Form 10-Q
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
|
|
|
þ |
|
QUARTERLY REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the Quarterly Period Ended December 31, 2009
OR
|
|
|
o |
|
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 o 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.
|
|
|
|
|
|
|
Large accelerated filer þ
|
|
Accelerated filer o
|
|
Non-accelerated filer o
|
|
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.
|
|
|
Class
|
|
Outstanding January 31, 2010 |
|
|
|
Common Stock, no par value
|
|
40,604,296 |
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 successfully integrated into Meridians operations. The
Company cannot predict the possible effects of potential healthcare reform in the United States and
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.
MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Consolidated Statements of Operations (Unaudited)
(in thousands, except per share data)
|
|
|
|
|
|
|
|
|
Three Months Ended December 31 |
|
2009 |
|
|
2008 |
|
NET SALES |
|
$ |
42,457 |
|
|
$ |
34,293 |
|
|
|
|
|
|
|
|
|
|
COST OF SALES |
|
|
16,972 |
|
|
|
10,949 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GROSS PROFIT |
|
|
25,485 |
|
|
|
23,344 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
2,078 |
|
|
|
2,064 |
|
Selling and marketing |
|
|
4,887 |
|
|
|
4,967 |
|
General and administrative |
|
|
4,764 |
|
|
|
4,155 |
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
11,729 |
|
|
|
11,186 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING INCOME |
|
|
13,756 |
|
|
|
12,158 |
|
|
|
|
|
|
|
|
|
|
OTHER INCOME (EXPENSE) |
|
|
|
|
|
|
|
|
Interest income |
|
|
31 |
|
|
|
262 |
|
Other, net |
|
|
(118 |
) |
|
|
(148 |
) |
|
|
|
|
|
|
|
Total other income (expense) |
|
|
(87 |
) |
|
|
114 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EARNINGS BEFORE INCOME TAXES |
|
|
13,669 |
|
|
|
12,272 |
|
|
|
|
|
|
|
|
|
|
INCOME TAX PROVISION |
|
|
4,748 |
|
|
|
4,196 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET EARNINGS |
|
$ |
8,921 |
|
|
$ |
8,076 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BASIC EARNINGS PER COMMON SHARE |
|
$ |
0.22 |
|
|
$ |
0.20 |
|
|
|
|
|
|
|
|
|
|
DILUTED EARNINGS PER COMMON SHARE |
|
$ |
0.22 |
|
|
$ |
0.20 |
|
|
|
|
|
|
|
|
|
|
AVERAGE NUMBER OF COMMON SHARES OUTSTANDING BASIC |
|
|
40,496 |
|
|
|
40,318 |
|
|
|
|
|
|
|
|
|
|
DILUTIVE COMMON SHARE OPTIONS |
|
|
689 |
|
|
|
807 |
|
|
|
|
|
|
|
|
|
|
AVERAGE NUMBER OF COMMON SHARES OUTSTANDING DILUTED |
|
|
41,185 |
|
|
|
41,125 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ANTI-DILUTIVE SECURITIES: |
|
|
|
|
|
|
|
|
Common share options |
|
|
141 |
|
|
|
112 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DIVIDENDS DECLARED PER COMMON SHARE |
|
$ |
0.17 |
|
|
$ |
0.14 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
Page 1
MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Consolidated Statements of Cash Flows (Unaudited)
(dollars in thousands)
|
|
|
|
|
|
|
|
|
Three Months Ended December 31 |
|
2009 |
|
|
2008 |
|
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net earnings |
|
$ |
8,921 |
|
|
$ |
8,076 |
|
Non-cash items: |
|
|
|
|
|
|
|
|
Depreciation of property, plant and equipment |
|
|
762 |
|
|
|
731 |
|
Amortization of intangible assets |
|
|
395 |
|
|
|
404 |
|
Stock based compensation |
|
|
559 |
|
|
|
286 |
|
Deferred income taxes |
|
|
(431 |
) |
|
|
(290 |
) |
Unrealized loss on auction-rate securities and rights, net |
|
|
15 |
|
|
|
104 |
|
Change in accounts receivable, inventory, and prepaid expenses |
|
|
6,194 |
|
|
|
(209 |
) |
Change in accounts payable, accrued expenses, and income taxes payable |
|
|
(3,282 |
) |
|
|
(2,936 |
) |
Other |
|
|
37 |
|
|
|
11 |
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
13,170 |
|
|
|
6,177 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
Acquisitions of property, plant and equipment |
|
|
(880 |
) |
|
|
(618 |
) |
Purchases of short-term investments |
|
|
(1,000 |
) |
|
|
|
|
Proceeds from calls of auction-rate securities |
|
|
|
|
|
|
425 |
|
|
|
|
|
|
|
|
Net cash used for investing activities |
|
|
(1,880 |
) |
|
|
(193 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Dividends paid |
|
|
(6,885 |
) |
|
|
(5,644 |
) |
Proceeds and tax benefits from exercises of stock options |
|
|
96 |
|
|
|
160 |
|
Other |
|
|
|
|
|
|
(12 |
) |
|
|
|
|
|
|
|
Net cash used for financing activities |
|
|
(6,789 |
) |
|
|
(5,496 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of Exchange Rate Changes on Cash and Equivalents |
|
|
(71 |
) |
|
|
(24 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Increase in Cash and Equivalents |
|
|
4,430 |
|
|
|
464 |
|
|
|
|
|
|
|
|
|
|
Cash and Equivalents at Beginning of Period |
|
|
54,030 |
|
|
|
49,297 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and Equivalents at End of Period |
|
$ |
58,460 |
|
|
$ |
49,761 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
Page 2
MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Consolidated Balance Sheets (Unaudited)
(dollars in thousands)
ASSETS
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
September 30, |
|
|
|
2009 |
|
|
2009 |
|
CURRENT ASSETS: |
|
|
|
|
|
|
|
|
Cash and equivalents |
|
$ |
58,460 |
|
|
$ |
54,030 |
|
Short-term investments |
|
|
8,270 |
|
|
|
7,285 |
|
Accounts receivable, less allowances of $232 and $247 |
|
|
17,854 |
|
|
|
26,981 |
|
Inventories |
|
|
26,766 |
|
|
|
23,284 |
|
Prepaid expenses and other current assets |
|
|
2,897 |
|
|
|
3,632 |
|
Deferred income taxes |
|
|
1,904 |
|
|
|
1,935 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
116,151 |
|
|
|
117,147 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PROPERTY, PLANT AND EQUIPMENT: |
|
|
|
|
|
|
|
|
Land |
|
|
890 |
|
|
|
894 |
|
Buildings and improvements |
|
|
19,720 |
|
|
|
19,718 |
|
Machinery, equipment and furniture |
|
|
31,531 |
|
|
|
30,997 |
|
Construction in progress |
|
|
1,811 |
|
|
|
1,586 |
|
|
|
|
|
|
|
|
Subtotal |
|
|
53,952 |
|
|
|
53,195 |
|
Less: accumulated depreciation and amortization |
|
|
33,369 |
|
|
|
32,721 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net property, plant and equipment |
|
|
20,583 |
|
|
|
20,474 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER ASSETS: |
|
|
|
|
|
|
|
|
Goodwill |
|
|
9,866 |
|
|
|
9,866 |
|
Other intangible assets, net |
|
|
6,922 |
|
|
|
7,317 |
|
Restricted cash |
|
|
1,000 |
|
|
|
1,000 |
|
Other assets |
|
|
201 |
|
|
|
193 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other assets |
|
|
17,989 |
|
|
|
18,376 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL ASSETS |
|
$ |
154,723 |
|
|
$ |
155,997 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
Page 3
MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Consolidated Balance Sheets (Unaudited)
(dollars in thousands)
LIABILITIES AND SHAREHOLDERS EQUITY
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
September 30, |
|
|
|
2009 |
|
|
2009 |
|
CURRENT LIABILITIES: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
5,705 |
|
|
$ |
6,901 |
|
Accrued employee compensation costs |
|
|
3,869 |
|
|
|
5,338 |
|
Other accrued expenses |
|
|
3,287 |
|
|
|
3,803 |
|
Income taxes payable |
|
|
602 |
|
|
|
710 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
13,463 |
|
|
|
16,752 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DEFERRED INCOME TAXES |
|
|
834 |
|
|
|
1,340 |
|
|
|
|
|
|
|
|
|
|
COMMITMENTS AND CONTINGENCIES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SHAREHOLDERS EQUITY: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, no par value, 1,000,000
shares authorized, none issued |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common shares, no par value, 71,000,000
shares authorized, 40,597,121 and
40,493,313 shares issued, respectively |
|
|
|
|
|
|
|
|
Additional paid-in capital |
|
|
92,321 |
|
|
|
91,668 |
|
Retained earnings |
|
|
47,551 |
|
|
|
45,515 |
|
Accumulated other comprehensive income |
|
|
554 |
|
|
|
722 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total shareholders equity |
|
|
140,426 |
|
|
|
137,905 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
|
$ |
154,723 |
|
|
$ |
155,997 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
Page 4
MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Consolidated Statement of Changes in Shareholders Equity (Unaudited)
(dollars and shares in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
Common |
|
|
Additional |
|
|
|
|
|
|
Other |
|
|
|
|
|
|
Total |
|
|
|
Shares |
|
|
Paid-In |
|
|
Retained |
|
|
Comprehensive |
|
|
Comprehensive |
|
|
Shareholders |
|
|
|
Issued |
|
|
Capital |
|
|
Earnings |
|
|
Income (Loss) |
|
|
Income (Loss) |
|
|
Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2009 |
|
|
40,493 |
|
|
$ |
91,668 |
|
|
$ |
45,515 |
|
|
$ |
722 |
|
|
|
|
|
|
$ |
137,905 |
|
Cash dividends paid |
|
|
|
|
|
|
|
|
|
|
(6,885 |
) |
|
|
|
|
|
|
|
|
|
|
(6,885 |
) |
Exercise of stock options |
|
|
9 |
|
|
|
94 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
94 |
|
Issuance of restricted shares |
|
|
95 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation |
|
|
|
|
|
|
559 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
559 |
|
Comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net earnings |
|
|
|
|
|
|
|
|
|
|
8,921 |
|
|
|
|
|
|
$ |
8,921 |
|
|
|
8,921 |
|
Other comprehensive income taxes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
89 |
|
|
|
89 |
|
|
|
89 |
|
Foreign currency translation adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(257 |
) |
|
|
(257 |
) |
|
|
(257 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
8,753 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2009 |
|
|
40,597 |
|
|
$ |
92,321 |
|
|
$ |
47,551 |
|
|
$ |
554 |
|
|
|
|
|
|
$ |
140,426 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
Page 5
MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
Dollars in Thousands, Except Per Share Amounts
(Unaudited)
1. |
|
Basis of Presentation: |
The consolidated financial statements included herein have not been audited by an independent
registered public accounting firm, but include all adjustments (consisting of normal recurring
entries), which are, in the opinion of management, necessary for a fair presentation of the results
for such periods.
Certain information and footnote disclosures normally included in financial statements prepared in
accordance with generally accepted accounting principles have been omitted pursuant to the
requirements of the Securities and Exchange Commission. Meridian believes that the disclosures
included in these financial statements are adequate to make the information not misleading.
It is suggested that these consolidated interim financial statements be read in conjunction with
the consolidated annual financial statements and notes thereto, included in Meridians Annual
Report on Form 10-K for the Year Ended September 30, 2009.
The results of operations for interim periods are not necessarily indicative of the results to be
expected for the year.
Further, in connection with preparation of the condensed consolidated financial statements, we
evaluated subsequent events after the balance sheet date of December 31, 2009 through January 31,
2010.
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 US 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 $5,933 at December 31, 2009 and $4,776 at September 30, 2009.
Life Science revenue for contract services may come from standalone arrangements for process
development and/or optimization work (contract research and development services) or custom
manufacturing, or multiple-deliverable arrangements that include process development work
followed by larger-scale manufacturing (both contract research and development services and
contract manufacturing services). Revenue is recognized based on each of the multiple
deliverables in a given arrangement having distinct and separate fair values. Fair values
are determined via consistent pricing between standalone arrangements and multiple
deliverable arrangements, as well as 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 pursuant to the satisfaction of criteria
in SEC Staff Accounting Bulletins Nos. 101 and 104 related to bill-and-hold revenue
recognition.
Trade accounts receivable are recorded in the accompanying consolidated balance sheet 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,
changes in the fair value of forward exchange contracts accounted for as cash flow hedges
(fiscal 2009 only), and changes in the fair value of available-for-sale (AFS) fixed income
securities (fiscal 2009 only).
Assets and liabilities of foreign operations are translated using period-end exchange rates
with gains or losses resulting from translation included in a separate component of
accumulated other 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 Euro
currency. These gains and losses are included in other income and expense in the
accompanying consolidated statements of operations.
Comprehensive income for the interim periods was as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
|
Ended December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
Net earnings |
|
$ |
8,921 |
|
|
$ |
8,076 |
|
Hedging activity |
|
|
|
|
|
|
(22 |
) |
Transfer of AFS securities to trading classification |
|
|
|
|
|
|
270 |
|
Income taxes |
|
|
89 |
|
|
|
(5 |
) |
Foreign currency translation adjustment |
|
|
(257 |
) |
|
|
(234 |
) |
|
|
|
|
|
|
|
Comprehensive income |
|
$ |
8,753 |
|
|
$ |
8,085 |
|
|
|
|
|
|
|
|
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 ultimately 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 consolidated statements of operations.
|
(d) |
|
Share-based Compensation |
We recognize compensation expense for all share-based awards made to employees based upon
the fair value of the share-based award on the date of the grant.
Page 7
|
(e) |
|
Cash, Cash Equivalents, and Investments |
Our investment portfolio includes the following components:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2009 |
|
|
September 30, 2009 |
|
|
|
Cash and |
|
|
|
|
|
|
Cash and |
|
|
|
|
|
|
Equivalents |
|
|
Other |
|
|
Equivalents |
|
|
Other |
|
Taxable investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Overnight repurchase agreements |
|
$ |
11,936 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Money market funds |
|
|
38,274 |
|
|
|
|
|
|
|
29,032 |
|
|
|
|
|
Fixed-rate municipal note |
|
|
|
|
|
|
1,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax-exempt investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
|
151 |
|
|
|
|
|
|
|
10,383 |
|
|
|
|
|
Student loan auction-rate
securities and rights |
|
|
|
|
|
|
7,270 |
|
|
|
|
|
|
|
7,285 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash on hand |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted |
|
|
|
|
|
|
1,000 |
|
|
|
|
|
|
|
1,000 |
|
Unrestricted |
|
|
8,099 |
|
|
|
|
|
|
|
14,615 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
58,460 |
|
|
$ |
9,270 |
|
|
$ |
54,030 |
|
|
$ |
8,285 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our investment portfolio includes student loan auction-rate securities, which are long-term
student loan revenue bonds whose interest rates are reset every 35 days via a Dutch auction
process. All of our auction-rate securities are backed by pools of student loans originated
under the Federal Family Education Loan Program (FFELP). FFELP student loans are guaranteed
by State guarantors who have reinsurance agreements with the US Department of Education.
All of our student loan auction-rate securities were rated Aaa and AAA by Moodys and
Standard & Poors, respectively, at the time of purchase, and have continued to maintain
these credit ratings through the present time.
The Dutch auction process historically provided the necessary liquidity mechanism to either
purchase or sell these securities. Beginning in mid-February 2008, liquidity issues in the
US credit markets resulted in the failure of auctions across a broad spectrum of tax-exempt
securities, including student loan revenue bonds. Auctions for the student loan revenue
bonds that we hold have continued to fail through the present time. The consequence of a
failed auction is that we do not have access to the principal amount of our investments.
Issuers are still required to make interest payments when due in the event of failed
auctions. We have not experienced any missed interest payments to date.
Our auction-rate securities were purchased through UBS Financial Services, Inc. During
November 2008, we accepted an offer from UBS, AG (UBS) of Auction Rate Security Rights.
These rights permit us to require UBS between June 30, 2010 and July 2, 2012 (the exercise
period) to purchase our auction-rate securities at par value. In exchange, UBS is granted
the right, at their sole discretion, to sell or otherwise dispose of our auction-rate
security investments until July 2, 2012 as long as we receive a payment of par value upon
the sale or disposition. In addition, the rights permit us to establish a demand revolving
credit line in an amount equal to the par value of the securities at a net no cost. We are
still able to sell the auction-rate securities on our own, but in such a circumstance, we
would lose the par value support from UBS. In February 2010, we
notified UBS that we would be exercising our Auction Rate Security
Rights effective June 30, 2010. Pursuant to the terms of the Auction Rate
Security Rights, we expect to receive the par value of our
auction-rate securities on July 1, 2010.
Upon executing the settlement agreement with UBS, we recognized the Auction Rate Security
Rights as a stand-alone financial instrument and elected the fair value option. We also
transferred the student loan auction-rate securities from the available-for-sale
classification, to the trading classification. Adjustments to the fair value of student
loan auction-rate securities and Auction Rate Security Rights are recorded to other income
and expense in each accounting period. As of December 31, 2009, the fair value of the
student-loan auction rate securities was $6,682 compared to a par value of $7,275. As of
December 31, 2009, the fair value of the Auction Rate Security Rights was $588. The student
loan auction-rate securities
and Auction Rate Security Rights are included in current assets in the accompanying
consolidated balance sheet based on the earliest exercise date of June 30, 2010.
Page 8
Certain reclassifications have been made to the prior period financial statements to conform
to the current fiscal period presentation.
Inventories are comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
September 30, |
|
|
|
2009 |
|
|
2009 |
|
|
|
|
|
|
|
|
|
|
Raw materials |
|
$ |
6,120 |
|
|
$ |
6,079 |
|
Work-in-process |
|
|
5,891 |
|
|
|
5,916 |
|
Finished goods |
|
|
15,866 |
|
|
|
12,314 |
|
|
|
|
|
|
|
|
Gross inventory |
|
|
27,877 |
|
|
|
24,309 |
|
|
|
|
|
|
|
|
Less: Reserves |
|
|
(1,111 |
) |
|
|
(1,025 |
) |
|
|
|
|
|
|
|
Net inventory |
|
$ |
26,766 |
|
|
$ |
23,284 |
|
|
|
|
|
|
|
|
4. |
|
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 certain respiratory, gastrointestinal, viral and parasitic infectious diseases,
(ii) the manufacture and distribution of bulk antigens, antibodies, and reagents used by
researchers and other diagnostic manufacturers and (iii) the contract manufacture of proteins and
other biologicals under clinical cGMP conditions for use by biopharmaceutical and biotechnology
companies engaged in research for new drugs and vaccines.
Our reportable operating segments are US Diagnostics, European Diagnostics, and Life Science. The
US Diagnostics operating segment consists of manufacturing operations in Cincinnati, Ohio, and the
sale and distribution of diagnostic test kits in North America, South America and the Pacific Rim.
The European Diagnostics operating segment consists of the sale and distribution of diagnostic test
kits in Europe, Scandinavia, Africa, and the Middle East. The Life Science operating segment
consists of manufacturing operations in Memphis, Tennessee, Saco, Maine, and Boca Raton, Florida,
and the sale and distribution of bulk antigens, antibodies 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 68% and 59% of the US Diagnostics operating segment third-party sales
during the three months ended December 31, 2009 and 2008, respectively. Two customers accounted
for 34% and 32% of the Life Science operating segment third-party sales during the three months
ended December 31, 2009 and 2008, respectively.
Page 9
Segment information for the interim periods is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
European |
|
|
|
|
|
|
|
|
|
|
|
|
US Diagnostics |
|
|
Diagnostics |
|
|
Life Science |
|
|
Eliminations(1) |
|
|
Total |
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Third-party |
|
$ |
23,485 |
|
|
$ |
5,671 |
|
|
$ |
5,137 |
|
|
$ |
|
|
|
$ |
34,293 |
|
Inter-segment |
|
|
2,488 |
|
|
|
|
|
|
|
188 |
|
|
|
(2,676 |
) |
|
|
|
|
Operating income |
|
|
10,387 |
|
|
|
850 |
|
|
|
847 |
|
|
|
74 |
|
|
|
12,158 |
|
Total assets (September 30, 2009) |
|
|
131,587 |
|
|
|
18,220 |
|
|
|
55,592 |
|
|
|
(49,402 |
) |
|
|
155,997 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(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 US Diagnostics and Life Science operating segments include goodwill of $1,381 and
$8,485, respectively, at December 31, 2009 and September 30, 2009.
A summary of our acquired intangible assets subject to amortization, as of December 31, 2009 and
September 30, 2009 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Wtd |
|
|
|
|
|
|
|
|
|
Avg |
|
|
December 31, 2009 |
|
|
September 30, 2009 |
|
|
|
Amort |
|
|
Gross |
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Period |
|
|
Carrying |
|
|
Accumulated |
|
|
Carrying |
|
|
Accumulated |
|
|
|
(Yrs) |
|
|
Value |
|
|
Amortization |
|
|
Value |
|
|
Amortization |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Core products and cell lines |
|
|
15 |
|
|
$ |
4,698 |
|
|
$ |
2,964 |
|
|
$ |
4,698 |
|
|
$ |
2,892 |
|
Manufacturing technologies |
|
|
13 |
|
|
|
6,057 |
|
|
|
4,862 |
|
|
|
6,057 |
|
|
|
4,780 |
|
Trademarks, licenses and patents |
|
|
7 |
|
|
|
2,772 |
|
|
|
2,013 |
|
|
|
2,772 |
|
|
|
1,974 |
|
Customer lists and supply
agreements |
|
|
11 |
|
|
|
11,038 |
|
|
|
7,804 |
|
|
|
11,040 |
|
|
|
7,604 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
24,565 |
|
|
$ |
17,643 |
|
|
$ |
24,567 |
|
|
$ |
17,250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The actual aggregate amortization expense for these intangible assets for the three months ended
December 31, 2009 and 2008 was $395 and $404, respectively.
Page 10
Prior to February 1, 2009, we managed exchange rate risk related to forecasted intercompany sales
denominated in the Euro currency through the use of forward exchange contracts and designated such
forward contracts as cash flow hedges. As such, the effective portion of the gain or loss on the
derivative instrument was reported as a component of other comprehensive income and reclassified
into revenues in the Consolidated Statement of Operations in the same period or periods during
which the hedged transaction affected earnings. As of December 31, 2009 and September 30, 2009, we
had no such contracts outstanding.
The gain reclassified from accumulated other comprehensive income into income on the effective
portion of these foreign exchange contracts was $85 for the three months ended December 31, 2008.
Gains and losses on the derivative instruments representing either hedge ineffectiveness or hedge
components excluded from the assessment of effectiveness were recognized in current earnings. For
the three months ended December 31, 2008, no portion of the gain was excluded from other
comprehensive income due to effectiveness testing. All such forward contracts were recognized as
either other assets or other accrued expenses at fair value in the consolidated balance sheet.
7. |
|
Fair Value Measurements: |
We value certain financial assets and liabilities at fair value. 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 the Companys 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, the
Company utilizes valuation techniques that maximize the use of observable inputs and minimize the
use of unobservable inputs to the extent possible and considers counterparty credit risk in the
assessment of fair value.
Financial assets and liabilities carried at fair value at December 31, 2009 and September 30, 2009
and are classified in the tables below into one of the three categories described above:
Balances as of December 31, 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
Money market funds |
|
$ |
38,425 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
38,425 |
|
Student loan auction-rate securities |
|
|
|
|
|
|
|
|
|
|
6,682 |
|
|
|
6,682 |
|
UBS Auction-Rate Security Rights |
|
|
|
|
|
|
|
|
|
|
588 |
|
|
|
588 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
38,425 |
|
|
$ |
|
|
|
$ |
7,270 |
|
|
$ |
45,695 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Page 11
Balances as of September 30, 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
Money market funds |
|
$ |
39,415 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
39,415 |
|
Student loan auction-rate securities |
|
|
|
|
|
|
|
|
|
|
6,708 |
|
|
|
6,708 |
|
UBS Auction-Rate Security Rights |
|
|
|
|
|
|
|
|
|
|
577 |
|
|
|
577 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
39,415 |
|
|
$ |
|
|
|
$ |
7,285 |
|
|
$ |
46,700 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The failed auction status and lack of liquidity for our student loan auction-rate securities and
the non-transferability of our UBS Auction Rate Security Rights requires the use of a valuation
methodology that relies exclusively on Level 3 inputs including market, tax status, credit quality,
duration, recent market observations and overall capital market liquidity. The valuation of our
student loan auction-rate securities and UBS Auction Rate Security Rights is subject to
uncertainties that are difficult to predict. Factors that may impact the valuations include
changes to credit ratings of the securities as well as to the underlying assets supporting those
securities, rates of default of the underlying assets, underlying collateral value, discount rates,
counterparty risk and ongoing strength and quality of market credit and liquidity. The following
table provides a summary of changes in fair value of our auction-rate securities and UBS Auction
Rate Security Rights for the three months ended December 31, 2009 and December 31, 2008.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Student loan |
|
|
UBS Auction |
|
|
|
|
|
|
auction-rate |
|
|
Rate Security |
|
|
|
|
|
|
securities |
|
|
Rights |
|
|
Total Level 3 |
|
Balance at September 30, 2009 |
|
$ |
6,708 |
|
|
$ |
577 |
|
|
$ |
7,285 |
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains (losses)
included in current period
earnings |
|
|
(26 |
) |
|
|
11 |
|
|
|
(15 |
) |
|
|
|
|
|
|
|
|
|
|
Total at December 31, 2009 |
|
$ |
6,682 |
|
|
$ |
588 |
|
|
$ |
7,270 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Student loan |
|
|
UBS Auction |
|
|
|
|
|
|
auction-rate |
|
|
Rate Security |
|
|
|
|
|
|
securities |
|
|
Rights |
|
|
Total Level 3 |
|
Balance at September 30, 2008 |
|
$ |
7,480 |
|
|
$ |
|
|
|
$ |
7,480 |
|
|
|
|
|
|
|
|
|
|
|
Acquire UBS Auction Rate Security Rights |
|
|
|
|
|
|
660 |
|
|
|
660 |
|
Proceeds from redemptions of auction-rate securities |
|
|
(425 |
) |
|
|
|
|
|
|
(425 |
) |
Unrealized losses included in current period earnings |
|
|
(494 |
) |
|
|
|
|
|
|
(494 |
) |
|
|
|
|
|
|
|
|
|
|
Total at December 31, 2008 |
|
$ |
6,561 |
|
|
$ |
660 |
|
|
$ |
7,221 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
Overview:
Our consolidated sales increased 24% to $42,457 for the first quarter of fiscal 2010. Sales growth
was driven by Upper Respiratory volumes in our Diagnostic operating segments, volume growth in
Foodborne and H. pylori products for our US Diagnostics operating segment, and improved growth in
our Life Science operating segment. Sales of influenza products within our Upper Respiratory
family comprised approximately 19% of consolidated sales. Sales of C. difficile products were down
20%+ for our Diagnostic operating segments as a result of distributor buying patterns in our US
Diagnostics operating segment in fiscal 2009 and increased competition from new
immunoassays and emerging molecular technologies. January sales of C. difficile products showed
positive growth as the effects of distributor buying patterns from the first quarter of fiscal 2009
began to turn around. We expect that sales of C. difficile products will be flat until the launch
of our illumigeneTM molecular product later this fiscal year.
Page 12
Our consolidated gross profit, operating income and net earnings margins for the first quarter of
fiscal 2010 reflect a drag caused by the effects of a higher mix of lower margin Upper Respiratory
products and a lower mix of higher margin C. difficile products. Despite the mix of Upper
Respiratory products, we continue to increase sales of our own manufactured influenza and
respiratory syncytial virus products (TRU FLU® and TRU RSV®) for our US
Diagnostics operating segment. Sales of these products were 44% of our total influenza and
respiratory syncytial virus products for the first quarter of fiscal 2010 compared to approximately
25% for all of fiscal 2009. We expect this percentage to continue to increase, yielding continuing
improvements in gross profit margins. Our TRU® format, with its sample tube and test
device, offers better containment of the specimen sample compared to card-type devices. Customers
continue to react positively to this feature.
Upper Respiratory Products
The novel A (H1N1) influenza outbreak in the Northern hemisphere created an early start to the
2009-2010 influenza season that has continued into the first quarter of our fiscal 2010. For our
US Diagnostics operating segment, sales of influenza products comprised 24% of total sales for the
first quarter of fiscal 2010. We believe that our US distributors have stocked inventories of
influenza products in anticipation of further outbreaks over the coming months.
The novel A (H1N1) influenza pandemic also created an increased interest in influenza testing in
European markets where rapid testing has not been traditionally performed, resulting in sales
growth of approximately 75% in this operating segment on an organic basis (excluding currency) for
the first quarter of fiscal 2010 for this product family.
We expect influenza product sales to moderate somewhat during the remainder of our fiscal year, in
light of current inventory levels at our US distributors and expectations of lighter novel A (H1N1)
influenza activity as we emerge from the pandemic. To put this in some perspective, sales of
influenza products accounted for 14% of the total sales of our US Diagnostics operating segment for
all of fiscal 2009, compared to 24% for the first quarter of fiscal 2010.
During the first quarter of fiscal 2010, we also saw significant sales growth in our US Diagnostics
export area for both influenza and mycoplasma.
Foodborne Products
During the first quarter of fiscal 2010, sales of our Foodborne products grew 40%+ for our US
Diagnostics operating segment and 20% for our European Diagnostics operating segment on an organic
basis. We continue to see significant volume growth coming from new products launched over the
last few fiscal years (ImmunoCard STAT!® EHEC launched in fiscal 2007, and
PremierTM CAMPY and ImmunoCard STAT!® CAMPY launched in fiscal 2009). This
disease family is expected to continue to generate significant sales growth in fiscal 2010.
C. difficile Products
Sales of C. difficile products for our US Diagnostics operating segment were impacted by
distributor buying patterns during the first quarter of fiscal 2009, where one of our distributors
stocked higher than normal inventory levels in advance of our January 1st price
increase. This distributor did not stock higher than normal inventory levels for our C. difficile
products during the current quarter.
The C. difficile market also continues to experience considerable confusion around the relative
benefits of the various test methods available (toxin testing, antigen testing and molecular
testing). Several new competitive products, including molecular assays, have been introduced into
this market, causing competitive pressures for our products. These competitive factors resulted in
significant sales declines in both of our Diagnostic operating segments.
We expect to combat the competitive pressures in this disease family with our strong position in
toxin testing and the launch of our illumigeneTM molecular C. difficile product. Our
new molecular test for C. difficile on our illumigeneTM platform is currently in clinical trials. We are targeting revenue
contributions from the launch of this technology later this fiscal year.
Page 13
H. pylori Products
During the first quarter of fiscal 2010, sales of our H. pylori products grew 30%+ for our US
Diagnostics operating segment and 3% for our European Diagnostics operating segment on an organic
basis. Although the sales growth rate for our US Diagnostics operating segment reflects a level of
buying pattern difference in our national reference lab customer base, our partnerships with
managed care companies in promoting the health and economic benefits of a test and treat strategy
is beginning to move physician behavior away from serology-based testing to direct antigen testing.
Life Science
Sales for our Life Science operating segment increased 6% for the first quarter of fiscal 2010.
This increase reflects growth from our two largest diagnostic manufacturing customers, as well as
growth in contract research and development work and contract manufacturing work in our cGMP
clinical facilities. We expect high single-digit growth for this operating segment during the
remainder of fiscal 2010.
Significant Customers
Two national distributors in our US Diagnostics operating segment accounted for 68% and 59% of
total sales for this operating segment for the first quarter of fiscal 2010 and 2009, respectively.
The higher percentage of sales during the first quarter of fiscal 2010 reflects inventory stocking
of influenza and other products for these national distributors.
Two diagnostic manufacturing customers in our Life Science operating segment accounted for 34% and
32% of total sales for this operating segment for the first quarters of fiscal 2010 and 2009,
respectively.
Foreign Currency
Sales growth for our European Diagnostics operating segment included currency translation gains in
the amount of approximately $600 for the first quarter of fiscal 2010. Sales for this operating
segment were flat on an organic basis for the first quarter of fiscal 2010.
Operating Segment Revenues
Our reportable operating segments are US Diagnostics, European Diagnostics, and Life Science. The
US Diagnostics operating segment consists of manufacturing operations in Cincinnati, Ohio, and the
sale and distribution of diagnostic test kits in North America, South America and the Pacific Rim.
The European Diagnostics operating segment consists of the sale and distribution of diagnostic test
kits in Europe, Scandinavia, Africa, and the Middle East. The Life Science operating segment
consists of manufacturing operations in Memphis, Tennessee, Saco, Maine, and Boca Raton, Florida,
and the sale and distribution of bulk antigens, antibodies 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.
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.
Page 14
Revenues for our each of our operating segments are shown below.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31 |
|
|
|
2009 |
|
|
2008 |
|
|
Inc (Dec) |
|
US Diagnostics |
|
$ |
30,704 |
|
|
$ |
23,485 |
|
|
|
+31 |
% |
European Diagnostics |
|
|
6,294 |
|
|
|
5,671 |
|
|
|
+11 |
% |
Life Science |
|
|
5,459 |
|
|
|
5,137 |
|
|
|
+6 |
% |
|
|
|
|
|
|
|
|
|
|
Consolidated |
|
$ |
42,457 |
|
|
$ |
34,293 |
|
|
|
+24 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
International |
|
|
|
|
|
|
|
|
|
|
|
|
US Export |
|
$ |
1,729 |
|
|
$ |
1,099 |
|
|
|
+57 |
% |
Life Science Export |
|
|
2,460 |
|
|
|
2,369 |
|
|
|
+4 |
% |
European Diagnostics |
|
|
6,294 |
|
|
|
5,671 |
|
|
|
+11 |
% |
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
10,483 |
|
|
$ |
9,139 |
|
|
|
+15 |
% |
|
|
|
|
|
|
|
|
|
|
% of total sales |
|
|
25 |
% |
|
|
27 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Profit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
Inc (Dec) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Profit |
|
$ |
25,485 |
|
|
$ |
23,344 |
|
|
|
+9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Profit Margin |
|
|
60 |
% |
|
|
68 |
% |
|
-8 points |
% |
|
|
|
|
|
|
|
|
|
|
Gross profit margin for the first quarter of fiscal 2010 reflects a drag of approximately seven
points related to the strong mix of Upper Respiratory sales. As we move forward, we expect that
our internally developed and manufactured TRU FLU® and TRU RSV® products will
improve overall gross profit margins for the Upper Respiratory product family, as these products
now contribute in excess of 40% of total influenza and respiratory syncytial virus product sales
for our US Diagnostics operating segment.
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 and antibodies,
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.
Page 15
Operating Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
Research & |
|
|
Sales & |
|
|
General & |
|
|
Operating |
|
|
|
Development |
|
|
Marketing |
|
|
Administrative |
|
|
Expenses |
|
Q1 2009 Expenses |
|
$ |
2,064 |
|
|
$ |
4,967 |
|
|
$ |
4,155 |
|
|
$ |
11,186 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of Sales |
|
|
6 |
% |
|
|
14 |
% |
|
|
12 |
% |
|
|
33 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal 2010 Increases (Decreases): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
US Diagnostics |
|
|
(105 |
) |
|
|
(6 |
) |
|
|
613 |
|
|
|
502 |
|
European Diagnostics |
|
|
|
|
|
|
(32 |
) |
|
|
37 |
|
|
|
5 |
|
Life Science |
|
|
119 |
|
|
|
(42 |
) |
|
|
(41 |
) |
|
|
36 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q1 2010 Expenses |
|
$ |
2,078 |
|
|
$ |
4,887 |
|
|
$ |
4,764 |
|
|
$ |
11,729 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% of Sales |
|
|
5 |
% |
|
|
12 |
% |
|
|
11 |
% |
|
|
28 |
% |
% Increase (Decrease) |
|
|
1 |
% |
|
|
-2 |
% |
|
|
15 |
% |
|
|
5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
We continue to closely control spending for each of our operating segments. For our US Diagnostics
operating segment, we have continued to invest in the development of our illumigeneTM
molecular platform, and our first product, C. difficile, is currently in clinical trials. The
increase in general and administrative expenses for our US Diagnostics operating segment includes
stock based compensation costs related to a time-vested restricted stock grant in November 2009.
This grant has four-year cliff vesting provisions.
Operating Income
Operating income increased 13% to $13,756 for the first quarter of fiscal 2010, as a result of the
factors discussed above.
Other Income and Expense
Interest income decreased 88% during for the first quarter of fiscal 2010 compared to the first
quarter of fiscal 2009. This decrease was driven by lower interest yields due to a higher
concentration of investments in money market funds in fiscal 2010 and lower interest rates in the
current interest rate environment.
Income Taxes
The effective rate for income taxes was 35% for the first quarter of fiscal 2010 compared to 34%
for the first quarter of fiscal 2009. For the fiscal year ending September 30, 2010, Meridian
expects the effective tax rate to be 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. This credit facility has been supplemented by the
proceeds from a September 2005 common share offering, which are invested in overnight repurchase
agreements, institutional money-market mutual funds, municipal debt obligations and tax-exempt
auction-rate securities.
Page 16
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 a result of conditions in the financial markets, we have chosen to keep
the maturity of our investment portfolio very short. 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 collectability 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 113% for the first quarter of fiscal 2010 to
$13,170. This increase was primarily attributable to higher earnings levels and improved net
working capital changes. Net cash flows from operating activities are anticipated to be adequate
to fund working capital requirements, capital expenditures 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, 2010, 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 2010, or during the full year of fiscal 2009.
Our capital expenditures are estimated to be approximately $5,000 for fiscal 2010 and may be funded
with operating cash flows, availability under the $30,000 credit
facility, or cash and investments on-hand. Capital expenditures relate to manufacturing and other equipment of a normal and
recurring nature, as well as the build out of the recently purchased property in the Village of
Newtown, Ohio.
We do not utilize any special-purpose financing vehicles or have any undisclosed off balance sheet
arrangements.
|
|
|
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,
2009.
|
|
|
ITEM 4. |
|
CONTROLS AND PROCEDURES |
As of December 31, 2009, 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, 2009. 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, 2009.
Page 17
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.
|
|
|
|
|
|
|
|
31.1 |
|
|
|
|
Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rule
13a-14(a)/15d-14(a) |
|
|
|
|
|
|
|
|
31.2 |
|
|
|
|
Certification of Principal Financial Officer Pursuant to Securities Exchange Act Rule
13a-14(a)/15d-14(a) |
|
|
|
|
|
|
|
|
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 |
Page 18
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 8, 2010 |
/s/ Melissa Lueke
|
|
|
Melissa Lueke |
|
|
Executive Vice President and Chief
Financial
Officer |
|
|
Page 19