or $0.75 per share. As a result of this share acquisition,
the consummation of the initial transactions contemplated by the investment made by ERBA, as further described below, including
ERBA’s purchase from us, and our issuance to ERBA, of 6,666,667 shares of our common stock, and ERBA’s exercise, in
part, of the warrant, as further described below, for 600,000 shares of our common stock, ERBA now beneficially owns, directly
or indirectly, approximately 78.0% of the outstanding shares of our common stock.
RESULTS OF OPERATIONS
THREE MONTHS ENDED MARCH 31, 2012 COMPARED
TO THE THREE MONTHS ENDED MARCH 31, 2011
OVERVIEW
Net loss totaled $78,000 for the three
months ended March 31, 2012 compared to net loss of $1,020,000 for the three months ended March 31, 2011. Operating loss was $119,000
in the 2012 period compared to operating loss of $1,008,000 for the 2011 period. The decrease in both net loss and operating loss
in the 2012 period compared to the 2011 period resulted primarily from decreases in operating expenses. Net revenues increased
by $139,000 to $4,273,000 in the 2012 period from $4,134,000 in the 2011 period, consisting of an increase in net revenues from
domestic operations of $119,000, from $2,744,000 in the 2011 period to $2,863,000 in the 2012 period, and an increase in net revenues
from European operations of $20,000, including the effect of exchange rate fluctuations of the United States dollar relative to
the Euro, from $1,390,000 in the 2011 period to $1,410,000 in the 2012 period. Gross profit increased by $7,000 to $2,122,000
in the 2012 period from $2,115,000 in the 2011 period, as the result of the higher revenue, offset by lower margin percentage.
Gross profit as a percentage of net revenues decreased to 49.7% for the 2012 period from 51.2% for the 2011 period, principally
as a result of an increase in the sale of instruments and increase in contract research revenue, which have a lower average margin
than reagent sales.
Operating expenses decreased to $2,242,000
in the 2012 period from $3,123,000 in the 2011 period as a result of decreases in all three categories of operating expenses.
Comparing the 2012 period to the 2011 period, selling expenses decreased by $255,000, general and administrative expenses decreased
by $272,000 and research and development expenses decreased by $355,000.
NET REVENUES AND GROSS PROFIT
|
|
|
|
|
|
|
|
Period over Period
|
|
Three months ended March 31,
|
|
2012
|
|
|
2011
|
|
|
Increase (Decrease)
|
|
Net Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
Domestic
|
|
$
|
2,863,000
|
|
|
$
|
2,744,000
|
|
|
$
|
119,000
|
|
European
|
|
|
1,410,000
|
|
|
|
1,390,000
|
|
|
|
20,000
|
|
Total
|
|
|
4,273,000
|
|
|
|
4,134,000
|
|
|
|
139,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of Sales
|
|
|
2,150,000
|
|
|
|
2,019,000
|
|
|
|
132,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Profit
|
|
$
|
2,122,000
|
|
|
$
|
2,115,000
|
|
|
$
|
7,000
|
|
% of Total Net Revenue
|
|
|
49.7%
|
|
|
|
51.2%
|
|
|
|
|
|
Total net revenues in the three months
ended March 31, 2012 increased by $139,000, or 3.4%, from the three months ended March 31, 2011. This increase was composed of
an increase of $119,000 in net revenues from domestic operations and an increase of $20,000 in net revenues from European operations.
Exchange rate differences resulting from the strength or weakness of
the United States dollar against the Euro resulted in a decrease of approximately $77,000 in net revenues in the 2012 period as
compared to the 2011 period, as further discussed in “Currency Fluctuations” below.
As measured in Euros, net
revenues from European operations in the 2012 period increased by 1.4% compared to the 2011 period. The increase in net revenues
from European operations was mainly due to increase in instrument and contract research and development revenue less the declines
in reagent sales in both Italy and other international markets. Net revenues from domestic operations in the 2012 period increased
by 4.3% compared to the 2011 period. The increase in net revenue from domestic operations was due to increases in volumes of reagent
and instrument sales.
Gross profit in the 2012 period increased
by $7,000, or 0.3%, from the 2011 period. The increase in gross profit was primarily attributable to the increase in net revenues.
The decrease in gross profit as a percentage of net revenues to 49.7% in the 2012 period from 51.2% in the 2011 period resulted
mainly from an increase in the sale of instruments and contract research and development, which have a lower average margins than
reagent sales.
OPERATING EXPENSES
|
|
|
|
|
% of
|
|
|
|
|
|
% of
|
|
|
Period over Period
|
|
Three months ended March 31,
|
|
2012
|
|
|
Revenue
|
|
|
2011
|
|
|
Revenue
|
|
|
(Decrease)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling
|
|
$
|
971,000
|
|
|
|
22.7%
|
|
|
$
|
1,226,000
|
|
|
|
29.6%
|
|
|
$
|
(255,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and Administrative
|
|
|
1,075,000
|
|
|
|
25.2%
|
|
|
|
1,347,000
|
|
|
|
32.6%
|
|
|
|
(272,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and Development
|
|
|
196,000
|
|
|
|
4.6%
|
|
|
|
550,000
|
|
|
|
13.3%
|
|
|
|
(354,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Operating Expenses
|
|
$
|
2,242,000
|
|
|
|
52.5%
|
|
|
$
|
3,123,000
|
|
|
|
75.5%
|
|
|
$
|
(881,000
|
)
|
Total
operating expenses decreased to $2,242,000 in the 2012 period from $3,123,000 in the 2011 period as a result of decreases in
all
three categories of operating expenses.
The decrease of $255,000 in selling expenses
during the 2012 period compared to the 2011 period was primarily due to open sales positions in the United States and, in Italy,
reduction in workforce and lower commissions from lower sales in commissionable categories.
The decrease of $272,000 in general and
administrative expenses during the 2012 period compared to the 2011 period was due principally to reduction in workforce in Italy,
reduction in rent and related building expenses in Italy and reduction in provision for doubtful accounts in Italy.
The decrease in research and development
expenses of $354,000 was due principally to reduction of research and development activities in the United States and funding
of research and development in Italy, for which the relevant expenses are now included in cost of sales (see Note 14 to the financial
statements).
LOSS FROM OPERATIONS
Loss from operations totaled $119,000
in the 2012 period as compared to loss from operations of $1,008,000 in the 2011 period, primarily due to reduction in operating
expenses. Loss from operations in the 2012 period was composed of a $153,000 loss from domestic operations and a $34,000 income
from European operations. Loss from operations in the 2011 period was composed of a $577,000 loss from domestic operations and
a $431,000 loss from European operations. Domestic operations include corporate expenditures, including costs required to maintain
our status as a public company.
OTHER INCOME, NET
Other income, net totaled $69,000 in the
2012 period as compared to $16,000 in the 2011 period. Amounts included in other income, net in the 2012 and 2011 periods were
primarily net foreign currency gains, from deposits held in Euros and transactions of our Italian subsidiary which were denominated
in currencies other than its functional currency.
INCOME TAX PROVISION
We recorded income tax provisions of $28,000
in both the 2012 and 2011 periods. The current tax provision of $12,000 for both periods relates to Italian local income taxes
based upon applicable statutory rates effective in Italy. The deferred tax provision of $16,000 for both periods relates to domestic
tax deductible goodwill. No current tax benefit was recorded during the two periods on our losses because we had a full valuation
allowance against the net deferred income tax assets.
NET LOSS
We generated a net loss of $79,000 in
the 2012 period as compared to a net loss of $1,020,000 in the 2011 period. Our basic and diluted loss per common share was $0.00
in 2012 as compared to a basic and diluted loss per common share of $0.04 in the 2011 period. The net loss for both periods resulted
from the various factors discussed above.
LIQUIDITY
AND CAPITAL RESOURCES
At March 31, 2012, our working capital was $8,847,000 compared
to $8,631,000 at December 31, 2011. Cash and cash equivalents totaled $3,511,000 at March 31, 2012 and $3,653,000 at December
31, 2011.
Net cash flows of $110,000 were used in
operating activities during the three months ended March 31, 2012 as compared to $855,000 that were used in operating activities
during the three months ended March 31, 2011.
Cash
used in operating activities of $110,000 during the 2012 period was the result of the net loss of $78,000 and changes in operating
assets and liabilities of $(224,000), partially offset by non-cash items of $192,000. The non-cash items
include depreciation
and amortization, reduction in the provision for doubtful accounts receivable, amortization of other assets and deferred income
taxes. Cash provided by changes in operating assets and liabilities was due to changes in accounts receivable, inventories, other
current assets, accounts payable and accrued expenses and other long-term liabilities.
Cash used in operating activities of $855,000
during the 2011 period was the result of the net loss of $1,020,000 and changes in operating assets and liabilities of $66,000,
partially offset by non-cash items of $231,000. The non-cash items include depreciation and amortization, a recovery for doubtful
accounts receivable, a provision for inventory obsolescence and deferred income taxes.
Net cash of $43,000 was used in investing
activities during the 2012 and 2011 periods. In both periods, the use was primarily for equipment on lease and capital expenditures.
Financing activities during the period
consisted of capital lease payments during 2012 and 2011, as well as payments during 2012 to reduce outstanding borrowings under
the revolving line of credit.
Liquidity is expected to be sufficient
through the end of 2012 from the combination of the existing cash and cash equivalents at March 31, 2012, the exercise of warrants
subsequent to March 31, 2012 and the investment that ERBA has agreed to make under the Stock Purchase Agreement, including the
Warrant, as described throughout this Quarterly Report on Form 10-Q.
A significant portion of our cash and
cash equivalents is presently held at one international securities brokerage firm. Accordingly, we are subject to credit risk
if this brokerage firm is unable to repay the balance in the account or deliver our securities or if the brokerage firm should
become bankrupt or otherwise insolvent. We invest in only select money market instruments, United States treasury investments,
municipal and other governmental agency securities and corporate issuers.
Our product research and development expenditures
were $1,451,000 during the year ended December 31, 2011 and $195,000 for the three months ended March 31, 2012. In the fourth
quarter of 2011, a subsidiary of the Company entered into a contract research and development agreement with ERBA, as amended,
for a total of Euro 754,000 ($1,003,000) in 2011 and 2012. A total of Euro 133,000 and Euro 54,000 was invoiced under the contract
in the fourth quarter of 2011 and the first quarter of 2012, respectively. Actual expenditures will depend upon, among other things,
the outcome of clinical testing of products under development, delays or changes in government required testing and approval procedures,
technological and competitive developments, strategic marketing decisions and liquidity. There can be no assurance that these
expenditures will result in the development of new products or product enhancements, that we will successfully complete products
under development, that we will obtain regulatory approval or that any approved product will be produced in commercial quantities,
at reasonable costs, and be successfully marketed.
In connection with our evaluation of our
operating results, financial condition and cash position, and specifically considering our results of operations and cash utilization
during 2011, we continue to implement measures expected to improve future cash flow. To this end, we expect operating results
to continue to improve from the operating results achieved during 2011 based principally upon increases in revenue as a result
of new channels of distribution in the United States and international markets.
We maintain allowances for doubtful accounts,
particularly in Italy where payment cycles are longer than in the United States, for estimated losses resulting from the inability
of our customers to make required or timely payments. Additionally, we periodically receive payments based upon negotiated agreements
with governmental regions in Italy, acting on behalf of hospitals located in the region, in satisfaction of previously outstanding
accounts receivable balances. We may anticipate collection of these amounts through a payment as described above, and, therefore,
not provide an allowance for doubtful accounts for these amounts. If contemplated payments are not received, if existing agreements
are not complied with or cancelled, or if we require additional allowances, then our operating results could be materially adversely
affected during the period in which we make the determination to increase the allowance for doubtful accounts.
We cannot guarantee that we can generate
net income, increase revenues, improve our cash flow or successfully obtain debt or equity financing on acceptable terms, or at
all, and, if we cannot do so, then we may not be able to survive and any investment in our company may be lost. We are evaluating
various forms of debt and equity financing arrangements. Any such financing arrangements would likely impose positive and
negative covenants on us, which could restrict various aspects of our business, operations and finances. In addition, any issuance
of equity securities, or securities convertible into shares of our common stock, would be dilutive to our existing stockholders.
For the long-term, we intend to utilize principally existing cash and cash equivalents, as well as internally generated funds,
which are anticipated to be derived primarily from the sale of existing diagnostic and instrumentation products and diagnostic
and instrumentation products currently under development as well as possible sources of debt and equity financings. If we
are not successful in improving our operating results and cash flows or if existing and possible future sources of liquidity described
above are insufficient, then we may be required to curtail or reduce our operations.
CRITICAL ACCOUNTING POLICIES
Our discussion and analysis of our financial
condition and results of operations are based upon our consolidated financial statements, which have been prepared in accordance
with GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported
amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an on-going
basis, we evaluate our estimates, including those related to product returns, allowance for doubtful accounts, inventories, intangible
assets, stock compensation, income and other tax accruals, the realization of long-lived assets and contingencies and litigation.
We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances,
the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily
apparent from other sources. Our assumptions and estimates may, however, prove to have been incorrect and our actual results may
differ from these estimates under different assumptions or conditions. We believe the following critical accounting policies and
the judgments and estimates we make concerning their application have significant impact on our consolidated financial statements.
REVENUE RECOGNITION
A principal source of revenue is our "reagent
rental" program in which customers make reagent kit purchase commitments with us that will usually last for a period of three
to five years. In exchange, we typically include an instrument system, which remains our property (or, in the case of a lease
financing arrangement, that of the financing company). We also include any required instrument service. Both the instrumentation
and service are paid for by the customer through these reagent kit purchases over the life of the commitment. We recognize revenue
from the reagent kit sales when title passes, which is generally at the time of shipment. Should actual reagent kit or instrument
failure rates significantly increase, our future operating results could be negatively impacted by increased warranty obligations
and service delivery costs.
During the year ended December 31, 2011,
a subsidiary of the Company entered into a contract research and development agreement with the parent company, as amended. Expenses
incurred pursuant to that contract are included in cost of sales as the related revenues are recorded from the achievement of
milestones.
ALLOWANCE FOR DOUBTFUL ACCOUNTS
The Company grants credit without collateral
to its customers based on the Company’s evaluation of a particular customer’s credit worthiness. In addition, allowances
for doubtful accounts are maintained, particularly in Italy where payment cycles are longer than in the United States and in some
instances may take in excess of a year to collect, for potential credit losses based on the age of the accounts receivable and
the results of the Company’s periodic credit evaluations of its customers’ financial condition.
We
maintain allowances for doubtful accounts, particularly in Italy for the operations of our European subsidiary, for estimated
losses based on historical loss percentages resulting from the inability of our customers to make required payments. In the first
quarter of 2012, the Company re-evaluated the formula used to determine the allowance for doubtful accounts, resulting in a reduction
in the allowance of $157,000.
INVENTORY
We regularly review inventory quantities
on hand, which include components for current or future versions of products and instrumentation. If necessary, we record a provision
for excess and obsolete inventory based primarily on our estimates of component obsolescence, product demand and production requirements,
as well as based upon the status of a product within the regulatory approval process. In accordance with our inventory accounting
policy, our inventory balance at March 31, 2012 included components for current or future versions of products and instrumentation.
Our inventory balance as of March 31,
2012 and December 31, 2011 included approximately $200,000 of inventory relating to our hepatitis product, substantially all of
which has a shelf life exceeding five years, for which we obtained “CE Marking” approval in the European Union during
2011 and which we recently began marketing in certain markets. Inventory reserves were $391,000 and $419,000 as of March 31, 2012
and December 31, 2011, respectively.
GOODWILL AND OTHER INTANGIBLES
The determination as to whether a write-down
of goodwill is necessary involves significant judgment based upon our short-term and long-term projections for the company. The
assumptions supporting the estimated future cash flows of the reporting unit, including profit margins, long-term forecasts, discount
rates and terminal growth rates, reflect our best estimates. All of our goodwill is currently recorded at ImmunoVision, one of
our domestic subsidiaries. Although we consider our current market capitalization, we do not believe it to be an appropriate measure
for the fair value of ImmunoVision, as ImmunoVision represents less than 10% of our net revenues and total assets, and we believe
that it is more meaningful to compute fair value based primarily upon discounted cash flows. However, the continued decline in
our market capitalization could also potentially require us to record additional impairment charges in future periods for the
remaining $870,000 of goodwill at ImmunoVision.
Our product license is existing technology,
obtained from an Italian diagnostics company that had developed and successfully commercialized this technology to manufacture
hepatitis products sold by them and for which it had already received “CE Marking” approval from the European Union.
Through the acquisition of this existing technology in its current form, we expect to be able to derive revenue from the manufacture
and sale of new hepatitis products. In exchange for the Italian diagnostics company’s assistance in transferring the know-how
of the manufacturing technology, we agreed to pay a total of 1,000,000 Euros in the form of four milestone payments upon the Italian
diagnostics company’s achievement of certain enumerated performance objectives related to the transfer of such existing
technology. We made the first three milestone payments upon the achievement of the enumerated performance objectives in prior
years. We expect to make, or otherwise settle, the fourth and final milestone payment of $133,000 during 2012 as we have now received
“CE Marking” approval from the European Union for our hepatitis products.
During the fourth quarter of 2008, we
determined that the carrying amount of the product license was in excess of its fair value and recorded a non-cash impairment
charge to operations totaling $560,000, reducing the carrying value of the product license to $683,000 as of December 31, 2008,
from $1,243,000 as of December 31, 2007. During the fourth quarter of 2009, we determined that the carrying amount of the product
license was in excess of its fair value and recorded a non-cash impairment charge to operations totaling $400,000, reducing the
carrying value of the product license to $283,000 as of December 31, 2009. Fair value was determined based upon the income approach,
which estimates fair value based upon future discounted cash flows. Based upon amended regulatory standards adopted by the applicable
notifying body during the fourth quarter of 2009 to obtain “CE Marking” and additional requirements specified during
2010 by the applicable notifying body, we revised our assumptions supporting our computation of discounted cash flows to reflect
the further delay in product launch and the possibility of a decrease in projected market share as a result of this delay, as
well as to estimate the impact of the current global economic conditions. Based upon this methodology, estimated future cash flows
generated by the technology granted by the product license was then calculated, reflecting our best estimate of fair value. While
we obtained “CE Marking” during 2011, there remains a risk that we will not be able to market or manufacture our own
hepatitis products. While we believe that we will be able to bring these hepatitis kits to market, if the progress of our efforts
to begin marketing these kits is adversely impacted, then we may be required to record an additional impairment charge with respect
to all or a portion of the remaining $283,000 intangible product license of the hepatitis technology asset.
STOCK-BASED COMPENSATION
Stock-based compensation expense for all
stock-based compensation awards is based on the grant-date fair value estimate calculated in accordance with applicable accounting
guidance. We recognize these compensation costs on a straight-line basis over the requisite service period of the award, which
is generally the option vesting term of either immediately or in equal annual amounts over a four year period.
Valuations are based on highly subjective
assumptions about the future, including stock price volatility and exercise patterns. The fair value of share-based payment awards
was estimated using the Black-Scholes option pricing model. Expected volatilities are based on the historical volatility of our
stock. We use historical data to estimate expected term, taking into account option exercise and employee terminations. The expected
term of options granted represents the period of time that options granted are expected to be outstanding. The risk-free rate
for periods within the expected life of the option is based on the United States Treasury yield curve in effect at the time of
the grant.
INCOME TAXES
We have experienced net losses from our
operations. In accordance with GAAP, we are required to record a valuation allowance against the deferred tax asset associated
with these losses if it is "more likely than not" that we will not be able to utilize the net operating loss to offset
future taxes. Due to the cumulative net losses from the operations of both our domestic and European operations, we have provided
a full valuation allowance against our deferred tax assets as of March 31, 2012. Over time we may reach levels of profitability
that could cause our management to conclude that it is more likely than not that we will realize all or a portion of our net operating
loss carryforwards and other temporary differences. Upon reaching such a conclusion, and upon such time as we reverse the entire
amount or a portion of the valuation allowance against the deferred tax asset, we would then provide for income taxes at a rate
equal to our effective tax rate.
Under Section 382 of the Internal Revenue
Code, our ability to use our net operating loss carryforwards will be limited in the future as a result of the September 1, 2010
acquisition by ERBA of the approximately 72.4% of the outstanding shares of our common stock previously owned by the Debregeas-Kennedy
Group. As a result of that acquisition, our ability to utilize net operating loss carryforwards to offset future taxable income
is currently limited to approximately $825,000 per year, plus both any limitation unused since the acquisition and any unused
net operating losses generated after the September 1, 2010 acquisition date. The amount of the annual limitation will be adjusted
upwards for any recognized built-in gains on certain assets sold during the five year period commencing with the September 1,
2010 ownership change, but may be further limited in the event of any future change in control or similar transaction. Our results
for the three months ended March 31, 2012 and 2011 were not impacted by these limitations.
The critical accounting policies discussed
above are not intended to be a comprehensive list of all of our accounting policies. In many cases, the accounting treatment of
a particular transaction is specifically dictated by GAAP, with no need for management's judgment in their application. There
are also areas in which management's judgment in selecting any available alternative would not produce a materially different
result.
RECENTLY
ISSUED ACCOUNTING STANDARDS
Refer to Note 13,
Recently Issued Accounting
Standards
, to our consolidated financial statements included in this Quarterly Report on Form 10-Q regarding recently issued
accounting standards applicable to us.
CURRENCY FLUCTUATIONS
For the three months ended March 31, 2012
and 2011, approximately 33% and 35%, respectively, of our net revenues were generated in currencies other than the United States
dollar. We expect that this percentage may increase in the future as a result of our efforts to increase our international presence,
particularly in key markets in Europe, Asia and South America. Fluctuations in the value of foreign currencies relative to the
United States dollar affect our reported results of operations. If the United States dollar weakens relative to the foreign currency,
then our earnings generated in the foreign currency will, in effect, increase when converted into United States dollars and vice
versa. Exchange rate differences resulting from the strength or weakness of the United States dollar against the Euro resulted
in a decrease of approximately $77,000 in net revenues in the 2012 period as compared to the 2011 period. Our European subsidiary
incurs most of its revenue and expenses in Euro, which, to some extent, serves as a natural hedge and limits the net currency
exposure.
During the three months ended March 31,
2012 and 2011, none of our subsidiaries were domiciled in a highly inflationary environment and the impact of inflation and changing
prices on our net revenues and on our loss from continuing operations was not material.
Conducting an international business inherently
involves a number of difficulties, risks, and uncertainties, such as export and trade restrictions, inconsistent and changing
regulatory requirements, tariffs and other trade barriers, cultural issues, labor and employment laws, longer payment cycles,
problems in collecting accounts receivable, political instability, local economic downturns, seasonal reductions in business activity
in Europe during the traditional summer vacation months and potentially adverse tax consequences.
INCOME
TAXES
We recorded income tax provisions of $28,000
in both the 2012 and 2011 periods. The current tax provision of $12,000 for both periods relates to Italian local income taxes
based upon applicable statutory rates effective in Italy. The deferred tax provision of $16,000 for both periods relates to domestic
tax deductible goodwill. No current tax benefit was recorded during the two periods on our losses because we had a full valuation
allowance against the net deferred income tax assets.
As of March 31, 2012, we had no net domestic
or foreign deferred tax asset, as a full valuation allowance has been established against deferred tax assets. As of March 31,
2012, we had net deferred tax liabilities of $444,549 relating to tax deductible goodwill at ImmunoVision, and we recorded a corresponding
deferred tax provision of $16,000 during the three months ended March 31, 2012. Subsequent revisions to the estimated net realizable
value of the deferred tax asset or deferred tax liability could cause our provision for income taxes to vary significantly from
period to period. Upon such time as we reverse the entire valuation allowance against the deferred tax asset, we would then provide
for income taxes at a rate equal to our effective tax rate.
Under Section 382 of the Internal Revenue
Code, our ability to use our net operating loss carryforwards will be limited in the future as a result of the September 1, 2010
acquisition by ERBA of the approximately 72.4% of the outstanding shares of our common stock previously owned by the Debregeas-Kennedy
Group. As a result of that acquisition, our ability to utilize net operating loss carryforwards to offset future taxable income
is currently limited to approximately $825,000 per year, plus both any limitation unused since the acquisition and any unused
net operating losses generated after the September 1, 2010 acquisition date. The amount of the annual limitation will be adjusted
upwards for any recognized built-in gains on certain assets sold during the five year period commencing with the September 1,
2010 ownership change, but may be further limited in the event of any future change in control or similar transaction. Our results
for the three months ended March 31, 2012 and 2011 were not impacted by these limitations.
RISK
OF PRODUCT LIABILITY CLAIMS
Developing,
manufacturing and marketing diagnostic test kits, reagents and instruments subject us to the risk of product liability claims.
We believe that we continue to maintain an adequate amount of product liability insurance, but there can be no assurance that
our insurance will cover all existing and future claims. There can be no assurance that claims arising under any pending or future
product liability cases, whether or not covered by insurance, will not have a material adverse effect on our business, results
of operations or financial condition. Our current products liability insurance is
a “claims made” policy.
Item 4 – Controls and Procedures
Evaluation of Disclosure Controls and
Procedures
As of the end of the period covered by
this Quarterly Report on Form 10-Q, our management evaluated, with the participation of our principal executive officer and principal
financial officer, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under
the Securities Exchange Act of 1934). Based upon that evaluation, our principal executive officer and principal financial officer
concluded that our disclosure controls and procedures are effective in ensuring that information required to be disclosed by us
in the reports that we file or submit under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported
within the time periods specified in the Securities and Exchange Commission’s rules and forms and is accumulated and communicated
to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions
regarding required disclosure.
Changes in Internal Control over Financial
Reporting
There were no changes in our internal
control over financial reporting that occurred during the first quarter of 2012 that have materially affected, or are reasonably
likely to materially affect, our internal control over financial reporting.
PART II - OTHER INFORMATION
Item 1 - Legal Proceedings
We are involved in various legal claims
and actions and regulatory matters, and other notices and demand proceedings arising in the ordinary course of business. While
it is not possible to predict or determine the outcome of these proceedings, in the opinion of management, based on a review with
legal counsel, any losses resulting from such legal proceedings would not have a material adverse impact on our financial position,
results of operations or cash flows.
Item 6 - Exhibits
Exhibit
|
|
|
Number
|
|
Description
|
|
|
|
31.1
|
|
Certification of Chief Executive Officer pursuant
to Section 302 of the Sarbanes-Oxley Act of 2002
|
31.2
|
|
Certification of Chief Financial Officer pursuant
to Section 302 of the Sarbanes-Oxley Act of 2002
|
32.1
|
|
Certification of Chief Executive Officer pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002 *
|
32.2
|
|
Certification of Chief Financial Officer pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002 *
|
101.INS
|
|
XBRL Instance Document **
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document **
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
**
|
101.LAB
|
|
XBRL Taxonomy Extension Labels Linkbase Document
**
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
**
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase
Document **
|
|
*
|
Pursuant to Item 601(b)(32) of Regulation
S-K, this exhibit is furnished, rather than filed, with this Annual
Report on Form 10-K.
|
|
**
|
Pursuant to Rule 406T of SEC Regulation
S-T, these interactive data files are deemed not filed or part of a
registration statement or prospectus for purposes of Section 11 or
12 of the Securities Act of 1933 or Section 18 of the Securities Exchange
Act of 1934 and otherwise are not subject to liability under these
sections.
|
Signatures
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly
authorized.
|
|
IVAX Diagnostics, Inc.
|
|
|
|
Date: May 23, 2012
|
By:
|
/s/ Arthur R. Levine
|
|
|
Arthur R. Levine,
|
|
|
Chief Financial Officer
|
EXHIBIT INDEX
Exhibit
|
|
|
Number
|
|
Description
|
|
|
|
31.1
|
|
Certification of Chief Executive Officer pursuant
to Section 302 of the Sarbanes-Oxley Act of 2002
|
31.2
|
|
Certification of Chief Financial Officer pursuant
to Section 302 of the Sarbanes-Oxley Act of 2002
|
32.1
|
|
Certification of Chief Executive Officer pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002 *
|
32.2
|
|
Certification of Chief Financial Officer pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002 *
|
101.INS
|
|
XBRL Instance Document **
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document **
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
**
|
101.LAB
|
|
XBRL Taxonomy Extension Labels Linkbase Document
**
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
**
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase
Document **
|
*
|
Pursuant to Item 601(b)(32) of Regulation S-K, this exhibit is
furnished, rather than filed, with this Annual Report on Form 10-K.
|
**
|
Pursuant to Rule 406T of SEC Regulation S-T, these interactive
data files are deemed not filed or part of a registration statement or prospectus for purposes
of Section 11 or 12 of the Securities Act of 1933 or Section 18 of the Securities Exchange Act
of 1934 and otherwise are not subject to liability under these sections.
|
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