Form 10-Q
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the Quarterly Period Ended December 31, 2010
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 0-14902
MERIDIAN BIOSCIENCE, INC.
Incorporated under the laws of Ohio
31-0888197
(I.R.S. Employer Identification No.)
3471 River Hills Drive
Cincinnati, Ohio 45244
(513) 271-3700
Indicate by a check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period
that the registrant was required to submit and post such files).
Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
a non-accelerated filer, or a smaller reporting company. See definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
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Large accelerated filer þ
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
Yes o No þ
Indicate the number of shares outstanding of each of the issuers classes of common stock, as of
the latest practicable date.
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Class |
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Outstanding January 31, 2011 |
Common Stock, no par value
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40,968,750 |
MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
INDEX TO QUARTERLY REPORT ON FORM 10-Q
The Private Securities Litigation Reform Act of 1995 provides a safe harbor from civil
litigation for forward-looking statements accompanied by meaningful cautionary statements. Except
for historical information, this report contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange
Act of 1934, which may be identified by words such as estimates, anticipates, projects,
plans, seeks, may, will, expects, intends, believes, should and similar expressions
or the negative versions thereof and which also may be identified by their context. Such
statements, whether expressed or implied, are based upon current expectations of the Company and
speak only as of the date made. The Company assumes no obligation to publicly update or revise any
forward-looking statements even if experience or future changes make it clear that any projected
results expressed or implied therein will not be realized. These statements are subject to various
risks, uncertainties and other factors that could cause actual results to differ materially,
including, without limitation, the following: Meridians continued growth depends, in part, on its
ability to introduce into the marketplace enhancements of existing products or new products that
incorporate technological advances, meet customer requirements and respond to products developed by
Meridians competition. While Meridian has introduced a number of internally developed products,
there can be no assurance that it will be successful in the future in introducing such products on
a timely basis. Ongoing consolidations of reference laboratories and formation of multi-hospital
alliances may cause adverse changes to pricing and distribution. Recessionary pressures on the
economy and the markets in which our customers operate, as well as adverse trends in buying
patterns from customers can change expected results. Costs and difficulties in complying with laws
and regulations administered by the United States Food and Drug Administration can result in
unanticipated expenses and delays and interruptions to the sale of new and existing products.
Changes in the relative strength or weakness of the U.S. dollar can also change expected results.
One of Meridians main growth strategies is the acquisition of companies and product lines. There
can be no assurance that additional acquisitions will be consummated or that, if consummated, will
be successful and the acquired businesses will be successfully integrated into Meridians
operations. There may be risks that acquisitions may disrupt operations and may pose potential
difficulties in employee retention and there may be additional risks with respect to Meridians
ability to recognize the benefits of acquisitions, including potential synergies and cost savings
or the failure of acquisitions to achieve their plans and objectives. The Company cannot predict
the possible impact of recently-enacted United States healthcare legislation and any similar
initiatives in other countries on its results of operations. In addition to the factors described
in this paragraph, Part I, Item 1A Risk Factors of our Form 10-K contains a list and description of
uncertainties, risks and other matters that may affect the Company.
Item 1. Financial Statements
MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share data)
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Three Months Ended December 31, |
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2010 |
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2009 |
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NET SALES |
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$ |
37,263 |
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$ |
42,457 |
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COST OF SALES |
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13,643 |
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16,972 |
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GROSS PROFIT |
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23,620 |
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25,485 |
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OPERATING EXPENSES |
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Research and development |
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2,328 |
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2,078 |
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Selling and marketing |
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5,687 |
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4,887 |
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General and administrative |
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6,515 |
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4,764 |
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Total operating expenses |
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14,530 |
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11,729 |
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OPERATING INCOME |
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9,090 |
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13,756 |
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OTHER INCOME (EXPENSE) |
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Interest income |
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17 |
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31 |
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Other, net |
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203 |
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(118 |
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Total other income (expense) |
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220 |
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(87 |
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EARNINGS BEFORE INCOME TAXES |
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9,310 |
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13,669 |
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INCOME TAX PROVISION |
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3,285 |
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4,748 |
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NET EARNINGS |
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$ |
6,025 |
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$ |
8,921 |
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BASIC EARNINGS PER COMMON SHARE |
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$ |
0.15 |
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$ |
0.22 |
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DILUTED EARNINGS PER COMMON SHARE |
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$ |
0.15 |
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$ |
0.22 |
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AVERAGE NUMBER OF COMMON SHARES
OUTSTANDING BASIC |
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40,615 |
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40,496 |
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EFFECT OF DILUTIVE STOCK OPTIONS |
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679 |
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689 |
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AVERAGE NUMBER OF COMMON SHARES
OUTSTANDING DILUTED |
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41,294 |
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41,185 |
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ANTI-DILUTIVE SECURITIES: |
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Common share options |
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160 |
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141 |
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DIVIDENDS DECLARED PER COMMON SHARE |
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$ |
0.19 |
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$ |
0.17 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
Page 1
MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(dollars in thousands)
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Three Months Ended December 31, |
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2010 |
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2009 |
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CASH FLOWS FROM OPERATING ACTIVITIES |
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Net earnings |
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$ |
6,025 |
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$ |
8,921 |
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Non-cash items: |
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Depreciation of property, plant and equipment |
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845 |
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762 |
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Amortization of intangible assets |
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595 |
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395 |
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Stock-based compensation |
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967 |
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559 |
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Deferred income taxes |
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(955 |
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(431 |
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Loss on disposition of fixed assets |
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4 |
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Unrealized loss on auction-rate securities and rights, net |
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15 |
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Change in current assets |
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2,276 |
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6,194 |
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Change in current liabilities |
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3,177 |
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(3,282 |
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Other, net |
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665 |
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37 |
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Net cash provided by operating activities |
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13,599 |
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13,170 |
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CASH FLOWS FROM INVESTING ACTIVITIES |
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Purchases of property, plant and equipment |
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(2,559 |
) |
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(880 |
) |
Purchases of intangibles and other assets |
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(12 |
) |
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Purchases of short-term investments |
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(1,000 |
) |
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Net cash used for investing activities |
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(2,571 |
) |
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(1,880 |
) |
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CASH FLOWS FROM FINANCING ACTIVITIES |
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Dividends paid |
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(7,720 |
) |
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(6,885 |
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Proceeds and tax benefits from exercises of stock options |
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739 |
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96 |
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Net cash used for financing activities |
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(6,981 |
) |
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(6,789 |
) |
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Effect of Exchange Rate Changes on Cash and Equivalents |
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(447 |
) |
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(71 |
) |
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Net Increase in Cash and Equivalents |
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3,600 |
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|
4,430 |
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Cash and Equivalents at Beginning of Period |
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|
37,879 |
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|
54,030 |
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Cash and Equivalents at End of Period |
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$ |
41,479 |
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$ |
58,460 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
Page 2
MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(Unaudited)
(dollars in thousands)
ASSETS
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December 31, |
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September 30, |
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2010 |
|
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2010 |
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CURRENT ASSETS |
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Cash and equivalents |
|
$ |
41,479 |
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$ |
37,879 |
|
Accounts receivable, less allowances of $152 and $241 |
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20,278 |
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|
22,064 |
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Inventories |
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28,711 |
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27,965 |
|
Prepaid expenses and other current assets |
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2,679 |
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|
4,277 |
|
Deferred income taxes |
|
|
2,041 |
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|
1,871 |
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|
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Total current assets |
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95,188 |
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|
94,056 |
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|
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PROPERTY, PLANT AND EQUIPMENT, at Cost |
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Land |
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|
987 |
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|
991 |
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Buildings and improvements |
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20,849 |
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|
20,670 |
|
Machinery, equipment and furniture |
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|
32,845 |
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|
31,945 |
|
Construction in progress |
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4,126 |
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|
2,800 |
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Subtotal |
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|
58,807 |
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|
|
56,406 |
|
Less: accumulated depreciation and amortization |
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|
34,418 |
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|
33,689 |
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|
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Net property, plant and equipment |
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24,389 |
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|
22,717 |
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|
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OTHER ASSETS |
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Goodwill |
|
|
22,755 |
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|
23,025 |
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Other intangible assets, net |
|
|
12,590 |
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|
|
13,327 |
|
Restricted cash |
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|
1,000 |
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|
|
1,000 |
|
Other assets |
|
|
246 |
|
|
|
239 |
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|
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|
|
|
|
|
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Total other assets |
|
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36,591 |
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|
|
37,591 |
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|
|
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TOTAL ASSETS |
|
$ |
156,168 |
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|
$ |
154,364 |
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|
|
|
|
|
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The accompanying notes are an integral part of these condensed consolidated financial statements.
Page 3
MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets (Unaudited)
(dollars in thousands)
LIABILITIES AND SHAREHOLDERS EQUITY
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December 31, |
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September 30, |
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2010 |
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|
2010 |
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CURRENT LIABILITIES |
|
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Accounts payable |
|
$ |
5,183 |
|
|
$ |
4,466 |
|
Accrued employee compensation costs |
|
|
4,310 |
|
|
|
3,451 |
|
Other accrued expenses |
|
|
5,150 |
|
|
|
5,521 |
|
Income taxes payable |
|
|
2,842 |
|
|
|
809 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Total current liabilities |
|
|
17,485 |
|
|
|
14,247 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
DEFERRED INCOME TAXES |
|
|
2,131 |
|
|
|
2,756 |
|
|
|
|
|
|
|
|
|
|
COMMITMENTS AND CONTINGENCIES |
|
|
|
|
|
|
|
|
|
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SHAREHOLDERS EQUITY |
|
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|
|
|
|
|
|
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Preferred stock, no par value, 1,000,000 shares authorized, none issued |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common shares, no par value, 71,000,000 shares authorized, 40,960,986
and 40,654,286 shares issued, respectively |
|
|
|
|
|
|
|
|
Additional paid-in capital |
|
|
96,026 |
|
|
|
94,529 |
|
Retained earnings |
|
|
40,482 |
|
|
|
42,177 |
|
Accumulated other comprehensive income |
|
|
44 |
|
|
|
655 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total shareholders equity |
|
|
136,552 |
|
|
|
137,361 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
|
$ |
156,168 |
|
|
$ |
154,364 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
Page 4
MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Condensed Consolidated Statement of Changes in Shareholders Equity
(Unaudited)
(dollars and shares in thousands)
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
Common |
|
|
Additional |
|
|
|
|
|
|
Other |
|
|
|
|
|
|
Total |
|
|
|
Shares |
|
|
Paid-In |
|
|
Retained |
|
|
Comprehensive |
|
|
Comprehensive |
|
|
Shareholders |
|
|
|
Issued |
|
|
Capital |
|
|
Earnings |
|
|
Income (Loss) |
|
|
Income (Loss) |
|
|
Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2010 |
|
|
40,654 |
|
|
$ |
94,529 |
|
|
$ |
42,177 |
|
|
$ |
655 |
|
|
|
|
|
|
$ |
137,361 |
|
Cash dividends paid |
|
|
|
|
|
|
|
|
|
|
(7,720 |
) |
|
|
|
|
|
|
|
|
|
|
(7,720 |
) |
Exercise of stock options |
|
|
119 |
|
|
|
530 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
530 |
|
Issuance of restricted shares |
|
|
188 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock compensation expense |
|
|
|
|
|
|
967 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
967 |
|
Comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings |
|
|
|
|
|
|
|
|
|
|
6,025 |
|
|
|
|
|
|
$ |
6,025 |
|
|
|
6,025 |
|
Foreign currency translation adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(936 |
) |
|
|
(936 |
) |
|
|
(936 |
) |
Other comprehensive income taxes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
325 |
|
|
|
325 |
|
|
|
325 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
5,414 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2010 |
|
|
40,961 |
|
|
$ |
96,026 |
|
|
$ |
40,482 |
|
|
$ |
44 |
|
|
|
|
|
|
$ |
136,552 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed consolidated financial
statements.
Page 5
MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
Dollars in Thousands, Except Per Share Amounts
(Unaudited)
1. Basis of Presentation
The interim condensed consolidated financial statements are unaudited and are prepared in
accordance with accounting principles generally accepted in the United States of America for
interim financial information, and the rules and regulations of the Securities and Exchange
Commission. Certain information and footnote disclosures normally included in financial statements
prepared in accordance with generally accepted accounting principles have been condensed or omitted
pursuant to such rules and regulations. In the opinion of Management, the interim financial
statements include all normal adjustments and disclosures necessary to present fairly the Companys
financial position as of December 31, 2010, the results of its operations for the three month
periods ended December 31, 2010 and 2009, and its cash flows for the three month periods ended
December 31, 2010 and 2009. These statements should be read in conjunction with the financial
statements and footnotes thereto included in the Companys fiscal 2010 Annual Report on Form 10-K.
Financial information as of September 30, 2010 has been derived from the Companys audited
consolidated financial statements.
The results of operations for interim periods are not necessarily indicative of the results to be
expected for the year.
2. Significant Accounting Policies
(a) |
|
Revenue Recognition and Accounts Receivable |
|
|
Revenue is generally recognized from sales when product is shipped and title has passed to
the buyer. Revenue for the U.S. Diagnostics operating segment is reduced at the date of
sale for estimated rebates that will be claimed by customers. Management estimates accruals
for rebate agreements based on historical statistics, current trends, and other factors.
Changes to the accruals are recorded in the period that they become known. Our rebate
accruals were $5,276 at December 31, 2010 and $5,273 at September 30, 2010. |
|
|
Life Science revenue for contract services may come from research and development services
or manufacturing services, including process development work, or a combination of both.
Revenue is recognized based on each of the deliverables in a given arrangement having
distinct and separate customer pricing. Pricing is often subject to a competitive bidding
process. Contract research and development services may be performed on a time and
materials basis or fixed fee basis. For time and materials arrangements, revenue is
recognized as services are performed and billed. For fixed fee arrangements, revenue is
recognized upon completion and acceptance by the customer. For contract manufacturing
services, revenue is generally recognized upon delivery of product and acceptance by the
customer. In some cases, customers may request that we store on their behalf clinical grade
biologicals that we produce under contract manufacturing agreements. These cases arise when
customers do not have clinical grade storage facilities or do not want to risk contamination
during transport. For such cases, revenue may be recognized on a bill-and-hold basis. |
|
|
Trade accounts receivable are recorded in the accompanying Condensed Consolidated Balance
Sheets at invoiced amounts less provisions for rebates and doubtful accounts. The allowance
for doubtful accounts represents our estimate of probable credit losses and is based on
historical write-off experience. The allowance for doubtful accounts and related metrics,
such as days sales outstanding, are reviewed monthly. Accounts with past due balances over
90 days are reviewed individually for collectibility. Customer invoices are charged off
against the allowance when we believe it is probable that the invoices will not be paid. |
Page 6
(b) |
|
Comprehensive Income (Loss) |
|
|
Our comprehensive income or loss is comprised of net earnings, foreign currency translation
and the related income tax effects. |
|
|
Assets and liabilities of foreign operations are translated using period-end exchange rates
with gains or losses resulting from translation included as a separate component of
comprehensive income or loss. Revenues and expenses are translated using exchange rates
prevailing during the period. We also recognize foreign currency transaction gains and
losses on certain assets and liabilities that are denominated in the Australian dollar,
British pound and Euro currencies. These gains and losses are included in other income and
expense in the accompanying Condensed Consolidated Statements of Operations. |
Comprehensive income for the interim periods was as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
|
Ended December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
|
|
|
Net earnings |
|
$ |
6,025 |
|
|
$ |
8,921 |
|
Foreign currency translation adjustment |
|
|
(936 |
) |
|
|
(257 |
) |
Income taxes |
|
|
325 |
|
|
|
89 |
|
|
|
|
|
|
|
|
Comprehensive income |
|
$ |
5,414 |
|
|
$ |
8,753 |
|
|
|
|
|
|
|
|
|
|
The provision for income taxes includes federal, foreign, state and local income taxes
currently payable and those deferred because of temporary differences between income for
financial reporting and income for tax purposes. We prepare estimates of permanent and
temporary differences between income for financial reporting purposes and income for tax
purposes. These differences are adjusted to actual upon filing of our tax returns,
typically occurring in the third and fourth quarters of the current fiscal year for the
preceding fiscal years estimates. |
|
|
We account for uncertain tax positions using a benefit recognition model with a two-step
approach: (i) a more-likely-than-not recognition criterion; and (ii) a measurement attribute
that measures the position as the largest amount of tax benefit that is greater than 50%
likely of being realized upon ultimate settlement. If it is not more likely than not that
the benefit will be sustained on its technical merits, no benefit is recorded. We recognize
accrued interest and penalties related to unrecognized tax benefits as a portion of our
income tax provision in the Condensed Consolidated Statements of Operations. |
(d) |
|
Stock-based Compensation |
|
|
We recognize compensation expense for all stock-based awards made to employees, based upon
the fair value of the stock-based award on the date of the grant. Shares are expensed over
their requisite service period. |
Page 7
(e) |
|
Cash, Cash Equivalents and Investments |
|
|
Our investment portfolio includes the following components: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2010 |
|
|
September 30, 2010 |
|
|
|
Cash and |
|
|
|
|
|
|
Cash and |
|
|
|
|
|
|
Equivalents |
|
|
Other |
|
|
Equivalents |
|
|
Other |
|
Taxable investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Overnight repurchase agreements |
|
$ |
19,047 |
|
|
$ |
|
|
|
$ |
14,862 |
|
|
$ |
|
|
Money market funds |
|
|
10,254 |
|
|
|
|
|
|
|
10,249 |
|
|
|
|
|
Cash on hand |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted |
|
|
|
|
|
|
1,000 |
|
|
|
|
|
|
|
1,000 |
|
Unrestricted |
|
|
12,178 |
|
|
|
|
|
|
|
12,768 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
41,479 |
|
|
$ |
1,000 |
|
|
$ |
37,879 |
|
|
$ |
1,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certain reclassifications have been made to the prior period financial statements to conform
to the current fiscal period presentation. |
3. Acquisition of Bioline Group
On July 20, 2010, we acquired all of the outstanding common stock of the Bioline group of companies
(collectively the Bioline Group). We paid $23,849 from cash and equivalents on hand to acquire
the Bioline Group. Headquartered in London, England, the Bioline Group is a leading manufacturer
and distributor of molecular biology reagents with additional operations in Germany, Australia and
the United States. The highly specialized molecular biology reagents it supplies to the life
science research, biotech, pharmaceutical and commercial diagnostics markets are the critical
components used in PCR testing for DNA, RNA and other genomic testing.
As a result of the consideration paid exceeding the fair value of the net assets being acquired,
goodwill in the amount of $12,725 was recorded in connection with this acquisition, none of which
will be deductible for tax purposes. This goodwill results largely from the addition of key global
operations and direct sales capabilities, management talent and a research-oriented customer base,
to complement our existing Life Science operations. In addition to the Bioline Groups results of
operations, which are included in our Condensed Consolidated Statement of Operations for the three
months ended December 31, 2010 and reported as part of the Life Science operating segment, the
consolidated results for the three months ended December 31, 2010 also include:
|
i) |
|
$350 of Cost of Sales related to the roll-out of fair value inventory adjustments for
sales of products that were in the Bioline Groups inventory on the date of acquisition
and, therefore, were valued at fair value, rather than manufactured cost, in the opening
balance sheet; and |
|
ii) |
|
$252 of General and Administrative Expenses related to the amortization of specific
identifiable intangible assets recorded on the opening balance sheet, including customer
relationships, license agreements, non-compete agreements, manufacturing processes and
trade names. |
The results of the Bioline Group included in the consolidated results of the Company for the three
months ended December 31, 2010 are Net Sales of $3,378 and Net Loss of $77, reflecting the items
noted above.
Page 8
The recognized amounts of identifiable assets acquired and liabilities assumed in the acquisition
of the Bioline Group are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
July 20, |
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
Measurement |
|
|
July 20, |
|
|
|
(as initially |
|
|
Period |
|
|
2010 |
|
|
|
reported) |
|
|
Adjustments |
|
|
(as adjusted) |
|
Fair value of assets acquired |
|
|
|
|
|
|
|
|
|
|
|
|
Cash and equivalents |
|
$ |
3,445 |
|
|
|
|
|
|
$ |
3,445 |
|
Accounts receivable |
|
|
1,897 |
|
|
|
|
|
|
|
1,897 |
|
Inventories |
|
|
2,807 |
|
|
|
|
|
|
|
2,807 |
|
Other current assets |
|
|
371 |
|
|
$ |
(21 |
) |
|
|
350 |
|
Property, plant and equipment, net |
|
|
816 |
|
|
|
|
|
|
|
816 |
|
Goodwill |
|
|
13,166 |
|
|
|
(441 |
) |
|
|
12,725 |
|
Other intangible assets (estimated useful life): |
|
|
|
|
|
|
|
|
|
|
|
|
Customer relationships (10 years) |
|
|
3,898 |
|
|
|
|
|
|
|
3,898 |
|
Manufacturing processes (6 years) |
|
|
1,467 |
|
|
|
|
|
|
|
1,467 |
|
License agreements (approx. 8 year wtd. avg.) |
|
|
718 |
|
|
|
|
|
|
|
718 |
|
Non-compete agreements (1 year) |
|
|
122 |
|
|
|
|
|
|
|
122 |
|
Trade names (10 years) |
|
|
995 |
|
|
|
|
|
|
|
995 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
29,702 |
|
|
|
(462 |
) |
|
|
29,240 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair value of liabilities assumed |
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
|
2,817 |
|
|
|
97 |
|
|
|
2,914 |
|
Deferred income tax liabilities |
|
|
3,036 |
|
|
|
(559 |
) |
|
|
2,477 |
|
|
|
|
|
|
|
|
|
|
|
Total consideration paid |
|
$ |
23,849 |
|
|
$ |
|
|
|
$ |
23,849 |
|
|
|
|
|
|
|
|
|
|
|
The above estimated fair values of the assets acquired and liabilities assumed continue to be
preliminary and are based on the information that was available as of the acquisition date and the
subsequent filing of this Form 10-Q and are reflected in the accompanying Condensed Consolidated
Balance Sheets, including retrospective adjustment of the September 30, 2010 Condensed Consolidated
Balance Sheet. We believe that the information provides a reasonable basis for estimating the fair
values of assets acquired and liabilities assumed, however the preliminary measurements of fair
value set forth above are subject to change. We expect to complete the purchase price allocation
as soon as practicable, but no later than one year from the date of acquisition.
The consolidated pro forma results of the combined entities of Meridian and the Bioline Group, had
the acquisition date been October 1, 2009, are as follows for the period indicated:
|
|
|
|
|
|
|
Three |
|
|
|
Months |
|
|
|
Ended |
|
|
|
December 31, |
|
|
|
2009 |
|
Net Sales |
|
$ |
45,411 |
|
Net Earnings |
|
$ |
9,235 |
|
Diluted Earnings Per Common Share |
|
$ |
0.22 |
|
Page 9
4. Inventories
Inventories are comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31, 2010 |
|
|
September 30, 2010 |
|
Raw materials |
|
$ |
6,876 |
|
|
$ |
6,221 |
|
Work-in-process |
|
|
6,933 |
|
|
|
6,784 |
|
Finished goods |
|
|
16,277 |
|
|
|
16,090 |
|
|
|
|
|
|
|
|
Gross inventory |
|
|
30,086 |
|
|
|
29,095 |
|
Less: Reserves |
|
|
(1,375 |
) |
|
|
(1,130 |
) |
|
|
|
|
|
|
|
Net inventory |
|
$ |
28,711 |
|
|
$ |
27,965 |
|
|
|
|
|
|
|
|
As of December 31, 2010, our reserves for finished goods inventory whose shelf life may expire
before sale to customers included $160 related to influenza kits manufactured by a third-party
supplier. This inventory generally has expiration dating of September 30, 2011 and a net carrying
value of approximately $1,100 at December 31, 2010. We estimated the reserve for this inventory
based on our sales volumes for the influenza season immediately prior to the H1N1 pandemic, as well
as an estimate of the amount of inventory in distribution channels. This inventory needs to be
sold during the present influenza season, which typically runs into April, in order to allow for
sale to customers before expiration. The ultimate magnitude of this years influenza season and
corresponding sales volumes will not be known until the conclusion of our fiscal quarter ended
March 31, 2011.
5. Major Customers and Segment Information
Meridian was formed in 1976 and functions as a fully-integrated research, development,
manufacturing, marketing and sales organization with primary emphasis in the field of life science.
Our principal businesses are (i) the development, manufacture and distribution of diagnostic test
kits primarily for gastrointestinal, viral, respiratory and parasitic infectious diseases; (ii) the
manufacture and distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides,
competent cells and bioresearch reagents used by researchers and other diagnostic manufacturers;
and (iii) the contract development and manufacture of proteins and other biologicals for use by
biopharmaceutical and biotechnology companies engaged in research for new drugs and vaccines.
Our reportable operating segments are U.S. Diagnostics, European Diagnostics and Life Science. The
U.S. Diagnostics operating segment consists of manufacturing operations in Cincinnati, Ohio, and
the sale and distribution of diagnostic test kits in the U.S. and countries outside of Europe,
Africa and the Middle East. The European Diagnostics operating segment consists of the sale and
distribution of diagnostic test kits in Europe, Africa and the Middle East. The Life Science
operating segment consists of manufacturing operations in Memphis, Tennessee; Saco, Maine; Boca
Raton, Florida; London, England; Luckenwalde, Germany; and Sydney, Australia, and the sale and
distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells and
bioresearch reagents domestically and abroad. The Life Science operating segment also includes the
contract development and manufacture of cGMP clinical grade proteins and other biologicals for use
by biopharmaceutical and biotechnology companies engaged in research for new drugs and vaccines.
Two customers accounted for 52% and 68% of the U.S. Diagnostics operating segment third-party sales
during the three months ended December 31, 2010 and 2009, respectively. Four customers accounted
for 25% and 38% of the Life Science operating segment third-party sales during the three months
ended December 31, 2010 and 2009, respectively.
Page 10
Segment information for the interim periods is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
|
European |
|
|
|
|
|
|
|
|
|
|
|
|
Diagnostics |
|
|
Diagnostics |
|
|
Life Science |
|
|
Eliminations(1) |
|
|
Total |
|
Three Months Ended December 31, 2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Third-party |
|
$ |
22,650 |
|
|
$ |
5,929 |
|
|
$ |
8,684 |
|
|
$ |
|
|
|
$ |
37,263 |
|
Inter-segment |
|
|
2,608 |
|
|
|
4 |
|
|
|
213 |
|
|
|
(2,825 |
) |
|
|
|
|
Operating income |
|
|
8,574 |
|
|
|
753 |
|
|
|
(221 |
) |
|
|
(16 |
) |
|
|
9,090 |
|
Total assets (December 31, 2010) |
|
|
129,321 |
|
|
|
36,321 |
|
|
|
90,119 |
|
|
|
(99,593 |
) |
|
|
156,168 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Third-party |
|
$ |
30,704 |
|
|
$ |
6,294 |
|
|
$ |
5,459 |
|
|
$ |
|
|
|
$ |
42,457 |
|
Inter-segment |
|
|
2,927 |
|
|
|
1 |
|
|
|
92 |
|
|
|
(3,020 |
) |
|
|
|
|
Operating income |
|
|
12,130 |
|
|
|
970 |
|
|
|
904 |
|
|
|
(248 |
) |
|
|
13,756 |
|
Total assets (December 31, 2009) |
|
|
131,963 |
|
|
|
17,959 |
|
|
|
55,670 |
|
|
|
(50,869 |
) |
|
|
154,723 |
|
|
|
|
(1) |
|
Eliminations consist of inter-segment transactions. |
Transactions between operating segments are accounted for at established intercompany prices for
internal and management purposes with all intercompany amounts eliminated in consolidation. Total
assets for the U.S. Diagnostics and Life Science operating segments include goodwill of $1,381 and
$21,374, respectively, at December 31, 2010, and $1,381 and $21,644, respectively, at September 30,
2010.
6. Intangible Assets
A summary of our acquired intangible assets subject to amortization, as of December 31, 2010 and
September 30, 2010 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2010 |
|
|
September 30, 2010 |
|
|
|
Gross |
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Carrying |
|
|
Accumulated |
|
|
Carrying |
|
|
Accumulated |
|
|
|
Value |
|
|
Amortization |
|
|
Value |
|
|
Amortization |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Manufacturing technologies, core
products and cell lines |
|
$ |
11,611 |
|
|
$ |
7,909 |
|
|
$ |
11,644 |
|
|
$ |
7,693 |
|
Trademarks, licenses and patents |
|
|
3,520 |
|
|
|
1,081 |
|
|
|
3,547 |
|
|
|
997 |
|
Customer lists and supply agreements |
|
|
12,448 |
|
|
|
6,071 |
|
|
|
12,537 |
|
|
|
5,816 |
|
Non-compete agreements |
|
|
124 |
|
|
|
52 |
|
|
|
126 |
|
|
|
21 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
27,703 |
|
|
$ |
15,113 |
|
|
$ |
27,854 |
|
|
$ |
14,527 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The actual aggregate amortization expense for these intangible assets for the three months ended
December 31, 2010 and 2009 was $595 and $395, respectively.
Page 11
7. Fair Value Measurements
We use fair value measurements to value our financial assets and liabilities. Fair value is the
price that would be received to sell an asset or paid to transfer a liability in an orderly
transaction between market participants at the measurement date. Fair value hierarchy prioritizes
inputs to valuation techniques used to measure fair value into three broad levels, which are
described below:
Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that are
accessible at the measurement date for assets and liabilities. The fair value hierarchy gives the
highest priority to Level 1 inputs.
Level 2: Inputs other than quoted prices included within Level 1 that are observable for the assets
or liabilities, either directly or indirectly. These include quoted prices for
identical or similar assets or liabilities in markets that are not active, that is, markets in
which there are few transactions for the asset or liability, the prices are not current, or price
quotations vary substantially either over time or among market makers, or in which little
information is released publicly and inputs that are derived principally from or corroborated by
observable market data by correlation or other means.
Level 3: Unobservable inputs, developed using our estimates and assumptions, which reflect those that the
market participants would use. Such inputs are used when little or no market data is available.
The fair value hierarchy gives the lowest priority to Level 3 inputs.
Determining where an asset or liability falls within the hierarchy depends on the lowest level
input that is significant to the fair value measurement as a whole. In determining fair value, we
utilize valuation techniques that maximize the use of observable inputs and minimize the use of
unobservable inputs to the extent possible and consider counterparty credit risk in the assessment
of fair value.
Financial assets and liabilities carried at fair value at December 31, 2010 and September 30, 2010
and are classified in the tables below into one of the three categories described above:
Balances as of December 31, 2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
Money market funds |
|
$ |
10,254 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
10,254 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
10,254 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
10,254 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances as of September 30, 2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
Money market funds |
|
$ |
10,249 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
10,249 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
10,249 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
10,249 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ITEM 2. |
|
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
Refer to Forward Looking Statements following the Index in front of this Form 10-Q. In the
discussion that follows, all amounts are in thousands (both tables and text), except per share data
and percentages.
Following is a discussion and analysis of the financial statements and other statistical data that
management believes will enhance the understanding of Meridians financial condition and results of
operations. This discussion should be read in conjunction with the financial statements and notes
thereto beginning on page 1.
Page 12
Results of Operations
Net earnings for the first quarter of fiscal 2011 decreased 32% to $6,025, or $0.15 per diluted
share, from net earnings for the first quarter of fiscal 2010 of $8,921, or $0.22 per diluted
share. This decrease reflects the combined effects of decreased sales and increased operating
expenses, resulting primarily from having a full quarter of expenses from the Bioline Group, which
was acquired in July 2010. Consolidated sales decreased 12% to $37,263 for the first quarter of
fiscal 2011 compared to the same period of the prior year, reflecting an approximate $7,500 decline
in influenza product sales.
Sales for the U.S. Diagnostics operating segment for the first quarter of fiscal 2011 decreased 26%
compared to the first quarter of fiscal 2010, reflecting the dramatic impact on the fiscal 2010
first quarter of the novel A (H1N1) influenza outbreak and the abrupt halt of the outbreak in
December 2009, along with a slight sales decrease in our C. difficile product family and double
digit growth in our foodborne and H. pylori product families. First quarter 2011 sales for our
European Diagnostics operating segment decreased 6% compared to the first quarter of fiscal 2010
largely due to negative currency effect, while, as a result of the Bioline Group acquisition, our
Life Science segment experienced a 59% increase in sales during this period. Excluding the effect
of the Bioline Group, sales of our Life Science operating segment decreased by 3% during the first
quarter of fiscal 2011 compared to the first quarter of fiscal 2010, reflecting the business
ongoing dependency on the timing of customers buying patterns.
Revenue Overview
Our Diagnostics operating segments provide the largest share of our consolidated revenues, 77% and
87% for the first quarters of fiscal 2011 and 2010, respectively, with the percentage decline
resulting primarily from the addition of the Bioline Group to our Life Science operating segment
and the impact of the influenza outbreak in 2010. Sales from our four focus families (C.
difficile, H. pylori, Foodborne and Upper Respiratory) comprised 67% and 73% of our Diagnostics
operating segments revenues during the first quarters of fiscal 2011 and 2010, respectively.
Overall revenue change for the fiscal 2011 first quarter for our Diagnostics operating segments was
a decrease of 23%, largely due to a relatively mild worldwide flu season in the first quarter of
fiscal 2011 compared to the fiscal 2010 first quarter, including the effects on the prior year of
the world-wide outbreak of novel A (H1N1) influenza. Further contributing to the first quarter
year-over-year sales decline was the fact that sales of our C. difficile family of products
continued to be negatively impacted by significant competitive pressures and ongoing confusion
surrounding the various testing methods, factors which we believe are being countered by our
recently-introduced illumigene® molecular C. difficile product, which offset much of the
decline. Partially offsetting the effects of the declines in these products were sales increases
in our H. pylori and foodborne families of products of 11% and 10%, respectively, compared to the
first quarter of fiscal 2010. On an organic basis, which excludes the effects of currency
translation, sales for our European Diagnostics operating segment increased by 1% during the first
quarter, reflecting the combined effects of growth in our foodborne products category, partially
offset by declines in our upper respiratory and C. difficile product families.
C. difficile Products
During the third quarter of fiscal 2010, we launched our illumigene® molecular C.
difficile product in non-U.S. markets, with launch of the product into U.S. markets following in
the fourth quarter of fiscal 2010, upon receiving FDA clearance. As a result, we currently have
approximately 200 customer accounts and others that are evaluating our illumigene®
molecular C. difficile product. We expect sales of the product, which totaled approximately $775
in the first quarter of fiscal 2011, to continue to grow significantly throughout fiscal 2011 and
recently executed an agreement with a large U.S. medical products distributor to sell the product
in the U.S. market.
As a result of competitive pressures in this disease family over the last several years from new
competitive products, including molecular assays, we have experienced overall declines in the sales
of our C. difficile products. Although sales of C. difficile products decreased 3% for all of our
Diagnostics operating segments during the first quarter of fiscal 2011, this rate of decline is a
marked improvement over the double digit declines experienced during fiscal 2010 and continued
improvement is expected as result of ongoing illumigene® molecular C. difficile product
sales. With the launch of our molecular product, we believe we are in a unique position to offer a
full line of testing solutions to our clinical laboratory customers around the world to counter the
competitive pressures surrounding this market.
Page 13
Upper Respiratory Products
During the first quarter of fiscal 2011, upper respiratory product sales for our Diagnostics
operating segments decreased 72% compared to the first quarter of fiscal 2010. This dramatic sales
reduction for this family of products was driven by the abrupt halt, in December 2009, of the
outbreak of the novel A (H1N1) influenza virus that began to spread across the countries in the
northern hemisphere during the second half of fiscal 2009. The outbreak also created an increased
interest in influenza testing in European markets where rapid testing has not been traditionally
performed and resulted in significant sales activity for the these products during the fiscal 2010
first quarter. However, similar to U.S. markets, these sales levels have not been repeated in the
fiscal 2011 first quarter, as evidenced by the approximate 42% decline in this operating segments
upper respiratory product sales on an organic basis (excluding effects of currency translation)
since the first quarter of fiscal 2010.
While the severity of upcoming influenza seasons can never be predicted with complete certainty, we
are neither expecting nor relying upon significant revenue contribution from influenza products
during the balance of fiscal 2011.
Foodborne Products
During the first quarter of fiscal 2011, sales of our foodborne products increased approximately 9%
for our U.S. Diagnostics operating segment and approximately 45% for our European Diagnostics
operating segment on an organic basis. While first quarter foodborne comparisons were difficult
due to the effects of certain distributor order patterns, as expected January sales demonstrated
strong sales growth in excess of 100%, as we rebound from the first quarter order patterns.
H. pylori Products
During the first quarter of fiscal 2011, sales of our H. pylori products grew 16% for our U.S.
Diagnostics operating segment. This increase continues to reflect the benefits of our partnerships
with managed care companies in promoting the health and economic benefits of a test and treat
strategy, and the ongoing effects of such strategy moving physician behavior away from
serology-based testing toward direct antigen testing. Sales of H. pylori products for our European
Diagnostics operating segment grew 4% on an organic basis for the fiscal 2011 first quarter,
compared to the first quarter of fiscal 2010.
Group Purchasing Organizations
In our U.S. Diagnostics operating segment, consolidation of the U.S. healthcare industry over the
last several years has led to the creation of group purchasing organizations (GPOs) that aggregate
buying power for hospital groups and put pressure on our selling prices. We have multi-year supply
agreements with several GPOs. During the first three months of fiscal 2011, we have experienced
approximately $550 in unfavorable price variance, as a result of these agreements. However, these
agreements help secure our products with these customers and have led to new business. While in
the near term this has negatively impacted gross profit, further increases in volumes are expected
from these contracts. Furthermore, given the timing of entering into these agreements, the effect
of the related price declines will not be reflected in the year-over-year comparisons beginning in
the second quarter of fiscal 2011.
Foreign Currency
Sales for our European Diagnostics operating segment included the effect of less favorable currency
rates, which led to currency translation losses in the amount of approximately $435 for the first
quarter of fiscal 2011, compared to $600 of currency translation gains in the fiscal 2010 first
quarter.
Life Science Operating Segment
Sales for our Life Science operating segment increased 59% for the first quarter of fiscal 2011 due
primarily to the revenue contribution of the Bioline Group acquired in July 2010. Excluding the
impact of the Bioline Group, sales for the operating segment declined 3%, reflecting the buying
patterns of our two largest diagnostic manufacturing customers. Including the effect of the
addition of the Bioline Group, we expect approximate 50% revenue growth for this operating segment
in fiscal 2011, compared to fiscal 2010, and approximate 6% growth excluding the effects of the
Bioline Group.
Page 14
Significant Customers
Two national distributors in our U.S. Diagnostics operating segment accounted for 52% and 68% of
total sales for this operating segment for the first quarters of fiscal 2011 and 2010,
respectively. The lower percentage of sales during the first quarter of fiscal 2011 reflects the
comparative decline in the distributors inventory stocking of influenza and other products.
Four diagnostic manufacturing customers in our Life Science operating segment accounted for 25% and
38% of total sales for this operating segment for the first quarters of fiscal 2011 and 2010,
respectively. The lower percentage of sales during the first quarter of fiscal 2011 results from
the addition of the Bioline Group.
Operating Segment Revenues
Our reportable operating segments are U.S. Diagnostics, European Diagnostics and Life Science. The
U.S. Diagnostics operating segment consists of manufacturing operations in Cincinnati, Ohio, and
the sale and distribution of diagnostic test kits in the U.S. and countries outside of Europe,
Africa and the Middle East. The European Diagnostics operating segment consists of the sale and
distribution of diagnostic test kits in Europe, Africa and the Middle East. The Life Science
operating segment consists of manufacturing operations in Memphis, Tennessee; Saco, Maine; Boca
Raton, Florida; London, England; Luckenwalde, Germany; and Sydney, Australia and the sale and
distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells and
bioresearch reagents domestically and abroad. The Life Science operating segment also includes the
contract development and manufacture of proteins and other biologicals for use by biopharmaceutical
and biotechnology companies engaged in research for new drugs and vaccines.
Revenues for the Diagnostics operating segments, in the normal course of business, may be affected
from quarter to quarter by buying patterns of major distributors, seasonality and strength of
certain diseases and foreign currency exchange rates. Revenues for the Life Science operating
segment, in the normal course of business, may be affected from quarter to quarter by the timing
and nature of arrangements for contract services work, which may have longer production cycles than
bioresearch reagents and bulk antigens and antibodies, as well as buying patterns of major
customers. We believe that the overall breadth of our product lines serves to reduce the
variability in consolidated revenues.
Revenues for each of our operating segments are shown below.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
Inc (Dec) |
|
U.S. Diagnostics |
|
$ |
22,650 |
|
|
$ |
30,704 |
|
|
|
(26 |
)% |
European Diagnostics |
|
|
5,929 |
|
|
|
6,294 |
|
|
|
(6 |
)% |
Life Science |
|
|
8,684 |
|
|
|
5,459 |
|
|
|
59 |
% |
|
|
|
|
|
|
|
|
|
|
Consolidated |
|
$ |
37,263 |
|
|
$ |
42,457 |
|
|
|
(12 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
International |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Diagnostics |
|
$ |
1,596 |
|
|
$ |
1,729 |
|
|
|
(8 |
)% |
European Diagnostics |
|
|
5,929 |
|
|
|
6,294 |
|
|
|
(6 |
)% |
Life Science |
|
|
4,589 |
|
|
|
2,460 |
|
|
|
87 |
% |
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
12,114 |
|
|
$ |
10,483 |
|
|
|
16 |
% |
|
|
|
|
|
|
|
|
|
|
% of total sales |
|
|
33 |
% |
|
|
25 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Page 15
Gross Profit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
Change |
|
Gross Profit |
|
$ |
23,620 |
|
|
$ |
25,485 |
|
|
|
(7 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Profit Margin |
|
|
63 |
% |
|
|
60 |
% |
|
+3 points |
Gross profit margin improvement for the first quarter of fiscal 2011 results primarily from the
combined effects of continued operating efficiencies in our Cincinnati, Ohio diagnostic test
manufacturing facility and the quarter-over-quarter decline in upper respiratory product sales.
Our upper respiratory product family generally has a lower gross profit margin than our other focus
product families (C. difficile, H. pylori and foodborne). Sales of upper respiratory products
during the first quarter of fiscal 2011 were approximately 8% of our consolidated sales, compared
to 27% of our consolidated sales during the first quarter of fiscal 2010.
Our overall operations consist of the sale of diagnostic test kits for various disease states and
in alternative test formats, as well as bioresearch reagents, bulk antigens, antibodies, PCR/qPCR
reagents, nucleotides, competent cells, proficiency panels, contract research and development, and
contract manufacturing services. Product sales mix shifts, in the normal course of business, can
cause the consolidated gross profit margin to fluctuate by several points.
Operating Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research & |
|
|
Selling & |
|
|
General & |
|
|
Total Operating |
|
|
|
Development |
|
|
Marketing |
|
|
Administrative |
|
|
Expenses |
|
Q1 2010 Expenses |
|
$ |
2,078 |
|
|
$ |
4,887 |
|
|
$ |
4,764 |
|
|
$ |
11,729 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of Sales |
|
|
5 |
% |
|
|
12 |
% |
|
|
11 |
% |
|
|
28 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal 2011 Increases (Decreases): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Diagnostics |
|
|
(46 |
) |
|
|
40 |
|
|
|
355 |
|
|
|
349 |
|
European Diagnostics |
|
|
|
|
|
|
(81 |
) |
|
|
(36 |
) |
|
|
(117 |
) |
Life Science |
|
|
296 |
|
|
|
841 |
|
|
|
1,432 |
|
|
|
2,569 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q1 2011 Expenses |
|
$ |
2,328 |
|
|
$ |
5,687 |
|
|
$ |
6,515 |
|
|
$ |
14,530 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of Sales |
|
|
6 |
% |
|
|
15 |
% |
|
|
17 |
% |
|
|
39 |
% |
% Increase |
|
|
12 |
% |
|
|
16 |
% |
|
|
37 |
% |
|
|
24 |
% |
We continue to closely control spending for each of our operating segments.
The $2,801 increase in all three operating expense categories results primarily from the addition
of the Bioline Groups operating expenses of approximately $2,365. Additionally, the general and
administrative expenses for the U.S. Diagnostics operating segment reflect an approximate $400
increase in stock-based compensation expense for restricted stock grants during the fiscal 2011
first quarter.
Operating Income
Operating income decreased 34% to $9,090 for the first quarter of fiscal 2011, as a result of the
factors discussed above.
Page 16
Other Income and Expense
The increase in other income, net, can primarily be attributed to the addition of the Bioline
Group, as it contributed to an improvement in net currency exchange gains/losses of approximately
$165 and grant income from a foreign governmental agency of approximately $100.
Income Taxes
The effective rate for income taxes was 35% for the first quarters of both fiscal 2011 and fiscal
2010. For the fiscal year ending September 30, 2011, we expect the effective tax rate to remain at
approximately 35%.
Liquidity and Capital Resources
Comparative Cash Flow Analysis
Our cash flow and financing requirements are determined by analyses of operating and capital
spending budgets, consideration of acquisition plans, and consideration of common share dividends.
We have historically maintained a credit facility to augment working capital requirements and to
respond quickly to acquisition opportunities. Our investment portfolio presently contains
overnight repurchase agreements and institutional money-market mutual funds. We used $23,849 from
our investment portfolio to complete the acquisition of the Bioline Group during July 2010.
We have an investment policy that guides the holdings of our investment portfolio. Our objectives
in managing the investment portfolio are to (i) preserve capital; (ii) provide sufficient liquidity
to meet working capital requirements and fund strategic objectives such as acquisitions; and (iii)
capture a market rate of return commensurate with market conditions and our policys investment
eligibility criteria. As we look forward, we will continue to manage the holdings of our
investment portfolio with preservation of capital being the primary objective.
Except as otherwise described herein, we do not expect current conditions in the financial markets,
or overall economic conditions to have a significant impact on our liquidity needs, financial
condition, or results of operations. We intend to continue to fund our working capital
requirements and dividends from current cash flows from operating activities. We also have
additional sources of liquidity through our investment portfolio and a $30,000 bank credit
facility, if needed. To date, we have not experienced any significant deterioration in the aging
of our customer accounts receivable nor in our vendors ability to supply raw materials and
services and extend normal credit terms. Our liquidity needs may change if overall economic
conditions worsen and/or liquidity and credit within the financial markets remains tight for an
extended period of time, and such conditions impact the collectibility of our customer accounts
receivable, or impact credit terms with our vendors, or disrupt the supply of raw materials and
services.
Net cash provided by operating activities increased 3% for the first quarter of fiscal 2011 to
$13,599, despite a 32% decrease in net earnings. This modest increase was primarily attributable
to net working capital changes related to fluctuations in sales levels and the timing of payments
with suppliers. Net cash flows from operating activities are anticipated to be adequate to fund
working capital requirements and dividends during the next 12 months.
Capital Resources
We have a $30,000 credit facility with a commercial bank which expires on September 15, 2012. As
of January 31, 2011, there were no borrowings outstanding on this facility and we had 100%
borrowing capacity available to us. We have had no borrowings outstanding under this facility
during the first three months of fiscal 2011, or during the full year of fiscal 2010.
Our capital expenditures are estimated to range between approximately $6,000 to $9,500 for fiscal
2011, with the actual amount depending upon actual operating results and the phasing of certain
projects. Such expenditures may be funded with cash and cash equivalents on hand, operating cash
flows, and/or availability under the $30,000 credit facility discussed above. Capital expenditures
relate to manufacturing and other equipment of a normal and recurring nature, as well as costs
associated with production line automation in Cincinnati, facilities expansions in
Cincinnati and Memphis, computer system and software purchases for the Bioline Group, and
instrumentation to support the ongoing illumigene® product launch.
Page 17
We do not utilize any special-purpose financing vehicles or have any undisclosed off balance sheet
arrangements.
Critical Accounting Policies Inventories
Our inventories are carried at the lower of cost or market. Cost is determined on a first-in,
first-out basis. We establish reserves against cost for excess and obsolete materials, finished
goods whose shelf life may expire before sale to customers, and other identified exposures.
Management estimates these reserves based on assumptions about future demand and market conditions.
If actual demand and market conditions were to be less favorable than such estimates, additional
inventory write-downs would be required and recorded in the period known. Such adjustments would
negatively affect gross profit margin and overall results of operations.
As of December 31, 2010, our reserves for finished goods inventory whose shelf life may expire
before sale to customers included $160 related to influenza kits manufactured by a third-party
supplier. This inventory generally has expiration dating of September 30, 2011 and a net carrying
value of approximately $1,100 at December 31, 2010. We estimated the reserve for this inventory
based on our sales volumes for the influenza season immediately prior to the H1N1 pandemic, as well
as an estimate of the amount of inventory in distribution channels. This inventory needs to be
sold during the present influenza season, which typically runs into April, in order to allow for
sale to customers before expiration. The ultimate magnitude of this years influenza season and
corresponding sales volumes will not be known until the conclusion of our fiscal quarter ended
March 31, 2011.
|
|
|
ITEM 3. |
|
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
There have been no material changes in the Companys exposure to market risk since September 30,
2010.
|
|
|
ITEM 4. |
|
CONTROLS AND PROCEDURES |
As of December 31, 2010, an evaluation was completed under the supervision and with the
participation of our management, including our Chief Executive Officer and Chief Financial Officer,
of the effectiveness of the design and operation of our disclosure controls and procedures pursuant
to Rule 13a-15(b) and 15d-15(b) promulgated under the Securities Exchange Act of 1934, as amended.
Based on that evaluation, our management, including the CEO and CFO, concluded that our disclosure
controls and procedures were effective as of December 31, 2010. There have been no changes in our
internal control over financial reporting identified in connection with the evaluation of internal
control that occurred during the first fiscal quarter that has materially affected, or is
reasonably likely to materially affect, our internal control over financial reporting, or in other
factors that could materially affect internal control subsequent to December 31, 2010.
Page 18
PART II. OTHER INFORMATION
There have been no material changes from risk factors as previously disclosed in the Registrants
Form 10-K in response to Item 1A to Part I of Form 10-K.
|
|
|
|
|
|
10.18.3 |
|
|
Second Amendment to Loan and Security Agreement among Meridian Bioscience, Inc., Meridian
Bioscience Corporation, Omega Technologies, Inc., Meridian Life Science, Inc. and Fifth Third
Bank dated December 1, 2010 (Filed herewith) |
|
|
|
|
|
|
31.1 |
|
|
Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rule
13a-14(a)/15d-14(a) (Filed herewith) |
|
|
|
|
|
|
31.2 |
|
|
Certification of Principal Financial Officer Pursuant to Securities Exchange Act Rule
13a-14(a)/15d-14(a) (Filed herewith) |
|
|
|
|
|
|
32 |
|
|
Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C.
Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Filed
herewith) |
Page 19
SIGNATURE
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.
|
|
|
|
|
|
MERIDIAN BIOSCIENCE, INC.
|
|
Date: February 9, 2011 |
/s/ Melissa A. Lueke
|
|
|
Melissa A. Lueke |
|
|
Executive Vice President and
Chief Financial Officer |
|
|
Page 20