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| VIVO > SEC Filings for VIVO > Form 10-K on 26-Nov-2008 | All Recent SEC Filings |
26-Nov-2008
Annual Report
Financial discipline continues to be one of our fundamental principles in running the day-to-day business. The following table illustrates key income and expense elements as a percentage of sales. We look for continued improvement in each of these measures each year, in spite of macro-economic market conditions.
2008 2007 2006
Gross profit 62 % 61 % 60 %
Operating expenses 30 % 32 % 35 %
Operating income 32 % 28 % 25 %
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Preservation of the capital of our investment portfolio is also a fundamental
principle in our cash management philosophy. During October 2008, we moved
substantially all of our investments in municipal variable rate demand notes to
institutional money market mutual funds invested in either US Treasuries, or
repurchase agreements collateralized by US Treasuries. Existing investments in
institutional tax-exempt money market mutual funds are covered under the US
Treasury's Temporary Guarantee Program for Money Market Funds. This program
provides a guarantee to money market mutual fund shareholders of $1 per share
net asset value for funds invested as of September 19, 2008, if the fund were to
liquidate its assets as a result of its net asset value falling below $0.995. As
we look forward, we will continue to manage the holdings of our investment
portfolio with preservation of capital being the primary objective.
Operating Segments:
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 the US 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, 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 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 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 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.
Results of Operations:
Fourth Quarter
Net earnings for the fourth quarter of fiscal 2008 increased 19% to $7,684,000,
or $0.19 per diluted share (increased 19%) from net earnings for the fourth
quarter of fiscal 2007 of $6,444,000, or $0.16 per diluted share. This increase
is primarily attributable to increased sales and continuing efforts to improve
operating efficiency across all businesses. Net sales for the fourth quarter of
fiscal 2008 were $36,475,000, an increase of $4,089,000 or 13% compared to the
fourth quarter of fiscal 2007.
Net sales for the US Diagnostics operating segment for the fourth quarter of
fiscal 2008 increased 24% compared to the fourth quarter of fiscal 2007, and
benefited from volume increases in influenza and respiratory syncitial virus
products in advance of the 2008-2009 upper respiratory season in the amount of
approximately $1,500,000. The early start to the season was driven by the timing
of promotions offered by a third-party manufacturer of certain products, which
are passed along to our customers. We expect that the US Diagnostics operating
segment's sales of these products during the first quarter of fiscal 2009 will
be flat compared to the first quarter of fiscal 2008 as a result of the timing
of this third-party manufacturer promotion. We ultimately measure our growth and
level of success for upper respiratory products based on the full selling
season, which typically runs from August through March, also taking into
consideration the relative strength of the season. Net sales for our European
Diagnostics and Life Science operating segments increased 9% and decreased 13%,
respectively, during the fourth quarter of fiscal 2008 compared to the fourth
quarter of fiscal 2007.
Fiscal Year
Net earnings for fiscal 2008 increased 13% to $30,202,000, or $0.74 per diluted
share (increased 12%) from net earnings for fiscal 2007 of $26,721,000, or $0.66
per diluted share including the tax benefit of $2,425,000, described below.
Results of operations for fiscal 2008 compared to fiscal 2007 are discussed
below.
Net earnings and earnings per share for fiscal 2007 include the effects of a tax
benefit in the amount of $2,425,000, or $0.06 per basic and diluted share,
related to a discrete adjustment to tax reserves that was recorded in the third
quarter upon the expiration of the statute of limitations on certain income tax
returns (see Note 5 to the consolidated financial statements herein). The tables
below provide information on net earnings, basic earnings per share, and diluted
earnings per share, excluding this tax benefit, as well as reconciliations to
amounts reported under US Generally Accepted Accounting Principles. We believe
that this information is useful to those who read our financial statements and
evaluate our operating results because:
1. These measures help to appropriately evaluate and compare the results of
operations from period to period by removing the favorable impact of a discrete
material item that is not expected to recur in the future; and
2. These measures are used by our management for various purposes, including evaluating performance against incentive bonus achievement targets, comparing performance from period to period in presentations to our Board of Directors, and as a basis for strategic planning and forecasting.
2008 2007 Change
Net Earnings -
US GAAP basis $ 30,202,000 $ 26,721,000 13 %
Tax benefit not expected to recur in the future - (2,425,000 ) 100 %
Excluding tax benefit $ 30,202,000 $ 24,296,000 24 %
2008 2007 Change
Net Earnings per Basic Common Share -
US GAAP basis $ 0.75 $ 0.67 12 %
Tax benefit not expected to recur in the future - (0.06 ) 100 %
Excluding tax benefit $ 0.75 $ 0.61 23 %
2008 2007 Change
Net Earnings per Diluted Common Share -
US GAAP basis $ 0.74 $ 0.66 12 %
Tax benefit not expected to recur in the future - (0.06 ) 100 %
Excluding tax benefit $ 0.74 $ 0.60 23 %
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Prior to July 1, 2007, the cost of certain inventories within the Life Science operating segment was determined by the last-in, first-out ("LIFO") method. Effective July 1, 2007, we changed our method of accounting for this inventory from the LIFO method to the FIFO method, and now substantially all of our inventories are reflected at the lower of cost or market with cost determined by the FIFO method. We changed to the FIFO method for these inventories because it conforms substantially all of our worldwide inventories to a consistent basis of accounting; and it provides better comparability to our industry peers, many of whom use the FIFO method of accounting for inventories. In accordance with Statement of Financial Accounting Standards ("SFAS") No. 154, Accounting Changes and Error Corrections, the change in accounting has been retrospectively applied to all prior periods presented herein.
Fiscal Year Ended September 30, 2008 Compared to Fiscal Year Ended September 30,
2007 and Fiscal Year Ended September 30, 2007 Compared to Fiscal Year Ended
September 30, 2006.
Net sales
2008 vs. 2007 vs.
2007 2006
2008 2007 2006 Inc (Dec) Inc (Dec)
US Diagnostics $ 88,419,000 $ 74,845,000 $ 65,721,000 18 % 14 %
European Diagnostics 27,980,000 23,563,000 19,828,000 19 % 19 %
Life Science 23,240,000 24,555,000 22,864,000 (5 )% 7 %
Consolidated $ 139,639,000 $ 122,963,000 $ 108,413,000 14 % 13 %
International -
Exported from US $ 16,450,000 $ 15,128,000 $ 14,729,000 9 % 3 %
European Diagnostics 27,980,000 23,563,000 19,828,000 19 % 19 %
Total $ 44,430,000 $ 38,691,000 $ 34,557,000 15 % 12 %
% of total sales 32 % 31 % 32 %
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Sales growth for US Diagnostics was primarily driven by volume increases across
our four major infectious disease categories, C. difficile, H. pylori, upper
respiratory and foodborne in both fiscal 2008 and 2007. Each of these product
families experienced double-digit growth rates in fiscal 2008 and 2007. New
product sales contributions in fiscal 2008 came from our upper respiratory TRU
products for influenza and respiratory syncytial virus launched in the first
quarter of fiscal 2008, and our ImmunoCard STAT!® EHEC product launched in
fiscal 2007. The EHEC product was developed in collaboration with Merck for
detection of toxin-producing E. coliin patients that may have ingested
contaminated produce or meat products. We also saw market share expansions in
fiscal 2008 and 2007 in infectious diseases where we have established leadership
positions, C. difficile and H. pylori. The identification of more virulent
strains of C. difficilehas led to increased testing in hospitals. New AGA
guidelines have created increased focus on direct antigen testing for H. pylori,
as this infection is a known cause of ulcers. Our managed care efforts are also
contributing to volume growth in H. pylori products. Two national distributors
accounted for 54%, 50% and 46% of total third-party sales for the US Diagnostics
operating segment for fiscal 2008, 2007, and 2006, respectively.
The 2007-2008 upper respiratory season was relatively strong, which also
contributed to the volume growth in influenza and respiratory syncytial virus
products during the first half of fiscal 2008. Although we cannot predict the
strength of the 2008-2009 upper respiratory season and its impact on sales
volumes, to date, we have experienced healthy orders for our upper respiratory
products.
Sales growth for the European Diagnostics operating segment includes currency
translation gains in the amounts of $2,743,000 and $1,510,000, for fiscal 2008
and 2007, respectively. Organic sales growth, which excludes the effects of
currency translation, was 7% and 11% during fiscal 2008 and 2007, respectively.
The organic growth in fiscal 2008 and 2007 was driven by volume increases in C.
difficile products, principally
ImmunoCardŇ Toxins A & B, as well as the third quarter fiscal 2008 launch of TRU
EBV-M® and TRU EBV-G®.
Fiscal 2008 sales for the Life Science operating segment reflect changes in
demand and buying patterns of certain of our major diagnostic manufacturing
customers and non-renewal of a supply contract with the US Department of
Defense. Changes in the US Department of Defense's Critical Reagents program led
to non-renewal of this contract after fiscal 2007. Fiscal 2007 sales for the
Life Science operating segment reflect volume growth in make-to-order bulk
antigens and antibodies, offset by lower sales activity from contract research
and development and contract manufacturing services.
We sell three main products to a major diagnostic manufacturing customer, who
accounted for 21%, 27%, and 18% of total sales for the Life Science operating
segment for fiscal 2008, 2007 and 2006, respectively. During the first quarter
of fiscal 2008, this customer reduced its forecasted requirements for two
antigen products due to its internal inventory management initiatives and its
market factors. The impact of this reduction was partially offset by the
customer's increased purchases of a bulk reagent product. For fiscal 2008, these
demand changes and buying patterns resulted in a net revenue reduction of
approximately $1,800,000.
Gross Profit
2008 vs. 2007 vs.
2007 2006
2008 2007 2006 Inc (Dec) Inc (Dec)
Gross Profit $ 86,480,000 $ 74,940,000 $ 64,684,000 15 % 16 %
Gross Profit Margin 62 % 61 % 60 % 1 % 1 %
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The increases in gross profit margins from 2006 to 2008 reflect a stronger mix
of sales from our diagnostic operating segments, including higher margins on
rapid tests, and production efficiencies from automation initiatives in our
diagnostics manufacturing facility.
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, and 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 &
Development Marketing Administrative
2006 Expenses $ 4,799,000 $ 16,698,000 $ 16,293,000
% of Sales 4 % 15 % 15 %
Fiscal 2007 Increases (Decreases):
US Diagnostics 1,229,000 (9,000 ) 1,606,000
European Diagnostics - 469,000 (392,000 )
Life Science 57,000 (34,000 ) (806,000 )
2007 Expenses $ 6,085,000 $ 17,124,000 $ 16,701,000
% of Sales 5 % 14 % 14 %
% Increase (Decrease) 27 % 3 % 3 %
Fiscal 2008 Increases (Decreases):
US Diagnostics 307,000 1,523,000 (293,000 )
European Diagnostics - 423,000 389,000
Life Science (209,000 ) (300,000 ) 380,000
2008 Expenses $ 6,183,000 $ 18,770,000 $ 17,177,000
% of Sales 4 % 13 % 12 %
% Increase (Decrease) 2 % 10 % 3 %
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Operating expenses increased 6% for both fiscal 2008 and fiscal 2007. The
overall increase in operating expenses for both periods is discussed below.
The increase in research and development expenses for the US Diagnostics
operating segment during fiscal 2008 reflects additional salaries and benefits
related to a new vice president hired in May 2007, planned staff headcount
additions, and development costs for our ILLUMIgeneTMmolecular technology and
other products in development. These increases were partially offset by
decreased professional fees and clinical trial costs related to new products
which were launched during the first fiscal quarter of 2008. The increase in
research and development expenses for the US Diagnostics operating segment
during fiscal 2007 were primarily attributable to clinical trial and other costs
associated with new product development, including planned headcount additions,
as well as increased stock-based compensation expense. The decrease in research
and development expenses for the Life Science operating segment during fiscal
2008 primarily related to retirements of staff personnel that occurred during
fiscal 2007 and lower incentive compensation.
Selling and marketing expenses for the US Diagnostics operating segment for
fiscal 2008 increased primarily due to costs for new product launches, increased
salaries and benefits related to planned headcount additions, and higher
incentive compensation from sales growth. The decrease for the US Diagnostics
operating segment for fiscal 2007 was primarily attributable to lower costs for
sales promotions, advertising, and distributor incentives, offset by increased
salaries and benefits related to headcount additions and stock-based
compensation costs. Selling and marketing expenses for the European Diagnostics
operating segment increased primarily as a result of fluctuations in the Euro
currency for both fiscal 2008 and 2007, and one planned headcount addition in
fiscal 2007. The decrease in selling and marketing expenses for the Life Science
operating segment for fiscal 2008 primarily related to lower incentive
compensation and staff reductions.
The decrease in general and administrative expenses for fiscal 2008 for the US
Diagnostics operating segment was primarily attributable to reduced incentive
compensation costs, both corporate incentive bonus and stock-based compensation.
These decreases were partially offset by increased salaries and benefits related
to planned headcount additions. The increase in general and administrative
expenses for the US Diagnostics operating segment for fiscal 2007 was primarily
attributable to higher costs for stock-based compensation, an insurance recovery
in fiscal 2006, and increased salaries and benefits, including the effects of
planned headcount additions. The increase for the Life Science operating segment
for fiscal 2008 reflects severance costs for certain personnel changes and
increased salaries and benefits. The decrease for the Life Science operating
segment for fiscal 2007 was primarily attributable to the 2006 impairment of the
supply contract with the United States Department of Defense. See Note 1(h) to
the consolidated financial statements contained herein. The increase for the
European Diagnostics operating segment for fiscal 2008 was primarily
attributable to currency fluctuations, as well as increased salaries and
benefits. The decrease for the European Diagnostics operating segment for fiscal
2007 was primarily attributable to expenses connected with an employee matter in
fiscal 2006, which were covered by the aforementioned insurance recovery.
We account for our stock option plans pursuant to SFAS No. 123(R), Share-Based
Payment. The amount of stock-based compensation expense reported for fiscal
2008, fiscal 2007, and fiscal 2006 was $1,772,000, $2,632,000, and $1,082,000,
respectively. During November 2007, we granted to certain employees stock
options that were contingent upon Meridian achieving a specified net earnings
level for fiscal 2008. Because Meridian's fiscal 2008 net earnings did not reach
the minimum level, these stock options were not earned. No stock-based
compensation has been recorded for these options. Similarly, during
November 2006, we granted to certain employees stock options that were
contingent upon Meridian achieving a specified net earnings level for fiscal
2007. Because Meridian's fiscal 2007 net earnings surpassed the minimum level,
these stock options were earned and are now exercisable over a vesting period.
Operating Income
Operating income increased 27% and 30% in fiscal 2008 and 2007, respectively, as
a result of the factors discussed above.
Other Income and Expense
Interest income was $1,533,000, $1,642,000, and $1,123,000 for fiscal 2008,
2007, and 2006, respectively. The decrease during fiscal 2008 was driven by
lower interest yields in the current interest rate environment, somewhat offset
by higher average investment balances. The increase during fiscal 2007 was
driven by higher interest yields and higher investment balances in fiscal 2007.
See Note 1(e) to the consolidated financial statements herein for discussion of
our investment portfolio.
Income Taxes
The effective rate for income taxes was 34%, 27%, and 35% for fiscal 2008, 2007,
and 2006, respectively. Both the increase in the effective tax rate for fiscal
2008 and the decrease in the effective tax rate for fiscal 2007 were primarily
attributable to a discrete adjustment to tax reserves in the third quarter of
fiscal 2007 in the amount of $2,425,000. This discrete adjustment reduced the
effective tax rate for fiscal 2007 by 7 points. See Note 5 to the consolidated
financial statements included herein for a complete discussion of this matter.
Effective October 1, 2007, we adopted FASB Interpretation No. 48, Accounting for
Uncertainty in Income Taxes (FIN 48). FIN 48 prescribes a comprehensive model
for the recognition, measurement, presentation and disclosure of uncertain tax
positions, assuming full knowledge of all relevant facts by the applicable tax
authorities. The cumulative effect of adopting FIN 48, $305,000, was charged to
opening retained earnings. See Note 5 to the consolidated financial statements
herein.
Impact of Inflation
To the extent feasible, we have consistently followed the practice of adjusting
our prices to reflect the impact of inflation on salaries and fringe benefits
for employees and the cost of purchased materials and services. Inflation and
changing prices did not have a material adverse impact our gross margin, revenue
or operating income in fiscal 2008, 2007 or 2006.
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
. . .
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