SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

Form10-Q

 

 

 

xQUARTERLY REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Quarterly Period Ended DecemberMarch 31, 20132014

OR

 

¨TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                    to                    

Commission file number0-14902

 

 

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  x    No  ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).     Yes  x    No  ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer x  Accelerated filer ¨
Non-accelerated filer ¨  Smaller reporting company ¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).     Yes  ¨    No  x

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

 

Class

 

Outstanding January 31,April 30, 2014

Common Stock, no par value

 41,551,15341,555,911


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

TABLE OF CONTENTS TO QUARTERLY REPORT ON FORM10-Q

 

   Page(s) 

PART I. FINANCIAL INFORMATION

  

Item 1. Financial Statements (Unaudited)

  

Condensed Consolidated Statements of Operations Three and Six Months Ended DecemberMarch 31, 20132014 and 20122013

   1  

Condensed Consolidated Statements of Comprehensive Income Three and Six Months Ended DecemberMarch 31, 20132014 and 20122013

   2  

Condensed Consolidated Statements of Cash Flows ThreeSix Months Ended DecemberMarch 31, 20132014 and 20122013

   3  

Condensed Consolidated Balance Sheets DecemberMarch 31, 20132014 and September 30, 2013

   4-5  

Condensed Consolidated Statement of Changes in Shareholders’ Equity ThreeSix Months Ended DecemberMarch 31, 20132014

   6  

Notes to Condensed Consolidated Financial Statements

   7-117-12  

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

   12-1812-20  

Item 3. Quantitative and Qualitative Disclosures About Market Risk

   1820  

Item 4. Controls and Procedures

   1820  

PART II. OTHER INFORMATION

  

Item 1A. Risk Factors

   1921  

Item 6. Exhibits

   1921  

Signature

   2022  

FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements. 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: Meridian’s 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 Meridian’s competition, and its ability to effectively sell such products. 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. Meridian relies on proprietary, patented and licensed technologies, and the Company’s ability to protect its intellectual property rights, as well as the potential for intellectual property litigation, would impact its results. 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, including those 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. The international scope of Meridian’s operations, including changes in the relative strength or weakness of the U.S. dollar and general economic conditions in foreign countries, can impact results and make them difficult to predict. One of Meridian’s 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 Meridian’s 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 Meridian’s 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 StatesU.S. healthcare legislation enacted in 2010 – the Patient Protection and Affordable Care Act, as amended by the Healthcare and Education Reconciliation Act – and any modification or repeal of any of the provisions thereof, 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.


PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations (Unaudited)

(in thousands, except per share data)

 

  Three Months Ended   Three Months Ended   Six Months Ended 
  December 31,   March 31,   March 31, 
  2013 2012   2014 2013   2014 2013 

NET SALES

  $44,794  $45,351 

NET REVENUES

  $50,134  $47,265   $94,928  $92,616 

COST OF SALES

   16,787  16,555    18,541  16,522    35,328  33,077 
  

 

  

 

   

 

  

 

   

 

  

 

 

GROSS PROFIT

   28,007   28,796    31,593   30,743    59,600   59,539 
  

 

  

 

   

 

  

 

   

 

  

 

 

OPERATING EXPENSES

         

Research and development

   2,853   2,517    3,186   2,811    6,039   5,328 

Selling and marketing

   5,978   5,693    6,461   5,471    12,538   11,164 

General and administrative

   7,550   7,495    6,280   7,208    13,731   14,703 
  

 

  

 

   

 

  

 

   

 

  

 

 

Total operating expenses

   16,381   15,705    15,927   15,490    32,308   31,195 
  

 

  

 

   

 

  

 

   

 

  

 

 

OPERATING INCOME

   11,626   13,091    15,666   15,253    27,292   28,344 

OTHER INCOME (EXPENSE)

         

Interest income

   4   7    6   19    10   26 

Other, net

   (220  128    (28  257    (248  385 
  

 

  

 

   

 

  

 

   

 

  

 

 

Total other income (expense)

   (216  135    (22  276    (238  411 
  

 

  

 

   

 

  

 

   

 

  

 

 

EARNINGS BEFORE INCOME TAXES

   11,410   13,226    15,644   15,529    27,054   28,755 

INCOME TAX PROVISION

   3,984   4,752    5,344   5,280    9,328   10,032 
  

 

  

 

   

 

  

 

   

 

  

 

 

NET EARNINGS

  $7,426  $8,474   $10,300  $10,249   $17,726  $18,723 
  

 

  

 

   

 

  

 

   

 

  

 

 

BASIC EARNINGS PER COMMON SHARE

  $0.18  $0.21   $0.25  $0.25   $0.43  $0.45 

DILUTED EARNINGS PER COMMON SHARE

  $0.18  $0.20   $0.24  $0.24   $0.42  $0.45 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - BASIC

   41,408   41,148    41,471   41,266    41,434   41,188 

EFFECT OF DILUTIVE STOCK OPTIONS AND RESTRICTED SHARES AND UNITS

   691   604    676   681    686   642 
  

 

  

 

   

 

  

 

   

 

  

 

 

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - DILUTED

   42,099   41,752    42,147   41,947    42,120   41,830 
  

 

  

 

   

 

  

 

   

 

  

 

 

ANTI-DILUTIVE SECURITIES:

         

Common share options and restricted shares and units

   110   294    168   262    137   295 
  

 

  

 

   

 

  

 

   

 

  

 

 

DIVIDENDS DECLARED PER COMMON SHARE

  $0.19  $0.38   $0.20  $—     $0.39  $0.38 
  

 

  

 

   

 

  

 

   

 

  

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

Page 1


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Comprehensive Income (Unaudited)

(in thousands)

 

  Three Months Ended 
  December 31,   

Three Months Ended

March 31,

 Six Months Ended
March 31,
 
  2013   2012   2014   2013 2014   2013 

NET EARNINGS

  $7,426   $8,474   $10,300   $10,249  $17,726   $18,723 

Foreign currency translation adjustment

   723    246    337    (1,217 1,060    (971
  

 

   

 

   

 

   

 

  

 

   

 

 

COMPREHENSIVE INCOME

  $8,149   $8,720   $10,637   $9,032  $18,786   $17,752 
  

 

   

 

   

 

   

 

  

 

   

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

Page 2


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows (Unaudited)

(in thousands)

 

Three Months Ended December 31,

  2013 2012 

Six Months Ended March 31,

  2014 2013 

CASH FLOWS FROM OPERATING ACTIVITIES

      

Net earnings

  $7,426  $8,474   $17,726  $18,723 

Non-cash items included in net earnings:

      

Depreciation of property, plant and equipment

   888  815    1,756  1,666 

Amortization of intangible assets

   526  580    1,042  1,165 

Amortization of deferredillumigene instrument costs

   438  381    864  746 

Stock-based compensation

   1,651  1,146    2,157  1,573 

Deferred income taxes

   293  (136   (31 (278

Loss on disposition and write-down of fixed assets and other assets

   —    9    —    10 

Change in current assets

   1,600  5,231    (6,656 477 

Change in current liabilities

   (3,434 150    (3,143 (1,116

Other, net

   (43 (603   (159 (586
  

 

  

 

   

 

  

 

 

Net cash provided by operating activities

   9,345   16,047    13,556   22,380 
  

 

  

 

   

 

  

 

 

CASH FLOWS FROM INVESTING ACTIVITIES

      

Purchases of property, plant and equipment

   (899  (403   (2,573  (1,408

Purchases of intangible assets

   (1,638  —      (1,677  (20
  

 

  

 

   

 

  

 

 

Net cash used for investing activities

   (2,537  (403   (4,250  (1,428
  

 

  

 

   

 

  

 

 

CASH FLOWS FROM FINANCING ACTIVITIES

      

Dividends paid

   (7,875  (15,652   (16,169  (15,652

Proceeds and tax benefits from exercises of stock options

   407   1,390    540   2,055 
  

 

  

 

   

 

  

 

 

Net cash used for financing activities

   (7,468  (14,262   (15,629  (13,597
  

 

  

 

   

 

  

 

 

Effect of Exchange Rate Changes on Cash and Equivalents

   107   174    254   (354
  

 

  

 

   

 

  

 

 

Net Increase (Decrease) in Cash and Equivalents

   (553  1,556 

Net (Decrease) Increase in Cash and Equivalents

   (6,069  7,001 

Cash and Equivalents at Beginning of Period

   44,282   31,593    44,282   31,593 
  

 

  

 

   

 

  

 

 

Cash and Equivalents at End of Period

  $43,729  $33,149   $38,213  $38,594 
  

 

  

 

   

 

  

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

Page 3


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(in thousands)

ASSETS

 

  March 31,   September 30, 
  December 31,   September 30,   2014   2013 
  2013
(Unaudited)
   2013   (Unaudited)   

 

 

CURRENT ASSETS

        

Cash and equivalents

  $43,729   $44,282   $38,213   $44,282 

Accounts receivable, less allowances of $206 and $233

   22,495    26,183    26,799    26,183 

Inventories

   37,674    34,835    38,133    34,835 

Prepaid expenses and other current assets

   3,083    4,643    6,454    4,643 

Deferred income taxes

   4,240    4,145    4,352    4,145 
  

 

   

 

   

 

   

 

 

Total current assets

   111,221    114,088    113,951    114,088 
  

 

   

 

   

 

   

 

 

PROPERTY, PLANT AND EQUIPMENT, at Cost

        

Land

   1,186    1,183    1,186    1,183 

Buildings and improvements

   26,868    26,848    26,900    26,848 

Machinery, equipment and furniture

   38,928    38,502    39,315    38,502 

Construction in progress

   1,027    554    2,190    554 
  

 

   

 

   

 

   

 

 

Subtotal

   68,009    67,087    69,591    67,087 

Less: accumulated depreciation and amortization

   41,886    40,996    42,702    40,996 
  

 

   

 

   

 

   

 

 

Net property, plant and equipment

   26,123    26,091    26,889    26,091 
  

 

   

 

   

 

   

 

 

OTHER ASSETS

        

Goodwill

   23,389    23,115    23,507    23,115 

Other intangible assets, net

   9,279    8,057    8,841    8,057 

Restricted cash

   1,000    1,000    1,000    1,000 

Deferredillumigene instrument costs, net

   2,852    3,270    2,719    3,270 

Deferred income taxes

   679    823    930    823 

Other assets

   316    304    318    304 
  

 

   

 

   

 

   

 

 

Total other assets

   37,515    36,569    37,315    36,569 
  

 

   

 

   

 

   

 

 

TOTAL ASSETS

  $174,859   $176,748   $178,155   $176,748 
  

 

   

 

   

 

   

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

Page 4


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(dollars in thousands)

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

  March 31,   September 30, 
  December 31,   September 30,  2014   2013 
  2013
(Unaudited)
   2013  (Unaudited)   

 

 

CURRENT LIABILITIES

        

Accounts payable

  $5,044   $5,592   $7,829   $5,592 

Accrued employee compensation costs

   4,268    9,670    3,586    9,670 

Other accrued expenses

   5,463    5,462    5,570    5,462 

Income taxes payable

   2,714    979    838    979 
  

 

   

 

   

 

   

 

 

Total current liabilities

   17,489    21,703    17,823    21,703 
  

 

   

 

   

 

   

 

 

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, 41,544,709 and 41,517,839 shares issued, respectively

   —      —   

Common shares, no par value, 71,000,000 shares authorized, 41,555,653 and 41,517,839 shares issued, respectively

   —      —   

Additional paid-in capital

   109,463    107,412    110,082    107,412 

Retained earnings

   46,439    46,888    48,445    46,888 

Accumulated other comprehensive income

   1,468    745    1,805    745 
  

 

   

 

   

 

   

 

 

Total shareholders’ equity

   157,370    155,045    160,332    155,045 
  

 

   

 

   

 

   

 

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

  $174,859   $176,748   $178,155   $176,748 
  

 

   

 

   

 

   

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

Page 5


MERIDIAN BIOSCIENCE, INC. AND SUBSIDIARIES

Condensed Consolidated Statement of Changes in Shareholders’ Equity (Unaudited)

(dollars and shares in thousands)

 

  Common
Shares
Issued
   Additional
Paid-In
Capital
   Retained
Earnings
 Accumulated
Other
Comprehensive
Income (Loss)
   Total
Shareholders’
Equity
   Common
Shares
Issued
   Additional
Paid-In
Capital
   Retained
Earnings
 Accumulated
Other
Comprehensive
Income (Loss)
   Total
Shareholders’
Equity
 

Balance at September 30, 2013

   41,518   $107,412   $46,888  $745   $155,045    41,518   $107,412    $46,888  $745    $155,045 

Cash dividends paid

   —      —      (7,875  —      (7,875   —      —      (16,169  —      (16,169

Exercise of stock options

   26    400    —     —      400    36    513    —     —      513 

Conversion of restricted stock units

   1    —      —     —      —      2     —      —     —      —   

Stock compensation expense

   —      1,651    —     —      1,651    —      2,157    —     —      2,157 

Net earnings

   —      —      7,426   —      7,426    —      —      17,726   —      17,726 

Foreign currency translation adjustment

   —      —      —    723    723    —      —      —    1,060    1,060 
  

 

   

 

   

 

  

 

   

 

   

 

   

 

   

 

  

 

   

 

 

Balance at December 31, 2013

   41,545   $109,463   $46,439  $1,468   $157,370 

Balance at March 31, 2014

   41,556   $110,082    $48,445  $1,805    $160,332 
  

 

   

 

   

 

  

 

   

 

   

 

   

 

   

 

  

 

   

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

Page 6


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,management, the interim financial statements include all normal adjustments and disclosures necessary to present fairly the Company’s financial position as of DecemberMarch 31, 2013,2014, the results of its operations for the three and six month periods ended DecemberMarch 31, 20132014 and 2012,2013, and its cash flows for the threesix month periods ended DecemberMarch 31, 20132014 and 2012.2013. These statements should be read in conjunction with the consolidated financial statements and footnotes thereto included in the Company’s fiscal 2013 Annual Report on Form 10-K. Financial information as of September 30, 2013 has been derived from the Company’s 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 customer. Revenue for the Diagnostics segment is reduced at the date of sale for product price adjustments due certain distributors under local contracts. Management estimates accruals for distributor price adjustments based on local contract terms, sales data provided by distributors, estimates of inventories of our products held by distributors, historical statistics, current trends, and other factors. Changes to the accruals are recorded in the period that they become known. Such accruals were $3,974$4,207 at DecemberMarch 31, 20132014 and $3,866 at September 30, 2013, and have been netted against accounts receivable.

Revenue for our Diagnostics segment includes revenue for ourillumigene®molecular test system. This system includes an instrument, instrument accessories and test kits. In markets where the test system is sold via multiple deliverable arrangements (i.e., the United States, Australia, Belgium, France, Holland and Italy), the cost of the instrument and instrument accessories are deferred upon placement at a customer and amortized on a straight-line basis into cost of sales over the expected utilization period, generally three years.

We evaluate whether each deliverable in the arrangement is a separate unit of accounting. The significant deliverables are an instrument, instrument accessories (e.g., printer) and test kits. An instrument and instrument accessories are delivered to the customer prior to the start of the customer utilization period, in order to accommodate customer set-up and installation. There isde minimis consideration received from the customer at the time of instrument placement. We have determined that the instrument and instrument accessories are not a separate unit of accounting because such equipment can only be used to process and read the results from ourillumigene diagnostic tests (i.e., our instrument and test kits function together to deliver a diagnostic test result), and therefore the instrument and instrument accessories do not have standalone value to the customer. Consequently, there is no revenue allocated to the placement of the instrument and instrument accessories. Test kits are delivered to the customer over the utilization period of the instrument, which we estimate has a useful life of three years. Our average customer contract period, including estimated renewals, is at least equal to the estimated three-year utilization period. Revenue for the sale of test kits is recognized upon shipment and transfer of title to the customers.

 

Page 7


In markets where the test system is not sold via multiple deliverable arrangements (i.e., countries other than the United States, Australia, Belgium, France, Holland and Italy), the cost of the instrument and instrument accessories is charged to cost of sales at the time of shipment and transfer of title to the customer. Revenue for the sales of instruments and instrument accessories and test kits is recognized upon shipment and transfer of title to the customers. In these markets, ourillumigenemolecular test system is sold to independent distributors who inventory the instruments, instrument accessories and test kits for resale to end-users.

Our products are generally not subject to a customer right of return except for product recall events under the rules and regulations of the Food and Drug Administration or equivalent agencies outside the United States. In this circumstance, the costs to replace affected products would be accrued at the time a loss was probable and estimable.

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. Depending on the nature of the arrangement, revenue is recognized as services are performed and billed, upon completion and acceptance by the customer, or 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. No such bill-and-hold arrangements existed at December 31, 2013 or September 30, 2013.

Trade accounts receivable are recorded in the accompanying Condensed Consolidated Balance Sheets at invoiced amounts less provisions for distributor price adjustments under local contracts 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.

 

(b)Comprehensive Income (Loss)

As reflected in the accompanying Condensed Consolidated Statements of Comprehensive Income, our comprehensive income or loss is comprised of net earnings and foreign currency translation.

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, Euro and Singapore dollarnon-functional currencies. These gains and losses are included in other income and expense in the accompanying Condensed Consolidated Statements of Operations.

 

(c)Income Taxes –

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 year’s 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 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.

 

Page 8


In September 2013, the Internal Revenue Service issued Treasury Decision 9636, which enacted final tax regulations regarding the capitalization and expensing of amounts paid to acquire, produce, or improve tangible property. The regulations also include guidance regarding the retirement of depreciable property. The regulations are required to be effective in taxable years beginning on or after January 1, 2014, although taxpayers may choose to apply them in taxable years beginning on or after January 1, 2012. The Company is currently assessing the impact of the final regulations on its financial statements.

 

(d)Stock-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. Awards are expensed over their requisite service periods.

 

(e)Cash and Cash Equivalents –

Cash and cash equivalents include the following components:

 

  December 31, 2013   September 30, 2013   March 31, 2014   September 30, 2013 
  Cash and
Equivalents
   Other   Cash and
Equivalents
   Other   Cash and
Equivalents
   Other   Cash and
Equivalents
   Other 

Overnight repurchase agreements

  $30,107   $—     $32,103   $—     $23,791   $—     $32,103   $—   
                

Cash on hand -

                

Restricted

   —      1,000    —      1,000    —      1,000    —      1,000 

Unrestricted

   13,622    —      12,179    —      14,422    —      12,179    —   
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total

  $43,729   $1,000   $44,282   $1,000   $38,213   $1,000   $44,282   $1,000 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

 

(f)Recent Accounting Pronouncements –

In February 2013, the FASB issued ASU No. 2013-02,Comprehensive Income (Topic 220): Reporting of Amounts Reclassified Out of Accumulated Other Comprehensive Income, to improve the transparency of reporting reclassifications out of accumulated other comprehensive income. Specifically, the new amendments to ASU No. 2013-02 required, depending upon the items being reclassified, the (i) presentation (either on the face of the statement where net income is presented or in the notes) of the effects on the line items of net income of significant amounts reclassified out of accumulated other comprehensive income; and/or (ii) the cross-reference to other disclosures currently required under U.S. GAAP that provide additional detail about such items. These requirements were effective prospectively for the Company beginning October 1, 2013, and their adoption had no impact on the Company’s consolidated results of operations, cash flows or financial position.

Issued but not yet effective accounting pronouncements are not expected to have a material impact on the Company’s Condensed Consolidated Financial Statements.

(g)Reclassifications –

Certain reclassifications have been made to the prior period financial statements to conform to the current fiscal period presentation. Such reclassifications had no impact on net earnings or shareholders’ equity.

 

Page 9


3.Inventories

Inventories are comprised of the following:

 

  December 31,
2013
   September 30,
2013
   March 31,
2014
   September 30,
2013
 

Raw materials

  $7,007   $7,170   $6,591   $7,170 

Work-in-process

   6,943    8,585    5,989    8,585 

Finished goods -illumigene instruments

   2,981    1,980    2,694    1,980 

Finished goods - kits and reagents

   20,743    17,100    22,859    17,100 
  

 

   

 

   

 

   

 

 

Total

  $37,674   $34,835   $38,133   $34,835 
  

 

   

 

   

 

   

 

 

 

Page 9


4.Reportable Segment and Major Customers Information

Meridian was formed in 1976 and functions as a fully-integrated research, development, manufacturing, marketing and sales organization with primary emphasis in the fields of in vitro diagnostics and 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; and (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 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.

In the fourth quarter of fiscal 2013, we aggregated our Diagnostics operating segments into a single reportable segment, thereby resulting in our reportable segments being Diagnostics and Life Science. The prior period information reflected herein has been conformed to the current period presentation.

The Diagnostics segment is headquartered in Cincinnati, Ohio, which also serves as the base of manufacturing operations and research and development. The Diagnostics segment has sales and distribution facilities in the United States, Europe and Australia. The Life Science segment consists of manufacturing operations in Memphis, Tennessee; 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, including a sales and business development location in Singapore. The Life Science 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.

Amounts due from two Diagnostics distributor customers accounted for 14%15% and 17% of consolidated accounts receivable at DecemberMarch 31, 20132014 and September 30, 2013, respectively. Sales toRevenue from these two distributor customers accounted for 38%35% and 47%42% of the Diagnostics segment third-party salesrevenue during the three months ended DecemberMarch 31, 2014 and 2013, respectively, and 2012,36% and 44% during the six months ended March 31, 2014 and 2013, respectively. In addition, approximately $3,100 and $3,500 of our accounts receivable at Decemberboth March 31, 20132014 and September 30, 2013 respectively, is due from Italian hospital customers whose funding ultimately comes from the Italian government, representing 14% and 13% of consolidated accounts receivable in each of the respective periods.

Within our Life Science segment, two diagnostic manufacturing customers accounted for 10%23% and 18% of the segment’s third-party salesrevenue during the three months ended DecemberMarch 31, 2014 and 2013, respectively, and 2012,17% and 18% during the six months ended March 31, 2014 and 2013, respectively.

 

Page 10


Segment information for the interim periods is as follows:

 

  Diagnostics   Life
Science
   Eliminations(1) Total   Diagnostics   Life
Science
   Eliminations(1) Total 

Three Months Ended December 31, 2013

       

Net sales -

       

Three Months Ended March 31, 2014

Three Months Ended March 31, 2014

  

Net revenues -

       

Third-party

  $34,837   $9,957   $—    $44,794   $37,061   $13,073   $—    $50,134 

Inter-segment

   109    259    (368  —      154    225    (379  —   

Operating income

   9,384    2,261    (19 11,626    12,301    3,306    59  15,666 

Goodwill (December 31, 2013)

   1,250    22,139    —    23,389 

Other intangible assets, net (December 31, 2013)

   3,064    6,215    —    9,279 

Total assets (December 31, 2013)

   109,721    111,028    (45,890 174,859 

Three Months Ended December 31, 2012

       

Net sales -

       

Goodwill (March 31, 2014)

   1,250    22,257    —    23,507 

Other intangible assets, net (March 31, 2014)

   2,968    5,873    —    8,841 

Total assets (March 31, 2014)

   111,319    115,444    (48,608 178,155 

Three Months Ended March 31, 2013

       

Net revenues -

       

Third-party

  $35,669   $9,682   $—    $45,351   $36,403   $10,862   $—    $47,265 

Inter-segment

   98    158    (256  —      105    350    (455  —   

Operating income

   11,340    1,634    117  13,091    12,494    3,046    (287 15,253 

Goodwill (September 30, 2013)

   1,250    21,865    —    23,115    1,250    21,865    —    23,115 

Other intangible assets, net (September 30, 2013)

   1,561    6,496    —    8,057    1,561    6,496    —    8,057 

Total assets (September 30, 2013)

   112,054    110,111    (45,417 176,748    112,054    110,111    (45,417 176,748 

Six Months Ended March 31, 2014

       

Net revenues -

       

Third-party

  $71,898   $23,030   $—    $94,928 

Inter-segment

   263    484    (747  —   

Operating income

   21,685    5,567    40  27,292 

Six Months Ended March 31, 2013

       

Net revenues -

       

Third-party

  $72,072   $20,544   $—    $92,616 

Inter-segment

   203    508    (711  —   

Operating income

   23,834    4,680    (170 28,344 

 

(1)Eliminations consist of inter-segment transactions.

Transactions between segments are accounted for at established intercompany prices for internal and management purposes, with all intercompany amounts eliminated in consolidation.

 

Page 11


5.Intangible Assets

A summary of our acquired intangible assets subject to amortization, as of DecemberMarch 31, 20132014 and September 30, 2013 is as follows:

 

  December 31, 2013   September 30, 2013   March 31, 2014   September 30, 2013 
  Gross
Carrying
Value
   Accumulated
Amortization
   Gross
Carrying
Value
   Accumulated
Amortization
   Gross
Carrying
Value
   Accumulated
Amortization
   Gross
Carrying
Value
   Accumulated
Amortization
 

Manufacturing technologies, core products and cell lines

  $11,709   $10,254   $11,676   $10,097   $11,723   $10,375   $11,676   $10,097 

Trademarks, licenses and patents

   6,430    2,300    4,748    2,130    6,474    2,481    4,748    2,130 

Customer lists and supply agreements

   12,442    8,748    12,353    8,493    12,481    8,981    12,353    8,493 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 
  $30,581   $21,302   $28,777   $20,720   $30,678   $21,837   $28,777   $20,720 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

During the first quarter of fiscal 2014, we acquired the remaining licensing rights related to ourillumigenemolecular technology for $1,638. These rights will beare being amortized over a weighted average period of approximately 8.5 years.

The actual aggregate amortization expense for these intangible assets was $526$516 and $580$585 for the three months ended DecemberMarch 31, 2014 and 2013, respectively, and 2012,$1,042 and $1,165 for the six months ended March 31, 2014 and 2013, respectively. The estimated aggregate amortization expense for these intangible assets for each of the fiscal years through fiscal 2019 is as follows: remainder of fiscal 2014 – $1,474,$967, fiscal 2015 – $1,767,$1,777, fiscal 2016 – $1,422,$1,432, fiscal 2017 – $1,156,$1,163, fiscal 2018 – $1,132$1,140 and fiscal 2019 – $1,092.

$1,099.

 

Page 11


ITEM 2.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Refer to “Forward Looking Statements” following the Table of Contents in front of this Form 10-Q. In the discussion that follows, all dollar amounts are in thousands (both tables and text), except per share data.

Following is a discussion and analysis of the financial statements and other statistical data that management believes will enhance the understanding of Meridian’s financial condition, changes in financial condition and results of operations. This discussion should be read in conjunction with the financial statements and notes thereto beginning on page 1.

Results of Operations

Three Months Ended March 31, 2014

Net earnings for the firstsecond quarter of fiscal 2014 decreased 12%increased less than 1% to $7,426,$10,300, or $0.18$0.24 per diluted share, from net earnings for the firstsecond quarter of fiscal 2013 of $8,474,$10,249, or $0.20$0.24 per diluted share. This increase reflects the combined effects of increased revenues, slightly decreased gross profit margins and modestly increased operating expenses. Consolidated revenues increased 6% to $50,134 for the second quarter of fiscal 2014 compared to the same period of the prior year.

Included within the second quarter 2014 results were revenues from ourillumigene®molecular platform of products totaling $9,853, representing a 23% increase over the fiscal 2013 second quarter. Also contributing to the consolidated revenue increase were increased revenues in ourH. pylori focus product family, as well as in both of our Life Science segment’s product lines (i.e., molecular component and immunoassay component). Serving to partially offset these revenue increases were decreased revenues in our largest diagnostic focus product family (C. difficile) and our respiratory product family.

Page 12


Revenues for the Diagnostics segment for the second quarter of fiscal 2014 increased 2% compared to the second quarter of fiscal 2013, reflecting the following for each of our focus product families: 6% decline in ourC. difficile products, 11% growth in ourH. pylori products, and 1% growth in our foodborne products. In addition, we experienced an 8% decline in revenues from our respiratory products, which include both molecular and immunoassay products, compared to the prior year fiscal second quarter. With 15% growth in its molecular component product sales and 24% growth in its immunoassay component product sales, revenues from our Life Science segment increased by 20% during the second quarter of fiscal 2014 compared to the second quarter of fiscal 2013, reflecting the effect of shipping certain orders during the fiscal 2014 second quarter that were delayed from the fiscal 2014 first quarter.

Six Months Ended March 31, 2014

For the six month period ended March 31, 2014, net earnings decreased 5% to $17,726, or $0.42 per diluted share, from net earnings for the comparable fiscal 2013 period of $18,723, or $0.45 per diluted share. This decrease reflects the combined effects of decreased sales,increased revenues, slightly decreased gross profit margins and modestly increased operating expenses, along with thea $450 (pre-tax) negative effect of $400 (pre-tax) offrom medical device tax that did not exist during the first quarter of fiscal 2013 (see discussion in Medical Device Tax below). Consolidated sales decreased 1%revenues increased 2% to $44,794$94,928 for the first quartersix months of fiscal 2014 compared to the same period of the prior fiscal year. Contributing

Included within the six month year-to-date fiscal 2014 results were revenues from ourillumigene molecular platform of products totaling $18,348, representing a 19% increase over the first six months of fiscal 2013. Also contributing to this decreasethe consolidated revenue increase were increased revenues in ourH. pylori focus product family, as well as in both of our Life Science segment’s business lines (i.e., molecular component and immunoassay component). Serving to substantially offset these revenue increases were decreased salesrevenues in our largest diagnostic focus product family (C. difficile), and our respiratory product family and our Life Science segment’s immunoassay component business. Serving to partially offset these sales decreases were increased sales in ourH. pylori focus product family, as well as our Life Science segment’s molecular component business. Included withinfamily.

During the first quartersix months of fiscal 2014, results were sales of ourillumigene®molecular platform of products totaling $8,495, representing a 15% increase over the fiscal 2013 first quarter.

Salesrevenues for the Diagnostics segment fordecreased less than 1% from the first quarter ofcomparable fiscal 2014 decreased 2% compared to the first quarter of fiscal 2013 period, reflecting the following for each of our focus product families: 11%8% decline in ourC. difficile products, 8%10% growth in ourH. pylori products, and 1% growth in our foodborne products. In addition, we experienced a 19%13% decline in sales ofrevenues from our respiratory products compared tofrom the prior yearcomparable fiscal first quarter.2013 period. With 16% growth in its molecular component business being partially offset by a 7% declineproduct sales and 10% growth in its immunoassay component businesses,product sales, ofrevenues from our Life Science segment increased by 3%12% during the first quarter ofsix months ended March 31, 2014 over the comparable fiscal 2014 compared to the first quarter of fiscal 2013.2013 period.

REVENUE OVERVIEW

Below are analyses of the Company’s revenue, provided for each of the following:

- By Reportable Segment & Geographic Region

- By Product Platform/Type

- By Disease Family (Diagnostics only)

Revenue Overview- By Reportable Segment & Geographic Region

Our reportable segments are Diagnostics and Life Science. The Diagnostics segment is headquartered in Cincinnati, Ohio, which also serves as the base of manufacturing operations and research and development. The Diagnostics segment sells diagnostic test kits in the U.S. and Canada (“North America”); Europe, Middle East and Africa (“EMEA”); and other countries outside of North America and EMEA (rest of the world, or “ROW”). The Life Science segment consists of manufacturing operations in Memphis, Tennessee; 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, including a sales and business development location in Singapore. The Life Science 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.

Page 13


Revenues for the Diagnostics segment, 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 segment, in the normal course of business, may be affected from quarter to

Page 12


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, and foreign currency exchange rates. We believe that the overall breadth of our product lines serves to reduce the variability in consolidated revenues.

 

  Three Months Ended December 31,   Three Months Ended March 31, Six Months Ended March 31, 
  2013 2012 Inc(Dec)   2014 2013 Inc (Dec) 2014 2013 Inc (Dec) 

Diagnostics -

           

North America

  $27,943  $28,814  (3)%   $29,952  $28,882  4 $57,895  $57,696  —  

EMEA

   5,373  5,129  5   5,919  5,958  (1)%  11,292  11,087  

ROW

   1,521  1,726  (12)%    1,190  1,563  (24)%  2,711  3,289  (18)% 
  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

Total Diagnostics

   34,837   35,669   (2)%    37,061   36,403   2  71,898   72,072   —  
  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

Life Science -

           

North America

   4,306   4,251   1   5,023   4,311   17  9,329   8,562   9

EMEA

   3,810   4,126   (8)%    6,199   4,471   39  10,009   8,597   16

ROW

   1,841   1,305   41   1,851   2,080   (11)%   3,692   3,385   9
  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

Total Life Science

   9,957   9,682   3   13,073   10,862   20  23,030   20,544   12
  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

Consolidated

  $44,794  $45,351   (1)%   $50,134  $47,265   6 $94,928  $92,616   2
  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

% of total sales -

    

% of total revenues -

       

Diagnostics

   78  79    74  77   76  78 

Life Science

   22  21    26  23   24  22 
  

 

  

 

    

 

  

 

   

 

  

 

  

Total

   100  100    100  100   100  100 
  

 

  

 

    

 

  

 

   

 

  

 

  

Ex-North America

   28  27    30  30   29  28 
  

 

  

 

    

 

  

 

   

 

  

 

  

Revenue Overview- By Product Platform/Type

The revenues generated by each of our reportable segments result primarily from the sale of the following segment-specific categories of products:

Diagnostics

 

 1)Molecular tests that operate on ourillumigene platform

 

 2)Immunoassay tests

Life Science

 

 1)Molecular components

 

 2)Immunoassay components

Page 14


Revenue for each product platform/type, as well as its relative percentage of segment revenue, is shown below.

 

   Three Months Ended December 31, 
   2013   2012   Inc(Dec) 

Diagnostics -

      

Molecular

  $8,495   $7,394    15

Immunoassay

   26,342    28,275    (7)% 
  

 

 

   

 

 

   

 

 

 

Total Diagnostics

  $34,837   $35,669    (2)% 
  

 

 

   

 

 

   

 

 

 

Life Science -

      

Molecular components

  $4,870   $4,196    16

Immunoassay components

   5,087    5,486    (7)% 
  

 

 

   

 

 

   

 

 

 

Total Life Science

  $9,957   $9,682    3
  

 

 

   

 

 

   

 

 

 

Page 13


% of Diagnostics sales -

    
  Three Months Ended March 31, Six Months Ended March 31, 
  2014 2013 Inc (Dec) 2014 2013 Inc (Dec) 

Diagnostics -

       

Molecular

   24  21   $9,853  $8,033  23 $18,348  $15,427  19

Immunoassay

   76  79    27,208  28,370  (4)%  53,550  56,645  (5)% 
  

 

  

 

    

 

  

 

  

 

  

 

  

 

  

 

 

Total Diagnostics

   100  100   $37,061  $36,403   2 $71,898  $72,072   —  
  

 

  

 

    

 

  

 

  

 

  

 

  

 

  

 

 

% of Life Science sales -

    

Life Science -

       

Molecular components

   49  43   $5,023  $4,369   15 $9,893  $8,565   16

Immunoassay components

   51  57    8,050   6,493   24  13,137   11,979   10
  

 

  

 

    

 

  

 

  

 

  

 

  

 

  

 

 

Total Life Science

   100  100   $13,073  $10,862   20 $23,030  $20,544   12
  

 

  

 

    

 

  

 

  

 

  

 

  

 

  

 

 

% of Diagnostics revenues -

       

Molecular

   27  22   26  21 

Immunoassay

   73  78   74  79 
  

 

  

 

   

 

  

 

  

Total Diagnostics

   100  100   100  100 
  

 

  

 

   

 

  

 

  

% of Life Science revenues -

       

Molecular components

   38  40   43  42 

Immunoassay components

   62  60   57  58 
  

 

  

 

   

 

  

 

  

Total Life Science

   100  100   100  100 
  

 

  

 

   

 

  

 

  

Following is a discussion of the revenues generated by each of these product platforms/types:

Diagnostics Products

illumigene Molecular Platform Products

We have just over 1,2001,235 customer account placements. Of these account placements, over 1,000just under 1,100 accounts have completed evaluations and validations and are regularly purchasing product, with the balance of our account placements being in some stage of product evaluation and/or validation. Of our account placements, we have over 200approximately 250 accounts that are regularly purchasing, evaluating and/or validating two or more assays. Upon receiving FDA clearance on March 25, 2014, we launched ourBordetella pertussis molecular diagnostic test in early April – the most recent test available on ourillumigene molecular testing platform.

We continue to invest in new product development for our molecular testing platform,illumigene. This molecular testing platform, and with the launch of theBordetella pertussis test, now has fourhave five commercialized tests with oneon the platform and three additional testtests expected to be available for sale later in fiscal 2014 and three additional tests in fiscal 2015:

 

 1.illumigene® C. difficile – commercialized in August 2010

 

 2.illumigene® Group BStreptococcus (Group B Strep or GBS) – commercialized in December 2011

 

 3.illumigene® Group AStreptococcus (Group A Strep) – commercialized in September 2012

 

 4.illumigene® Mycoplasma ((M.M. pneumonia; walking pneumonia) – commercialized in June 2013

 

 5.illumigene®Bordetella pertussis (whooping cough) – expected fiscalcommercialized in March 2014

 

 6.illumigene®Chlamydia trachomatis – expected fiscal 2015

 

 7.illumigene®Neisseria gonorrhea – expected fiscal 2015

 

 8.illumigene® Herpes Simplex Virus I & II – expected fiscal 2015

Additionalillumigene tests in early-stage research or development include enteric parasites such as Giardia, foodborne pathogens such asE. coli, and bloodborne pathogens such as malaria.

Page 15


We believe that the diagnostic testing market is continuing to move away from culture and immunoassay testing to molecular testing for diseases where there is a favorable cost/benefit position for the total cost of healthcare. While this market is competitive, with molecular companies such as Cepheid and Becton Dickinson and new entrants such as Quidel, Great Basin, Nanosphere, and others, we believe we are well positioned to capitalize on the migration to molecular testing. Our simple, easy-to-use,illumigene platform, with its expanding menu, requires no expensive equipment purchase and little to no maintenance cost. These features, along with its small footprint and the performance of theillumigene assays, makeillumigene an attractive molecular platform to any size hospital.

Immunoassay Products

Sales ofRevenues from our DiagnosticDiagnostics segment’s immunoassay products decreased 7%4% in the firstsecond quarter of fiscal 2014. This current quarter decrease results2014 and decreased 5% on a six month, year-to-date basis. These decreases result primarily from the decline in sales ofrevenues from ourC. difficile and respiratory products, partially offset by the revenue growth of ourH. pylori products, as described below.

Life Science Products

During the firstsecond quarter of fiscal 2014, sales ofrevenues from our Life Science segment increased 3%20%, with sales of ourrevenues from molecular component businesssales increasing 16%15% over the comparable fiscal 2013 quarter and sales of ourrevenues from immunoassay component business decreasing 7%sales increasing 24%. For the first six months of fiscal 2014, revenues from our Life Science segment increased 12%, with revenues from molecular component sales increasing 16% over the comparable prior year period and revenues from immunoassay component sales increasing 10%. Our molecular component business continuesrevenues continue to benefit from new product launches and advancements – most notably SensiFAST™ and MyTaq™ PCR components. The firstfiscal 2014 second quarter salesrevenue level of our bulk immunoassay component business reflects the effect of shipping certain customer shipments beingorders during the quarter that were delayed untilfrom the fiscal 2014 second quarter.first quarter, which totaled approximately $1,100.

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Diagnostic Revenue Overview- By Disease Family

SalesRevenues from our focus families (C. difficile, foodborne andH. pylori) comprised 60%59% of our Diagnostics segment’s revenue during each ofboth the firstsecond quarter of fiscal 2014 and 2013.first six months of the fiscal year, compared to 60% during both of the corresponding fiscal 2013 periods. Following is a discussion of the revenues generated by each product family:

C. difficile Products

During the fiscal 2014 first quarterRevenues for ourC. difficile product family sales totaled $8,600, representing a decline of 11% fromdeclined 6% to $9,300 for the firstfiscal 2014 second quarter, of fiscal 2013. Dueand declined 8% to factors including reduced hospital admissions and decliningC. difficile incidence rates in hospitals putting further pressure on an already competitive market, sales decreases were experienced in both$17,900 for the six month, year-to-date period. Revenues for ourillumigene C. difficile product which represents approximately 75% of totalC. difficileincreased 3% and were flat during the three and six month periods ended March 31, 2014, respectively, while revenues andfor our immunoassayC. difficile product. While the products declined as expected. TheC. difficile market continueshas become highly competitive, with over 10 suppliers in the United States. Certain of these suppliers choose to be highly competitive,compete solely on price. We believe that two factors will help us respond to these challenging market conditions. First, our marketing programs emphasize that we are the only company that can offer a full range of high performing, FDA cleared,C. difficile testing formats, including toxin, GDH and molecular tests. Second, ourillumigene molecular platform, with its expanding menu, requires no expensive equipment purchase or maintenance contract, which makes it an attractive and affordable option for any size hospital.

Foodborne Products

With first quarterRevenues for our foodborne products (Enterohemorrhagic E. coli(“EHEC”) andCampylobacter), all of which are immunoassay products, grew to $5,400 during the fiscal 2014 sales totaling $5,700,second quarter, or 1% growth over the fiscal 2013 first quarter, we continue to see demand for our foodborne products, allsecond quarter; $11,100 of whichrevenues, or 1% year over year growth, during the six months ended March 31, 2014. We are immunoassay products. Despitedisappointed in these sales results reflecting the negative impact of buying patterns for these products, laboratories continue to realizegrowth rates and have re-emphasized the benefits of increased sensitivity and faster turnaround time withversus culture methods in our fully CDC compliant rapid immunoassay tests for Enterohemorrhagic E. coli(EHEC) andCampylobacter, compared to traditional culture methods.marketing programs. While historically the primary competition for our foodborne products has been laboratory culture methods, during 2012 one of our competitors Alere, cleared through the FDA a shiga toxin test that competes with our EHEC test. We believe that our products have two principal advantages versus culture methods: (i) test accuracy;offers better workflow, less hands-on time and (ii) improved work flow, resultingquicker results, in a significantly shortened timeaddition to test result (20 minutes vs. 24-48 hours for culture).being fully CDC-compliant.

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H. pylori Products

During the second quarter of fiscal 2014, first quarter, sales ofrevenues from ourH. pylori products, all of which are immunoassay products, grew 8%11% to $6,500. This increase continues$7,100; and grew 10% to $13,600 during the first six months of fiscal 2014. These increases continue 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. A significant amount of theH. pylori product salesrevenues are to reference labs, whose buying patterns may not be consistent period to period.

Respiratory Products

Total respiratory sales forrevenues from our Diagnostics segment decreased 19%8% to $4,800$5,300 during the fiscal 2014 first quarter.second quarter; and decreased 13% to $10,100 for the six month year-to-date period. Contributing to this decreased revenue volume were decreased sales ofdouble digit revenue decreases from influenza products, reflecting the relative late start of this year’swhich reflect a weak influenza season, compared to last year’s.coupled with a crowded influenza test market. Partially offsetting the impact of lower influenza product salesrevenues was growth in ourillumigene Group A Strep andillumigene Mycoplasma products, which received FDA approval in September 2012 and June 2013, respectively.

Foreign Currency

During the firstsecond quarter of fiscal 2014, currency exchange rates had a $150$200 favorable impact on revenue; $200$150 favorable within the Diagnostics segment and $50 unfavorablefavorable in the Life Science segment. On a six month year-to-date basis, currency exchange rates had a $350 favorable impact on revenue, all of which was within the Diagnostics segment.

Significant Customers

Two U.S. distributors accounted for 38%35% and 47%42% of our Diagnostics segment’s total salesrevenues for firstthe second quarter of fiscal 2014 and 2013, respectively, and 36% and 44% during the six months ended March 31, 2014 and 2013, respectively. These salesrevenues represented 29%26% and 37%32% of consolidated salesrevenues for the fiscal 2014 and 2013 firstsecond quarters, respectively.respectively, and 27% and 34% for the respective year-to-date six month periods.

Within our Life Science segment, two diagnostic manufacturing customers accounted for 10%23% and 18% of the segment’s total salesrevenues for the firstsecond quarter of fiscal 2014 and 2013, respectively, and 17% and 18% during the six months ended March 31, 2014 and 2013, respectively.

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Medical Device Tax

On January 1, 2013, the medical device tax established as part of the U.S. healthcare reform legislation became effective, and as a result, the Company made its first required tax deposit near the end of January 2013. During the first quarter of fiscal 2014, theThe Company recorded approximately $400$450 of medical device tax expense during each of the fiscal 2014 and 2013 second quarters, which is reflected as a component of cost of sales in the accompanying Condensed Consolidated Statements of Operations. During the six month periods ended March 31, 2014 and 2013, medical device tax expense totaling approximately $900 and $450, respectively, was recorded.

Gross Profit

 

  Three Months Ended December 31,   Three Months Ended March 31, Six Months Ended March 31, 
  2013 2012 Change   2014 2013 Change 2014 2013 Change 

Gross Profit

  $28,007  $28,796   (3)%   $31,593  $30,743  3 $59,600  $59,539  —  

Gross Profit Margin

   63 64  -1point     63 65  -2 points   63 64  -1 point  
  

 

  

 

  

 

   

 

  

 

  

 

  

 

  

 

  

 

 

The overall slight gross profit margin decrease for the three and six months ended DecemberMarch 31, 20132014 primarily results from the combined effects of (i) mix of salesrevenues from the Company’s segments; (ii) mix of products sold; and for the six month period only (iii) the medical device tax, which did not exist during the first quarter of fiscal 2013 (see discussion in Medical Device Tax above).

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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, PCR/qPCR reagents, nucleotides, competent cells, proficiency panels, and contract research and development, and contract manufacturing services. Product salesrevenue mix shifts, in the normal course of business, can cause the consolidated gross profit margin to fluctuate by several points.

Operating Expenses

 

  Three Months Ended December 31, 2013   Three Months Ended March 31, 2014 
  Research &
Development
 ��Selling &
Marketing
 General &
Administrative
 Total Operating
Expenses
   Research &
Development
 Selling &
Marketing
 General &
Administrative
 Total Operating
Expenses
 

2013 Expenses

  $2,517  $5,693  $7,495  $15,705   $2,811  $5,471  $7,208  $15,490 
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

% of Sales

   6  13  17  35

% of Revenues

   6  12  15  33

Fiscal 2014 Increases (Decreases):

          

Diagnostics

   281   219   247   747    434   664   (710  388 

Life Science

   55   66   (192  (71   (59  326   (218  49 
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

2014 Expenses

  $2,853  $5,978  $7,550  $16,381   $3,186  $6,461  $6,280  $15,927 
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

% of Sales

   6  13  17  37

% of Revenues

   6  13  13  32

% Increase (Decrease)

   13  5  1  4   13  18  (13)%   3
  Six Months Ended March 31, 2014 
  Research &
Development
 Selling &
Marketing
 General &
Administrative
 Total Operating
Expenses
 

2013 Expenses

  $5,328  $11,164  $14,703  $31,195 
  

 

  

 

  

 

  

 

 

% of Revenues

   6  12  16  34

Fiscal 2014 Increases (Decreases):

     

Diagnostics

   715   883   (463  1,135 

Life Science

   (4  491   (509  (22
  

 

  

 

  

 

  

 

 

2014 Expenses

  $6,039  $12,538  $13,731  $32,308 
  

 

  

 

  

 

  

 

 

% of Revenues

   6  13  14  34

% Increase (Decrease)

   13  12  (7)%   4

Overall, total operating expense increased during both the second quarter and first quartersix months of fiscal 2014 relative to the comparable prior fiscal year quarter andperiods, decreasing slightly as a percentage of quarterly consolidated sales. The increase resultsrevenues and remaining a consistent percentage of revenues on a year-to-date basis. These levels of operating expenses result in large part from the combined effects of our (i) ongoing efforts to control spending in each of our segments while investing the necessary resources in our strategic areas of growth, including increased investment in Research & Development for our molecular platform products; and (ii) overall decreased incentive compensation expense in light of the decline in corporate-wide operating profits. We expect to continue to have higher levels of Research & Development spending during the remainder of fiscal 2014 related to clinical trials for ourillumigene Chlamydia trachomatis andNeisseria gonorrhea products.

 

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Operating expenses for the Diagnostics segment increased $747$388 for the firstsecond quarter of fiscal 2014 compared to the fiscal 2013 second quarter, and in the first quarter.six months of fiscal 2014, increased $1,135 over the comparable prior year period. These overall increases result largely from the combined effects of (i) currency exchange rates (increases of $50 and $100 for the quarter and year-to-date, respectively); and (ii) the following:

Research & Development

Overall increase in spending on new product development activities, related primarily to the previously noted products for ourillumigene molecular platform, as well as immunoassay products in development.

Selling & Marketing

Addition of field sales force personnel, including the filling of open territorial positions, since the prior year quarter, resulting in an approximate $200$400 increase in personnel-related expenses.expenses on a quarterly basis ($600 on a year-to-date basis), along with increased product sample expense of approximately $150 both quarterly and year-to-date.

General & Administrative

An approximate $500 increase in stock-based compensation during the first quarter of fiscal 2014, along with other less significant general operating expense increases, partially offset by aA decrease in bonus and profit sharing expenses as a result of the previously noted year-to-date decline in corporate-wide operating profits.profits, partially offset by an approximate $100 and $600 increase in stock-based compensation during the second quarter and first six months of fiscal 2014, respectively, and other less significant general operating expense increases.

Operating expenses for the Life Science segment increased $49 and decreased $71$22 for the second quarter and first quartersix months of fiscal 2014, compared to the fiscal 2013 first quarter.respectively. This activity reflects in large part the net effects of (i) currency exchange rates (decreases of $10 and $50 for the quarter and year-to-date, respectively); (ii) ongoing increased sales and marketing investments; and (iii) decreased bonus expenses resulting from the decline in corporate-wide operating profits.

Operating Income

Operating income increased 3% to $15,666 for the second quarter of fiscal 2014, and decreased 11%4% to $11,626$27,292 for the first quartersix months of fiscal 2014, as a result of the factors discussed above.

Income Taxes

The effective rate for income taxes was 34% for the second quarters of both fiscal 2014 and fiscal 2013, and 34% and 35% for the first quarter of fiscalsix month year-to-date periods ended March 31, 2014 and 36% for the first quarter of fiscal 2013.2013, respectively. For the fiscal year ending September 30, 2014, we expect the effective tax rate to approximate 34%-35%.

In September 2013, the Internal Revenue Service issued Treasury Decision 9636, which enacted final tax regulations regarding the capitalization and expensing of amounts paid to acquire, produce, or improve tangible property. The regulations also include guidance regarding the retirement of depreciable property. The regulations are required to be effective in taxable years beginning on or after January 1, 2014, although taxpayers may choose to apply them in taxable years beginning on or after January 1, 2012. The Company is currently assessing the impact of the final regulations on its financial statements.

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 consists of overnight repurchase agreements.

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 policy’s 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.

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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, although no assurances can be made in this regard. We intend to continue to fund our working capital requirements and dividends from current cash flows from operating activities and cash on hand. If needed, we also have an additional source of liquidity through our

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$30,000 $30,000 bank credit facility. Approximately $3,100$3,500 of our accounts receivable at DecemberMarch 31, 20132014 is due from Italian hospital customers whose funding ultimately comes from the Italian government, an amount which is down from approximately $3,500consistent with the balance due on such accounts at September 30, 2013. Our liquidity needs may change if overall economic conditions worsenchange and/or liquidity and credit within the financial markets remains tighttightens 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 decreased 42%39% for the first quartersix months of fiscal 2014 to $9,345,$13,556, reflecting the 12%5% decrease in net earnings, along with the effects of the payment of incentive bonus payments related to fiscal 2013, the timing of federal income tax payments, inventory purchases, and the timing of payments from and to customers and suppliers, respectively. Net cash flows from operating activities and cash on hand 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 that expires on September 15, 2015. As of January 31,April 30, 2014, 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 threesix months of fiscal 2014 or during the full year of fiscal 2013.

Our capital expenditures are estimated to range between approximately $7,500$5,000 to $9,000$7,000 for fiscal 2014, with the actual amount depending upon actual operating results and the phasing of certain projects. Such expenditures may be funded with cash and equivalents on hand, operating cash flows, and/or availability under the $30,000 credit facility discussed above. This range of capital expenditures includes approximately $4,000 related to an expansion of our molecular diagnostic manufacturing capacity in Cincinnati, Ohio.

We do not utilize any special-purpose financing vehicles or have any undisclosed off-balance sheet arrangements.

 

ITEM 3.QUANTITATIVE AND QUALITATIVEDISCLOSURESQUALITATIVE DISCLOSURES ABOUT MARKET RISK

There have been no material changes in the Company’s exposure to market risk since September 30, 2013.

 

ITEM 4.CONTROLS AND PROCEDURES

As of DecemberMarch 31, 2013,2014, 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 DecemberMarch 31, 2013.2014. 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 firstsecond 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 DecemberMarch 31, 2013.2014.

 

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PART II. OTHER INFORMATION

 

ITEM 1A.RISK FACTORS

There have been no material changes from risk factors as previously disclosed in the Registrant’s Form 10-K in response to Item 1A to Part I of Form 10-K.

 

ITEM 6.EXHIBITS

The following exhibits are being filed or furnished as a part of this Quarterly Report on Form 10-Q.

 

31.1Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rule 13a-14(a)/15d-14(a)

 

31.2Certification of Principal Financial Officer Pursuant to Securities Exchange Act Rule 13a-14(a)/15d-14(a)

 

32Certification 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

 

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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 10,May 12, 2014  By: 

/s/ Melissa A. Lueke

   Melissa A. Lueke
   

Executive Vice President and

Chief Financial Officer

(Principal Financial and Accounting Officer)

 

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